Knowledge Translation Program, Li Ka Shing Knowledge Institute, St Michael's Hospital, 209 Victoria Street, East Building, Toronto, M5B 1W8, ON, Canada
Epidemiology Division, Dalla Lana School of Public Health, University of Toronto, 155 College Street, Toronto, M5T 3M7, ON, Canada.
BMJ. 2018 Oct 25;363:k4029. doi: 10.1136/bmj.k4029.
To compare the efficacy, effectiveness, and safety of the herpes zoster live attenuated vaccine with the herpes zoster adjuvant recombinant subunit vaccine or placebo for adults aged 50 and older.
Systematic review with bayesian meta-analysis and network meta-analysis.
Medline, Embase, and Cochrane Library (inception to January 2017), grey literature, and reference lists of included studies.
Experimental, quasi-experimental, and observational studies that compared the live attenuated vaccine with the adjuvant recombinant subunit vaccine, placebo, or no vaccine in adults aged 50 and older. Relevant outcomes were incidence of herpes zoster (primary outcome), herpes zoster ophthalmicus, post-herpetic neuralgia, quality of life, adverse events, and death.
27 studies (22 randomised controlled trials) including 2 044 504 patients, along with 18 companion reports, were included after screening 2037 titles and abstracts, followed by 175 full text articles. Network meta-analysis of five randomised controlled trials found no statistically significant differences between the live attenuated vaccine and placebo for incidence of laboratory confirmed herpes zoster. The adjuvant recombinant subunit vaccine, however, was statistically superior to both the live attenuated vaccine (vaccine efficacy 85%, 95% credible interval 31% to 98%) and placebo (94%, 79% to 98%). Network meta-analysis of 11 randomised controlled trials showed the adjuvant recombinant subunit vaccine to be associated with statistically more adverse events at injection sites than the live attenuated vaccine (relative risk 1.79, 95% credible interval 1.05 to 2.34; risk difference 30%, 95% credible interval 2% to 51%) and placebo (5.63, 3.57 to 7.29 and 53%, 30% to 73%, respectively). Network meta-analysis of nine randomised controlled trials showed the adjuvant recombinant subunit vaccine to be associated with statistically more systemic adverse events than placebo (2.28, 1.45 to 3.65 and 20%, 6% to 40%, respectively).
Using the adjuvant recombinant subunit vaccine might prevent more cases of herpes zoster than using the live attenuated vaccine, but the adjuvant recombinant subunit vaccine also carries a greater risk of adverse events at injection sites.
Prospero CRD42017056389.
比较 50 岁及以上成人的带状疱疹活疫苗与带状疱疹佐剂重组亚单位疫苗或安慰剂的疗效、有效性和安全性。
系统评价与贝叶斯荟萃分析和网络荟萃分析。
Medline、Embase 和 Cochrane 图书馆（从建库至 2017 年 1 月）、灰色文献以及纳入研究的参考文献列表。
比较活疫苗与佐剂重组亚单位疫苗、安慰剂或无疫苗在 50 岁及以上成人中的实验、准实验和观察性研究。主要结局为带状疱疹的发病率（首要结局）、带状疱疹眼病、疱疹后神经痛、生活质量、不良事件和死亡。
经过筛选 2037 篇标题和摘要，随后筛选 175 篇全文文章，共筛选出 27 项研究（22 项随机对照试验），纳入了 2044504 例患者，以及 18 项配套报告。对五项随机对照试验的网络荟萃分析发现，活疫苗与安慰剂在实验室确诊的带状疱疹发病率方面无统计学差异。然而，佐剂重组亚单位疫苗在统计学上优于活疫苗（疫苗效力 85%，95%可信区间 31%至 98%）和安慰剂（94%，79%至 98%）。对 11 项随机对照试验的网络荟萃分析显示，佐剂重组亚单位疫苗在注射部位的不良事件发生率方面高于活疫苗（相对风险 1.79，95%可信区间 1.05 至 2.34；风险差异 30%，95%可信区间 2%至 51%）和安慰剂（5.63，3.57 至 7.29 和 53%，30% 至 73%）。对 9 项随机对照试验的网络荟萃分析显示，佐剂重组亚单位疫苗在全身不良事件发生率方面高于安慰剂（2.28，1.45 至 3.65 和 20%，6%至 40%）。
使用佐剂重组亚单位疫苗可能比使用活疫苗预防更多的带状疱疹病例，但佐剂重组亚单位疫苗在注射部位的不良反应风险更高。
PROSPERO CRD42017056389。
