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[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(P<0.05);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(P<0.05)。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(P<0.05)。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。
[Objective] To observe the safety and efficacy of Jinlida granules combined with metformin in the newly diagnosed type 2 diabetic patients. [Method] A total of 156 newly diagnosed type 2 diabetic patients participated in the study. All patients were randomized to receive either Jinlite granules (placebo) or placebo (control group) on a regular basis with metformin. The end point of the study was Hb A1c, fasting plasma glucose (FPG) and 2 h postprandial blood glucose (2 h PG) in the 12th week of follow-up. [Results] The Hb A1c was 6.61 ± 0.63% in the treatment group and 6.91 ± 1.09% in the placebo group at 12-week follow-up. The difference was statistically significant (P <0.05). The FPG in the treatment group was ( 7.31 ± 1.12 mmol / L for the placebo group and 7.63 ± 0.77 mmol / L for the placebo group; PG was (10.63 ± 1.80) mmol / L for 2 h in the treatment group and 11.46 ± 2.42 mmol for the placebo group / L, the differences were statistically significant (P <0.05). The compliance rate of the treatment group was 83.3% and that of the control group was 67.9%. The effective rate of TCM syndrome was 85.8% in the treatment group and 57.7% in the control group, with significant difference (P <0.05). There were no serious adverse drug events associated with study drug in either group. [Conclusion] The results show that the combined use of Jinlida granules can better control the blood glucose level of newly diagnosed type 2 diabetic patients on the basis of metformin treatment, and is safe and effective for the newly diagnosed type 2 diabetic patients.