Chinese Journal of Pharmacovigilance ›› 2016, Vol. 13 ›› Issue (8): 452-455.

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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

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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