主 办:北 京 中 医 药 大 学
ISSN 2095-6606 CN 10-1157/R

现代中医临床 ›› 2021, Vol. 28 ›› Issue (2): 9-15.doi: 10.3969/j.issn.2095-6606.2021.02.003

• 临床研究 • 上一篇    下一篇

真实世界中使用醒脑静注射液致肾功能异常患者的临床特征分析*

段江南1,2, 高阳1, 谢雁鸣1#, 孙粼希1, 接传红2, 张敏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 中国中医科学院眼科医院;
    3 中国人民大学统计学院
  • 收稿日期:2020-05-12 出版日期:2021-03-30 发布日期:2021-03-30
  • 通讯作者: #谢雁鸣,女,研究员,博士生导师,E-mail:ktzu2018@163.com
  • 作者简介:段江南,女,在读硕士生
  • 基金资助:
    *国家重点研发计划项目资助(No.2018YFC1707400)

Clinical characteristics of Xing nao jing injection-induced abnormal renal functions in reality*

Duan Jiangnan1,2, Gao Yang1, Xie Yanming1#, Sun Linxi1, Jie Chuanhong2, Zhang Min3   

  1. 1 Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700;
    2 Eye Hospital China Academy of Chinese Medical Science;
    3 School of Statistics, Renmin University
  • Received:2020-05-12 Online:2021-03-30 Published:2021-03-30

摘要: 目的 分析真实世界中使用醒脑静注射液致肾功能异常患者的临床特征,探讨使用醒脑静注射液后出现肾功能异常的相关影响因素。方法 基于中国中医科学院中医临床基础医学研究构建的39家三甲医院医疗电子数据仓库,提取1998年1月―2016年12月间至少使用过1次醒脑静注射液的住院患者病历信息,共53 075例,经纳入标准筛选,最终纳入肾功能异常患者病例553例。采用回顾性巢式病例对照研究设计、少数类过取样算法(synthetic minority oversampling technique,SMOTE)抽样与logistic回归相结合的方法,分析使用醒脑静注射液后出现肾功能异常的患者特征因素。纳入分析的影响因素共65个,分别为年龄、性别、疗程、住院天数、单次剂量、合并病、合并用药。结果 53 075例使用醒脑静注射液的患者合并疾病频次最高的是脑梗死,共9 370例,占17.87%。合并用药频次最高的是甘露醇26 537例,占48.53%。采用SMOTE抽样与二元logistic回归分析共获取23个变量,包括:年龄分段在18到75岁之间,性别为男性,病程、住院天数超过7 d时,或者合并患有肺部感染、骨折、糖尿病、脑部相关疾病等疾病,或者合并使用氨溴索、碳酸氢钠、奥拉西坦、利多卡因、纳络酮、依达拉奉、苯巴比妥、胰岛素、异丙嗪、泮托拉唑、呋塞米、地西泮等药品。上述变量可能是使用醒脑静注射液后出现肾功能异常的相关因素。结论 通过分析真实世界中使用醒脑静注射液致肾功能异常患者的临床特征,当临床使用醒脑静注射液与上述因素同时存在时,应加强观察,预防肾功能异常的发生,以确保患者的用药安全。

关键词: 真实世界, 醒脑静注射液, 肾功能异常, SOMTE抽样, 二元logistic回归, 影响因素

Abstract: Objective To analyze the clinical characteristics of patients with renal dysfunctions induced by Xing nao jing Injection in the real world, and to explore the relavant risk factors for renal dysfunction caused by Xing nao jing Injection. Methods Based on HIS database of 39 Grade A hospitals constructed by TCM Clinical Basic Medicine Research of China Academy of Traditional Chinese Medicine, medical records of 53,075 in patients who had used Xing nao jing Injection at least once from January 1998 to December 2016 were extracted. 553 patients with renal dysfunctions were included. A retrospective nest-control study design, SOMTE sampling and Logistic regression were used to analyze the characteristic factors of patients with abnormal renal functions after Xing Nao jing Injection. A total of 65 influencing factors were included in the analysis, including age, gender, course of treatment, length of hospital stay, single dose, combined disease and combined medication. Results Among the 553 patients with renal dysfunctions after Xing nao jing Injection, the most frequent complication was cerebral infarction (9,370 cases, 17.87%). The highest frequency of combined drug use was mannitol 26,537 cases, accounting for 48.53%, followed by insulin 20,340 cases. SMOTE sampling with binary logistic regression analysis were used for 23 variables, includingage between 18 and 75 years of age, gender, male, duration, hospitalization days more than 7 days, or combined with pulmonary infections, fracture, diseases such as diabetes, brain related diseases, or a combination of ammonia bromine rope, sodium bicarbonate, olathe, lidocaine, adr mentioned, naloxone, phenobarbital, insulin, promethazine, panxitoraetc, Sammy, diazepam and other drugs. These variables may be related to renal dysfunctions after Xing nao jing Injection. Conclusions Through the analysis of the clinical characteristics of patients with abnormal renal functions caused by Xing nao jing Injection in the real world, when the clinical use of Xing nao jing Injection and the above-mentioned factors exist at the same time, it is necessary to strengthen observation to prevent potential abnormal renal functions, so as to ensure the safety of medication.

Key words: real world, Xing nao jing Injection, renal dysfunction, SOMTE sampling, risk factor

中图分类号: 

  • R285.6