| Objective: To evaluate the clinical efficacy and safety of keluoxin collocystis in treatment of Nonproliferative diabetic retinopathy(qi and Yin deficiency and blood stasis)Methods: All cases of this clinical study screen set the patient of Wuhan General Hospital Of Guangzhou Command ophthalmology clinic and endocrinology inpatient between December 2013 and November 2014,a total of 47 cases.All screening qualified subjects in maintaining the original hypoglycemic therapy on the basis of random divided into two groups. Treatment group(24 cases) oral keluoxin collocystis. The control group(23 cases) in patients with a placebo treatment. Two groups of patients with continuous medication for 24 weeks.Assessing indicators such as vision, ophthalmic imaging, scores of traditional Chinese medicine and security at the end of the week 24. The main evaluation goal:(1) Evaluate the change of retinal hemorrhage score;(2) Evaluate the change of vascular leakage area. Secondary goals:(1) Evaluate best corrected visual acuity(BCVA) a baseline change situation;(2) Evaluation of micro hemangioma, rigid, soft oozy and macular edema imaging index; in the case of a change;(3)Assess grading score a baseline change in diabetic retinopathy;(4) Evaluation of traditional Chinese medicine syndrome score from baseline to change;(5) Evaluation sugar net patients accept thirsty collaterals xin capsule safety after treatment.Line with SPSS20.0 software statistical processing in the experiments, the application of two independent samples to compare the rank and inspection. Two groups(P > 0.05) said there was no evident difference data statistics,(P < 0.05)said data are statistically significant differences in the two groups.Results:(1)The clinical studies were screened subjects met diagnostic criteria of 47 cases related to the treatment group of 24 patients in the control group of 23 patients.The treatment group fall off in 1 case, actually completed the test cases for 46 cases of patients。(2)Treatment group 14 males and 10 females, age range is between 37 to 67 years, with an average of 54.75 years; diabetes duration ranging from 2 months to 19 years, an average of 10.13 years.In the control group, 14 cases of male patients, female patients nine cases, the age range of 40 to 67 years, an average of 55.17 years; duration ranges 0.5 to 20 years, the average of 9.89 years.Through statistical analysis showed no significant difference between both groups in gender, age, duration.The two groups were comparable。(3)After 24 weeks of intervention,treatment group to improve vision, lower blood sugar, reduce the number of capillary hemangioma, reducing vascular leakage range compared with the control group were statistically significant differences.(p<0.05).(4)For TCM symptom score, the total effective rate of treatment group 86.96%, while the total effective rate of the control group 17.40%. Comparison of efficacy between the two groups appear significant.(5)Serology,treatment group in reducing gly- cated hemoglobin, glucose, LDL have difference compared with the control groups.(p<0.05).(6)The course of treatment, 3 patients of the treatment group had mild diarrhea, and 3 patients hypoglycemia. Other patients and the control group patients had no adverse events occurred within the group.Conclusions:Keluoxin has effects of supplementing Qi and nourishing Yin, nourishing the liver and kidney, blood circulation and removing blood stasis,Yijing Mingmu. For the treatment of Nonproliferative diabetic retinopathy(qi and Yin deficiency and blood stasis) has a certain effect. It can improve local symptoms to some extent, such as to improve vision, reduce eye retinal microvascular changes in the test, reducing macular edema, it can also improve the performance of patients with systemic Qi, blood stasis syndrome symptoms. Adverse smaller, with relatively good efficacy and safety. |
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