中国药物警戒 ›› 2016, Vol. 13 ›› Issue (5): 291-294.

• 安全性评估与合理用药 • 上一篇    下一篇

基于真实世界分析双环醇片对肾功能的影响

侯道瑞1,2,李园1,谢雁鸣1,赵维3,庄严4,   

  1. 1中国中医科学院中医临床基础医学研究所，北京100700;
    2中国中医科学院广安门医院，北京100053;
    3中国人民大学统计学院，北京100782;
    4中国人民解放军海军总医院，北京 100048
  • 收稿日期:2015-05-19 修回日期:2016-06-30 出版日期:2016-05-20 发布日期:2016-06-30
  • 通讯作者: 谢雁鸣，女，本科，研究员·博导，中医药临床评价与再评价。E-mail：ktzu2014@163.com
  • 作者简介:侯道瑞，男，在读硕士，中西医结合临床。
  • 基金资助:
    国家“重大新药创制”科技重大专项（2015ZX09501004-001-002）；中国中医科学院中药上市后再评价创新团队课题（PY1303）第9批自主选题：中国中医科学院基本科研业务费自主选题课题（Z0406）。

Analysis of Influence of Bicyclol Tablets on Renal Function Based on Real World

HOU Dao-rui1,2, LI Yuan1, XIE Yan-ming1,* ZHAO Wei3, ZHUANG Yan4   

  1. 1Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China;
    2Guang An Men Hospital, China Academy of Traditional Chinese Medicine, Beijing 100053, China;
    3School of Statistics, Renmin University, Beijing 100872, China;
    4 Navy Ceneral Hospital, Chinese People’s Liberation Army, Beijing 100048, China
  • Received:2015-05-19 Revised:2016-06-30 Online:2016-05-20 Published:2016-06-30

PDF (PC)

199

摘要： 目的 通过对真实世界中使用双环醇片的数据进行描述分析，以肾功能检测的常规指标血肌酐和血尿素氮作为结局指标，了解临床中双环醇片的使用对血肌酐和血尿素氮是否有影响，为深入探讨其对肾脏的安全性提供依据。方法 选择全国18家医院中双环醇片的临床使用信息，运用配对χ2检验方法对使用和未使用双环醇片患者的肌酐和尿素氮异常发生率分别进行分析。结果 使用双环醇片患者血肌酐和血尿素氮异常发生率均显著低于未使用双环醇片的患者（χ2=10.784 6，P=0.001 0；χ2=11.442 1，P=0.000 7）。结论 在真实世界中双环醇片对肾脏无明显损害。

关键词: 双环醇, 肾功能, 真实世界, 安全性

Abstract: Objective To understand the effect of bicyclol tablets on serum creatinine and blood urea nitrogen in clinical practice through descriptively analyzing real world use data of bicyclol tablets, which used serum creatinine and blood urea nitrogen, the conventional test of renal function test, as final indicators, so as to provide evidence for further discussion on the safety to kidney. Methods The clinical use information of the bicyclol tablets from 18 hospitals in China was selected. The abnormal rates of serum creatinine and blood urea nitrogen in patients with or without the bicyclol tablets were analyzed by Chi-square test respectively. Results The abnormal rates of serum creatinine and blood urea nitrogen in patients with the bicyclol tablets were significantly lower than that without use (χ2=10.784 6, P=0.001 0; χ2=11.442 1, P=0.000 7). Conclusion In the real world, the bicyclol tablets have no significant damages to kidney.

Key words: bicyclol, renal function, real world, safety

中图分类号: