雷美替胺治疗成人慢性失眠的系统评价_《中国循证医学杂志》

作者：

 周俊翔 ^1,2 , 吴逢波 ¹ , 唐尧 ¹

1. 四川大学华西医院药剂科（成都 610041）；2. 四川大学华西药学院（成都 610041）;

关键词：

雷美替胺慢性失眠成人安全性系统评价 Meta分析

DOI：

10.7507/1672-2531.20120051

视频：

导出 下载 收藏 扫码 引用

摘要 全文 图表 视频 参考文献 施引文献 补充材料

目的　系统评价雷美替胺治疗成人慢性失眠的疗效和安全性。
方法　计算机检索CENTRAL、PubMed、EMbase、ISI、CNKI、CBMdisc、VIP和WanFang Data，检索时间均从建库至2010年11月，纳入有关雷美替胺治疗成人慢性失眠的随机对照试验，按照Cochrane系统评价方法进行文献数据提取和质量评价后，采用RevMan 5.0软件进行Meta分析。
结果　最终纳入5个RCT，共计1 772例患者。Meta分析结果显示：① 疗效：治疗1周后在持续睡眠潜伏期［MD=18.36，95%CI（11.55，25.18），P lt;0.000 01］、总睡眠时间［MD= –15.47，95%CI（–22.50，–8.43），P lt;0.000 1］、睡眠效率［MD= –3.39，95%CI（–5.32，–1.46），P=0.000 6］、睡眠质量［MD=0.14，95%CI（0.03，0.25），P=0.01］，以及治疗1个月后在持续睡眠潜伏期［MD=13.02，95%CI（6.01，20.03），P=0.000 3］方面雷美替胺均优于安慰剂，而在治疗1个月后的入睡后觉醒时间［MD= –8.79，95%CI（–17.24，–0.35），P=0.04］上效果差于安慰剂，但在其他指标上两组差异均无统计学意义；② 安全性：两组仅在女性体内催乳素浓度［MD=5.50，95%CI（2.02，8.98），P=0.002］和男性体内游离睾酮浓度［MD=15.30，95%CI（0.62，29.98），P=0.04］方面差异有统计学意义，而在其他激素水平、反跳性失眠、停药综合征、次日残留效应和不良反应发生率方面差异无统计学意义。
结论　雷美替胺治疗成人慢性失眠1周后效果显著，1个月后疗效不明显。不良反应主要表现为嗜睡、男性游离睾酮浓度和女性催乳素浓度升高。

引用本文： 周俊翔,吴逢波,唐尧. 雷美替胺治疗成人慢性失眠的系统评价. 中国循证医学杂志, 2012, 12(3): 314-319. doi: 10.7507/1672-2531.20120051 复制

1.	Ota A, Masue T, Yasuda N, et al. Association between psychosocial job characteristics and insomnia: an investigation using two relevant job stress models—the demand -control-support (DCS) model and the effort-reward imbalance (ERI) model. Sleep Medicine, 2005, 6(4): 353-358.
2.	Neubauer DN. A review of ramelteon in the treatment of sleep disorders. Neuropsychiatric Disease and Treatment, 2008, 4(1): 69-79.
3.	Daley M, Morin CM, Leblanc M, et al. The Economic Burden of Insomnia: Direct and Indirect Costs for Individuals with Insomnia Syndrome, Insomnia Symptoms, and Good Sleepers. Sleep, 2009, 32(1): 55-64.
4.	Higgins JPT, Green S. Cochrane Handbook for systematic Reviews of Interventions Version 5.0. The Cochrane Collaboration, 2008. Available at: www.Cochranehandbook.org.
5.	Erman M, Seiden D, Zammit G, et al. An efficacy, safety, and dose-response study of Ramelteon in patients with chronic primary insomnia. Sleep medicine, 2006, 7(1): 17-24.
6.	Richardson G, Wang-Weigand S. Effects of long-term exposure to ramelteon, a melatonin receptor agonist, on endocrine function in adults with chronic insomnia. Human Psychopharm acology, 2009, 24(2): 103-111.
7.	Zammit G, Erman M, Wang-Weigand S, et al. Evaluation of the efficacy and safety of ramelteon in subjects with chronic insomnia. Journal of Clinical Sleep Medicine, 2007, 3(5): 495-504.
8.	Hajak G, Ferini-Strambi L, Wang-Weigand S, et al. Objective and subjective efficacy of ramelteon 4 mg in adults with chronic insomnia. Journal of Cancer Education, 2009, 24: S354-S355.
9.	Mayer G, Wang-Weigand S, Roth-Schechter B, et al. Efficacy and safety of 6-month nightly ramelteon administration in adults with chronic primary insomnia. Sleep, 2009, 32(3): 351-360.
10.	Van der HeiJden KB, Smits MG, Van Someren EJ, et al. Prediction of melatonin efficacy by pretreatment dim light melatonin onset in children with idiopathic chronic sleep onset insomnia. J Sleep Res, 2005, 14(2): 187-194.
11.	Zhdanova IV, Wurtman RJ. Efficacy of melatonin as a sleep-promoting agent. J Biol Rhythms, 1997, 12: 644-650.
12.	Stone BM, Turner C, Mills SL, et al. Hypnotic activity of melatonin. Sleep, 2000, 23(5): 663-669.
13.	Srinivasan V, Pandi-Perumal SR, Trahkt I, et al. Melatonin and melatonergic drugs on sleep: possible mechanisms of action. Int J Neurosci, 2009, 119 (6): 821-846.
14.	Stimmel GL, Dopheide JA. Sleep disorders: focus on insomnia. US Pharmacist, 2000, 25: 69.
15.	Kato K, Hirai K, Nishiyama K, et al. Neurochemical properties of ramelteon(TAK-375), a selective MT1/MT2 receptor agonist. Neuropharmacology, 2005, 48(2): 301-310.
16.	Stevenson S, Bryson S, Amakye D, et al. Study to investigate the absolute bioavailability of a single oral dose of ramelteon(TAK-375) in healthy male subjects. Clinical Pharmacology & Therapeutics, 2004, 75: 22.
17.	Pandi-Perumal SR, Srinivasan V, Spence DW, et al. Ramelteon: a review of its therapeutic potential in sleep disorders. Advances In Therapy, 2009, 26(6): 613-626.

