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Background Silicone adhesive multilayer foam dressings are used as adjuvant therapy to prevent hospital-acquired pressure ulcers (PUs). Objectives To determine whether silicone foam dressings in addition to standard prevention reduce the incidence of PUs of category 2 or worse compared with standard prevention alone. Methods This was a multicentre, randomized controlled medical device trial conducted in eight Belgian hospitals. At-risk adult patients were centrally randomized (n = 1633) to study groups based on a 1 : 1 : 1 allocation: experimental groups 1 (n = 542) and 2 (n = 545) - pooled as the treatment group - and the control group (n = 546). The experimental groups received PU prevention according to hospital protocol, and a silicone foam dressing on the relevant body sites. The control group received standard of care. The primary endpoint was the incidence of a new PU of category 2 or worse at the studied body sites. Results In the intention-to-treat population (n = 1605), PUs of category 2 or worse occurred in 4·0% of patients in the treatment group and 6·3% in the control group [relative risk (RR) 0·64, 95% confidence interval (CI) 0·41-0·99, P = 0·04]. Sacral PUs were observed in 2·8% and 4·8% of the patients in the treatment group and the control group, respectively (RR 0·59, 95% CI 0·35-0·98, P = 0·04). Heel PUs occurred in 1·4% and 1·9% of patients in the treatment and control groups, respectively (RR 0·76, 95% CI 0·34-1·68, P = 0·49). Conclusions Silicone foam dressings reduce the incidence of PUs of category 2 or worse in hospitalized at-risk patients when used in addition to standard of care. The results show a decrease for the sacrum, but no statistical difference for the heel and trochanter areas.

Allogeneic human keratinocyte cultures have been used to treat burn wounds, donor sites, and chronic skin ulcers with some success. Cryopreservation of these cultures allows for the production of large standardized batches that are readily available for use. The aim of the study presented in this report was to study effects of cryopreserved cultured allogenic human keratinocytes (Cryo Ceal) on chronic lower extremity wounds. Parameters were measured to study efficacy, tolerability, pain associated with chronic wounds, and quality of life of patients. Twenty-seven patients with hard-to-heal venous leg ulcers received a maximum of 9 applications of Cryo Ceal in a prospective, uncontrolled multicenter study lasting 48 weeks. Eleven out of 27 patients (41%; 95% CI: 22%-61%) had complete wound closure within 24 weeks (1 week). The time required for complete wound closure in these 11 patients ranged from 4.1 to 24.9weeks. Only 1 patient had recurrence of the ulcer at 48 weeks. Local (wound) pain scores decreased from a mean of 2.5 at baseline to 0.9 at week 24. Fifty percent of the patients attained a pain score of 0 after 12 weeks and remained stable at this score until the end of the study. Overall, the patient quality of life was better at week 24, compared to baseline values. The treatment was well tolerated, and wound infection was the most frequently occurring adverse event.

Aims/Background: We report the results of a university surgical intensive care (SICU), which are influenced by a reorganization of the department because of a downsizing of beds with the corresponding reduction of personnel resulting in a decrease in nurse-to-bed ratio. Moreover, we report the subsequent interventions and adjustments resulting in favorable results. Design: We performed a prospective observational cohort study of all consecutive surgical patients entering the SICU of our hospital, over the period 2000-2004. Methods: In order to meet the budget cuts, a reduction of number of SICU beds with a corresponding reduction of nursing staff was implemented. In the subsequent period culminating on the year 2002, collaboration problems arose between medical and nursing staff: resulting in fierce discussions on the floor. Supported through external mediators, structures/work ethics/communication/collaborative behavior, and organization of the SICU were reviewed and restructured. Results: A total of 1477 patients were admitted to the SICU. The characteristics, Acute Physiology and Chronic Health Evaluation II score and therapeutic intervention scoring system points, were not different throughout the years. The intensive care unit-length of stay (ICU-LOS) in the admission year 2002 was significantly longer (P = .001) and the crude ICU mortality was higher (P = .02) compared with the 2 admission years before. The adjusted mortality (ICU standardized mortality ratio) was also worse in 2002, however, statistically not different. After the intervention (2003 and 2004), a better result (crude ICU mortality, length of ICU stay, and ICU standardized mortality ratio) was achieved. Conclusion: Intensive care reorganization, in which higher workload is seen in medical and nursing staff, could have a negative effect on ICU outcome and length of ICU stay. Relevance to clinical practice: Interventions in ICU structures, communication, work ethics, and organization have a positive impact in conflict management.

