Maia Carlos Renato Moreira, Matte Breno Córdova, Ludwig Henrique Tschoepke, Rohde Luis Augusto
Graduate Program of Psychiatry, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.
Eur Child Adolesc Psychiatry. 2008 Apr;17(3):133-42. doi: 10.1007/s00787-007-0647-7.
To assess ADHD symptoms after switching from Methylphenidate Immediate-release (MPH-IR) to Methylphenidate Spheroidal Oral Drug Absorption System (MPH-SODAS) in clinically stable patients with ADHD and to identify predictors of dissatisfaction with MPH-SODAS.
This is an 8-week open clinical trial. Patients were assigned to MPH-SODAS according to their pre-study dose of MPH-IR. Assessments at baseline were conducted using the Swanson, Nolan, and Pelham-IV Questionnaire (SNAP-IV), and the Barkley's Side Effect Rating Scale (SERS). Potentials predictors of treatment response were evaluated.
From 62 patients, 47 completed the protocol. There was no significant change in the total score at the SNAP-IV (F (1,51.26) = 0.01; P = 0.91) and its subscales scores during the trial. Although no significant effect on the SERS total score (F (1,111.49) = 0.75; P = 0.39) was found, one adult patient with a previous cardiovascular condition presented a hemorrhagic cerebral vascular accident resulting in her obit. Overall, 46 (74.2%) patients reported to be satisfied. No factor assessed predicted dissatisfaction in univariated analyses.
Results suggested that switching from MPH-IR to MPH-SODAS did not affect stabilization of ADHD symptoms in the majority of patients. MPH prescription in patients with previous cardiovascular conditions must be extremely careful. Further studies with long-acting MPH including larger samples and patients not responsive to MPH-IR are needed especially in countries outside the US.
评估注意力缺陷多动障碍(ADHD)临床症状稳定的患者从速释哌甲酯(MPH-IR)转换为球形口服药物吸收系统哌甲酯(MPH-SODAS)后的ADHD症状,并确定对MPH-SODAS不满意的预测因素。
这是一项为期8周的开放临床试验。根据患者研究前MPH-IR的剂量将其分配至MPH-SODAS组。使用斯旺森、诺兰和佩勒姆第四版问卷(SNAP-IV)以及巴克利副作用评定量表(SERS)在基线时进行评估。对治疗反应的潜在预测因素进行评估。
62例患者中,47例完成了方案。试验期间,SNAP-IV总分(F(1,51.26)=0.01;P=0.91)及其各子量表得分无显著变化。虽然未发现对SERS总分有显著影响(F(1,111.49)=0.75;P=0.39),但一名既往有心血管疾病的成年患者发生出血性脑血管意外导致死亡。总体而言,46例(74.2%)患者报告满意。单因素分析中,所评估的因素均未预测出不满意情况。
结果表明,在大多数患者中,从MPH-IR转换为MPH-SODAS并不影响ADHD症状的稳定。对于既往有心血管疾病的患者,MPH处方必须极其谨慎。需要对长效MPH进行进一步研究,包括更大样本以及对MPH-IR无反应的患者,尤其是在美国以外的国家。