鹿瓜多肽注射液对骨折患者肝功能影响的真实世界研究

doi:10.19803/j.1672-8629.2021.06.10

中国药物警戒 ›› 2021, Vol. 18 ›› Issue (6): 542-546.
DOI: 10.19803/j.1672-8629.2021.06.10

• 真实世界中成药对肝肾功能影响研究专栏 • 上一篇下一篇

鹿瓜多肽注射液对骨折患者肝功能影响的真实世界研究

陈帆^1,2, 黎元元^1#, 张清², 谢雁鸣^1,*, 高明慧³

¹中国中医科学院中医临床基础医学研究所,北京 100700;
²中国中医科学院望京医院,北京,100102;
³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:陈帆,男,硕士研究生,中西医结合骨伤。
基金资助:
国家重点研发计划项目（2018YFC1707410）

A Real World Study on the Effect of Cervus and Cucumis Polypeptide Injection on Liver Function in Fractured Patients

CHEN Fan^1,2, LI Yuanyuan^1#, ZHANG Qing², XIE Yanming^1,*, GAO Minghui³

¹Institute of Clinical Basic Medicine of Traditional Chinese Medicine, Chinese Academy of Traditional Chinese Medicine, Beijing 100700, China;
²Wangjing Hospital, Chinese Academy of Traditional Chinese Medicine, Beijing 100102, China;
³School of Statistics, Renmin University of China, Beijing 100872, China

Received:2021-02-15 Online:2021-06-15 Published:2021-07-02

摘要/Abstract

摘要： 目的基于真实世界医疗电子数据研究鹿瓜多肽注射液对骨折人群肝功能的影响。方法通过全国26家三甲医院的医院信息系统（HIS）和实验室信息管理系统（LIS）数据库,提取2003年7月1日至2014年12月31日间使用鹿瓜多肽注射液的骨折患者（鹿瓜组）12 847例和未使用鹿瓜多肽注射液的骨折患者（对照组）12 619例的信息。采用广义增强模型（GBM）倾向评分加权法控制混杂因素,Logistic回归对比分析真实世界中2组人群肝功能异常是否具有统计学差异。结果采用倾向评分加权后的Logistic分析2组人群的肝功能变化[谷丙转氨酶（ALT）、谷草转氨酶（AST）],P值均大于0.05,差异无统计学意义。结论基于现有数据和分析方法认为,鹿瓜多肽注射液不会对骨折患者肝功能产生影响。

关键词: 鹿瓜多肽注射液, 肝功能异常, 倾向性评分, 真实世界

Abstract: Objective To study the effect of cervus and cucumis polypeptide injection on liver function in fractured patients based on real-world medical electronic data. Methods The information about 12 847 fractured patients who received cervus and cucumis polypeptide injection (experimental group) and 12 619 fractured patients who did not between July 1, 2003 and December 31, 2014 (control group) was retrieved from the database of the hospital information system (HIS) and laboratory information management system (LIS) of 26 tertiary hospitals in China. Propensity score weighting using the generalized boosted model (GBM) was employed to control confounders, while Logistic regression was used to analyze whether there were statistically significant differences in liver function abnormalities between the two groups in the real world. Results The changes of liver function (ALT and AST) in the two groups were analyzed using Logistic regression following propensity score weighting. P values were all greater than 0.05, and the difference was not statistically significant. Conclusion Based on the available data and this analysis, cervus and cucumis polypeptide injection may not affect the liver function of patients with fractures.

Key words: cervus and cucumis polypeptide injection, abnormal liver function, propensity score, the real world

中图分类号:

R994.11

陈帆, 黎元元, 张清, 谢雁鸣, 高明慧. 鹿瓜多肽注射液对骨折患者肝功能影响的真实世界研究[J]. 中国药物警戒, 2021, 18(6): 542-546.

CHEN Fan, LI Yuanyuan, ZHANG Qing, XIE Yanming, GAO Minghui. A Real World Study on the Effect of Cervus and Cucumis Polypeptide Injection on Liver Function in Fractured Patients[J]. Chinese Journal of Pharmacovigilance, 2021, 18(6): 542-546.

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鹿瓜多肽注射液对骨折患者肝功能影响的真实世界研究

A Real World Study on the Effect of Cervus and Cucumis Polypeptide Injection on Liver Function in Fractured Patients

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