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Introduction Parents of hospitalized children with chronic illness (HCCI) during the COVID-19 epidemic may face huge pressure and worry, leading to mental health issues. Parent’s depression and anxiety disorders increase the risk of mental health problems in the child and affect his/her recovery. Objectives The aim of this study was to assess the prevalence rate of depressive and anxiety symptoms among a pilot sample of parents of HCCI (in- and out-patients) with diagnosis of epilepsy (9), cystic fibrosis (8) and congenital heart anomalies (6) during COVID-19 pandemic. Pediatric patients were under a regular Children Hospital medical and psychological follow-up program. Methods We conducted a cross-sectional study among 23 Italian parents (15 F; 8 M) of HCCI during the COVID-19 epidemic period. We performed face-to face interviews and assessed depressive and anxiety symptoms with the Patient Health Questionnaire (PHQ-9) and the Generalized Anxiety Disorders (GAD-7) questionnaire during scheduled follow up visits. Results The anxiety score of parents of HCCI was 4.43 ± 3.17, of which 39.1% of parents were anxious (≥5 points), while the depression score was 4.04 ± 2.67, of which 30.4% of parents show depressive symptoms (≥5 points). The prevalence of comorbid depressive and anxiety symptoms was 26.1% among the entire sample. Conclusions Preliminary data of our pilot study showed a high prevalence of anxious depressive symptoms and comorbidity among parents of HCCI. Timely provision of psychologic interventions are needed during and after COVID-19 pandemic in order to empower parenting and promote children recovery and quality of life. Disclosure No significant relationships.

Background: Italy initiated elexacaftor/tezacaftor/ivacaftor (ETI) for people with cystic fibrosis (pwCF) in July 2021. It has led to dramatic improvements in lung function, BMI, sweat chloride, and respiratory symptoms. However, few data are available on side effects or effects on a broad range of outcomes., Research Question: How does ETI affect mental health, cognitive processing, neuropsychological side effects, GI symptoms, and health-related quality of life over time?, Study Design and Methods: This was a prospective, "real-world" longitudinal study. Participants were recruited consecutively and evaluated at initiation (T0) and after 1 month, 3 months, and 6 months of starting treatment. Assessments included depression (nine-item Patient Health Questionnaire), anxiety (seven-item Generalized Anxiety Disorder), cognition (Symbol Digit Modalities Test), GI Symptom Tracker, and health-related quality of life (Cystic Fibrosis Questionnaire-Revised). Based on literature, an ad hoc questionnaire was developed to assess side effects: insomnia, headache, memory problems, "brain fog," and concentration problems. Following descriptive analyses, longitudinal data were analyzed by using mixed models for repeated measures, controlling for age and sex when appropriate., Results: Ninety-two consecutive pwCF (female/male, 46/46; mean age, 25.4 years) participated. FEV 1 increased initially and then remained stable. BMI also increased significantly from T0 to 6 months (P < .01). Depression improved from T0 to 1 month (P < .001); however, no changes in anxiety were found. Cognitive processing improved from T0 to subsequent assessments. Positive changes were reported on the GI Symptom Tracker for stools and adherence challenges, although no changes were found for abdominal pain and digestion. Side effects occurred in 10% to 29%, with no reduction over time; insomnia increased significantly across time. Female participants reported more side effects than male participants (ie, insomnia, headache, concentration problems, brain fog)., Interpretation: This prospective study evaluated the effects of ETI using multiple measures. Significant improvements were found in many domains; however, side effects were reported by a substantial proportion of pwCF, with no improvements over time. Female participants reported more side effects than male participants. pwCF should be followed up systematically to assess the frequency of side effects after starting this new modulator., Competing Interests: Financial/Nonfinancial Disclosures The authors have reported to CHEST the following: S. G. has received consulting fees from Vertex Pharmaceuticals. A. Q. has received consulting fees from Vertex Pharmaceuticals. F. Majo has received consulting fees from Vertex Pharmaceuticals. None declared (F. B., G. R. P., F. Milo, L. C., E. M., F. A., S. B., R. C., A. G. F., P. T.)., (Copyright © 2023 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.)

Background and Aim: Parental self-efficacy is recognized as a core element of the transition to parenthood process. It affects parental mental health, as well as children's psychosocial, neurodevelopmental and health outcomes since early infancy. Parents with higher parenting self-efficacy have a higher likelihood of engaging in quality parenting practices that support optimal self-regulation development in children. Our study evaluated the psychometric properties of the Italian TOPSE-Short Form (I-TOPSE-SF) questionnaire., Methods: 673 Italian mothers (Mage=37.5; SD=5.7) of children aging 0 to 6 years (Mage=3.9; SD=1.7) were involved in this study., Results: Initial results of Confirmatory Factor Analysis highlighted that the fit indices of the hypothesized 6-factor structure of the TOPSE weren't satisfactory. Acceptable internal consistencies for the total score and the six dimensions of the measure were observed. Evidence for convergent and divergent validity were provided., Conclusions: The I-TOPSE-SF could be a valuable tool to assess parental self-efficacy up to school age, but it is in need of further considerations about its measurement properties.

