Coplan J, Souders M C, Mulberg A E, Belchic J K, Wray J, Jawad A F, Gallagher P R, Mitchell R, Gerdes M, Levy S E
Division of Child Development and Rehabilitation, Children's Seashore House of The Children's Hospital of Philadelphia, Philadelphia, PA 19104, USA.
Arch Dis Child. 2003 Aug;88(8):737-9. doi: 10.1136/adc.88.8.737.
Standardised measures of behaviour have failed to detect short term improvement in children with autism following treatment with secretin. However, it is possible that standardised measures are insensitive to dimensions of child behaviour that are nonetheless detectable by parents.
To determine the ability of parents of children with autism to guess, under double blind conditions, whether their child had received secretin or placebo.
2x2 crossover randomised blinded study, comparing the effect of synthetic human secretin 2 U/kg to placebo (saline). Sixty two children with autism (aged 43-103 months) were randomly allocated to two groups: group 1 received placebo, followed six weeks later by secretin, and group 2 received secretin followed by placebo. At the conclusion of the study, parents were asked to guess their child's group assignment.
Twenty seven families guessed their child's group assignment correctly and 27 guessed incorrectly. In 48 instances, parents based their guess on perceived improvement; in six cases, parents based their guess on perceived deterioration. Six families saw no difference after either infusion, and offered no guess. One family dropped out after the first infusion, and one family was lost to follow up after the second infusion.
In a controlled setting, parents of young children with autism are unable to distinguish the short term behavioural effects of secretin from placebo.
行为标准化测量未能检测出自闭症儿童接受促胰液素治疗后的短期改善情况。然而,标准化测量可能对儿童行为的某些维度不敏感,而这些维度父母却能够察觉。
确定自闭症儿童的父母在双盲条件下猜测其孩子接受的是促胰液素还是安慰剂的能力。
2×2交叉随机双盲研究,比较合成人促胰液素2 U/kg与安慰剂(生理盐水)的效果。62名自闭症儿童(年龄43 - 103个月)被随机分为两组:第1组先接受安慰剂,六周后接受促胰液素,第2组先接受促胰液素,后接受安慰剂。在研究结束时,要求父母猜测孩子所属的分组。
27个家庭猜对了孩子的分组,27个家庭猜错。在48例中,父母根据感知到的改善情况进行猜测;在6例中,父母根据感知到的恶化情况进行猜测。6个家庭在两次输注后均未发现差异,未进行猜测。1个家庭在第一次输注后退出,1个家庭在第二次输注后失访。
在对照环境中,自闭症幼儿的父母无法区分促胰液素与安慰剂对行为的短期影响。