Objective. To assess the results of open management of the abdomen and planned re-operations in severe bacterial peritonitis after perforation or anastomotic disruption of the digestive tract. Design. Retrospective study. Setting. University Hospital, The Netherlands. Subjects: 67 consecutive patients. Interventions: Open management of the abdomen and planned reoperations. Main outcome measures: Hospital morbidity and mortality, long-term follow-up. Results: 38 patients developed multiple organ failure (MOF), but 29 needed only ventilatory and inotropic support. The mean number of re-operations was nine. 16 patients developed severe bleeding and 16 fistulas. In-hospital mortality was 42% (n = 28). Long-term morbidity, particularly the number of abdominal wall defects (n = 10), was considerable. Conclusion. Despite open management of the abdomen and planned re-operations, mortality of severe bacterial peritonitis still continues to be too high, and both short and long-term morbidity are appreciable. The value of open management of the abdomen and planned re-operations rests only on the clinical observation that other conventional surgical treatments of severe bacterial peritonitis often fail.

Tropisetron (Navoban") suppresses nausea and vomiting induced by cancer chemotherapy by antagonizing central and peripheral 5-HT3 receptors. In this open-label study, tropisetron was evaluated in 873 patients who were either refractory to antiemetic treatment during previous chemotherapy or at high risk of emesis as a result of current chemotherapy. The most commonly used agents alone or in combination were cyclophosphamide (35%), fluorouracil (30%), carboplatin (24%) and cisplatin (21%). The primary tumors were breast cancer (27%), lung cancer (16%), gynecological cancers (12%) and lymphoma (9%). Tropisetron was administered as a 15 min infusion prior to chemotherapy and an additional oral 5 mg dose was taken by 80% of the patients on subsequent days. During course 1, complete response to tropisetron was obtained in 64% of patients on day 1, 54% on day 2, 63% on day 3, 71% on day 4 and 77% on day 5. Very similar response rates were found for the six chemotherapy courses. There were few failures after complete and partial response, at maximum 3 and 15%, respectively. Moreover, 24-38% of those with partial response and 7-29% of those with failure could achieve a complete response during the following cycle. The treatment was well tolerated, the most frequently reported adverse events being constipation (3.7%) and headache (2.6%).

UNLABELLED Tropisetron can prevent postoperative nausea and vomiting (PONV) at doses smaller than those used to control chemotherapy-induced nausea and vomiting. In this placebo-controlled study, the efficacy and tolerability of three different doses of tropisetron were compared for the treatment of established PONV after surgical procedures in general anesthesia. Of 1513 patients who satisfied inclusion criteria, 314 experiencing PONV during the first 2 h after recovery from anesthesia were treated with one of three different doses of tropisetron (0.5, 2, or 5 mg) or placebo, administered i.v. as a single dose. Patients were then observed during 24 h for efficacy and tolerability. All three doses of tropisetron were significantly better than placebo in controlling emetic episodes and in reducing the need for rescue treatment. There were no significant differences among the three doses. However, in the subgroup of patients who had previous PONV, and in those randomized for nausea alone, the 2-mg and 5-mg doses controlled emetic episodes better than the 0.5-mg dose. All studied doses of tropisetron were well tolerated and did not affect vital signs. We conclude that a single i.v. administration of tropiestron significantly reduces the recurrence of emetic episodes in patients with established PONV after elective surgery with general anesthesia. Its optimal dose seems to be 2 mg. IMPLICATIONS Three hundred-fourteen patients suffering from postoperative nausea and vomiting received different i.v. doses of a new antiemetic drug, tropisetron, to determine the lowest effective dose. We found that a single i.v. administration of tropisetron significantly reduced postoperative nausea and vomiting after elective surgery with general anesthesia.

