消渴丸治疗气阴两虚证2型糖尿病的临床研究

Clinical Study on Xiaoke Pill in Treating Type 2 Diabetes Mellitus with Qi and Yin Deficiency

目的 进一步评价消渴丸治疗气阴两虚证2型糖尿病的疗效和安全性。方法 采用多中心、随机对照的方法,治疗组304例,口服消渴丸,对照组101例,口服格列本脲片。结果 消渴丸治疗气阴两虚的中医症状疗效,显效率为45.07％,有效率为48.68％,与格列本脲片对照组比较,有显著性的差异(P<0.01)。结论 消渴丸的降糖效果与格列本脲片相当,对糖尿病受试者气阴两虚症状的改善优于格列本脲片。

Objective To further assess the therapeutic effect and safety of Xiaoke Pill (XP) in treating type 2 diabetes mellitus with qi and yin deficiency. Methods A multicentre randomized controlled trial was adopted. Three hundred and four cases were treated with XP and one hundred and one cases treated with glibenclamide troche served as control. Results In XP treatment group, the remarkably effective rate in relieving symptoms was 45. 07 % and the effective rate was 48. 68 % , the differences being significant as compared with that in the control group ( P < 0. 01) . Conclusion The effect of XP in decreasing blood sugar level is similar to glibenclamide troche and is superior in relieving the symptoms of type 2 diabetes mellitus with qi and yin deficiency.