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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   
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目的:观察灯盏乙素(Scu)对β淀粉样蛋白(Aβ)诱导的细胞模型中1,4,5-三磷酸肌醇受体(IP3R)-Ca2+途径的影响,探讨其在阿尔茨海默病(AD)病程中可能发挥的积极作用。方法:选用神经母细胞瘤细胞分为对照组、Scu处理组、Aβ处理组、Aβ+Scu (高、中、低)处理组及Aβ+IP3R拮抗剂组,用CCK-8法筛选药物浓度并检测各组细胞生存率;用酶联免疫吸附法检测各组细胞中1,4,5-三磷酸肌醇(IP3)的含量;用蛋白印迹和实时荧光定量聚合酶链反应方法检测各组细胞IP3R和凋亡相关因子Caspase-3、Bcl-2、Bax的蛋白及mRNA的表达水平;用激光共聚焦显微镜观察各组细胞内Ca2+浓度的变化;用AnnexinV/PI双染法测定各组细胞的凋亡率。结果:与对照组和Scu处理组相比,Aβ处理组细胞存活率下降,IP3含量升高,IP3R、Bax和Caspase-3的蛋白及mRNA表达上调,Bcl-2蛋白及mRNA的表达下调,细胞胞浆内Ca2+浓度及细胞凋亡率升高;Aβ+Scu处理组细胞中各检测指标的变化与Aβ处理组的结果正好相反,IP3R通道下游指标的变化与Aβ+IP3R拮抗剂组基本一致。结论:Scu能够下调通路蛋白IP3、IP3R的表达,抑制Aβ介导的Ca2+内流所致的细胞凋亡,可能通过对IP3R-Ca2+途径的调控来影响AD病程。  相似文献   
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Introduction: Cutaneous T-cell lymphomas (CTCL) are rare non-Hodgkin lymphomas of skin-homing T-cells that initially or mainly manifest cutaneously. Treatment of CTCL is challenging given the disease states’ varying presentation and prognosis. Systemic treatment options often lack comparative evidence and have relatively low response rates and short duration of response. The recent Food and Drug Administration (FDA) approval of mogamulizumab in adult patients with relapsed or refractory (R/R) CTCL after at least one prior line of therapy provided a new treatment option to patients with advanced disease.

Areas covered: The authors discuss basic information about CTCL and mogamulizumab’s mechanism of action. Then, the authors discuss the agent’s efficacy. Finally, the authors evaluate the safety of mogamulizumab in comparison to other agents available in CTCL.

Expert opinion: Mogamulizumab has been shown to be an effective and well tolerated therapy for patients with relapsed and refractory MF/SS with excellent activity in the circulating component of the disease.  相似文献   

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INTRODUCTIONThis study aimed to investigate the therapeutic response to injected human umbilical cord blood mesenchymal stem cells (UCBMSCs) among albino rats with streptozotocin (STZ)-induced diabetes mellitus.METHODSControl group (GI; n = 25) rats were fed with standard rat diet. Rats with STZ-induced diabetes mellitus without (GII; n = 25) and with (GIII; n = 25) differentiated human UCBMSCs implantation were the test groups. Rats were sacrificed in Week 11 following implantation. Liver biopsies were sectioned and stained in order to highlight both the presence and function of impregnated cells in the liver tissue.RESULTSHaematoxylin and eosin-stained sections in GI and GII rats showed normal liver architecture while GIII rats showed presence of cell clusters inside the liver tissue and around the central veins. Cell clusters with blue cytoplasm were present in sections in GIII rats but absent in GI and GII rats, indicating the presence of injected differentiated human UCBMSCs. The anti-human insulin immunostaining of GIII rats showed clusters of cells within the liver parenchyma and around central veins, indicating that these cells were active and secreting insulin.CONCLUSIONUCBMSCs are proficient in differentiating into insulin-producing cells in vivo under specific conditions and, when transplanted into the liver of albino rats with STZ-induced diabetes mellitus, were able to secrete insulin and partially control the status of diabetes mellitus in rats.  相似文献   
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AIM: To introduce a novel technique for transscleral fixation of the PC-IOL that requires no sutures on the IOL haptics. METHODS: Instead of suturing polypropylene onto the IOL haptics, the method simply winds the thread on the haptics. Fifteen eyes of 15 patients underwent this technique and were followed up for more than 18 months. Surgical outcomes and post-operative complications were evaluated and compared with those of the conventional transscleral fixation method. RESULTS: Postoperative cylinder was significantly lower in the thread winding group than in the conventional transscleral fixation method group (-1.02±0.46 diopters vs -1.57±0.77 diopters; P=0.01). Further, no postoperative complications, such as optic capture, IOL dislocation, and hyphema, were detected in the thread winding group. CONCLUSION: We believe that our thread winding technique is better than previously reported methods because it is simple, mechanically stable, and free from suture-related complications.  相似文献   
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目的:描述胚胎种植前遗传诊断在1例携带Ⅰ型白细胞黏附缺陷病(LAD-1)携带者并完成健康妊娠夫妇中的应用。设计:病例报道。机构:大学医院生殖中心。患者:1例男女双方都是LAD-1携带者的夫妇,女方CD18基因的外显子4携带有G400A置换,男方的外显子5携带有C562T置换。干预:标准体外受精(IVF)后第3天行卵裂期活检和分裂球遗传分析以检测2处突变以及21号染色体标记物。主要观察指标:1个未罹患LAD-1婴儿的出生。结果:得到15个卵母细胞,其中10个受精。8个胚胎适宜胚胎活组织检查。  相似文献   
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