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基于医院信息系统的参麦注射液不同使用剂量对肾功能作用分析
引用本文:姜俊杰,唐浩,谢雁鸣,杨虎,庄严.基于医院信息系统的参麦注射液不同使用剂量对肾功能作用分析[J].中国中药杂志,2013,38(18):3060-3067.
作者姓名:姜俊杰  唐浩  谢雁鸣  杨虎  庄严
作者单位:中国中医科学院 中医临床基础医学研究所, 北京 100700;中国人民大学, 北京 100872;中国中医科学院 中医临床基础医学研究所, 北京 100700;中国人民大学, 北京 100872;中国人民解放军 海军总医院, 北京 100048
基金项目:国家"重大新药创制"科技重大专项(2009ZX09502-030);国家自然科学基金青年基金项目(81202776);中国中医科学院第7批自主选题项目(Z0255);中国中医科学院客座研究员联合创新研究项目(ZZ070817)
摘    要:目的: 了解参麦注射液不同使用剂量对肾功能是否有影响。 方法: 以全国18家三级甲等医院的医院信息系统(HIS)为数据来源,从中选择使用参麦注射液、年龄在18~80岁、使用参麦注射液前后7 d有2次血肌酐与尿素氮检测者作为研究对象,将患者2次理化指标测定期间内的最大单次给药剂量大于100 mL的纳入超说明书推荐剂量组,其余纳入未超说明书推荐剂量组。采用倾向性评分法,比较2组间肾功能发生异常的差异。 结果: 超说明书推荐剂量组与未超说明书推荐剂量组比较,导致血肌酐、尿素氮发生异常变化的可能性相同,统计学差异不显著。 结论: 基于现有数据,未发现"超说明书推荐剂量使用参麦注射液对肾功能有损害"的情况,但临床中用药仍需谨慎。

关 键 词:参麦注射液  肾功能  超说明书推荐剂量  真实世界  倾向性评分
收稿时间:2013/5/22 0:00:00

Based on hospital information system data, analysis of effects of different doses of Shenmai injection on renal function
JIANG Jun-jie,TANG Hao,XIE Yan-ming,YANG Hu and ZHUANG Yan.Based on hospital information system data, analysis of effects of different doses of Shenmai injection on renal function[J].China Journal of Chinese Materia Medica,2013,38(18):3060-3067.
Authors:JIANG Jun-jie  TANG Hao  XIE Yan-ming  YANG Hu and ZHUANG Yan
Institution:Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China;Renmin University of China, Beijing 100872, China;Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China;Renmin University of China, Beijing 100872, China;The PLA Navy General Hospital, Beijing 100048, China
Abstract:Objective: To assess whether the dosage of Shenmai injection influences renal function. Method: Analysis of hospital information system(HIS) data from 18 national hospitals using Shenmai injections. Patients were aged between 18 to 80 years old. Blood analysis of creatinine and serum urea nitrogen was undertaken 7 days before and after exceeding the maximum recommended dose of 100 mL of Shenmai injection. Propensity score method was used to compare the differences between the two groups of renal function scores. Result: The differences in abnormal changes in creatinine and serum urea nitrogen levels between the groups before and after exceeding the recommended dose was not statistically significant, but abnormal changes were detected. Conclusion: Based on the available data we did not find that exceeding the recommended dose of Shenmai injection had a significantly deleterious effect on renal function. However, caution should be applied in its clinical use.
Keywords:Shenmai injection  kidney function  overdose  real world research  propensity score
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