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1.

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.
ObjectiveTo examine how relatives evaluate the quality of communication with the treating physician of a dying resident in long-term care facilities (LTCFs) and to assess its differences between countries.DesignA cross-sectional retrospective study in a representative sample of LTCFs conducted in 2015. Relatives of residents who died during the previous 3 months were sent a questionnaire.Settings and participants761 relatives of deceased residents in 241 LTCFs in Belgium, England, Finland, Italy, the Netherlands, and Poland.MethodsThe Family Perception of Physician-Family Communication (FPPFC) scale (ratings from 0 to 3, where 3 means the highest quality) was used to retrospectively assess how the quality of end-of-life communication with treating physicians was perceived by relatives. We applied multilevel linear and logistic regression models to assess differences between countries and LTCF types.ResultsThe FPPFC score was the lowest in Finland (1.4 ± 0.8) and the highest in Italy (2.2 ± 0.7). In LTCFs served by general practitioners, the FPPFC score differed between countries, but did not in LTCFs with on-site physicians. Most relatives reported that they were well informed about a resident's general condition (from 50.8% in Finland to 90.6% in Italy) and felt listened to (from 53.1% in Finland to 84.9% in Italy) and understood by the physician (from 56.7% in Finland to 85.8% in Italy). In most countries, relatives assessed the worst communication as being about the resident's wishes for medical treatment at the end of life, with the lowest rate of satisfied relatives in Finland (37.6%).ConclusionThe relatives' perception of the quality of end-of-life communication with physicians differs between countries. However, in all countries, physicians' communication needs to be improved, especially regarding resident's wishes for medical care at the end of life.ImplicationsTraining in end-of-life communication to physicians providing care for LTCF residents is recommended.  相似文献   
3.
In a retrospective study using univariate analysis, we identified tumor type (nonendometrioid vs endometrioid), depth of myoinvasion (MI), mode of MI (infiltrative vs cohesive), and direct anatomic invasion of the cervical wall from the isthmus as significant positive risk factors for intramyometrial lymphvascular space involvement (LVSI). On multivariate analysis, tumor grade, depth of MI, and mode of MI retained their significance. We created a grid for the relative risks of LVSI with respect to these variables individually or in combination. We suggest that our indirect estimate of the risk of LVSI can help in assessing prognosis and determining the need for adjuvant therapy whenever LVSI is important in clinical decision making, but its pathologic diagnosis is uncertain.  相似文献   
4.
目的 对比分析食管癌病例组与对照组血缘亲属食管癌患病风险,并了解食管癌家族中危险亲属人群患病的新线索.方法 采用病例对照研究方法 ,对食管癌病例组及对照组各720例进行逐层分析,以比较两组各血缘亲属父系、母系食管癌患病危险度(OR)的大小及差异.结果 (1)病例组Ⅰ级亲属食管癌患病危险度(1.34%~2.24%)显著高于对照组(0.78%~1.21%)(P<0.01);Ⅰ级亲属中病例组父母亲食管癌患病危险度为6.11%,显著高于对照组父母亲食管癌患病危险度2.97%(P<0O01).(2)以血缘亲属中父系和母系亲属逐层分析可见,病例组父系食管癌患病危险度(0.87%~1.01%)与母系患病危险度(0.50%~0.79%)均显著高于对照组父系食管癌患病危险度(0.53%~0.65%)与母系患病危险度(0.38%~0.47%)(P<0.05).进一步分析显示,病例组父系中男性亲属与母系中女性亲属,即父系中祖父、父亲、叔伯食管癌患病危险度为2.68%与母系中外祖母、母亲、姨的食管癌患病危险度1.91%均显著高于对照组父系中男性亲属食管癌患病危险度1.50%与母系中女性亲属食管癌患病危险度0.92%(P<0.01).结论 山西省食管癌患者血缘亲属发病危险主要是父亲及其兄弟、母亲及其姐妹,其下代患食管癌风险要大.  相似文献   
5.
作者对自制新荧光剂EPQS进行了性能测试。结果:量子产率为0.21;最大激发波长和荧光波长分别为375nm和484nm,stokes位移109nm;检测生物化合物常用的缓冲溶液对荧光峰位无影响,对荧光强度影响很小;温度的影响也小(18~43℃,FRI61.5~58.1),PH的影响也不大。说明EPQS不仅荧光参数好,而且稳定性也好。适合在较广泛的环境条件下使用。  相似文献   
6.
7.
R波相关振动法血压测量   总被引:1,自引:0,他引:1  
为了提高振地血压测量的准确性,提出了一咱基于心电R波与血压振动波之间相关性,识别振动信号的一种抗干扰方法=-R波相关法,结合振动波形特征识别,该方法可有效地提取信号,消除干扰影响,该算法已在16位8098单片机上实现,本文同时给出了程序的详细流程图。  相似文献   
8.
目的通过化学方法制成动物核性白内障模型,探讨相对能量复合指数(RECP)与角膜内皮细胞活性的关系。方法将5种化学物质注入晶状体,以透过黑白条纹的清晰程度判断晶状体混浊程度并分级。然后将实验眼球分为6组(Ⅰ组为对照组;Ⅱ-Ⅵ为实验组),行标准超声乳化白内障摘除手术。手术后立即取下角膜,作锥蓝-茜素红联合染色标本和扫描电镜标本。结果晶状体内注入甲醛、冰醋酸、无水乙醇、丙酮和苯扎溴铵均能形成晶状体混浊,其中:冰醋酸致晶状体混浊能力最弱,无水乙醇、丙酮次之,甲醛、苯扎溴铵最强。当RECP≤90时,锥蓝-茜素红双重染色和扫描电镜均表明角膜内皮细胞活性好,其形态和细胞联接均无改变。当RECP=120时,角膜内皮细胞形态尚正常,但是细胞联结和胞膜部分破坏。当RECP=150时,角膜内皮细胞严重损伤。结论用化学方法制作核性白内障模型供过渡训练使用是可行的。当RECP超过某一数值(>90)时,即与角膜内皮细胞的活性成负相关。  相似文献   
9.
10.
A new method for estimating relative efficacies and relative intrinsic efficacies of agonists is described. Relative efficacy is estimated by employing a newly defined efficacy related parameter (eES) and it may be estimated without prior knowledge of efficacy values or the value of the equilibrium dissociation constants, KA, of agonist-receptor complexes. The parameter eES is directly related to efficacy (e) and is defined as the ratio of maximal stimulus to maximal effect of an agonist. The value of eES indicates whether or not spare receptors are present for a particular agonist–effector system. The eES values of agonists are estimated by utilizing submaximal concentration–effect curves determined with fixed agonist-competitive antagonist concentration combinations and choosing a suitable reference (height of an agonistic concentration–effect curve) to which the height of the stimulus concentration–effect curves of the agonist may be compared. In addition to eES, other new agonist–effector parameters, namely SEm/Sm and φmin, were also defined.  相似文献   
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