中国药物警戒 ›› 2016, Vol. 13 ›› Issue (8): 452-455.

• 基础与临床研究 • 上一篇    下一篇

真实世界中注射用丹参多酚酸盐对肾功能影响的安全性分析

王海洋1, 2, 谢雁鸣1, 姜俊杰1*, *, 杨薇1, 张辉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中国中医科学院望京医院,北京100102;
    3中国人民大学统计学院,北京100872;
    4中国人民解放军海军总医院,北京100048
  • 收稿日期:2016-09-14 修回日期:2016-09-14 出版日期:2016-08-20 发布日期:2016-09-14
  • 通讯作者: 姜俊杰,女,博士,助理研究员,中医药临床评价与再评价。E-mail：18910206360 @163.com
  • 基金资助:
    国家“重大新药创制”科技重大专项（2015ZX09501004-001-002）; 2014第七批中国博士后科学基金特别资助（2014T70202）; 中国中医科学院科技创新团队建设课题“中药上市后临床再评价关键技术创新团队”（PY1303）

Analysis of Clinical Effects of Salvianolate Injection on Renal Function in Real Word

WANG Hai-yang1, 2, XIE Yan-ming1, JIANG Jun-jie1, *, YANG Wei1, ZHANG Hui3, ZHUANG Yan4   

  1. 1 Institute of Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China;
    2 Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing 100102, China;
    3 School of Statistics, Renmin University of China, Beijing 100872, China;
    4 Chinese People ’s Liberation Army Navy Hospital, Beijing 100037, China
  • Received:2016-09-14 Revised:2016-09-14 Online:2016-08-20 Published:2016-09-14

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摘要： 目的 探究真实世界中注射用丹参多酚酸盐对肾功能的影响。方法 选取全国18家大型三甲医院的医院信息系统（hospital information system,HIS）的数据为研究对象,将使用注射用丹参多酚酸盐的治疗组与未使用的对照组进行对比研究,以血肌酐（SCr）和血尿素氮（BUN）的检测值是否发生异常变化作为结局指标,利用generalized boosted models（GBM）倾向评分平衡混杂因素,采用带协变量调整的倾向性评分加权Logistic回归进行安全性结局分析。结果 治疗组和对照组比较,SCr指标异常变化有显著性差异（P<0.05）,BUN指标异常变化没有显著性差异（P>0.05）。结论 基于现有数据综合分析,尚不能说明丹参多酚酸盐能引起肾功能损害,仍需前瞻性随机对照试验加以证明。临床中使用丹参多酚酸盐时,要严格按照说明书使用,避免不规范用药,以保障用药安全。

关键词: 丹参多酚酸盐, 血肌酐, 血尿素氮, 真实世界, 回顾性研究

Abstract: Objective To explore the effects on renal function of salvianolate injection in real word. Methods Based on the data extracted from the hospital information system (HIS) of 18 large hospitals, the treatment group of salvianolate injection and the control group of not using were compared with the level of serum creatinine (SCr) and blood urea nitrogen (BUN) abnormal changes as the ending index. After using the generalized boosted models propensity score (GBM) to balance the confounding factors, the Logistic regression adopting the propensity score with covariate adjustment was used to analyze safety outcomes. Results The abnormal change of SCr had significant difference in the treatment group compared with the control group (P<0.05), And there was no significant difference on the abnormal change of BUN (P>0.05). Conclusion After a comprehensive analysis, it is not suggested that the kidney damage is caused by salvianolate injection based on existing data. In order to confirm the cause of the damage, a prospective randomized controlled trial was necessary. And in the clinic, the instructions to use salvianolate injection should be strictly followed, and non-standard medication should be avoided, so as to ensure the drug safety.

Key words: salvianolate injection, serum creatinine, blood urea nitrogen, real world, retrospective study

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