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41.
Marta López-Fauqued Laura Campora Frédérique Delannois Mohamed El Idrissi Lidia Oostvogels Ferdinandus J. De Looze Javier Diez-Domingo Thomas C. Heineman Himal Lal Janet E. McElhaney Shelly A. McNeil Wilfred Yeo Fernanda Tavares-Da-Silva 《Vaccine》2019,37(18):2482-2493
Background
The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies.Methods
Adults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years were randomly vaccinated with RZV or placebo. Safety analyses were performed on the pooled total vaccinated cohort, consisting of participants receiving at least one dose of RZV or placebo. Solicited and unsolicited adverse events (AEs) were collected for 7 and 30?days after each vaccination, respectively. Serious AEs (SAEs) were collected from the first vaccination until 12?months post-last dose. Fatal AEs, vaccination-related SAEs, and potential immune-mediated diseases (pIMDs) were collected during the entire study period.Results
Safety was evaluated in 14,645 RZV and 14,660 placebo recipients. More RZV than placebo recipients reported unsolicited AEs (50.5% versus 32.0%); the difference was driven by transient injection site and solicited systemic reactions that were generally seen in the first week post-vaccination. The occurrence of overall SAEs (RZV: 10.1%; Placebo: 10.4%), fatal AEs (RZV: 4.3%; Placebo: 4.6%), and pIMDs (RZV: 1.2%; Placebo: 1.4%) was balanced between groups. The occurrence of possible exacerbations of pIMDs was rare and similar between groups. Overall, except for the expected local and systemic symptoms, the safety results were comparable between the RZV and Placebo groups irrespective of participant age, gender, or race.Conclusions
No safety concerns arose, supporting the favorable benefit-risk profile of RZV. 相似文献42.
Walid K. Abu Saleh Phillip Mason Odeaa Al Jabbari Hany Samir Brian A. Bruckner 《Texas Heart Institute journal / from the Texas Heart Institute of St. Luke's Episcopal Hospital, Texas Children's Hospital》2015,42(6):569-571
The Impella 5.0, a percutaneously inserted left ventricular assist device, has been used to support patients who have severe heart failure or who are undergoing high-risk percutaneous coronary intervention. We report our surgical placement of the Impella 5.0, through a graft sewn to the aorta, to unload the left ventricle of a 59-year-old man who was undergoing venoarterial extracorporeal membrane oxygenation for postcardiotomy shock. The patient underwent successful placement of a long-term left ventricular assist device before his discharge from the hospital. The versatility of the Impella 5.0 is exemplified in this patient who was successfully bridged to long-term support. 相似文献
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Frédéric Janvier Deborah Delaune Thomas Poyot Eric Valade Audrey Mérens Pierre E. Rollin Vincent Foissaud 《Emerging infectious diseases》2016,22(2):292-294
We evaluated RNA stability of Ebola virus in EDTA blood and urine samples collected from infected patients and stored in West Africa’s environmental conditions. In blood, RNA was stable for at least 18 days when initial cycle threshold values were <30, but in urine, RNA degradation occurred more quickly. 相似文献
45.
《Cor et vasa》2015,57(3):e157-e162
IntroductionObstructive sleep apnea (OSA) is often connected with arterial hypertension and it could also be a cause of secondary hypertension. Treatment of arterial hypertension and optimal blood pressure level are important for prevention of cardiovascular complications. It is not well known how to treat patients with OSA and arterial hypertension. Also many patients with OSA suffer from metabolic syndrome which worsen their prognosis.AimThe aim of our study was to assess arterial hypertension compensation in patients with metabolic syndrome and moderate to severe OSA and to analyze used pharmacotherapy.Materials and methods85 hypertensive patients (75 men) with metabolic syndrome, average age 53.6 ± 9.3 years, were evaluated using overnight sleep study with diagnosis of OSA, average apnea–hypopnea index (AHI) 56.3 ± 23. Patients underwent 24 h ambulatory blood pressure monitoring (ABPM) and their current pharmacotherapy data were obtained. Appropriate combinations of antihypertensive drugs (patients with metabolic syndrome) were derived from ESH/ESC 2013 guidelines.ResultsArterial hypertension was well compensated in only 11.8% of the patients. 24.7% patients were treated according to current guidelines. Fisher's exact test with analysis of adjusted residues has found higher rate of blood pressure subcompensation in patients treated with triple+ combination of drugs (p = 0.035, 51.4% vs 10%).ConclusionOnly a small number of patients had optimal blood pressure level and were treated according to current ESH/ESC guidelines. We have to constantly appeal to all physicians to perform ABPM in patients with OSA. 相似文献
46.
Parallel enzyme‐linked immunosorbent assay screening for human immunodeficiency virus among blood donors in five Chinese blood centres: a retrospective analysis 下载免费PDF全文
47.
Nirmanmoh Bhatia Buddhadeb Dawn Tariq S. Siddiqui Marcus F. Stoddard 《Texas Heart Institute journal / from the Texas Heart Institute of St. Luke's Episcopal Hospital, Texas Children's Hospital》2015,42(1):16-24
Determining aortic stenosis (AS) severity is clinically important. Calculating aortic valve (AV) area by means of the continuity equation assumes a circular left ventricular outflow tract (LVOT). The full impact of this assumption in calculating AV area is unknown. Predictors of noncircular LVOT shape in patients with AS are undefined.In 109 adult patients with AS who underwent multiplanar transesophageal echocardiography, we calculated AV area by means of the standard continuity method and by a modified method involving planimetric LVOT area.We found 54 circular, 37 horizontal-oval, 8 vertical-oval, and 10 irregular LVOTs. Area derived by direct planimetry correlated better with the modified than the standard continuity method (r=0.89 vs r=0.85; both P=0.0001). Valve areas of patients with mild, moderate, or severe AS by planimetry were more often mischaracterized with use of the standard than modified method (29 vs 18; P <0.0001). Horizontal-oval AV area derived by planimetry (1.28 ± 0.55 cm2) was underestimated by the standard method (1.05 ± 0.47 cm2; P=0.001), but not by the modified method. Congenital AV morphology and low cardiac index were the only multivariate predictors of horizontal-oval shape. Low cardiac index was the only predictor of noncircular shape.More than half our patients with AS had noncircular LVOTs. Using the modified method reduces mischaracterizations of AS severity. Congenital AV morphology and low cardiac index predict horizontal-oval or noncircular shape. These data suggest the value of direct LVOT measurement to calculate AS severity in patients who have congenital AV or a low cardiac index. 相似文献
48.
目的探讨8周基础军训(basic military training,BMT)对入伍新兵血像中红细胞及其相关指标的影响,为指导科学的军事训练提供参考。方法数据来自新疆边防部队2015年度入伍的50名男性新兵,分别在BMT前后测定并记录受试新兵的红细胞计数、血红蛋白浓度及血清铁蛋白等。结果经过8周的BMT,新兵血液中血红蛋白浓度、红细胞计数及血清铁蛋白均显著下降(P0.05,P0.01)。结论 8周BMT可能导致入伍新兵发生运动性贫血,铁缺乏可能是其主要原因。 相似文献
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