血脂康对2型糖尿病血脂异常的疗效及安全性观察

Comparative study of the effects and the safety of Xuezhikang and simvastatin on patients with hyerlipidmia in type2 diabetic

目的观察比较血脂康（北京北大微信生物科技有限公司）与辛伐他汀对2型糖尿病血脂异常的临床疗效及安全性。方法共入选60例2型糖尿病血脂异常患者，随机分入血脂康组（0.6Bid，n=30）与辛伐他汀组（10mg／d，n=30），疗程均为6周。观察治疗前后主要血脂参数、血糖的变化以及不良反应。结果（1）两组均能改善明显2型糖尿病患者的血脂异常，血脂康组及辛伐他汀组降低血清总胆固醇（TC）、低密度脂蛋白胆固醇（LDL-C）和甘油三酯（TG）分别为21％、36％、20％和23％、27％、30％（P值均小于0．05），升高血清高密度脂蛋白胆固醇（HDL-C）分别为19％和7％，血脂康组降TG及升HDL-C明显优于辛伐他汀组（P〈0．05）。（2）血脂康组治疗后血糖明显改善（P〈0．01）。（3）两组不良反应的发生率相比差异无统计学意义（P〉0．05）。结论本研究结果提示，血脂康在较全面地改善2型糖尿病患者的血脂异常的同时可改善血糖，具有良好的安全性和耐受性。

Objective The aim of this study was to evaluate the efficacy and safety of xuezhikang and simvastatin in type 2 diabetic patients with hyperlipidemia. Methods A total of 60 type 2 diabetic patients with hyperlipldemia were randomly assigned to receive xuezhikang 0.6 bid（ n = 30） or 10 mg qn simvastatin （ n = 30） for 6 weeks. Serum levers of TC、TG、LDL-C、HDL-C .FBG and 2Hpg were measured at the beginning and the end of 6 weeks of the trial period. Results （ 1 ） At the and of 6 weeks treatment, levels of TC, TG and LDL-C in xuezhikang treatment and simvastatin treatment are reduced by 21% .36 % .20 % and 23 % . 27 % .30 % , while HDL-C increased by 19% and 7%. The decreasing in TG and increasing in HDL-C by xuezhikang treatement are superio to slmvastatin. （2）Mter treatment of 6 weeks, levels of FBG and 2hpg are improved. （3）Both treatments are well tolerated with no increase in adverse events. Conclusion The results of this study demonstrated that xuezhikang is more effective in type 2 diabetic patients with hyperlipidemia, and is generally safe and well tolerated.