中药注射剂超说明书用药研究与合理性评价

Study and rationality evaluation on off-label drug use of traditional Chinese medicine injection

目的:了解中药注射剂超说明书用药情况,为建立超说明书用药评价标准及规范化管理超说明书用药提供参考。方法:以药品说明书为依据,从功能主治、给药剂量、给药途径、给药频次、给药浓度、给药疗程、溶媒选择、禁忌及配伍问题等方面对某院2017年销量前10位中药注射剂出院病历各24例的超说明书用药情况进行统计分析,参考国家中医药管理局颁发的《中医诊疗方案》、中医辨证论治原理、文献资料等评价其合理性。结果:240例出院病历中,超说明书用药123例,其中超功能主治、超给药疗程、超溶媒选择列前3位,部分超功能主治用药有《中医诊疗方案》或相关指南推荐;疑似药品不良反应24例。结论:中药注射剂超说明书用药常见,应注意加强安全管理,规范临床合理使用。

AIM:To understand off-label drug use of traditional Chinese medicine injection,and to provide reference for establishing off-label drug use evaluation standard and standardized management of off-label drug use.METHODS:Based on the drug instructions,24 cases of each of the top 10 Chinese medicine injections discharged from hospital in 2017 were statistically analyzed from the indication,dosage,route of administration,frequency of administration,drug concentration,course of treatment,selection of solvent,taboo and compatibility.Reference was made to the Chinese Medicine Diagnosis and Treatment Prescription issued by the State Administration of Traditional Chinese Medicine.The reasonableness of the case,the principle of syndrome differentiation,treatment of traditional Chinese medicine,and the literature were evaluated.RESULTS:Among the 240 discharge cases,123 cases were treated with off-label drugs,among which the first three were super-functional attending treatment,over-dose course and super-solvent selection,some of which were recommended by TCM Diagnosis and Treatment Program or related guidelines,and 24 were suspected adverse drug reactions.CONCLUSION:Off-label drug use of traditional Chinese medicine injection is common,safety management should be strengthened and rational clinical use should be standardized.