[Effect of Dengzhan Xxin Injection Dosage on Renal function Using Propensity Score Estimation].

中国中西医结合杂志 Pub Date : 2016-12-01
Yuan-Yuan Li, Hao Tang, Lin Li, Yan-Ming Xie
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Abstract

Objective To observe clinical dose of Dengzhan Xixin Injection (DZI) on renal func- tion and analyze its relation with abnormal changes of renal function indices [serum creatinine (SCr) and blood urea nitrogen (BUN) ]. Methods The information of 21 498 patients who used DZI were recruited from 20 hospital information system (HIS) database across China. Of them, 13 696 patients in line with 18 -80 years old were taken as subjects. They were assigned to the ultra-dose group ( >40 mL) and the conventional dose group ( ≤40 mL) according to whether the single DZI dosage exceeded the recommended dosage in the drug instruction. Changes of SCr and BUN were taken as outcome evaluation indicators 7 days before and after administration of DZI. There were 650 cases with two SCr values, 87 in the ultra-dose group and 563 in the conventional dose group. There were 651 cases with two BUN values, 87 in the ultra-dose group and 564 in the conventional dose group. Data were analyzed using stratified analysis and propensity score estimation. Results No statistical difference existed in age, gender, admission condi- tion, or stratification estimation results of DZI course between the ultra-dose group. and t6e conventional dose group (P >0. 05). No statistical difference existed in changes of abnormal renal functions between the ultra-dose group and the conventional dose group after balancing 71 confounders factors by propensity score estimation (P >0. 05). Conclusion Analyzed based on HIS data, use of DZI exceeding recommended dosage did not result in abnormal changes of renal function.

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[用倾向评分法估计灯盏心注射液剂量对肾功能的影响]。
目的观察灯盏西心注射液(DZI)临床剂量对肾功能的影响,并分析其与肾功能指标[血清肌酐(SCr)、尿素氮(BUN)]异常变化的关系。方法从全国20家医院信息系统(HIS)数据库中收集21 498例使用DZI的患者信息。选取年龄在18 ~ 80岁的患者13696例作为研究对象。根据单次DZI剂量是否超过药物说明书推荐剂量分为超剂量组(>40 mL)和常规剂量组(≤40 mL)。以给药前后7 d SCr和BUN的变化作为结局评价指标。有两个SCr值的650例,超剂量组87例,常规剂量组563例。两个BUN值651例,超剂量组87例,常规剂量组564例。数据分析采用分层分析和倾向评分估计。结果超剂量组在年龄、性别、入院条件、DZI病程分层估计结果等方面均无统计学差异。与常规剂量组比较(P > 0.05)。05). 经倾向评分估计平衡71个混杂因素后,超剂量组与常规剂量组肾功能异常变化无统计学差异(P > 0.05)。05). 结论根据HIS数据分析,使用超过推荐剂量的DZI未引起肾功能异常变化。
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