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81.

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   
82.
档案管理是医院管理中一项重要的内容。医院传统档案管理已经不能满足现代化社会发展的要求,基于此需要加强对医院档案管理的创新,只有在加快医院档案管理创新的基础上才能提高档案管理的效率和水平,并推动社会的进一步发展,可见创新医院档案管理方法是时代发展的必然选择。该文主要针对现阶段创新医院档案管理工作方法的相关问题进行研究,目的是为医院档案管理纳入新的工作方法,提高医院管理水平。  相似文献   
83.
目的探讨喉癌患者血小板表面血小板膜糖蛋白Ⅱb/Ⅲa纤维蛋白原受体(PAC-1)、血小板P-选择素(CD62P)阳性表达率以及与患者临床病理特征和复发的关系。方法选取2014年1月~2015年12月间在我院耳鼻喉科手术治疗的116例喉癌患者,随访≥2年,并选取同期在我院体检的健康人群60例为对照组,采用流式细胞仪检测法检测外周血PAC-1和CD62P阳性率,并分析与临床病理特征、复发的关系。结果喉癌患者PAC-1和CD62P阳性表达率分别为(17.82±1.76)%和(22.87±3.13)%,明显高于健康人群(P<0.05);而且在喉癌患者PAC-1表达和CD62P表达呈正相关性(r=0.238,P<0.05)。T3-T4分期或N2-N3分期患者PAC-1和CD62P阳性表达率高于T1-T2分期或N0-N1分期患者(P<0.05)。另外远处转移组PAC-1和CD62P阳性表达率高于未发生转移组(P<0.05);随访期间有24例患者复发,复发率为20.69%。复发喉癌患者PAC-1、CD62P阳性表达率分别为(17.02±0.85)%和(21.84±1.17)%,明显高于未复发的喉癌患者(P<0.05)。经Logistics回归分析,PAC-1和CD62P是喉癌患者复发的独立危险因素(P<0.05)。结论PAC-1和CD62P阳性表达率与喉癌患者T分期、淋巴结转移和远处转移密切相关,同时可作为喉癌局部复发、区域淋巴结转移、远处转移的预测指标。  相似文献   
84.
85.
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   
86.
87.
Background and Study AimsIn developing countries, endemic indications, blood shortages, and the scarcity of liver surgeons and intensive care providers can affect liver resection (LR) outcomes, but these have been rarely addressed in the literature. Therefore, in this study we determined risk factors for major complications after LR in a North African general surgery and teaching department.Patients and MethodsFrom January 2010 to December 2015, 213 consecutive LRs were performed on 203 patients. All patients underwent a postoperative follow-up of >90 days. Postoperative complications were assessed according to the Clavien–Dindo (CD) classification of surgical complications. A score of CD ≥III is considered as major postoperative complications. In this study, we analyzed the variables assumed to affect these complications.ResultsThe overall 90-day complication rate was 35.7% (n = 76), including a CD ≥III of 14% (n = 30) and a mortality rate of 6.1% (n = 14). According to the multivariate analysis, a preoperative performance status (PS) of ≥2 (P = 0.011; odds ratios [OR], 6.8; 95% confidence intervals [CI], 1.55–29.8), an estimated intraoperative blood loss of >500 ml (P = 0.002; OR, 3.71; 95% CI, 1.23–11.20), and bilioenteric anastomosis (P < 0.004; OR, 7.76; 95% CI, 1.5–3.89) were independent risk factors for major complications after LR.ConclusionWe recommend that, in the setting of a non-Eastern/non-Western general surgery and teaching department, patients with a PS of ≥2 should undergo a specific selection and preoperative optimization protocol; intermittent clamping indications should be extended; and special attention should paid to patients undergoing LR associated with biliary reconstruction, such as for perihilar cholangiocarcinoma.  相似文献   
88.
89.
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   
90.
目的:评定LC-MS/MS法测定人血浆中布康唑浓度的不确定度。方法:分析测定过程中不确定度的来源,包括对照品的称量、仪器误差、标准溶液的配制、含药血浆样品的配制、血浆样品的处理、标准曲线的拟合、基质效应、重复性等,评定各来源分量的不确定度,计算合成不确定度和扩展不确定度。结果:人血浆中低(60.0 pg·mL-1)、中(600.0 pg·mL-1)、高(6 400.0 pg·mL-1)浓度布康唑的扩展不确定度分别为5.62,63.90,626.26 pg·mL-1k=2,P=95%)。结论:LC-MS/MS法测定人血浆中布康唑浓度的不确定度主要由基质效应、血浆样品的处理(提取回收率),仪器误差、重复性(精密度)引入。  相似文献   
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