巢氏病例对照联合SMOTE算法分析注射用灯盏花素肾功能异常影响因素

Influencing Factors of Abnormal Renal Function of Breviscapine for Injection Analyzed via Nested Case-control Study Combined with SMOTE Algorithm

目的分析真实世界中使用注射用灯盏花素出现肾功能异常的影响因素,为其临床应用提供依据。方法搜集全国34家医院2002年1月1日至2015年12月31日医院信息系统(HIS)至少使用过1次注射用灯盏花素注射剂的患者住院数据,提取出肾功能异常者数据,采用巢式病例对照研究的设计按照1:4进行病例匹配分组,运用SMOTE算法对2组抽样后采用二元logistic回归模型对数据进行分析,计算所有自变量被选中的频数、回归系数及P值。结果研究纳入的43962例住院患者中,共有17例出现肾功能异常,发生率约为0.039%,经分析后发现,男性、肾炎、2型糖尿病、联合用药为呋塞米时回归系数β为正值,结果具有统计学意义(P<0.05)。结论临床中当患者为男性、合并有肾炎、2型糖尿病、联合用药为呋塞米时,应慎用注射用灯盏花素,并注意监测肾功能。

Objective To analyze the influencing factors of renal dysfunction caused by breviscapine for injection in the real world,and to provide data for its clinical application.Methods The data on inpatients from 34 hospitals in China who had used breviscapine for injection at least once between January 1,2002 and 31 December,2015 was collected from the HIS,and the data on patients with abnormal renal function was retrieved.The design of nested case-control study was used to group cases at the ratio of 1∶4.Two groups were sampled using the SMOTE algorithm,and the data was analyzed with a binary logistic regression model.The selected frequency,regression coefficient and P value of all independent variables were calculated.Results Of the 43962 inpatients included in the study,17 patients had abnormal renal function,with an incidence of about 0.039%.It was found that the regression coefficientβwas positive when the treatment with breviscapine for injection involved males,nephritis,type 2 diabetes,and combination with furosemide.The difference was statistically significant(P<0.05).Conclusion In clinical application of breviscapine for injection,renal function should be monitored when the patient is male,complicated with nephritis or type 2 diabetes and is using furosemide.