雷珠单抗联合复方血栓通与单独雷珠单抗治疗渗出老年性黄斑变性的前瞻性随机对照试验研究

Combined Ranibizumab with Fufang Xueshuantong Capsule Vesus Ranibizumab Alone for the Treatment of Exudative Age-related Macular Degeneration: a Prospective Randomized Controlled Pilot Study

目的:探讨复方血栓通(cFXST)对玻璃体腔注射雷珠单抗(IVR)治疗湿性老年性黄斑变性(wet-AMD)的辅助治疗作用。方法:纳入湿性老年性黄斑变性患者38例,以1:1的比例随机纳入Lucentis组(单独玻璃体腔注射雷珠单抗,19例)和cFXST组(玻璃体腔注射雷珠单抗联合复方血栓通,19例)。Lucentis组患者每月行玻璃体腔注射雷珠单抗(IVR),共计3次;cFXST组患者除IVR外,每日口服cFXST。分别在基线、玻璃体腔注射Lucentis后1个月、3个月记录最佳矫正视力(BCVA)和光学相干断层扫描(OCT)影像上视网膜新生血干至色素上皮下厚度(CNV-PED)。结果:cFXST组CNV-PED厚度在1月和3月分别降低31.7%和36.1%,高于Lucentis组的19.7%(P=0.021)、24.2%(P=0.018)。3个月后,cFXST组BCVA变化(P=0.045)及视力提高显著的患者比例(16/16 vs 8/17,P=0.001)明显高于Lucentis组。结论:每日口服cFXST治疗可提高抗VEGF治疗老年wet-AMD的短期疗效。

Objective: To determine the complementary therapeutic effect of cFXST to intravitreal injection of ranibizumab(IVR)in the treatment of wet-AMD. Methods: A total of 38 patients with wet age-related macular degeneration were included and randomly included in the Lucentis group(19 cases) and the cFXST group(19 cases) at a ratio of 1:1. Patients in Lucentis group received three monthly IVR while patients in cFXST also received daily oral supplementation of cFXST in addition to IVR. Best corrected visual acuity(BCVA) and total centerpoint thickness CNV-pigment epithelial detachment(CNV-PED) complex by optical coherence tomography(OCT) were recorded at baseline and 1 month, and 3 months after first intravitreal injection of Lucentis. Results: Nineteen patients with wet-AMD were allocated in cFXST group and 19 in Lucentis group. In cFXST group, the thickness of CNV-PED reduced by 31.7% and36.1% at Month 1 and Month 3, respectively, higher than 19.7%(P=0.021), 24.2%(P=0.018) in Lucentis group. The BCVA increase of cFXST group after 3 months was significantly higher than that of Lucentis group(P=0.045) and the proportion of patients with functional response was also higher in cFXST group after 3 months(16/16 vs 8/17, P=0.001). Conclusions: Adjunctive daily oral cFXST might be capable to increase the short-time effectiveness of anti-VEGF therapy.