It is widely believed that multiple sclerosis is a T-cell mediated autoimmune disease associated with abnormalities in immunoregulation. This large, prospective study evaluated the lymphocyte immunophenotypic profile of 246 MS patients, divided clinically into a remitting/relapsing group (n = 176) and a progressive group (n = 70), and compared their results to those of 117 healthy controls. All patients were found to have significantly elevated percentage and absolute numbers of IL2R(+)CD3(+) cells as well as depressed percentages of CD45RA(+)CD4(+) cells. However, when the factor of treatment with cyclophosphamide (CY) versus no treatment or treatment with other agents was used to group patients, dramatic declines in both percentages and absolute numbers of CD45RA(+) CD4(+) cells were discovered. These declines were associated specifically with CY and could be explained by this factor independent of the clinical state of the patient. The effects were seen in patients undergoing current treatment or in those exposed to CY in the near or remote past. These findings highlight the confounding effect of specific treatments on the immune profile of MS patient groups and suggest that there may be important implications for cellular function and clinical outcome in these and other patient groups.

One hundred and thirty-one children with a median age of 5 years were administered Navoban(R) (tropisetron), a selective antagonist of the serotonin receptor (5-HT3), dosed once daily at 0.2 mg/kg (with a maximum of 5 mg daily) in a study aimed at evaluating the prevention of nausea and vomiting induced by anti-cancer chemotherapy. The most common malignancy (in 49% of patients) was acute lymphocytic leukaemia, Patients received Navoban(R) during one or more courses of emetogenic chemotherapy for a total of 455 courses administered intravenously or intravenously and intrathecally (IV + IT), Most patients (89%) had already received cytotoxic chemotherapy before enrolment for the trial, On Day 1, Navoban(R) was administered slowly and intravenously as a single dose before the start of chemotherapy, or by mouth as a single daily dose on subsequent days (median treatment duration = 5 days), On the first 5 days of each course of chemotherapy, response to Navoban(R) per 24-hour period was graded as: complete (absence of both nausea and vomiting), partial (1-4 vomits and/or less than 5 hours of nausea), or failure(more than; 4 vomits and/or at least 5 hours of nausea). Ninety-six per cent of the intravenous chemotherapy group and 97% of the IV + IT chemotherapy group had a complete (70% and 55% respectively) or partial(26% and 42% respectively) response during the first 24-hour period of the first course in which Navoban(R) was used. The second and subsequent courses yielded similar percentages. Delayed emesis was observed mainly during those courses employing the most emetogenic chemotherapy. No side effects of Navoban(R), other than one case of diarrhoea, were documented in this study.

Innovative high-risk medical devices, such as new types of heart valves or hip prostheses, become available on the European market more rapidly than in USA. This is due to the European legislation allowing early marketing of innovative high-risk medical devices before high-quality clinical evidence is obtained from randomized controlled trials.We studied the premarket clinical evaluation of innovative high-risk medical devices in Europe compared with the USA. We also discussed patient safety and the transparency of information. The literature and regulatory documents were checked. Representatives from industry, competent authorities, notified bodies, ethics committees, and health technology assessment agencies were consulted.In contrast to the US, there is no requirement in Europe to demonstrate the clinical efficacy of high-risk devices in the premarket phase. For the patient, this implies earlier access to innovative technology, but at the risk of potential safety issues. At this moment, European requirements for clinical studies are lower for medical devices than for drugs, and data from premarket clinical trials are scarce or remain unpublished. The European Medical Device Directives are currently being reworked.For innovative high-risk devices, and while awaiting a reworked Medical Device Directive, patient risk should be minimized by limiting the market introduction of novel high-risk devices with minimal clinical data to physicians with the necessary training and expertise. The new European legislation should require the premarket demonstration of clinical efficacy and safety, using a randomized controlled trial if possible, and a transparent clinical review, preferably centralized.

