Levy S E, Souders M C, Wray J, Jawad A F, Gallagher P R, Coplan J, Belchic J K, Gerdes M, Mitchell R, Mulberg A 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):731-6. doi: 10.1136/adc.88.8.731.
To examine the effect of a single dose of human synthetic secretin (HSS) on behaviour and communication in children with autism spectrum disorder (ASD) using an objective measure of communication and social reciprocity and standardised rating scales.
Randomised, crossover, double blind, and placebo controlled trial of a single intravenous dose of human synthetic secretin (HSS) 2 CU/kg. The 62 subjects (3-8 years) were assigned to group 1 (saline placebo/HSS) or group 2 (HSS/saline placebo). Diagnosis was confirmed by ADI-R (Autism Diagnostic Interview-Revised) algorithm. Severity of symptoms was rated using the CARS (Childhood Autism Rating Scale). Outcome measures included Communication and Symbolic Behavior Scale (CSBS), Ritvo Real-life Rating Scale, weekly Global Rating Scale (GBRS) by parents and teachers, and daily log of gastrointestinal symptoms. The communication subscale of the CSBS, specifying communication function, reciprocity, and social-affective signalling was videotaped and scored by a blinded, trained observer.
Sixty one children completed the study. After randomisation, there were no significant differences in gender, race, age, and parent and teacher GBRS and Ritvo Scale between the two groups. Compared with placebo, secretin treatment was not associated with significant improvement of CSBS standard scores from baseline to 2 or 4 weeks post-infusion. Five children showed clinical improvement in standard scores: two after HSS and three after placebo. There were no significant changes in gastrointestinal symptoms after HSS or saline placebo.
A single dose of intravenous human secretin is not effective in changing behaviour and communication in children with ASD when compared to placebo.
采用客观的沟通和社会互动测量方法及标准化评定量表，研究单剂量人合成促胰液素（HSS）对自闭症谱系障碍（ASD）儿童行为和沟通的影响。
对单静脉注射剂量为2 CU/kg的人合成促胰液素（HSS）进行随机、交叉、双盲和安慰剂对照试验。62名3至8岁的受试者被分配到第1组（生理盐水安慰剂/HSS）或第2组（HSS/生理盐水安慰剂）。通过ADI-R（自闭症诊断访谈修订版）算法确诊。使用儿童自闭症评定量表（CARS）对症状严重程度进行评分。结果测量包括沟通和象征行为量表（CSBS）、里特沃现实生活评定量表、家长和教师每周总体评定量表（GBRS）以及胃肠道症状每日记录。由一名经过盲法培训的观察者对CSBS中指定沟通功能、互动性和社会情感信号的沟通子量表进行录像和评分。
61名儿童完成了研究。随机分组后，两组在性别、种族、年龄、家长和教师GBRS以及里特沃量表方面无显著差异。与安慰剂相比，促胰液素治疗在输注后2周或4周时，CSBS标准分数与基线相比无显著改善。5名儿童的标准分数有临床改善：2名在接受HSS治疗后，3名在接受安慰剂治疗后。HSS或生理盐水安慰剂治疗后胃肠道症状无显著变化。
与安慰剂相比，单剂量静脉注射人促胰液素对ASD儿童的行为和沟通改变无效。
