角膜磨损的抗生素预防。

IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL
Sueko M Ng, Louis Leslie, Chih-Chen Tzang, Abdullah M Algarni, Irene C Kuo, Annali L Lawrenson
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We used GRADE to assess the certainty of evidence for prespecified outcomes.</p><p><strong>Included studies: </strong>We included four RCTs enrolling a total of 998 participants, ranging from 20 to 437 participants. The included studies were published from 1975 to 1998, and conducted in Denmark (1), the Republic of Korea (1), and the UK (2). The length of follow-up was 24 hours to four weeks, or unspecified in two studies. Two studies had industry support. Participants had a mean age of 35 years (range 5 to 80 years) in one study, while the other three studies reported age ranges from 15 to 64 years. Most participants had traumatic corneal abrasions, commonly following foreign body removal. Two studies compared topical antibiotics with placebo (vehicle ointment or sodium hyaluronic acid drops), while three studies compared chloramphenicol ointment with antibiotics from other classes. One study was a three-arm study that compared two antibiotic regimens and one vehicle control. We judged the risk of bias from one study as raising some concerns about two efficacy outcomes, and three studies as having a high risk of overall bias across three outcomes.</p><p><strong>Synthesis of results: </strong>We classified study interventions into two comparisons: 1) antibiotics versus placebo, and 2) chloramphenicol versus other classes of antibiotics. Overall, we judged the certainty of evidence as very low for all outcomes due to imprecision, indirectness, and risk of bias. Two studies compared antibiotics with placebo. For one study, we combined the data for the sulfacetamide sodium and chloramphenicol ointment groups and compared them with a vehicle control group in a three-arm study. This study suggested that antibiotics may increase the risk of ocular infection (RR 1.32, 95% CI 1.03 to 1.70; 1 study, 320 participants). The same study found little to no difference in healing within 48 hours (RR 0.94, 95% CI 0.88 to 1.00). Another study compared tobramycin with sodium hyaluronic acid and reported complete healing in most eyes by 48 hours, with no incidence of infection; however, the study was not included in the meta-analysis because of unit-of-analysis issues. One study reported severe allergic reactions to medication or other adverse events leading to participant withdrawal. The analysis showed no evidence of a difference in treatment-related adverse events between antibiotics and placebo (RR 0.77, 95% CI 0.40 to 1.47; 1 study, 437 participants). Another study reported no adverse events in both arms but was not included in the analysis because it was unclear how the outcomes were measured. Three studies compared chloramphenicol with other classes of antibiotics (fusidic acid or sulfacetamide sodium). The pooled analysis showed little to no difference in the risk of ocular infection within one month (RR 1.07, 95% CI 0.87 to 1.31; 3 studies, 651 participants). One study reported no positive cultures in either group, although minor inflammatory signs (e.g. conjunctival hyperemia) were noted in the chloramphenicol arm. For corneal healing within 48 hours, three studies assessed cure rates within 24 hours using slightly different definitions, but the pooled analysis again showed no clinically meaningful difference between groups (RR 1.00, 95% CI 0.94 to 1.06; 3 studies, 651 participants). Two studies found no evidence of a difference in the incidence of treatment-related adverse events between groups (RR 1.01, 95% CI 0.47 to 2.17; 2 studies, 677 participants). Another study reported that one-third of participants in both groups experienced discomfort or itching, although these outcomes were not reported separately by each treatment arm. 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引用次数: 0

