中药注射剂超说明书用药调查与分析

目的促进临床合理、规范使用中药注射剂。方法通过医院信息系统筛选出2018年9月某院使用数量排名前5位中药注射剂的住院患者病历,并对照药品说明书进行超说明书用药统计与分析。结果共抽取病历1 731份,其中超说明书用药病历1 295份,占74. 81%。超说明书适应证用药777份(60. 00%),其次分别为超给药途径(41. 00%)、超溶剂(30. 66%)、超剂量(14. 29%)、超给药频次(6. 18%)、超疗程(0. 54%)。结论中药注射剂超说明书用药情况较普遍,且存在不合理用药情况,应加强其超说明书应用管理,促进其使用的合理性和安全性。

Investigation and Analysis of Off-Label Drug Use in TCM Injections

Objective To promote rational and standard use of traditional Chinese medicine( TCM) injections in the clinic. Methods The top 5 TCM injections used in the inpatients’ medical records in September 2018 were screened from the hospital information system,and the statistics and analysis of the off-label drug use were conducted according to the drug instructions. Results A total of 1 731 medical records were collected,and 1 295( 74. 81%) belonged to off-label use of TCM injections. Among them,777 cases belonged to off-label drug indications use( 60. 00%),followed by off-label administration route( 41. 00%),over-solvent( 30. 66%),over-dosage( 14. 29%),over-frequency( 6. 18%) and over the course of treatment( 0. 54%). Conclusion Off-label usage of TCM injections is common,and there are some unrational drug use cases. The management of off-label uses should be strengthened to promote the rationality and safety of their usage.