【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。更多还原

【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.更多还原