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复发性角膜糜烂的干预措施。

Interventions for recurrent corneal erosions.

作者信息

Watson Stephanie L, Leung Vannessa

机构信息

Save Sight Institute, University of Sydney, Sydney, NSW, Australia.

出版信息

Cochrane Database Syst Rev. 2018 Jul 9;7(7):CD001861. doi: 10.1002/14651858.CD001861.pub4.

Abstract

BACKGROUND

Recurrent corneal erosion is a common cause of disabling ocular symptoms and predisposes the cornea to infection. It may follow corneal trauma. Measures to prevent the development of recurrent corneal erosion following corneal trauma have not been firmly established. Once recurrent corneal erosion develops, simple medical therapy (standard treatment) may lead to resolution of the episode. However, some people continue to suffer when such therapy fails and repeated episodes of erosion develop. A number of treatment and prophylactic options are then available but there is no agreement as to the best option. This review version is an update to the original version published in 2007 and a previous update published in 2012.

OBJECTIVES

To assess the effectiveness and adverse effects of regimens for the prophylaxis of further recurrent corneal erosion episodes, the treatment of recurrent corneal erosion and prophylaxis of the development of recurrent corneal erosion following trauma.

SEARCH METHODS

We searched CENTRAL, which contains the Cochrane Eyes and Vision Trials Register; MEDLINE; Embase; LILACS; the ISRCTN registry; ClinicalTrials.gov and the ICTRP. The date of the search was 14 December 2017.

SELECTION CRITERIA

We included randomised and quasi-randomised trials that compared a prophylactic or treatment regimen with another prophylaxis/treatment or no prophylaxis/treatment for people with recurrent corneal erosion.

DATA COLLECTION AND ANALYSIS

We used standard methods expected by Cochrane. Two authors independently screened search results, extracted data and assessed risk of bias in the included studies using the Cochrane tool for assessing risk of bias. We considered the following outcome measures: resolution of symptoms after treatment; recurrence after complete or partial resolution; symptoms (pain); adverse effects (corneal haze, astigmatism). We graded the certainty of the evidence using GRADE for the three most clinically relevant comparisons.

MAIN RESULTS

We included eight randomised and two quasi-randomised controlled trials in the review, encompassing 505 participants. Seven studies were from Europe (Germany, Sweden and the UK), two from East Asia (Hong Kong and Japan) and one from Australia. Nine of the studies examined treatments for episodes of recurrent corneal erosions and one study considered prophylaxis to prevent development of recurrent corneal erosions after injury. Two of the nine treatment studies also enrolled participants in a study of prophylaxis to prevent further episodes of recurrent corneal erosions. The studies were poorly reported; we judged only one study low risk of bias on all domains.Two studies compared therapeutic contact lens with topical lubrication but one of these studies was published over 30 years ago and used a therapeutic contact lens that is no longer in common use. The more recent study was a two-centre UK study with 29 participants. It provided low-certainty evidence on resolution of symptoms after treatment with similar number of participants in both groups experiencing resolution of symptoms at four months (risk ratio (RR) 0.97, 95% confidence interval (CI) 0.62 to 1.53). There was very low-certainty evidence on recurrence after partial or total resolution at seven months' follow-up (RR 1.07, 95% CI 0.07 to 15.54). There was no evidence of an important difference in pain score (score of 3 in the contact lens group and score of 2 in the topical lubrication group, low-certainty evidence) and no adverse effects were reported. The older study, using a contact lens no longer in common use, found an increased risk of pain and complications with the contact lens compared with hypromellose drops and paraffin ointment at night.A single-centre, Australian study, with 33 participants, provided low-certainty evidence of an increased risk of recurrence with phototherapeutic keratectomy compared with alcohol delamination but with wide confidence intervals, compatible with increased or decreased risk (RR 1.27, 95% CI 0.48 to 3.37). Time to recurrence was similar in both groups (6.5 and 6 months, low-certainty evidence). On average people receiving phototherapeutic keratectomy reported less pain but confidence intervals included no difference or greater pain (mean difference (MD) -0.70, 95% CI -2.23 to 0.83, low-certainty evidence). No adverse effects were reported.A 48-participant study in Hong Kong found recurrences were less common in people given diamond burr superficial keratectomy after epithelial debridement compared with sham diamond burr treatment after epithelial debridement (RR 0.07, 95% CI 0.01 to 0.50, moderate-certainty evidence). The study did not report pain scores but adverse effects such as corneal haze (RR 0.92, 95% CI 0.06 to 13.87, low-certainty evidence) and astigmatism (0.88 versus 0.44 dioptres, moderate-certainty evidence) were similar between the groups.A study comparing transepithelial versus subepithelial excimer laser ablation in 100 people found low-certainty evidence of a small increased risk of recurrence of corneal erosion at one-year follow-up in people given the transepithelial compared with subepithelial technique, however, the confidence intervals were wide and compatible with increased or decreased risk (RR 1.20, 95% CI 0.58 to 2.48, low-certainty evidence). Other outcomes were not reported.Other treatment comparisons included in this review were only addressed by studies published two decades or more ago. The results of these studies were inconclusive: excimer laser ablation (after epithelial debridement) versus no excimer laser ablation (after epithelial debridement), epithelial debridement versus anterior stromal puncture, anterior stromal puncture versus therapeutic contact lens, oral oxytetracycline and topical prednisolone (in addition to 'standard therapy') versus oral oxytetracycline (in addition to 'standard therapy') versus 'standard therapy'.

