Alves Carlos, Ribeiro Inês, Penedones Ana, Mendes Diogo, Batel Marques Francisco
Central Portugal Regional Pharmacovigilance Unit (UFC), Centre for Health Technology Assessment and Drug Research (CHAD), AIBILI - Association for Innovation and Biomedical Research on Light and Image, Coimbra, Portugal.
Ophthalmic Res. 2017;57(1):60-69. doi: 10.1159/000446845. Epub 2016 Jul 13.
This meta-analysis aims to evaluate the risk of ophthalmic adverse effects associated with MEK inhibitors.
A literature search was conducted in PubMed and the Cochrane Library to identify randomized clinical trials (RCTs) which have been designed to evaluate the efficacy and safety of MEK inhibitors. Overall risk of ophthalmic adverse effects, chorioretinopathy, retinal detachment, blurred vision, uveitis, and eye haemorrhage were the assessed outcomes. Peto odds ratios (ORs) with their 95% confidence intervals (CIs) were pooled. Between-study heterogeneity was assessed using I2 statistics.
Thirteen RCTs were included in this meta-analysis. Overall, MEK inhibitors were associated with an increased risk of ophthalmic adverse effects (OR 2.24; 95% CI 1.75-2.87; p < 0.0001; I2 = 86.5%). An increased risk was also estimated for chorioretinopathy (OR 5.44; 95% CI 2.89-10.23; p < 0.0001; I2 = 0%), retinal detachment (OR 6.54; 95% CI 3.28-13.03; p < 0.0001; I2 = 0%), and blurred vision (OR 2.30; 95% CI 1.50-3.54; p < 0.0001; I2 = 60.1%), but not for uveitis (OR 0.99; 95% CI 0.14-7.03; p = 0.991; I2 = 2.9%) or eye haemorrhage (OR 0.72; 95% CI 0.04-12.39; p = 0.824; I2 = 29.8%).
Treatment with MEK inhibitors seems to increase the risk of ophthalmic adverse effects. A need for monitoring the safety of this class of drugs exists. Regulators, clinicians, and other health care professionals must, together, be involved in this process.
本荟萃分析旨在评估与MEK抑制剂相关的眼部不良反应风险。
在PubMed和Cochrane图书馆进行文献检索,以识别旨在评估MEK抑制剂疗效和安全性的随机临床试验(RCT)。评估的结果包括眼部不良反应、脉络膜视网膜病变、视网膜脱离、视力模糊、葡萄膜炎和眼部出血的总体风险。汇总Peto比值比(OR)及其95%置信区间(CI)。使用I²统计量评估研究间的异质性。
本荟萃分析纳入了13项RCT。总体而言,MEK抑制剂与眼部不良反应风险增加相关(OR 2.24;95%CI 1.75 - 2.87;p < 0.0001;I² = 86.5%)。脉络膜视网膜病变(OR 5.44;95%CI 2.89 - 10.23;p < 0.0001;I² = 0%)、视网膜脱离(OR 6.54;95%CI 3.28 - 13.03;p < 0.0001;I² = 0%)和视力模糊(OR 2.30;95%CI 1.50 - 3.54;p < 0.0001;I² = 60.1%)的风险也有所增加,但葡萄膜炎(OR 0.99;95%CI 0.14 - 7.03;p = 0.991;I² = 2.9%)或眼部出血(OR 0.72;95%CI 0.04 - 12.39;p = 0.824;I² = 29.8%)的风险未增加。
MEK抑制剂治疗似乎会增加眼部不良反应的风险。需要监测这类药物的安全性。监管机构、临床医生和其他医疗保健专业人员必须共同参与这一过程。