依折麦布联合舒洛地特对高龄冠心病和糖尿病患者调脂、抗炎作用的临床观察

Clinical observation of ezetimibe co-administration with sulodexide adjusting lipids and anti-inflammation in elderly patients with CHD and DM

目的探讨依折麦布联合舒洛地特对高龄冠心病和糖尿病患者全面调脂、抗炎降低肿瘤坏死因子-α(TNF-α)、C反应蛋白(CRP)的作用及安全性。方法选取高龄冠心病、糖尿病患者180例,随机均分为三组。试验组:依折麦布/舒洛地特组(依/舒组),给予依折麦布片10 mg口服,1次/d,舒洛地特胶囊250LSU口服,2次/d;对照组一:依折麦布/辛伐他汀组(依/辛组),给予依折麦布片10 mg口服,1次/d,辛伐他汀片20 mg口服,1次/d;对照组二:辛伐他汀组(辛组),给予辛伐他汀片20 mg口服,1次/d。所有患者在治疗前及治疗后4周、12周末空腹采血,检测总胆固醇(TC)、低密度脂蛋白胆固醇(LDL-C)、高密度脂蛋白胆固醇(HDL-C)、三酰甘油(TG)。在治疗前及治疗12周末空腹采血测定血浆TNF-α、CRP。结果①治疗后三组TC、LDL-C均明显下降(P<0.05)。12周末,依/辛组较依/舒组、依/舒组较辛组TC、LDL-C变化显著(P<0.05)。②12周末,依/舒组HDL-C明显升高(P<0.05)。③4周、12周末,依/舒组、依/辛组TG明显下降(P<0.05),依/舒组较依/辛组,TG下降显著(P<0.05)。④12周末,依/舒组TC、LDL-C、HDL-C、TG的达标率皆优于辛组(P<0.05),TG的达标率优于依/辛组。依/辛组TC、LDL-C达标率在三组中最高,皆为100%。⑤三组在12周末血浆TNF-α、CRP较基线水平明显降低(P<0.05),彼此之间无显著差异。结论依折麦布、舒洛地特联用于冠心病、2型糖尿病高龄患者,有良好的全面调脂、抗炎作用,安全性佳,还能发挥舒洛地特的经典临床药理作用,是一种有前途的临床用药方案。

Objective To investigate the therapeutic effectiveness and safety of ezetimibe combined with sulodexide on overall lipid-adjustings, lowering TNF-aand CRP in elderly patients with CHD and DM. Methods 180 elerly patients with CHD.,DM were divided equally into 3 groups. All the subjects received therapy as follows：①10 mg ezetimibe qd. ＋ 250 LSU sulodexide bid （the observed group, n = 60） ;②10 mg ezetimibe qd ＋ 20 mg simvastatin qd. （the 1 st control group, n=60） ;③20 mg simvastatin qd. （the 2nd control group, n = 60）. Serum total cholesterol （ TC）, low density lipoprotein cholesterol （ LDL-C）, high density lipo- protein cholesterol （HDL-C）,total triglyeride （TG） were determined before treatment, at 4 weeks and at 12 weeks; serum tumor necrosis factor-α （TNF-α） and C- reactive protein （CRP） were also determined before treatment and at 12 weeks. Results ①TC and LDL-C in the 3 groups were significantly lower （P 〈 0.05 ） after treatment compared with the basic level. TC and LDL-C were significantly lower in the 1st control group than the observed group （ P 〈 0〈 05 ）, and lower in the observed group than the -2rid control group （ P 〈 0.05 ） at 12 weeks. ②HDL-C was significantly higher in the observed group compared with the basic level at 12 weeks. ③TG was significantly lower in the observed group and the 1 st control group compared with their respective baseline （P 〈0. 05）, and in the observed group than the 1 st control group at 4 weeks and at 12 weeks （P 〈0. 05）. ④At 12 weeks, the compliance rates of TC, LDL-C, HDL-C and TG in the observed group were higher than in the 2nd control group respectively;the compliance rate of TG in the observed group was higher than in the 1 st control group ;the compliance rates of TC and LDL-C in the 1 st control group were the highest （reached at 100% ） than the other 2 groups. ⑤TNF-α and CRP were significantly lower in the 3 groups compared with their respective baseline （ P 〈 0.05 ）, and there was no difference on the therapeutic effectiveness between in the 3 groups. Conclusion Ezetimibe co-administration with sulodexide in elderly patients with CHD and DM can not only show pleiotropie effects on overall lipid-adjusting, anti-inflammation, good safeness, but also can educes classical phar- macological actions of sulodexide,so it is a prospective clinical medication combination.