某院活血化瘀类中药注射剂使用评价标准建立的探索  

Applicability of evaluation standards for use of traditional Chinese medicine injections for promoting blood circulation and removing blood stasis

作　　者：张建 方慧华[2] ZHANG Jian;FANG Huihua(Department of Pharmacy,Sihong Hospital,Suqian Jiangsu 223900,China;Department of Pharmacy,Jiangsu Provincial Hospital of Traditional Chinese Medicine,Nanjing Jiangsu 210029,China)

机构地区：[1]江苏省泗洪医院药剂科,江苏宿迁223900 [2]江苏省中医院药学部,江苏南京210029

出　　处：《中国药物警戒》2024年第2期185-189,共5页Chinese Journal of Pharmacovigilance

基　　金：江苏省药学会恒瑞药学基金(H202021);江苏省重点研发计划(社会发展)项目(BE2020727)。

摘　　要：目的 建立活血化瘀类中药注射剂临床使用评价标准。方法 根据《中华人民共和国药典》(2020年版)、《国家基本医疗保险、工伤保险和生育保险药品目录》(2021年版)、《中成药治疗冠心病临床应用指南》(2020版)、《中成药治疗心力衰竭临床应用指南》(2021年版)梳理所有活血化瘀类中药注射剂,根据其药品说明书信息、指南信息和临床使用情况,设立评价指标,运用德尔菲法建立评价标准。收集2022年1月1日至6月30日某院心内科活血化瘀类中药注射剂使用数据,采用评价标准结合优劣解距离法(technique for order preference by similarity to an ideal solution,TOPSIS)进行评价。结果 共纳入21种活血化瘀类中药注射剂适应证,分别从适应证、溶媒、用法用量、辅料和溶剂、配伍使用、特殊人群等方面建立一级、二级评价指标。根据评价结果分析120例心内科使用活血化瘀类中药注射剂患者中,相对接近度(Ci)≥60%的有107例(89.17%),表明某院心内科使用活血化瘀类中药注射剂应用情况基本合理。结论 评价标准的建立有利于提高活血化瘀类中药注射剂使用的合理性,可促进活血化瘀类中药注射剂临床的安全使用。Objective To establish the standard for evaluation of clinical use of traditional Chinese medicine injections for promoting blood circulation and removing blood stasis.Methods According to the National Pharmacopoeia of the People’s Republic of China(2020 edition),the Drug Catalogues for National Basic Medical Insurance,Work-related Injury Insurance and Maternity Insurance(2021),the Guidelines for Clinical Application of Proprietary Chinese Medicine for Coronary Heart Disease(2020 edition)and the Guidelines for Clinical Application of Proprietary Chinese Medicine for Heart Failure(2021),all TCM injections for promoting blood circulation and removing blood stasis were sorted out.According to drug instructions,guidelines and clinical use,the indicators for evaluation were identified,and the standard for evaluation was established using the Delphi method.Data on TCM injections for promoting blood circulation and removing blood stasis used in the Department of Cardiology between January 1 and June 30,2022 was collected.The Technique for Order Preference by Similarity to an Ideal Solution was used for evaluation.Results A total of 21 indications of TCM injections for promoting blood circulation and removing blood stasis were included before primary and secondary evaluation indexes were established in terms of indications,solvents,usage and dosage,excipients,compatibility and special populations.According to the results of evaluation,107 patients(89.17%)with Ci≥60%were identified from among 120 patients receiving TCM injections for promoting blood circulation and removing blood stasis,indicating that the usage of these TCM injections in the Department of Cardiology was generally proper.Conclusion The establishment of a standard for evaluation can help improve the rationality of the way in which TCM injections for promoting blood circulation and removing blood stasis are used.

关 键 词：心内科 活血化瘀 中药注射剂 药品说明书 评价标准 优劣解距离法 

分 类 号：R944[医药卫生—药剂学] R994.11[医药卫生—药学]