摘要

基本原理:角膜磨损是眼科保健专业人员、急诊医生和初级保健医生经常治疗的一种疾病。眼用抗生素是治疗角膜磨损最常用的方法。然而,关于外伤性角膜擦伤的抗生素预防的证据还没有全面的总结和综合。在这篇综述更新中,我们评估了目前关于抗生素治疗这种相对常见的紧急情况的益处和危害的证据。这是对2022年发表的一篇综述的更新。目的:评价局部抗生素预防治疗角膜磨损的利弊。检索方法:我们检索了CENTRAL、MEDLINE、Embase.com、其他两个数据库和两个试验注册库,并进行了参考检查,以确定纳入综述的研究。最近一次搜索日期是2025年3月28日。入选标准:我们纳入了在儿童和成人角膜磨损患者中比较抗生素与另一种抗生素或安慰剂的随机对照试验(rct)。结果:结果包括:角膜磨损后1个月内任何眼部感染的风险,48小时内眼睛愈合的比例,参与者报告的疼痛强度在24小时内减少50%或更多,1个月时失去一条或多条最佳矫正视力线,疼痛干扰从基线到24小时的变化,角膜磨损并发症,以及最长随访时治疗相关的不良事件。偏倚风险:使用Cochrane偏倚风险(RoB) 2工具,我们评估了三个报告结果的风险。综合方法:在可能的情况下,我们通过计算风险比(RR)和95%置信区间(CI),使用荟萃分析对每个结局进行综合;另外,我们对结果进行了叙述性的总结。我们使用GRADE来评估预先指定结果证据的确定性。纳入的研究:我们纳入了4项随机对照试验,共纳入998名受试者,范围从20至437名。纳入的研究发表于1975年至1998年,分别在丹麦(1)、韩国(1)和英国(2)进行。随访时间从24小时到四周不等,两项研究未明确随访时间。有两项研究得到了业界的支持。在一项研究中,参与者的平均年龄为35岁(5至80岁),而其他三项研究报告的年龄范围为15至64岁。大多数参与者都有外伤性角膜擦伤,通常是在异物移除后。两项研究比较了局部抗生素与安慰剂(车辆软膏或透明质酸钠滴剂),三项研究比较了氯霉素软膏与其他种类的抗生素。其中一项研究是一项三组研究,比较了两种抗生素方案和一种载体对照。我们判断一项研究的偏倚风险引起了对两项疗效结果的一些关注,三项研究在三个结果中具有较高的总体偏倚风险。结果综合:我们将研究干预措施分为两个比较:1)抗生素与安慰剂,2)氯霉素与其他种类的抗生素。总的来说,由于不精确性、间接性和偏倚风险,我们认为所有结果的证据确定性都很低。两项研究比较了抗生素和安慰剂。在一项研究中,我们结合了磺胺乙胺钠和氯霉素软膏组的数据,并将其与三组研究中的载体对照组进行了比较。本研究提示抗生素可能增加眼部感染的风险(RR 1.32, 95% CI 1.03 - 1.70; 1项研究,320名受试者)。同一项研究发现,48小时内的愈合几乎没有差异(RR 0.94, 95% CI 0.88至1.00)。另一项研究将妥布霉素与透明质酸钠进行比较,报告大多数眼睛在48小时内完全愈合,无感染发生率;然而,由于分析单元问题,该研究未纳入meta分析。一项研究报告了严重的药物过敏反应或其他不良事件导致参与者退出。分析显示,没有证据表明抗生素和安慰剂在治疗相关不良事件方面存在差异(RR 0.77, 95% CI 0.40至1.47;1项研究,437名参与者)。另一项研究报告两组均未发生不良事件,但由于尚不清楚如何测量结果,因此未纳入分析。三项研究比较了氯霉素与其他种类的抗生素(氟西地酸或磺胺钠)。合并分析显示一个月内眼部感染的风险几乎没有差异(RR 1.07, 95% CI 0.87至1.31;3项研究,651名参与者)。一项研究报告两组均无阳性培养,尽管在氯霉素组中发现了轻微的炎症体征(如结膜充血)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Antibiotic prophylaxis for corneal abrasion.

Rationale: Corneal abrasion is a condition frequently treated by eye care professionals, emergency physicians, and primary care physicians. Topical ophthalmic antibiotics are the most common therapy for corneal abrasion. However, there has been no comprehensive summary and synthesis of the evidence regarding antibiotic prophylaxis in traumatic corneal abrasion. In this review update, we evaluated the current evidence regarding the benefits and harms of antibiotic treatment for this relatively common emergency condition. This is an update of a review published in 2022.

Objectives: To assess the benefits and harms of topical antibiotic prophylaxis for corneal abrasion.

Search methods: We searched CENTRAL, MEDLINE, Embase.com, two other databases, and two trials registries together with reference checking to identify studies that are included in the review. The latest search date was 28 March 2025.

Eligibility criteria: We included randomized controlled trials (RCTs) comparing an antibiotic with another antibiotic or with placebo in children and adults with corneal abrasion(s).

Outcomes: Outcomes included the following: risk of any ocular infection up to one month following corneal abrasion, proportion of eyes healed within 48 hours, participant-reported pain intensity reduction of 50% or more at 24 hours, loss of one or more lines of best-corrected visual acuity at one month, change in pain interference from baseline to 24 hours, complications of corneal abrasion, and treatment-related adverse events at the longest follow-up.

Risk of bias: Using the Cochrane risk of bias (RoB) 2 tool, we assessed the RoB for the three reported outcomes.

Synthesis methods: We synthesized results for each outcome using meta-analysis by calculating risk ratios (RR) with 95% confidence intervals (CI) for dichotomous outcomes where possible; otherwise, we summarized the results narratively. We used GRADE to assess the certainty of evidence for prespecified outcomes.

