他汀类药物致肝损害的不同处理方法比较

Comparison of different strategies in patients with hepatic lesion induced by statins

目的探讨他汀类药物致肝损害的不同临床处理方法对患者的影响。方法 80例患者随机分为发生他汀类药物肝损害后减至最小维持量继续治疗组(A组)及发生他汀类药物肝损害后立即停药组(B组)。观察两组患者肝功能、血脂变化及近期主要心脏事件发生情况。结果本研究中80例患者,无胆汁淤积性黄疸、肝功能衰竭及死亡病例。A组患者在治疗后4周治愈22例(55.0%)、好转17例(42.5%)、恶化1例(2.5%),8周治愈33例(82.5%)、好转7例(17.5%)、恶化0例,12周治愈37例(92.5%)、好转3例(7.5%)、恶化0例;B组患者在停药后4周治愈23例(57.5%)、好转17例(42.5%)、恶化0例,8周治愈35例(87.5%)、好转5例(12.5%)、恶化0例,12周治愈38例(95.0%)、好转2例(5.0%)、恶化0例。两组患者在治疗后4周、8周、12周比较在治愈、好转、恶化例数差异无统计学意义(P>0.05)。A组患者甘油三酯(TG)、总胆固醇(TC)、低密度脂蛋白胆固醇(LDL-C)水平在治疗期间与基线比较持续降低(P<0.01)。B组患者TG、TC、LDL-C水平与基线比较无明显变化(P>0.05)。A、B两组患者TG、TC、LDL-C在组间、不同时点以及组间和不同时点的交互作用差异均有统计学意义(P<0.01)。3个月随访总的主要心脏事件(包括非致死性心肌梗死、心绞痛和靶血管重建)A组低于B组,但是差异无统计学意义(25.0%vs37.5%,P>0.05)。结论他汀类药物致肝损害患者采取减至最小维持量继续治疗及立即停药的方法均安全可行,采取减至最小维持量继续治疗可维持降脂作用,并且近期心脏事件发生率有下降趋势。

Objective To explore the effect of different treatments on patients with hepatic lesion induced by statins.Methods Eighty patients with hepatic lesion induced by statins were divided into two groups.Patients in group A were treated with statins in minimum quantity and patients in group B were discontinued statins immediately after hepatic lesion.Patients were followed up with liver function,blood fat and recent major adverse cardiac events.Results There were no patients with cholestatic jaundice,liver failure and deaths in two groups.Patients in group A were treated of cure 22 cases（55.0%）,better 17 cases（42.5%）,worse 1 case（2.5%） after 4 weeks,cure 33 cases（82.5%）,better 7 cases（17.5%）,worse 0 after 8 weeks,cure 37 cases（92.5%）,better 3 cases（7.5%）,worse 0 after 12 weeks;Patients in group B were drug withdrawal of cure 23 cases（57.5%）,better 17 cases（42.5%）,worse 0 after 4 weeks,cure 35 cases（87.5%）,better 5 cases（12.5%）,worse 0 after 8 weeks,cure 38 cases（95.0%）,better 2 cases（5.0%）,worse 0 after 12 weeks.There were no significant differences in the patients with cure rate,better or worse rate in two groups at 4,8 and 12 weeks after treatment（P〉0.05）.Comparing with baseline,the levels of TG,TC,and LDL-C were significantly lower during treatment in patients of group A（P〈0.01）,but they were no significant change in patients of group B（P〉0.05）.And there were significant differences in the levels of TG,TC and LDL-C in between different time points in group,and between groups and different time points of the interaction between group A and group B（P〈0.01）.During 3-months’ follow-up,major adverse cardiac events,including nonfatal myocardial infarction,angina and target-vessel revascularization occurred in 10 patients in group A compared with 15 patients in group B（25.0% vs 37.5%,P〉0.05）.Conclusion When treating patients with hepatic lesion induced by statins,drug withdrawal or treatment with minimum maintenance dose of statins are both safe and feasible.To maintain minimum dose in continuous treatment can decrease LDL-C and reduce short-term major adverse cardiac events.