疏血通注射液临床使用合理性与安全性再评价研究

Re-evaluation on the clinical rationality and safety of the traditional Shuxuetong Injection in clinical use

目的探讨疏血通注射液临床使用合理性与安全性再评价问题。方法本研究按照分层随机抽取某医院某年度1月至12月份临床使用疏血通注射液住院病历120份,用药品说明书推荐评价、药物利用研究和药物不良反应(ADR)监测的方法,探讨疏血通注射液临床使用合理性与安全性再评价问题。结果疏血通注射液评价指标合理性百分率以西医辨病(45.83%)、中医辨病(29.17%)、中医辨证(29.17%)和给药浓度(22.50%)均相对偏低;其超浓度使用情况严重(aDDDs/aDDCs=10.25/20.48,dDUI/cDUI=1.06/2.12);未见与疏血通注射液相关的ADR。结论应加强疏血通注射液临床监测工作,尤其是超浓度使用问题。

Objective To re-evaluate the clinical rationality and safety of the Shuxuetong Injection in clinical use.Methods In this study,120 medical records from the certain hospital,which contained Shuxuetong Injection prescription,were selected randomly and evaluated by criteria according to drug information leaflets,drug utilization index for dose/concentration(dDUI/cDUI)and average defined daily dose/concentration(aDDDs/aDDCs),and adverse drug reaction(ADR)monitoring.Results There were poor clinical rationality and safety for Shuxuetong Injection,such as in disease differentiation of western medicine(45.83%),disease and syndrome differentiation of traditional Chinese medicine(29.17%and 29.17%),and the administration concentration(22.50%),and especially in super-concentration administration(aDDCs=10.25/20.48;cDUI=1.06/2.12).No ADR about Shuxuetong Injection was reported in the hospital.Conclusion It should strengthen to monitor the rationality and safety of Shuxuetong Injection in clinical use,especially on the super-concentration administration.