中医院中药注射剂超说明书用药调查与合理性分析  

Investigation and Rationality Analysis of Off- label Use in Traditional Chinese Medicine Injections

作　　者：张盛敏[1] 杨冬梅[1] 黄娟[1] 张庆莲[1] 梁丽[1] 

机构地区：[1]四川省泸州市中医医院,四川泸州646000

出　　处：《中国药业》2015年第6期7-9,共3页China Pharmaceuticals

摘　　要：目的为规范中药注射剂临床使用提供参考。方法在医院信息系统(HIS)中筛选出2013年用药例次前10位的中药注射剂电子病历,根据药品说明书判定是否超说明书使用,对合理用药情况进行分类和统计,并参考国家中医药管理局颁布的《诊疗方案》、中医辨证论治原理及相关文献分析其合理性。结果检索到符合条件的病历共17 100份,超说明书用药病历5 599份,占32.74%,其中1 977份属合理用药,3 622份属不合理用药。结论中药注射剂超说明书用药较普遍,仅有部分为合理性用药;为满足临床用药与保障用药安全,应加强对超说明书用药的管理,并继续规范与完善药品说明书内容。Objective To provide reference for standardizing the clinical use of traditional Chinese medicine（ TCM） injections. Methods The electronic medical records of the TCM injections in the top 10 of case- times of TCM injection use during 2013 were screened out from the hospital information system（ HIS） and each case was judged whether or not off- label use. The rational drug use situation was conducted the classification and statistics,and its rationality was analyzed according to the Diagnosis and Treatment Schemes issued by the State Administration of Traditional Chinese Medicine,syndrome differentiation principles of Chinese medicine and the related literatures. Results 17 100 cases of medical records were retrieved,in which 5 599 cases（ 32. 74%） were the off- label use of TCM injection,among them,1 977 cases belonged to the rational drug use and 3 622 cases belonged to the irrational drug use. Conclusion The off- label use of TCM injections is universal and only a part of use is rational. Therefore the management of the off- label use of TCM injections should be strengthened for satisfying the clinical medication and ensuring the medication safety; moreover the contents of drug instruction should be standardized and perfected.

关 键 词：中药注射剂 超说明书用药 调查 合理用药 

分 类 号：R288[医药卫生—中药学] R954[医药卫生—中医学]