Liu Jiarui, Huang Yufan, Dong Zongyu, Qian Chen, Huang Binglin
College of Clinical Medical, Jiangxi University of Chinese Medicine, Jiangxi, Nanchang Province, China.
The First Clinical Medical College, Guangzhou University of Chinese Medicine, Guangdong, Guangzhou Province, China.
Medicine (Baltimore). 2025 Sep 12;104(37):e44426. doi: 10.1097/MD.0000000000044426.
This study systematically reviews the clinical efficacy and safety of traditional Chinese medicine (TCM) in the treatment of age-related macular degeneration (AMD), assesses the quality of evidence, and verifies the credibility of the research findings.
Literature on TCM treatment for AMD was retrieved from PUBMED, Cochrane, Embase, China National Knowledge Infrastructure, SINOMED, Wanfang, and Technology Periodical Database (VIP) from inception to January 17, 2025. The selected literature was screened, data extracted, and evaluated. Meta-analysis was conducted using Review Manager 5.3, trial sequential analysis (TSA) using TSA v0.9 software, and grading of recommendations, assessment, development and evaluation evidence quality rating using.
A total of 52 randomized controlled trials were included. Meta-analysis results showed that the experimental group demonstrated better clinical efficacy compared with the control group (risk ratio [RR] = 1.24, 95% confidence interval [CI]: 1.19-1.29, P < .00001), lower recurrence rates (RR = 0.35, 95% CI: 0.21-0.57, P < .0001), and improvements in central macular thickness (weighted mean difference = 0.79, 95% CI: -0.86 to -0.71, P < .00001) and best-corrected visual acuity (weighted mean difference = -0.76, 95% CI: -1.01 to -0.52), P < .00001). TSA further confirmed the efficacy of TCM in treating AMD. The grading of recommendations, assessment, development and evaluation evidence quality rating indicated that recurrence rates and best-corrected visual acuity (early treatment diabetic retinopathy study) were of very low-quality evidence, while other outcomes were of low-quality evidence.
TCM is safe and effective in the treatment of AMD, but additional high-quality clinical studies are necessary to further verify the results.
本研究系统评价了中药治疗年龄相关性黄斑变性(AMD)的临床疗效和安全性,评估证据质量,并验证研究结果的可信度。
从创刊至2025年1月17日,在PUBMED、Cochrane、Embase、中国知网、中国生物医学文献数据库、万方数据库和维普资讯网检索关于中药治疗AMD的文献。对入选文献进行筛选、数据提取和评估。使用Review Manager 5.3进行荟萃分析,使用TSA v0.9软件进行试验序贯分析(TSA),并使用推荐分级、评估、制定与评价证据质量等级进行评价。
共纳入52项随机对照试验。荟萃分析结果显示,与对照组相比,试验组临床疗效更好(风险比[RR]=1.24,95%置信区间[CI]:1.19-1.29,P<.00001),复发率更低(RR=0.35,95%CI:0.21-0.57,P<.0001),中心黄斑厚度改善(加权均数差=0.79,95%CI:-0.86至-0.71,P<.00001),最佳矫正视力改善(加权均数差=-0.76,95%CI:-1.01至-0.52),P<.00001。TSA进一步证实了中药治疗AMD的疗效。推荐分级、评估、制定与评价证据质量等级表明,复发率和最佳矫正视力(早期糖尿病视网膜病变研究)的证据质量极低,而其他结局的证据质量低。
中药治疗AMD安全有效,但需要更多高质量的临床研究进一步验证结果。