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《The Chinese Journal of Clinical Pharmacology》 2017-16
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Re-evaluation on the rationality and safety of Shuxuening injection in clinical use

WANG Qun;SUN Li-jun;SUN Shi-guang;College of Traditional Chinese Medicine,Shandong University of Traditional Chinese Medicine;Department of Neurology, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Shandong Provincial Hospital of Traditional Chinese Medicine;Department of Pharmacy,Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Shandong Provincial Hospital of Integrated Medicine;  
Objective To explore the method of research on the rationality and safety of traditional Chinese medicine injections( TCMIs),Shuxuening injection on clinical. Methods In this study, 120 inpatients records, which contained Shuxuening injection prescription from certain hospitals during 2016 were selected and evaluated by criteria according to drug information leaflets,drug utilization index for dose/concentration( dDUI/c DUI), and multivariate conditional Logistic regression analysis. Results There were poor rationality and safety,such as in syndrome differentiation of traditional Chinese( 48. 33%) and administration concentration( 38. 33%), especially in overdose and super-concentration administration( dDUI/c DUI = = 1. 45/3. 17 1)of Shuxuening injection. Multivariate conditional logistic regression analysis showed that,syndrome differentiation of traditional Chinese( OR = 0. 71,95% CI: 0. 54-0. 90, P 0. 05) and administration concentration( OR =0. 58,5%CI: 0. 45-0. 72,P 0. 05) as two protective factors were valid indicators for evaluation and prediction of the adverse drug reactions/events of Shuxuening injection. Conclusion It should strengthen to monitor Shuxuening injection on clinical,and especially it should pay attention to syndrome differentiation of traditional Chinese and administration concentration.
【Key Words】: Shuxuening injection drug information leaflet drug utilization research adverse drug reaction rationality safety
【Fund】: 山东省中医药科技发展计划基金资助项目(2015-128;2015-134);; 山东省医务职工科技创新基金资助项目(鲁医工字[2014]32;鲁医工字[2015]33;鲁医工字[2016]35)
【CateGory Index】: R286
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