Résumé
OBJECTIVE:To provide reference for rational use of TCM injection in the clinic. METHODS:Retrieved from CNKI,VIP,Wanfang database and PubMed database,literatures about top 10 TCM injections in the list of report number stated in 2014 CFDA ADR monitoring report were researched in recent 30 years. By literature retrospective study,ADR/ADE induced by TCM injection were analyzed. Combining with post-marketing drug safety re-evaluation and rationality study,the security of clini-cal use of TCM injection was evaluated. RESULTS:A total of 2013 literatures were retrieved,1354 were. Most organs or systems were involved in ADR,especially cardiovascular system,respiratory system,skin and its appendants. Allergic reaction was main clinical manifestation,among which server ADR was allergic shock. Ten ADR/ADE-inducing TCM injections had the lower consis-tency with instructions in the original diseases,solvent,dosage concentration and compatibility application. Consistency rate of original diseases,solvent and dosage concentration was 78.30%,77.94% and 74.64%;81.73% of them were used individually. CON-CLUSIONS:ADR/ADE induced by TCM injection is serious. It is urgent to improve post-marketing revaluation scheme from the aspects of safety and rationality.