Analysis of clinical adverse reactions and countermeasures of Troxerutin injection
QIN Hua1 YU Dezhi
1.Ji'nan Center for Food and Drug Control,Shandong Province,Ji'nan 250102,China;
2.NMPA Key Laboratory for Quality Research and Evaluation of Traditional Marine Chinese Medicine,Qingdao Institute for Food and Drug Control,Shandong Province,Qingdao 266071,China
Abstract：Objective To explore the regularity of clinical adverse reactions of Troxerutin injection through literature analysis,and the safety countermeasures were sought from the aspects of clinical use,production process and quality control,so as to provide suggestions for the safety of the drug injection.Methods A total of 97 adverse drug reactions cases of Troxerutin injection were collected from January 2015 to December 2021 by searching the related literature reports in CNKI,WANFANG,VIP-CSTJ and other databases,the relevant information obtained provide guidance and suggestions for clinical use.And the research progress and countermeasures to improve the quality and safety of the injection were reported from the perspectives of use,process and quality control through the literature.Results Among the 97 cases with clinical adverse reactions,75.26%of all cases were between the ages of 51 and 80,and most of the adverse reactions occurred within 30 min of medication.Allergic reaction accounted for 36.08%,which was mainly manifested as general type allergic reaction.Attention should be paid to the standard use of compatibility in clinical dispensing,also should pay attention to control the introduction of risky impurities on the synthesis of pharmaceutical raw materials and the production process of preparations.Conclusion When Troxerutin injection is clinically selected,the dosage and incompatibilities should be fully clarified,and the first 30 min of monitoring should be strengthened to improve the emergency treatment ability for adverse reactions,especially allergic reactions.Pharmaceutical factory should pay close attention to the monitoring and analysis of clinical adverse reactions,strengthen the research on production and quality control,standards and test methods,promote the re-evaluation of the quality and safety of Troxerutin injection,improve the instructions and the drug quality.
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