AUTHORS' CONCLUSIONS: Well-designed, masked, randomised controlled trials using standardised methods are needed to establish the benefits of new and existing prophylactic and treatment regimes for recurrent corneal erosion. Studies included in this review have been of insufficient size and quality to provide firm evidence to inform the development of management guidelines. International consensus is also needed to progress research efforts towards evaluation of the major effective treatments for recurrent corneal erosions.

摘要

背景

复发性角膜糜烂是导致眼部症状致残的常见原因,且易使角膜发生感染。它可能继发于角膜外伤。角膜外伤后预防复发性角膜糜烂发生的措施尚未完全确立。一旦发生复发性角膜糜烂,单纯的药物治疗(标准治疗)可能使病情缓解。然而,当这种治疗失败且糜烂反复发生时,一些患者会持续遭受痛苦。此时有多种治疗和预防方法可供选择,但对于最佳方案尚无定论。本综述版本是对2007年发表的原始版本以及2012年发表的一次更新的更新。

目的

评估预防复发性角膜糜烂进一步发作、治疗复发性角膜糜烂以及预防外伤后复发性角膜糜烂发生的治疗方案的有效性和不良反应。

检索方法

我们检索了CENTRAL(其中包含Cochrane Eyes and Vision试验注册库)、MEDLINE、Embase、LILACS、ISRCTN注册库、ClinicalTrials.gov和ICTRP。检索日期为2017年12月14日。

入选标准

我们纳入了随机和半随机试验,这些试验比较了预防性或治疗性方案与另一种预防/治疗方案或不进行预防/治疗方案,用于复发性角膜糜烂患者。

数据收集与分析

我们采用Cochrane期望的标准方法。两位作者独立筛选检索结果、提取数据,并使用Cochrane偏倚风险评估工具评估纳入研究的偏倚风险。我们考虑了以下结局指标:治疗后症状缓解;完全或部分缓解后的复发情况;症状(疼痛);不良反应(角膜混浊、散光)。我们使用GRADE对三个最具临床相关性的比较进行证据确定性分级。

主要结果

本综述纳入了八项随机试验和两项半随机对照试验,共505名参与者。七项研究来自欧洲(德国、瑞典和英国),两项来自东亚(中国香港和日本),一项来自澳大利亚。九项研究考察了复发性角膜糜烂发作的治疗方法,一项研究考虑了预防损伤后复发性角膜糜烂的发生。九项治疗研究中的两项还将参与者纳入了预防复发性角膜糜烂进一步发作的研究。这些研究报告质量较差;我们仅判断一项研究在所有领域的偏倚风险较低。两项研究比较了治疗性隐形眼镜与局部润滑,但其中一项研究发表于30多年前,使用的是一种已不常用的治疗性隐形眼镜。较新的一项研究是英国的一项双中心研究,有29名参与者。它提供了低确定性证据,表明治疗后症状缓解情况,两组中经历症状缓解的参与者数量相似(风险比(RR)0.97,95%置信区间(CI)0.62至1.53)。关于七个月随访时部分或完全缓解后的复发情况,有极低确定性证据(RR 1.07,95%CI 0.07至15.54)。没有证据表明疼痛评分有显著差异(隐形眼镜组评分为3,局部润滑组评分为2,低确定性证据),且未报告不良反应。较早的研究使用的是已不常用的隐形眼镜,发现与夜间使用羟丙甲纤维素滴眼液和石蜡油眼膏相比,隐形眼镜导致疼痛和并发症的风险增加。一项澳大利亚的单中心研究,有33名参与者,提供了低确定性证据,表明与酒精分层术相比,光治疗性角膜切削术复发风险增加,但置信区间较宽,可能增加或降低风险(RR 1.27,95%CI 0.48至3.37)。两组的复发时间相似(6.5个月和6个月,低确定性证据)。接受光治疗性角膜切削术的患者平均报告疼痛较轻,但置信区间包括无差异或疼痛更严重(平均差(MD)−0.70 , 95% CI −2.23至0.83,低确定性证据)。未报告不良反应。中国香港一项有48名参与者的研究发现,与上皮清创术后假钻石磨盘治疗相比,上皮清创术后接受钻石磨盘浅层角膜切除术的患者复发较少(RR 0.07,95%CI 0.01至0.50,中度确定性证据)。该研究未报告疼痛评分,但两组间角膜混浊(RR 0.92,95%CI 0.06至13.87,低确定性证据)和散光(0.88与0.44屈光度,中度确定性证据)等不良反应相似。一项比较100人经上皮与上皮下准分子激光消融的研究发现,有低确定性证据表明,与上皮下技术相比,接受经上皮技术的患者在一年随访时角膜糜烂复发风险略有增加,然而,置信区间较宽,可能增加或降低风险(RR 1.20,95%CI 0.58至2.48,低确定性证据)。未报告其他结局。本综述中纳入的其他治疗比较仅由二十多年前发表的研究涉及。这些研究结果尚无定论:准分子激光消融(上皮清创术后)与不准分子激光消融(上皮清创术后)、上皮清创术与前基质穿刺、前基质穿刺与治疗性隐形眼镜、口服土霉素和局部泼尼松龙(除“标准治疗”外)与口服土霉素(除“标准治疗”外)与“标准治疗”。

作者结论

需要设计良好、采用标准化方法的盲法随机对照试验,以确定新的和现有的复发性角膜糜烂预防及治疗方案的益处。本综述纳入的研究规模和质量不足以提供确凿证据来指导管理指南的制定。还需要国际共识,以推动对复发性角膜糜烂主要有效治疗方法评估的研究工作。

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