Chinese Journal of Pharmacovigilance ›› 2019, Vol. 16 ›› Issue (5): 270-276.

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Analysis of Clinical Characteristics and Medication Rationality of Polygonum Multiflorum Thunb. and Its Preparation-related Liver Injury

TU Can1,2, GE Feilin1, GUO Yuming1, ZHANG Yaming1, XIAO Xiaohe1, WANG Jiabo1,*   

  1. 1 China Military Institute of Chinese Medicine, the Fifth Medical Centre of PLA General Hospital, Beijing 100039, China;
    2 School of Pharmacy, Chengdu University of Traditional Chinese Medicine, Sichuan Chengdu 611137, China
  • Received:2019-03-18 Revised:2019-06-11 Online:2019-05-20 Published:2019-06-11

Abstract: Objective To investigate the clinical characteristics of liver injury related to Polygonum multiflorum Thunb.(PM) and its common preparations, and analyze their risk factors, so as to provide reference for rational drug use in clinic. Methods Based on the cases of PM and preparation-related liver injury for the past 5 years (2012~2016), the clinical characteristics of PM-related liver injury, the rationality of drug use and possible risk factors were analyzed. Results The incidence age ranged from 8 to 93 years, and the median age of onset was 47 years (the median age of onset was 40.5 for men and 51 for women, respectively). The time span from administration to liver injury was 1~376 days, with a median of 31 days. The daily dose was 1~200 g, with a median of 10 g, suggesting that PM-induced liver injury had idiosyncratic properties. The results from further exploration of the risk factors showed that some unreasonable drug uses were important risk factors for liver injury of PM, such as individual self-medication (not under the guidance of a physician), mixed use of crude and processed PM, unconventional drug use (diet, alcohol, powder and tea) and irregular processing, etc. In addition, clinical repeated drug use, exceeding the drug instructions and inappropriate combination therapy were also important risk factors for liver injury caused by PM. Conclusion This article explores the safety risk factors of liver injury caused by PM and its preparations, suggesting that the clinical application of PM should be paid great attention to the risk of liver injury, avoid irrational use of drugs, and improve the level of safe drug use.

Key words: adverse drug reaction, Polygonum multiflorum Thunb., irrational drug use, risk factors

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