骨科中成药“辨证辨量辨毒”合理用药模式的构建与实践

骨科中成药多含有毒性中药饮片,且使用量大、用药人群特殊,一直是中成药安全合理用药的热点和难点。该文切入医院药学工作实际和中医药基本理论,提出骨科中成药"辨证辨量辨毒"的合理用药模式,拟定相关参考规范,为临床合理用药提供支持。首先,梳理骨科中成药临床应用特点,提出"证"、"量"、"毒"三位一体的用药核心监护点;接着,以常见81个同类品种为示例,建立说明书信息库,并以2 000张回顾性处方点评分析结果圈定高频药物和常见不合理因素;同时,从知网、万方等数据库中系统搜集汇总不良反应案例文献,辅以问卷调研形式,明确了各药品的核心监护点信息。整合以上信息,拟定《骨科中成药临床用药参考》并经专家讨论后完善修订。初步预实践2个月后效果显示,该模式符合临床用药实际,能够提供实用有效的合理用药信息,效果良好。综上,"辨证辨量辨毒"是骨科中成药临床用药的关键要素和核心监护点,该模式立足临床实际,为合理用药研究提供思路创新、理论保障和数据支持。

Construction and practice on rational medication model of Chinese patent medicine for orthopedics based on "symdrome-dosage-toxicity differentiation" theory

Chinese patent medicines for orthopedics are among the hotspot and difficulty in the rational medication of traditional Chinese medicine (TCM), because they mostly contain toxic medicinal herbs and oriented to special patients. According to the hospital pharmacy practices and the therapeutic theories of TCM, this paper focused on a novel model of rational drug use of Chinese patent medicine for orthopedics based on the principles of "syndrome-dosage-toxicity differentiation". We also proposed relevant specifications for guiding their clinical use. Firstly, we proposed a list of the primary clinical application characteristics for rational drug use of orthopedic TCMs, including the syndromes of patient, the dosage of medicine and the toxic ingredients in medicine. Secondly, a database was established for recording the package inserts of all of the 81 orthopedic patent medicines in our hospital, and 2 000 retrospective recipes were analyzed for looking for the high-frequency medicines and common irrational factors. Then clinical case reports involving the adverse reactions and side effects of related drugs were searched from CNKI, VIP and WanFang databases. Then the key information for rational application of each medicine was extracted from these resources and some survey questionnaires. Finally, we established a guide named instructions for clinical use of orthopedic Chinese patient medicines (ICUOCPM) after the discusstion with experts. According to the effect after the practice in hospital for 2 months, the proposed principles of "syndrome-dosage-toxicity differentiation" in this paper were believed to be the core elements and the most important clinical monitoring points in TCM for orthopedic patents. It would provide innovative ideas, theoretical guarantee and data support for the development of TCM clinical pharmacy.