Chinese Journal of Pharmacovigilance ›› 2016, Vol. 13 ›› Issue (5): 291-294.

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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

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

CLC Number: