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World J Gastroenterol. Jan 28, 2007; 13(4): 628-632
Published online Jan 28, 2007. doi: 10.3748/wjg.v13.i4.628
Evaluation of prognostic markers in severe drug-induced liver disease
Bo Li, Zhi Wang, Jian-Jiang Fang, Ci-Yi Xu, Wei-Xing Chen
Bo Li, Jian-jiang Fang, Department of Emergency, Lihuili Hospital of Ningbo Medical Center, Ningbo 315041, Zhejiang Province, China
Zhi Wang, Department of Pediatrics, Ningbo Women and Children’s Hospital, Ningbo 315012, Zhejiang Province, China
Ci-Yi Xu, Department of ICU, Lihuili Hospital of Ningbo Medical Center, Ningbo 315041, Zhejiang Province, China
Wei-Xing Chen, Department of Gastroenterology, First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, Zhejiang Province, China
Author contributions: All authors contributed equally to the work.
Correspondence to: Bo Li, Department of Emergency, Lihuili Hospital of Ningbo Medical Center, Ningbo, 315041, Zhejiang Province, China. libo19810427@163.com
Telephone: +86-574-87018638 Fax: +86-574-87392232
Received: October 27, 2006
Revised: November 3, 2006
Accepted: November 14, 2006
Published online: January 28, 2007
Abstract

AIM: To analyze the outcome of patients with severe drug-induced liver disease (DILD) associated with jaundice classified as hepatocellular, cholestatic or mixed liver injury and to evaluate the validity of Hy’s rule and the most important predictors for outcome.

METHODS: The Adverse Drug Reaction Advisory Committee was set up in 1997 in our hospital to identify all suspicions of DILD following a structured prospective report form. Liver damage was divided into hepatocellular, cholestatic, and mixed types according to laboratory and histologic criteria when available. Further evaluation of causality assessment was performed.

RESULTS: From January 1997 to December 2004, 265 patients were diagnosed with DILD,and 140 (52.8%) of them were female. hepatocellular damage was the most common (72.1%), the incidence of death was 9.9% in patients with hepatocellular damage and 9.5% in patients with cholestatic/mixed damage (P < 0.05). There was no difference in age of dead and recovered patients. The proportion of females and males was similar in recovered and dead patients, no difference was observed in duration of treatment between the two groups. The serum total bilirubin (P < 0.001), direct bilirubin (P < 0.001) and aspartate transaminase (AST) (P = 0.013) values were higher in dead patients than in recovered patients. Chinese herbal medicine was the most frequently prescribed, accounting for 24.2% of the whole series. However, antitubercular drugs (3.4%) were found to be the primary etiological factor for fetal DILD. Factors associated with the development of fulminant hepatic failure were hepatic encephalopathy (OR = 43.66, 95% CI = 8.47-224.95, P < 0.0001), ascite (OR = 28.48, 95% CI = 9.26-87.58, P < 0.0001), jaundice (OR = 11.43, 95% CI = 1.52-85.96, P = 0.003), alcohol abuse (OR = 3.83, 95% CI = 1.26-11.67, P = 0.035) and direct bilirubin (OR = 1.93, 95% CI = 1.25-2.58, P = 0.012).

CONCLUSION: Death occurs in 9.8% of patients with DILD. Chinese herbal medicine stands out as the most common drug for DILD. While antitubercular drugs are found to be the primary etiological factor for fetal DILD, hepatic encephalopathy, ascites, jaundice, alcohol abuse and direct bilirubin levels are associated with the death of DILD patients.

Keywords: Drug-induced liver disease; Prognosis; Prognostic marker; Mortality