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ObjectiveEpratuzumab, a monoclonal antibody that targets CD22, modulates B cell signaling without substantial reductions in the number of B cells. The aim of this study was to report the results of 2 phase III multicenter randomized, double-blind, placebo-controlled trials, the EMBODY 1 and EMBODY 2 trials, assessing the efficacy and safety of epratuzumab in patients with moderately to severely active systemic lupus erythematosus (SLE).MethodsPatients met ≥4 of the American College of Rheumatology revised classification criteria for SLE, were positive for antinuclear antibodies and/or anti-double-stranded DNA antibodies, had an SLE Disease Activity Index 2000 (SLEDAI-2K) score of ≥6 (increased disease activity), had British Isles Lupus Assessment Group 2004 index (BILAG-2004) scores of grade A (severe disease activity) in ≥1 body system or grade B (moderate disease activity) in ≥2 body systems (in the mucocutaneous, musculoskeletal, or cardiorespiratory domains), and were receiving standard therapy, including mandatory treatment with corticosteroids (5-60 mg/day). BILAG-2004 grade A scores in the renal and central nervous system domains were excluded. Patients were randomized 1:1:1 to receive either placebo, epratuzumab 600 mg every week, or epratuzumab 1,200 mg every other week, with infusions delivered for the first 4 weeks of each 12-week dosing cycle, for 4 cycles. Patients across all 3 treatment groups also continued with their standard therapy. The primary end point was the response rate at week 48 according to the BILAG-based Combined Lupus Assessment (BICLA) definition, requiring improvement in the BILAG-2004 score, no worsening in the BILAG-2004 score, SLEDAI-2K score, or physician's global assessment of disease activity, and no disallowed changes in concomitant medications. Patients who discontinued the study medication were classified as nonresponders.ResultsIn the EMBODY 1 and EMBODY 2 trials of epratuzumab, 793 patients and 791 patients, respectively, were randomized, 786 (99.1%) and 788 (99.6%), respectively, received study medication, and 528 (66.6%) and 533 (67.4%), respectively, completed the study. There was no statistically significant difference in the primary end point between the groups, with the week 48 BICLA response rates being similar between the epratuzumab groups and the placebo group (response rates ranging from 33.5% to 39.8%). No new safety signals were identified.ConclusionIn patients with moderate or severely active SLE, treatment with epratuzumab + standard therapy did not result in improvements in response rates over that observed in the placebo + standard therapy group.

Purpose: The current study examined possible links between threat perception, anxiety, conscientiousness and parental noncompliance with preoperative fasting instructions for their children., Methods: 100 mothers of children about to undergo an ambulatory elective surgery were divided to two equal groups based on compliance/noncompliance with pre surgery fasting requirements. Logistic regression analysis was preformed to predict compliance/noncompliance. In addition a logistic model estimating the effect of anxiety and conscientiousness levels, and their interaction, on the probability of fasting was performed., Results: Mothers who did not comply with fasting requirements perceived the procedure as more threatening, were more anxious and had lower conscientiousness levels. Additionally, mother's anxiety prior to surgery mediated the association between mothers' threat perception and compliance. Finally, conscientiousness moderated the anxiety and compliance association so that high conscientiousness levels reduced the effect of anxiety, elevating the likelihood of anxious mothers to comply with fasting guidelines., Conclusions: Based on these findings we recommend medical staff to make significant efforts to identify highly anxious parents as early as possible during the preoperative process. Innovative assessment and intervention tools should be developed in order to conduct a smooth medical operation and reduce the chance of unnecessary and costly surgery cancelation., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Purpose: Meatotomy is a simple, common procedure for the treatment of meatal stenosis. We compared the outcomes of meatotomy performed using local anesthesia and sedation, and general anesthesia with and without penile block., Materials and Methods: A prospective comparative design was used. Participants included 76 boys 1.5 to 10 years old treated for meatal stenosis at a tertiary, university affiliated, pediatric medical center in 2008. Children were randomly allocated to undergo surgery with sedation and local anesthesia, or general anesthesia with or without penile block. All procedures were performed with the same method by the same surgeon. For local anesthesia EMLA 5% cream (lidocaine 2.5% and prilocaine 2.5%) covered with an occlusive dressing was applied 1 hour preoperatively, and midazolam (in patients younger than 5 years) or nitrous oxide (older than 5 years) was used for sedation. General anesthesia was induced with inhaled sevoflurane, and ropivacaine was used for dorsal penile nerve block., Results: There was no difference among the groups in pain level intraoperatively (no pain in 92% to 93% of patients), 24 hours postoperatively (no pain in 81% to 88%) or after 1 month, or in complication rates (bleeding in 3 patients, laryngospasm in 2). General anesthesia with penile block was associated with a trend of less dysuria. Quality of void was excellent in 87% of patients at 24 hours and in 70% at 1 month, and parental satisfaction was high (88% to 92%)., Conclusions: Meatotomy performed using local anesthesia and sedation has an equally good outcome to meatotomy performed using general anesthesia with or without penile block., (Copyright © 2011 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Evaluation of the renal changes by conventional and Doppler ultrasound (US) was performed in patients with hypertension and obesity. 67 persons were examined and divided in 3 groups. Group I includes 27 patients--15 M and 12 F, average age 52+/-4.87 with well controlled diabetes mellitus type II and hypertension, Ccr.--139+/-1.31. Group II includes 20 patients--9 M and 11 F, average age 53+/-7 with well controlled hypertension without diabetes, with Ccr 128+/-7.8. Group III--20) pts. 8 F and 12 M, average age 54+/-5 with uncontrolled hypertension without diabetes, with Ccr 128+/-7.8. All examined pts. were with BMI>30 and hyperlipidemia--total cholesterol>6.5 mmol/l. Tests for microalbuminuria were negative in all 3 groups. In all three groups, using conventional US, the following parameters were detected by Aloca 4000 machine: renal (RV) and parenchyma (PV) volumes as well as Doppler parameters RI, PI, Vmax, Vmin, and Vmean. There were no significant differences between RV and PV of all examined groups: Group I--254+/-53, Group II--238+/-38, Group III--263+/-38, p=0.1. The strong correlation between renal volumes and BMI was found (Pearson's r 0.58). There were no significant differences between Vmax, Vmin, Vmean in all three groups. RI is normal <0.7 in all examined patients: Group I--0.63+/-0.06, Group II--0.61+/-0.02, Group III--0.66+/-0.03. RI in group III was significantly higher, p<0.05 compared to RI indices detected in other two groups but remains at normal levels. Intrarenal hemodynamics exhibited no difference in all examined groups. Analysis of the Doppler spectrum of the intrarenal arteries provides an accurate information about renal vascular changes but has no significant advantages in patients with hypertension and obesity with normal renal function and signs of hypertensive nephropathy "benign nephrosclerosis". Nevertheless Duplex Doppler Ultrasound is a noninvasive method which is an important part of the diagnostic algorithm in patients with diseases characterized by vascular involvement such as hypertension.

