芪药消渴胶囊联合盐酸二甲双胍片治疗2型糖尿病患者150例多中心随机对照临床观察

Clinical Observation on 150 Patients with Diabetes Type Ⅱ Treated by Qiyao Xiaoke Capsule Combined with Metformin Hydrochloride Tablets:A Multi-centered Random-Controlled Study

目的观察芪药消渴胶囊联合盐酸二甲双胍片治疗2型糖尿病的临床疗效。方法将240例2型糖尿病患者随机分为治疗组150例,对照组90例,另外将未系统服用西药降糖药的2型糖尿病患者30例设为开放组。治疗组患者在服西药降糖药盐酸二甲双胍片基础上口服芪药消渴胶囊,对照组患者在服用同样西药降糖药基础上加服消渴灵胶囊,开放组患者单独服用芪药消渴胶囊,导入期2周,观察治疗12周。分别于治疗前、治疗12周后检测3组患者空腹血糖(FBG)、餐后2h血糖(2hPG)、糖化血红蛋白(HbA1c),并计算中医证候疗效、症状评分以评价临床疗效。结果治疗组临床总有效率74.67%,对照组72.22%,开放组70.00%;除开放组2hPG外,3组患者FBG、2hPG、HbA1c治疗后均较治疗前下降(P<0.05或P<0.01);治疗组除尿赤便秘外,其他症状均较治疗前明显改善(P<0.05),与对照组和开放组比较差异亦有统计学意义(P<0.05)。结论芪药消渴胶囊具有降血糖、改善糖尿病患者症状的功效。

Objective To observe the therapeutic effect of Qiyao Xiaoke Capsule （Capsule for Diabetes） on the diabetes type Ⅱ . Methods Totally 240 diabetes type Ⅱ patients were randomized into a treatment group （n= 150）, and a control group （n= 90） ; and other 30 diabetes patients who didn＇t regularly take hypoglycemic drugs were set as opening group. The treatment group was administered Qiyao Xiaoke Capsule plus Metformin Hydrochloride Tablets, while the control group was prescribed Xiaoketing Capsule in addition to Metformin Hydrochloride Tablets, and the opening group was given Qiyao Xiaoke Capsule only, with a leading period of two weeks. The patients were treated for 4 weeks. Before treatment and at the end of the 4 weeks＇ treatment, the fasting blood glucose （FBG）, 2 hours postprandial blood glucose （2hPG）, and glycosylated hemoglobin （HbAle） of all groups were determined, and scores of TCM syndromes and symptoms were observed to evaluate the therapeutic effect. Results The total effective rate of the treatment group was 74.67%, of the control group 72.22%, and in the opening group 70. 00%. Except for the 2hPG of the opening group, the FBG, 2hPG and HbAlc of 3 groups were decreased （P〈0.05 or P〈0.01）. In the treatment group, except for deep-colored urine and constipation, all other symptoms were significantly relieved （P〈0.05）, compared with those of the control and opening groups, the difference was significant （P〈0. 05）. Conclusion Qiyao Xiaoke Capsule is effective in decreasing the blood glucose and relieving the symptoms of diabetics type Ⅱ .