Table_1_The comparative effects of oral Chinese patent medicines in non-proliferative diabetic retinopathy: A Bayesian network meta-analysis of randomized controlled trials.docx

BackgroundNon-proliferative diabetic retinopathy (NPDR), a common diabetic complication with high morbidity, is featured by impaired visual function and fundus lesions. It has been reported that oral Chinese patent medicines (OCPMs) may improve visual acuity and fund signs. However, the best possible OCPMs for NPDR remain questionable and merit further investigation.
MethodsFrom inception to October 20, 2022, seven databases were searched for eligible randomized controlled trials (RCTs). The outcomes were clinical effective rate, visual acuity, visual field gray value, microaneurysm volume, hemorrhage area, macular thickness, and adverse events rate. The revised Cochrane risk-of-bias tool (ROB 2) was used to assess the quality of the included studies. Network meta-analysis was performed using R 4.1.3 and STATA 15.0 software.
ResultsWe included 42 RCTs with 4,858 patients (5,978 eyes). The Compound Danshen Dripping Pill (CDDP) combined with calcium dobesilate (CD) had the most improvement in clinical efficacy rate (SUCRA, 88.58%). The Compound Xueshuantong Capsule (CXC) combined with CD may be the best intervention (SUCRA, 98.51%) for the improvement of visual acuity. CDDP alone may be the most effective treatment option (SUCRA, 91.83%) for improving visual field gray value. The Hexuemingmu Tablet (HXMMT) and Shuangdan Mingmu Capsule (SDMMC) combined with CD may be the most effective treatment for reducing microaneurysm volume and hemorrhage area (SUCRA, 94.48%, and 86.24%), respectively. Referring to reducing macular thickness, CXC combined with CD ranked first (SUCRA, 86.23%). Moreover, all OCPMs did not cause serious adverse reactions.
ConclusionOCPMs are effective and safe for NPDR. CDDP alone, and combined with CD, may be the most effective in improving visual field gray value and clinical efficacy rate, respectively; CXC combined with CD may be the best in enhancing BCVA and reducing macular thickness; HXMMT and SDMMC combined with CD, maybe the most effective regarding microaneurysm volume and hemorrhage area, respectively. However, the reporting of methodology in the primary study is poor, potential biases may exist when synthesizing evidence and interpreting the results. The current findings need to be confirmed by more large-sample, double-blind, multi-center RCTs of rigorous design and robust methods in the future.
Systematic review registrationhttps://www.crd.york.ac.uk/prospero/, identifier CRD42022367867.

背景 非增殖性糖尿病视网膜病变（Non-proliferative diabetic retinopathy, NPDR）是一种发病率较高的常见糖尿病并发症，以视觉功能受损及眼底病变为主要特征。已有研究表明，口服中成药（oral Chinese patent medicines, OCPMs）可改善患者视力与眼底体征，但目前针对NPDR的最优口服中成药仍不明确，有待进一步探索。
方法 检索自建库至2022年10月20日的7个数据库，筛选符合纳入标准的随机对照试验（randomized controlled trials, RCTs）。本次研究的结局指标包括临床有效率、视力、视野灰度值、微动脉瘤体积、出血面积、黄斑厚度及不良事件发生率。采用修订版Cochrane偏倚风险评估工具（revised Cochrane risk-of-bias tool, ROB 2）评价纳入研究的方法学质量，使用R 4.1.3与STATA 15.0软件开展网状Meta分析。
结果 共纳入42项随机对照试验，涉及4858例患者（共计5978只患眼）。其中，复方丹参滴丸（Compound Danshen Dripping Pill, CDDP）联合羟苯磺酸钙（calcium dobesilate, CD）在提升临床有效率方面效果最优（累积排序曲线下面积，surface under the cumulative ranking, SUCRA=88.58%）；复方血栓通胶囊（Compound Xueshuantong Capsule, CXC）联合CD在改善视力方面或为最佳干预方案（SUCRA=98.51%）；单用复方丹参滴丸是改善视野灰度值的最有效治疗选择（SUCRA=91.83%）；和血明目片（Hexuemingmu Tablet, HXMMT）联合CD、双丹明目胶囊（Shuangdan Mingmu Capsule, SDMMC）联合CD分别为降低微动脉瘤体积（SUCRA=94.48%）与减少出血面积（SUCRA=86.24%）的最优方案；针对降低黄斑厚度，复方血栓通胶囊联合CD排名首位（SUCRA=86.23%）。此外，所有口服中成药均未引发严重不良反应。
结论 口服中成药用于治疗非增殖性糖尿病视网膜病变安全有效。单用复方丹参滴丸、复方丹参滴丸联合羟苯磺酸钙分别为改善视野灰度值与提升临床有效率的最优方案；复方血栓通胶囊联合羟苯磺酸钙或为提升最佳矫正视力（best corrected visual acuity, BCVA）及降低黄斑厚度的最佳方案；和血明目片联合羟苯磺酸钙、双丹明目胶囊联合羟苯磺酸钙分别在降低微动脉瘤体积与减少出血面积方面效果最优。但现有原始研究的方法学报告质量欠佳，在整合证据与解读结果时可能存在潜在偏倚。未来需开展更多样本量充足、设计严谨且方法稳健的双盲多中心随机对照试验，以验证当前研究结论。
系统评价注册信息 https://www.crd.york.ac.uk/prospero/，标识符为CRD42022367867。