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那屈肝素钙与阿司匹林治疗视网膜静脉阻塞的随机、双盲、对照研究。

Parnaparin versus aspirin in the treatment of retinal vein occlusion. A randomized, double blind, controlled study.

机构信息

University of Insubria, Varese, Italy.

出版信息

Thromb Res. 2010 Feb;125(2):137-41. doi: 10.1016/j.thromres.2009.05.007. Epub 2009 May 27.

Abstract

INTRODUCTION

Retinal vein occlusion (RVO) is a common cause of unilateral visual loss. Evidence based treatment recommendations for patients with RVO cannot be made because of the lack of adequate clinical trials. To compare the efficacy and safety of aspirin and of a low molecular weight heparin, parnaparin, in the treatment of RVO.

MATERIALS AND METHODS

In a multicenter, randomized, double blind, controlled trial eligible patients with a delay between symptoms onset and objective diagnosis of less than 15 days were randomized to aspirin 100 mg/day for 3 months or to a fixed daily dose of parnaparin, 12.800 IU for 7 days followed by 6.400 IU for a total of 3 months. Primary end-point of the study was the incidence of functional worsening of the eye with RVO at 6 months, as assessed by fluorescein angiography, visual acuity, and visual field. Study end-points were adjudicated by an independent committee.

RESULTS

Sixty-seven patients were enrolled in the study and 58 of them (28 treated with parnaparin, 30 with aspirin) were evaluable for the analysis. Baseline characteristics were well balanced between groups. Functional worsening was adjudicated in 20.7% of patients treated with parnaparin and in 59.4% of patients treated with ASA (p=0.002). Recurrent RVO was diagnosed in 3 patients, all treated with ASA (p=n.s.). Bleeding rates were similar between the two groups.

CONCLUSIONS

Parnaparin appears to be more effective than aspirin in preventing functional worsening in patients with RVO. The results of this study need to be confirmed in a larger clinical trial.

摘要

简介

视网膜静脉阻塞(RVO)是单侧视力丧失的常见原因。由于缺乏足够的临床试验,无法为 RVO 患者制定基于证据的治疗建议。评估阿司匹林和低分子肝素那曲肝素在治疗 RVO 中的疗效和安全性。

材料和方法

在一项多中心、随机、双盲、对照试验中,纳入症状发作和客观诊断之间的时间间隔小于 15 天的合格患者,随机分为每天服用阿司匹林 100mg 治疗 3 个月或每天固定剂量那曲肝素 12800IU 治疗 7 天,随后总疗程为 3 个月的 6400IU。研究的主要终点是 6 个月时通过荧光素血管造影、视力和视野评估 RVO 眼的功能恶化发生率。研究终点由独立委员会裁决。

结果

67 例患者入组,其中 58 例(28 例接受那曲肝素治疗,30 例接受阿司匹林治疗)可进行分析。组间基线特征均衡。那曲肝素治疗组 20.7%的患者出现功能恶化,而阿司匹林治疗组 59.4%的患者出现功能恶化(p=0.002)。3 例患者再次发生 RVO,均接受 ASA 治疗(p=n.s.)。两组出血发生率相似。

结论

那曲肝素似乎比阿司匹林更能有效预防 RVO 患者的功能恶化。需要在更大的临床试验中进一步证实这些结果。

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