Introduction: Individuals with chronic respiratory diseases and caregivers are at higher risk for depression and anxiety. Primary ciliary dyskinesia (PCD) and cystic fibrosis (CF) are both rare genetic diseases, characterized by recurrent respiratory infections. This study compared depression and anxiety in people with PCD (pwPCD) and CF (pwCF), and caregivers, using the screening tools recommended in the CF guidelines., Methods: Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder (GAD-7) were administered to a PCD and CF sample. Given that PCD is extremely rare, they were matched on age and sex to pwCF at a 1:2 ratio. Similar procedures were performed with parents., Results: A total of 63 patients and 129 caregivers participated: 21 pwPCD and 42 pwCF (ages 12-34 years) plus 43 caregivers of pwPCD and 86 caregivers of pwCF. A high percentage of patients scored above the cut-off for depression (PCD: 33%; CF: 43%) and anxiety (PCD and CF both: 43%), mostly mild. Similarly, a high percentage of caregivers scored above the cut-off for depression (PCD: 42-54%; CF: 45-46%) and anxiety (PCD: 47-54%; CF: 39-56%). Suicidal ideation was endorsed by 9.5% of pwPCD, 20% of mothers and 10% of fathers and 5% of pwCF, 3% of mothers, but no fathers., Conclusion: A large percentage of patients and caregivers reported elevated psychological distress and suicidal ideation. Addressing psychological symptoms is critical given they are associated with poor adherence, missed clinic visits, increased inflammation and worse quality of life. Mental health screening and treatment should be integrated into PCD care., Competing Interests: Declaration of competing interest There are no conflicts of interest., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Background: The spread of COVID-19 was associated with increased stress and new mental health concerns for people with cystic fibrosis (pwCF), already at increased risk for depression and anxiety. This study assessed stress and mental health in adolescents and young adults with CF 1 year from when the pandemic began., Methods: Sixty-six pwCF (mean age = 24; range 14-36) completed a new measure of the impact of COVID-19 (COVID-19 Exposure and Family Impact Scale-Adolescence and Young Adult; CEFIS-AYA); the Patient Health Questionnaire-9, and the Generalized Anxiety Disorder-7. The Italian translation of the CEFIS-AYA was performed., Results: On the CEFIS-AYA, the mean Exposure score was 5.2 (SD = 2.6) out of 28. The mean Impact score was 1.8 (SD = 0.7; negative valence &gt; 2.5). Individuals were more sedentary and undertaking less exercise. Average stress rating was 5.9 (SD = 2), indicating moderate stress. No significant differences were found between those who did (N = 12) and who did not have a COVID infection (N = 54). A high percentage of participants scored above the clinical cut-off for depression (45%) and anxiety (41%), with a low proportion reporting moderate-severe symptomatology., Conclusion: After 1 year, the pandemic was having a less significant impact on patients' daily lives. Sedentary activity and reduced exercise were common. Despite expectations that this group was particularly vulnerable, depression and anxiety scores were similar to the rates described for this population before the pandemic. Overall, these results suggested that pwCF are highly resilient and nearly 1 year after the onset of COVID-19, have returned to similar daily activities and emotional health., (© 2022 Wiley Periodicals LLC.)

Parenting children with developmental disabilities (DD) can be generally characterized by a considerable psychological burden. The effects on parental and familial psychological well-being and, consequently, on children's developmental outcomes should not be underestimated, especially in early childhood. The current review aims to advance our understanding of the key factors (e.g., formats, sample characteristics, research design) that characterize parent training interventions, and that could be related to their outcomes, to guide researchers and clinical practitioners to develop and provide efficient programs. Studies were identified via an Internet search from three electronic databases, following PRIMSA guidelines. Studies published until November 2021 were taken into account. The initial search yielded a total of 2475 studies. Among them, 101 studies were fully reviewed. Finally, ten of the studies, which met all the inclusion criteria, formed the basis for this review. Participants' characteristics, main features of the interventions (i.e., study design, structure, and contents), outcome variables and treatment efficacy were deeply examined and discussed. Key factors of parent training interventions with parents of children affected by DD are enlightened, to guide researchers and clinicians in the design and implementation of tailored specific programs, aimed to sustain parenting and foster children's developmental outcomes, from early stages of life.

Background: Delirium, bed immobilization, and heavy sedation are among the major contributors of pediatric post-intensive care syndrome. Recently, the Society of Critical Care Medicine has proposed the implementation of daily interventions to minimize the incidence of these morbidities and optimize children functional outcomes and quality of life. Unfortunately, these interventions require important clinical and economical efforts which prevent their use in many pediatric intensive care units (PICU). Aim: First, to evaluate the feasibility and safety of a PICU bundle implementation prioritizing delirium screening and treatment, early mobilization (<72 h from PICU admission) and benzodiazepine-limited sedation in a human resource-limited PICU. Second, to evaluate the incidence of delirium and describe the early mobilization practices and sedative drugs used during the pre- and post-implementation periods. Third, to describe the barriers and adverse events encountered during early mobilization. Methods: This observational study was structured in a pre- (15th November 2019-30th June 2020) and post-implementation period (1st July 2020-31st December 2020). All patients admitted in PICU for more than 72 h during the pre and post-implementation period were included in the study. Patients were excluded if early mobilization was contraindicated. During the pre-implementation period, a rehabilitation program including delirium screening and treatment, early mobilization and benzodiazepine-sparing sedation guidelines was developed and all PICU staff trained. During the post-implementation period, delirium screening with the Connell Assessment of Pediatric Delirium scale was implemented at bedside. Early mobilization was performed using a structured tiered protocol and a new sedation protocol, limiting the use of benzodiazepine, was adopted. Results: Two hundred and twenty-five children were enrolled in the study, 137 in the pre-implementation period and 88 in the post-implementation period. Adherence to delirium screening, benzodiazepine-limited sedation and early mobilization was 90.9, 81.1, and 70.4%, respectively. Incidence of delirium was 23% in the post-implementation period. The median cumulative dose of benzodiazepines corrected for the total number of sedation days (mg/kg/sedation days) was significantly lower in the post-implementation period compared with the pre-implementation period: [0.83 (IQR: 0.53-1.31) vs. 0.74 (IQR: 0.55-1.16), p = 0.0001]. The median cumulative doses of fentanyl, remifentanil, and morphine corrected for the total number of sedation days were lower in the post-implementation period, but these differences were not significant. The median number of mobilizations per patient and the duration of each mobilization significantly increased in the post-implementation period [3.00 (IQR: 2.0-4.0) vs. 7.00 (IQR: 3.0-12.0); p = 0.004 and 4 min (IQR: 3.50-4.50) vs. 5.50 min (IQR: 5.25-6.5); p < 0.0001, respectively]. Barriers to early mobilization were: disease severity and bed rest orders (55%), lack of physicians' order (20%), lack of human resources (20%), and lack of adequate devices for patient mobilization (5%). No adverse events related to early mobilization were reported in both periods. Duration of mechanical ventilation and PICU length of stay was significantly lower in the post-implementation period as well as the occurrence of iatrogenic withdrawal syndrome. Conclusion: This study showed that the implementation of a PICU liberation bundle prioritizing delirium screening and treatment, benzodiazepine-limited sedation and early mobilization was feasible and safe even in a human resource-limited PICU. Further pediatric studies are needed to evaluate the clinical impact of delirium, benzodiazepine-limited sedation and early mobilization protocols on patients' long-term functional outcomes and on hospital finances., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Di Nardo, Boldrini, Broccati, Cancani, Satta, Stoppa, Genuini, Zampini, Perdichizzi, Bottari, Fischer, Gawronski, Bonetti, Piermarini, Recchiuti, Leone, Rossi, Tabarini, Biasucci, Villani, Raponi, Cecchetti and Choong.)

