摘要
初步评价中药(中药饮片、中成药)的不良反应(ADR)及安全性。通过Meta分析显示,中药ADR累及系统-器官有心血管系统、消化系统合并效应量[RR=0.48,95%CI(0.37,0.61)],在神经系统、呼吸系统合并效应量[OR=1.62,95%CI(1.25,2.11)],在皮肤及其附件和其他方面合并效应量[OR=2.95,95%CI(2.24,3.88)]。中药按注射剂与非注射剂的ADR在合并效应量[RR=2.81,95%CI(2.16,3.67)],中药按给药途径内用与外用的ADR合并效应量[RR=23.19,95%CI(16.52,32.57)]。中药ADR主要发生在心血管系统、消化系统、呼吸系统、神经系统、皮肤等方面,中药注射剂的不良反应要高于非注射剂,但这个结果还需要更多大样本、高质量的回顾性调查进行验证,为临床安全合理有效用药提供借鉴。
In this paper,a preliminary evaluation of traditional Chinese medicine（ TCM）（ Chinese medicine yinpian,proprietary Chinese medicine）,adverse reaction（ ADR） and safety. By Meta-analysis showed that TCM ADR involving system-organ has the cardiovascular system,digestive system [RR = 0. 48,95 % CI（ 0. 37,0. 61） ],in the nervous system,respiratory system [OR =1. 62,95 % CI（ 1. 25,2. 11） ],in the skin and accessories and other [OR = 2. 95,95 % CI（ 2. 24,3. 88） ]. TCM by injection and non-injection of ADR [RR = 2. 81,95 % CI（ 2. 16,3. 67） ],TCM according to the method in use with internal and external of ADR [RR = 23. 19,95 % CI（ 16. 52,32. 57） ]. TCM ADR occurred mainly in the cardiovascular system,digestive system,respiratory system,nervous system,skin,etc.,TCM injection adverse reaction than the non-injection,but the results need more large sample,high quality retrospective investigation of verification,provide reference for clinical rational and effective medication safety.
出处
《中国药物评价》
2016年第3期155-164,共10页
Chinese Journal of Drug Evaluation
关键词
中药
不良反应
系统评价
亚组分析
Traditional Chinese medicine
Adverse reaction
System evaluation
Subgroup analysis