Included studies: We included four RCTs enrolling a total of 998 participants, ranging from 20 to 437 participants. The included studies were published from 1975 to 1998, and conducted in Denmark (1), the Republic of Korea (1), and the UK (2). The length of follow-up was 24 hours to four weeks, or unspecified in two studies. Two studies had industry support. Participants had a mean age of 35 years (range 5 to 80 years) in one study, while the other three studies reported age ranges from 15 to 64 years. Most participants had traumatic corneal abrasions, commonly following foreign body removal. Two studies compared topical antibiotics with placebo (vehicle ointment or sodium hyaluronic acid drops), while three studies compared chloramphenicol ointment with antibiotics from other classes. One study was a three-arm study that compared two antibiotic regimens and one vehicle control. We judged the risk of bias from one study as raising some concerns about two efficacy outcomes, and three studies as having a high risk of overall bias across three outcomes.

Synthesis of results: We classified study interventions into two comparisons: 1) antibiotics versus placebo, and 2) chloramphenicol versus other classes of antibiotics. Overall, we judged the certainty of evidence as very low for all outcomes due to imprecision, indirectness, and risk of bias. Two studies compared antibiotics with placebo. For one study, we combined the data for the sulfacetamide sodium and chloramphenicol ointment groups and compared them with a vehicle control group in a three-arm study. This study suggested that antibiotics may increase the risk of ocular infection (RR 1.32, 95% CI 1.03 to 1.70; 1 study, 320 participants). The same study found little to no difference in healing within 48 hours (RR 0.94, 95% CI 0.88 to 1.00). Another study compared tobramycin with sodium hyaluronic acid and reported complete healing in most eyes by 48 hours, with no incidence of infection; however, the study was not included in the meta-analysis because of unit-of-analysis issues. One study reported severe allergic reactions to medication or other adverse events leading to participant withdrawal. The analysis showed no evidence of a difference in treatment-related adverse events between antibiotics and placebo (RR 0.77, 95% CI 0.40 to 1.47; 1 study, 437 participants). Another study reported no adverse events in both arms but was not included in the analysis because it was unclear how the outcomes were measured. Three studies compared chloramphenicol with other classes of antibiotics (fusidic acid or sulfacetamide sodium). The pooled analysis showed little to no difference in the risk of ocular infection within one month (RR 1.07, 95% CI 0.87 to 1.31; 3 studies, 651 participants). One study reported no positive cultures in either group, although minor inflammatory signs (e.g. conjunctival hyperemia) were noted in the chloramphenicol arm. For corneal healing within 48 hours, three studies assessed cure rates within 24 hours using slightly different definitions, but the pooled analysis again showed no clinically meaningful difference between groups (RR 1.00, 95% CI 0.94 to 1.06; 3 studies, 651 participants). Two studies found no evidence of a difference in the incidence of treatment-related adverse events between groups (RR 1.01, 95% CI 0.47 to 2.17; 2 studies, 677 participants). Another study reported that one-third of participants in both groups experienced discomfort or itching, although these outcomes were not reported separately by each treatment arm. For both comparisons, none of the included studies reported the following prespecified outcomes: participant-reported pain intensity reduction of 50% or more at 24 hours, loss of one or more lines of best-corrected visual acuity at one month, change in pain interference from baseline to 24 hours, and complications of corneal abrasion up to the longest follow-up.

Authors' conclusions: Given that the evidence supporting antibiotic use in corneal abrasion is of very low certainty, we are not able to support a specific antibiotic regimen or draw conclusions about the effects of antibiotic prophylaxis in preventing ocular infection or accelerating epithelial healing. Future research could explore adequately powered RCTs or alternative approaches, such as target trial emulation, while focusing on high-risk populations and antibiotic formulations.

Funding: The Cochrane Eyes and Vision US Project is supported by grant UG1EY020522, National Eye Institute, National Institutes of Health.

Registration: Protocol (2021) DOI: 10.1002/14651858.CD014617 Original Review (2022) DOI: 10.1002/14651858.CD014617.pub2.

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来源期刊
CiteScore
10.60
自引率
2.40%
发文量
173
审稿时长
1-2 weeks
期刊介绍: The Cochrane Database of Systematic Reviews (CDSR) stands as the premier database for systematic reviews in healthcare. It comprises Cochrane Reviews, along with protocols for these reviews, editorials, and supplements. Owned and operated by Cochrane, a worldwide independent network of healthcare stakeholders, the CDSR (ISSN 1469-493X) encompasses a broad spectrum of health-related topics, including health services.
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