阿昔莫司对高脂血症伴肝功能异常的疗效及用药安全性研究

Study on the efficacy and safety of acycamycin in the treatment of hyperlipidemia with abnormal liver function

目的研究阿昔莫司对高脂血症伴肝功能异常患者的疗效及用药安全性。方法研究对象选取2015年1月~2016年12月间我院收治的150例高脂血症伴非酒精性脂肪肝所致肝功能异常患者,采用数字表法随机分为大剂量组、小剂量组和安慰剂组各50例,大剂量组给予阿昔莫司0.5 g/次,3次/d口服,小剂量组给予阿昔莫司0.25 g/次,3次/d,口服,安慰剂组则给予维生素C 0.2 mg/次,3次/d,口服,三组患者均连续用药8周,治疗结束后评价疗效,对比三组患者治疗前后的血脂水平和肝功能水平变化情况,统计三组患者治疗期间的不良反应情况。结果大剂量组总有效率为86.0%(43/50),小剂量组总有效率为84.0%(42/50),安慰剂组总有效率为4.0%(2/50),大剂量组和小剂量组疗效均显著优于安慰剂组(P<0.05),但大剂量组和小剂量组对比无显著差异(P>0.05);治疗前三组的血脂水平对比无显著差异,治疗后大剂量组和小剂量组与治疗前TC、TG、LDL-C、HDL-C相比均显著改善(P<0.05);治疗后大剂量组和小剂量组的ALT、AST、TB水平显著改善,且组间差异具有统计学意义(P<0.05);三组均未见明显不良反应。结论大剂量阿昔莫司能够更好地改善高脂血症伴肝功能异常患者的肝功能。

Objective To study the efficacy and safety of acycamycin in patients with hyperlipidemia and liver dys- function. Methods A total of 150 patients with hyperlipidemia and non-alcoholic fatty liver were enrolled in our hospital from Jan 2015 to Dec 2016 were randomly divided into high-dose group, low-dose group and placebo group 50 cases in the high dose group and 0.5 g/time in the high dose group. The low dose group was treated with avermectin 0.25 g/ time and 3 times/day orally. The placebo group was given vitamin C 0.2 mg/time, 3 times/d, oral, three groups of pa- tients were continuous medication for 8 weeks, after the end of treatment, the efficacy of three groups of patients before and after treatment of blood lipid levels and changes in liver function levels were evaluated, reaction situation of pa- tients in the three groups during treatment was statistic analyzed. Results The total effective rate was 86.0%（43/50） in the high dose group and 84.0%（42/50） in the low dose group. The total effective rate was 4.0%（2/50） in the placebo group. The efficacy of the high dose group and the low dose group was significant superior to the placebo group（P〈0.05）, but there was no significant difference between the high dose group and the low dose group（P〉0.05）. There was no significant difference in the serum lipid levels among the three groups before and after treatment. Compared with before treatment, the levels of TC, TG, LDL-C and HDL-C in the high dose group and the low dose group were significantly lower than those before treatment（P〈0.05）. The levels of ALT, AST and TB in the high dose group and the low dose group were significantly improved after treatment（P〈0.05）, the difference between the two groups was statistically signif- icant （P〈0.05）; There were no significant adverse reactions in the three groups. Conclusion High dose of acyeamycin can improve the liver function of patients with hyperlipidemia and abnormal liver function.