中药注射剂超适应证用药情况分析

Analysis of Off-label Use of Traditional Chinese Medicine Injections

目的:调查中药注射剂超适应证使用的情况,为合理使用中药注射剂提供建议。方法:抽取我院2013年9月的242份出院患者病历,对其中的中药注射剂超适应证用药情况进行分析,并结合用药实例,从中药注射剂超适应证用药出现的原因、风险规避等方面进行了讨论。结果:我院中药注射剂超适应证用药占10.19%,大部分超适应证用药为合理用药。结论:临床医师应结合中医理论及临床疗效辨证用药,同时遵守医院相关规定,规避风险;中药注射剂生产厂家应尽快对药品说明书进行修订,并加强对传统中药剂型和中药注射剂的基础研究。

OBJECTIVE： To investigate the off-label use of traditional Chinese medicine （TCM） injections so as to provide sug- gestions for rational use of TCM injections. METHODS ： A total of 242 medical records of the discharged patients collected during September 2013 were analyzed with regard to the off-label use as well as its causes and risk aversion, taking medication cases as example. RESULTS： The off-label use of drugs of TCM injections in our hospital accounted for 10.19%; however, rational use of drugs was noted in the majority of off-label drug use cases. CONCLUSIONS： Clinicians should achieve dialectical medication based on traditional Chinese medicine theory and clinical efficacy, and comply with the relevant rules of the hospital to avoid risks. The manufacturers of TCM injections should amend their package inserts as soon as possible and strengthen basic research on tradi- tional Chinese medicine dosage forms and Chinese medicine injections.