Chinese Journal of Pharmacovigilance ›› 2016, Vol. 13 ›› Issue (6): 351-358.

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Meta-analysis of Adverse Drug Reactions of Ceftriaxone Sodium for Injection

WEI Fen-fang1, SUN Yi-Yuan2, YANG Yue*   

  1. College of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China
  • Received:2016-07-22 Revised:2016-07-22 Online:2016-06-20 Published:2016-07-22

Abstract: Objective To preliminarily evaluate the safety of ceftriaxone sodium for injection in clinical practice. Methods Medline, EBsco, Cochrane Library and Chinese Biomedical Literature Database, China National Knowledge Database, VIP database were retrieved, and randomized controlled trials (RCTs) related to ceftriaxone were included. Meta-analysis for adverse drug reaction (ADR) rates of ceftriaxone sodium was performed by RevMan 5.1. In addition, subgroup analyses including different countries, different indications and different doses were performed according to PRISAM guidelines. Results A total of 21 RCTs were included, involving 5417 cases. The result of Meta-analysis showed that the rate of adverse reactions in ceftriaxone sodium for injection group was significantly higher than that in the control group [OR=1.18, 95% CI (1.02, 1.35), Z=2.26, P=0.002]. Heterogeneity of several studies was statistically significant. Subgroup analyses showed that heterogeneity of several studies in foreign group was statistically significant [OR=1.20, 95% CI (1.03, 1.41), Z = 2.33, P=0.02]. The ADR incidence of the conventional dose group was higher than that in the control group, and its heterogeneity was statistically significant (Z=2.17, P=0.03). Conclusion Treatment with ceftriaxone sodium for injection has higher adverse reaction incidence than other treatments. The Results need more high-quality randomized controlled trials to testify.

Key words: ceftriaxone sodium for injection, adverse drug reaction, Meta-analysis, subgroup analysis

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