The Longitudinal Idiopathic Intracranial Hypertension Trial: Outcomes From Months 6-12.
The Longitudinal Idiopathic Intracranial Hypertension Trial: Outcomes From Months 6-12.
复制标题
纵向特发性颅内高压试验：第 6-12 个月的结果。
DOI：
10.1016/j.ajo.2017.01.004
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发表时间：
2017
影响因子：
4.2
通讯作者：
NORDICIdiopathicIntracranialHypertensionStudyGroup
中科院分区：
文献类型：
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作者：
Wall,Michael;Kupersmith,MarkJ;Thurtell,MatthewJ;Moss,HeatherE;Moss,ElizabethAnn;Auinger,Peggy;NORDICIdiopathicIntracranialHypertensionStudyGroup
PurposeTo确定是否乙酰唑胺（ACZ）在改善视力在6个月的有益效果持续到12个月的参与者的特发性颅内高压治疗试验（IIHTT）。DesignNonrandomized clinical study. Methods在IIHTT，受试者被随机分配到安慰剂加饮食或最大耐受剂量的乙酰唑胺加饮食。6个月时，受试者从研究药物转换为ACZ。这导致以下组：（1）ACZ至ACZ; n = 34;（2）安慰剂至ACZ; n = 35;（3）ACZ至无治疗; n = 16;和（4）安慰剂至无治疗; n = 11。96例IIHTT受试者在6个月和12个月时接受了评价。我们的主要成果措施是从第6个月到第12个月的视野平均偏差（MD）的变化与次要措施是在视神经乳头水肿等级，ETDRS评分，和生活质量（QoL）measurements.ResultsThe ACZ ACZ组改善0.35 dB，P= 0.05;安慰剂受试者没有ACZ改善0.81 dB MD，P= 0.07在12个月。其他组MD改善0.35-0.46 dB。视神经乳头水肿等级的平均改善在用ACZ代替安慰剂的组中最为显著（0.91单位，P<0.001）。生活质量和头痛残疾评分显示，在安慰剂组与ACZ. ConclusionImprovement MD持续6个月至12个月的IIHTT在所有治疗组中，最显着的安慰剂组逐渐减少研究药物的显着改善。安慰剂组加用ACZ显著改善视神经乳头水肿分级、头痛和生活质量指标。
PurposeTo determine whether the beneficial effects of acetazolamide (ACZ) in improving vision at 6 months continues to month 12 in participants of the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT).DesignNonrandomized clinical study.MethodsIn the IIHTT, subjects were randomly assigned to placebo-plus-diet or maximally tolerated dosage of acetazolamide-plus-diet. At 6 months subjects transitioned from study drug to ACZ. This resulted in the following groups: (1) ACZ to ACZ; n = 34; (2) placebo to ACZ; n = 35; (3) ACZ to no treatment; n = 16; and (4) placebo to no treatment; n = 11. Ninety-six IIHTT subjects had evaluations at 6 and 12 months. Our main outcome measure was change from month 6 to month 12 in visual field mean deviation (MD) with secondary measures being change in papilledema grade, ETDRS scores, and quality-of-life (QoL) measures.ResultsThe ACZ to ACZ group improved 0.35 dB,P= .05; placebo subjects with no ACZ improved 0.81 dB MD,P= .07 at 12 months. The other groups improved 0.35–0.46 dB MD. Mean improvements in papilledema grade occurred most markedly in the group that exchanged placebo for ACZ (0.91 units,P< .001). QoL and headache disability scores showed significant improvements in the placebo group with added ACZ.ConclusionImprovements in MD continued from month 6 to month 12 of the IIHTT in all treatment groups, most marked in the placebo group tapered off study drug. Adding ACZ to the placebo group significantly improved papilledema grade, headache, and QoL measures.