Sensitive caregiver-child interactions appear fundamental throughout childhood, supporting infants' wellbeing and development not only in a familial context but in professional caregiving as well. The main aim of this review was to examine the existing literature about Early Childhood Education Context (ECEC) intervention studies dedicated to caregiver-child interaction, fostering children's socioemotional developmental pathways. Studies published between January 2007 and July 2021 were identified in four electronic databases following PRIMSA guidelines. The initial search yielded a total of 342 records. Among them, 48 studies were fully reviewed. Finally, 18 of them met all inclusion criteria and formed the basis for this review. Main factors characterizing implemented programs were recorded (e.g., intervention and sample characteristics, dimensions of the teacher-child interaction targeted by the intervention, outcome variables, main results) in order to frame key elements of ECE intervention programs. Our review points to a range of fundamental issues that should consider to enhance ECEC interventions' efficacy, supporting children's socioemotional development and caregiver-child interaction. Reflections and considerations for future research are provided.

Introduction: Coronavirus disease 2019 (COVID-19) emerged in China, leading to worldwide morbidity and mortality, including depression and anxiety. As the pandemic spread throughout Italy, mental health concerns increased for people with cystic fibrosis (pwCF), who are at greater risk. The aim was to pilot a Telehealth Psychological Support Intervention for pwCF and caregivers to reduce stress, depression, and anxiety during the lockdown in Italy in March 2020., Methods: This intervention utilized cognitive behavioral skills (e.g., cognitive reframing). Participants included 16 pwCF and 14 parents, who completed four individual telehealth sessions with a psychologist. Stress ratings, Patient Health Questionnaire and General Anxiety Disorder, PHQ-8 and GAD-7, were completed, in addition to Feasibility and Satisfaction ratings., Results: Ratings of stress significantly decreased from pre- to post-testing for pwCF (paired t(14) = -4.06, p < .01) and parents (paired t = -5.2, p < .001). A large percentage of both groups scored in the clinical range for depression and anxiety at baseline (pwCF: depression/anxiety = 71%; parents: depression = 57%; anxiety = 79%); a large proportion (20%-40%) reported moderate to severe symptomatology. Significant reductions in depression for pwCF were found (pre: M = 8.0 to post: M = 4.7; paired t(14) = 2.8, p < .05) but not anxiety (pre: M = 6.9 to post: M = 5.6, t(14) = 1.2, p = NS-non-significant). Parental depression decreased for parents (pre: M = 6.4 to post: M = 5.1, t(14) = -2.5, p < .05), but not anxiety (pre: M = 8.1 to post: M = 7.9, t(14) = -0.2, p = NS). Feasibility and Satisfaction were positive., Conclusion: This telehealth intervention yielded reductions in stress and depression for participants. Anxiety did not significantly decrease, possibly because COVID was ongoing. This feasible, satisfactory intervention was effective for improving mental health., (© 2021 Wiley Periodicals LLC.)

Background: Although most infants consolidate their sleep habits during the first year of life, for many children, sleep is described as disrupted during toddlerhood. Along with individual child variables such as temperamental characteristics, parenting behaviors play a key role in determining children's sleep-wake patterns. The aims of the current study were to evaluate the relationship among toddlers' sleep quality, emotion regulation, bedtime routines, parental bedtime involvement, parental perceived social support and stress, and to integrate a novel combination of the aforementioned dimensions into predictive models of toddlers' sleep quality and parental stress., Methods: One hundred and sixty parents with 2-3-year-old children filled out the following self-report questionnaires: the Parent-Child Sleep Interaction Scale; the Emotion Regulation Checklist; the Social Provisions Scale; and an ad-hoc questionnaire to assess parental involvement in everyday and bedtime care for children. Three multiple regression analyses were conducted by regressing maternal and paternal parenting stress and infant's quality sleep onto the independent variables described above., Results: Toddlers' emotion regulation and parental psychosocial functioning were related to parental stress. Toddlers' night awakenings and the time required by toddlers to fall asleep were related to parental distress., Conclusions: The findings evidenced the bidirectional associations among the studied variables, highlighting the protective role of social support in reducing parenting stress and of paternal bedtime involvement in improving toddlers' sleep quality.

