加巴噴丁治療不寧腿綜合征的系統評價_《中國循證醫學雜志》

作者：

陳梓斌 ,  吳原 , 劉曉菲 , 劉云 , 馬美剛 , 劉秋弟 , 譚明會

廣西醫科大學神經內科（南寧 530021）;

關鍵詞：

加巴噴丁抗癲癇藥不寧腿綜合征系統評價隨機對照試驗 Meta分析

DOI：

10.7507/1672-2531.20120118

視頻：

導出 下載 收藏 掃碼 引用

摘要 全文 圖表 視頻 參考文獻 施引文獻 補充材料

目的系統評價加巴噴丁治療不寧腿綜合征的臨床療效和安全性。
方法計算機檢索PubMed、EBMbase、CENTRAL及CBM等數據庫，全面收集加巴噴丁治療不寧腿綜合征的隨機對照試驗（RCT）。按Cochrane系統評價方法對納入研究進行資料提取和質量評價后，采用RevMan5.1軟件進行Meta分析。
結果共納入7個RCT，1 163例患者，包括4個安慰劑平行對照試驗和3個安慰劑交叉試驗。Meta分析結果顯示：① 不寧腿綜合征改變量（IRLSSG評分），加巴噴丁組明顯優于安慰劑組［MD=–3.24，95%CI（–4.40，–2.09），P lt;0.000 01］；② 反應率（用研究者評價的CGI-I評分），加巴噴丁組（77%）較安慰劑組（50%）有更高的反應率［RR=1.81，95%CI（1.54，2.11），P lt;0.000 01］；③ 睡眠質量：加巴噴丁組較安慰劑組能更好地減少睡眠紊亂［MD=–11.31，95%CI（–14.46，–8.16）］、保證睡眠質量［MD=0.27，95%CI（0.10，0.44）］和減輕日間嗜睡［MD=–3.96，95%CI（–6.42，–1.50）］；④ 不寧腿綜合征疼痛評分，加巴噴丁組較安慰劑組更好地減輕疼痛［MD=–0.97，95%CI（–1.47，–0.47）］。不良反應主要有嗜睡（3.1%～26.5%）、頭暈（2.1%～19.5%），且加巴噴丁組發生率更高（嗜睡：P lt;0.000 01；頭暈：P lt;0.000 1）。
結論加巴噴丁能有效改善不寧腿綜合征患者的病情，提升睡眠質量，減輕疼痛，耐受性良好。

引用本文： 陳梓斌,吳原,劉曉菲,劉云,馬美剛,劉秋弟,譚明會. 加巴噴丁治療不寧腿綜合征的系統評價. 中國循證醫學雜志, 2012, 12(6): 727-734. doi: 10.7507/1672-2531.20120118 復制