PURPOSE This study evaluated tropisetron (Navoban; Sandoz Pharma, Basle, Switzerland)-based combination therapy in patients who had incomplete control of chemotherapy-induced nausea or vomiting when using tropisetron as a single antiemetic agent. PATIENTS AND METHODS One thousand seventy-two patients, who were scheduled to receive at least two identical cycles of emetogenic chemotherapy, were treated with 5 mg tropisetron once daily in their first chemotherapy course. A 2 x 2 x 2 factorial design was used to evaluate three additional treatments to the recommended 5 mg once daily (intravenously [i.v.] on day 1; orally on days 2 through 6) tropisetron regimen during course 2 in those patients who had shown incomplete control of nausea and/or vomiting on any day of course 1. Four hundred forty-five patients were centrally randomized to receive, in addition, open-label dexamethasone (day 1, 0.2 mg/kg i.v.; days 2 through 6, 8 mg orally) and/or open-label alizapride (day 1, 100 mg i.v. and 4 x 50 mg orally; days 2 through 6, 4 x 50 mg orally) and/or double-blind tropisetron (ie, doubling the dose to 10 mg once daily) or corresponding placebo. RESULTS Complete response rates (no nausea and no vomiting) were 72% for day 1 and 48% for days 1 through 6 of course 1. During course 2, more complete responders were observed when dexamethasone was added, both for day 1 (76% v 66%, P = .020) and for days 1 through 6 (50% v 34%, P = .0004). A moderate increase in the complete response rate was seen with the addition of conventional-dose alizapride (day 1, 75% v 68%, P = .14; days 1 through 6: 47% v 37%, P = .041). Doubling the dose of tropisetron did not change the complete response rate. CONCLUSION The addition of dexamethasone significantly increases the complete response rate of both acute and delayed emesis in patients who have incomplete disease control with tropisetron alone.

Flow cytometry and monoclonal antibodies are promising tools for HLA-antigen detection. Previous approaches have been hampered by the lack of a carefully standardized system for calibration and sample analysis. A new system for HLA-B27 screening was developed using a FACScan flow cytometer, software for automated calibration and analysis, calibration beads, and the anti-HLA-B27-FITC/anti-Leu4-PE (CD3) monoclonal antibodies. The median fluorescence channel result for the HLA-B27-FITC signal of CD3+ T lymphocytes is compared to a decision marker. Values lower than this threshold are read as HLA-B27 negative and those above are recommended for retesting with the classic microcytotoxicity assay on the presumption of HLA-B27 positivity. The anti-HLA-B27 antibody reacts with all six HLA-B27 subtypes and shows a weaker binding to HLA-B7. The screening test results were compared with those from the microcytotoxicity assay for HLA-typing in studies involving several European centers. The observed sensitivity was 100% (95% Cl:98.6-100) and the specificity was 97.4% (95% Cl: 96.4-98.3). Other performance studies verified the reproducibility and reliability of results obtained with the screening system.

A reference range for lymphocyte populations, with particular emphasis on T lymphocyte subsets, was obtained for normal individuals covering age cohorts from birth through adulthood. This report confirms and extends findings from a developmental reference range published earlier (1). Absolute numbers of WBC, lymphocytes, and T, B, and NK subsets decline significantly during childhood. However, differences in the rate of decline of certain lymphocyte subsets leads to discordance between absolute numbers and percentages. Those lymphocyte subsets which decline less rapidly with age than the total lymphocyte count will show an increase in percentage, whereas those which decline more rapidly will show further declines in percentage values. T cell percentages were seen to increase over time whereas B cell percentages decline. Markers of immaturity such as CD45RA on CD4 cells and CD38 on CD8 cells declined in both percentages and absolute numbers. Activation markers, such as HLA-DR on CD8 cells and IL2-R on CD3 cells, increased in percentages with time but changed inconsistently in cell number from infancy to adulthood. These findings extend the lymphocyte reference range to markers thought to be informative in various disease states, including HIV infection.

Two-color immunofluorescence using multiparameter flow cytometry was employed to examine the antigenic characteristics of peripheral blood lymphocytes in whole blood of healthy Caucasians and Japanese. The CD4/CD8 ratio in Japanese was significantly decreased compared with that in Caucasians, because of the increased number of CD8+ cells. Although the proportions of suppressor-inducer T cells (CD4+, Leu-8+) and helper-inducer T cells (naive T cells) (CD4+, CD45RA-) were low in Japanese subjects, there were no differences in the absolute numbers of suppressor-inducer T cells and helper-inducer T cells (naive T cells) in circulation. The level of activated T cells in Japanese was similar to that in Caucasians. NK cells, CD57+, CD8+ cells and CD57+, CD3+ cells were high in Japanese. Regarding B cell subsets, CD5+ B cells and activated B cells remained unchanged. However, there were slight differences in Leu-8+ B cells and Fc epsilon R+ B cells (CD20+, CD23+) between the two groups. Thus, a differing influence of racial and environmental background between healthy Caucasians and healthy Japanese on human lymphocyte subsets is present in the lymphocyte immunophenotype.

