心脑舒通片辅助治疗2型糖尿病合并颈动脉斑块老年患者的临床疗效观察

Clinical efficacy of Xinnao Shutong tablet on type 2 diabetes elderly patients complicated with carotid plaque

目的观察心脑舒通片辅助治疗2型糖尿病(T2DM)合并颈动脉斑块老年患者的临床疗效和安全性。方法 96例T2DM合并颈动脉斑块老年患者随机分为观察组(n=48)和对照组(n=48)。两组均接受常规治疗,观察组加用心脑舒通片,一日3次,每次2片,口服12周。利用超声诊断仪观察两组治疗前后颈动脉内中膜厚度(IMT)、颈动脉斑块积分变化,同时检测治疗前后血清Hcy、hs-CRP、空腹血糖(FBG)、糖化血红蛋白(HbA1c)、总胆固醇(TC)、甘油三酯(TG)、低密度脂蛋白-胆固醇(LDL-C)和高密度脂蛋白-胆固醇(HDL-C)水平。结果观察组治疗后颈动脉IMT及颈动脉斑块积分与治疗前及对照组相比,均显著下降,差异有统计学意义(P<0.05)。观察组治疗后血清Hcy及hs-CRP与治疗前及对照组比较,均显著降低,差异均具有统计学意义(P<0.05)。观察组治疗后FBG、HbA、TC、TG、LDL-C、HDL-C与治疗前及对照组相比均明显改善,差异具有统计学意义(P<0.05)。两组治疗前后均未观察到明显不良反应。结论心脑舒通片可改善T2DM合并颈动脉斑块老年患者的颈动脉粥样硬化程度,降低炎症反应,辅助调节糖脂代谢,且未发现明显不良反应。

Objective To observe the efficacy and safety of Xinnao Shutong tablet on type 2 diabetes mellitus （T2DM） elderly patients complicated with carotid plaque. Methods A total of 96 elderly patients with T2DM complicated with carotid plaque were randomly divided into observation group （n=48） and control group （n=48）. Both groups were given conventional treatment; the observation group also received Xinnao Shutong tablet, 2 tablets each time, 3 times a day. Carotidintimal-medialthickness （IMT） and plaques cores were observed by Doppler ultrasound examination, and the levels of Hcy, hs-CRP, FBG, HbAlc, TC, TG, HDL-C and LDL-C were measured before and after 12 week treatment. Results Compared with before treatment and control group, the IMT and plaque scores of observation group were significantly decreased after 12 week treatment, the differences were statistically significant （P〈0.05）. The levels of Hcy and hs-CRP were significantly reduced from baseline and those of control group （P〈0.05）. The levels of FBG, HbAlc, TC, TG and LDL-C were significantly reduced, and HDL-C was significantly elevated in observation group 12 weeks later （P〈0.05）. There were no adverse reactions observed. Conclusion The Xinnao Shutong tablet can improve the carotid atherosclerosis, inflammation and glucose-lipid metabolism in T2DM elderly patients complicated with carotid plaque.