从复方枣仁胶囊的综合评价引发中药上市后临床研究的思考和启示  

Post-marketing clinical study of traditional Chinese medicine——lessons learned from comprehensive evaluation of Fufang Zaoren capsule

作　　者：青山 高林 张力[2] 贾建平[3] 刘新民 季绍良[5] 杨晓晖[6] 

机构地区：[1]贵阳市药品不良反应监测中心,贵州贵阳550003 [2]国家食品药品监督管理局药品评价中心,北京100045 [3]首都医科大学宣武医院神经内科,北京100053 [4]中国医学科学院药用植物所,北京100094 [5]北京中医药大学,北京100029 [6]北京中医药大学东方医院,北京100078

出　　处：《中国中药杂志》2013年第21期3790-3794,共5页China Journal of Chinese Materia Medica

摘　　要：该研究通过对复方枣仁胶囊国内外上市后有效性、安全性临床研究信息进行全面回顾与分析,提出该制剂有一定疗效,但现有临床研究证据的质量有待提高。目前上市后临床研究提示用药后可能出现寒战发热、头晕、恶心、呼吸困难、胸闷、心悸等不良反应,并有超大剂量服用后引起迟发性锥体外系反应的个案病例报告;加拿大卫生部还通报了该方中左旋四氢巴马汀可能引起孕妇肝损害的风险。该研究同时还总结了该制剂临床使用过程中的风险点、影响因素和风险控制措施;初步提出我国中药上市后临床研究现状、存在的问题和对策,为推动我国中药上市后临床研究和再评价工作提供参考。By comprehensive review and analysis of post-marketing clinical research on the efficacy and safety,we concluded that Fufang Zaoren capsule has certain therapeutic effects for insomnia, although current clinical research design needs improving. The post-marketing clinical studies also showed that it causes several adverse reactions at the recommended doses, such as chills, fever, dizziness, nausea, shortness of breath, chest tightness and palpitations,whereas high doses of Fufang Zaoren capsule can cause delayed extrapyramidal symptoms.Health Canada government website also prompted the L-tetrahydropalmatine in Fufang Zaoren capsule caused liver damage in pregnant women. The authors summarized the risk points,factors and risk control in the clinical use of Fufang Zaoren capsule and also present their perspective on the research status,existing problems and corresponding countermeasures in the post-marketing clinical re-evaluation of traditional Chinese medicine.keywords：Fufang Zaoren capsule

关 键 词：复方枣仁胶囊 中西药复方制剂 上市后临床研究 再评价 风险管理 

分 类 号：R285[医药卫生—中药学]