The present quantitative multi-trait cross-sectional study aims to gain a better understanding of the network of relationship between subjective happiness, compassion, levels of work engagement, and proactive strategies (self- and co-regulation) in a sample of teachers. Participants were 187 full-time in-service teachers (89% female; age M = 48.5; SD = 7.88) from Rome, Italy. We hypothesized that subjective happiness and compassion of early childhood teachers would be related with work engagement in such a way that subjective happiness would promote the engagement of teachers. In a similar fashion, we theorized that subjective happiness would be positively related to self- and co-regulation strategies and that proactive strategies would be in turn associated to work engagement. As expected, the results revealed that subjective happiness and compassion showed effects on work engagement and that this association among constructs was mediated by the role of proactive strategies (β = 0.22, p < 0.001; β = 0.37, p < 0.001, respectively). Proactive strategies also have a significant direct effect on work engagement (β = 0.56, p < 0.001). The study's findings suggest the importance of investing in the quality of the working environment., (Copyright © 2019 De Stasio, Fiorilli, Benevene, Boldrini, Ragni, Pepe and Maldonado Briegas.)

Introduction: A growing body of literature has shown an association between somatic symptoms and insecure "attachment style." In a recent study, we found a relationship between migraine severity, ambivalent attachment style, and psychological symptoms in children/adolescents. There is evidence that caregivers' attachment styles and their way of management/expression of emotions can influence children's psychological profile and pain expression. To date, data dealing with headache are scarce. Our aim was to study the role of maternal alexithymia and attachment style on their children's migraine severity, attachment style, and psychological profile., Materials and Methods: We enrolled 84 consecutive patients suffering from migraine without aura (female: 45, male: 39; mean age 11.8 ± 2.4 years). According to headache frequency, children/adolescents were divided into two groups: (1) high frequency (patients reporting from weekly to daily attacks), and (2) low frequency (patients having ≤3 episodes per month). We divided headache attacks intensity into two groups (mild and severe pain). SAFA "Anxiety," "Depression," and "Somatization" scales were used to explore children's psychological profile. To evaluate attachment style, the semi-projective test SAT for patients and ASQ Questionnaire for mothers were employed. Maternal alexithymia traits were assessed by TAS-20., Results: We found a significant higher score in maternal alexithymia levels in children classified as "ambivalent," compared to those classified as "avoiding" (Total scale: p  = 0.011). A positive correlation has been identified between mother's TAS-20 Total score and the children's SAFA-A Total score ( p  = 0.026). In particular, positive correlations were found between maternal alexithymia and children's "Separation anxiety" ( p  = 0.009) and "School anxiety" ( p  = 0.015) subscales. Maternal "Externally-oriented thinking" subscale correlated with children's school anxiety ( p  = 0.050). Moreover, we found a correlation between TAS-20 Total score and SAFA-D "Feeling of guilt" subscale ( p  = 0.014). Our data showed no relationship between TAS-20 and ASQ questionnaires and children's migraine intensity and frequency., Conclusion: Maternal alexithymia and attachment style have no impact on children's migraine severity. However, our results suggest that, although maternal alexithymic traits have no causative roles on children's migraine severity, they show a relationship with patients' attachment style and psychological symptoms, which in turn may impact on migraine severity.

Purpose: Evaluation the hypoglycemic and healing effects of the Strychnos pseudoquina., Methods: 33 Wistar rats were divided in the following groups, group 1 not sensitized with alloxan and untreated by aqueous extracts; group 2 sensitized with aloxana and untreated by aqueous extracts of Quina; group 3 sensitized by aloxana ad treated with the aqueous extract of quina. Diabetes was induced by alloxan diabetogenic drugs at a dose of 42 mg/kg of weight. The glycemias was evaluated by glycemic measuring Accu-check. To verify the healing, was made a longitudinal cut of 1 cm in the back of the mouse. The group 3 was treated with a microemulsion containing Strychnos pseudoquina. Wounds were macroscopically evaluated during pre-determined days after the cut (1st, 3rd, 7th, 9th, 14th)., Results: The glycemia levels in the group treated with Strychnos pseudoquina were lower than the group sensitized by alloxan and not treated with Strychnos pseudoquina. There was no difference between the healing of the wounds treated with quina and another groups., Conclusions: Strychnos pseudoquina presents hypoglycemic effect. Meanwhile the topical use of the microemulsion of Strychnos pseudoquina presents no macroscopically significant effect on the healing of wounds in diabetic rats.

The assessment of white coat hypertension is complicated by the lack of generally agreed-on normal limits of ambulatory blood pressure. To assess the influence of four of these limits on the prevalence of white coat hypertension and the corresponding distribution of left ventricular hypertrophy, we performed 24-hour ambulatory blood pressure monitoring and echocardiographic studies in 346 untreated patients with essential hypertension and 47 age-matched normotensive control subjects. The upper limits of normal daytime ambulatory blood pressure were lower using standards drawn from clinically normotensive populations than using standards drawn, partly or entirely, from general populations. The prevalence of white coat hypertension differed markedly using the different standards, being 12.1%, 16.5%, 28.9%, and 53.2% (chi 2 = 346.0, p less than 0.0001). Left ventricular mass index averaged 77 g/m2 in the control group, 85 g/m2 in the two groups with white coat hypertension defined by using standards drawn from normotensive populations (both comparisons not significant versus control group), and 90 and 98 g/m2 in the two groups with white coat hypertension defined by using the other two standards (both p less than 0.01 versus control group). The prevalence of echocardiographic left ventricular hypertrophy was 0% in the control group, 2.4% and 3.5% in the two groups with white coat hypertension defined by using standards drawn from normotensive populations, and 9.0% and 14.7% in the other two groups with white coat hypertension (p less than 0.05 and p less than 0.01, respectively, versus control group).(ABSTRACT TRUNCATED AT 250 WORDS)

