摘要
疗程和用药时长是中成药合理用药和处方点评的又一重要问题,目前存在的管控难点除了说明书相关信息的缺失、医嘱整合的忽视之外,还涉及中成药上市前先期临床试验在疗程设定和疗程研究方面的不足,以及传统中药"随症停药"的药后调护理念所带来的疗程不确定性难题。基于以上认识,本文从现阶段认识和现有资料水平出发,提出中成药临床应用的参考疗程和合理停药理念,并遴选了345种中成药说明书的疗程信息和《中药新药临床研究指导原则》所列50种病证的推荐疗程信息,例举了从学术指南、中医医案、相关专著和临床研究文献中捕获的疗程信息;同时,提出合理停药理念的重要性和实际应用价值。综合以上资料,尝试提出中成药疗程合理性评价的标准和尺度,为中成药处方点评提供启发和参考。
Course of treatment and medication duration are other important issues in prescription review of Chinese patent medicines. Current bottleneck of this issue does not only come from incomplete instruction information and medication integra- tion, but is also influenced by study design of course of treatment in early clinical trials. A kind of therapeutic concept named 'flexible drug adjustment plan in Traditional Chinese Medicine (TCM), however, increases the difficulty of course setting. Based on current knowledge this paper tried to collect course information as much as possible and proposed reasonable drug ad- justment principles. A total of 345 kinds of instructions of Chinese patent medicines and the book Guiding Principles of New Clinical Research of Traditional Chinese Medicines were referred. Resource of academic guidance, TCM eonsilia, relevant mon- ographs and clinical research literatures were also used for seeking treatment course information. Meanwhile, we also tried to propose the criteria and compromise of prescription review on course of treatment.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2015年第22期1979-1985,共7页
Chinese Journal of Hospital Pharmacy
基金
首都卫生发展科研专项重点攻关项目(编号:首发2011-2008-01)
北京市中医管理局中西医结合项目(编号:2014-ZYJ14)
北京药学会临床药学研究项目(编号:2013-03)
首都医科大学附属北京世纪坛医院中青年学科骨干培养专项(编号:院国青2015-QB04)
关键词
中成药
中药
处方点评
临床药学
疗程
用药时长
Chinese patent medicine
herbal medicine
prescription review
clinical pharmacy
course of treatment
medica-tion duration