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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
作者姓名:段江南  高阳  谢雁鸣  孙粼希  接传红  张敏
作者单位:中国中医科学院中医临床基础医学研究所 北京100700;中国中医科学院眼科医院;中国中医科学院中医临床基础医学研究所 北京100700;中国中医科学院眼科医院;中国人民大学统计学院
基金项目:国家重点研发计划项目资助(No.2018YFC1707400)。
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53075例,经纳入标准筛选,最终纳...

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

Clinical characteristics of Xing nao jing injection-induced abnormal renal functions in reality
Authors:Duan Jiangnan  Gao Yang  Xie Yanming  Sun Linxi  Jie Chuanhong  Zhang Min
Affiliation:(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700;Eye Hospital China Academy of Chinese Medical Science;School of Statistics,Renmin University)
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.
Keywords:real world  Xing nao jing Injection  renal dysfunction  SOMTE sampling  risk factor
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