Page 123 - 《中国药房》2022年4期

·循证药学·

耐药结核病治疗药物对妊娠期妇女及胎儿不良影响的Meta分析

全淑燕 ，许汝福 ，应德美 ，罗梦林 ，张 蓉 （1.陆军军医大学第二附属医院药剂科，重庆 400037；2.陆军军
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1＊
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医大学第二附属医院妇产科，重庆 400037）
中图分类号 R969.3 文献标志码 A 文章编号 1001-0408（2022）04-0497-06
DOI 10.6039/j.issn.1001-0408.2022.04.19

摘 要 目的 系统评价耐药结核病（DR-TB）治疗药物对妊娠期妇女及胎儿的不良影响，为临床用药提供循证参考。方法 计算机
检索PubMed、Cochrane图书馆、Embase、中国生物医学文献数据库、中国知网、万方数据和维普网，收集妊娠期妇女暴露于DR-TB
治疗药物的随机对照试验（RCT）、队列研究、病例对照研究、病例系列及病例报道，检索时限均为各数据库建库起至2021年8月20
日。筛选文献，提取资料后采用Cochrane系统评价员手册6.2版推荐的偏倚风险评估工具对纳入的RCT进行质量评价，采用纽卡
斯尔-渥太华量表对纳入的队列研究和病例对照研究进行质量评价，采用加拿大卫生经济学研究所（IHE）发布的IHE量表对纳入
的病例系列和病例报道进行质量评价。采用RevMan 5.1软件进行无对照二分类数据的Meta分析。结果 共纳入13篇文献，包括
病例系列7篇、病例报告6篇，共计203例患者、204例新生儿；其中无对照二分类数据文献6篇。Meta分析结果显示，妊娠期妇女
暴露于DR-TB治疗药物后，未有新生儿出现出生缺陷，妊娠期妇女的死亡率为0.09[95％CI（0.06，0.15），P＜0.000 01]，新生儿死亡
发生率为 0.02[95％CI（0，0.06），P＜0.000 01]，早产发生率为 0.14[95％CI（0.03，0.43），P＝0.02]，低出生体质量儿发生率为
0.17[95％CI（0.04，0.51），P＝0.06]，发育迟缓发生率为 0.15[95％CI（0.09，0.22），P＜0.000 01]，死胎发生率为 0.05[95％CI（0.02，
0.09），P＜0.000 01]，流产发生率为0.08[95％CI（0.05，0.14），P＜0.000 01]。结论 妊娠期妇女暴露于DR-TB治疗药物后，可出现妊
娠期妇女死亡、流产和新生儿死亡、早产、低出生体质量儿、发育迟缓、死胎等情况，但未见新生儿出生缺陷；这些不良妊娠结局可
能与DR-TB疾病史有关。
关键词 耐药结核病；妊娠期妇女；胎儿；安全性；Meta分析

Meta-analysis of the adverse effects of drug-resistant tuberculosis drugs on pregnant women and fetuses
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QUAN Shuyan ，XU Rufu ，YING Demei ，LUO Menglin ，ZHANG Rong（1. Dept. of Pharmacy，the Second
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Affiliated Hospital of Army Medical University， Chongqing 400037， China； 2. Dept. of Obstetrics and
Gynecology，the Second Affiliated Hospital of Army Medical University，Chongqing 400037，China）
ABSTRACT OBJECTIVE To systematically evaluate the adverse effects of drug-resistant tuberculosis （DR-TB） drugs on
pregnant women and fetuses，so as to provide evidence-based reference for clinical medication. METHODS PubMed，Cochrane
Library，Embase，CBM，CNKI，Wanfang database and VIP were searched by computer to collect randomized controlled trials
（RCTs），cohort studies，case-control studies，case series and case reports about pregnant women exposed to DR-TB drugs. The
retrieval time limit was from the establishment of each database to August 20，2021. After selecting the literature and extracting the
data，the bias risk assessment tool recommended by 6.2 version of Cochrane system evaluator manual was used to evaluate the
quality of the included RCTs；Newcastle-Ottawa scale was used to evaluate the quality of the included cohort studies and
case-control studies；IHE scale issued by the Canadian Institute of Health Economics（IHE）was used to evaluate the quality of the
included case series and case reports. RevMan 5.1 software was used for Meta-analysis of non-comparative binary data. RESULTS
A total of 13 literature were included，including 7 case series and 6 case reports，involving 203 patients and 204 newborns；among
them，there were 6 literature about non-comparative binary data. The results of meta-analysis showed that after exposure to DR-TB
drugs，no newborn had birth defects；the mortality of pregnant women was 0.09[95％CI（0.06，0.15），P＜0.000 01]；the neonatal
mortality was 0.02[95％CI（0，0.06），P＜0.000 01]；the incidence of preterm birth was 0.14[95％CI（0.03，0.43），P＝0.02]；the
incidence of infants with low birth weight was 0.17[95％ CI（0.04，0.51），P＝0.06]；the incidence of growth retardation was
0.15[95％CI（0.09，0.22），P＜0.000 01]；the incidence of stillbirth was 0.05[95％CI（0.02，0.09），P＜0.000 01]；the incidence of
abortion was 0.08[95％ CI（0.05，0.14），P＜0.000 01]. CONCLUSIONS Pregnant women exposed to DR-TB drugs can cause
pregnant women’s death and abortion，neonatal death，premature birth，infants with low birth weight，growth retardation and
stillbirth，but there is no neonatal birth defect；these adverse
＊主管药师，硕士。研究方向：妇产科临床药学。电话：023-
outcomes may be related to the history of DR-TB.
68755407。E-mail：597834270@qq.com
KEYWORDS drug-resistant tuberculosis；pregnant women；
# 通信作者：主任药师，博士。研究方向：医院药事管理。电话：
fetuses；safety；meta-analysis
023-68755407。E-mail：zrcq73@163.com

中国药房 2022年第33卷第4期 China Pharmacy 2022 Vol. 33 No. 4 ·497 ·