Meta-analysis of the adverse effects of drug-resistant tuberculosis drugs on pregnant women and fetuses / 中国药房

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 outcomes may be related to the history of DR-TB.