[Retrospective study on Xiaohe tablet-related liver damage and discussion on risk control].
To investigate the clinical characteristics and risk factors of liver damage cases related to Xiaohe tablet so as to propose risk control measures. We search literatures on cases and group cases reports of Xiaohe tablet-related liver damage published domestically from 1978 to 2009, and then conduct a statistical analysis on the data. The 194 reports (9 cases reports and 185 group cases) of Xiaohe tablet-related liver damage are involved, the main clinical manifestations are gastrointestinal symptoms, skin stained yellow, icteric sclera, abnormal hepatic function and even hepatic failure. Most liver damage cases are reversible and can be cured by timely treatment after stopping use of this drug. There is a certain correlation between Xiaohe tablet and liver damage. Therefore, the following measures may be effective for risk control of Xiaohe tablet: to use drug under the guidance of physician, according to the recommended dose and indications in drug specification; to closely monitor liver function during the clinical treatment; to strengthen safety-related basic study.
National Center for Drug Reevaluation, State Food and Drug Administration, Beijing 100045, China. yty0616@hotmail.com
Li
L
Zhang
Xiaohui
X
Yang
Peng
P
Guo
Yuanyuan
Y
Tong
D000293:Adolescent; D000328:Adult; D056486:Chemical and Drug Induced Liver Injury / Q000209:etiology / Q000378:metabolism / Q000473:pathology*; D004365:Drugs, Chinese Herbal / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008875:Middle Aged; D012189:Retrospective Studies; D055815:Young Adult
D004365:Drugs, Chinese Herbal