中药注射剂临床应用的不良反应发生率调查

Investigation on incidence rate of adverse reaction in clinical application of traditional Chinese medicine injection

目的调查中药注射剂临床应用的不良反应发生率,为合理使用中药注射剂提供参考。方法选择收治的应用各类中药注射剂进行治疗的1860例患者的临床资料作为研究对象,调查患者不良反应发生情况,不良反应累及器官和发生不良反应的危险因素。结果不同中药注射剂不良反应发生情况比较,清开灵注射剂的不良发生率达到11.76%,为各类注射剂中不良率最高,其次是参麦注射剂和双黄连注射剂。不良反应累及器官与表现情况比较,主要累及器官为皮肤及附件、循环系统,占到所有不良反应的56.15%,其余器官系统的不良反应发生率较少。未辨证施治、合并注射剂、超疗程施药和配液静置时间过长所有差异均有统计学意义(P<0.05),是导致不良反应发生的主要危险因素。结论中药注射剂发生不良反应发生率较高,范围较广,累及器官主要为皮肤及附件和循环系统,未辩证施治和不合理用药是导致不良发生的危险因素,要积极预防和及时处理以减少不良反应发生率。

Objective To survey the incidence of adverse reaction induced by traditional Chinese medicine injection and provide valuable suggestion for using traditional Chinese medicine injection. Methods Clinical data of 1860 patients who were under treatment of traditional Chinese medicine injection during January 2010 to December 2014 were studied to survey adverse reaction incidence,effected system-organs and risk factors of adverse reaction. Results Comparison of incidence adverse reaction of traditional Chinese medicine injection,Qingkailing injection adverse occurrence rate reached the highest 11. 76% for all types,followed by Shenmai injection and Shuanghuanglian injection. Adverse reactions involving the organ and the performance was compared,adverse reactions mainly involved the organs for the skin and accessories,circulatory system,accounting for 56. 15%,the incidence of adverse reactions of the rest of the organ system was less. Not determine the treatment based on differentiation of symptoms and signs,combined with injection,ultra treatment application and distribution of liquid static for a long time all differences were statistically significant（ P〈0. 05）,leading to the main risk factors of the occurrence of adverse reactions. Conclusion Traditional Chinese medicine injections occurred and the incidence of adverse reactions was higher,wider range,organ involvement mainly skin and its appendages and circulatory system,not dialectical treatment and rational drug use is lead to adverse risk factors,actively preventment and timely treatment to reduce the incidence of adverse reactions.