免疫功能正常的老年人带状疱疹的并发症：两项大型 3 期临床试验中疫苗组和安慰剂组的发生率。
Complications of herpes zoster in immunocompetent older adults: Incidence in vaccine and placebo groups in two large phase 3 trials.
机构信息
GSK, Rockville, MD, USA.
GSK, King of Prussia, PA, USA.
出版信息
Vaccine. 2018 Mar 14;36(12):1537-1541. doi: 10.1016/j.vaccine.2018.02.029. Epub 2018 Feb 17.
BACKGROUND
An adjuvanted herpes zoster (HZ) subunit vaccine, HZ/su, demonstrated high efficacy against HZ and postherpetic neuralgia (PHN) in two randomized, observer-blind, placebo-controlled trials in adults aged ≥50 and ≥70 years (ZOE-50 and ZOE-70, respectively).
METHODS
Data from ZOE-50 and ZOE-70 trials were analyzed to evaluate the efficacy of HZ/su against mortality, hospitalizations, and non-PHN complications of HZ including HZ-associated vasculitis, stroke, and disseminated, ophthalmic, neurologic, and visceral diseases.
RESULTS
In the pooled ZOE-50/ZOE-70 analysis, 1 of 32 HZ/su recipients (3.1%) and 16 of 477 placebo recipients (3.4%) with a confirmed HZ episode had complications other than PHN. Efficacy against HZ-related complications was 93.7% (95% confidence interval, 59.5-99.9%) in adults aged ≥50 years and 91.6% (43.3-99.8%) in adults ≥70 years. Five HZ-related hospitalizations, all in placebo recipients, and no HZ-related deaths were reported.
CONCLUSIONS
HZ/su reduces the risk of HZ-associated complications in older adults (NCT01165177; NCT01165229).
背景
在两项针对≥50 岁和≥70 岁成人的随机、观察者盲、安慰剂对照临床试验（ZOE-50 和 ZOE-70）中，一种佐剂带状疱疹（HZ）亚单位疫苗 HZ/su 显示出对 HZ 和带状疱疹后神经痛（PHN）的高疗效。
方法
分析 ZOE-50 和 ZOE-70 试验的数据，以评估 HZ/su 对死亡率、HZ 相关住院和非 PHN 并发症（包括 HZ 相关血管炎、中风以及播散性、眼部、神经和内脏疾病）的疗效。
结果
在汇总的 ZOE-50/ZOE-70 分析中，32 名 HZ/su 接受者中有 1 名（3.1%）和 477 名安慰剂接受者中有 16 名（3.4%）在确诊的 HZ 发作后出现了除 PHN 以外的并发症。在≥50 岁的成年人中，HZ/su 对 HZ 相关并发症的疗效为 93.7%（95%置信区间，59.5-99.9%），在≥70 岁的成年人中为 91.6%（43.3-99.8%）。报告了 5 例与 HZ 相关的住院治疗，均发生在安慰剂接受者中，没有与 HZ 相关的死亡病例。
结论
HZ/su 降低了老年人发生 HZ 相关并发症的风险（NCT01165177；NCT01165229）。
Zotero 插件