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用于外伤性视神经病变的类固醇药物。

Steroids for traumatic optic neuropathy.

作者信息

Yu-Wai-Man Patrick, Griffiths Philip G

机构信息

Department of Ophthalmology, Royal Victoria Infirmary, Newcastle upon Tyne, UK, NE1 4LP.

出版信息

Cochrane Database Syst Rev. 2011 Jan 19(1):CD006032. doi: 10.1002/14651858.CD006032.pub3.

Abstract

BACKGROUND

Traumatic optic neuropathy (TON) is an important cause of severe visual loss following blunt or penetrating head trauma. Following the initial injury, optic nerve swelling within the optic nerve canal can result in secondary retinal ganglion cell loss. Optic nerve decompression with steroids or surgical interventions or both has therefore been advocated as a means of improving visual prognosis in TON.

OBJECTIVES

The aim of this review was to examine the effectiveness and safety of using steroids in TON.

SEARCH STRATEGY

We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2010, Issue 11), MEDLINE (January 1950 to November 2010), EMBASE (January 1980 to November 2010), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to November 2010), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (http://clinicaltrials.gov) and Web of Science Conference Proceedings Citation Index- Science (CPCI-S). There were no language or date restrictions in the search for trials. The electronic databases were last searched on 23 November 2010. We also searched the reference lists of included studies, other reviews and book chapters on TON to find references to additional trials. The Science Citation Index was used to look for papers that cited the studies included in this review. We did not manually search any journals or conference proceedings. We contacted trial investigators and experts in the field to identify additional published and unpublished studies.

SELECTION CRITERIA

We planned to include only randomised controlled trials (RCTs) of TON in which any steroid regime, either on its own or in combination with surgical optic nerve decompression, was compared to surgery alone or no treatment.

DATA COLLECTION AND ANALYSIS

Two review authors independently assessed the titles and abstracts identified from the electronic searches.

MAIN RESULTS

We included one study that met our selection criteria; a double-masked, placebo-controlled, randomised trial of high dose intravenous steroids in patients with indirect TON diagnosed within seven days of the initial injury. A total of 31 eligible participants were randomised to receive either high dose intravenous steroids (n = 16) or placebo (n = 15), and they were all followed-up for three months. Mean final best corrected visual acuity (BCVA) was 1.78±1.23 Logarithm of the Minimum Angle of Resolution (LogMAR) in the placebo group, and 1.11±1.14 LogMAR in the steroid group. The mean difference in BCVA between the placebo and steroid groups was 0.67 LogMAR (95% confidence interval -1.54 to 0.20), and this difference was not statistically significant (P = 0.13). At three months follow-up, an improvement in BCVA of 0.40 LogMAR occurred in eight eyes (8/15, 53.3%) in the placebo group, and in 11 eyes (11/16, 68.8%) in the treatment group. This difference was not statistically significant (P = 0.38).

AUTHORS' CONCLUSIONS: There is a relatively high rate of spontaneous visual recovery in TON and there is no convincing data that steroids provide any additional visual benefit over observation alone. Recent evidence also suggests a possible detrimental effect of steroids in TON and further studies are urgently needed to clarify this important issue. Each case therefore needs to be assessed on an individual basis and proper informed consent is paramount.

摘要

背景

创伤性视神经病变(TON)是钝性或穿透性头部外伤后导致严重视力丧失的重要原因。在初始损伤后,视神经管内的视神经肿胀可导致继发性视网膜神经节细胞丢失。因此,有人主张使用类固醇或手术干预或两者结合进行视神经减压,作为改善TON视力预后的一种方法。

目的

本综述的目的是研究在TON中使用类固醇的有效性和安全性。

检索策略

我们检索了CENTRAL(其中包含Cochrane眼科与视觉组试验注册库)(《Cochrane图书馆》2010年第11期)、MEDLINE(1950年1月至2010年11月)、EMBASE(1980年1月至2010年11月)、拉丁美洲和加勒比地区健康科学文献数据库(LILACS)(1982年1月至2010年11月)、对照试验元注册库(mRCT)(www.controlled-trials.com)、ClinicalTrials.gov(http://clinicaltrials.gov)以及科学网会议论文被引频次索引-科学版(CPCI-S)。检索试验时没有语言或日期限制。电子数据库最后一次检索时间为2010年11月23日。我们还检索了纳入研究的参考文献列表、关于TON的其他综述和书籍章节,以查找其他试验的参考文献。使用科学引文索引查找引用本综述中所纳入研究的论文。我们没有手动检索任何期刊或会议论文集。我们联系了试验研究者和该领域的专家,以确定其他已发表和未发表的研究。

选择标准

我们计划仅纳入TON的随机对照试验(RCT),其中任何类固醇治疗方案,单独使用或与手术视神经减压联合使用,与单独手术或不治疗进行比较。

数据收集与分析

两位综述作者独立评估从电子检索中识别出的标题和摘要。

主要结果

我们纳入了一项符合我们选择标准的研究;一项对初始损伤后7天内诊断为间接TON的患者进行高剂量静脉注射类固醇的双盲、安慰剂对照随机试验。共有31名符合条件的参与者被随机分配接受高剂量静脉注射类固醇(n = 16)或安慰剂(n = 15),并对他们全部进行了3个月的随访。安慰剂组最终最佳矫正视力(BCVA)的平均对数最小分辨角(LogMAR)为1.78±1.23,类固醇组为1.11±1.14。安慰剂组和类固醇组之间BCVA的平均差异为0.67 LogMAR(95%置信区间为-1.54至0.20),且该差异无统计学意义(P = 0.13)。在3个月的随访中,安慰剂组15只眼中有8只眼(8/15,53.3%)的BCVA改善了0.40 LogMAR,治疗组16只眼中有11只眼(11/16,68.8%)改善。该差异无统计学意义(P = 0.38)。

作者结论

TON中自发视力恢复的发生率相对较高,且没有令人信服的数据表明类固醇比单独观察能提供任何额外的视力益处。最近的证据还表明类固醇在TON中可能有有害作用,迫切需要进一步研究来阐明这一重要问题。因此,每个病例都需要进行个体化评估,适当的知情同意至关重要。

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