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1.
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2.
Peter J. Morgan Lynda M. Williams Gary Davidson Wilfred Lawson Edward Howell 《Journal of neuroendocrinology》1989,1(1):1-4
The functional significance of the pars tuberalis (PT) of the mammalian adenohypophysis has remained an enigma (1, 2). One view of its function is that it acts as an auxiliary gland to support the endocrine role of the pars distalis (PD) (2), as it has been shown to contain immunocytochemically identifiable thyrotrophs and gonadotrophs (1). Many of the cells of the PT are, however, ultrastructurally unique suggesting an independent function for this tissue. Our recent demonstration that the PT of the rat is a major binding site for the ligand iodomelatonin lends further support to this idea (3). We have utilized the highly specific ligand [125 l]melatonin, and have demonstrated that it binds exclusively, with very high affinity, to the PT but not the PD of the adult sheep adenohypophysis. These findings support the conclusion that the PT has a distinct role in relation to melatonin action and seasonal reproduction. 相似文献
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Amit Dang MBBS Gaurav Garg Padmanabh V. Rataboli MD 《The International journal of eating disorders》2009,42(4):385-386
Nocturnal Sleep‐Related Eating Disorder (NSRED) is a well‐documented sleeping disorder where the person is reported to experience bizarre eating behavior during sleep. Although various causes are implicated in this disorder, role of drugs cannot be ruled out. Here we narrate an interesting rare case report of a drug‐induced new onset NSRED, where a 45‐year‐old man on zolipdem performed an unexpected and bizarre eating behavior during somnambulistic state, type of which has not been reported earlier in the literature. The case falls under even rarer category as such behavior in sleep is reported mainly in woman. © 2008 by Wiley Periodicals, Inc. Int J Eat Disord 2009 相似文献
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本试验探讨了华南双季稻区利用亚种同杂种优势的特点和问题,结果表明:当前,两系亚种问杂种一代主要存在的问题是结实率低和谷草比低;籼粳交杂种易受环境条件的影响;每穗实粒数和单株有效穗数是决定单株产量的重要因子;每穗实粒数增加的关键在于结实率的提高,本文还就提高结实率和谷草比等问题提出了意见。 相似文献
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Didier Chatel Laurent Delamare Patrick Dang Daniel Lebouvier Franqois Trocherie 《Artificial organs》1997,21(10):1098-1104
Abstract: For original ovoid shaped artificial ventricles. a biomechanical double sac consisting of a biological sac (porcine pericardium) as the blood contact interface and a synthetic sac (Pebax 3533) as the mechanical support to assume systolic-diastolic dynamic constraints was conceived. The volumetric and mechanical properties were assessed with a three-dimensional modeling of Pebax sacs and computerized simulations of their systolic distortions for both right and left ventricular configurations. The stresses and strains of these sacs were represented as quantitative mappings for a maximum end-systolic state and were below the respective threshold values above which the Pebax material is jeopardized for permanent structure impairment. After fatigue tests applied on Pebax strips under the alleged working conditions of Pebax sacs, the material structure was unchanged and maintained its intrinsic mechanical properties. The theoretical maximum stroke volumes were 74.4 cm3 and 62.4 cm for the left and right ventricular configurations, respectively. With these mechanical and volumetric features, the biomechanical double sac concept was considered valid and could be provided for a consequent specific total artificial heart. 相似文献
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CT图象的面罩式覆盖法定量诊断脂肪肝 总被引:1,自引:0,他引:1
目的 探讨脂肪肝的脂肪浸润程度的无创性检查方法及临床意义。方法 用 GE 30 0 0 I CT机扫描 36例脂肪肝患者肝脏、脾脏 ,用 CT机配备软件处理数据 ,面罩式覆盖法计算肝脏各个层面的脂肪面积与对应层面肝脏面积 ,并得出比值 (脂肪浸润指数 )。用生化仪检测肝功能指标。肝穿刺病理检测肝组织内脂肪浸润程度。结果 平均脂肪浸润指数与肝功能状态呈显著正相关 ,亦与肝穿刺的病理结果呈正相关 (r=0 .86 5 ,P<0 .0 1)。结论 CT图象面罩式覆盖法对脂肪浸润的定量分析是诊断脂肪肝可靠的无创性检查方法 ,对非均匀性脂肪肝该方法优于肝穿刺 相似文献