Objective: To test the hypothesis of a difference between men and women in the left ventricular hypertrophic response to diurnal variations of ambulatory blood pressure in essential hypertension., Design: Non-invasive ambulatory blood pressure monitoring and echocardiography in untreated hypertensive patients and healthy normotensive subjects., Setting: Community-based ambulatory population in tertiary care centers., Patients: Two hundred and sixty hypertensive patients and sixty-three healthy normotensive subjects., Main Outcome Measure: Patients with average daytime systolic blood pressure (SBP) and diastolic blood pressure (DBP) falling by less than 10% during the night were defined as non-dippers, the others as dippers., Results: In the hypertensive group, dippers and non-dippers did not differ, in either gender, in several covariates possibly affecting left ventricular structure, including daytime ambulatory blood pressure, prevalence of white coat hypertension, age, body mass index, family history and known duration of hypertension, funduscopic changes, diabetes, alcohol consumption and renal function. Left ventricular mass (LVM) did not differ between dippers and non-dippers in hypertensive men whilst in hypertensive women it was significantly lower in dippers than in non-dippers. This sex difference held for all quartiles of the distribution of mean daytime blood pressure. In hypertensive women there was an inverse correlation between LVM and the per cent reduction of SBP and DBP from day to night, but this relationship was absent in hypertensive men. Other indices of left ventricular structure differed between dippers and non-dippers in both genders, as did LVM., Conclusions: For any level of daytime ambulatory blood pressure, a reduction of SBP and DBP by less than 10% from day to night identifies a subset of hypertensive patients at increased risk of left ventricular hypertrophy only in the female gender. These data suggest that, compared with men, hypertensive women require a longer duration of exposure to high blood pressure levels during the 24 h to develop left ventricular hypertrophy.

To investigate whether the level of clinical blood pressure (BP) may serve to stratify the risk of left ventricular (LV) hypertrophy in essential hypertension regardless of the level of ambulatory BP, we performed 24-hour noninvasive ambulatory BP monitoring and echocardiography in 115 consecutive hypertensive patients who had never been treated before and in 92 normotensive subjects. Hypertensive patients were grouped according to the difference between the observed clinical BP and the predicted value of clinical BP, defined by regressing the observed clinical BP on the 24-hour average of the ambulatory BP: "low" clinical BP group (clinical systolic BP less than = 10 mmHg, diastolic BP less than = 6 mmHg than predicted values), "high" clinical BP group (systolic greater than = 10 mmHg, diastolic greater than = 6 mmHg than predicted values), "intermediate" clinical BP group (values within the above mentioned limits). Ambulatory BP did not show any statistically significant differences between the three groups. LV mass index was higher in hypertensive patients in each of the three groups (including the "low" clinical BP group) as compared with the normotensive group (all p less than 0.01), but did not show any statistically significant difference among the three groups of hypertensive patients, either defined by systolic BP or by diastolic BP. Other indexes of LV anatomy (relative wall thickness, cross-sectional area) showed a similar pattern.(ABSTRACT TRUNCATED AT 250 WORDS)

We investigated the long-term effects of benazepril, a new non-sulfydryl angiotensin converting enzyme inhibitor, on ambulatory blood pressure (BP) and left ventricular (LV) anatomy and function in 13 never treated hypertensive patients (mean age 55 years--SD 9). Non-invasive ambulatory BP monitoring (Spacelabs 90202, a reading every 15 min for 24 hours) and standard and pulsed Doppler echocardiography were performed basally and after 12 months of therapy. Echocardiography was performed also at the end of 18th month of treatment. Eleven patients required a single daily dose of benazepril 10 (n = 9) or 20 (n = 2) mg, and two patients of 20 mg plus chlorthalidone 25 mg, to achieve clinical BP control. Average 24 h systolic/diastolic BP was 156/100 mmHg (SD 17/5) basally and 144/90 mmHg (SD 16/7) at the end of the 12th month of treatment (all p less than 0.01), LV mass index was 133 g/m2 basally and 113 g/m2 at the 12th month (p less than 0.01), early transmitral flow velocity (peak E) was 0.43 m/s (SD 0.11) basally and 0.62 (SD 0.13) m/s at the 12th month (p less than 0.01), and late transmitral flow velocity (peak A) did not change [0.67 (SD 0.10) m/s basally and 0.64 (SD 0.11) m/s at the 12th month]. Peak A/peak E ratio decreased from 1.69 (SD 0.57) to 1.31 (SD 0.37) (p less than 0.01). Peak aortic velocity, aortic acceleration time and aortic acceleration did not change. The per cent reduction of LV mass index was more closely related to the reduction of average 24 h systolic (r = 0.66, p = 0.013) and diastolic (r = 0.72, p = 0.005) BP than to the reduction of casual systolic (r = 0.37, p = NS) and diastolic (r = 0.42, p = NS) BP. None of the echocardiographic indices changed between the 12th and 18th month of treatment. In a control group of 13 age- and sex-matched healthy normotensive volunteers who underwent 24 h ambulatory BP monitoring and echocardiography twice, 12 months apart, there were no statistically significant BP or echographic changes. In summary, long-term antihypertensive treatment with benazepril provided and effective 24 h BP control, associated with regression of LV hypertrophy and improvement in LV diastolic filling, without changes in LV systolic function.

