Chinese Journal of Pharmacovigilance ›› 2018, Vol. 15 ›› Issue (11): 674-676.

• Orginal Article • Previous Articles     Next Articles

Literature Analysis of 168 Adverse Drug Reactions Induced by Bailemian Capsule

PENG Lili, FAN Yan, LIU Wei, GUO Xue, HU Jun*   

  1. Centre for Drug Reevaluation, CFDA, Beijing 100022, China
  • Received:2019-01-09 Revised:2019-01-09 Online:2018-11-20 Published:2019-01-09

Abstract: Objective To analyze the literatures on clinical application and adverse drug reactions (ADRs) induced by Bailemian capsule, so as to provide reference for its rational use in clinic. Methods The literatures on the clinical application and ADRs of Bailemian capsule were retrieved in CNKI, Wangfang data and VIP Chinese full-text database. The related literatures were screened out and analyzed. Results 29 available literatures were retrieved where 168 cases with adverse drug reactions were reported. Female patients were 1.54 times that of male patients, the most of patients were 32 to 65 years old, the ADRs were mainly gastrointestinal disorders, liver and biliary disorders, psychiatric and neurological disorders, skin and appendages disorders, including nausea, mouth dry, constipation, appetite decreased, sedation excessive, drug eruption etc, and there has been an individual case safety report about the hepatic function abnormal. Conclusion We should strengthen the safe application of Bailemian capsule, standardize and improve the drug labelling, promote the rational use of drug and guarantee the safety of patients.

Key words: Bailemian capsule, clinical application, adverse drug reactions

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