加减和血明目方联合抗VEGF治疗非急性期湿性年龄相关性黄斑病变的临床观察

The Clinical Observation of Combined Treatment with Jia Jian He Xue Ming Mu Fang and Anti-VEGF Therapy for Non-Acute Wet Age-Related Macular Degeneration

摘要: 背景：年龄相关性黄斑变性(AMD)，特别是新生血管性(湿性) AMD (nAMD)，是老年人视力丧失的主要原因。传统的抗VEGF疗法虽然有效，但存在治疗费用高、周期长和侵入性操作等问题。本研究探讨了中药方剂加减和血明目方联合抗VEGF药物雷珠单抗治疗非急性湿性AMD的疗效。方法：66例nAMD患者被随机分为两组：单药治疗组(仅使用雷珠单抗)和联合治疗组(雷珠单抗联合口服加减和血明目方)。主要观察指标包括最佳矫正视力(BCVA)和中心凹视网膜厚度(CMT)，分别在治疗前及治疗后1、2、3个月进行测量。通过BCVA改善和CMT减少情况评估疗效，并进行统计学比较。结果：两组治疗后BCVA和CMT均显著改善。然而，联合治疗组表现出更显著的CMT降低(107.1 μm vs. 82.3 μm)和持续至3个月的BCVA改善(P = 0.021)。尽管两组总体疗效无显著差异，但联合治疗显示出在增强抗VEGF治疗效果方面的潜在益处，特别是在视网膜微循环和水肿减轻方面。结论：加减和血明目方联合雷珠单抗治疗非急性湿性AMD显示出良好的疗效，在减少视网膜厚度和改善视功能方面具有增强效果。这种中西医结合的治疗方法可能通过整合传统中药与现代抗VEGF疗法，为改善患者预后提供新选择。需要更大样本量和更长随访期的研究来证实这些发现。

Abstract: Background: Age-related macular degeneration (AMD), especially the neovascular form (nAMD), is a leading cause of vision loss in the elderly. Traditional anti-VEGF therapies, although effective, involve high costs, long treatment cycles, and invasive procedures. This study explores the efficacy of combining Jia Jian He Xue Ming Mu Fang, a Traditional Chinese Medicine (TCM) formula, with Ranibizumab, an anti-VEGF drug, for treating non-acute wet AMD. Methods: Sixty-six patients with nAMD (disease duration > 3 months) were randomly assigned to two groups: a monotherapy group (Ranibizumab alone) and a combined therapy group (Ranibizumab with oral Jia Jian He Xue Ming Mu Fang). The primary outcomes included Best Corrected Visual Acuity (BCVA) and Central Macular Thickness (CMT), measured before treatment and at 1, 2, and 3 months after treatment. Efficacy was assessed using improvement in BCVA and reduction in CMT, alongside statistical comparisons. Results: Both groups showed significant improvements in BCVA and CMT after treatment. However, the combined therapy group demonstrated a more significant reduction in CMT (107.1 μm vs. 82.3 μm) and continuous improvement in BCVA up to 3 months (P = 0.021). Despite no significant differences in the overall efficacy between the two groups, the combined therapy suggested potential benefits in enhancing the therapeutic effects of anti-VEGF treatment, particularly in retinal microcirculation and edema reduction. Conclusion: The combination of Jia Jian He Xue Ming Mu Fang and Ranibizumab in treating non-acute wet AMD demonstrates promising results, with enhanced efficacy in reducing retinal thickness and improving visual function. This treatment approach could provide a synergistic benefit by integrating traditional Chinese medicine with modern anti-VEGF therapy, offering an alternative to improve patient outcomes. Further studies with larger sample sizes and longer follow-up are needed to confirm these findings.