Background Early classification of patients presenting with pcritonitis and intra-abdominal sepsis by means of objective scoring systems is desirable to select patients for 'aggressive' surgery and to compare results of different treatment regimens. However, none of the existing scoring systems has fulfilled all expectations. Methods Evaluation of the value of various scoring systems (Acute Physiology And Chronic Health Evaluation (APACHE) II, Simplified Acute Physiology Score, Sepsis Severity Score, Multiple Organ Failure, Mannheim Peritonitis Index (MPI), Ranson and Imrie) was performed in 50 patients. Additionally, scoring systems were combined to obtain a 'combined score' for the prediction of peritonitis-related in-hospital death. Hazard ratios were calculated in a univariate and multivariate analysis. Results In the univariate analysis all scoring systems, except Ranson and Imrie, predicted the primary outcome. In the multivariate analysis, only the APACHE II score (hazard ratio 6.7) and the MPI (hazard ratio 9.8) contributed independently to the prediction of outcome. All patients with an APACHE II score of 20 or more and a MPI of 27 or more died in hospital. Conclusion Combination of the APACHE II and the MPI provides the best scoring system fitting clinical goals.

To assess a scoring system for predicting recurrence of fulminant bacterial peritonitis after discontinuation of antimicrobial treatment in patients being treated by open management of the abdomen for persistent bacterial peritonitis after perforation of the digestive tract, anastomotic disruption, or necrotising pancreatitis.Retrospective study.University Hospital, The Netherlands.58 consecutive patients.Recurrence of fulminant bacterial peritonitis and survival.13 of the 58 patients (22%) died during the initial course of antimicrobial drugs. 14 of the remaining 45 patients had a recurrence of fulminant bacterial peritonitis after discontinuation of antimicrobial drugs, 4 of whom died. Predictive criteria included raised white cell count (WCC) (p = 0.02), duration of initial antibiotic treatment (p = 0.05), and deterioration in Simplified Acute Physiology Score (p = 0.05). Using the WCC and the duration of initial antimicrobial treatment together with other variables that showed a predictive trend (body temperature, percentage band cells, underlying disease, and use of inotropic agents), in a new scoring system (0-12), fulminant bacterial peritonitis did not recur when the score was 0-3, but in 9 of 11 patients with a score of 6 or more it did (p0.001).Patients at increased risk of recurrence of fulminant bacterial peritonitis during open management of the abdomen can be identified at the time of discontinuation of antimicrobial treatment by a new scoring system; antimicrobial treatment should not be discontinued in patients with a score of 6 or more.

In a prospective, randomized, multicentre, double-blind, placebo-controlled study, we have compared the efficacy of a single i.v. dose of tropisetron 0.5 mg, 2 mg and 5 mg in the prevention of postoperative nausea and vomiting (PONV). We studied 385 ASA class I and II female patients undergoing abdominal or vaginal gynaecological surgery, including laparoscopy. Tropisetron or placebo were administered before a standardized general anaesthetic. The frequency of vomiting in the 24-h period after entry into the recovery room was reduced from 44% after placebo to 31%, 26% and 30% after tropisetron 0.5 mg, 2 mg and 5 mg, respectively (P = 0.06, P = 0.009 and P = 0.043; unadjusted). Compared with placebo, nausea was reduced from 55% to 46%, 34% and 46% (P = 0.25, P = 0.003, P = 0.22), and need for rescue treatment from 39% to 29%, 23% and 35% (P = 0.13, P = 0.017 and P = 0.59) for the same groups. Tropisetron 2 mg appeared to be the optimal dose for prophylaxis against PONV with a side-effect profile similar to that of placebo.

