复方血栓通胶囊联合激光治疗糖尿病视网膜病变有效性和安全性的系统评价

Effectively and systematic review on diabetic retinopathy treated with therapeutic alliance of Laser and compound Xueshuantong capsule

关键词:  复方血栓通胶囊  糖尿病视网膜病变  系统评价  Meta分析

Key words:  compound xueshuantong capsule  diabetic retinopathy  systematic review  Meta-analysis

摘要:

[目的] 系统评价复方血栓通胶囊（CXSTC）联合激光治疗对糖尿病视网膜病变（DR）的疗效和安全性。[方法] 计算机检索中文科技期刊数据库（VIP）、万方数据库（Wanfang Data）、中国学术期刊全文数据库（CNKI）、PubMed及Cochrane Library数据库，收集有关CXSTC治疗DR的随机或半随机对照试验，质量评价参考Cochrane Reviewer's Handbook 5.2.8标准，数据分析采用RevMan 5.2软件。[结果] 共纳入6个随机对照试验（RCT），但研究质量均不高，仅1个研究描述随机方法为随机数字表法。Meta分析结果显示：对DR患者视力[RR=1.20，95%CI（1.12，1.28）]、眼底病变[RR=1.22，95%CI（1.14，1.31）]和黄斑水肿[RR=1.33，95%CI（1.13，1.58）]的治疗效果，以及对玻璃体混浊、视野光敏感度的疗效，CXSTC联合激光治疗组均优于单纯激光治疗组。2个研究报告了不良反应，包括一过性眼压增高和持续性黄斑水肿。无严重不良事件报告。[结论] 现有证据表明，加载CXSTC可作为提高常规激光治疗DR疗效，改善DR患者视力、眼底病变和黄斑水肿的一种选择。由于本研究纳入的原始文献质量不高，其确切或潜在疗效及安全性，有待于更严格设计的高质量RCT证实。

Abstract:

[Objective] To assess the efficacy and safety of diabetic retinopathy treated with therapeutic alliance of Laser and compound Xueshuantong capsule (CXSTC). [Methods] All randomized and quasi-randomized controlled trials (RCTs and quasi-RCTs) on CXSTC for diabetic retinopathy were searched from databases including VIP, Wangfang Data, CNKI, PubMed and the Cochrane Library. The Cochrane Reviewer's Handbook 5.2.8 was used to evaluate the quality of included studies, and the RevMan 5.2 software provided by the Cochrane Collaboration was used for data analyses. [Results] A total of 6 RCTs were included. The quality of the included trials was low. Only one study mentioned the use of random number table for sequence generation. The results of meta-analysis showed that: the improvement in vision[RR=1.20, 95%CI(1.12, 1.28)], alleviation of fundus lesions[RR=1.22, 95%CI(1.14, 1.31)]and of macular oedem[RR=1.33, 95%CI(1.13, 1.58)], as well as the effective rate calculated for enhancement in vitreous opacity and light sensitivity were greater in the CXSTC group than that in the routine therapy group. Adverse reactions caused by CXSTC were reported in 2 studies, which included transient ocular hypertention and persistent macular oedema. No severe adverse reactions were reported. [Conclusion] The currently existing evidence showed that CXSTC may have better effects on diabetic retinopathy when used in combination with routine western therapy, including improving vision, and alleviating fundus lesions and macular oedema. However, because of the low methodological quality of the included trials this conclusion needs to be interpreted with caution and more well-designed, high-quality RCTs need to be performed.