| With the constant improvement of the social economic, modern lifestyle also obvious changes, the incidence of diabetes increased year by year. It brought about the great vessels and microvascular complications, which affect the patient’s psychological and physiological seriously. Diabetic retinopathy, as one of the microvascular lesions, can lead to blindness. So in the early treatment can make the visual acuity stable. Western medicine in early treatment can use drugs or laser photocoagulation treatment, but the effect is not exact, and will bring certain side effects; Traditional Chinese medicine in the non-proliferation period the prevention and treatment is a big advantage.Objective:To observe the effect of ShuHe capsules on treating the syndrome of GanPiBuHe partial wet side hot constitution of non-proliferative diabetic retinopathy through the randomized controlled clinical trial. The effect of ShuHe capsules on blood glucose, HbAlc, visual acuity, clinical symptoms of patients with non-proliferative diabetic retinopathy will be evaluated.Method:This subject adopts the prospective randomized single-blind controlled clinical research method, according to the proposed admission criteria and exclusion criteria to select a total of43patients who from GuangDong Second Provincial Traditional Chinese Medicine Hospital in2013.03to2014.03included ithe inpatients and outpatients. Using SAS9.2version statistical software to form a set of random Numbers, the subjects were randomly classified as treatment group and control group, treatment group (22cases)and control group (21cases), in the case of strictly controling the blood glucose, blood pressure. The treatment group take Shuhe capsule but not the control group. Main outcome indicators cover the vision and Fundus situation; Secondary indicators include the blood glucose, blood fat and Symptoms of Chinese medicine, At the same time the liver and kidney function also are observed. Within the12weeks Observation, use the above two groups before and after treatment index data for statistical analysis.Results:(1)Contrasting the treatment group before and after treatment, the visual acuity was statistically significant (P<0.05), suggests that the treatment group can improve the eyesight of patients with NPDR. After the treatment, comparison between groups was statistically significant (P<0.05), the treatment group improving eyesight was better than that of control group (p<0.05);(2)Contrasting the total effective rate, the DM course≤5years was higher than that of DM course>5years, p<0.05, the difference was statistically significant, in the treatment group, the curative effect of the DM course≤5years was better than DM course>5years;(3) The fundus curative effect, micro hemangioma, eyeground hemorrhage absorption area, the macular area fluorescence leakage, after treatment between the two way compared with significant difference (p<0.05), the treatment group in improving fundus disease curative effect is superior to the control group;(4)Improve TCM symptoms in treatment group is better than that of control group (p<0.05);(5)Two groups of their contrast before and after treatment was statistically significant (p<0.05) on the blood glucose, HbAlc, indicates that both treatments can improve blood sugar levels;compared the two groups after treatment was significant difference (p<0.01), the treatment group improving the blood glucose, HbAlc was better than that of control group;(6)The comparison of blood fat, contrast treatment group before and after treatment was statistically significant (P<0.05), treatment group TC levels lower than the control group after treatment (P<0.05), indicating that the treatment group improved the TC level obviously.Conclusion:From the preliminary clinical research results show that the ShuHe capsule can be improved the syndrome of GanPiBuHe partial wet side hot constitution of patients with NPDR of eyesight, delay the fundus lesions, and also blood sugar, glycosylated hemoglobin, blood lipid, still can improve relieve symptoms of traditional Chinese medicine side which effect is outstanding, indicating that ShuHe is safe and effective treatment of non-proliferative diabetic retinopathy. |