Armodafinil to reduce the sleepiness related side-effects of sleep restriction therapy being used to treat insomnia disorder: An open label clinical trial pilot study compared with historical controls

Sleep restriction therapy (SRT) is an effective stand-alone behavioural intervention for insomnia disorder. However, its daytime side effects, particularly sleepiness, may be troubling for patients and/or may be a necessary part of the patient's treatment journey. This pilot trial aims to explore the potential benefit of armodafinil, a wakefulness promoter. Patients were treated with SRT with open label adjunctive armodafinil (150 mg/day). Thirty-three patients from previous studies that have undergone exactly the same SRT intervention acted as controls. The primary outcome measure was the insomnia severity index (ISI), and secondary outcomes were the Epworth sleepiness scale, sleep restriction adherence scale (SRAS), and safety from baseline through to 12 weeks. We recruited 25 patients into the trial. Data for the primary end point (ISI at 12 weeks) was available for 20 of the participants. The baseline insomnia severity index was 20.2 (SD 3.3) and decreased to 9.1 (SE 1.1), with no change, to 10.2 and 11.2 at weeks 6 and 12 respectively (all p > 0.05 compared with baseline). The insomnia severity index values for armodafinil patients were statistically inferior to historical controls at the primary time point of 12 weeks (11.2 vs. 6.7, p < 0.01). Sleep restriction therapy plus armodafinil treatment was associated with frequent minor side effects but was generally safe and acceptable to patients. Sleep restriction therapy was associated with a robust clinical response in the insomnia severity index values for insomnia patients. Based upon historical control data, armodafinil does not appear to have beneficial adjunctive effects in addition to sleep restriction therapy alone.     

医源性输尿管损伤的早期诊断和治疗

目的探讨医源性输尿管损伤的早期诊断和最佳治疗方案,提高手术成功率,减少合并症的发生。方法对1999至2009年22例医源性输尿管损伤患者进行回顾性研究。分析治疗方法和预后及并发症之间的关系。结果 16例术中发现输尿管损伤患者立刻行手术修复成功。6例术后确诊患者,1～5个月后手术,均一期手术修复成功。22例均获得随访1～4年,无严重并发症。结论医源性输尿管损伤患者一般情况较好时,无论确诊时间早晚,均可考虑一期手术修复。     

Iatrogenic arteriovenous fistula in an infant mimicking an arteriovenous malformation

We report the case of a 12-month-old infant who presented with progressive lower limb enlargement associated with erythema mimicking an arteriovenous malformation. Computed tomography confirmed an arteriovenous fistula (AVF) between the deep femoral artery and the common femoral vein. This case describes the unique clinical and imaging findings of iatrogenic AVF and contrasts them with other congenital vascular entities.