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JAMA:乙酰唑胺对有特发性颅内高压和轻度视力缺损患者视功能的影响

2014-06-16 NORDIC特发性颅内高压研究组写作委员会 中国医学论坛报JAMA专版

意义  乙酰唑胺常用于治疗特发性颅内高压(IIH),但建立其应用的证据库信息尚不充分。【原文下载】   目的  在IIH和轻度视力缺损的患者中,确定低钠减重饮食加乙酰唑胺是否有益于改善视力。   设计、场所和患者  在165名接受低钠减重饮食且有IIH和轻度视力缺损的参与者中,进行乙酰唑胺多中心、随机、双盲、安慰剂对照

意义  乙酰唑胺常用于治疗特发性颅内高压(IIH),但建立其应用的证据库信息尚不充分。【原文下载】
   

目的  在IIH和轻度视力缺损的患者中,确定低钠减重饮食加乙酰唑胺是否有益于改善视力。
   
设计、场所和患者  在165名接受低钠减重饮食且有IIH和轻度视力缺损的参与者中,进行乙酰唑胺多中心、随机、双盲、安慰剂对照研究。从2010年3月至2012年11月,在北美38家学术机构和私人诊所纳入参与者,并随访6个月(最后一次就诊为2013年6月)。所有参与者均满足修订版丹迪IIH标准,视野计平均偏差(PMD)为-2~-7dB。平均年龄为29岁,除了4名之外的所有参与者均为女性。
   
干预措施  给予低钠减重饮食加最大耐受剂量的乙酰唑胺(最大剂量4g/d)或匹配的安慰剂,治疗6个月。
   
主要转归与检测指标  计划主要转归变量为受累最严重眼睛PMD从基线至第6个月的改变,通过汉弗莱视野分析仪进行检查。PMD是全视野缺损的一个指标(相对于年龄校正正常值的平均偏差),范围为-32~2dB,较大负值表示视力缺损较严重。次要转归变量包括6个月内视乳头水肿分级、生活质量[视功能问卷25(VFQ-25)和36项简明健康调查表]、头痛所致失能以及体重的变化。
   
结果  乙酰唑胺组(1.43dB,n=86)PMD平均增幅大于安慰剂组(0.71dB,n=79),两组PMD分别从基线-3.53dB增至第6个月时的-2.10dB,从-3.53dB增至-2.82dB,差异为0.71dB[95%可信区间(CI)为0~1.43dB,P=0.050]。乙酰唑胺组观察指标如下:视乳头水肿分级平均改善(乙酰唑胺:-1.31,从2.76~1.45;安慰剂:-0.61,从2.76~2.15;治疗效果为-0.70,95%CI为-0.99~-0.41,P<0.001)、美国国立眼科研究所VFQ-25检测的视力相关生活质量改善(乙酰唑胺:8.33,从82.97~91.30;安慰剂:1.98,从82.97~84.95,治疗效果为6.35,95%CI为2.22~10.47,P=0.003)、10项神经眼科补充项目(乙酰唑胺:9.82,从75.45~85.27;安慰剂:1.59,从75.45~77.04,治疗效果为8.23,95%CI为3.89~12.56,P<0.001)。被分至乙酰唑胺治疗组的参与者,体重也减轻(乙酰唑胺:-7.50kg,从107.72~100.22kg;安慰剂:-3.45kg,从107.72~104.27kg;治疗效果为-4.05kg,95%CI为-6.27~-1.83kg,P<0.001)。
   
结论和相关性  在有IIH和轻度视力缺损的患者中,与单纯饮食相比,乙酰唑胺与低钠减重饮食联合可使视野功能轻度改善。上述改善的临床意义还有待确定。

原始出处:

NORDIC Idiopathic Intracranial Hypertension Study Group Writing Committee, Wall M1, McDermott MP2, Kieburtz KD2, Corbett JJ3, Feldon SE4, Friedman DI5, Katz DM6, Keltner JL7, Schron EB8, Kupersmith MJ9.Effect of acetazolamide on visual function in patients with idiopathic intracranial hypertension and mild visual loss: the idiopathic intracranial hypertension treatment trial.JAMA. 2014 Apr 23-30;311(16):1641-51. doi: 10.1001/jama.2014.3312.【原文下载】


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