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高压氧治疗儿童自闭症:一项随机对照试验。

Hyperbaric oxygen in the treatment of childhood autism: a randomised controlled trial.

作者信息

Sampanthavivat Mayuree, Singkhwa Wararat, Chaiyakul Thanasawat, Karoonyawanich Sangdaw, Ajpru Haruthai

机构信息

Somdej Prapinklao Hospital, Naval Medical Department, Royal Thai Navy, Thailand.

出版信息

Diving Hyperb Med. 2012 Sep;42(3):128-33.

PMID:22987458
Abstract

BACKGROUND

Promising results with hyperbaric therapy for children with autism have been reported, but most involved the use of only mild pressure with oxygen supplementation. To date, there has been no randomised, blinded trial of 100% oxygen administered at hyperbaric pressure. This study evaluated the efficacy of hyperbaric oxygen therapy (HBOT).

METHODS

Sixty Thai children with autism, aged three to nine years, were randomly assigned to receive 20 one-hour sessions of either HBOT at 153 kPa (1.5 ATA) or sham air at 116 kPa (1.15 ATA). Effects on behaviour were measured using the Autism Treatment Evaluation Checklist score (ATEC) and clinical improvement was measured with the Clinical Global Impression (CGI) system; in particular the clinical change (CGIC) and severity (CGIS) sub-scores. These were evaluated by parents and clinicians, both of whom were blinded to the actual exposure.

RESULTS

The mean total ATEC scores by both parents and clinicians were significantly improved after intervention in both arms of the study compared to the score before intervention (P < 0.001 in both groups by parents, P = 0.015 in HBOT group and P = 0.004 in sham group by clinician). There were no statistically significant differences in average percentage changes of total ATEC score and all subscales scores when comparing the HBOT and sham air groups, either by parents or clinicians. Changes in the CGI scores following intervention were inconsistent between parents and clinicians. For severity scores (CGIS), parents rated their children as more improved following HBOT (P = 0.005), while the clinicians found no significant differences (P = 0.10). On the other hand, for change scores (CGIC) the clinicians indicated greater improvement following HBOT (P = 0.03), but the parents found no such difference (P = 0.28).

CONCLUSIONS

Children with autism who received 20 sessions of either HBOT or a sham air exposure had significant improvements in overall behaviour but there were no significant differences in improvement between groups. The inconsistent changes on CGI sub-scores between parents and clinicians are difficult to interpret, but no overall clinically significant benefit from HBOT could be shown. Both interventions were safe and well tolerated with minimal side effect from middle ear barotraumas.

摘要

背景

已有报道称高压氧疗法对自闭症儿童有显著效果,但大多数研究仅采用轻度压力并补充氧气。迄今为止,尚无关于在高压下给予100%氧气的随机、双盲试验。本研究评估了高压氧疗法(HBOT)的疗效。

方法

60名年龄在3至9岁的泰国自闭症儿童被随机分配,分别接受20次时长为1小时的153 kPa(1.5 ATA)的高压氧治疗或116 kPa(1.15 ATA)的模拟空气治疗。使用自闭症治疗评估清单评分(ATEC)来衡量对行为的影响,并用临床总体印象(CGI)系统来衡量临床改善情况,特别是临床变化(CGIC)和严重程度(CGIS)子评分。这些由家长和临床医生进行评估,他们均对实际治疗情况不知情。

结果

与干预前的评分相比,研究的两个组在干预后家长和临床医生评估的平均ATEC总分均有显著改善(家长评估两组均P < 0.001,临床医生评估高压氧治疗组P = 0.015,模拟空气组P = 0.004)。在比较高压氧治疗组和模拟空气组时,无论是家长还是临床医生评估的ATEC总分及所有子量表分数的平均百分比变化均无统计学显著差异。干预后CGI评分的变化在家长和临床医生之间不一致。对于严重程度评分(CGIS),家长认为其孩子在接受高压氧治疗后改善更大(P = 0.005),而临床医生未发现显著差异(P = 0.10)。另一方面,对于变化评分(CGIC),临床医生指出高压氧治疗后改善更大(P = 0.03),但家长未发现此差异(P = 0.28)。

结论

接受20次高压氧治疗或模拟空气暴露的自闭症儿童在总体行为上有显著改善,但两组之间的改善无显著差异。家长和临床医生在CGI子评分上的变化不一致,难以解释,但未显示出高压氧治疗有总体临床显著益处。两种干预措施均安全且耐受性良好,中耳气压伤的副作用最小。

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