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目的评价住院患者舒血宁注射液临床使用合理性与安全性。方法本研究筛选某医院2016年临床使用舒血宁注射液的住院患者病历,用药品说明书推荐评价、药物利用研究及药品不良反应/事件Logistic回归分析综合评价住院患者舒血宁注射液的临床使用情况。结果该医院2016年住院患者舒血宁注射液临床使用中医辨证(48.33%)、给药浓度(38.33%)评价指标合理性百分率平均值普遍偏低,药物利用研究提示超剂量、超浓度使用情况严重(dDUI/c DUI=1.45/3.17>1)。多因素条件Logistic回归分析提示,中医辨证(OR=0.71,95%CI:0.54~0.90,P<0.05)与给药浓度(OR=0.58,95%CI:0.45~0.72,P<0.05)可以作为保护因素,用于中药注射剂药品不良反应/事件评价和预测。结论应加强舒血宁注射液临床监测工作,尤其是进一步加强临床中医辨证论治,同时要密切关注超浓度给药安全性问题。
Objective To evaluate the rationality and safety of clinical use of Shuxuening injection in hospitalized patients. Methods This study screened the clinical records of inpatients using Shuxuening Injection in 2016 in a hospital, recommended evaluation of drug manual, drug use study and adverse drug reaction / event logistic regression analysis to evaluate the clinical use of inpatient Shuxuening injection Happening. Results The hospital use of traditional Chinese medicine syndrome differentiation (48.33%) and the administration percentage (38.33%) were generally low in the 2016 inpatient Shuxuening injection. The drug utilization research indicated that the use of overdose and hyperconcentration Serious (dDUI / c DUI = 1.45 / 3.17> 1). Multivariate logistic regression analysis showed that TCM syndrome differentiation (OR = 0.71, 95% CI: 0.54-0.90, P <0.05) and administration concentration (OR = 0.58, 95% CI: 0.45-0.72, P < Protection factors for the adverse reactions of traditional Chinese medicine injection / event evaluation and prediction. Conclusion It is necessary to strengthen the clinical monitoring of Shuxuening Injection, in particular to further strengthen the clinical diagnosis and treatment of traditional Chinese medicine, and pay close attention to the issue of safety of super-concentrated drug delivery.