弹性酶治疗高脂血症性非酒精性脂肪性肝病的临床观察

目的观察弹性酶肠溶片治疗高脂血症性非酒精性脂肪性肝病的有效性、安全性及耐受性,为临床应用提供依据.方法将76例高脂血症性非酒精性脂肪性肝病患者,随机分为弹性酶组（n=44）,口服弹性酶肠溶片（300 IU/粒）,每次2粒,每日3次,疗程60天,安慰剂组（n=32）,口服安慰剂（淀粉）,剂量及疗程相同;治疗前、治疗30天、60天分别检测肝、肾功能、血脂,并B超随访.结果 6例患者治疗中失访,70例患者纳入疗效统计.弹性酶组总有效率为85%（34/40）,安慰剂组总有效率为20%（6/30）,两组比较差异有统计学意义（P=0.000）;弹性酶组肝功能、血脂明显改善,两组比较差异有统计学意义（P《0.05）;弹性酶对肾功能无明显毒副作用.结论弹性酶肠溶片具有改善肝功能、降低血脂、防治高脂血症性非酒精性脂肪性肝病的作用.

Clinical observation of therapeutic efficacy of elastase on nonalcoholic fatty liver disease with hyperlipidemia

Objective To observe the therapeutic efficacy,safty,and tolerability of elastase versus placebo on nonalcoholic fatty liver disease with hyperlipidemia.Methods Seventy-six patients diagnosed nonalcoholic fatty liver disease with hyperlipidemia were randomliy divided into two groups(treated group and control group).The treated group(n=44) was treated with elastase,two capsules once,three times a day,while the control group(n=32) was treated with placebo,the period of treatment was sixty days.Before and after the treatment,serum lipid,liver function,kidney function and B ultrasonography of liver were monitored.Results Six patients were dropped and excluded due to inconsistencies in the included standard,therefore,the efficacy,safety of 70 cases were analyzed.The degree of improvement of the liver function and serum lipid of the treated group more than the control group,The comprehensive effective rate of the treated group was 85%(34/40),while the placebo group was 20%(6/20),the treated group was better than the control group significantly(P=(0.000)).There was no adverse reaction on renal function.Conclusion Elastase could be used as a safe and effective drug in treatment of nonalcoholic fatty liver disease with hyperlipidemia.