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首页> 外文期刊>The journal of clinical psychiatry >An open-label study of the tolerability of mixed amphetamine salts in adults with attention-deficit/hyperactivity disorder and treated primary essential hypertension.
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An open-label study of the tolerability of mixed amphetamine salts in adults with attention-deficit/hyperactivity disorder and treated primary essential hypertension.

机译：对患有注意力缺陷/多动障碍和治疗的原发性原发性高血压的成年人的苯丙胺盐混合盐的耐受性的开放标签研究。

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OBJECTIVE: To evaluate the short-term tolerability of an extended-release preparation of the stimulant medication mixed amphetamine salts (MAS XR) in adults with attention-deficit/hyperactivity disorder (ADHD) whose hypertension has been successfully treated with antihypertensive medications. METHOD: An 8-week, 2-phase, open-label study design was implemented. All adults had ADHD (DSM-IV diagnosis) and essential hypertension and were required to be normotensive (blood pressure < 135/85 mm Hg, treated) for at least 4 weeks at entry into the study. MAS XR was given for a 6-week period, titrated once each week to a target maximum dose of 60 mg/day given once daily in the morning (phase 1), and then discontinued for 2 weeks at the end of the study (phase 2). At baseline, subjects underwent a comprehensive clinical assessment, medical history, vital signs assessment, and electrocardiogram (ECG). Rating scales were used throughout the study to assess response to treatment, and blood pressure was measured manually at each study visit. The primary outcome was the effect of MAS XR on blood pressure and the development of hypertension. RESULTS: Thirteen subjects receiving antihypertensive therapy were entered and placed on MAS XR treatment and completed the trial. There were no serious adverse events. No sustained elevated blood pressure (> 140/90 mm Hg at 2 consecutive visits) was observed in the subjects treated with MAS XR. Similar rates of single episodes of hypertension were observed in phases 1 and 2. Similarly, there was no group mean increase in systolic or diastolic blood pressure or pulse during treatment with MAS XR. No clinically significant changes in the ECG were observed. During the 6-week medication phase, significant improvement was found on rating scales assessing ADHD symptoms and severity that reversed with discontinuation of MAS XR. CONCLUSION: The results of this open study suggest that adults with ADHD and controlled hypertension can be safely treated with MAS XR.
机译：目的：评估缓释/多动障碍（ADHD）成人高血压患者已成功使用降压药治疗的兴奋剂混合苯丙胺盐（MAS XR）缓释制剂的短期耐受性。方法：实施了为期8周，2期，开放标签的研究设计。所有成年人均患有ADHD（DSM-IV诊断）和原发性高血压，在进入研究之初至少要保持血压正常（血压<135/85 mm Hg，已治疗）。 MAS XR的使用期为6周，每周一次滴定至每天一次的最大最大剂量60毫克/天，每天一次（阶段1），然后在研究结束时停药2周（阶段1） 2）。在基线时，对受试者进行全面的临床评估，病史，生命体征评估和心电图（ECG）。在整个研究过程中使用评分量表评估对治疗的反应，并在每次研究访视时手动测量血压。主要结果是MAS XR对血压和高血压发展的影响。结果：13名接受降压治疗的受试者进入并接受了MAS XR治疗，并完成了试验。没有严重的不良事件。在用MAS XR治疗的受试者中未观察到持续的血压升高（连续2次访视> 140/90 mm Hg）。在第1和第2阶段中观察到了单发高血压的相似发生率。类似地，在用MAS XR治疗期间，收缩压或舒张压或脉搏无组平均增加。没有观察到ECG的临床显着变化。在为期6周的用药阶段中，评估多动症症状和严重程度的评分量表得到了显着改善，该评分量表因停用MAS XR而逆转。结论：这项开放性研究的结果表明，MAS XR可以安全治疗ADHD并控制高血压的成年人。

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