杞黄降糖胶囊对二甲双胍控制不佳2型糖尿病疗效和安全性一项240例多中心、随机、双盲、安慰剂对照临床研究

Efficacy and Safety of Qihuang Jiangtang Capsules(杞黄降糖胶囊) for Type 2 Diabetes Mellitus Patients with Poor Glycemic Control after Metformin Treatment:A Multicenter,Randomized,Double-Blind,Placebo-Controlled Trial of 240 Cases

目的 观察中成药杞黄降糖胶囊对二甲双胍单药控制不佳的2型糖尿病患者的临床疗效和安全性。方法 按照随机、双盲、安慰剂对照方法,纳入全国14家医院240例二甲双胍控制不佳的糖尿病患者,随机分别为试验组和对照组(各120例),在原治疗基础上分别加用杞黄降糖胶囊和模拟剂。干预12周后评估疗效,观察降糖效果[糖化血红蛋白(glycosylated hemoglobin, HbA1c)、空腹血糖(fasting blood sugar, FPG)、餐后2 h血糖(two-hour postprandial blood glucose, 2 h PPG)]、中医气阴两虚证候和临床症状评分,并评估安全性。结果 最终共完成205例(试验组97例、对照组108例),12周后试验组HbA1c降低了0.28%±0.60%,空腹血糖下降0.14±1.56 mmol/L;而对照组HbA1c则增高了0.03%±0.62%,空腹血糖上升(0.83±1.58) mmol/L;两组有明显差别(P<0.01)。试验组口苦咽干,手足心热等症状及气阴两虚兼热证候明显改善(P<0.05),未见严重不良反应。结论 对单纯二甲双胍疗效不佳的患者,加用杞黄降糖胶囊安全有效,可协同控糖,改善患者症状。

Objective To observe the clinical effects and safety of Qihuang Jiangtang Capsules(杞黄降糖胶囊)for type 2 diabetes mellitus patients with poor glycemic control after metformin treatment.Methods Randomized,double blind,placebo controlled clinical trial design was adopted,and 240 patients with poor glycemic control after metformin treatment were enrolled in 14 parallel hospitals.The patients were divided into experimental group and control group randomly with 120 cases in each group,and recerived Qihuang Jiangtang Capsules+metformin and simulant+metformin respectively.The treatment course was 12 weeks.The levels of glycosylated hemoglobin(HbA1 c),fasting blood sugar(FPG)and two-hour postprandial blood glucose(2 h PPG),the symptoms of Qi and Yin deficiency syndrome and diabetes symptom score were evaluated,and security was assessed.Results A total of 205 cases completed the trial(97 cases in experimental group,108 cases in control group).After 12 weeks,HbA1 c decreased 0.28%±0.60%,FPG decreased(0.14±1.56)mmol/L in the experimental group.HbA1 c increased 0.03%±0.62%and FPG increased(0.83±1.58)mmol/L in control group,and there were statistically significant differences between the two groups(P<0.01).The symptoms of bitter taste and dry throat,feverish feeling in palms and soles,and Qi and Yin deficiency syndrome with heat improved greatly in the experimental group(P<0.01),and no serious adverse reactions were found.Conclusions Qihuang Jiangtang Capsules could reduce blood glucose and improve clinical symptoms for patients with poor glycemic control after metformin treatment.