Children's ibuprofen suspension for the acute treatment of pediatric migraine
Children's ibuprofen suspension for the acute treatment of pediatric migraine
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DOI：
10.1046/j.1526-4610.2002.02180.x
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发表时间：
2002-09-01
期刊：
影响因子：
5
通讯作者：
Lawson, L
中科院分区：
文献类型：
--
作者：
Lewis, DW;Kellstein, D;Lawson, L
目的：比较单次非处方剂量（7.5 毫克/公斤，口服）儿童布洛芬混悬液与安慰剂对小儿偏头痛急性治疗的疗效。背景：4% 的幼儿患有偏头痛。治疗儿童偏头痛的对照临床研究很少，目前美国还没有批准用于治疗 12 岁以下儿童偏头痛的药物。本研究的目的是评估单次 OTC 剂量的布洛芬混悬液用于急性治疗儿童偏头痛的功效和耐受性。方法。-对 6-12 岁偏头痛儿童进行的前瞻性、双盲、安慰剂对照、平行组、随机研究 (I.H.S.-R1997)，用 7.5 mg/kg 液体治疗 1 次发作。布洛芬与匹配的安慰剂。功效测量：(1) 给药后 30、60、90、120、180 和 240 分钟时基于 4 分等级的头痛严重程度（重度、中度、轻度、无头痛），以及 (2) 120 分钟时恶心、呕吐和恐光/恐声症。 1 度终点是 120 分钟内响应者（重度或轻度头痛减轻至轻度或无头痛）的累积百分比。次要终点是 4-24 小时内头痛复发以及 4 小时内需要救援药物。结果 -138 人入组； 84 份处理/完成的日记。 45 名活性剂，39 名安慰剂。两组具有可比性（活性组：安慰剂） - 年龄：9：9.1，性别男孩/女孩 - 1.25：1.6，诊断：无先兆偏头痛 - 86%：79%。联合使用预防性 Rx：24%：10%。
Objective.-To compare the efficacy of a single over-the-counter dose (7.5 mg/kg, p.o.) of children's ibuprofen suspension vs. placebo for the acute treatment of pediatric migraine.Background.-Migraine occurs in 4% of young children. There is a paucity of controlled clinical research in the treatment of childhood migraine and there are currently no approved drugs in the USA for treatment of migraine in children less than or equal to12 years of age. The purpose of this study is to assess the efficacy and tolerability of a single OTC dose of ibuprofen suspension for the acute treatment of childhood migraine.Methods.-Prospective, double-blind, placebo-controlled, parallel group, randomized study of children 6-12 yrs with migraine (I.H.S.-R1997) treating 1 attack with a 7.5 mg/kg liq. ibuprofen vs matching placebo. Efficacy measures: (1) Headache severity based upon a 4 pt scale (severe, mod., mild, no headache) at 30, 60, 90, 120, 180 and 240 minutes post dose, and (2) nausea, vomiting, and photo/phonophobia at 120 min. The 1degrees endpoint was cumulative % of responders (severe or mod. headache reduced to mild or none) by 120 minutes. Secondary endpoints were headache recurrence within 4-24 hours and need for rescue medicines within 4 hours.Results.-138 enrolled; 84 treated/completed diary. 45 active agent, 39 placebo. The 2 groups were comparable (active: placebo) - Ages: 9: 9.1, gender boy/girl - 1.25: 1.6, and diagnosis: migraine w/o aura - 86%: 79%. Concomitant use of prophylactic Rx: 24%: 10%.