降高血脂藥物於治療糖尿病視網膜病變之療效：系統性文獻回顧與統合分析

Abstract

研究目的 已知血脂異常為糖尿病視網膜病變的危險因子，且降血脂療法可以預防該疾病進展。然而，降血脂藥物對於糖尿病視網膜病變及黃斑部水腫之治療或預防效果有待釐清。本研究的目的即為透過系統性文獻回顧與統合分析，來探討降血脂藥物statin對於糖尿病視網膜病變之療效。

方法 本研究探討的問題為罹患糖尿病視網膜病變的病人，使用降血脂藥物中最常用的statin類藥物後，是否可以防止或改善視網膜病變的臨床症狀。我們透過系統性文獻回顧，依據訂定的PICOS，於PubMed、Embase以及Cochrane Library資料庫針對隨機對照試驗進行文獻檢索。

結果 截至107年4月8日，分別於PubMed、Embase以及Cochrane Library檢索到191、730和83篇文獻。經過文獻篩選與分析後，最後找到3篇相關之隨機對照試驗文獻，總樣本數為110人，介入措施分別為安慰劑與10 mg atorvastatin、20 mg atorvastatin和20 mg simvastatin。利用隨機效應模式分析後的結果顯示，相較於安慰劑組，給予口服statin治療有益於防止視力惡化（odds ratio = 0.28，95%信賴區間：0.08、1.05），但不具備統計上顯著差異性；對於黃斑部水腫（odds ratio = 0.34，95%信賴區間：0.11、1.02）和視網膜血管硬滲出物（odds ratio = 0.23，95%信賴區間：0.03、1.61）可能有幫助，但亦不顯著。

結論 系統性文獻回顧的結果顯示，缺乏大型、高證據等級的隨機對照試驗，只有一些小型的臨床試驗嘗試釐清statin類藥物對於糖尿病視網膜病變的療效，但統合分析的結果無法證實statin的臨床效益。

Purposes Dyslipidemia is known to be a risk factor for diabetic retinopathy, and antihyperlipidemic therapy can prevent disease progression. However, the therapeutic or preventive effects of lipid-lowering drugs on diabetic retinopathy and macular edema remain to be clarified. The purpose of this study is to explore the efficacy of statin, one of the antihyperlipidemic drugs, for diabetic retinopathy through systematic review and meta-analysis.

Methods This study examined the question of whether patients with diabetic retinopathy have the benefit of clinical symptoms of retinopathy after treatment with statin. We systematically reviewed randomized controlled trials on PubMed, Embase, and Cochrane Library databases according to previously defined PICOS （participants, interventions, comparators, outcomes, and study design）.

Results The search results showed that 191, 730 and 83 articles were found in PubMed, Embase and Cochrane Library respectively （update to April 8, 2018）. After literature screening and analysis, 3 related randomized controlled trials were found （the total number of samples was 110）. The interventions were placebo and 10 mg atorvastatin, 20 mg atorvastatin, and 20 mg simvastatin. The results of the random-effect model analysis showed that oral administration of statin therapy was beneficial to prevent vision loss compared with placebo group （odds ratio = 0.28, 95% confidence interval: 0.08, 1.05）, but there was no significant difference. For macular edema （odds ratio = 0.34, 95% confidence interval: 0.11, 1.02） and retinal vascular hard exudates （odds ratio = 0.23, 95% confidence interval: 0.03, 1.61）, statin may be effective, but there is no statistically significant difference.

Conclusion The results of a systematic literature review show that in the absence of large, high-level of evidence, only small randomized controlled trials attempted to clarify the efficacy of statin drugs for diabetic retinopathy, but the results of meta-analysis did not confirm the clinical benefit of statin.