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创伤性前房积血的医学干预措施。

Medical interventions for traumatic hyphema.

机构信息

Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.

Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands.

出版信息

Cochrane Database Syst Rev. 2023 Mar 13;3(3):CD005431. doi: 10.1002/14651858.CD005431.pub5.

Abstract

BACKGROUND

Traumatic hyphema is the entry of blood into the anterior chamber, the space between the cornea and iris, following significant injury to the eye. Hyphema may be associated with significant complications that uncommonly cause permanent vision loss. Complications include elevated intraocular pressure, corneal blood staining, anterior and posterior synechiae, and optic nerve atrophy. People with sickle cell trait or disease may be particularly susceptible to increases in intraocular pressure and optic atrophy. Rebleeding is associated with an increase in the rate and severity of complications.

OBJECTIVES

To assess the effectiveness of various medical interventions in the management of traumatic hyphema.

SEARCH METHODS

We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2022, Issue 3); MEDLINE Ovid; Embase.com; PubMed (1948 to March 2022); the ISRCTN registry; ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). The last date of the search was 22 March 2022.

SELECTION CRITERIA

Two review authors independently assessed the titles and abstracts of all reports identified by the electronic and manual searches. We included randomized and quasi-randomized trials that compared various medical (non-surgical) interventions versus other medical interventions or control groups for the treatment of traumatic hyphema following closed-globe trauma. We applied no restrictions on age, gender, severity of the closed-globe trauma, or level of visual acuity at time of enrollment.

DATA COLLECTION AND ANALYSIS

We used standard methodological procedures expected by Cochrane and assessed the certainty of evidence using GRADE.

MAIN RESULTS

We included 23 randomized and seven quasi-randomized studies with a total of 2969 participants. Interventions included antifibrinolytic agents (systemic and topical aminocaproic acid, tranexamic acid, and aminomethylbenzoic acid), corticosteroids (systemic and topical), cycloplegics, miotics, aspirin, conjugated estrogens, traditional Chinese medicine, monocular versus bilateral patching, elevation of the head, and bed rest. We found no evidence of an effect on visual acuity for any intervention, whether measured within two weeks (short term) or for longer periods. In a meta-analysis of two trials, we found no evidence of an effect of aminocaproic acid on long-term visual acuity (RR 1.03, 95% confidence interval (CI) 0.82 to 1.29) or final visual acuity measured up to three years after the hyphema (RR 1.05, 95% CI 0.93 to 1.18). Oral tranexamic acid appeared to provide little to no benefit on visual acuity in four trials (RR 1.12, 95% CI 1.00 to 1.25). The remaining trials evaluated the effects of various interventions on short-term visual acuity; none of these interventions was measured in more than one trial. No intervention showed a statistically significant effect (RRs ranged from 0.75 to 1.10). Similarly, visual acuity measured for longer periods in four trials evaluating different interventions was also not statistically significant (RRs ranged from 0.82 to 1.02). The evidence supporting these findings was of low or very low certainty. Systemic aminocaproic acid reduced the rate of recurrent hemorrhage (RR 0.28, 95% CI 0.13 to 0.60), as assessed in six trials with 330 participants. A sensitivity analysis omitting two studies not using an intention-to-treat analysis reduced the strength of the evidence (RR 0.43, 95% CI 0.17 to 1.08). We obtained similar results for topical aminocaproic acid (RR 0.48, 95% CI 0.20 to 1.10) in two trials with 131 participants. We assessed the certainty of the evidence as low. Systemic tranexamic acid had a significant effect in reducing the rate of secondary hemorrhage (RR 0.33, 95% CI 0.21 to 0.53) in seven trials with 754 participants, as did aminomethylbenzoic acid (RR 0.10, 95% CI 0.02 to 0.41), as reported in one study. Evidence to support an associated reduction in risk of complications from secondary hemorrhage (i.e. corneal blood staining, peripheral anterior synechiae, elevated intraocular pressure, and development of optic atrophy) by antifibrinolytics was limited by the small number of these events. Use of aminocaproic acid was associated with increased nausea, vomiting, and other adverse events compared with placebo. We found no evidence of an effect on the number of adverse events with the use of systemic versus topical aminocaproic acid or with standard versus lower drug dose.  The number of days for the primary hyphema to resolve appeared to be longer with the use of systemic aminocaproic acid compared with no use, but this outcome was not altered by any other intervention. The available evidence on usage of systemic or topical corticosteroids, cycloplegics, or aspirin in traumatic hyphema was limited due to the small numbers of participants and events in the trials. We found no evidence of an effect between a single versus binocular patch on the risk of secondary hemorrhage or time to rebleed. We also found no evidence of an effect on the risk of secondary hemorrhage between ambulation and complete bed rest.

AUTHORS' CONCLUSIONS: We found no evidence of an effect on visual acuity of any of the interventions evaluated in this review. Although the evidence was limited, people with traumatic hyphema who receive aminocaproic acid or tranexamic acid are less likely to experience secondary hemorrhage. However, hyphema took longer to clear in people treated with systemic aminocaproic acid. There is no good evidence to support the use of antifibrinolytic agents in the management of traumatic hyphema, other than possibly to reduce the rate of secondary hemorrhage. The potentially long-term deleterious effects of secondary hemorrhage are unknown. Similarly, there is no evidence to support the use of corticosteroids, cycloplegics, or non-drug interventions (such as patching, bed rest, or head elevation) in the management of traumatic hyphema. As these multiple interventions are rarely used in isolation, further research to assess the additive effect of these interventions might be of value.

