Unis Alan S, Munson Jeffrey A, Rogers Sally J, Goldson Ed, Osterling Julie, Gabriels Robin, Abbott Robert D, Dawson Geraldine
Department of Psychiatry and Behavioral Science, University of Washington, Seattle, WA 98195, USA.
J Am Acad Child Adolesc Psychiatry. 2002 Nov;41(11):1315-21. doi: 10.1097/00004583-200211000-00012.
To compare the effects of a single dose of biologic and synthetic porcine secretin to placebo on a variety of autism symptoms.
Eighty-five children with autism without other medical conditions and not taking other psychotropic medications participated (ages between 3 and 12 years, mean IQ = 55). Children were grouped into trios matched by age and communication level and then randomly assigned to one of three treatment groups: biologic secretin (2 CU/kg), synthetic secretin (0.4 microg/kg), and placebo. Measures collected 1 week before and 4 weeks after infusion included autism symptoms, language skills, and problem behaviors, gathered from parents, teachers, and investigators, who were all blind to treatment. Two-factor, repeated-measures analyses of variance (3 treatment levels by 2 repeated measures, pre- and postinfusion) were used to examine efficacy.
Direct observation measures did not show change over time related to secretin. Parent reports showed an overall reduction of symptom severity for all treatment groups, including the placebo group. One teacher-report measure showed decreases in autism symptoms in the placebo and synthetic secretin groups.
No evidence that either biologic or synthetic secretin provided amelioration of symptoms beyond placebo was observed. This held true when children with and without gastrointestinal problems were examined separately.
比较单剂量生物猪促胰液素和合成猪促胰液素与安慰剂对多种自闭症症状的影响。
85名无其他疾病且未服用其他精神药物的自闭症儿童参与研究(年龄在3至12岁之间,平均智商=55)。儿童按年龄和沟通水平匹配成三人小组,然后随机分配到三个治疗组之一:生物促胰液素(2 CU/kg)、合成促胰液素(0.4微克/千克)和安慰剂。在输注前1周和输注后4周收集的测量指标包括自闭症症状、语言技能和问题行为,这些数据来自家长、教师和研究人员,他们均对治疗情况不知情。采用双因素重复测量方差分析(3个治疗水平×2个重复测量,输注前和输注后)来检验疗效。
直接观察指标未显示与促胰液素相关的随时间变化。家长报告显示所有治疗组,包括安慰剂组,症状严重程度总体有所降低。一项教师报告指标显示安慰剂组和合成促胰液素组的自闭症症状有所减轻。
未观察到生物促胰液素或合成促胰液素比安慰剂更能改善症状的证据。对有胃肠道问题和无胃肠道问题的儿童分别进行检查时,情况也是如此。