Clinical Analysis And The Modification Of Diagnostic Criteria Of Drug-induced Liver Injury

Objective The aim of this study was to analyze the clinical characteristics of drug-induced liver injury(DILI) patients in recent ten years, and might prove reference and improving for the diagnosis and cure the disease of DILI.Methods A retrospective study was carried out on 647 patients who were considered as drug-induced liver injury in three hospitals of Guangdong province in recent 10 years. There were total 462 patients according with Chinese diagnostic criteria for DILI, from 1995 to 1999 were divided in group of Al, and those from 2000 to 2004 in group of A2. The difference among the sex, age, weight, time from treatment to liver injury, symptoms, serological examination, type of liver injury, drugs induced liver injury and prognosis of the patients were compared in SPSS 11.5 software respectively. The author modified the Chinese criteria, and compared the diagnosis of new criteria and old criteria on these 647 patients, and also compared their diagnosis on 189 patients who were case reported as drug-induced liver injury on Chinese medical databases in recent 10 years.Results The time from treatment to liver injury in the group Al was 15.15±6.76d, and that in group the A2 was 19.46 + 7.74 d, P<0.05. The frequency of jaundice in the group Al was 36.9%, and that in the group A2 was 47.9%, P<0.05. The frequency of fever or anthems or titillation in the group Al was 67.5%, and that in the group A2 was 55.6%, P<0.05. The DBIL in the group Al was 62.63±58.92μmol/L, and that in the group A2 was 79.97±72.51μmol/L, P<0.05. The ALP in the group Al was 157.96 ±55.20μmol/L, and that in the group A2 was 178.85 ±80.23μmol/L, P<0.05. The frequency of eosinophilia in the group Al was 64.0%, and that in the group A2 was 53.3%, P<0.05. The frequency of acute cholestatic hepatitis in the group Al was 16.7%, and that in the group A2 was 25.1%, P<0.05. The drugs induced liver injuries in the two groups were changed. Herbal induced liver injury in the group Al were 7 cases, and those in the group A2 were 27 cases. The modified Chinese criteria diagnosed 87.9% cases out of the 647 patents in Guangdong province as drug-induced liver injury, and the rate on the base of the old Chinese criteria was 71.4%, P<0.05. The modified Chinese criteria diagnosed 91.0% cases out of reported patients as drug-induced liver injury, and the rate on the base of the oldChinese criteria was 71.4%, P<0.05.Conclusion (1)The clinical characteristics of the drug-induced liver injury patients have changed greatly : The time from treatment to liver injury was prolonged. The frequency of jaundice was higher than before. The frequency of fever or anthems or titillation was lower than before. The DBIL and ALP was higher than before. The frequency of eosinophilia was lower than before. The frequency of acute cholestatic hepatitis was higher than before. Herbal induced liver injury was more than before. (2)Chinese criteria can be modified according to the result above and Europe criteria, which may prove reference for increasing the clinical diagnose ratio of DILI.