目的：蒙药明目十一味丸联合康柏西普治疗湿性年龄相关性黄斑变性(wARMD)的临床疗效。

方法：前瞻性研究。纳入2020-11/2021-12内蒙古民族大学附属医院眼科收治的wARMD患者72例72眼。随机分成两组：对照组36眼每月行玻璃体腔注射康柏西普0.05 mL，连续3 mo； 联合治疗组36眼在对照组基础上给予明目十一味丸(2次/日，15粒/次，3 wk为1个疗程，共3个疗程)。观察两组患者治疗前后最佳矫正视力(BCVA)、黄斑区视网膜中央厚度变化(CMT)及N1、P1波振幅密度及潜伏期的变化。

结果：治疗后3、5 mo两组患者BCVA(字母数)均较治疗前改善(P<0.05)，CMT均较治疗前降低(P<0.05)。联合治疗组BCVA(字母数)治疗后3 mo(17.42±3.29 vs 14.61±3.14，P<0.001)、治疗后5 mo(19.75±3.25 vs 16.81±2.77，P<0.001)改善情况优于对照组； 联合治疗组CMT治疗后3 mo(304.58±53.34 vs 351.94±52.99 μm，P<0.001)、治疗后5 mo(274.17±62.26 vs 321.78±63.22 μm，P<0.05)均低于对照组。治疗后3 mo N1、P1波r1-r3振幅密度均高于治疗前(P<0.05)，P1波 r1-r3潜伏期较治疗前缩短(P<0.05)，N1波r1-r3潜伏期较治疗前无差异(P>0.05)，联合治疗组治疗后3 mo N1、P1波振幅密度均高于对照组(P<0.05)， P1波r1-r3潜伏期较对照组均缩短(P<0.05)， N1波r1-r3潜伏期较对照组无差异(P>0.05)。

结论：明目十一味丸联合玻璃体腔注射康柏西普治疗wARMD在改善视力和降低黄斑水肿方面具有明显疗效。

METHODS: Prospective study. All cases in this study were wARMD patients(72 cases, 72 eyes)admitted to the Ophthalmology Department of Affiliated Hospital of Inner Mongolia University from November 2020 to December 2021. They were randomly divided into a combined treatment group and a control group, each with 36 eyes, and the control group received intravitreal injection of conbercept 0.05 mL for 3 consecutive months. The combined treatment group was given Mingmu-11 Pills twice a day after surgery, with 3 wk as a course of treatment, a total of 3 courses, and the control group was not given Mongolian medicine treatment. The best corrected visual acuity(BCVA), changes in central macular thickness(CMT)in the macular area, and changes in N1, P1 wave amplitude density and latency were observed after treatment in both groups.

RESULTS:The BCVA(letter number)of the two groups were improved(P<0.05), and the CMT were decreased(P<0.05). The improvement of BCVA(letter number)in the combined treatment group was better than that in the control group at 3 mo(17.42±3.29 vs 14.61±3.14, P<0.001)and 5 mo(19.75±3.25 vs 16.81±2.77, P<0.001)after treatment; compared with the control group, CMT of the combined treatment group was thinner than that of the control group at 3 mo(304.58±53.34 vs 351.94±52.99 μm, P<0.001)and 5 mo(274.17±62.26 vs 321.78±63.22 μm, P<0.05)after treatment. The amplitude density of N1 and P1 wave in mfERG in both groups at 3 mo after treatment was higher than that before treatment(P<0.05), and r1-r3 latency of P1 wave was shorter than that before treatment(P<0.05), with no differences in the r1-r3 latency of N1 wave(P>0.05). In addition, the amplitude density of N1 and P1 wave in the combined treatment group was higher than that in the control group at 3 mo after treatment(P<0.05), the latency of P1 wave in the treatment group was significantly shorter than that in the control group(P<0.05), and there was no significant difference in the latency of N1 wave between the two groups(P>0.05).

CONCLUSIONS:Mingmu-11 Pills combined with intravitreal injection of conbercept in the treatment of wARMD has obvious efficacy in improving vision and reducing macular edema.