中国药物警戒 ›› 2021, Vol. 18 ›› Issue (6): 537-541.
DOI: 10.19803/j.1672-8629.2021.06.09

• 真实世界中成药对肝肾功能影响研究专栏 • 上一篇    下一篇

基于倾向性评分的真实世界脉络舒通丸对肾功能指标影响研究

成冯镜茗1, 谢雁鸣1,*, 王连心1#, 苗雨2   

  1. 1中国中医科学院中医临床基础医学研究所,北京 100700;
    2中国人民大学统计学院,北京 100872
  • 收稿日期:2021-02-15 出版日期:2021-06-15 发布日期:2021-07-02
  • 通讯作者: *谢雁鸣,女,首席研究员·博导,中医临床评价。E-mail: ktzu2018@163.com;#为共同通信作者。
  • 作者简介:成冯镜茗,女,硕士,中西医结合临床（中成药上市后循证评价）。
  • 基金资助:
    国家重点研发计划（2018YFC1707400）：国家自然科学基金资助项目（81973982）; 全国中医药创新骨干人才培养项目（Z0687）

Effect of Mailuoshutong Pills on Renal Function Indexes in the Real World Based on Propensity Scores

CHENG Fengjingming1, XIE Yanming1,*, WANG Lianxin1#, MIAO Yu2   

  1. 1Institute of Basic Research in Clinical Medicine, Chinese Academy of Chinese Medical Sciences, Beijing 100700, China;
    2College of Statistics,Renmin University of China, Beijing 100872, China
  • Received:2021-02-15 Online:2021-06-15 Published:2021-07-02

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摘要： 目的 了解真实世界脉络舒通丸对肾功能指标时影响。方法 基于集成数据仓库,提取全国14家三甲医院医疗电子数据库中2006~2016年服用脉络舒通丸（脉络舒通丸组）和未服用脉络舒通丸患者（对照组）的病例数据,以性别相同、年龄±5岁为匹配条件,按照1∶1比例匹配,匹配后2组均为2 395例,以用药后对肾功能指标[肌酐（Cr）、尿素氮（BUN）]的影响为结局评价指标,通过倾向性评分方法控制本研究中存在的混杂因素,采用4种统计学方法进行安全性分析。结果 采用倾向性评分方法加权平衡了11个的混杂因素,4种统计学方法得到的结果均P>0.05,脉络舒通丸组和对照组相比,导致肾功能指标异常变化的可能性相同,2组差异无统计学意义,真实世界使用脉络舒通丸对患者肾功能指标不具有直接影响。结论 本研究数据没有发现脉络舒通丸会对肾功能指标产生显著影响,但用药仍需谨慎。

关键词: 脉络舒通丸, 医疗电子数据, 真实世界, 肾功能指标, 倾向性评分, Logistic回归

Abstract: Objective To investigate the effect of Mailuoshutong pills on renal function indexes in the real world. Methods Based on the integrated data warehouse, the data on patients who took Mailuoshutong pills and those who did not between 2006 and 2016 was retrieved from the medical electronic database of fourteen tertiary hospitals in China. With the same gender and age of ±5 years as the matching conditions, patients in the Mailuoshutong pill group and control group were matched at the ratio of 1∶1. After matching, there were 2 395 patients in either group. The effect of medication on renal function indexes (Cr, BUN) was used as the outcome evaluation index. Propensity scoring was used to control the confounders in this study, and four statistical methods were used for safety analysis. Results Eleven confounders were weighted and balanced with the propensity scoring method, and the results obtained by the four statistical methods were all P>0.05. Abnormal changes in renal function indexes were as likely in the control group as in the Mailuoshutong pill group, and the difference between the two groups was not statistically significant. In the real world, the use of Mailuoshutong pills had no direct effect on renal function indexes. Conclusion Based on the data of this study, no significant effect of MailuoShutong pills on renal function indexes is found, but this drug should be used with caution.

Key words: Mailuoshutong pills, hospital information system, the real world, renal function index, propensity score, logistic regression

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