卡双平治疗T2DM的疗效和安全性研究  

Combination therapy of pigolitazonelmetformin for type 2 diabetes mellitus

作　　者：程海梅[1] 王宏宇[1] 高飞[1] 马永华[1] 王意[1] 朱泊羽 何紫薇 徐春[1] Cheng Haimei, Wang Hongyu, Gao Fei, Ma Yonghua, Wang Yi, Zhu Boyu, He Ziwei, Xu Chun(Department of Endocrinology, the General Hospital of the Armed Police Forces, Be ijing 100039, Chin)

机构地区：[1]武警总医院内分泌科,北京100039

出　　处：《中华内分泌外科杂志》2017年第6期471-475,共5页Chinese Journal of Endocrine Surgery

基　　金：中华国际医学交流基金会青年医生糖尿病研究项目（WZHZ2016010）

摘　　要：目的观察卡双平（吡格列酮15ms／二甲双胍500mg）替换单用或联用二甲双胍血糖控制不佳的rr2DM的疗效及安全性。方法选取单用或联用二甲双胍血糖控制欠佳（糖化血红蛋白（HbAlc）7．0％-11．0％）的患者80例，余治疗不变的基础上卡双平替换二甲双胍，观察12周后HbAlc、空腹血糖（fasting plasma glu-cose,FPG）的变化，同时观察血脂谱、肝肾功、体重的变化。结果入组80例，男性48例，女性32例，平均年龄（54．79±13．99）岁，病程（9．76±6．59）年，平均HbAlc（9．06±1．34）％，共68例完成试验。与基线比较，第12周时．FPG下降（2．06±0．16）mmol／L，差异有统计学意义（P〈0．001）；HbAlc下降（0．84±0．23）％，差异有统计学意义（P〈O．001）。与基线比较，体重增加（0．34±1．13）kg，差异无统计学意义（P=O．07）；总胆固醇（totalcholesterol，TC）、低密度脂蛋白（low density lipoprotein-cholesterol，LDL-C）、甘油三酯（triglyceride，TG）均下降，但差异无统计学意义（P〉0．05），高密度脂蛋白（high density lipoprotein-cholesterol，HDL．C）较基线升高，差异有统计学意义（P=0．012）。肝肾功能各项指标（ALT、AST、TBIL、DBIL、Urea、UA、Cr）无明显变化。不良事件分析：无严重低血糖及严重心血管事件发生：6例出现浮肿，4例因严重下肢浮肿退出试验；无新增胃肠道反应。结论卡双平在T2DM患者治疗中安全有效。耐受性好，可作为单用或联用二甲双胍血糖控制欠佳患者联合用药的选择。Objective To observe the efficacy and safety of pigolitazone/metformin fixed-dose combina- tion therapy replacing metformin alone or combined with other anti-diabetes drugs in type 2 diabetes with poor glycemic control. Methods 80 cases were recruited, with an average age of （54.79±13.99）years,diabetes history of （9.76±6.59） and baseline HbAlc （9.06±1.34）%. All participants received pigolitazone/metformin instead of metformin without other treatment changes. Glycemic control （level of fast blood glucose, HbAlc） was evaluated at 12 weeks , as well as lipid profiles, liver and renal function, adverse events and body weight. Results 8 cases were lost to visit, 4 cases were withdrawn for edema,only 68 subjects finished the study. Compared to the base- line, after 12-week treatment, FPG decreased for （2.06±0.16） mmol/L, HbAlc decreased for （0.84±0.23）%, both of the differences were statistically significant （P〈0.001, P〈0.001）. Body weight increased （0.34±1.13）kg, with no difference compared to the baseline. The lipid profile presented elevated high density lipoprotein cholesterol （P= O.O12）and decreased total cholesterol, low density lipoprotein cholesterol, triglyceride, while the latter three items showed no differences （P〉O.05, P〉0.05, P〉0.05）. Indexes reflecting liver and renal function, such as ALT, AST, TBIL, DBIL, Urea, UA, Cr showed no differences compared with the baseline. Adverse events analysis showed at the end of the study, no severe hypoglycemia and serious cardiovascular events occurred, 6 cases suffered edema, among whom 4 patients exited the study for severe lower limb edema. No extra gastrointestinal symptom happened. Conclusion Pigolitazone/metformin fixed-dose combination exhibits an excellent efficacy and safety for T2DM, with satisfying tolerability and compliance, which is a selection for those patients with poor glycemic control.

关 键 词：吡格列酮二甲双胍片 血糖 糖化血红蛋白 2型糖尿病 

分 类 号：R587.1[医药卫生—内分泌]