摘要
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 observe clinical dose of Dengzhan Xixin Injection（DZI）on renal function 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 from20 hospital information system（HIS）database across China.Of them,13 696 patients in line with18-80 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 and564 in the conventional dose group.Data were analyzed using stratified analysis and propensity score estimation.Results No statistical difference existed in age,gender,admission condition,or stratification estimation results of DZI course between the ultra-dose group and the 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.
出处
《中国中西医结合杂志》
CAS
CSCD
北大核心
2016年第12期1430-1434,共5页
Chinese Journal of Integrated Traditional and Western Medicine
基金
国家自然科学基金青年科学基金资助项目(No.81403196)
关键词
灯盏细辛注射液
用药剂量
肾功能
倾向性评分
实效研究
Dengzhan Xixin Injection
dosage
renal function
propensity score estimation
practical research
