津力达颗粒联合二甲双胍治疗新诊断2型糖尿病患者的临床观察

[目的]观察津力达颗粒联合二甲双胍治疗新诊断2型糖尿病患者的安全性及有效性。[方法]总计156名新诊断2型糖尿病患者参与研究。所有患者在接受二甲双胍常规治疗基础上,被随机分配服用津力达颗粒(治疗组)或安慰剂(对照组)。研究终点为随访第12周受试者糖化血红蛋白(Hb A1c)、空腹血糖(FPG)、餐后2 h血糖(2 h PG)。[结果 ]在12周随访时,治疗组Hb A1c为(6.61±0.63)%,安慰剂组Hb A1c为(6.91±1.09)%,差异有统计学意义(P0.05);治疗组FPG为(7.31±1.12)mmol/L,安慰剂组FPG为(7.63±0.77)mmol/L;治疗组2 h PG为(10.63±1.80)mmol/L,安慰剂组2 h PG为(11.46±2.42)mmol/L,差异均具有统计学意义(P0.05)。治疗组达标率为83.3%,对照组为67.9%;治疗组中医证候有效率为85.8%,对照组为57.7%,差异有统计学意义(P0.05)。2组均未发生与研究药物相关的严重不良事件。[结论]研究结果显示,在二甲双胍治疗基础上,联合使用津力达颗粒可使新诊断2型糖尿病患者血糖水平得到更好控制,应用于新诊断2型糖尿病患者安全有效。

The clinical observation of Jinlida granule as Add-On metformin treat the newly diagnosed type 2 diabetic patients

[Objective] To observe the safety and efficacy of Jinlida granule combined with metformin in the treatment of newly diagnosed type 2 diabetes mellitus.[Methods] A total of 156 newly diagnosed type 2 diabetic patients were enrolled in the study. All of the patients on the basis of metformin to conventional treatment, were randomly assigned to take Jinlida granule(treatment group) or placebo (control group). The end of the study was followed by the 12th week of subject Glycated HemoglobinA1c(HbA1c), Fasting plasma glucose(FPG), 2 h postprandial glucose(2 h PG).[Results] At 12 weeks of follow-up, the treatment group HbA1c was (6.61±0.63)%, the placebo group HbA1c was (6.91±1.09)%. The difference was statistically significant(P<0.05). The FPG of the treatment group was (7.31±1.12) mmol/L. The placebo group FPG was (7.63±0.77). The 2 h PG of the treatment group was (10.63±1.80) mmol/L. The placebo group 2 h PG was (11.46±2.42) mmol/L. The difference was statistically significant(P<0.05). The treatment group success rate was 83.3%, the control group is 67.9%. The effective rate of Chinese Medicine(CM) syndromes was 85.8% in the treatment group and 57.7% in the control group, the difference was statistically significant (P<0.05). Two groups of treatment group were not serious adverse events related to study drug.[Conclusion] The results showed that on the basis of metformin treatment, combination of Jinlida granule can make the patients with newly diagnosed type 2 diabetes better control of blood sugar level. Applied in newly diagnosed type 2 diabetes is safe and effective.