Shi Rui, Zhao Lei, Wang Feng, Liu Fen, Chen Zhuo, Li Rong, Liu Yang, Lin Rong
Department of Ophthalmology, Shaanxi Provincial People's Hospital, Xi'an 710068, Shaanxi Province, China.
Department of Molecular Physiology and Biophysics, Holden Comprehensive Cancer Center, University of Iowa Carver College of Medicine, Iowa City 52242, IA, USA.
Int J Ophthalmol. 2018 Feb 18;11(2):287-295. doi: 10.18240/ijo.2018.02.18. eCollection 2018.
To clarify this controversy and to provide evidence for application of lipid lowering agents in treatment of diabetic retinopathy (DR).
We searched the databases of PubMed, Embase and Cochrane Library Central Register of Controlled Trials (CENTRAL) and abstracts from main annual meetings up to January 1, 2017. Google scholar and ClinicalTrials.gov were also searched for unpublished relevant studies. We included randomized controlled trials (RCTs) that studied lipid-lowering agents in type 1 or type 2 diabetes in this Meta-analysis. The primary endpoint was the progression of DR, and the secondary endpoints included vision loss, development of diabetic macular edema (DME) and aggravation of hard exudates. The pooled odds ratios (OR) with corresponding 95% confidence intervals (95%CIs) were calculated.
After systemic and manual literature search by two independent investigators, we included 8 RCTs from 7 published articles with 13 454 participants in this Meta-analysis. The results revealed that lipid-lowering drugs were associated with reduced risk in DR progression [OR=0.77 (95%CI: 0.62, 0.96), =0.02]. Lipid-lowering agents might have protective effect on DME compared to placebo, although the difference was not statistically significant [OR=0.60 (95%CI: 0.34, 1.08), =0.09]. However, no significant differences in the worsening of vision acuity [OR=0.96 (95%CI: 0.81,1.14), =0.64] and hard exudates [OR=0.50 (95%CI:0.15, 1.74), =0.28] were found between the lipid-lowering drugs and the placebo groups.
In DR patients, lipid-lowering agents show a protective effect on DR progression and might be associated with reduced risk in the development of DME. However, lipid-lowering agents have no effects on vision loss and hard exudates aggravation. Further clinical trials in larger scale are required to confirm the conclusion of this study and thus justify the use of intensive control lipids with anti-lipid agents at the early stages of DR.
澄清这一争议,并为降脂药物在糖尿病视网膜病变(DR)治疗中的应用提供证据。
我们检索了截至2017年1月1日的PubMed、Embase和Cochrane图书馆临床试验中央注册库(CENTRAL)数据库以及主要年会的摘要。还在谷歌学术和ClinicalTrials.gov上检索了未发表的相关研究。在这项荟萃分析中,我们纳入了研究1型或2型糖尿病患者降脂药物的随机对照试验(RCT)。主要终点是DR的进展,次要终点包括视力丧失、糖尿病性黄斑水肿(DME)的发生和硬性渗出物的加重。计算合并比值比(OR)及相应的95%置信区间(95%CI)。
经过两名独立研究者的系统和人工文献检索,我们在这项荟萃分析中纳入了7篇已发表文章中的8项RCT,共13454名参与者。结果显示,降脂药物与DR进展风险降低相关[OR = 0.77(95%CI:0.62,0.96),P = 0.02]。与安慰剂相比,降脂药物可能对DME有保护作用,尽管差异无统计学意义[OR = 0.60(95%CI:0.34,1.08),P = 0.09]。然而,降脂药物组与安慰剂组在视力恶化[OR = 0.96(95%CI:0.81,1.14),P = 0.64]和硬性渗出物[OR = 0.50(95%CI:0.15,1.74),P = 0.28]方面未发现显著差异。
在DR患者中,降脂药物对DR进展具有保护作用,可能与降低DME发生风险相关。然而,降脂药物对视力丧失和硬性渗出物加重无影响。需要进一步开展大规模临床试验来证实本研究的结论,从而证明在DR早期使用降脂药物强化控制血脂的合理性。