雷美替胺治療成人慢性失眠的系統評價_《中國循證醫學雜志》

作者：

 周俊翔 ^1,2 , 吳逢波 ¹ , 唐堯 ¹

1. 四川大學華西醫院藥劑科（成都 610041）；2. 四川大學華西藥學院（成都 610041）;

關鍵詞：

雷美替胺慢性失眠成人安全性系統評價 Meta分析

DOI：

10.7507/1672-2531.20120051

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目的　系統評價雷美替胺治療成人慢性失眠的療效和安全性。
方法　計算機檢索CENTRAL、PubMed、EMbase、ISI、CNKI、CBMdisc、VIP和WanFang Data，檢索時間均從建庫至2010年11月，納入有關雷美替胺治療成人慢性失眠的隨機對照試驗，按照Cochrane系統評價方法進行文獻數據提取和質量評價后，采用RevMan 5.0軟件進行Meta分析。
結果　最終納入5個RCT，共計1 772例患者。Meta分析結果顯示：① 療效：治療1周后在持續睡眠潛伏期［MD=18.36，95%CI（11.55，25.18），P lt;0.000 01］、總睡眠時間［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］、睡眠質量［MD=0.14，95%CI（0.03，0.25），P=0.01］，以及治療1個月后在持續睡眠潛伏期［MD=13.02，95%CI（6.01，20.03），P=0.000 3］方面雷美替胺均優于安慰劑，而在治療1個月后的入睡后覺醒時間［MD= –8.79，95%CI（–17.24，–0.35），P=0.04］上效果差于安慰劑，但在其他指標上兩組差異均無統計學意義；② 安全性：兩組僅在女性體內催乳素濃度［MD=5.50，95%CI（2.02，8.98），P=0.002］和男性體內游離睪酮濃度［MD=15.30，95%CI（0.62，29.98），P=0.04］方面差異有統計學意義，而在其他激素水平、反跳性失眠、停藥綜合征、次日殘留效應和不良反應發生率方面差異無統計學意義。
結論　雷美替胺治療成人慢性失眠1周后效果顯著，1個月后療效不明顯。不良反應主要表現為嗜睡、男性游離睪酮濃度和女性催乳素濃度升高。

引用本文： 周俊翔,吳逢波,唐堯. 雷美替胺治療成人慢性失眠的系統評價. 中國循證醫學雜志, 2012, 12(3): 314-319. doi: 10.7507/1672-2531.20120051 復制

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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.

《中國循證醫學雜志》

雷美替胺治療成人慢性失眠的系統評價

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《中國循證醫學雜志》

雷美替胺治療成人慢性失眠的系統評價

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