一种新的血管性年龄相关性黄斑变性的中成药ZQMT：多中心随机临床试验

Title:A Traditional Chinese Patent Medicine ZQMT for Neovascular Age- Related Macular Degeneration: A Multicenter Randomized Clinical Trial

Volume: 18 Issue: 9

关键词: 年龄相关性黄斑变性，中医，临床试验

摘要: Background: Anti-VEGF agent ranibizumab has been extensively used as a standard treatment for wet AMD. We investigated whether traditional Chinese medicine could serve as a complementary therapy for this disease.

Methods: 144 patients with neovascular age-related macular degeneration received either intravitreal ranibizumab treatment as needed plus placebo or intravitreal ranibizumab treatment as needed plus an FDA approved traditional Chinese patent medicine named ZQMT. Both groups received treatment for 24 weeks. The primary outcome was the mean change of visual acuity at week 24 as compared to the baseline.

Results: We found that intravitreal ranibizumab treatment plus ZQMT was non-inferior to the treatment with intravitreal ranibizumab alone in improving visual acuity scores at week 24 with patients in both groups who gained substantial numbers of letters. In addition, we found that ZQMT treatment resulted in significant improvements in reducing retinal hemorrhage, fluid, and lesion size. Importantly, administration of ZQMT reduced the number of needed ranibizumab injections (P<0.0001, analysis of variance) in wet AMD patients leading to a significant reduction of drug cost.

Conclusion: The combinatory therapy of ranibizumab and traditional Chinese patent medicine ZQMT had equivalent effects on visual acuity improvement and safety profiles as the ranibizumab treatment alone. Ranibizumab injections coupled with ZQMT offer therapeutic advantages in terms of reduction of retinal lesions and ease the financial burden of patients undergoing treatment by reducing the frequency of necessary ranibizumab injections.

Cite this article as:

A Traditional Chinese Patent Medicine ZQMT for Neovascular Age- Related Macular Degeneration: A Multicenter Randomized Clinical Trial, Current Molecular Medicine 2018; 18 (9) . https://dx.doi.org/10.2174/1566524019666190107155311