活血化瘀中药注射剂超说明书应用合理性评价  

Rationality Evaluation of Off-label Uses Instructions of Traditional Chinese Medicine Injection for Blood-activating Stasis-removing

作　　者：祁旺 缪阳 黄磊 卞海林 QI Wang;MIAO Yang;HUANG Lei;BIAN Hai-lin(The First People′s Hospital of Yancheng City,Yancheng 224000,China)

机构地区：[1]盐城市第一人民医院药学部,江苏盐城224000

出　　处：《海峡药学》2023年第4期75-79,共5页Strait Pharmaceutical Journal

摘　　要：目的 评价活血化瘀中药注射剂超说明书应用合理性。方法 采用回顾性分析方法,利用医院HIS系统调取2021年10月~2022年03月于盐城市第一人民医院住院出院使用活血化瘀中药注射剂的病历信息,统计超说明书用药情况,参考相关指南共识对超说明书应用的合理性进行评价分析。结果 超说明书用药共计442例(77.70%),超说明书用药使用率排名前三的药品为大株红景天注射液97.96%、注射用红花黄色素91.84%、注射用血栓通90.82%;超说明书用药类型主要表现为超适应症、超溶媒、超剂量、超疗程、超给药禁忌、超配伍禁忌6个方面;仅126例超适应症用药符合《中医诊疗方案》或有相关指南共识推荐。结论 活血化瘀中药注射剂超说明书用药现象严重,不合理问题较多,应加强管理,保障临床用药安全。OBJECTIVE To investigate the use of traditional Chinese medicine injection for blood-activating stasis-removing beyond the instructions and analyze its rationality.METHODS Retrospective analysis was used to collect the medical record information of traditional Chinese medicineinjection for blood-activating stasis-removing in our hospital from October 2021 to March 2022;Evaluate and analyze the rationality of the use of drugs beyond the instructions with reference to the drug instructions,the TCM diagnosis and treatment plan issued by the State Administration of traditional Chinese medicine,the principle of TCM syndrome differentiation and treatment,relevant disease or drug guidelines,expert consensus and literature.RESULTS 442 cases(77.70%)were used beyond the instructions.The top three drugs in the use rate of drugs beyond the instructions were Dazhu Rhodiola injection 97.96%,safflower yellow for injection 91.84%and Xueshuantong for injection 90.82%;The types of drug use beyond the instructions are mainly manifested in six aspects:over indication,over solvent,over dose,over course of treatment,over administration taboo and over compatibility taboo;Only 126 patients with off-label uses met the“TCM diagnosis and treatment plan”or had consensus recommendations of relevant guidelines.CONCLUSION The phenomenon of over instruction medication of traditional Chinese medicine injection for promoting blood circulation and removing blood stasis is serious,and there are many problems of unreasonable medication.The management of over instruction medication should be strengthened to ensure the safety of clinical medication.

关 键 词：活血化瘀类 中药注射剂 超说明书用药 合理性分析 

分 类 号：R969.4[医药卫生—药理学]