Miguel Ana, Henriques Filipe, Azevedo Luís Filipe, Pereira Altamiro Costa
Center for Research in Health Technologies and Information Systems (CINTESIS) and Department of Health Information and Decision Sciences, Faculty of Medicine, University of Porto, Portugal; Department of Ophthalmology, Central University Hospital of Coimbra, Coimbra, Portugal.
Pharmacoepidemiol Drug Saf. 2014 Mar;23(3):221-33. doi: 10.1002/pds.3566. Epub 2014 Jan 27.
To perform a comprehensive and systematic review regarding ophthalmic adverse drug reactions (ADRs) to systemic drugs to: (i) systematically summarize existing evidence, (ii) identify areas, ophthalmic ADRs or drugs that lacked systematization or assessment (namely drugs with original studies characterizing specific ophthalmic ADRs but without causality assessment nor without meta-analysis).
Systematic review of several electronic databases (last search 1/7/2012): Medline, SCOPUS, ISI web of knowledge, ISI Conference Proceedings, International Pharmaceutical Abstracts and Google scholar. Search query included: eye, ocular, ophthalmic, ophthalmology, adverse and reaction. Inclusion criteria were: (i) Primary purpose was to assess an ophthalmic ADR to a systemic medication; (ii) Patient evaluation performed by an ophthalmologist; (iii) Studies that specified diagnostic criteria for an ocular ADR. Different types of studies were included and analyzed separately. Two independent reviewers assessed eligibility criteria, extracted data and evaluated risk of bias.
From 562 studies found, 32 were included (1 systematic review to sildenafil, 11 narrative reviews, 1 trial, 1 prospective study, 6 transversal studies, 6 spontaneous reports and 6 case series). Drugs frequently involved included amiodarone, sildenafil, hydroxychloroquine and biphosphonates. Frequent ophthalmic ADRs included: keratopathy, dry eye and retinopathy.
To increase evidence about ophthalmic ADRs, there is a need for performing specific systematic reviews, applying strictly the World Health Organization's (WHO) definition of ADR and WHO causality assessment of ADRs. Some ophthalmic ADRs may be frequent, but require ophthalmological examination; therefore, ophthalmologists' education and protocols of collaboration between other specialties whenever they prescribe high-risk drugs are suggestions for the future.
对全身性药物引起的眼部药物不良反应（ADR）进行全面系统的综述，以：（i）系统地总结现有证据；（ii）识别缺乏系统性或评估的领域、眼部ADR或药物（即有描述特定眼部ADR的原始研究但未进行因果关系评估或未进行荟萃分析的药物）。
对多个电子数据库进行系统综述（最后一次检索时间为2012年7月1日）：医学文献数据库（Medline）、Scopus数据库、科学网（ISI Web of Knowledge）、ISI会议论文数据库、国际药学文摘数据库（International Pharmaceutical Abstracts）和谷歌学术。检索词包括：眼睛、眼部、眼科、眼科学、不良反应和反应。纳入标准为：（i）主要目的是评估全身性药物引起的眼部ADR；（ii）由眼科医生对患者进行评估；（iii）明确眼部ADR诊断标准的研究。纳入不同类型的研究并分别进行分析。两名独立的评审员评估纳入标准、提取数据并评估偏倚风险。
在检索到的562项研究中，纳入了32项（1项关于西地那非的系统综述、11项叙述性综述、1项试验、1项前瞻性研究、6项横断面研究、6项自发报告和6项病例系列）。经常涉及的药物包括胺碘酮、西地那非、羟氯喹和双膦酸盐。常见的眼部ADR包括：角膜病变、干眼和视网膜病变。
为增加关于眼部ADR的证据，需要进行特定的系统综述，严格应用世界卫生组织（WHO）对ADR的定义以及WHO对ADR的因果关系评估。一些眼部ADR可能很常见，但需要眼科检查；因此，对眼科医生的教育以及其他专科在开具高风险药物时的协作方案是未来的建议。