Background: Preeclampsia (PE) is a pregnancy complication usually of the third trimester. The clinical manifestations are hypertension and proteinuria with or without edema. Its pathogenesis is characterized by generalized vasoconstriction and endothelial dysfunction. The aim of this study was to evaluate the diagnostic value of the Doppler ultrasound examination of the renal interlobar vessels in pregnancy complicated with preeclampsia in the context of the theory about the increased vessel resistance in this pregnancy disorder., Methods: Fifty two women aged 16-38, (mean age 23+/-9.54) streamed into three groups were examined by abdominal ultrasound in Triplex regime. The first group included 18 pregnant with PE, the second 21 women in the third trimester of normal pregnancy, and the third group 13 non-pregnant women. In all 3 groups the renal volume (RV) and parenchyma volume (PV) were determined by conventional ultrasound (CU). The doppler waveform analysis (DWA) of the interlobar renal arteries (IRA) gave the following indices: resistance index (RI), pulsatility index (PI), peak systolic velocity (Vmax) and end diastolic velocity (Vmin). RESULTS. RV and PV in the PE group were significantly higher then those of the healthy pregnant women: RV: 231.4+/-58 to 187+/-45, p<0.05 and for PV: 200+/-11 to 130+/-6.78, p<0.05. Such a difference was not found out for the healthy pregnant women compared to the non-pregnant ones. No significant differences of the examined doppler indices were found in the three groups., Conclusion: Although the arteriolar vasoconstriction and the tissue hypoxia are leading in the PE pathogenesis, the DWA of the IRA in PE pregnancy does not differ from those of the healthy pregnant and nonpregnant women. As one of the most frequently used imaging technique Doppler Ultrasound (DU) of the renal IRA and DWA of these vessels shows no diagnostic advantage as compared to the renal CU in pregnancy complicated with PE.

Background: Different autoantibodies and immunologic abnormalities have been described in heroin abusers positive for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus, as well as in addicts with negative viral markers., Objectives: To investigate the prevalence of different autoantibodies in heroin addicts., Methods: We studied 10 heroin addicts (8 males and 2 females aged 18-30 years) with a mean duration of heroin abuse of 46.5 months (range 6-96) for the presence of the following autoantibodies: antinuclear antibodies and anti-neutrophil cytoplasmic antibodies--using indirect immunofluorescent technique; ds-DNA, ss-DNA, Sm, RNP, Ro and La antibodies--using counter immunoelectrophoresis; and immunoglobulins G and M anticardiolipin and beta 2-glycoprotein-I antibodies--using enzyme-linked immunosorbent assay. All patients were tested for VDRL, HIV, HBsAG and anti-HCV antibodies., Results: Four patients were positive for ANA, of whom two were positive for anti-HCV and two for ANCA. Three patients were positive for IgM aCL, one of whom was positive for IgG beta 2 GPI with clinical data of acute renal failure in the course of heroin coma and antiphospholipid syndrome (deep vein thrombosis) and positive Sm and ds-DNA antibodies, and another had subacute endocarditis and biopsy-proven chronic tubulo-interstitial nephritis (in both these patients aCL gradually fell to normal levels after the cessation of heroin abuse). One patient was HBsAG positive with negative autoantibodies. All patients were HIV and VDRL negative., Conclusion: Our data support the importance of ANA and aCL determination as a predictor of some systemic complications in heroin addicts.