| Objective:1.To study the changes in retinal vascular calibers in microangiopathy complications of diabetes (MCD), and their correlation with MCD;2.To study the effect of Qi Ming granule intervention in patients with diabetic retinopathy (DR) complicated with diabetic kidney disease (DKD) with retinal vascular caliber and other related indicators.Methods:1.A multi-center clinical trial was conducted, normal subjects, DR and DKD patients were included and grouped into normal group, DR group and DKD group, with the sample size of 50,54 and 65 cases respectively. With the information of retinal vascular caliber extracted by image software according to the fudus camera, we compared the difference of the three groups of retinal vascular calibers and analyzed their correlation with MCD.2.A randomized, multi-center, parallel, Ke Luo Xin capsule-controlled, clinical trial was conducted,97 DR with DKD patients were included, and randomly devided into Qi Ming group (50 cases) and Ke Luo Xin group(47 cases). Qi Ming group given Qi Ming granule and Ke Luo Xin group given Ke Luo Xin capsule, were treated for 12 weeks. Blood pressure, fasting blood-glucose(FBG), glycosylated haemoglobin (HbAlc), vision, fundus, urinary albumin/creatinine ratio (ACR), retinal vascular caliber were observed.Results:1. The changes in retinal vascular calibers of MCD(1) Compare the retinal vascular calibers between normal group, DR group and DKD group:① Comparison between DR group and normal group:DR group had increased in the superior temporal, superior quadrants and average vein calibers, decreased in the supratemporal, superior quadrants and average artery to vein ratios, the difference was statistically significant(P<0.05); compared with normal group, DR group in the superior nasal, inferior nasal, superior and inferior quadrants artery calibers had a certain decrease trend, but the difference was not statistically significant (P>0.05).② Comparison between DKD group and normal group:DKD group had decreased in the superior, inferior quadrants and average artery calibers, in the superior temporal quadrant vein calibers increased, the superior temporal, inferior temporal, superior quadrants and average artery to vein ratios decreased, the difference was statistically significant (P< 0.05); compared with normal group, DKD group in the superior temporal, inferior temporal, superior nasal and inferior nasal quadrants artery calibers had a certain decrease trend, and the inferior temporal, inferior quadranst and average vein calibers had a certain increase trend, but the difference was not statistically significant (P>0.05).③ Comparison between DR group and DKD group:in DR group, the vein caliber of the inferior nasal quadrant and the artery caliber of the superior temporal quadrant artery were larger than those of the DKD group, and the difference was statistically significant (P< 0.05); compared with DKD group, DR group in the rest quadrants artery and vein calibers had a certain increase trend, but the difference was not statistically significant (P>0.05).(2) Study the correlation of retinal vascular calibers:① DR group:there was no correlation between retinal vascular caliber and course of diabetes mellitus (DM); the calibers in the inferior temporal, inferior nasal, inferior quadrants and average vein were positively correlated with DR stage (P<0.05), and the artery to vein ratios in the inferior temporal, inferior quadrants negatively correlated with DR stage (P<0.05).② DKD group:the artery to vein ratio in the inferior nasal quadrant negatively correlated with course of DM (P<0.05); the calibers in the inferior temporal quadrant and average vein were positively correlated with DKD stage (P<0.05); the calibers in the superior temporal, inferior nasal, inferior quadrants and average vein positively correlated with ACR (P<0.05).2. Observe the effect of Qi Ming granule in the treatment of DR’DKD(1) There was no significant difference between the treatment of 4 weeks,8 weeks and 12 weeks after and before treatment in the systolic blood pressure, diastolic blood pressure and visual acuity in the two groups (P>0.05).(2) In Qi Ming group after the treatment, the FBG and HbAlc were significantly lower than before treatment, the difference was statistically significant (P<0.05); In Ke Luo Xin group after the treatment, the FBG and HbAlc had a certain decrease trend, but there was no significant difference between before and after treatment (P>0.05).(3) By using computer to analyze the fundus photos, microaneurysm quantity and hemorrhage area after treatment in the two groups was more significantly reduced(P< 0.05). However, there was no significant significance in microaneurysm quantity and hemorrhage area before and after treatment between the two groups (P>0.05); hard exudates area after treatment in Qi Ming groups was more significantly reduced(P<0.05). However, there was no statistically difference in hard exudates area after treatment in Ke Luo Xin group (P>0.05), and there was no statistically difference in hard exudates area before and after treatment between the two groups (P>0.05).(4) After treatment, ACR in the two groups was more significantly reduced (P<0.05). However, there was no significant difference in ACR before and after treatment between the two groups (P>0.05).(5) After treatment, significantly increased in the artery caliber in the inferior quadrant in the two groups (P<0.05), however, there was no significant difference in the artery caliber in the inferior quadrant before and after treatment between the two groups (P>0.05).Conclusion:1.Patients with non-proliferative diabetic retinopathy (NPDR) compared with normal person, artery to vein ratios decreased and retinal vein calibers in the part quadrants increased; the vein calibers were positively correlated with DR stage, and the artery to vein ratios in the part quadrants negatively correlated with DR stage,but there was no correlation between retinal vascular caliber and course of DM.2.Patients with Ⅱ-Ⅳ stage of DKD compared with normal person, retinal artery calibers and artery to vein ratios decreased, and the part quadrants vein calibers increased; the artery to vein ratios in the part quadrants were negatively correlated with course of DM; the vein calibers positively correlated with DKD stage; the vein calibers positively correlated with ACR.3. Patients with Ⅱ-Ⅳ stage of DKD compared with patients with NPDR, both retinal artery and vein calibers in the part quadrants decreased in patients with Ⅱ-Ⅳ stage of DKD.4.Qi Ming granule can effectively reduce FBG and HbAlc, statistically superior to curative effect of Ke Luo Xin capsule.5.By means of the information of fundus disease extracted by image software and quantitative analysis of the lesion by the combined computer, Qi Ming granule can effectively improve the fundus lesions in patients with DR, statistically superior to curative effect of Ke Luo Xin capsule.6. Qi Ming granule can effectively reduce ACR in patients with DKD.7. Qi Ming granule can expand the artery caliber in the inferior quadrant in patients with DR’DKD. |
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