Clinical And Experimental Study Of Treating Wet Age-Related Macular Degeneration With Ming Jing Ke Li

Object1.To evaluate the therapeutic effect of modified Ming Jing Ke Li(MJK L), empirical formula of Professor Youzhi Tang on treatment of wet age-rel ated macular degeneration (AMD) through three-months'multicenter,prospect ive and matched pair study, summary the clinical experinece of famous vet eran doctors of Traditional Chinese Medicine, furthermore to investigate t he advantage and mechanism of TCM in treatment of AMD.2. To observe the inhibition effect of Ming Jing Ke Li on the development of experimental CNV induced by laser through means of FFA and blood vessel quantitative analysis of choroidal stretched preparation.Methods1. Matched pair clinical study:120 AMD cases were enrolled in the study according to the enrolled standard. The patients were paired based on their age, course of disease and fundus features,60 cases in each group. The TCM group was treated by modified Ming Jing Ke Li. For patients with fresh hemorrhage, added Sheng Di (rehmannia dride rhizome,生地) and Ce Bai Ye(cacumen biotae,侧柏叶). For cases with macula edema, palpitation and dyspnea, dark red tongue, wiry and unsmooth pulse, added Chuan Xiong (ligusticum chuanxiong hort,川芎) and Di Fu Zi (Fructus Kochiae Scopariae,地肤子). The controlled group was treated by photodynamic therapy (PDT). The treatment course was three months, and follow up was continued for three months after treatment. The observation indexes included corrected visual acuity, area of retinal hemorrhage and exudates, retina thickness and cost of treatment.2. Animal experimental study:10 BN rats were selected randomly from 50 rats as the normal control group. The left 40 rats were induced CNV by laser photo-coagulation with the index of 659nm,350 mw,50 um and 0.05s. The spots were scattered around the disc with one papilla diameter in distance,10 spots in each retina. After photo-coagulation, the 40 mice were divided into 4 groups as model group, low dose MJKL group, medium dose MJKL group, and high dose MJKL group. After 4 weeks'treatment, the mice were examined by fundus colorful photo, FFA and blood vessel quantitative analysis of choroidal stretched preparation.Results1. Clinical Study:After three months'treatment, there were significantly more patients whose visual acuity was improved>2 lines in MJKL group than those of PDT group (P<0.05). However, for the number of eyes with stable visual acuity, there was no significant difference between the two groups. Fundus exudates:the number of eyes in which the area of fundus exudates decreased>75% is significantly higher in the MJKL group than that of PDT group (P<0.05). Retinal hemorrhage:The hemorrhage area was significantly decreased after treatment in the MJKL group (P<0.05), meanwhile, there was no significant difference in PDT group (P>0.05). Retinal thickness:there was no significant difference in both groups before and after treatment. Activity of CNV:there was no significant difference in both groups at the time point of 3 months. However, when observed at 6 months after treatment, it was found that the activity of CNV in MJKL group decreased obviously (P<0.05). Treatment cost:The average cost of MJKL group is 3160.17±1309.34 yuan, while the cost of PDT group is 32349.33±7897.94 yuan, the difference is significant. Follow up:After three months'follow up, it showed that the-average visual acuity of MJKL group is better that of PDT group (P<0.05). There was no obvious complication both in MJKL group and PDT group.2. Experimental study:4 weeks later after laser photocoagulation, CNV areas of the groups were calculated. It was found that the CNV area of medium group was smaller than that of the control group (P<0.05). However, there was no significant difference when low dose MJKL group and high dose MJKL group compared with control group respectively (P>0.05).Conclusion1.MJKL can stabilize the visual acuity of wet AMD patients.2. MJKL can promote absorption of retinal hemorrhage and exudates, thus can improve the patient's syndrome. 3. MJKL can inhibit CNV activity as well as promote CNV shrinkage and scarring.4. The treatment cost by MJKL is much less than by PDT, which is more suitable to China's condition.5. MJKL can inhibit experimental CNV of BN mice. The effect is related with MJKL doses, the medium dose is the best choice.