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双丹明目胶囊治疗糖尿病视网膜病变:随机对照试验的系统评价与Meta分析

Shuangdan Mingmu Capsule for Diabetic Retinopathy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

作者信息

Du Jiaan, Mao Yingqi, Xu Youhua, Qu Kai, Han Aiwei, Wu Qibiao, Yu Lili

机构信息

Faculty of Chinese Medicine, Macau University of Science and Technology, Macau 999078, China.

The State Key Laboratory for Quality Research in Chinese Medicines of the Macau University of Science and Technology, Macau 999078, China.

出版信息

Evid Based Complement Alternat Med. 2023 Jan 25;2023:4655109. doi: 10.1155/2023/4655109. eCollection 2023.

Abstract

OBJECTIVE

To systematically evaluate the efficacy and safety of the Shuangdan Mingmu capsule in the treatment of diabetic retinopathy (DR).

METHODS

Common Chinese and English databases, including PubMed, Medline, Embase, VIP, Wanfang, and the Chinese National Knowledge Infrastructure (CNKI), were searched from their inception to May 31, 2022. According to the Cochrane Handbook, two reviewers independently evaluated and collected data on the included studies. Meta-analysis was performed by RevMan software 5.4.

RESULTS

Seven trials with a total of 835 patients were included. The clinical effectiveness rate was defined as the primary outcome, and the TCM symptom score, Chinese-Version Low Vision Quality of Life Questionnaire (CLVQOL) scores, macular thickness, hemorrhagic spot area, vascular endothelial growth factor levels, platelet-derived growth factor levels, and the incidence of adverse effects were the secondary outcome. The results of the meta-analysis showed that, compared with conventional medical treatment alone, the Shuangdan Mingmu capsule combined with conventional treatment could significantly improve the clinical effectiveness rate of treating DR (OR = 4.07, 95% CI (2.10, 7.89), < 0.0001), and reduce the incidence of adverse reactions in DR patients (OR = 0.47, 95% CI (0.26, 0.86), =0.01). In addition, other results showed that TCM symptom score(OR = -3.47, 95% CI (-3.84, -3.10), < 0.00001); CLVQOL scores (OR = 23.93, 95% CI (21.37, 26.49), < 0.00001); macular thickness (OR = -47.34, 95% CI (-50.67, 44.00), < 0.00001); hemorrhagic spot area (OR = -0.91, 95% CI (-1.01, -0.81), < 0.00001); vascular endothelial growth factor levels (OR = -45.76, 95% CI (-49.74, 41.79), < 0.00001); platelet-derived growth factor levels (OR = -1.73, 95% CI (-2.15, -1.31), < 0.00001).

CONCLUSION

Compared with conventional treatment alone, the Shuangdan Mingmu capsule combined with conventional treatment is more effective and safer in the treatment of diabetic retinopathy. However, due to the limitations of the included studies, more high-quality studies are still needed to further assess the efficacy and safety of the Shuangdan Mingmu capsule in the treatment of diabetic retinopathy.

摘要

目的

系统评价双丹明目胶囊治疗糖尿病视网膜病变(DR)的疗效和安全性。

方法

检索包括PubMed、Medline、Embase、维普、万方和中国知网(CNKI)在内的中英文常用数据库,检索时间从建库至2022年5月31日。根据Cochrane手册,两名评价员独立对纳入研究进行评估并收集数据。采用RevMan 5.4软件进行Meta分析。

结果

纳入7项试验,共835例患者。将临床有效率定义为主要结局指标,中医症状评分、中文版低视力生活质量问卷(CLVQOL)评分、黄斑厚度、出血斑面积、血管内皮生长因子水平、血小板衍生生长因子水平及不良反应发生率为次要结局指标。Meta分析结果显示,与单纯常规药物治疗相比,双丹明目胶囊联合常规治疗可显著提高DR的临床有效率(OR = 4.07,95%CI(2.10,7.89),P < 0.0001),并降低DR患者不良反应的发生率(OR = 0.47,95%CI(0.26,0.86),P = 0.01)。此外,其他结果显示,中医症状评分(OR = -3.47,95%CI(-3.84,-3.10),P < 0.00001);CLVQOL评分(OR = 23.93,95%CI(21.37,26.49),P < 0.00001);黄斑厚度(OR = -47.34,95%CI(-50.67,-44.00),P < 0.00001);出血斑面积(OR = -0.91,95%CI(-1.01,-0.81),P < 0.00001);血管内皮生长因子水平(OR = -45.76,95%CI(-49.74,-41.79),P < 0.00001);血小板衍生生长因子水平(OR = -1.73,95%CI(-2.15,-1.31),P < 0.00001)。

结论

与单纯常规治疗相比,双丹明目胶囊联合常规治疗在糖尿病视网膜病变的治疗中更有效、更安全。然而,由于纳入研究存在局限性,仍需要更多高质量研究进一步评估双丹明目胶囊治疗糖尿病视网膜病变的疗效和安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/12d2/9891817/0a1dbf5fd627/ECAM2023-4655109.001.jpg

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