Chinese Journal of Pharmacovigilance ›› 2018, Vol. 15 ›› Issue (8): 470-475.

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Literature Study on Adverse Drug Reactions and Analysis of Risk Factors of Polygonum multiflorum Thunb. and its Common Preparations

YU Hongli1, YU Dongmei2, SONG Haibo1, REN Jingtian1*   

  1. 1Center for Drug Reevaluation, CFDA, Beijing 100045, China;
    2Center for Health Food Review, CFDA, Beijing 100070, China
  • Received:2018-10-11 Revised:2018-10-11 Online:2018-08-20 Published:2018-10-11

Abstract: Objective To investigate the general characteristics of adverse drug reaction (ADR) induced by Polygonum multiflorum Thunb. and its common preparations, and analyze their risk factors, so as to provide reference for rational drug use in clinic. Methods The cases of ADR reduced by Polygonum multiflorum Thunb. and its common preparations were retrieved, to analyze the characteristics of ADRs and risk factors. Results In 69 cases included, most of ADR occurred in ten days to one month after treatment. The mainly involved system-organ was hepatobiliary disorders, followed by gastrointestinal disorders. The main clinical manifestations were icteric sclera and skin coloring yellow, ALT and AST increased, TBiL and DBiL increased, urinary coloring yellow, etc. Most patients could recover better after drug withdrawal or symptomatic treatment. Conclusion The mainly involved system-organ was hepatobiliary disorders and gastrointestinal disorders. And the clinical outcomes of patients were better. However, further research is still needed, while strengthening regulation to ensure the rational drug use.

Key words: Polygonum multiflorum Thunb., adverse reaction, literature analysis, risk factors

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