Tropisetron (Navoban(R), Sandoz Pharma Ltd., Basel, Switzerland), a selective antagonist of the serotonin receptor (5-HT3) dosed once-daily at 0.2 mg/kg (with a maximum of 5 mg daily), was evaluated in the prevention of chemotherapy-induced nausea and vomiting in 131 children with a median age of 5 years (age 10 weeks to 21 years). Acute lymphocytic leukemia was the most common malignancy (49%). Most children (82%) had received cytotoxic chemotherapy before enrollment. Patients received tropisetron during one or more courses of chemotherapy (455 courses in total). Tropisetron was administered slowly intravenously as a single dose before the start of chemotherapy on day 1 and intravenously or by mouth the subsequent days as a single daily dose (median treatment duration: 5 days). Response to tropisetron per 24 hour period on the first 5 days of each chemotherapy course was graded as complete (absence of both nausea and vomiting), partial (one to four vomits and/or less than 5 hours of nausea), or failure. Overall complete response on day 1 was observed in 305 out of 455 chemotherapy courses (67%). The patients receiving intravenous chemotherapy (N = 92) had a 70% complete response rate and a 26% partial response rate on day 1, both for course 1 and course 2. The percentage of complete responders increased the subsequent days of the course. Emesis after day 1 was observed primarily during courses with the most emetogenic chemotherapy. No side-effects of tropisetron other than a single case of diarrhoea were documented in this study. (C) 1995 Wiley-Liss, Inc.

SUMMARY The objective of this prospective cohort study was to evaluate the expression of activation markers on CD8 lymphocytes at various clinical stages of HIV infection and to determine the value of these markers in identifying patients likely to have rapidly progressive disease. One hundred and three HIV+ patients, divided into four disease stages, and 34 seronegative controls were evaluated at study entry using flow cytometric immunophenotyping. The HIV patients were followed clinically for disease progression during the following 2 years. CD8 cell numbers and percentage of lymphocytes are increased after HIV infection. Expression of the CD38, HLA-DR and CD57 markers on CD8 cells was significantly increased in asymptomatic HIV-infected patients when compared with controls, as was the CDS cell population which did not coexpress Leu-8. These activation markers were observed to be further increased in patient groups with more clinically advanced infection. The percentage of CD38 on CD8 cells emerged not only as a discriminator of disease severity, but was a strong predictor of progression in asymptomatic, lymphadenopathy and ARC patients. Given the utility of activation markers on CDS lymphocytes in staging disease and predicting clinical outcome, the measurement of these parameters should be considered in the monitoring and management of HIV patients.

Flow cytometric analysis of major lymphocyte populations and their subsets reveals age-related changes in the cellular human immune system. Immunophenotypic markers were evaluated in 110 normal pediatric subjects, divided into groups of newborn infants, infants aged 2 days to 11 months, and children aged 1 to 6 years and 7 to 17 years; results were then compared with those obtained from 101 normal adults aged 18 to 70 years. Comparisons among age groups from newborn infants through adults reveal progressive declines in the absolute numbers of leukocytes, total lymphocytes, and T, B, and natural killer (NK) cells. The percentages of T cells within the total lymphocyte population increase with age; in both CD4 + and CD8 + subsets. Percentages of B and NK cells are higher in newborn infants than in adults. The expression of the activation markers interleukin-2R and HLA-DR on T cells increases with age, as does the NK-associated expression of CD57 on CD8 cells. The proportions of B lymphocytes that coexpress CD5 of CDw78 decrease with age, whereas expression of Leu-8 and CD23 increases. The proportion of CD4 cells bearing the CD45RA and Leu-8 markers is consistently lower in adults than in children. These data may serve as a reference range for studies of pediatric subjects.

Using two colour immunofluorescence with fluorescein isothiocyanate and phycoerythrin labelled monoclonal antibodies, multi-parameter flow cytometry was used to examine the antigenic characteristics of peripheral blood lymphocytes in whole blood of patients with ulcerative colitis and Crohn's disease who were not taking immunosuppressive drugs. The numbers of CD4+ and CD8+ lymphocytes in patients with ulcerative colitis and Crohn's disease remained unchanged so that the CD4/CD8 ratio was the same as that of normal control subjects. In Crohn's disease there were many activated T cells (CD3+, CD25+). Although natural killer cells in active Crohn's disease were lower than in normal control subjects, cytotoxic T lymphocytes, as defined by CD3+, CD16+, did not differ in patients with inflammatory bowel disease compared with normal control subjects. For B cell subsets, there were differences in Leu-1+ B cells, Leu-8+ B cells, Fc epsilon R+B cells (Leu-16+, Leu-20+), and activated B cells (Leu-12+, Leu-21+) between patients with inflammatory bowel disease and normal control subjects. These differences are compatible with local activation of B cells in the inflamed colon.

