三种他汀类药物对老年冠心病合并2型糖尿病患者安全性及有效性的对比

Comparative study on the safety and efficacy of three statins in elderly patients with CHD combined with T2DM

目的对比分析三种他汀类药物对老年冠心病(CHD)合并2型糖尿病(T2DM)患者的安全性及有效性。方法选取250例CHD合并T2DM的老年患者研究对象,用随机数字表法分为三组,分别予以辛伐他汀20毫克/次,阿托伐他汀20毫克/次,瑞舒伐他汀10毫克/次,均为1次/天,晨起空腹口服。统计分析三组患者非高密度脂蛋白胆固醇(non-HDL-C)、低密度脂蛋白胆固醇(LDL-C)达标率、终点事件发生情况及副作用等方面的差异。结果 (1)与辛伐他汀组相比,阿托伐他汀组、瑞舒伐他汀组在3～18个月时的non-HDL-C达标率明显更高,3～6个月时的LDL-C达标率明显较好。但在随访结束时,三组患者的non-HDL-C达标率、LDL-C达标率差异无统计学意义(P>0.05)。(2)随访结束时,根据non-HDLC、LDL-C达标情况的不同,将患者分为双不达标组、单LDL-C达标组、单non-HDL-C达标组及双达标组。结果发现,双不达标组的全因死亡率最高,单达标组次之,双达标组的死亡率最低。其他的主要及次要临床终点事件发生率均差异无统计学意义(P>0.05)。(3)多因素logistic分析发现,年龄≥80岁是影响患者全因死亡率的不可更改的独立性危险因素(OR>1,P <0.001),单non-HDL-C达标、双达标是影响患者全因死亡率的独立性保护因素(OR <1 <0. 05)。(4)随访过程中,60～<80岁组、≥80岁组均未出现丙氨酸转氨酶、天冬氨酸转氨酶超过上限值3倍、肌酸激酶超过上限值5倍及表皮生长因子受体(eGFR)下降超过50%的情况。两个年龄组患者在5个时间点的不良反应发生率差异无统计学意义(P> 0. 05)。结论对C H D合并T2 D M患者而言,阿托伐他汀与瑞舒伐他汀的短期疗效优于辛伐他汀,但远期效果无明显差异,长期应用他汀类药物安全性较高。

Objective To compare and analyze the safety and efficacy of three kinds of statins in elderly patients with CHD and T2DM.Methods 250 patients were selected and divided into three groups randomly,and given simvastatin 20 mg/time,atorvastatin 20 mg/time,rosuvastatin 10 mg/time respectively,with 1 time a day orally during the empty stomach in the morning.Results (1) Compared with the simvastatin group,the non-HDL-C standard rates at 3-18 months were significantly higher and the LDL-C standard rates at 3-6 months were obviously better in the atorvastatin and rosuvastatin groups.But at the end of the follow-up,there was no significant difference in the efficacy among the three groups.(2)The mortality rate of the double-substandard groups was the highest followed by the single standard group and the lowest mortality rate was in the double-standard group.There was no significant difference in the incidence of other major and minor clinical endpoints.(3)Multivariate analysis showed that age over 80 was an independent risk factor affecting the mortality of patients.The single non-HDL-C standard and double standard were independent factors affecting the mortality of patients.(4)During the follow-up,the main adverse reactions of statins included myalgia,elevated CK,elevated AST and ALT,and decreased eGFR by less than 50%.There was no significant difference in the incidence of adverse reactions at 5 time points between the two age groups (P>0.05).Conclusion The short term effects of atorvastatin and rosuvastatin are better than those of simvastatin for CHD combined with T2DM.However,there is no significant difference in the long-term effect,thus the long-term use of statins is safe.