| Background and ObjectiveAs consequences of increasing types of drugs, abuse of health-care products or Chinese traditional medicine and lack of recognition in drug security, the incidence of acute drug-induced liver injury (ADILI) gradually grew in recent years. Whether combined with glucocorticoid to treatment severe ADILI has became a controversial issue. The object of this study was to retrospectively analyze the ADILI patients and to explore the types of drugs which cause ADILI and the distribution of different liver injury types. The main purpose was to compare the clinical efficacy of glucocorticoid combined with liver-protecting drugs in treatment of severe ADILI.MethodsIn this retrospective study,364 hospitalized patients with ADILI in Qilu Hospital affiliated to Shandong University from January 2009 to December 2014 were recruited. Basic information (gender, age, etc.), underlying diseases, the suspected type and duration of drugs, clinical manifestations, the first abnormal liver biochemical tests, laboratory results during hospitalization, imaging examinations, treatment regimens and other information for all selected cases were collected. All suspected types of drug and types of liver injury of ADILI were counted. The 89 cases aged over 16 of severe ADILI were divided into two groups of hormone treatment group and control group according to whether they received glucocorticoid therapy. Efficacy evaluation standard was measuring the difference of liver function tests (ALT, AST, GGT, ALP, TBIL, DBIL) before and after treatment, the difference of obvious efficacy rate, efficacy rate and inefficacy rate between two groups. And the clinical efficacy was estimated by rate of decrease of liver function tests to basic vales. The data obeyed the normal distribution were descripted as the mean±standard deviation (x ±s) and were valued by t-test. The measurement data were valued by X2 test. And the ranked data or data does not conform to normal distribution were valued by Mann-Whitney U test and were descripted as M(Q1,Q3). The paired data of abnormal distribution were valued by Wilcoxon’s signed rank test. The P value less than 0.05 was considered statistically significant.Results1. The main types of suspected drugs were Chinese medicine and health-care products (128 cases,35.2%), anti-microbial drugs (48 cases,13.2%) and antineoplastic agents (24 cases,6.6%).2. The types outcome of ADILI were hepatocellular injury (247 cases,67.9%), mixed liver injury (63 cases,17.3%) and cholestatic liver injury (54 cases,14.8%).3. This study recruited 89 patients with severe ADILI (50 cases in the hormone group,39 cases in the control group). After one week treatment, the mainly liver function indexes were significantly decreased (P<0.05) both the two groups.4. The clinical efficacy of the different liver-protecting drugs combined with glucocorticoid or not were compared respectively. As for the reduced glutathione and glycyrrhizin combined with glucocorticoid, the rate of AST level decrease faster after 2 weeks treatment (.P<0.05). As for the reduced glutathione, glycyrrhizin, ademethionine and/or ursodeoxycholic acid, the rate of GGT level decrease faster after 2 weeks treatment (P<0.05).5. After 3 weeks treatment, the rate of liver function indexes decrease of the hormone group and the control group showed no statistically significant (P>0.05). And the clinical efficacy of the two groups showed no statistically significant (P= 0.308).6. For the type of hepatocellular injury, the rate of AST and TBIL level decrease faster in the hormone group after 1 week treatment (P<0.05), but the rate of all liver function indexes decrease of the two groups showed no statistically significant after 2 weeks treatment (P>0.05). For the type of cholestatic and mixed liver injury, the rate of liver function indexes decrease of the two groups showed no statistically significant (P>0.05).7. In the hormone group, the incidence of Leukocytosis (8 cases,16.0%) was higher than the control group (P= 0.001).Conclusion1. The commonest types of drugs causing ADILI were traditional Chinese medicine and health-care products, followed by anti-microbial drugs and antineoplastic agents. The commonest type of ADILI was hepatocellular injury, followed by mixed liver injury and cholestatic liver injury.2. Liver-protecting drugs combined with glucocorticoid or not could treat severe ADILI, and showed equivalent clinical effects.3. There were no serious adverse reactions occurred when using glucocorticoid for treatment of severe ADILI. |
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