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雷珠单抗联合复方血栓通胶囊与单用雷珠单抗治疗渗出性年龄相关性黄斑变性的对比研究

Ranibizumab plus fufang xueshuantong capsule versus ranibizumab alone for exudative age-related macular degeneration.

作者信息

Pan Hai-Tao, Wang Jun-Jun, Huang Jun-Long, Shuai Yuan-Lu, Li Jia, Hu Zi-Zhong, Ding Yu-Zhi, Liu Qing-Huai

机构信息

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.

出版信息

J Int Med Res. 2020 Sep;48(9):300060520931618. doi: 10.1177/0300060520931618.

Abstract

OBJECTIVE

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.

METHODS

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.

RESULTS

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).

CONCLUSION

Oral cFXST increases the efficacy of short-term ranibizumab treatment for exudative AMD.

摘要

目的

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。

方法

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)。

结果

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)。

结论

口服cFXST可提高雷珠单抗短期治疗渗出性AMD的疗效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0274/7520929/1357277e119b/10.1177_0300060520931618-fig1.jpg

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