摘要

背景

创伤性前房积血是指角膜和虹膜之间的前房内有血液进入,这是由于眼睛受到严重损伤所致。前房积血可能会导致一些罕见的并发症,这些并发症通常会导致永久性视力丧失。并发症包括眼压升高、角膜血染、前后粘连和视神经萎缩。镰状细胞特征或镰状细胞病患者可能特别容易出现眼压升高和视神经萎缩。再次出血与并发症的发生率和严重程度增加有关。

目的

评估各种医学干预措施在创伤性前房积血治疗中的效果。

检索方法

我们检索了 Cochrane 中央对照试验注册库(CENTRAL)(包含 Cochrane 眼部和视觉试验注册库)(2022 年,第 3 期);MEDLINE Ovid;Embase.com;PubMed(1948 年至 2022 年 3 月);ISRCTN 注册库;ClinicalTrials.gov;以及世界卫生组织(WHO)国际临床试验注册平台(ICTRP)。检索的最后日期为 2022 年 3 月 22 日。

选择标准

两位综述作者独立评估了通过电子和手动搜索确定的所有报告的标题和摘要。我们纳入了比较各种(非手术)医学干预措施与其他医学干预措施或对照组治疗闭合性眼球外伤后创伤性前房积血的随机和准随机试验。我们对年龄、性别、闭合性眼球外伤的严重程度或纳入时的视力水平没有任何限制。

数据收集和分析

我们使用了 Cochrane 预期的标准方法程序,并使用 GRADE 评估了证据的确定性。

主要结果

我们纳入了 23 项随机试验和 7 项准随机试验,共纳入 2969 名参与者。干预措施包括抗纤维蛋白溶解剂(全身和局部氨基己酸、氨甲环酸和氨基甲基苯甲酸)、皮质类固醇(全身和局部)、睫状肌麻痹剂、缩瞳剂、阿司匹林、结合雌激素、中药、单眼与双眼贴敷、头部抬高和卧床休息。我们发现,在视力方面,任何干预措施都没有效果,无论是在两周内(短期)还是更长时间内。在两项试验的一项荟萃分析中,我们发现氨基己酸对长期视力没有影响(RR 1.03,95%置信区间[CI] 0.82 至 1.29)或积血后三年时的最终视力(RR 1.05,95%CI 0.93 至 1.18)。口服氨甲环酸在四项试验中对视力的改善作用似乎很小(RR 1.12,95%CI 1.00 至 1.25)。其余试验评估了各种干预措施对短期视力的影响;这些干预措施都没有在超过一项试验中进行测量。没有一项干预措施具有统计学显著效果(RR 范围从 0.75 到 1.10)。同样,四项评估不同干预措施的长期视力测量结果也没有统计学意义(RR 范围从 0.82 到 1.02)。支持这些发现的证据确定性为低或极低。全身氨基己酸降低了再出血的发生率(RR 0.28,95%CI 0.13 至 0.60),这在六项试验中对 330 名参与者进行了评估。一项排除了两项未采用意向治疗分析的研究的敏感性分析降低了证据的强度(RR 0.43,95%CI 0.17 至 1.08)。我们在两项试验中也得到了相似的结果,两项试验共纳入 131 名参与者,结果显示局部氨基己酸(RR 0.48,95%CI 0.20 至 1.10)也有相同的效果。我们将证据的确定性评估为低。全身氨甲环酸在降低 754 名参与者的二次出血发生率(RR 0.33,95%CI 0.21 至 0.53)方面有显著效果,氨基甲基苯甲酸(RR 0.10,95%CI 0.02 至 0.41)也有同样的效果,这是一项研究的结果。支持抗纤维蛋白溶解剂降低继发性出血相关并发症(即角膜血染、周边前粘连、眼压升高和视神经萎缩)风险的证据有限,因为这些事件的数量较少。与安慰剂相比,使用氨基己酸会增加恶心、呕吐和其他不良反应。我们发现,使用全身与局部氨基己酸或标准与较低药物剂量之间,对不良事件数量没有影响。与不使用相比,全身使用氨基己酸似乎会使原发性前房积血消退的时间更长,但这一结果并没有因任何其他干预措施而改变。关于全身性或局部皮质类固醇、睫状肌麻痹剂或阿司匹林在创伤性前房积血中的使用的证据由于试验中参与者和事件数量较少而受到限制。我们发现,单眼与双眼贴敷对二次出血或再出血时间没有影响。我们还发现,在步行与完全卧床休息之间,对二次出血的风险也没有影响。

作者结论

我们发现,在本综述中评估的任何干预措施对视力都没有影响。尽管证据有限,但患有创伤性前房积血的人接受氨基己酸或氨甲环酸不太可能发生二次出血。然而,与全身使用氨基己酸相比,前房积血清除的时间更长。没有良好的证据支持在创伤性前房积血的治疗中使用抗纤维蛋白溶解剂,除了可能降低二次出血的发生率。继发性出血的潜在长期不良影响尚不清楚。同样,也没有证据支持在创伤性前房积血的治疗中使用皮质类固醇、睫状肌麻痹剂或非药物干预措施(如贴敷、卧床休息或头部抬高)。由于这些多种干预措施很少单独使用,因此进一步研究评估这些干预措施的附加效果可能是有价值的。

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Cochrane Database Syst Rev. 2019 Jan 14;1(1):CD005431. doi: 10.1002/14651858.CD005431.pub4.
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Medical interventions for traumatic hyphema.外伤性前房积血的医学干预措施。
Cochrane Database Syst Rev. 2013 Dec 3;12(12):CD005431. doi: 10.1002/14651858.CD005431.pub3.
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Cochrane Database Syst Rev. 2011 Jan 19(1):CD005431. doi: 10.1002/14651858.CD005431.pub2.
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Antifibrinolytic agents in traumatic hemorrhage.创伤性出血中的抗纤溶药物。
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