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与健康对照相比,系统性红斑狼疮患者流感疫苗接种的免疫原性和安全性:一项荟萃分析

Immunogenicity and Safety of Influenza Vaccination in Systemic Lupus Erythematosus Patients Compared with Healthy Controls: A Meta-Analysis.

作者信息

Liao Zhengfa, Tang Hao, Xu Xiaojia, Liang Yaping, Xiong Yongzhen, Ni Jindong

机构信息

Department of Epidemiology and Biostatistics, Guangdong Medical University, Dongguan, China.

School Clinic, Guangdong Medical University, Dongguan, China.

出版信息

PLoS One. 2016 Feb 4;11(2):e0147856. doi: 10.1371/journal.pone.0147856. eCollection 2016.

Abstract

OBJECTIVE

To assess the immunogenicity and safety of influenza vaccine in patients with systemic lupus erythematosus (SLE).

METHODS

Relevant articles were retrieved from electronic databases. Seroprotection rate, seroconversion rate and factors that increase antibody geometric mean titer (GMT) were used as indices to measure the immunogenicity. The safety of vaccine was assessed through monitoring adverse events, which included side effects and SLE exacerbations. We performed a meta-analysis of influenza vaccine seroprotection, seroconversion and adverse effects. SLE exacerbation after vaccination was comprehensively described. We used the Committee for Proprietary Medicinal Products (CPMP) guidelines to determine whether influenza can induce adequate immunogenicity in patients with SLE.

RESULTS

Eighteen studies with 1966 subjects met the inclusion criteria. At least 565 of the subjects were patients with low-to-moderate SLE Disease Activity Index (SLEDAI) score or stable SLE disease. Compared with the general population, seroprotection rate in SLE patients was significantly decreased in patients with H1N1 [odds ratio (OR) = 0.36, 95% confidence interval (CI): 0.27-0.50] and H3N2 vaccination (OR = 0.48, 95% CI: 0.24-0.93), but not influenza B vaccination (OR = 0.55, 95% CI: 0.24-1.25). Seroconversion rate also significantly decreased in patients with H1N1 (OR = 0.39, 95% CI: 0.27-0.57) and influenza B (OR = 0.47, 95% CI: 0.29-0.76) vaccination, but not H3N2 vaccination (OR = 0.62, 95% CI: 0.21-1.79). However, the immunogenicity of influenza vaccine in SLE patients almost reached that of the CPMP guidelines. The OR for side effects (patients versus healthy controls) was 3.24 (95% CI: 0.62-16.76). Among 1966 patients with SLE, 32 experienced mild exacerbation of SLE and five had serious side effects for other reasons.

CONCLUSION

Influenza vaccine has moderate effect on protecting patients with SLE. The side effects of influenza vaccine are not serious and are manageable. With consideration of a higher risk of SLE exacerbation and a more severe course of infection among SLE patients, influenza vaccination should be promoted among SLE patients with a low-to-moderate SLEDAI score or stable disease.

摘要

目的

评估流感疫苗在系统性红斑狼疮(SLE)患者中的免疫原性和安全性。

方法

从电子数据库中检索相关文章。采用血清保护率、血清转化率以及增加抗体几何平均滴度(GMT)的因素作为衡量免疫原性的指标。通过监测不良事件评估疫苗的安全性,不良事件包括副作用和SLE病情加重。我们对流感疫苗的血清保护、血清转化和不良反应进行了荟萃分析。全面描述了接种疫苗后SLE病情加重的情况。我们使用欧洲药品管理局(CPMP)的指南来确定流感疫苗是否能在SLE患者中诱导足够的免疫原性。

结果

18项研究共1966名受试者符合纳入标准。至少565名受试者为SLE疾病活动指数(SLEDAI)评分低至中度或SLE病情稳定的患者。与普通人群相比,SLE患者接种H1N1疫苗(优势比[OR]=0.36,95%置信区间[CI]:0.27 - 0.50)和H3N2疫苗(OR = 0.48,95% CI:0.24 - 0.93)后的血清保护率显著降低,但接种B型流感疫苗后未降低(OR = 0.55,95% CI:0.24 - 1.25)。接种H1N1疫苗(OR = 0.39,95% CI:0.27 - 0.57)和B型流感疫苗(OR = 0.47,95% CI:0.29 - 0.76)后的血清转化率也显著降低,但接种H3N2疫苗后未降低(OR = 0.62,95% CI:0.21 - 1.79)。然而,流感疫苗在SLE患者中的免疫原性几乎达到了CPMP指南的要求。副作用的OR值(患者与健康对照相比)为3.24(95% CI:0.62 - 16.76)。在1966名SLE患者中,32名患者出现了SLE轻度病情加重,5名患者因其他原因出现严重副作用。

结论

流感疫苗对保护SLE患者有中等效果。流感疫苗的副作用不严重且可控。考虑到SLE患者中SLE病情加重的风险较高以及感染病程更严重,应在SLEDAI评分低至中度或病情稳定的SLE患者中推广流感疫苗接种。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a77d/4742052/fb7726791253/pone.0147856.g001.jpg

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