Objective:To evaluate the clinical effects of Ming Mu-11 (MM-11) in the treatment of stage Ⅰ diabetic retinopathy (DR).

Methods:One hundred twenty patients (120 eyes) with stage Ⅰ DR in the Affiliated Hospital of Inner Mongolia University for the Nationalities were selected from July 2016 to March 2017. The 120 eyes with stage Ⅰ DR were divided into two groups: a Mongolian medicine group and a control group (60 eyes each). The control group was treated with calcium dobesilate capsules and the Mongolian medicine group was also treated with MM-11 pills. There were three courses of treatment in total and 28 days in each course. Patients in both groups underwent multifocal electroretinogram (mfERG) and ultra-wide angle fundus photography examinations before and after the treatment. The latencies and amplitudes of the N1 wave and P1 wave were recorded as well as the number of retinal microaneurysms and hemorrhagic spots. Data were analyzed by t-test and Chi-square test.

Results:The results of mfERG were as follows. There were significant differences in the amplitude density values of P1 in the R1-R5 regions before and after treatment ( t _{control group}=66.86, 18.05, 36.33, 47.43, 30.56, P<0.001; t _{mongolian medicine group}=31.52, 54.56, 101.98, 127.02, 45.74, P<0.001). There were significant differences in the amplitude density value of N1 in the R1-R5 regions before and after treatment ( t _{control group}=70.18, 47.02, 78.08, 57.44, 64.51, P<0.001; t _{mongolian medicine group}=46.09, 140.47, 145.14, 50.46, 73.94, P<0.001). Compared to the control group, the amplitude density value differences in the R1-R5 P1 and R1-R3 N1 regions in the Mongolian medicine group were significantly different before and after treatment ( t _P1=8.96, 23.96, 25.10, 28.80, 13.67, P<0.001; t _N1=9.38, 30.34, 52.06, P<0.001). However, there was no significant difference in the amplitude density value in the R4-R5 N1 regions. There was no significant difference in the latency of P1 in the R1-R5 regions before and after treatment. There was no significant difference in the latency of N1 in the R1-R5 regions before and after treatment. The results of fundus color photography were as follows. The difference in microaneurysms and number of bleeding points before and after treatment were statistically significant in the Mongolian medicine group ( t=2.08, P=0.042; t=2.07, P=0.043). The effective rates of the eye fundus photography in the Mongolian medicine group and the control group were 88% and 73%, respectively, which were analyzed by a chi-square test. The difference was statistically significant ( χ ²=4.36, P=0.037).

Conclusions:MM-11 is very effective for treating the damage of retinal functions in stage Ⅰ DR and therefore can be considered as a drug for routine use.