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(5)
[Abstract] 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、[Key words] Fufang Zaoren capsule； Chinese-western medicine compound preparation； post-marketing clinical study； re-evaluation； risk control
doi：10.4268/cjcmm20132132
[责任编辑 陈玲], http://www.100md.com(青山 高林 张力 贾建平 刘新民 季绍良 杨晓晖)
doi：10.4268/cjcmm20132132
[责任编辑 陈玲], http://www.100md.com(青山 高林 张力 贾建平 刘新民 季绍良 杨晓晖)