To investigate whether hospitalization may influence the circadian rhythm of blood pressure (BP), 15 untreated patients with essential hypertension underwent noninvasive ambulatory blood pressure monitoring twice, at home and in the hospital, in a random order, 11 days apart. During the hospital session, which took place on the ninth day of hospitalization, patients were allowed to move freely in the hospital area, to receive visits by friends and relatives and to engage in social activities with other inpatients. Home sessions were performed during a usual working day in 14 of 15 patients. Average 24-hour systolic/diastolic BP was 151/93 mmHg (DS 19/10) at home and 154/93 mmHg (DS 21/7) in the hospital; average daytime (6am-10pm) values were 155/97 mmHg (DS 19/10) at home and 157/96 mmHg (DS 20/5) in the hospital; average night-time (10pm-6am) values were 146/88 mmHg (DS 21/12) at home and 150/89 mmHg (DS 23/10). These values did not show any statistical differences (analysis of variance) due to status (home vs hospital), period or sequence. The hourly BP averages of the hospital recording did not differ significantly from the corresponding averages of the home recording. The correlation between hospital and home 24-hour averages of systolic and diastolic BP was close (r = 0.87 and r = 0.78, respectively; p less than 0.01). The chronobiological analysis (single cosinor) showed a statistically significant circadian rhythm of systolic BP in 10/15 patients at home and in 8/15 patients in the hospital (p = NS), and a statistically significant rhythm of diastolic BP in 9/15 patients at home and in 10/15 patients in the hospital (p = NS).(ABSTRACT TRUNCATED AT 250 WORDS)

To evaluate the difference between the sexes in the echocardiographic indices of left ventricular hypertrophy in essential hypertension, we analysed the results of 24-hour non invasive ambulatory blood pressure monitoring and echocardiography in 195 consecutive untreated hypertensive patients (101 males, 94 females). Patients were divided into 3 age groups: up to 40 years, 41-60 years, and greater than 60 years of age. Clinical blood pressure did not differ between sexes in any of the three groups, while average 24-hour ambulatory systolic and diastolic blood pressure levels were higher in males than in females up to 40 years of age (140/93 vs 129/87 mmHg, p less than 0.01), but not between 41 and 60 years (142/93 vs 141/90 mmHg) nor in those over 60 years of age (151/92 vs 145/91 mmHg). LV mass index was higher in males than in females up to 40 years (93 vs 68 g/m2, p less than 0.01), and between 41 and 60 years (115 vs 90 g/m2, p less than 0.01), but not dissimilar between the sexes over 60 years of age (102 vs 107 g/m2, p = n.s.). In females, LV mass index increased with age (r = 0.33) and body weight (r = 0.38; both p less than 0.01), but none of these relationships was significant in males (r = 0.01 and r = 0.19, respectively). Moreover, all the relations of LV mass to either clinical or ambulatory BP were closer in females than in males. None of the echocardiographic indices of left ventricular systolic function showed statistically significant differences between the sexes in any of the three age groups.(ABSTRACT TRUNCATED AT 250 WORDS)

Twenty-four-hour noninvasive ambulatory blood pressure (BP) monitoring and echocardiography were performed in 165 consecutive untreated hypertensive patients and in 92 healthy subjects. In the hypertensive group, left ventricular (LV) mass index showed closer correlations (all p less than 0.01 in the comparisons between the r coefficients) with average 24-hour ambulatory systolic (r = 0.47) and diastolic (r = 0.33) BP than with casual systolic (r = 0.35) and diastolic (r = 0.28) BP. Hypertensive patients were classified according to the difference between their observed and predicted levels of ambulatory BP (the latter assessed by regressing the observed ambulatory BP on the casual BP). When compared to those with lower than predicted ambulatory BP (less than or equal to 10 mm Hg systolic, less than or equal to 6 mm Hg diastolic), patients with higher than predicted ambulatory BP (greater than or equal to 10 mm Hg systolic and greater than or equal to 6mm Hg diastolic) had higher values of LV mass index and other indexes of LV hypertrophy (all p less than 0.01) but had similar values of casual BP. Prevalence of LV hypertrophy was 6 to 10% in the former and 35 to 39% in the latter (p less than 0.001). None of the indexes of LV structure differed between the group with low ambulatory BP and the normotensive group. It is concluded that hypertensive patients whose ambulatory BP readings are notably higher than one would predict from clinical BP readings are at highest risk of LV hypertrophy, an independent prognostic marker.(ABSTRACT TRUNCATED AT 250 WORDS)

The independent contribution of age, sex, duration of hypertension, heart rate, clinic and ambulatory blood pressure and echocardiographic left ventricular mass to left ventricular diastolic filling abnormalities in essential hypertension was investigated in 250 subjects (145 untreated and unselected hypertensives and 105 healthy normotensive controls) undergoing Doppler and standard echocardiography and non-invasive 24-h ambulatory blood pressure monitoring. Late and early diastolic transmitral peak flow velocities and their ratio (all P less than 0.01), the rate of deceleration of early diastolic mitral flow (P less than 0.01) and the time of deceleration of early diastolic mitral flow (P = 0.018) were abnormal in the hypertensive group vs controls. None of these parameters significantly varied in the presence vs absence of LV hypertrophy. In the hypertensive group, the prevalence of abnormal age-corrected Doppler values varied up to 46% (up to 45.4% and 50% in the absence and presence of left ventricular hypertrophy, respectively; P = n.s.). In a stepwise multivariate regression analysis, age and average daytime or night-time ambulatory blood pressure showed a significant independent relationship with each of these Doppler indexes of left ventricular diastolic filling. Late transmitral peak flow velocity and the ratio of late to early peak flow velocity were also independently affected by the heart rate. Sex, duration of hypertension, clinic systolic and diastolic blood pressure and left ventricular mass index did not show any independent relationship to these Doppler parameters of left ventricular filling. In conclusion, Doppler abnormalities of diastolic transmitral blood flow were detected in up to 46% of patients in an unselected hypertensive population with a low prevalence (14.5%) of left ventricular hypertrophy. Age and ambulatory blood pressure, but not sex, duration of hypertension, clinic blood pressure and left ventricular mass itself, were the major independent determinants of these abnormalities.

