摘要
该文旨在评价参芪扶正注射液临床用药剂量对肾功能的影响。通过选择全国20家三甲医院信息系统（HIS）数据库中参芪扶正注射液51898例患者用药信息，纳入年龄在18～80岁的患者27718例作为研究对象，以用药前后2次肾功能血肌酐（Ser）、尿素氮（BUN）指标的变化作为结局评价指标，依据说明书将患者分为病例组（剂量〉250mL）197例和对照组（剂量≤250mL）5728例，采用分层分析对年龄、性别、入院病情、疗程等4个变量，病例组与对照组相比较未出现肾功能异常变化；而采用平衡57个混杂因素后倾向性评分方法结果，病例组未出现肾功能异常变化。基于HIS数据分析，发现参芪扶正注射液超出说明书推荐剂量使用，对肾功能异常变化影响无显著差异，但仍需开展前瞻性研究以验证。
This study analyzes the clinical effects of parenterally administered Shenqi Fuzheng on renal function. 20 national, general hospitals were selected. Their hospital information system （HIS） data on 51 898 cases of parenterally administered Shenqi Fuzheng were mined for data. Patients ranged from 18 to 80 years old. 27 718 cases were selected for analysis. Serum creatinine （Scr） and blood urea nitrogen （BUN） levels were taken before and after treatment for outcome evaluation. According to instructions, we di- vided 197 cases into the treatment group （doses 〉 250 mL） and 5 728 cases acted as the control group （dose ~ 250 mL）. Stratified analysis adjusted for age, sex, hospital illness, treatment, etc. According to the four variables, the case group compared with the con- trol group did not show abnormal renal function changes; 57 confounding factors were balanced using propensity score method resulting in the treatment group showing no abnormal changes in renal function. This HIS b data analysis found that parenterally administered Shenqi Fuzheng above the recommended dosage did not significantly impact on renal function was no significant difference. Prospective studies should be carried out to validate this data.
出处
《中国中药杂志》
CAS
CSCD
北大核心
2013年第18期3031-3038,共8页
China Journal of Chinese Materia Medica
基金
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)
关键词
参芪扶正注射液
用药剂量
肾功能
倾向性评分
实效研究
parenterally administered Shenqi Fuzheng
dosage
renal function
propensity score
clinical research
