Compound danshen dripping pills for diabetic retinopathy in patients with type 2 diabetes: A superiority, randomized controlled trial

作者：Xue-Dong An, Guo-Liang Zhang, Yue-Hong Zhang, De Jin, Hangyu Ji, Li-Juan Wei, Ya-Lin He, Yan-Lin Zheng, Du-jun Li, Xingwei Wu, Yuanbin Li, Jian Zhou, Shaojian Tan, Mingchang Zhang, Ke Fan, Shan Lu, Jianpeng Yu, Yu-Liang Wang, Shao-Jun Chen, Qiu-Hong Liu, Ming Jin, Lie Wu, Fengmei Lian, Xiao-Lin Tong · 发表于：World Journal of Diabetes · 年份：2026 · DOI：10.4239/wjd.v17.i3.114002 · 被引用次数：1 · 研究领域：Traditional Chinese Medicine Analysis、Retinal Diseases and Treatments、Berberine and alkaloids research

BACKGROUND Compound danshen dripping pill (CDDP), an approved treatment for non-proliferative diabetic retinopathy (NPDR) in China, has demonstrated potential in both preclinical and clinical studies. However, its efficacy in NPDR has not been validated through large clinical trials. AIM To evaluate the therapeutic efficacy and safety of CDDP in NPDR. METHODS This randomized, placebo-controlled, double-blind, multicenter study included 484 NPDR patients across 16 centers in China from November 2013 to July 2017. Eligible NPDR patients were randomly assigned to the CDDP and placebo groups at a ratio of 3:1. The intervention lasted for 24 weeks. The primary outcome was the overall effective rate of fundus changes at 24 weeks, assessed through retinal microvascular status, the number of hemorrhages, and exudation area. Secondary outcomes included retinopathy severity, traditional Chinese medicine (TCM) symptoms, macular edema, and corrected visual acuity. The full analysis set (FAS) included all enrolled cases who were randomized and administered at least one study drug. RESULTS Of the 484 randomized participants, 483 (362 and 121 in the CDDP and placebo groups, respectively) were included in the FAS. At 24 weeks, the overall effective rate in the CDDP group was 77.07%, significantly higher than 53.72% found in the placebo group (P < 0.001). Results remained consistent after adjusting for central effects and baseline HbA1c. Additionally, CDDP outperformed placebo in improving...