Qi Ming Treatment Of Moderate To Severe Non-proliferative Diabetic Retinopathy Study

Objective:To evaluate the particle Qi Ming (traditional Chinese medicine integrated control program intervention group) of diabetic retinopathy to reduce the incidence of proliferative lesions, reduce the rate of retinal photocoagulation therapy, moderate visual loss (MVL) and Sustained moderate visual loss (SMVL) of the intervention effect Eventually form a highly efficient, optimized, easy application, easy to promote the comprehensive treatment program of Integrative Medicine.Methods:This clinical study was a multicenter,randomized,double-blind, placebo-controlled,parallel group design.This unit is sub-centers. By the development of inclusion and exclusion criteria included type 2 diabetes and severe non-proliferative and early proliferative diabetic retinopathy,card is Qi Yin deficiency, liver and kidney deficiency, currently a total of 28 cases of stasis network,randomized 1:1 For the two groups.Study Group (traditional Chinese medicine integrated control program intervention group) Treated by Qi Ming,the control group treated with simulated Qi Ming particles.Efficacy endpoint was the incidence of the primary end point,both proliferative diabetic retinopathy and retinal diseases incidence rate of primary endpoint photocoagulation treatment;addition to vision loss,retinal microvascular disease and macular edema is a secondary target.Observe the course of 12 months,followed up for 6 months.While observing the effects of TCM and other indicators as well as blood,urine,then normal,electrocardiogram,liver and kidney function and other safety indicators.Results:In the center of cases,28 cases were included,off 2 cases,of which 13 patients A, B group 13 patients. A, B group included general information and when the degree of retinopathy.There was no significant difference,P>0.05,two sets of data comparable. Preliminary statistics from the view,A, Bgroup (study did not end,not exposing the blind) are no end of events,neither of diabetes retinopathy proliferative lesions,and moderate visual loss (MVL) and the continuous loss of visual acuity (SMVL),has no adverse reactions.A group after treatment,the mean visual acuity improved by a statistically significant difference,P<0.05.Group B although the visual acuity improved after treatment,but by statistical studies, no significant difference,P>0.05. Between the two groups,A group was better than B group,A group visual acuity improved significantly higher than that of B group,P<0.05.A visual acuity improved in 6 cases,efficiency48%;B group vision improved in 1 case,for example,0.8% efficiency.Were compared before and after treatment level of retinal microvascular disease and macular edema score,A group after treatment,degree of retinal microvascular disease and macular edema score was significantly decreased,the statistically significant difference,P<0.05.B group after treatment level of retinal microvascular disease and macular edema score has decreased, there were statistically significant differences in study,P<0.05.However,after between the two groups,A group was better than B group,A group of retinal microvascular lesions and macular edema improved significantly higher,P<0.05.At present,because the shorter observation time,before the end of follow-up period and small number of cases observed,nor unblinding,the Qi Ming granule on pending end of the experiment,and then further statistics on its efficacy.Conclusion:(Set A group for the treatment group) particles with Qi Ming Sheng Jin, nourish liver and kidney meridians eyesight of the effect,for the treatment of diabetic retinopathy card is Qi Yin deficiency,liver and kidney deficiency,stasis target network Patients with a certain effect,to a certain extent,improve visual acuity,diabetic retinopathy,the incidence of proliferative lesions,reduce the rate of retinal photocoagulation therapy,and the role of moderate vision loss,to a certain extent,there is the role of microcirculation.Observation of current clinical treatment of diabetic retinopathy has not yet appeared proliferative lesions, and moderate visual loss (MVL) and continued vision loss (SMVL) and other end point,to be the whole end of the study, then a further judgments.The course of the study no adverse reactions.(Set B group for the treatment group) Qi Ming particles then for moderate to severe non-proliferative and proliferative diabetic retinopathy early treatment failure.