| 标题： | 促觉醒药物临床应用中国专家共识 |
| title： | Chinese expert consensus on clinical use of wake-promoting drugs |
| 版本： | 原创版 |
| version： | Original |
| 分类： | 专家共识 |
| classification： | Experts consensus |
| 领域： | 治疗 |
| field： | Treatment |
| 国家和地区： | 中国 |
| Country and region： | China |
| 指南使用者： | 所有涉及EDS患者促觉醒药物应用的临床工作者，既适用于睡眠医学及相关专业人员，也适用于非睡眠医学专业人员 |
| Guide users： | The consensus is intended for clinical workers involved in clinical practice with wake-promoting drugs in EDS patients, catering to professionals in sleep medicine and related fields, as well as non-sleep medicine specialists |
| 证据分级方法： | 采用牛津循证医学中心（OCEBM）证据分级体系进行证据质量评价和推荐等级分级 |
| Evidence grading method： | Using the Oxford Centre for Evidence-based Medicine (CEBM) Levels of Evidence to evaluate the quality of evidence and grade recommendations |
| 制定单位： | 中国睡眠研究会睡眠障碍专委会 |
| Formulating unit： | Sleep Disorders Special Committee of the Chinese Sleep Research Society |
| 注册时间： | 2024-03-26 |
| Registration time： | |
| 注册编号： | PREPARE-2024CN467 |
| Registration number： | |
| 指南制订的目的： | 日间过度思睡（Excessive daytime sleepiness，EDS）是指个体在白天无法保持应有的清醒和警觉，出现过度的睡眠需求甚至不自主地入睡。EDS通常是睡眠剥夺、夜间睡眠差、其他睡眠障碍，如阻塞性睡眠呼吸暂停（Obstructive sleep apnea，OSA）和昼夜节律紊乱的结果，嗜睡也可能是中枢性嗜睡障碍的核心症状，如发作性睡病、特发性嗜睡和Kleine-Levin综合征；此外，合并神经退行性病变、精神行为障碍、内分泌疾病或呼吸系统疾病，或使用某些药物也可能会导致EDS。据调查，美国成人EDS患病率为23.34%，多见于年轻女性、低收入和失业者，患者大多合并精神障碍或慢性疾病。中国儿童与青少年的EDS患病率为29.2%，从青春期前的19.8%增加至青春期后的47.8%不等。老年人的EDS患病率相对较低，中国农村65岁及以上高龄人群的EDS患病率为9.3%，65~69岁最多见并随年龄减少。既往研究表明，EDS可严重干扰患者的日常生活、工作学习与社交；据报道，EDS每年都会导致交通事故，事故率仅次于夜间疲劳驾驶和酒驾；医护人员存在EDS还可能增加医疗事故风险；此外，EDS还可能与心血管、精神和神经退行性疾病的发病和死亡风险增加相关。 EDS病因复杂、具有高度异质性且可能持续存在数年，需要个体化干预。EDS的治疗方法包括非药物干预和药物治疗。药物治疗主要针对潜在病因或过度思睡症状，除了积极干预原发性疾病外，促觉醒药物是改善过度思睡症状的主要方法。现有促觉醒药物分为两类，已获批EDS适应症和超适应症应用。目前，中国已有莫达非尼和替洛利生两种促觉醒药物获批用于治疗EDS，未来还可能会有更多促觉醒药物获批，例如索安非托已在中国获批启动治疗OSA所致EDS的临床III期试验；此外，还有哌甲酯、安非他明类似物的超适应症应用。 EDS具有高发性和高危性，有必要进行干预管理。我国现行EDS指南共识以疾病综合管理为主，暂无针对促觉醒药物临床应用的共识发表。考虑到我国已批准促觉醒药物用于EDS治疗，且获批种类还在逐渐增加，此外还存在超适应症治疗等情况，提示促觉醒药物这方面仍存在尚未满足的临床需求，有必要规范促觉醒药物的临床应用。因此制订本共识，旨在对疾病所致EDS的药物选择、启用指征、治疗策略和个体化治疗、安全性监测以及未来研究潜在方向进行统一的指导和规范。 |
| Purpose of the guideline： | Excessive Daytime Sleepiness (EDS) refers to the inability of an individual to maintain the necessary alertness and wakefulness during the day, leading to excessive sleep needs or involuntary sleep onset. EDS is often a consequence of sleep deprivation, poor nighttime sleep, other sleep disorders such as obstructive sleep apnea (OSA) and circadian rhythm disturbances. EDS can also be a core symptom of central hypersomnia disorders like narcolepsy, idiopathic hypersomnia, and Kleine-Levin syndrome. Additionally, it may result from neurodegenerative diseases, psychiatric disorders, endocrine disorders, respiratory diseases, or certain medications. In the United States, the prevalence of EDS in adults is 23.34%, more common in younger women, individuals with low income or unemployment, and often associated with psychiatric disorders or chronic diseases. In Chinese children and adolescents, the prevalence of EDS is 29.2%, varying from 19.8% before puberty to 47.8% after puberty. The prevalence of EDS in the elderly is relatively lower, with a rate of 9.3% in rural Chinese populations aged 65 and above, peaking at ages 65-69 and decreasing with age. EDS significantly disrupts patients' daily lives, work, study, and social interactions. Surveys indicate that EDS contributes to traffic accidents annually, ranking just below accidents caused by nighttime fatigue driving and drunk driving. healthcare workers with EDS may also face increased risks of medical errors[8]. Moreover, EDS is associated with an increased risk of cardiovascular, mental health and neurodegenerative diseases as well as mortality. The etiology of EDS is complex and highly heterogeneous, potentially persisting for several years and requiring individualized interventions. Treatment for EDS include non-pharmacological and pharmacological therapies targeting underlying causes or symptoms of EDS. Wake-promoting drugs are a primary approach to improving EDS symptoms other than intervening in primary diseases. These drugs are categorized into approved indications for EDS and off-label applications. In China, modafinil and pitolisant are already approved for EDS. More wake-promoting agents may receive approval in the future such as solriamfetol which has initiated Phase III clinical trials for EDS due to OSA in China. Additionally, there are off-label applications of methylphenidate and amphetamine. Given the high prevalence and risks associated with EDS, intervention management is crucial. The current Chinese consensus guidelines for EDS focus on comprehensive management without specific consensus on the clinical application of wake-promoting drugs. Considering the approval of wake-promoting agents for EDS in China and the increasing variety of approved agents along with off-label treatments available, there is a lot unmet clinical needs regarding wake-promoting drugs by establishing standardized clinical guidelines for their use. Therefore, this consensus aims to provide unified guidance on drug selection for EDS, initiation criteria, treatment strategies, personalized therapy approaches, safety monitoring, and potential directions for future research. |
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