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目的分析灯盏细辛注射液临床用药剂量与肾功能指标肌酐(serum creatinine,SCr)、尿素氮(blood urea nitrogen,BUN)异常变化的关系,探讨用药剂量对肾功能的影响。方法选择全国20家三甲医院信息系统(hospital information system,HIS)数据库中灯盏细辛注射液21 498例用药患者信息,符合年龄18~80岁的13 696例作为研究对象,依据单次给药剂量是否超药物说明书推荐剂量分为超剂量组(>40mL)和常规组(≤40mL)。以患者用药前后7天的SCr、BUN指标的变化作为结局评价指标,两次均有SCr检测值的650例,超剂量组87例,常规组563例;患者均有BUN检测值的651例,超剂量组87例,常规组564例。采用分层分析、倾向性评分方法进行分析。结果以年龄、性别、入院病情、灯盏细辛注射液疗程分层分析,超剂量组与常规组肾功能比较,差异无统计学意义(P>0.05);平衡71个混杂因素后倾向性评分方法,结果超剂量组与常规组肾功能异常变化比较,差异无统计学意义(P>0.05)。结论基于HIS数据分析发现超出说明书推荐剂量使用灯盏细辛注射液,未造成肾功能异常变化。
Objective To analyze the relationship between clinical dosage of Dengzhanxixin injection and abnormal changes of serum creatinine (SCr) and blood urea nitrogen (BUN), and to explore the effect of dosage on renal function. Methods The information of 21 498 patients of Erigeron Breviscapus injection in 20 hospital information systems (HIS) databases of China was selected and 13 696 patients aged 18-80 years were selected as study subjects. According to the single dose Whether super drug manual recommended dose is divided into overdose group (> 40mL) and conventional group (40mL). The change of SCr and BUN index in 7 days before and after treatment was taken as the outcome evaluation index. There were 650 cases of SCr test twice, 87 cases of overdose group and 563 cases of conventional group. There were 651 cases of BUN test value, 87 cases in the overdose group and 564 cases in the conventional group. Using stratified analysis, propensity score method for analysis. Results There were no significant differences in the renal function between the super-dose group and the conventional group (P> 0.05) by stratification analysis of the age, sex, admission condition, Results There was no significant difference in the abnormal renal function between the overdose group and the conventional group (P> 0.05). Conclusion Based on the HIS data analysis, it was found that the use of Erigeron Breviscapus Injection beyond the recommended dosage did not result in any abnormal changes in renal function.