Clinical Study Of Qi Kwai Granules In Early Type 2 Diabetic Nephropathy

Objective-In this article, the clinical effect and safety of Qi Kwai Granules in early stage of type 2 diabetic nephropathy is evaluated, the possible mechanism is explored and the index of this Chinese Medicine is verified.Method-A total of 72 patients in early stage of type 2 diabetic nephropathy with deficiency of Qi and Yin, dampness and blood-stasis stagnation Syndrome was measured by a double-blind, randomized, parallel controlled and multi-center clinical trial.31 out of 36 cases finished in experimental group, where 30 out of 36 cases finished in control group. Both groups used basical therapy to reduce the blood glucose (BG) and blood pressure (BP). Additional Qi Kwai Granules, composed of radix astragali, polygoni multiflori and flower of Abelmoschus manihot, were taken by experimental group, where placebo were taken by control group. A continuous treatment of 12 months was used and examined.Observation Index:microalbuminuria (mAlb), cytokine (IL-6, IL-1β,TNF-α), blood glucose (FBG, PBG), blood pressure (SBP, DBP), urinary NAG, urinaryβ2-MG, renal function (BUN, Scr), complete blood count, urinalysis, liver function ALT.Results-the microalbuminuria started to reduce in the second month in the experimental group, and became significance in the sixth month and the twelfth month (P<0.01).The reduction of microalbuminuria were significant different between the experimental group and the control group (P<0.05). The microalbumin to creatinine ratio reduced in the control group but showed no significance (P>0.05).The symptoms of languid and lumbar pain in the experimental group were improved and was significant better than control group (P<0.05). The IL-6 was slightly reduced in the experimental group after treatment, where the value was raised in the control group. There is a significant differences between two groups (P<0.05).Conclusion-Qi Kwai Granules is proved to be useful in reducing the microalbuminuria to the syndrome of deficiency of Qi and Yin, dampness and blood-stasis stagnation in the early type 2 diabetic nephropathy. It can also improve the symptoms of languid and lumbar pain of the patients. The results also show that the Qi Kwai Granules may provide positive effect on the suppression of inflammatory factors.