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• 药品评价-安全性研究 • 上一篇    下一篇

中药不良反应系统评价研究

孙利昆,柳芳,陈文倩,张丹,张相林   

  1. 北京中医药大学中药学院,中日友好医院北京,中日友好医院北京,中日友好医院北京,中日友好医院北京
  • 收稿日期:2015-12-24 修回日期:2016-02-14 出版日期:2016-06-25 发布日期:2016-06-25

Evaluation Analysis of Traditional Chinese Medicine Adverse Reaction System

孙利昆,,, and 张相林   

  1. School of Chinese Materia Medica,Bei JIng University OF Chinese Medicine,,,,
  • Received:2015-12-24 Revised:2016-02-14 Online:2016-06-25 Published:2016-06-25

摘要: [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。

Abstract: [Abstract]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.