中药注射剂说明书与合理用药相关性分析

Analysis on the Relation between Rational Use and TCM Injection Instructions

目的:分析中药注射剂说明书中与临床用药密切相关的项目,为完善中药注射剂说明书提供依据。方法:收集26份中药注射剂说明书,依据说明书书写指导原则,对其内容的完整性、规范性进行统计分析。结果:26份说明书中,标注辅料的有17份(63.39%);功能主治均以西医学术语表述的有5份(19.23%);未注明稀释溶剂及剂量的1份(3.85%);未注明静脉给药滴速的13份(50.00%);特殊人群用药项均未标注;相互作用项无任何参考价值;用法用量项内容亦不完善。结论:中药注射剂说明书内容不完善、文字描述不规范、各项内容混杂,仍需不断完善。

Objective： To analyze the items of TCM injection instructions which were closely related to clini- cal use and provide evidence for improving TCM injection instructions. Method： Altogether 26 pieces of TCM injec- tion instructions in our hospital were collected, the completeness and regularity of the contents in the structions were analyzed according to the guiding principles. Result： There were 17 pieces （63.39%） labeled the adjuvant materials among 26 pieces, in five pieces （19.23%）, the indication and functions were expressed with the terms of Western medicine; in one piece （3.85%）, the instruction didn＇t show diluting solvents and dosage; intravenous dripping speed wasn＇t included in 13 pieces （50.00%）; special groups weren＇t labeled; the item of interaction couldn＇t provide any value for reference; the items of dosage and directions were lacked. Conclusion： TCM injection instruction needs to be improved due to lack of the contents, irregular description in words and disordered contents in items.