猪促胰液素治疗自闭症的多中心、双盲、安慰剂对照试验。
Multisite, double-blind, placebo-controlled trial of porcine secretin in autism.
作者信息
Owley T, McMahon W, Cook E H, Laulhere T, South M, Mays L Z, Shernoff E S, Lainhart J, Modahl C B, Corsello C, Ozonoff S, Risi S, Lord C, Leventhal B L, Filipek P A
机构信息
Department of Psychiatry, University of Chicago, IL 60637, USA.
出版信息
J Am Acad Child Adolesc Psychiatry. 2001 Nov;40(11):1293-9. doi: 10.1097/00004583-200111000-00009.
OBJECTIVE
To examine the efficacy of intravenous porcine secretin for the treatment of autistic disorder.
METHOD
Randomized, double-blind, placebo-controlled, crossover design. Fifty-six subjects with autistic disorder received either a secretin or placebo infusion at baseline and the other substance at week 4. Subjects were given the Autism Diagnostic Observation Schedule (ADOS) and other pertinent developmental measures at baseline and at weeks 4 and 8 to assess drug effects.
RESULTS
For the primary efficacy analysis, change of ADOS social-communication total score from week 0 to week 4, no statistically significant difference was obtained between placebo (-0.8 +/- 2.9) and secretin groups (-0.6 +/- 1.4; t54 = 0.346, p < .73). The other measures showed no treatment effect for secretin compared with placebo.
CONCLUSION
There was no evidence for efficacy of secretin in this randomized, placebo-controlled, double-blind trial.
目的
研究静脉注射猪促胰液素治疗自闭症谱系障碍的疗效。
方法
随机、双盲、安慰剂对照、交叉设计。56名自闭症谱系障碍受试者在基线时接受促胰液素或安慰剂输注，在第4周接受另一种物质输注。在基线、第4周和第8周对受试者进行自闭症诊断观察量表（ADOS）和其他相关发育指标评估，以评估药物效果。
结果
对于主要疗效分析，即从第0周至第4周ADOS社交沟通总分的变化，安慰剂组（-0.8±2.9）和促胰液素组（-0.6±1.4；t54 = 0.346，p < 0.73）之间未获得统计学上的显著差异。与安慰剂相比，其他指标未显示促胰液素的治疗效果。
结论
在这项随机、安慰剂对照、双盲试验中，没有证据表明促胰液素具有疗效。
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