Wild John M, Ahn Hyo-sook, Baulac Michel, Bursztyn Joseph, Chiron Catherine, Gandolfo Enrico, Safran Avinoam B, Schiefer Ulrich, Perucca Emilio
Cardiff School of Optometry and Vision Sciences, Cardiff University, Cardiff, United Kingdom.
Epilepsia. 2007 Jul;48(7):1318-27. doi: 10.1111/j.1528-1167.2007.01133.x.
The risk factors for visual field loss attributable to vigabatrin (VAVFL) are equivocal. This multinational, prospective, observational study aimed to clarify the principal/major factors for VAVFL.
Interim analysis of three groups with refractory partial epilepsy, stratified by age (8-12 years; >12 years) and exposure to vigabatrin (VGB). Group I comprised participants treated with VGB for >or=6 months, Group II participants previously treated with VGB for >or=6 months who had discontinued the drug for >or=6 months and Group III those never treated with VGB. Perimetry was undertaken at least every six months, for up to 36 months; results were evaluated masked to drug exposure.
Based upon 563 participants in the locked data set, 432 yielded one or more Conclusive visual field examinations. For Group I, the frequency of VAVFL at the last Conclusive examination was 10/32 (31.2%) for those aged 8-12 years and 52/125 (41.6%) for those aged >12 years. For Group II, the proportions were 4/39 (10.3%) and 31/129 (24.0%). No cases resembling VAVFL manifested in Group III. VAVFL was associated with duration of VGB therapy (Odds ratio [OR] 14.2; 95% CI 5.0 to 40.5); mean dose of VGB (OR 8.5; 95% CI 2.2 to 33.2); and male gender (OR 2.1; 95% CI 1.2 to 3.7). VAVFL was more common with static than kinetic perimetry (OR 2.3, 95% CI 1.3 to 4.2).
The therapeutic benefit of VGB is counteracted by the progressive accrual of the risk of VAVFL with continued exposure and with increase in mean dose.
因vigabatrin导致视野缺损（VAVFL）的危险因素尚不明确。这项跨国、前瞻性、观察性研究旨在明确VAVFL的主要因素。
对三组难治性部分性癫痫患者进行中期分析，根据年龄（8 - 12岁；大于12岁）和vigabatrin（VGB）暴露情况分层。第一组包括接受VGB治疗≥6个月的参与者，第二组是先前接受VGB治疗≥6个月且已停药≥6个月的参与者，第三组是从未接受过VGB治疗的参与者。每六个月至少进行一次视野检查，最长持续36个月；结果在对药物暴露情况不知情的情况下进行评估。
基于锁定数据集中的563名参与者，432人进行了一次或多次确定性视野检查。对于第一组，8 - 12岁患者在最后一次确定性检查时VAVFL的发生率为10/32（31.2%），大于12岁患者为52/125（41.6%）。对于第二组，比例分别为4/39（10.3%）和31/129（24.0%）。第三组未出现类似VAVFL的病例。VAVFL与VGB治疗持续时间（比值比[OR] 14.2；95%置信区间5.0至40.5）、VGB平均剂量（OR 8.5；95%置信区间2.2至33.2）以及男性性别（OR 2.1；95%置信区间1.2至3.7）相关。与动态视野检查相比，静态视野检查中VAVFL更常见（OR 2.3，95%置信区间1.3至4.2）。
随着持续暴露和平均剂量增加，VAVFL风险逐渐累积，抵消了VGB的治疗益处。
