Pan Hai-Tao, Wang Jun-Jun, Huang Jun-Long, Shuai Yuan-Lu, Li Jia, Hu Zi-Zhong, Ding Yu-Zhi, Liu Qing-Huai
Department of Ophthalmology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Department of Cadre Health Care, Jinling Hospital of Nanjing Medical University, Nanjing, China.
J Int Med Res. 2020 Sep;48(9):300060520931618. doi: 10.1177/0300060520931618.
To compare the efficacy of ranibizumab plus fufang xueshuantong capsule (cFXST) with the efficacy of ranibizumab alone in treatment of exudative age-related macular degeneration.
This prospective, randomized, controlled, pilot study included 38 eyes from 38 patients with exudative age-related macular degeneration (AMD) that were randomly allocated into two cohorts of 19 eyes each: ranibizumab (C) and ranibizumab plus cFXST (C). All patients received three monthly injections of ranibizumab. Patients in C also received daily oral supplementation of cFXST. Best corrected visual acuity (BCVA) and thickness of the choroidal neovascularization-pigment epithelial detachment (CNV-PED) complex (measured by optical coherence tomography) were recorded at baseline and at 1 and 3 months after the first intravitreal injection of ranibizumab.
In the C, the CNV-PED complex thickness was reduced by 31.7% and 36.1% at 1 and 3 months, respectively; these reductions were significantly greater than the 19.7% and 24.2% reductions in the C. BCVA improvement was significantly greater in the C than in the C after 3 months; the proportion of patients with functional response was also greater in the C than in the C (16/16 vs. 8/17).
Oral cFXST increases the efficacy of short-term ranibizumab treatment for exudative AMD.
比较雷珠单抗联合复方血栓通胶囊(cFXST)与单纯雷珠单抗治疗渗出性年龄相关性黄斑变性的疗效。
这项前瞻性、随机、对照、试点研究纳入了38例渗出性年龄相关性黄斑变性(AMD)患者的38只眼,随机分为两组,每组19只眼:雷珠单抗组(C)和雷珠单抗联合cFXST组(C)。所有患者均接受每月3次的雷珠单抗注射。C组患者还每日口服cFXST。在基线以及首次玻璃体内注射雷珠单抗后1个月和3个月时,记录最佳矫正视力(BCVA)和脉络膜新生血管-色素上皮脱离(CNV-PED)复合体的厚度(通过光学相干断层扫描测量)。
在C组中,CNV-PED复合体厚度在1个月和3个月时分别降低了31.7%和36.1%;这些降低幅度显著大于C组的19.7%和24.2%。3个月后,C组的BCVA改善程度显著大于C组;C组功能反应患者的比例也高于C组(16/16对8/17)。
口服cFXST可提高雷珠单抗短期治疗渗出性AMD的疗效。