Oliveira Marcio M, Conti Cristiane, Prado Gilmar F
Universidade Federal de São Paulo, Rua Pedro de Toledo, 598, São Paulo, São Paulo, Brazil, 04039001.
Cochrane Database Syst Rev. 2013 Aug 14(8):CD006685. doi: 10.1002/14651858.CD006685.pub3.
This is an updated version of the original Cochrane review, published in Issue 2, 2009.Kleine-Levin syndrome (KLS) is a rare disorder that mainly affects adolescent men. It is characterised by recurrent episodes of hypersomnia, usually accompanied by hyperphagia, cognitive and mood disturbances, abnormal behavior such as hypersexuality and signs of dysautonomia.In 1990 the diagnostic criteria for Kleine-Levin syndrome were modified in the International Classification of Sleep Disorders, where KLS was defined as a syndrome composed of recurring episodes of undue sleepiness lasting some days, which may or may not be associated with hyperphagia and abnormal behavior.The cause of Kleine-Levin syndrome remains unknown, and several treatment strategies have been used. Some medications have been reported to provide benefit in the treatment of patients with KLS, but because of the rarity of the condition, no long-term follow-up therapies have yet been described.
This review aimed to evaluate:1. whether pharmacological treatment for Kleine Levin syndrome is effective and safe.2. which drug or category of drugs is effective and safe.
We obtained relevant trials from the following sources: the Cochrane Epilepsy Group Specialized Register (2 May 2013); the Cochrane Central Register of Controlled Trials (CENTRAL Issue 4, The Cochrane Library, April 2013); MEDLINE (1946 to 2 May 2013); SCOPUS (2 May 2013); LILACS (2 May 2013); ClinicalTrials.gov (2 May 2013); WHO International Clinical Trials Registry Platform ICTRP (2 May 2013); reference lists of sleep medicine textbooks; review articles and reference lists of articles identified by the search strategies.
All randomised controlled trials (RCTs) and quasi-randomised controlled trials looking at pharmacological interventions for Kleine-Levin syndrome were selected. We included both parallel-group and cross-over studies.
Two review authors (MMO and CC) extracted the data reported in the original articles.
No studies met the inclusion criteria for this systematic review.
AUTHORS' CONCLUSIONS: Therapeutic trials of pharmacological treatment for Kleine-Levin syndrome with a double-blind, placebo-controlled design are needed.
这是2009年第2期发表的原始Cochrane综述的更新版本。克莱恩-莱文综合征（KLS）是一种罕见疾病，主要影响青春期男性。其特征为反复出现的发作性嗜睡，通常伴有食欲亢进、认知和情绪障碍、诸如性欲亢进等异常行为以及自主神经功能障碍的体征。1990年，《国际睡眠障碍分类》对克莱恩-莱文综合征的诊断标准进行了修订，将KLS定义为由持续数天的反复出现的过度嗜睡发作组成的综合征，这种发作可能与食欲亢进和异常行为有关，也可能无关。克莱恩-莱文综合征的病因尚不清楚，已经采用了多种治疗策略。据报道，一些药物对KLS患者的治疗有益，但由于该病罕见，尚未有长期随访治疗的描述。
本综述旨在评估：1. 克莱恩-莱文综合征的药物治疗是否有效且安全。2. 哪种药物或药物类别有效且安全。
我们从以下来源获取相关试验：Cochrane癫痫专业注册库（2013年5月2日）；Cochrane对照试验中心注册库（CENTRAL，第4期，Cochrane图书馆，2013年4月）；MEDLINE（1946年至2013年5月2日）；SCOPUS（2013年5月2日）；LILACS（2013年5月2日）；ClinicalTrials.gov（2013年5月2日）；世界卫生组织国际临床试验注册平台ICTRP（2013年5月2日）；睡眠医学教科书的参考文献列表；综述文章以及通过检索策略确定的文章中的参考文献列表。
所有针对克莱恩-莱文综合征的药物干预的随机对照试验（RCT）和半随机对照试验均被选中。我们纳入了平行组研究和交叉研究。
两位综述作者（MMO和CC）提取了原始文章中报告的数据。
没有研究符合本系统综述的纳入标准。
需要开展采用双盲、安慰剂对照设计的克莱恩-莱文综合征药物治疗的试验性研究。
