DiTraglia J
Clin Pediatr (Phila). 1991 Dec;30(12):656-60. doi: 10.1177/000992289103001201.
This report examines the feasibility of double blind individual trials of methylphenidate versus placebo in a general pediatric practice to assess benefit of this medication in the treatment of attention deficit disorder. Children presenting with the diagnosis of attention deficit disorder were enrolled in a three-week protocol. The first week was a baseline week during which teachers and parents completed the Connors rating scales. During the second and third weeks of each trial, placebo or methylphenidate was given for a week each in an unknown order to parents, teachers or the investigator. Respective Connors rating scales were also completed for each of these weeks. At the end of the third week, the three parent questionnaires and the three teacher questionnaires were returned to the investigator for scoring and disclosure about findings. During a pilot period, 53% of the trials were improperly completed. Reasons for this were addressed and with simple measures the rate of successful completion was raised to 83%. During the study phase, 43% of the children were found to be hyperactive but they did not benefit from medication. In six trials there was disagreement between teachers and parents. The completed trials and many of the incompleted trials were helpful in the assessment of the children with attention deficit disorder and their response to medication. It is felt that this approach is suitable for a private general pediatric practice.
本报告探讨了在普通儿科诊所进行哌甲酯与安慰剂双盲个体试验的可行性，以评估该药物在治疗注意力缺陷障碍方面的益处。被诊断为注意力缺陷障碍的儿童参加了一项为期三周的方案。第一周为基线周，在此期间教师和家长完成康纳斯评定量表。在每次试验的第二周和第三周，以未知顺序分别给家长、教师或研究者服用一周的安慰剂或哌甲酯。这两周也分别完成了相应的康纳斯评定量表。在第三周结束时，三份家长问卷和三份教师问卷被返还给研究者进行评分并披露研究结果。在试验阶段，53%的试验未正确完成。针对此问题采取了措施，通过简单方法使成功完成率提高到了83%。在研究阶段，发现43%的儿童多动，但他们并未从药物治疗中获益。在六项试验中，教师和家长之间存在分歧。已完成的试验以及许多未完成的试验有助于评估患有注意力缺陷障碍的儿童及其对药物的反应。认为这种方法适用于私人普通儿科诊所。
