Collet J P, Vanasse M, Marois P, Amar M, Goldberg J, Lambert J, Lassonde M, Hardy P, Fortin J, Tremblay S D, Montgomery D, Lacroix J, Robinson A, Majnemer A
Randomised Clinical Trial Unit, Jewish General Hospital, Montreal, Quebec, Canada.
Lancet. 2001 Feb 24;357(9256):582-6. doi: 10.1016/s0140-6736(00)04054-x.
The use of hyperbaric oxygen for children with cerebral palsy has spread worldwide, despite little scientific evidence of efficacy. We did a randomised trial to assess the efficacy and side-effects of this form of therapy in children with cerebral palsy.
111 children with cerebral palsy aged 3-12 years were randomly assigned hyperbaric oxygen (n=57) or slightly pressurised room air (n=54). All children received 40 treatments over 2 months. Hyperbaric oxygen treatment was 1 h in 100% oxygen at 1.75 atmospheres absolute (ATA); children on slightly pressurised air received air at 1.3 ATA (the lowest pressure at which pressure can be felt, thereby ensuring the maintenance of masking). The main outcome measure was gross motor function. Secondary outcomes included performance in activities of daily living, attention, working memory, and speech.
For all outcomes, both groups improved over the course of the study, but without any difference between the two treatments. The score on the global gross motor function measure increased by 3.0% in the children on slightly pressurised air and 2.9% in those on hyperbaric oxygen. The mean difference between treatments was -0.40 (95% CI -1.69 to 0.90, p=0.544). Other changes were seen in speech, attention, memory, and functional skills. Ear problems occurred in 27 children treated by hyperbaric oxygen and in 15 treated with hyperbaric air (p=0.004).
In this study, hyperbaric oxygen did not improve the condition of children with cerebral palsy compared with slightly pressurised air. The improvement seen in both groups for all dimensions tested deserves further consideration.
尽管几乎没有科学证据证明其有效性,但高压氧治疗脑瘫患儿的方法已在全球范围内广泛应用。我们进行了一项随机试验,以评估这种治疗方式对脑瘫患儿的疗效和副作用。
111名年龄在3至12岁的脑瘫患儿被随机分为高压氧组(n = 57)或微压室内空气组(n = 54)。所有患儿在2个月内接受40次治疗。高压氧治疗是在绝对压力1.75个大气压(ATA)下吸入100%氧气1小时;微压空气组患儿吸入压力为1.3 ATA的空气(能感觉到压力的最低压力,从而确保面罩的佩戴)。主要结局指标是粗大运动功能。次要结局包括日常生活活动能力、注意力、工作记忆和言语能力。
在所有结局方面,两组在研究过程中均有改善,但两种治疗方法之间没有差异。微压空气组患儿的总体粗大运动功能评分提高了3.0%,高压氧组提高了2.9%。治疗组之间的平均差异为-0.40(95%置信区间-1.69至0.90,p = 0.544)。在言语、注意力、记忆和功能技能方面也有其他变化。27名接受高压氧治疗的患儿和15名接受微压空气治疗的患儿出现耳部问题(p = 0.004)。
在本研究中,与微压空气相比,高压氧并未改善脑瘫患儿的病情。两组在所有测试维度上的改善值得进一步研究。