Medication Adherence and Symptom Reduction in Adults Treated with Mixed Amphetamine Salts in a Randomized Crossover Study
Medication Adherence and Symptom Reduction in Adults Treated with Mixed Amphetamine Salts in a Randomized Crossover Study
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DOI：
10.3810/pgm.2011.09.2461
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发表时间：
2011-09-01
影响因子：
4.2
通讯作者：
Faraone, Stephen V.
中科院分区：
文献类型：
--
作者：
Adler, Lenard A.;Lynch, Lauren R.;Faraone, Stephen V.
研究目的：1)在一项随机交叉研究中，评估每日3次（TID）混合安非他明盐立即释放（MAS IR）与每日一次（qAM） MAS延长释放（MAS XR）治疗的成人注意缺陷/多动障碍（ADHD）的药物依从性；2)检查依从性与MAS IR和MAS XR疗效之间的关系。方法：纳入62名ADHD成人，其中49人完成了研究。治疗条件顺序（TID-qAM或qAM-TID）在参与者之间进行平衡，中间洗脱期为>= 7天。依从性通过3项措施进行评估：1)自我报告，2)药片计数，3)用药事件监测系统（MEMS (R)）。主要疗效指标为ADHD评定量表（ADHD- rs）；次要测量包括时间敏感性ADHD症状量表（TASS）和临床总体印象疾病严重程度量表（CGI-S）。结果：在MAS XR和MAS IR之间，通过自我报告和药片数量来衡量的治疗依从性没有显著差异。在所有MEMS测量中，MAS XR的依从性明显优于MAS IR。MAS IR和MAS X R的ADHD-RS、TASS和CGI-S评分在终点时的平均变化均显著改善，组间无显著差异。疗效相互作用没有显著的依从性。结论：通过药片数量和自我报告评估，成年ADHD患者对MAS IR和MAS XR的依从性相同，但通过MEMS (R)测量则不同。两种治疗方法均显著减轻ADHD症状，两组疗效无显著差异。依从性与治疗结果无关。
Objectives: The study objectives were to I) evaluate medication adherence for adults with attention-deficit/hyperactivity disorder (ADHD) treated with 3 times daily (TID) mixed amphetamine salts immediate release (MAS IR) versus once-daily (qAM) MAS extended release (MAS XR) in a randomized, crossover study; and 2) to examine the associations between adherence and efficacy for MAS IR and MAS XR. Methods: Sixty-two adults with ADHD were enrolled and 49 completed the study. The treatment condition order (TID-qAM or qAM-TID) was counterbalanced across participants, with an intervening washout period of >= 7 days. Adherence was assessed via 3 measures: I) self-report, 2) pill count, and 3) the Medication Event Monitoring System (MEMS (R)). The primary efficacy measure was the ADHD Rating Scale (ADHD-RS); secondary measures included the Time-Sensitive ADHD Symptom Scale (TASS) and Clinical Global Impressions Severity of Illness (CGI-S) scale. Results: Adherence to treatment as measured by self-report and pill count was not significantly different between MAS XR and MAS IR. Adherence was significantly better for MAS XR than MAS IR for all of the MEMS measures. The mean change in ADHD-RS, TASS, and CGI-S scores at endpoint was significantly improved for both MAS IR and MAS X R and did not differ significantly between groups. There was not a significant adherence by efficacy interaction. Conclusion: Adults with ADHD adhered equally well with MAS IR as with MAS XR when assessed by pill count and self-report, but not by the MEMS (R) measures. Both treatments significantly reduced ADHD symptoms, and efficacy was not significantly different between groups. Adherence was not associated with treatment outcome.