Chinese Journal of Pharmacovigilance ›› 2023, Vol. 20 ›› Issue (9): 1046-1048.
DOI: 10.19803/j.1672-8629.20220676

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Risks of safety Qingkailing oral preparation

YU Hongli1, YU Dongmei2,Δ, XIAO Aili1, ZHU Lan1, SONG Haibo1,*   

  1. 1Center for Drug Reevaluation, NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100076, China;
    2Center for Food Evaluation, State Administration for Marker Regulation/National Committee on the Assessment of the Protected Traditional Chinese Medicinal Products, Beijing 100070, China
  • Received:2023-03-24 Online:2023-09-15 Published:2023-09-14

Abstract: Objective To analyze the risk of Qingkailing oral preparation in order to provide reference for rational clinical use. Methods Cases of adverse reactions related to Qingkailing oral preparation that were retrieved from National ADR Monitoring System and literature , and the relevant control measures issued by regulatory agencies were analyzed. Results From 2015 to 2021, the National ADR Monitoring System has received 7 185 ADR/ADE reports involving Qingkailing oral preparations, which involved gastrointestinal, skin, nervous and other systems and organs. The systems and organs literature reports involved in ADR/ADE of Qingkailing oral preparations were basically consistent with the reports in National ADR Monitoring System. Conclusion Adverse drug reaction associated with oral preparations of Qingkailing involve multiple systems-organs, and clinical attention should be paid to the adverse reactions associated with oral preparations of Qingkailing to promote the safe and rational use of drugs.

Key words: Qingkailing, oral preparation, safety, adverse reaction

CLC Number: