中文专利药治疗非增殖性糖尿病视网膜病变的比较效果：一项基于随机对照试验的贝叶斯网状 Meta 分析。
The comparative effects of oral Chinese patent medicines in non-proliferative diabetic retinopathy: A Bayesian network meta-analysis of randomized controlled trials.
机构信息
Ophthalmology Department, Eye Hospital China Academy of Chinese Medical Sciences, Beijing, China.
Centre for Evidence-based Chinese Medicine, School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
出版信息
Front Endocrinol (Lausanne). 2023 Apr 3;14:1144290. doi: 10.3389/fendo.2023.1144290. eCollection 2023.
BACKGROUND
Non-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.
METHODS
From 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.
RESULTS
We 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.
CONCLUSION
OCPMs 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 REGISTRATION
https://www.crd.york.ac.uk/prospero/, identifier CRD42022367867.
背景
非增殖性糖尿病视网膜病变（NPDR）是一种常见的糖尿病并发症，发病率较高，其特征是视觉功能受损和眼底病变。据报道，口服中药（OCPM）可能改善视力和眼底征象。然而，对于 NPDR 最好的 OCPM 仍存在疑问，需要进一步研究。
方法
从成立到 2022 年 10 月 20 日，在七个数据库中检索符合条件的随机对照试验（RCT）。主要结局为临床有效率、视力、视野灰度值、微动脉瘤体积、出血面积、黄斑厚度和不良反应发生率。采用 Cochrane 偏倚风险评估工具（ROB 2）评估纳入研究的质量。使用 R 4.1.3 和 STATA 15.0 软件进行网络荟萃分析。
结果
共纳入 42 项 RCT，共 4858 例患者（5978 只眼）。复方丹参滴丸（CDDP）联合羟苯磺酸钙（CD）在临床有效率方面的改善最为显著（SUCRA，88.58%）。复方血栓通胶囊（CXC）联合 CD 可能是改善视力的最佳干预措施（SUCRA，98.51%）。CDDP 单独使用可能是改善视野灰度值最有效的治疗选择（SUCRA，91.83%）。和血明目片（HXMMT）联合 CD 和双丹明目胶囊（SDMMC）联合 CD 可能是降低微动脉瘤体积和出血面积的最有效治疗方法（SUCRA，94.48%和 86.24%）。关于黄斑厚度的降低，CXC 联合 CD 排名第一（SUCRA，86.23%）。此外，所有 OCPM 均未引起严重不良反应。
结论
OCPM 对 NPDR 有效且安全。CDDP 单独使用以及与 CD 联合使用可能在改善视野灰度值和临床有效率方面最有效；CXC 联合 CD 可能在提高 BCVA 和降低黄斑厚度方面效果最佳；HXMMT 和 SDMMC 联合 CD 在降低微动脉瘤体积和出血面积方面可能最为有效。然而，主要研究的方法报告较差，综合证据和解释结果时可能存在潜在偏倚。目前的研究结果需要更多设计严谨、方法可靠的大样本、双盲、多中心 RCT 来进一步证实。
系统综述注册
https://www.crd.york.ac.uk/prospero/，标识符 CRD42022367867。
Zotero 插件