1. Ota A, Masue T, Yasuda N, et al. Association between psychosocial job characteristics and insomnia: an investigation using two relevant job stress models—the demand -control-support (DCS) model and the effort-reward imbalance (ERI) model. Sleep Medicine, 2005, 6(4): 353-358.
2. Neubauer DN. A review of ramelteon in the treatment of sleep disorders. Neuropsychiatric Disease and Treatment, 2008, 4(1): 69-79.
3. Daley M, Morin CM, Leblanc M, et al. The Economic Burden of Insomnia: Direct and Indirect Costs for Individuals with Insomnia Syndrome, Insomnia Symptoms, and Good Sleepers. Sleep, 2009, 32(1): 55-64.
4. Higgins JPT, Green S. Cochrane Handbook for systematic Reviews of Interventions Version 5.0. The Cochrane Collaboration, 2008. Available at: www.Cochranehandbook.org.
5. Erman M, Seiden D, Zammit G, et al. An efficacy, safety, and dose-response study of Ramelteon in patients with chronic primary insomnia. Sleep medicine, 2006, 7(1): 17-24.
6. Richardson G, Wang-Weigand S. Effects of long-term exposure to ramelteon, a melatonin receptor agonist, on endocrine function in adults with chronic insomnia. Human Psychopharm acology, 2009, 24(2): 103-111.
7. Zammit G, Erman M, Wang-Weigand S, et al. Evaluation of the efficacy and safety of ramelteon in subjects with chronic insomnia. Journal of Clinical Sleep Medicine, 2007, 3(5): 495-504.
8. Hajak G, Ferini-Strambi L, Wang-Weigand S, et al. Objective and subjective efficacy of ramelteon 4 mg in adults with chronic insomnia. Journal of Cancer Education, 2009, 24: S354-S355.
9. Mayer G, Wang-Weigand S, Roth-Schechter B, et al. Efficacy and safety of 6-month nightly ramelteon administration in adults with chronic primary insomnia. Sleep, 2009, 32(3): 351-360.
10. Van der HeiJden KB, Smits MG, Van Someren EJ, et al. Prediction of melatonin efficacy by pretreatment dim light melatonin onset in children with idiopathic chronic sleep onset insomnia. J Sleep Res, 2005, 14(2): 187-194.
11. Zhdanova IV, Wurtman RJ. Efficacy of melatonin as a sleep-promoting agent. J Biol Rhythms, 1997, 12: 644-650.
12. Stone BM, Turner C, Mills SL, et al. Hypnotic activity of melatonin. Sleep, 2000, 23(5): 663-669.
13. Srinivasan V, Pandi-Perumal SR, Trahkt I, et al. Melatonin and melatonergic drugs on sleep: possible mechanisms of action. Int J Neurosci, 2009, 119 (6): 821-846.
14. Stimmel GL, Dopheide JA. Sleep disorders: focus on insomnia. US Pharmacist, 2000, 25: 69.
15. Kato K, Hirai K, Nishiyama K, et al. Neurochemical properties of ramelteon(TAK-375), a selective MT1/MT2 receptor agonist. Neuropharmacology, 2005, 48(2): 301-310.
16. Stevenson S, Bryson S, Amakye D, et al. Study to investigate the absolute bioavailability of a single oral dose of ramelteon(TAK-375) in healthy male subjects. Clinical Pharmacology & Therapeutics, 2004, 75: 22.
17. Pandi-Perumal SR, Srinivasan V, Spence DW, et al. Ramelteon: a review of its therapeutic potential in sleep disorders. Advances In Therapy, 2009, 26(6): 613-626.

《中国循证医学杂志》

雷美替胺治疗成人慢性失眠的系统评价

摘要 全文 图表 视频 参考文献 施引文献 补充材料

上一篇

下一篇

Format

Content

《中国循证医学杂志》

雷美替胺治疗成人慢性失眠的系统评价

摘要 全文 图表 视频 参考文献 施引文献 补充材料

上一篇

下一篇

Format

Content

摘要全文图表视频参考文献施引文献补充材料