津力达颗粒治疗2型糖尿病随机双盲临床研究

摘要

Objective To evaluate the validity and safety of Jinlida granule in treating type 2 diabetic patients. Methods Taking random double blind and parallel controlled design , 280 patients weve divided into treatment group and control group by 1: 1 ratio. The treatment group patients take Jinlida granule and metformin hydrochloride tablets placebo , and the control group patients take metformin hydrochloride tablets and Jinlida granule. Treatment course weve all 8 weeks for both groups. Results Totally there were 254 patients completed the trial ,130 patients in treatment group and 124 patients in control group. The FPG,2hPG, HbA1c of treatment group were (7.31 + 1. 99 ) mmol/L, (10.08 + 3.38 ) mmol/L, (7. 18 + 1. 65 ) % respectively , which were (7. 91 + 1. 76) mmol/L, (10. 97 + 3. 05 ) mmol/L, (7.88+1.56)% incontrol group, the effect of TCM symptoms was 90. 8% in teratment group and 79. 8% in controt group , there were statistic significances ( P < 0. 05, P <0.01). Conclusion Jinlida granule can reduce type 2 diabetic patients 'FPG、2hPG、HbA1c and improve TCM symptoms , which was super to control group.%目的 评价津力达颗粒治疗2型糖尿病患者的有效性及安全性.方法 采用随机双盲、平行对照设计,按照1∶1的比例将2型糖尿病患者280例随机分为2组,试验组服用津力达颗粒和盐酸二甲双胍片安慰剂,对照组服用盐酸二甲双胍片和津力达颗粒安慰剂,疗程均为8周.结果 共254例患者完成试验,试验组130例,对照组124例.治疗后试验组FPG、2hPG、HbA1c分别为(7.31±1.99)mmol/L、(10.08±3.38)mmol/L和(7.18±1.65)%,对照组分别为(7.91±1.76)mmol/L、(10.97±3.05)mmol/L、(7.88±1.56)%,差异有统计学意义(P<0.05或P<0.01);试验组中医症候总有效率为90.8%,高于对照组的79.8%,差异有统计学意义(P<0.05).结论 津力达颗粒能明显降低2型糖尿病患者的FPG、2hPG、HbA1c和改善中医症状.