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高剂量静脉注射甲基强的松龙治疗近期外伤性视神经病变;一项随机双盲安慰剂对照临床试验。

High-dose intravenous methylprednisolone in recent traumatic optic neuropathy; a randomized double-masked placebo-controlled clinical trial.

作者信息

Entezari Morteza, Rajavi Zhaleh, Sedighi Neda, Daftarian Narssis, Sanagoo Masoumeh

机构信息

Department of Ophthalmology, Emam Hossein Medical Center, Ophthalmic Research Center, Shaheed Beheshti University of Medical Sciences, Tehran, Iran.

出版信息

Graefes Arch Clin Exp Ophthalmol. 2007 Sep;245(9):1267-71. doi: 10.1007/s00417-006-0441-0. Epub 2007 Jan 31.

Abstract

BACKGROUND

To compare the effect of high-dose intravenous corticosteroid therapy with placebo in the treatment of recent traumatic optic neuropathy (TON).

METHODS

In a double-masked placebo-controlled clinical trial, 31 eyes of 31 patients were randomly assigned to two groups. Patients with history of trauma < or =7 days were included. Unconscious patients, eyes with penetrating trauma and candidates for decompression surgery were excluded. The treatment group (16 eyes) received 250 mg methylprednisolone intravenously every 6 h for 3 days, then 1 mg/kg prednisolone orally for 14 days; the placebo group (15 eyes) received 50 ml normal saline intravenously every 6 h for 3 days, then placebo for 14 days. Visual improvement was considered as a decrease of at least 0.4 logMAR in final visual acuity.

RESULTS

Mean final BCVA (best corrected visual acuity) in the treatment group was 1.11+/- 1.14 and the placebo group was 1.78 +/- 1.23. This difference was not significant (P = 0.13). Visual acuity was improved in 68.8% of the treatment group and 53.3% of the placebo group, but the difference was not statistically significant (P = 0.38). The difference between initial and final BCVA in both groups was determined to be statistically significant (P < 0.001 and 0.010 respectively).

CONCLUSIONS

Our study confirms earlier findings that there is no difference in visual acuity improvement between intravenous high-dose corticosteroids and placebo in treatment of recent TNO.

摘要

背景

比较大剂量静脉注射皮质类固醇疗法与安慰剂治疗近期外伤性视神经病变(TON)的效果。

方法

在一项双盲安慰剂对照临床试验中,31例患者的31只眼被随机分为两组。纳入创伤史≤7天的患者。排除无意识患者、穿透性眼外伤患者和减压手术候选者。治疗组(16只眼)每6小时静脉注射250毫克甲泼尼龙,共3天,然后口服1毫克/千克泼尼松龙,共14天;安慰剂组(15只眼)每6小时静脉注射50毫升生理盐水,共3天,然后服用安慰剂14天。视力改善定义为最终视力至少下降0.4 logMAR。

结果

治疗组的平均最终最佳矫正视力(BCVA)为1.11±1.14,安慰剂组为1.78±1.23。差异无统计学意义(P = 0.13)。治疗组68.8%的患者视力改善,安慰剂组为53.3%,但差异无统计学意义(P = 0.38)。两组初始和最终BCVA的差异均具有统计学意义(分别为P < 0.001和0.010)。

结论

我们的研究证实了早期的研究结果,即大剂量静脉注射皮质类固醇与安慰剂治疗近期外伤性视神经病变在视力改善方面无差异。

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