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50 岁及以上成年人接种佐剂重组带状疱疹疫苗对生活质量的影响。

Quality of Life Impact of an Adjuvanted Recombinant Zoster Vaccine in Adults Aged 50 Years and Older.

机构信息

GSK, Wavre, Belgium.

GSK, King of Prussia, Pennsylvania.

出版信息

J Gerontol A Biol Sci Med Sci. 2019 Jul 12;74(8):1231-1238. doi: 10.1093/gerona/gly150.

DOI:10.1093/gerona/gly150
PMID:29955836
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6625590/
Abstract

BACKGROUND

To determine the efficacy of an adjuvanted recombinant zoster vaccine in reducing the herpes zoster (HZ) burden of illness, HZ burden of interference with activities of daily living, and HZ impact on quality of life.

METHODS

The assessments were integrated in two Phase III trials, ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229). HZ burden of illness and HZ burden of interference with activities of daily living were assessed by the Zoster Brief Pain Inventory (ZBPI) instrument and quality of life by the EuroQol-5 Dimension (EQ-5D) utility index and the SF-36 health survey. We report the ZOE-50 results and a pooled analysis of patients aged 70 years and older from the trials combined.

RESULTS

The estimated vaccine efficacy in reducing HZ burden of illness and HZ burden of interference was greater than 90% in both the ZOE-50 and the pooled ZOE-70 analysis. In confirmed HZ cases, adjuvanted recombinant zoster vaccine reduced the maximal ZBPI worst-pain score in the pooled ZOE-70 analysis (p = .032) and the maximal ZBPI average-pain scores in both the ZOE-50 (p = .049) and the pooled ZOE-70 analysis (p = .043). In breakthrough HZ cases, trends for diminished loss of quality of life compared with placebo-recipient HZ cases were observed, with differences up to 0.14 on the EQ-5D index at time points during the 4 weeks following HZ onset.

CONCLUSIONS

Adjuvanted recombinant zoster vaccine reduced the HZ burden of illness significantly, particularly due to its very high vaccine efficacy in preventing HZ. For breakthrough HZ cases, the results suggest that the adjuvanted recombinant zoster vaccine mitigated severity of HZ-related pain, burden of interference with activities of daily living, and recipients' utility loss.

摘要

背景

为了确定佐剂重组带状疱疹疫苗在降低带状疱疹（HZ）疾病负担、HZ 对日常生活活动干扰的负担以及 HZ 对生活质量的影响方面的疗效。

方法

这些评估被整合在两项 III 期试验中，ZOE-50（NCT01165177）和 ZOE-70（NCT01165229）。HZ 疾病负担和 HZ 对日常生活活动干扰的负担通过带状疱疹简明疼痛量表（ZBPI）工具进行评估，生活质量通过欧洲五维健康量表（EQ-5D）效用指数和 SF-36 健康调查进行评估。我们报告了 ZOE-50 的结果，并对两项试验中年龄在 70 岁及以上的患者进行了汇总分析。

结果

在 ZOE-50 和汇总的 ZOE-70 分析中，疫苗对 HZ 疾病负担和 HZ 对日常生活活动干扰的估计疗效均大于 90%。在确诊的 HZ 病例中，佐剂重组带状疱疹疫苗降低了汇总的 ZOE-70 分析中最大 ZBPI 最痛评分（p=0.032）和 ZOE-50 分析中最大 ZBPI 平均疼痛评分（p=0.049）以及汇总的 ZOE-70 分析中最大 ZBPI 平均疼痛评分（p=0.043）。在突破性 HZ 病例中，与安慰剂组 HZ 病例相比，生活质量下降的趋势较小，在 HZ 发病后 4 周内的各个时间点，EQ-5D 指数差异高达 0.14。

结论

佐剂重组带状疱疹疫苗显著降低了 HZ 疾病负担，这主要是由于其在预防 HZ 方面的高疫苗疗效。对于突破性 HZ 病例，结果表明佐剂重组带状疱疹疫苗减轻了 HZ 相关疼痛的严重程度、HZ 对日常生活活动干扰的负担以及接种者的效用损失。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e4f/6625590/72cd68441f25/gly15003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e4f/6625590/ae186f9c69ac/gly15001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e4f/6625590/ea2088fd021b/gly15002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e4f/6625590/72cd68441f25/gly15003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e4f/6625590/ae186f9c69ac/gly15001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e4f/6625590/ea2088fd021b/gly15002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e4f/6625590/72cd68441f25/gly15003.jpg

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