ABSTRACT
OBJECTIVE:To evaluate the safety of Tripterysium glycosides tablet systematically,and to provide evidence-based reference.METHODS:Retrieved from Chinese Journal Full-text Database,China Science and Technology Journal Database,Wanfang database,PubMed,Embase,Medline (Ovid) and The Cochrane Library,randomized controlled trials (RCTs) about added or combined with Tripterysium glycosides tablet (trial group) versus basic treatment or combined with other drug (control group) in the treatment of various disease-induced ADR (the incidence of leukopenia,gastrointestinal reaction,irregular menstruation,lover dysfunction) were collected.After data extraction and quality evaluation with Cochrane 5.1.0 quality evaluation tool,RevMan 5.0 statistical software was used to conduct Meta-analysis.RESULTS:A total of 36 RCTs were included,involving 2 814 patients.Results of Meta-analysis showed that the incidence of leucopenia [OR=3.42,95 ％ CI (1.88,6.22),P＜ 0.001],irregular menstruation [OR=8.42,95％CI(4.93,14.38),P＜0.001] and abnormal liver function [OR=2.99,95％CI(2.01,4.46),P＜0.001] in trial group were significantly higher than control group,with statistical significance.Results of subgroup analysis showed that the incidence of irregular menstruation in trial group was significantly higher than control group,with statistical significance [OR=5.39,95％ CI (2.50,11.59),P＜0.001].When combining with glucocorticoids,the incidence of gastrointestinal adverse reactions in trial group was significantly lower than control group,with statistical significance [OR=0.40,95％CI(0.19,0.84),P=0.02].When the indications were the diseases of immune system,the incidence of leucopenia [OR=3.42,95％ CI (1.49,7.82),P=0.004] and abnormal liver function [OR=2.27,95％ CI (1.08,4.76),P=0.03] in trial group were significantly higher than control group,with statistical significance.CONCLUSIONS:ADR induced by Tripterysium glycosides tablet mainly include leucopenia,gastrointestinal reaction,irregular menstruation and abnormal liver function.More attentions should be paid on irregular menstruation when combining with other drugs.More attentions should be paid on leucopenia and abnormal liver function when treating the diseases of immune system.