中成药处方点评的标准与尺度探索(一):超说明书剂量用药

The exploration on the creteria and compromise of prescription review of Chinese patent medicines Ⅰ:the overdose medication

中成药处方点评是推动医院中成药合理应用的重要环节,也是中药临床药学的重要内容。然而,由于中成药特殊的治疗学背景和时代特征,单纯以说明书为标准的处方点评存在一定局限性,并突出表现在超说明书剂量用药方面。本研究基于目前中成药超说明书剂量用药的点评现状,结合古今文献,从中药现代常用量与经方本源剂量的对比、中成药质量和疗效的不稳定性、中成药说明书的欠规范性共3个角度,并援引十余种常见中成药临床应用中的真实超剂量使用案例,尝试剖析中成药超剂量用药的潜在"合理性"。在此基础上,提出3点建议:树立中成药使用剂量的上下限理念、区分管理低风险药品和高风险药品、根据不同适应证采用等级化剂量,从而规范超剂量用药的点评标准,探索超剂量用药的点评尺度,为中成药合理用药提供思考。

The prescription comment of Chinese patent medicine is the important part of clinical pharmacy in Traditional Chinese medicine（TCM）,which promotes the rational drug use in hospitals.However,due to the special therapeutic backgrounds and real-world features of TCM,only instructions of TCM patent medicines cannot be used as the only criteria for prescription comment,especially for drug use at overdoses.Based on the current status of TCM prescription comment mainly by instructions of TCM patent medicines,by combining comparison of ancient and modern doses,considering the unstable quality and efficacy of TCM drugs and substandard instructions,and introducing cases of overdose from clinical application,we dry to investigate the potential＂rationality＂for overdoses of TCM drugs.Moreover,three suggestions are proposed including setting the upper and lower limits for drug doses,distinguishing the drugs of low and high risks,and adopting graded doses according to different indications.In summary,we will try to elucidate the comment criteria to regulate and evaluate TCM overdose,and provide thoughts for rational use of TCM patient drugs.