HIV, the etiologic agent of AIDS, is tropic for human cells expressing the CD4 molecule on their surface and lytic for infected CD4 lymphocytes [1,2]. The immunologic characteristics of patients infected with this virus reveal a broad spectrum of abnormalities, most of which are related to the direct infection and destruction of T-helper cells. Other abnormalities, such as the polyclonal activation of B-lymphocytes and the alterations of T-suppressor cells are not entirely explained. Investigations of these abnormalities may lead to further insight into the mechanisms of disease and additional objective diagnostic and prognostic parameters. Prior investigations have demonstrated promising results, but have been hampered by the variable status of patient treatment, inappropriate grouping of patients, or nonstandardized reagent combinations [3,4]. The aim of the present study was to use standardized, well-characterized reagent combinations, with an established sample preparation technique and a routine analysis software to determine which CD8 subsets would discriminate among various clinically defined HIV-1 infected subsets.

In a prospective randomized study to determine whether prevention of colonization of Gram-negative bacteria results in prevention of Gram-negative bacterial infections, 96 intensive care patients were randomly allocated into a control group and a study group. The study group received oral nonabsorbable antimicrobial agents (i.e., tobramycin, amphotericin B, and polymyxin E) in addition to parenteral antibiotics. Colonization with Gram-negative microorganisms in the oropharynx, and respiratory and digestive tracts increased in the control group during their stay, while the study group did not tend to colonize with Gram-negative bacteria. In the control group, 107 nosocomial infections were diagnosed, vs. 42 nosocomial infections in the study group. Nosocomial infections caused by Gram-negative bacteria were significantly less frequent in the study group. Mortality due to an acquired infection was significantly less frequent in the study group. We conclude that colonization, infection, and subsequent mortality by nosocomial Gram-negative bacteria can be prevented by a regime of topically applied nonabsorbable antibiotics.

Pentagastrin (Peptavlon, ICI 50123) is known as a powerful stimulator of gastric acid secretion. Several authors have demonstrated a close relationship between gastric acid secretion and gastric blood flow. In this study the general hemodynamic properties of pentagastrin were investigated qualitatively and quantitatively. The study was performed on anesthetized mongrel dogs. Blood flow was assessed with non-cannulating electromagnetic flow probes. Pentagastrin was injected intravenously at intervals of 2 min in amounts between 1 ng and 8192 ng/kg, following a logarithmic scale. Pentagastrin dose-dependently increased splanchnic blood flow in a reversed U-shaped manner. The major vasoactivity occurred in two organ areas--the gastric area and the pancreatico-duodenal area. Pentagastrin increased blood flow in these areas to 300% and 350% of initial value, respectively, at a dose of 2-4 microgram/kg. Since heart rate, cardiac output, and arterial pressure were not influenced, pentagastrin had no general hemodynamic effect. This was confirmed by blood flow measurements in the renal a., common carotid a., and femoral a. It was therefore concluded that the splanchnic blood flow increase was due to an extreme decrease of splanchnic vascular resistance.

Lipids and apoproteins as well as other coronary risk factors were measured in offspring of patients who suffered from a myocardial infarction before the age of 50 years; the results are compared with the results of a control group matched for age and sex. Significant differences were observed in the apoprotein A1 level, in the protein/fat ratios of high- and low-density lipoproteins, and in smoking habits. In a multivariate analysis, the offspring group was found to be different from the control group in nonhigh-density lipoprotein cholesterol/apoprotein B ratio, high-density lipoprotein cholesterol/apoprotein A1 ratio, smoking habits, apoprotein A1, and apoprotein A2. By means of these variables a total of 85% of all subjects could be correctly classified. We conclude that as early as age 21 years the offspring of patients with premature coronary heart disease differ from matched control subjects in lipoprotein measurements and in smoking habits.

