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

doi:10.19803/j.1672-8629.2021.12.11

Abstract

Abstract: 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 43 962 inpatients included in the study, 17 patients had abnormal renal function, with an incidence of about 0.039%. It was found that the regression coefficient β was 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.

Key words: real world study, breviscapine, renal dysfunction, nested case control study, SMOTE coefficient

CLC Number:

R961R972R994.11

ZHANG Guanghui, SUN Linxi, WU Xianwen, XIE Yanming, GENG Hongjiao, YANG Xiaochen. Influencing Factors of Abnormal Renal Function of Breviscapine for Injection Analyzed via Nested Case-control Study Combined with SMOTE Algorithm[J]. Chinese Journal of Pharmacovigilance, 2021, 18(12): 1150-1154.

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