含乌头碱中成药临床安全用药风险评估量表的构建与验证  

Establishment and verification of risk assessment scale for clinical safety medication of aconitine

作　　者：金锐[1] 王宇光 张冰[3] JIN Rui1 , WANG Yu-guang2 , ZHANG Bing3(1. Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, China; 2. The Third Affiliated Hospital of Beijing University of Chinese Medicine, Beijing 100029, China;3. School of Materia Medica, Beijing University of Chinese Medicine, Beijing 100029, Chin)

机构地区：[1]首都医科大学附属北京世纪坛医院,北京100038 [2]北京中医药大学第三附属医院,北京100029 [3]北京中医药大学中药学院,北京100029

出　　处：《中国中药杂志》2018年第2期222-226,共5页China Journal of Chinese Materia Medica

基　　金：国家食品药品监督管理局药品评价中心项目(2020071420118);北京中医药大学新奥优秀传承团队建设项目(1000062720028/001);北京中医药大学基本科研业务费项目(2015-JYB-JSMS147);北京中医药科技发展资金项目(QN2016-04)

摘　　要：含乌头碱中成药是临床安全合理用药的重点,此类药品多含有川乌、草乌附子或雪上一枝蒿,以祛风除湿或温中补阳为功效,需要严格遵照适应症和用法用量使用。但此类药品种类繁多,不仅部分中西医师对于药品性效特征不了解,而且还时常存在多科室联合用药的情况,增加了乌头碱中毒的风险。该文在前期研究基础上,将近2年的含毒中成药处方点评和用药宣教工作经验提炼为＂辨证-辨量-辨毒＂3个核心要素,并采用客观化、标准化的评价方式,以虎力散胶囊和祛风止痛胶囊为例,构建包含3类9项36个指标的风险评估数字量表,实现对于含乌头碱中成药治疗方案的治疗风险预估和治疗现状评估。以现有上述中成药的不良反应案例报道的验证显示,该风险评估量表可以提示药物治疗方案的风险,标识药物治疗现状的风险等级。为科学、客观地评价含毒中成药的临床用药安全性提供了方法学范例,也有助于不熟悉中医药理论的医师和药师快速掌握含毒中成药合理使用的关键环节和风险防范。Chinese patent medicine containing aconitine is the key in clinical rational drug use. These drugs contain Chuanwu,Caowu or Fuzi,and Aconitum brachypodum with functions of expelling wind-dampness or tonifying Yang,all of which shall be used by strictly following the indications and dosage. However,there are many kinds of such drugs. Not only the unfamiliar knowledge of some Chinese and Western physicians about the characteristics of them,but also the combination of multiple drugs from different clinical departments,would increase the risk of aconitine poisoning. Based on the previous research,this paper proposed three core elements ＂ syndrome differentiation-dosage differentiation-toxicity differentiation＂ from the prescription review and pharmacy consulting work,and objective and standardized evaluation was used to build a risk assessment scale containing 3 categories,9 items and 36 indicators with Hulisan Jiaonang and Qufeng Zhitong Jiaonang as the example. This scale was used to evaluate the risk of a therapeutic regimen before and after the implementation. According to the verification of the existing adverse reaction cases,the risk assessment scale can be used to indicate the risk of drug treatment program and identify the risk level of drug treatment status. This paper tried to provide a methodological paradigm for scientific and objective evaluation on the safety of Chinese patent medicines,and help to identify the key links and risk prevention in the rational use by Chinese medicine physicians and pharmacists.

关 键 词：中成药 安全性评价 数学量表 乌头碱 虎力散胶囊 祛风止痛胶囊 

分 类 号：R286[医药卫生—中药学]