The effects of circadian blood pressure (BP) changes on the echocardiographic parameters of left ventricular (LV) hypertrophy were investigated in 235 consecutive subjects (137 unselected untreated patients with essential hypertension and 98 healthy normotensive subjects) who underwent 24-hour noninvasive ambulatory blood pressure monitoring (ABPM) and cross-sectional and M-mode echocardiography. In the hypertensive group, LV mass index correlated with nighttime (8:00 PM to 6:00 AM) systolic (r = 0.51) and diastolic (r = 0.35) blood pressure more closely than with daytime (6:00 AM to 8:00 PM) systolic (r = 0.38) and diastolic (r = 0.20) BP, or with casual systolic (r = 0.33) and diastolic (r = 0.27) BP. Hypertensive patients were divided into two groups by presence (group 1) and absence (group 2) of a reduction of both systolic and diastolic BP during the night by an average of more than 10% of the daytime pressure. Casual BP, ambulatory daytime systolic and diastolic BP, sex, body surface area, duration of hypertension, prevalence of diabetes, quantity of sleep during monitoring, funduscopic changes, and serum creatinine did not differ between the two groups. LV mass index, after adjustment for the age, the sex, the height, and the daytime BP differences between the two groups (analysis of covariance) was 82.4 g/m2 in the normotensive patient group, 83.5 g/m2 in hypertensive patients of group 1 and 98.3 g/m2 in hypertensive patients of group 2 (normotensive patients vs. group 1, p = NS; group 1 vs. group 2, p = 0.002).(ABSTRACT TRUNCATED AT 250 WORDS)

To assess the duration of the antihypertensive effect of the dihydropiridine calcium antagonist felodipine in conventional (C-F) and slow-release (ER-F) formulations, 12 patients with essential hypertension underwent ambulatory blood pressure monitoring (ABPM) at the end of a 2-week treatment period with C-F 5 mg b.d., ER-F 10 mg once daily (o.d.) and placebo. C-F, ER-F and placebo were given in a double-blind 3 x 3 latin square design 4 times replicated. There was no systematic change in the ABP profile over the three study periods regardless of the treatment. In comparison to placebo, the mean 24-h systolic and diastolic blood pressures showed a significant and similar reduction after both formulations of F. Compared to placebo, C-F and ER-F induced a significant reduction in systolic blood pressure for 15 and 21 h, respectively, and of diastolic blood pressure for 16 and 21 h, respectively. Three patients complained of headache (mild in 2, moderately severe in 1), and two patients of nocturia, with either formulation of F.

The aim of this study was to compare the effects of the prophylactic use of cefamandole versus oxacillin plus gentamicin on hemostasis in patients undergoing hip replacement with heparin prophylaxis. Twenty-four patients with a normal hemostatic profile were randomly allocated to receive either cefamandole or oxacillin plus gentamicin. All the patients received calcium heparin. Platelet count, bleeding time, prothrombin time (PT), activated partial thromboplastin time (aPTT), thrombin clotting time (TCT), fibrinogen and serum FDP were assessed before treatment and every day of antibiotic administration. Surgical bleeding was assessed using a four-grade score system. Platelet count, bleeding time, fibrinogen and serum FDP did not show any change with both treatments. PT, aPTT and TCT showed a similar and mild prolongation in the two groups of patients. No difference in the surgical bleeding was observed between the two groups. We conclude that a short-term prophylaxis with cefamandole is a safe regimen in patients undergoing hip replacement with heparin prophylaxis.

Norfloxacin (NOR) was compared to pipemidic acid (PA) in complicated urinary tract infections (UTIs) caused by pathogens susceptible to both agents to evaluate the antibacterial activity of the new 4-quinolone derivative. Sixty-five patients were randomly allocated to receive NOR or PA, 400 mg bid for 7 days, and the results evaluated for treatment efficacy at 5 weeks after completion of therapy. Overall microbiological cure was significantly greater in NOR-treated patients, as 19 of 26 were cured (73%), compared to only 16 of 39 (41%) in the PA group (p less than 0.05). Failures and relapses, considered together, were significantly (p less than 0.05) less frequent in patients treated with NOR (4/26) than in those receiving PA (18/39). Clinical response was strictly related to microbiological outcome: NOR had a broader antibacterial spectrum than PA and in this study seemed to be more efficacious in the treatment of complicated UTIs caused only by bacteria susceptible to both agents. This may be related to greater antibacterial activity and/or tissue penetration by NOR, which is thus to be preferred, according to the results of our study, in the treatment of complicated UTIs.

The antianginal properties and the duration of action of two doses of felodipine, a dihydropyridine calcium antagonist with a vascular:myocardial potency ratio approximating 100:1, were investigated in 15 patients suffering from disabling effort angina pectoris with reproducible exercise tolerance. Felodipine (5 mg, 10 mg) and placebo were administered once in the morning on three different days, with a 24 h interval between them, according to a double-blind 3 x 3 latin square design, 5 times replicated. Symptom-limited cycloergometric exercise tests were performed 3 and 12 h after administration. Duration of exercise to ST segment depression of 1 mm and to peak exercise was increased (all P less than 0.01) by both doses of felodipine in comparison with placebo. Twelve hours after administration, the 10-mg dose induced a significant improvement in the exercise time and a smaller ST segment depression (all P less than 0.01) in comparison with the 5-mg dose. The relationship between ST segment depression and the pressure-rate product during exercise was favourably influenced by the 10-mg dose at 3 and 12 h after intake, and by the 5-mg dose only at 3 h after intake. These findings suggest an increase in coronary blood flow induced by felodipine. Apart from mild headache there were no other unwanted effects. In conclusion, felodipine improves exercise tolerance and reduces electrocardiographic ischaemia for up to 12 h after single oral administration in patients with effort angina. Increasing the dose from 5 mg to 10 mg produces a more prolonged effect, with increased exercise tolerance 12 h after intake.