In anesthetized dogs the arterial hepatic flowproper was calculated by subtracting gastroduodenal artery flow from hepatic artery flow, using probes from a sine wave electromagnetic flowmeter. Additionally, renal blood flow was measured. Using this technique, earlier evidence that parathyroid extract (PTE) augmented arterial hepatic and renal flow was confirmed. This information was valuable because in the earlier study the effects had been assessed only on celiac flow after extirpation of stomach, pancreas and/or spleen. Synthetic bovine parathyroid hormone, containing the first 34 amino acids was shown to have a similar effect as PTE. Thus, the hemodynamic action of PTE indeed was due to the same chemical entity that influences calcium metabolism. The augmentation of arterial hepatic flow (4–5-fold) was large, the dosage needed small (ED50 appr. 200 ng/kg, i.e., 0.6 IU/kg), the effect (maximum within 1 min) as well as the disappearance rate quick (return to 50% of the maximum obtainable within 15 min). ...

A 5 to 12 year follow-up study of 132 patients with nonobstructive duodenal ulcer treated by HSV without a drainage procedure was done. The results of pre- and postoperative gastric emptying studies and pre- and postoperative acid secretion studies were related to recurrent ulceration and postoperative complaints. The almost 9 percent of instances of recurrent ulceration were found in the group of patients with preoperative PPAO values greater than 40 mmol/hr. In all 13 patients with preoperative PPAO values greater than 60 mmol/hr, HSV was considered a failure. It was concluded that at least the latter group should be excluded from HSV. In 4.3 percent of patients serious gastric stasis after HSV was cause for reoperation. In spite of meticulous denervation and peroperative open pH metry, inadequate vagotomy, defined as percent reduction of PIAO values after HSV less than 75 percent, was found in 33 out of 117 patients. In an experimental study, vascular occlusion alone also gives a positive Grassi test. From both facts the relative value of this test can be concluded. Symptoms after inadequate vagotomy were again clearly related to preoperative PPAO values.

Arterial blood flow was measured in 18 arteries leading to nearly all major organs in the anesthetized dog, to obtain information about the specificity of the blood flow effects caused by secretin. This gastro-intestinal hormone was administered intravenously in a sequence of bolus injections (0.001--4 U/kg). Blood flow increase in the pancreatico-duodenal arteries was highest of all arteries observed. This flow increase in the superior pancreatico-duodenal artery was also found in its truncal artery (gastroduodenal a.), but to a less extend: the effect was diluted by the other--less reacting--branch (right gastro-epiploic a.) of the same truncal artery. We conclude that secretin preferentially increased blood flow in the pancreatico-duodenal arteries. Since secretin effects on heart rate and arterial pressure were but small, the flow increase in the pancreatico-duodenal area were caused by a lowering of the resistance of the pancreatico-duodenal vasculature. Comparison between the flow responses, elicited by secretin (Boots) and secretin (Karolinska), is discussed.

The purpose of this study was to analyze the distribution and composition of the HDL subclasses in students whose parents suffered from a premature coronary heart disease (CHD), in comparison with a control group without any familial history of CHD. In the first part of this study [1], we observed significantly lower apo A-1 concentrations in the cases than in the controls. Since there was a significant difference in smoking habits between cases and controls, and since we wanted to study the effect of a parental history of premature CHD on the composition of the HDL subclasses independently of smoking, the present study was conducted on the 17 pairs of non-smokers male cases and controls. In agreement with the results on total serum, we observed lower apo A-I concentrations in the HDL 2b and HDL 2a+3a fractions in the cases compared to the controls. The apo A-II and cholesterol levels in these fractions were not significantly different between the 2 groups. The selective decrease of apo A-I in the HDL subclasses with the lowest density might be due to a decreased number of particles containing only apo A-I, with which a protective effect against atherosclerosis might be associated.

Nosocomial infections are a major problem in intensive care patients. Thirty-nine patients, requiring intensive care for 5 days or more (mean 15.8 days) were prospectively investigated, to determine the relation between colonisation and nosocomial infection. Thrice weekly, cultures from the oropharynx, respiratory and digestive tract were obtained. Colonization with aerobic gram-negative microorganisms of the oropharynx, respiratory and digestive tract significantly increased during the stay in the Intensive Care Unit. In 29 patients (74%) 78 nosocomial infections were diagnosed. The most frequent nosocomial infections were pneumonia (26 patients, 66.6%), catheter-related bacteraemia (11 patients, 28.2%), and wound infections (7 patients, 17.9%). In 59 instances (75.6%), colonization with the same potential pathogenic microorganism preceded the nosocomial infection. The overall mortality was 25.6% (10 patients), bacteraemia with aerobic gram-negative microorganisms being the cause of death in 7 patients.