The Therapeutic Efficacy, Safety, And Tolerability Of Elastase Versus Placebo On Nonalcoholic Fatty Liver Disease With Hyperlipidemia

Objective: To evaluate the therapeutic efficacy, safety, and tolerability of Elastase versus placebo on nonalcoholic fatty liver disease with hyperlipidemia.Methods: From Mar 2003 to Dec 2004, seventy-six patients diagnosed nonalcoholic fatty liver disease with hyperlipidemia from the First Hospital affiliated Ji Nan University, were randomly divided into 2 groups (treated group and control group).The treated group (n=44) were treated with Elastase, two capsules three times one day, while the control group (n=32) were treated with placebo, the period of treatment was sixty days. Before the treatment and after the treatment 30 days, 60 days, serum total cholesterol (Tch), triglycerides (TG) , high denstity lipoprotein (HDL) , low denstity lipoprotein (LDL) , alanine aminotransferase (ALT) , aspartate aminotransferase (AST), gamma-glutamytransferase (GGT), alkalinephosphatase (ALP), blood urea nitrogen( BUN), creatinine ( Cr) were monitored with BECKMAN — CX5 biochemistry apparatus. At the same time, ultrasonographic imaging of fatty liver patients and adverse reactions of drugs was observed before and after the treatment.Results: In 76 case of patients of nonalcoholic fatty liver disease with hyperlipidemia , 6 were dropped and excluded due to inconsistencies in the included standard, therefore, the efficacy , safety of 70 patients were analyzed . Before and after being treated for 30 days, 60 days, in the treatment group, it was found that the mean level of serum ALT were 77.35 ±29.37, 67.03 ± 23.91, 43. 15 ± 14. 19 respectively; serum AST were 64.75 ± 22. 78, 56.80 ± 18.95, 39.00±11.71 respectively; serum GGT were 72.57 ± 24. 03, 62.50 ± 21. 23, 56. 33 ± 18. 75 respectively. While in the control group , the mean level ofserumALT were 79.07 ± 20.72,79.17 ± 20.79, 78. 03 ± 21. 84 respectively; serum AST were 66.97 ± 15.96, 66.97±16.56, 66. 23±16.77 respectively; serum GGT were 76. 93 ± 27. 61,76. 00 ± 27. 26,76. 33 ± 26. 40 respectively; the treatment group were significantly improved than the control group (F value were 10.052, 10.916, 4.829, p value were 0.002, 0.002, 0. 031). In the treated group, the level of serum TCwere 5.744 + 1. 292, 5. 080 + 1. 135, 4. 709+1. 063 respectively; serum TG were 2.393 + 0.642, 2.393 + 0.642, 1,626 + 0.505 respectively; while in the control group the level of serum TC were 5. 889±0. 720, 5. 857 + 0. 707, 5. 679 + 0. 898 respectively; serum TG were 2.476 + 0.741, 2.456 + 0.732, 2.447 + 0.711 respectively; the treatment group were significantly decreased than that of the control group (F value were 6. 949, 7. 507, p value were 0. 010, 0. 008). The number of complete response was 4 and partial response was 30 in the Elastase group, while the number of complete response was 0 and partial response was 6 in the control group, there were significantly higher in the treated group than in the placebo group. The comprehensive effective rate of the treated group was 85% (34/40), while the control group was 20% (6/30), the treated group was better than that of the control group significantly^2 = 29.575, p=0.000). The adverse reaction rates of Elastase in the study and the placebo group were 7.5% and 6.62%, but there was no statistical significant difference between them. Elastase there was no side reaction on renal functions, the compare BUN and Cr in two groups, there were no statistics signification ( F value were 0.221, 0.223, p value were 0.640, 0.693 ).Conclusion: Elastase could be used as a safe and effective drug in the clinical treatment of nonalcoholic fatty liver disease with hyperlipidemia.