Clinical Study Of Qidengmingmu Capsule In The Treatment Of Non-proliferative Diabetic Retinopathy

Objective:To preliminarily evaluate the safety and effectiveness of qidengmingmu capsule in treating the diabetic retinopathy (DR)(deficiency of Qi and Yin and syndrome of collateral retardation due to blood stasis), probe into the therapeutic dose and course of treatment, develop a new medicine that can effectively prevent, cure and postpone the development of non-proliferative diabetic retinopathy.Methods:This clinical research was based on parallel controlled trial of multiple doses and placebo. During Sep.2011to Dec.2012,32eyes from the32patients with non-proliferative diabetic retinopathy (NPDR) with the TCM syndromes (deficiency of Qi and Yin and syndrome of collateral retardation due to blood stasis) diagnosed in the Department of Ophthalmology, Jiangsu Province Hospital of Traditional Chinese Medicine were divided into three groups:High dose group (4pieces of qidengmingmu capsule) comprised of11eyes from11patients; Low dose group (2pieces of qidengmingmu capsule+2pieces of simulated capsule) comprised of11eyes from11patients; Placebo group (4pieces of simulated capsule) was composed of10eyes from10patients, administered3times/day. The fundus microangiopathy (fundus fluorescien angiography, FFA) and macular edema (optical coherence tomography, OCT) were the main therapy indexes, corrected visual acuity (CVA) and TCM syndromes were the secondary indexes, and the adverse effects of blood, urine, stool-routine, electrocardiogram, hepatic and renal function, blood sugar and blood lipid were taken as the safety indexes. The course of treatment lasted for12weeks and the follow-up visit for6months.Results:1.32eyes from32patients with NPDR were enrolled in this test. They were divided into three groups:High dose group comprised of11eyes from11patients; Low dose group comprised of11eyes from11patients; Placebo group was composed of10eyes from10patients. Through the comparisons on age, sex, DM course of disease, GLU, HbA1c and other information of the first three recipients as well as their retinopathy degree, there was no significant difference, P>0.05. In the experimental observation process, the recipients of the three groups neither got the proliferative diabetic retinopathy (PDR) nor needed to take the retinal fundus laser photocoagulation treatment.2. In term of TCM symptom score, symptom score of each group was decreased obviously, P<0.01. However, from the perspective of improvements on TCM syndrome, the total effective rate of high dose group and low dose group were respectively72.73%and81.82%, which were superior to that of placebo group (30.00%), P<0.05.3. After the treatment, the vision of patients from both high and low dose groups was improved significantly, and there was also significant statistical difference, P<0.01. There was no obvious statistical difference in the placebo group after treatment, P>0.05. The comparison of vision of patients from both high and low dose groups after treatment showed no obvious difference, P>0.05.4. The retinal capillary non-perfusion area and vascular leakage range were all narrowed after the treatment of patients from high dose group, while the retinal capillary leakage range before and after the treatment had significant statistical difference, P<0.05; The retinal capillary non-perfusion area and vascular leakage range before and after the treatment of patients from the low dose group had significant statistical difference, P<0.05; For the comparison of the retinal capillary non-perfusion area and vascular leakage range before and after the treatment of the placebo group, there was no significant statistical difference, P>0.05.5. After the treatment of the placebo group, there was no significant statistical difference, P>0.05. After comparison, there was no obvious significance between the high dose group and low dose group after the treatment, P>0.05. The CST, CV, CAT of the low dose group after and before treatment are of statistical significance, and the values of CST, CV and CAT after treatment were all decreased, P<0.05. The CST and CAT differences after and before the treatment of patients from high dose group were of statistical significance, the CST and CAT after treatment were all decreased, P<0.05.6. By comparisons after and before the treatment, there was no obvious difference among the recipients of the three groups on GLU (limosis), HbA1C, hepatic and renal function, P>0.05. There was no statistical significance of the difference of blood lipid and other indexes before and after the treatment of patients from the placebo group, P>0.05. For the low dose group after and before the treatment, the CHO, TG, HDL and LDL difference was of statistical significance, P<0.05. And the values of CHO, HDL and LDL after treatment were all somewhat reduced, while the value of HDL was increased. The difference of CHO and LDL after and before treatment of the high dose group was of statistical significance, P<0.05. And the values of CHO and LDL after treatment were decreased.Conclusion:Qidengmingmu capsule can be applied in tonifying Qi and nourishing Yin. Its high dose and low dose all can be used for treating the patients with the mediate and severe NPDR-deficiency of Qi and Yin and syndrome of collateral retardation due to blood stasis, and certain curative effect can be achieved. It can improve the symptoms and vision to a certain extent, alleviate the fundus retinal microangiopathy and macular edema, reduce the retina thickness of macular region, and also can somehow regulate blood lipids. No adverse effects with respect to PDR during the trial process were occurred, showing that the qidengmingmu capsule is a kind of Chinese patent drug that can safely and effectively be used for treating patients with DR. For there is few sample volume and short observation period in this experiment and also part of patients were still in the period of follow-up visits, the most appropriate dosage and course of treatment need to be further studied.