药物利用指数与药品说明书评价相关性研究:中药注射剂

Study on the correlation between drug utilization index and drug information leaflets of six traditional Chinese medicine injections:From the new view of defined daily dose/concentration

目的:探讨药物利用指数(d DUI/c DUI)与药品说明书评价结果相关性。方法:以6种中药注射剂为例,分层随机抽取某医院使用该品种中药注射剂病例120例,采用d DUI/c DUI与药品说明书(给药剂量/给药浓度合理性百分率)评价中药注射剂临床使用合理性与安全性,并探讨两者评价结果相关性与一致性。结果:相关分析提示,除注射用丹参(冻干)外,其他5种中药注射剂药物利用指数c DUI与药品说明书(给药浓度)评价尚具有较好相关性(热毒宁注射液:Spearman=-0.7507,P<0.05;疏血通注射液:Spearman=-0.7723,P<0.05;血塞通注射液:Spearman=-0.8911,P<0.05;银杏内酯注射液:Spearman=0.7283,P<0.05;灯盏细辛注射液:S p e a r m a n=-0.5854,P<0.05);κ参数提示,c DUI与给药浓度仅银杏内酯注射液尚具有较好一致性(κ=0.613,P<0.05)。结论:药物利用指数与药品说明书评价相关性受多因素影响,其中从给药浓度角度评价中药注射剂临床使用合理性与安全性尚可接受,但应注意临床严重超剂量、超浓度使用等实际因素的影响。

Objective：To explore the correlation between drug utilization index（DUI） and drug information leal ets of six traditional Chinese medicine injections（TCMIs）,such as Danshen freeze-dried powder injection（DSP）,Reduning injection（RDN）,Shuxuetong injection（SXT）,Xuesaitong injection（XST）,Ginkgolid injection（GIN）,and Denzhanxixin injection（DZXX）,from a new view of dei ned daily dose/concentration（DDD/DDC）.Methods：The total of 120 medical cases of each TCMIs from the certain hospital were collected randomly and evaluated by both criteria（percentage of administration dose/concentration for rationality） according to drug information leal ets,and drug utilization index for dose/concentration（d DUI/c DUI）.Then,the Pearson or Spearman correlation coei cient,the intraclass correlation coei cient（ICC） and the kappa agreement index（κ） were calculated for each of TCMIs.Results：There was an acceptable correlation between c DUI and percentage of administration concentration for rationality,for all TCMIs except DSP（RDN：Spearman=-0.7507,P〈0.05;SXT：Spearman=-0.7723,P〈0.05;XST：Spearman=-0.8911,P〈0.05;GIN：Spearman=0.7283,P〈0.05;DZXX：Spearman=-0.5854,P〈0.05）,and a fair concordance only for GIN（κ=0.613,P〈0.05）.Conclusion：There are many influencing factors for correlation between DUI and drug information leal ets.It is acceptable that rationality and safety of TCMIs was evaluated from the view of DDC or administration concentration.But,more attention should be paid to overdose and over-concentration in the clinical practice.