Durham Veterans Affairs Medical Center Geriatric Research, Education and Clinical Center and Duke University Medical Centers, Durham, North Carolina, USA.
J Am Geriatr Soc. 2010 Sep;58(9):1634-41. doi: 10.1111/j.1532-5415.2010.03021.x.
To determine the efficacy of a zoster vaccine on herpes zoster (HR)-related interference with activities of daily living (ADLs) and health-related quality of life (HRQL).
Randomized double-blind placebo controlled trial.
Twenty-two U.S. sites.
Thirty eight thousand five hundred forty-six women and men aged 60 and olcer.
HZ burden of interference with ADLs and HRQL using ratings from the Zoster Brief Pain Inventory (ZBPI) and Medical Outcomes Study 12-item Short Form Survey (SF-12) mental component summary (MCS) and physical component summary (PCS) scores. Vaccine efficacy was calculated for the modified-intention-to-treat trial population and solely in participants who developed HZ.
For the modified-intention-to-treat population, the overall zoster vaccine efficacy was 66% (95% confidence interval (CI)=55-74%) for ZBPI ADL burden of interference score and 55% (95% CI=48-61%) for both the SF-12 MCS and PCS scores. Of participants who developed HZ, zoster vaccine reduced the ZBPI ADL burden of interference score by 31% (95% CI=12-51%) and did not significantly reduce the effect on HRQL.
Zoster vaccine reduced the burden of HZ-related interference with ADLs in the population of vaccinees and in vaccinees who developed HZ. Zoster vaccine reduced the effect of HZ on HRQL in the population of vaccinees but not in vaccinees who developed HZ.
评估带状疱疹疫苗对带状疱疹（HZ）相关日常生活活动（ADL）干扰和健康相关生活质量（HRQL）的疗效。
随机双盲安慰剂对照试验。
美国 22 个地点。
年龄在 60 岁及以上的 38546 名男女。
使用带状疱疹简明疼痛量表（ZBPI）和医疗结局研究 12 项简短健康调查问卷（SF-12）心理成分综合评分（MCS）和生理成分综合评分（PCS）评估 HZ 对 ADL 和 HRQL 的干扰负担。采用改良意向治疗试验人群和仅在发生 HZ 的参与者中计算疫苗效力。
在改良意向治疗人群中，带状疱疹疫苗对 ZBPI ADL 干扰负担评分的总体疗效为 66%（95%置信区间[CI]为 55%-74%），对 SF-12 MCS 和 PCS 评分的疗效均为 55%（95%CI 为 48%-61%）。在发生 HZ 的参与者中，带状疱疹疫苗使 ZBPI ADL 干扰负担评分降低了 31%（95%CI 为 12%-51%），但对 HRQL 没有显著影响。
带状疱疹疫苗降低了疫苗接种者和发生 HZ 的疫苗接种者的 HZ 相关 ADL 干扰负担。带状疱疹疫苗降低了疫苗接种者的 HZ 对 HRQL 的影响，但对发生 HZ 的疫苗接种者没有影响。
