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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。
Objective: To understand whether different doses of Shenmai injection have any effect on renal function. Methods: According to the hospital information system (HIS) of 18 Grade-3 Hospitals nationwide, we selected Shenmai injection, aged from 18 to 80 years old, had serum creatinine twice before and 7 days after using Shenmai injection And urea nitrogen test as the research object, the patient twice during the determination of physical and chemical indicators of the largest single dose of more than 100 mL into the super recommended dose group, the rest were not included in the manual recommended dose group. Tendency score method was used to compare the difference of renal function abnormalities between the two groups. Results: Compared with the recommended dosage group that did not exceed the recommended dosage in the super instruction manual, the possibility of abnormal changes of serum creatinine and urea nitrogen were the same, but the statistical difference was not significant. Conclusion: Based on the available data, we did not find out that the recommended dose of Shenmai Injection on renal function is impaired in the recommended dosage of “Super manual”, but caution should still be used in clinical practice.