123所医院5188例中药疑致不良反应报告评价与分析.pdf

2015 4 122 Chinese Journal of Drug Application and Monitoring, Vol.12, No.2, April 2015 123 5188 1,2 1 2 2 1. 100853 2. 100017 [ ] 2009 2013 5188 ADR 123 3743 1445679 34 ADR 30 min 43.35%/ 29.74%16.22%16.03% ADR ADR ADR [] [ ]R969.3 [ ]A [ ]1672 8157(2015)02 0094 04 Evaluation and analysis of 5188 cases of possible ADR reports caused by traditional Chinese medicine from 123 hospitals 1,2 1 2 2(1. Medical College of PLA, Beijing 100853, China; 2. The Health ZHU Feng , GUO Dai-hong , YUAN Feng-yi , LV Xiao-chuan Security Bureau of PLA General Staff Department, Beijing 100017, China) [ABSTRACT]Objective: To analyze the characteristics of ADRs caused by traditional Chinese medicine (TCM) and provide reference for rational drug use in clinic. Methods: All the adverse reactions of TCM collected by the PLA center of ADR monitoring from 2009 to 2013 were retrospectively analyzed. Results: A total of 5188 ADR cases of TCM from 123 hospitals were analyzed, including 3743 cases of injections and 1445 cases of non-injections. These reports involved 679 species and 34 dosage forms. Most ADRs happened within 30 minutes, accounting for 43.35%. The main clinical manifestations of these ADRs were skin and its accessories damage (29.74%), systemic damage (16.22%) and gastrointestinal system damage (16.03%). Top six species of TCM which caused serious ADR were Guanxinsuhe pills, Heshouwu pieces, Shenmai injections, Shenkang injections, Xuebijing injections and Longdanxiegan pills. Conclusion: It is important to be aware of the ADR caused by TCM and strengthen rational drug use. Special attention should be paid to the TCM that easily lead to severe ADRs in order to minimize the occurrence of ADR. [KEY WORDS]Traditional Chinese medicine; Adverse drug reaction; Drug safety [6] 496-500. [J]201130