■这是一篇发表在《睡眠》杂志上的文章的简单语言摘要。发作性睡病是一种具有2种不同亚型的睡眠状况:发作性睡病1型和发作性睡病2型。这些被简称为NT1和NT2。羟丁酸钠(SXB)被批准用于治疗白天过度嗜睡(EDS)和猝倒。患有NT1和NT2的人都有EDS,但猝倒只存在于NT1患者中。关于SXB如何在NT2人群中工作的信息有限。这是因为以前的试验仅包括NT1患者或未指明发作性睡病患者。20多年来,这种药唯一可用的配方必须在夜间服用两次。许多患有嗜睡症的人发现,在半夜醒来服用第二剂SXB会破坏自己或家中的其他人。人们还报告说通过闹钟睡觉,错过了他们的第二剂量,第二天感觉更糟。有些人不小心过早服用了第二剂,使他们面临严重不利影响的风险。这些副作用可能包括呼吸缓慢,低血压,或镇静剂。美国食品和药物管理局(FDA)于2023年5月批准了一种名为LUMRYZ™(羟丁酸钠)的药物用于缓释口服混悬剂。LUMRYZ是SXB(简称ON-SXB)的每晚一次制剂,在睡前服用单剂量。该药治疗嗜睡症患者的EDS和肌肉无力(也称为猝倒)。一项名为REST-ON的临床试验研究了ON-SXB,以了解它是否比没有活性成分的药物(安慰剂)更好地治疗发作性睡病症状。本摘要描述了一项研究,该研究测试了ON-SXB在治疗NT1或NT2患者的发作性睡病症状方面是否优于安慰剂。
■这项研究表明,与服用安慰剂的人相比,服用ON-SXB的人能够在白天保持清醒时间,白天感觉不那么困,少了猝倒,与服用安慰剂的人相比,他们的症状总体上有更多的改善。
■ON-SXB已被证明对NT1或NT2患者有效。与以前的SXB配方不同,ON-SXB在睡前服用一次,不需要在半夜醒来服用第二剂。
UNASSIGNED: This is a plain language summary of a published article in the journal Sleep.
Narcolepsy is a sleep condition that has 2 different subtypes:
narcolepsy type 1 and
narcolepsy type 2. These are called NT1 and NT2 for short. Sodium oxybate (SXB) is approved to treat excessive daytime sleepiness (EDS) and cataplexy. People with NT1 and NT2 both have EDS, but cataplexy is only present in people with NT1. Limited information is available about how SXB works in people with NT2. This is because previous trials have included only people with NT1 or people with unspecified
narcolepsy. For more than 20 years, the only available formulation of this medicine had to be given twice during the night. Many people with
narcolepsy find that chronically waking up in the middle of the night for a second dose of SXB is disruptive to themselves or others in their household. People have also reported sleeping through alarm clocks, missing their second dose, and feeling worse the next day. Some people have accidentally taken the second dose too early, putting them at risk for serious adverse effects. These adverse effects may include slow breathing, low blood pressure, or sedation. The US Food and Drug Administration (FDA) approved a medicine called LUMRYZ™ (sodium oxybate) for extended-release oral suspension in May 2023. LUMRYZ is a once-nightly formulation of SXB (ON-SXB for short) and is taken as a single dose before bedtime. This medicine treats EDS and muscle weakness (also known as cataplexy) in people with
narcolepsy. A clinical trial called REST-ON studied ON-SXB to find out if it was better at treating narcolepsy symptoms than a medicine with no active ingredients (placebo). This summary describes a study that tested whether ON-SXB was better than placebo at treating
narcolepsy symptoms in people with NT1 or NT2.
UNASSIGNED: This study showed that compared to people who took placebo, people who took ON-SXB were able to stay awake longer during the day, felt less sleepy during the daytime, had less cataplexy, and had more improvements in their symptoms overall than people who took placebo.
UNASSIGNED: ON-SXB has been proven effective for people with NT1 or NT2. Unlike prior formulations of SXB, ON-SXB is taken once at bedtime, without requiring waking up in the middle of the night for a second dose.