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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。
This study comprehensively reviewed and analyzed the information of effectiveness and safety of the compound Zaoren Capsule after its listing at home and abroad, and proposed that the preparation has a certain curative effect, but the quality of existing clinical research evidence needs to be improved. Currently listed clinical studies suggest that there may be chills fever, dizziness, nausea, dyspnea, chest tightness, heart palpitations and other adverse reactions after treatment, and cases of delayed extrapyramidal reactions after taking large doses reported case reports; the Canadian Department of Health also Reported that the party L-tetrahydropalmatine may cause liver damage in pregnant women risk. The research also summarizes the risk points, influencing factors and risk control measures in clinical use of the preparation. It also puts forward the clinical research status quo, existing problems and countermeasures after the listing of Chinese traditional medicine in order to promote the clinical research and re-evaluation Work for reference.