孕前或孕期暴露于HPV疫苗与不良妊娠结局的关联：一项采用试验序贯分析的系统评价和荟萃分析
Association of periconceptional or pregnancy exposure of HPV vaccination and adverse pregnancy outcomes: a systematic review and meta-analysis with trial sequential analysis.
作者信息
Yan Xiaoli, Li Hongyu, Song Bin, Huang Ge, Chang Qing, Wang Dan, Yan Ping
机构信息
Department of Gynecology and Obstetrics, Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing, China.
出版信息
Front Pharmacol. 2023 May 9;14:1181919. doi: 10.3389/fphar.2023.1181919. eCollection 2023.
To evaluate whether periconceptional or pregnancy exposure of human papillomavirus (HPV) vaccination would increase the risk of adverse pregnancy outcomes. The PubMed, Web of Science, Embase, the Cochrane Library of clinical trials were searched from inception to March 2023. We computed relative risk (RR) and 95% confidence intervals (CIs) and prediction intervals (PIs) regarding the association between HPV vaccination in periconceptional period or during pregnancy and the risks of adverse pregnancy outcomes by using R software Version 4.1.2 and STATA Version 12.0. A trial sequential analysis (TSA) was performed with TSA v0.9.5.10 Beta software. Four randomized controlled trials (RCTs) and eight cohort studies were included in this meta-analysis. Analysis of RCTs showed that HPV vaccination in periconceptional period or during pregnancy did not increase the risks of spontaneous abortion (RR = 1.152, 95% CI: 0.909-1.460, 95% PI: 0.442-3.000), birth defects (RR = 1.171, 95% CI: 0.802-1.709, 95% PI: 0.320-4.342), stillbirth (RR = 1.053, 95% CI: 0.616-1.800, 95% PI: 0.318-3.540), preterm birth (RR = 0.940, 95% CI: 0.670-1.318) and ectopic pregnancy (RR = 0.807, 95% CI: 0.353-1.842, 95% PI: 0.128-5.335). In cohort studies, periconceptional or pregnancy exposures of HPV vaccine were not associated with the increased risk of spontaneous abortion (RR = 0.987, 95% CI: 0.854-1.140, 95% PI: 0.652-1.493), birth defects (RR = 0.960, 95% CI: 0.697-1.322, 95% PI: 0.371-2.480), stillbirth (RR = 1.033, 95% CI: 0.651-1.639, 95% PI: 0.052-21.064), small size for gestational age (SGA) (RR = 0.971, 95% CI: 0.873-1.081, 95% PI: 0.657-1.462) and preterm birth (RR = 0.977, 95% CI: 0.874-1.092, 95% PI: 0.651-1.444). HPV vaccine exposures in periconceptional period or during pregnancy did not increase the risks of adverse pregnancy outcomes, including spontaneous abortion, birth defects, stillbirth, SGA, preterm birth and ectopic pregnancy. https://www.crd.york.ac.uk/prospero/, identifier CRD42023399777.
评估围孕期或孕期暴露于人乳头瘤病毒（HPV）疫苗是否会增加不良妊娠结局的风险。检索了PubMed、Web of Science、Embase以及Cochrane临床试验库，检索时间从建库至2023年3月。我们使用R软件4.1.2版和STATA 12.0版计算了围孕期或孕期HPV疫苗接种与不良妊娠结局风险之间关联的相对风险（RR）、95%置信区间（CI）和预测区间（PI）。使用TSA v0.9.5.10 Beta软件进行了试验序贯分析（TSA）。本荟萃分析纳入了四项随机对照试验（RCT）和八项队列研究。RCT分析显示，围孕期或孕期接种HPV疫苗不会增加自然流产风险（RR = 1.152，95% CI：0.909 - 1.460，95% PI：0.442 - 3.000）、出生缺陷风险（RR = 1.171，95% CI：0.802 - 1.709，95% PI：0.320 - 4.342）、死产风险（RR = 1.053，95% CI：0.616 - 1.800，95% PI：0.318 - 3.540）、早产风险（RR = 0.940，95% CI：0.670 - 1.318）和异位妊娠风险（RR = 0.807，95% CI：0.353 - 1.842，95% PI：0.128 - 5.335）。在队列研究中，围孕期或孕期暴露于HPV疫苗与自然流产风险增加无关（RR = 0.987，95% CI：0.854 - 1.140，95% PI：0.652 - 1.493）、出生缺陷风险增加无关（RR = 0.960，95% CI：0.697 - 1.322，95% PI：0.371 - 2.480）、死产风险增加无关（RR = 1.033，95% CI：0.651 - 1.639，95% PI：0.052 - 21.064）、小于胎龄儿（SGA）风险增加无关（RR = 0.971，95% CI：0.873 - 1.081，95% PI：0.657 - 1.462）和早产风险增加无关（RR = 0.977，95% CI：0.874 - 1.092，95% PI：0.651 - 1.444）。围孕期或孕期暴露于HPV疫苗不会增加不良妊娠结局的风险，包括自然流产、出生缺陷、死产、SGA、早产和异位妊娠。https://www.crd.york.ac.uk/prospero/，标识符CRD42023399777
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