中国中药杂志

2015, v.40(12) 2461-2463

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中药上市后再评价的临床实施质量潜在风险及质量控制
Post-marketing reevaluation for potential quality risk and quality control in clinical application of traditional Chinese medicines

李洪皎;何丽云;刘保延;
LI Hong-jiao;HE Li-yun;LIU Bao-yan;Clinical and Basic Research Institute for Traditional Chinese Medicine,China Academy of Chinese Medical Sciences;China Academy of Chinese Medical Sciences;

摘要(Abstract):

针对临床研究实施过程进行有效的质量控制是研究结果真实性和科学性的有效保障。中药上市后临床再评价要求针对已上市药品的疗效、不良反应、联合用药和有效剂量等采用扩大化的临床试验进行考察,即要求在更大样本量、更广泛的患者群体中对药物进行再评价,上述情况增加了临床实施质量控制的难度。该研究结合"抗病毒口服液治疗感冒的上市后再评价"临床实施质量控制经验,以提高临床实施质量控制效率为目标,基于整体观角度综合研究目的、方案设计、临床实施过程,分析中药上市后再评价研究特点和质量控制风险,针对质量影响因素设计质量控制内容、明确重点核查内容、总结临床实施质量控制注意事项。期望本研究为开展中药上市后再评价的临床单位和质量控制相关人员提供参考。
The effective quality control in clinical practices is an effective guarantee for the authenticity and scientificity of the findings. The post-marketing reevaluation for traditional Chinese medicines( TCM) focuses on the efficacy,adverse reaction,combined medication and effective dose of drugs in the market by expanded clinical trials,and requires a larger sample size and a wider range of patients. Therefore,this increases the difficulty of quality control in clinical practices. With the experience in quality control in clinical practices for the post-marketing reevaluation for Kangbingdu oral for cold,researchers in this study reviewed the study purpose,project,scheme design and clinical practice process from an overall point of view,analyzed the study characteristics of the post-marketing reevaluation for TCMs and the quality control risks,designed the quality control contents with quality impacting factors,defined key review contents and summarized the precautions in clinical practices,with the aim to improve the efficiency of quality control of clinical practices. This study can provide reference to clinical units and quality control-related personnel in the post-marketing reevaluation for TCMs.

关键词(KeyWords): 上市后再评价;随机对照试验;中医药;质量影响因素;质量控制内容
post-marketing reevaluation;randomized controlled trial;traditional Chinese medicine;impacting factors on quality control;quality control content

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基金项目(Foundation): 广州市香雪制药股份有限公司资助项目(Y000201)

作者(Author): 李洪皎;何丽云;刘保延;
LI Hong-jiao;HE Li-yun;LIU Bao-yan;Clinical and Basic Research Institute for Traditional Chinese Medicine,China Academy of Chinese Medical Sciences;China Academy of Chinese Medical Sciences;

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