Teicoplanin, a new glycopeptide antibiotic, is structurally related to ristocetin, an antibiotic known to induce human platelet agglutination and, thus, thrombocytopenia and thromboembolic side effects. The aim of this study was to evaluate the effects of teicoplanin on platelet function in vitro and ex vivo and on blood coagulation ex vivo. In the in vitro studies, spontaneous platelet aggregation; platelet aggregation induced by ADP, collagen, and ristocetin; and the release of beta-thromboglobulin from platelets were assessed. Platelets from healthy subjects were incubated with teicoplanin at final concentrations of 100, 1,500, 5,000, and 10,000 micrograms/ml. The maximal achievable concentration with therapeutic doses is 100 micrograms/ml. When compared with saline, teicoplanin at concentrations of 100 and 1,500 micrograms/ml had no effect on platelet function, but at concentrations of 5,000 and 10,000 micrograms/ml, it induced greater spontaneous platelet aggregation (P less than 0.01) and inhibited platelet aggregation induced by ADP, collagen, and ristocetin (P less than 0.01). Teicoplanin at concentrations of 100, 1,500, and 5,000 micrograms/ml did not induce the release of beta-thromboglobulin, in contrast to teicoplanin at a concentration of 10,000 micrograms/ml and ristocetin at a concentration of 1.5 mg/ml (P less than 0.01). In the ex vivo studies, platelet count, bleeding time, plasma beta-thromboglobulin, platelet aggregation induced by ADP, ristocetin, and epinephrine, activated partial thromboplastin time, prothrombin time, thrombin clotting time, and serum fibrinogen degradation products were evaluated at days 0, 3, and 6 and at 72 h after the end of therapy. All subjects completed the study without evidence of side effects. When compared with the pretreatment values, none of the values from these assays showed a significant change at any time during and after treatment. We concluded that platelet function and blood coagulation are not affected by therapeutic concentrations of teicoplanin and that in vitro platelet function is affected only by concentrations of teicoplanin far in excess of those that are clinically achievable.

Atenolol (A) and enalapril (E), two agents widely used as first-line monotherapy in arterial hypertension, have never been compared in their potency and duration of action by using 24-h ambulatory blood pressure monitoring (ABPM). Twelve out-patients (mean age 48.6 years - SD 7) with mild-to-moderate hypertension and supine diastolic blood pressure (Hawksley Random Zero Manometer) greater than 100 mmHg at the end of a 3-week placebo wash-out received, in double-blind and random order, A 100 mg daily, E 20 mg daily and placebo for 4 weeks each, according to a 3 x 3 latin square design. A 24-hour non-invasive ABPM (Spacelabs ICR 5200) was performed at the end of each of the 3 periods. In respect to placebo, both A and E produced a 24-h antihypertensive effect. The frequency of diastolic blood pressure values above 90 mmHg was 50.0% after placebo, 24.5% after A and 28.9% after E (a 51% reduction after A and a 42.3% reduction after E in respect to placebo - both p less than .05). Systolic blood pressure profiles differed less than 5 mmHg between placebo and A, as well as between placebo and E, between 9:30 and 10:30. Diastolic blood pressure profiles differed less than 5 mmHg between placebo and A over 2 h (between 2:30 and 3:30, and between 10:30 and 11:30), and between placebo and E over 2 other h (between 9:30 and 10:30, and between 11:30 and 12:30). None of the routine hematochemical parameters differed between placebo, A and E.(ABSTRACT TRUNCATED AT 250 WORDS)

Left ventricular involvement in type II diabetes mellitus is poorly understood. We performed a cross-sectional, M-mode and pulsed Doppler echocardiographic study on 27 diabetic patients and 27 controls accurately matched for age, sex, weight and height. All subjects also underwent 24-hour non-invasive ambulatory blood pressure monitoring. Left ventricular wall thicknesses and dimensions in diastole and systole, left ventricular mass index (82.7 g/m2 vs 78.4 g/m2) and the echocardiographic indices of left ventricular contractility did not show any statistical differences between diabetics and controls. Clinic and 24-hour ambulatory blood pressure did not show important differences between diabetics and controls. Doppler parameters for transmitral flow velocity (including peak A and peak E velocity and their ratio, pressure half time and pressure half slope) were the same in diabetics and controls. A stepwise multivariate regression analysis showed a significant positive independent relationship of peak A/peak E ratio with age (peak A/peak E = 0.0087 + 0.20 x age; F = 18.7; p = 0.0001), but not with diabetes or glycosylated haemoglobin (Hb 1 AC). Compared with non-diabetics, diabetics showed a slight increase in aortic peak flow velocity (0.83 m/sec vs. 0.70 m/sec; p = 0.011) and a very slight increase in peak aortic gradient. Peak aortic velocity showed a highly significant positive independent relation with the duration of diabetes (Vmax = 0.572 + 0.0028* diabetes duration (months); F = 92.6; p less than 0.0001), but not with age, systolic or diastolic blood pressure of HB 1 AC.(ABSTRACT TRUNCATED AT 250 WORDS)

In most hypertensives clinic blood pressure (BP) is variably higher than home BP, but the underlying mechanisms are uncertain. We investigated whether the 24-hour ambulatory home BP profile as well as the office-home BP discrepancy could vary with the time of day of application of the recording system (from 08.00 h to 19.00 h) in 135 untreated hypertensives who underwent non-invasive home BP monitoring (ICR 5200). Neither systolic nor diastolic 24-hour home BP (average of daily readings, area-under-the-curve) varied significantly with the time of day of application of the system. Clinic BP was about 12% higher than 24-hour home BP in the whole population, mean values being 161.4/102.9 mmHg (office BP) vs 141.2/90.8 mmHg (average 24-hour home readings), as well as in each of the subcohorts based on the time of day of application of the system (all P less than 0.01). However, in none of the subcohorts were there any statistically significant differences between clinic BP and home BP readings taken at the same time of day as the clinic readings. No correlation was found between clinic heart rate and clinic-home discrepancy. We conclude that in essential hypertension 24-hr non-invasive ambulatory BP monitoring can begin indifferently from 08.00 h to 19.00 h with no expected influence of time of application on results and that clinic BP is not dissimilar from home BP at the same time of day.