Chinese Journal of Pharmacovigilance ›› 2016, Vol. 13 ›› Issue (9): 547-556.

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Meta-analysis of Adverse Reactions of Zhengqingfengtongning Sustained Release Tablets

XIE Zhi-Xin1, WANG Mian2, LONG Li-Ping3, *, QIU Ping1, WEN Ying-Yi1   

  1. 1 Hunan Zhengqin Pharmaceutical Group Co., LTD, Hunan Changsha, 410006, China;
    2 Xiangya Medicine School, Central South University, Hunan Changsha, 410013, China;
    3 Hunan Center for ADR Monitoring, Hunan Changsha 410000, China
  • Received:2016-10-31 Revised:2016-10-31 Online:2016-09-20 Published:2016-10-31

Abstract: Objective To systematically review the characteristics of adverse reactions of Zhengqingfengtongning sustained release tablets, and to provide scientific evidence for related control and prevention work. Methods Databases such as CNKI, VIP, WanFang Data were searched for studies investigating the characteristics of adverse reactions of Zhengqingfengtongning sustained release tablets between 2000~2015. According to the inclusion and exclusion criteria, the data were extracted and the methodological quality of included studies was assessed. Then Meta-analysis was performed by using the RevMan 5.3 software. Results Forty-four studies involving 1 700 cases of treatment group and 1 688 cases of control group were included. The results of pooled analysis showed that the overall adverse reaction incidence of Zhengqingfengtongning was 14.2% and the risk was 0.83 times of the control group (RR: 0.83, 95% CI: 0.72~0.96). Sub-group analysis showed that the adverse reaction incidence of Zhengqinfengtongning alone group was 11.8%, 0.83 times of the risk for the control group (RR: 0.83, 95% CI: 0.62~1.10); the adverse reaction incidence of Zhengqinfengtongning combined use group(the control group treatments + Zhengqingfengtongning) was 14.8%, 0.91 times of the risk for the control group (RR: 0.91, 95% CI: 0.74~1.11); the types of adverse reactions mainly included rash reaction(8%), the risk was three times for the control group (RR: 3.00, 95% CI: 2.21~4.08); gastrointestinal reaction3.8% ,the risk was 0.58 times for the control group (RR: 0.58, 95% CI: 0.44~0.76); the other kind of adverse reactions 2.4%, the risk was 0.33 times for the control group (RR: 0.33, 95% CI: 0.24~0.44). Conclusion The treatment groups administrated Zhengqinfengtongning had a higher rash itchy reaction rate than the control groups, but the occurrence of gastrointestinal reaction and others were lower than the control groups. From the point of the overall adverse reactions, combined use of Zhengqinfengtongning had less adverse reaction incidences than the control group.

Key words: Zhengqingfengtongning sustained release tablet, adverse reaction, Meta-analysis

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