Qi Ming Particle Treatment Of Diabetic Retinopathy Is A Randomized, Positive Control, Multi-center Clinical Study

Purpose: To eveluate the efficacy and safety of the Qi Ming granule(with functions of replenishing qi and producting yin, nourshing liver and kindneys, activating channels of eyes to improve eyesight) for treatment of diabetic retinopathy(DR), and to explore the mechanism of treatment of DR.Methods: There are 360 eyes of 360 patients with DR who were enrolled and treated in the six medical centers with the same inclusion and exclusion criteria, ongoing randomized, Doxium-controlled, parallel eveluation Qi Ming granule versus Doxium(calcium dobesilate).Patients received periodic detailed ophthalmic examinations with color fundus photographs and fundus fluorescein angiography, Oscillatory potentials (OPs) ,and hematoloty/serum chemistry/ urnalysis with hemorheology, urinary albumim excretion rate(UAER), blood routine ,urine routine, hepatorenal function, blood sugar, haemoglobin A1c (%), and general physical examinations with electrocardiograms,and traditional Chinese medicine(TCM) syndrome inquiry and inspection. Patients were treated 3 months in each clincal center and 6months in two of the centers , with follow-up at 1-month intervals.Results (1) Qi Ming granule can improve vision and inhibiting DR lesion growth. The percent of cases of improving ocular manifestation was 66.18% at month 3and 79.49% at month 6 in Qi Ming granule group, statistically superior to doxium for clinical efficacy (P<0.01, P<0.05) . (2) The percent of cases of improving syndrome in TCM was 89.65% at month 3and 94.87% month 6 in Qi Ming granule group, statisticallysuperior to doxium (P<0.01) .(3) The ampoitudes of O3, wabelets of OPs was recovered from baseline statistically at month 3 (P<0.05) . Other ampoitudes of wavelets , summed ampoitudes and each wave in doxium group had no change from baseline statistically at month3.(4) The blood and plasma viscosity,fibrinogen level decreased significantly in Qi Ming granule group and doxium group (P<0.05) .The erythrocyte rigidity index in Qi Ming granule group decreased significantly (P<0.05) .(5) The number of cases UAER was less than 20 u g/min is increased from baseline statistically in Qi Ming granule group (P<0.05).UAER in doxium group had no change from baseline statistically at month 3 and at month 6. (6) The number of cases the erythrocyte rigidity index abnormity was the most, the erythrocyte specific volume was secondary, plasma viscosity and fibrinogen level was the least in patients with DR. (7) The presence of hard exudates for DR was statistically signifecantly associated with the erythrocyte rigidity index (P< 0.05). (8) There was no clinically relevant treatment-related safety issues.Conclusion: (1) Qi Ming granule(with functions of replenishing qi and producting jing, nourshing liver and kindneys, activating channels of eyes to improve eyesight) is clinically efficacious and safe for maintaining vision, preventing lesion growth for I -IIIDR. The numbers of cases(percent) of improving ocular manifestation were 66.18% at month 3 and 79.49%month 6, statistically superior to doxium for clinical efficacy. (2) The blood viscosity increased was mainly affected by the changes of erythrocyte deformability probably. The effect of the plasma viscosity and fibrinogen level was less relatively. The erythrocyte deformability and blood viscosity increased may increase the risk of hard exudates formation and associated vision loss in patients with diabetic retinopathy.