中国药物警戒 ›› 2021, Vol. 18 ›› Issue (12): 1150-1154.
DOI: 10.19803/j.1672-8629.2021.12.11

• 安全与合理用药 • 上一篇    下一篇

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

张广辉1,2, 孙粼希1, 吴显文2, 谢雁鸣1,*, 耿洪娇1, 杨晓晨3   

  1. 1中国中医科学院中医临床基础医学研究所,北京 100700;
    2中国中医科学院 西苑医院,北京 100091;
    3中国人民大学统计学院,北京 100872
  • 收稿日期:2021-02-04 出版日期:2021-12-15 发布日期:2021-12-16
  • 通讯作者: *谢雁鸣,女,首席研究员·博导,中药上市后评价。E-mail：ktzu2018@163.com
  • 作者简介:张广辉,男,在读硕士,肿瘤放化疗不良反应的中医药防治。
  • 基金资助:
    国家重点研发计划（2018YFC1707400）; 中国中医科学院自主选题项目（Z0597）

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

ZHANG Guanghui1,2, SUN Linxi1, WU Xianwen2, XIE Yanming1,*, GENG Hongjiao1, YANG Xiaochen3   

  1. 1Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China;
    2Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China;
    3School of Statistics, Renmin University, Beijing 100872, China
  • Received:2021-02-04 Online:2021-12-15 Published:2021-12-16

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摘要： 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43 962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。

关键词: 真实世界研究, 灯盏花素, 肾功能异常, 巢氏病例对照研究, SMOTE算法

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

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