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抗逆转录病毒疗法会导致先天性畸形吗?一项系统评价和荟萃分析。

Does antiretroviral therapy cause congenital malformations? A systematic review and meta-analysis.

作者信息

Alemu Fekadu Mazengia, Yalew Alemayehu Worku

机构信息

School of Public Health, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.

出版信息

Epidemiol Health. 2021;43:e2021008. doi: 10.4178/epih.e2021008. Epub 2021 Feb 3.

DOI:10.4178/epih.e2021008
PMID:33541012
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8060528/
Abstract

OBJECTIVES

This meta-analysis investigated the risk of congenital anomalies among infants of human immunodeficiency virus-infected pregnant women who were exposed to antiretroviral therapy (ART).

METHODS

Cohort studies, case-control studies, randomized controlled trials, and controlled clinical trials were reviewed by searching MEDLINE/PubMed, Embase, Web of Science, Scopus, AIDSLINE, CINAHL, Cochrane Library, and Google/Google Scholar. Methodological quality was assessed using the GRADE evaluation. A DerSimonian and Laird random-effects model was used. Subgroup analyses and meta-regression were used to investigate heterogeneity.

RESULTS

The electronic searches yielded 765 items. After quality assessment and grading, 30 studies were suitable for metaanalysis. In total, 1,461 congenital anomalies were found among 53,186 births. Children born to women receiving combined antiretroviral therapy (cART) had an approximately 10% higher risk of developing congenital anomalies (relative risk [RR], 1.09; 95% confidence interval [CI], 1.04 to 1.14). A subgroup analysis found no significant difference in the risk of congenital anomalies between cART and efavirenz users. However, zidovudine and protease inhibitor (RR, 1.09; 95% CI, 1.00 to 1.19) users were found to have a 10% increased risk of congenital anomalies, and integrase inhibitor users had a 60% increase in risk (RR, 1.61; 95% CI, 1.60 to 2.43). The subgroup results should be interpreted cautiously because of the moderate heterogeneity (I2 =58%).

CONCLUSIONS

The use of protease inhibitors, integrase inhibitors, zidovudine, and newer drugs should be carefully considered in pregnant women. Further studies are needed to address environmental, nutrition, and adherence factors related to ART. Establishing a congenital anomalies surveillance system is recommended.

摘要

目的

本荟萃分析调查了接受抗逆转录病毒疗法(ART)的人类免疫缺陷病毒感染孕妇所生婴儿出现先天性异常的风险。

方法

通过检索MEDLINE/PubMed、Embase、科学引文索引、Scopus、艾滋病在线数据库、护理学与健康领域数据库、考克兰图书馆以及谷歌/谷歌学术搜索,对队列研究、病例对照研究、随机对照试验和对照临床试验进行了综述。使用GRADE评估法对方法学质量进行评估。采用DerSimonian和Laird随机效应模型。进行亚组分析和荟萃回归以研究异质性。

结果

电子检索共获得765条记录。经过质量评估和分级后,有30项研究适合进行荟萃分析。在53186例出生婴儿中,共发现1461例先天性异常。接受联合抗逆转录病毒疗法(cART)的女性所生儿童出现先天性异常的风险大约高10%(相对风险[RR],1.09;95%置信区间[CI],1.04至1.14)。亚组分析发现,cART使用者和依非韦伦使用者在先天性异常风险方面无显著差异。然而,发现齐多夫定和蛋白酶抑制剂使用者出现先天性异常的风险增加了10%(RR,1.09;95%CI,1.00至1.19),整合酶抑制剂使用者的风险增加了60%(RR,1.61;95%CI,1.60至2.43)。由于存在中度异质性(I2 = 58%),亚组结果应谨慎解读。

结论

对于孕妇,应谨慎考虑使用蛋白酶抑制剂、整合酶抑制剂以及齐多夫定和新型药物。需要进一步研究以解决与抗逆转录病毒疗法相关的环境、营养和依从性因素。建议建立先天性异常监测系统。

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