Gehlbach Peter, Li Tianjing, Hatef Elham
Retina Division, Wilmer Eye Institute, Johns Hopkins University School of Medicine, 1550 Orleans Street, Cancer Research Building #2, Baltimore, MD 21231, USA.
Cochrane Database Syst Rev. 2009 Jul 8(3):CD006927. doi: 10.1002/14651858.CD006927.pub2.
Age-related macular degeneration (AMD) is a progressive late onset disorder of the macula affecting central vision. Age-related macular degeneration is the leading cause of blindness in people over 65 years in industrialized countries (Congdon 2003). Recent epidemiologic, genetic and pathological evidence has shown AMD shares a number of risk factors with atherosclerosis, leading to the hypothesis that statins may exert protective effects in AMD.
To examine the effectiveness of statins compared with other treatments, no treatment, or placebo in delaying the onset and/or progression of AMD.
We searched CENTRAL in The Cochrane Library, MEDLINE, EMBASE and LILACS on 30 April 2009 and the WHO International Clinical Trials Registry Platform on 11 May 2009. We searched reference lists and the Science Citation Index. There were no language or date restrictions in the search for trials.
We included randomized controlled trials (RCTs) that compared statins with other treatments, no treatment, or placebo in participants who were either susceptible to or diagnosed as having early stages of AMD.
Two authors independently evaluated the search results against the selection criteria. Two Italian speaking colleagues extracted data. One author entered data. We did not perform a meta-analysis because only one completed RCT was identified.
Two studies met the selection criteria. One trial reported insufficient details to assess the risk of bias; the other trial is ongoing.Of the completed trial, the analyses of 30 participants did not show a statistically significant difference between the simvastatin and the placebo arm in visual acuity at three months of treatment (decimal visual acuity 0.21+/- 0.56 in simvastatin and 0.19+/- 0.40 in placebo arm) or 45 days after the completion of treatment (decimal visual acuity 0.20+/- 0.50 in simvastatin and 0.19+/- 0.48 in placebo arm). The lens and retina status were unchanged during and after the treatment period for both groups.Of the ongoing trial, the preliminary analyses of 42 participants who completed 12 months follow-up did not show a statistically significant difference between the simvastatin and the placebo arm in visual acuity, drusen score or visual function (effect estimates and confidence intervals were not available). We contacted the investigators and will update the review as data become available.
AUTHORS' CONCLUSIONS: Evidence from currently available RCTs was insufficient to conclude that statins have any role in preventing or delaying the onset or progression of AMD.
年龄相关性黄斑变性(AMD)是一种影响中心视力的黄斑进行性迟发性疾病。在工业化国家,年龄相关性黄斑变性是65岁以上人群失明的主要原因(Congdon,2003年)。最近的流行病学、遗传学和病理学证据表明,AMD与动脉粥样硬化有许多共同的危险因素,这引发了他汀类药物可能对AMD具有保护作用的假说。
比较他汀类药物与其他治疗方法、不治疗或安慰剂在延缓AMD发病和/或进展方面的有效性。
我们于2009年4月30日检索了Cochrane图书馆中的CENTRAL、MEDLINE、EMBASE和LILACS,并于2009年5月11日检索了世界卫生组织国际临床试验注册平台。我们还检索了参考文献列表和科学引文索引。检索试验时没有语言或日期限制。
我们纳入了将他汀类药物与其他治疗方法、不治疗或安慰剂进行比较的随机对照试验(RCT),这些试验的参与者易患或已被诊断为患有早期AMD。
两位作者根据选择标准独立评估检索结果。两位讲意大利语的同事提取数据。一位作者录入数据。由于仅识别出一项完成的RCT,我们未进行荟萃分析。
两项研究符合选择标准。一项试验报告的细节不足以评估偏倚风险;另一项试验正在进行中。在已完成的试验中,对30名参与者的分析显示,在治疗三个月时,辛伐他汀组和安慰剂组的视力(辛伐他汀组的小数视力为0.21±0.56,安慰剂组为0.19±0.40)或治疗完成后45天(辛伐他汀组的小数视力为0.20±0.50,安慰剂组为0.19±0.48)没有统计学上的显著差异。两组在治疗期间及之后晶状体和视网膜状态均未改变。在正在进行的试验中,对42名完成12个月随访的参与者的初步分析显示,辛伐他汀组和安慰剂组在视力、玻璃膜疣评分或视觉功能方面没有统计学上的显著差异(效应估计值和置信区间未提供)。我们联系了研究人员,并将在有数据时更新本综述。
目前可用的RCT证据不足以得出他汀类药物在预防或延缓AMD发病或进展方面有任何作用的结论。