1.	Willis T. The London practice of physick. London: Thomas Basset and William Crook. 1685.
2.	Ekbom A. Restless legs: A clinical study. Acta Med Scand, 1945, 158(suppl): 1-123.
3.	Allen RP, Picchietti D, Hening WA, et al. Restless legs syndrome: diagnostic criteria, special considerations, and epidemiology. A report from the restless legs syndrome diagnosis and epidemiology workshop at the National Institutes of Health. Sleep Med, 2003, 4(2): 101-119.
4.	Allen RP, Walters AS, Montplaisir J, et al. Restless legs syndrome prevalence and impact: REST general population study. Arch Intern Med, 2005, 165(11): 1286-1292.
5.	Nomura T, Inoue Y, Kusumi M, et al. Prevalence of restless legs syndrome in a rural community in Japan. Mov Disord, 2008, 23(16): 2363-2369.
6.	Tan EK, Seah A, See SJ, et al. Restless legs syndrome in an Asian population: A study in Singapore. Mov Disord, 2001, 16(3): 577-579.
7.	Hening W, Walters AS, Allen RP, et al. Impact, diagnosis and treatment of restless legs syndrome (RLS) in a primary care population: the REST (RLS epidemiology, symptoms, and treatment) primary care study. Sleep Med, 2004, 5(3): 237-246.
8.	Trenkwalder C, Paulus W, Walters AS. The restless legs syndrome. Lancet Neurol, 2005, 4(8): 465-475.
9.	Trenkwalder C, Hening WA, Montagna P, et al. Treatment of restless legs syndrome: an evidence-based review and implications for clinical practice. Mov Disord, 2008, 23(16): 2267-2302.
10.	Conti CF, Oliveira MM, Valbuza JS, et al. Anticonvulsants to treat idiopathic restless legs syndrome: systematic review. Arq Neuropsiquiatr, 2008, 66(2b): 431-435.
11.	Walters AS, Lebrocq C, Dhar A, et al. Validation of the International Restless Legs Syndrome Study Group rating scale for restless legs syndrome. Sleep Med, 2003, 4(2): 121-132.
12.	National Institute of Medtal Health. Early Clinical Drug Evaluation Unit (ECDEU). Clinical Global Impressions. In: Guy W, ed ECDEU Assessment Manual for Psychopharmacology Rockville, MD: NIMH, USA, 1976, 218-222.
13.	Higgins J, Altman DG. Assessing risk of bias in included studies. In: Cochrane Handbook for Systematic Reviews of Interventions Version 510 [updated March 2011], 2011, Chapter 8.
14.	Micozkadioglu H, Ozdemir FN, Kut A, et al. Gabapentin versus levodopa for the treatment of restless legs syndrome in hemodialysis patients: An open-label study. Renal Failure, 2004, 26(4): 393-397.
15.	Thorp ML, Morris CD, Bagby SP. A crossover study of gabapentin in treatment of restless legs syndrome among hemodialysis patients. American Journal of Kidney Diseases, 2001, 38(1): 104-108.
16.	石強, 黃旭升, 崔芳, 等. 加巴噴丁治療不安腿綜合征的療效觀察. 中國臨床神經科學, 2008, 16(6): 627-629.
17.	Happe S, Sauter C, Klosch G, et al. Gabapentin versus ropinirole in the treatment of idiopathic restless legs syndrome. Neuropsychobiology, 2003, 48(2): 82-86.
18.	Adler CH. Treatment of restless legs syndrome with gabapentin. Clin Neuropharmacol, 1997, 20(2): 148-151.
19.	Saletu M, Anderer P, Saletu-Zyhlarz GM, et al. Comparative placebo-controlled polysomnographic and psychometric studies on the acute effects of gabapentin versus ropinirole in restless legs syndrome. Journal of Neural Transmission, 2010, 117(4): 463-473.
20.	Winkelman JW, Bogan RK, Schmidt MH, et al. Randomized polysomnography study of gabapentin enacarbil in subjects with restless legs syndrome. Mov Disord, 2011, 26(11): 2065-2072.
21.	Lee DO, Ziman RB, Perkins AT, et al. A randomized, double-blind, placebo-controlled study to assess the efficacy and tolerability of gabapentin enacarbil in subjects with restless legs syndrome. J Clin Sleep Med, 2011, 7(3): 282-292.
22.	Bogan RK, Bornemann MA, Kushida CA, et al. Long-term maintenance treatment of restless legs syndrome with gabapentin enacarbil: a randomized controlled study. Mayo Clin Proc, 2010, 85(6): 512-521.
23.	Walters AS, Ondo WG, Kushida CA, et al. Gabapentin enacarbil in restless legs syndrome: A phase 2b, 2-week, randomized, double-blind, placebo-controlled trial. Clinical Neuropharmacology, 2009, 32(6): 311-320.
24.	Kushida CA, Walters AS, Becker P, et al. A randomized, double-blind, placebo-controlled, crossover study of XP13512/GSK1838262 in the treatment of patients with primary restless legs syndrome. Sleep, 2009, 32(2): 159-168.
25.	Kushida CA, Becker PM, Ellenbogen AL, et al. Randomized, double-blind, placebo-controlled study of XP13512/GSK1838262 in patients with RLS. Neurology, 2009, 72(5): 439-446.
26.	Garcia-Borreguero D, Larrosa O, De La Llave Y, et al. Treatment of restless legs syndrome with gabapentin: A double-blind, cross-over study. Neurology, 2002, 59(10): 1573-1579.
27.	Ondo W, Jankovic J. Restless legs syndrome: clinicoetiologic correlates. Neurology, 1996, 47(6): 1435-1441.
28.	Pugsley TA, Whetzel SZ, Dooley DJ. Reduction of 3,4-diaminopyridine-induced biogenic amine synthesis and release in rat brain by gabapentin. Psychopharmacology (Berl), 1998, 137(1): 74-80.
29.	Fulda S, Wetter TC. Dopamine agonists for the treatment of restless legs syndrome. Expert Opin Pharmacother, 2005, 6(15): 2655-2666.
30.	Telstad W, Sorensen O, Larsen S, et al. Treatment of the restless legs syndrome with carbamazepine: a double blind study. Br Med J (Clin Res Ed), 1984, 288(6415): 444-446.
31.	Lundvall O, Abom PE, Holm R. Carbamazepine in restless legs. A controlled pilot study. European Journal of Clinical Pharmacology, 1983, 25(3): 323-324.
32.	Eisensehr I, Ehrenberg BL, Solti SR, et al. Treatment of idiopathic restless legs syndrome (RLS) with slow-release valproic acid compared with slow-release levodopa/benserazid: A randomized, placebo-controlled, double-blind, cross-over study. Journal of Neurology, 2004, 251(5): 579-583.
33.	Allen R, Chen C, Soaita A, et al. A randomized, double-blind, 6-week, dose-ranging study of pregabalin in patients with restless legs syndrome. Sleep Med, 2010, 11(6): 512-519.
34.	Partinen M, Hirvonen K, Jama L, et al. Efficacy and safety of pramipexole in idiopathic restless legs syndrome: a polysomnographic dose-finding study--the PRELUDE study. Sleep Med, 2006, 7(5): 407-417.
35.	Bliwise DL, Freeman A, Ingram CD, et al. Randomized, double-blind, placebo-controlled, short-term trial of ropinirole in restless legs syndrome. Sleep Med, 2005, 6(2): 141-147.
36.	Hogl B, Garcia-Borreguero D, Kohnen R, et al. Progressive development of augmentation during long-term treatment with levodopa in restless legs syndrome: results of a prospective multi-center study. J Neurol, 2010, 257(2): 230-237.

1. Willis T. The London practice of physick. London: Thomas Basset and William Crook. 1685.
2. Ekbom A. Restless legs: A clinical study. Acta Med Scand, 1945, 158(suppl): 1-123.
3. Allen RP, Picchietti D, Hening WA, et al. Restless legs syndrome: diagnostic criteria, special considerations, and epidemiology. A report from the restless legs syndrome diagnosis and epidemiology workshop at the National Institutes of Health. Sleep Med, 2003, 4(2): 101-119.
4. Allen RP, Walters AS, Montplaisir J, et al. Restless legs syndrome prevalence and impact: REST general population study. Arch Intern Med, 2005, 165(11): 1286-1292.
5. Nomura T, Inoue Y, Kusumi M, et al. Prevalence of restless legs syndrome in a rural community in Japan. Mov Disord, 2008, 23(16): 2363-2369.
6. Tan EK, Seah A, See SJ, et al. Restless legs syndrome in an Asian population: A study in Singapore. Mov Disord, 2001, 16(3): 577-579.
7. Hening W, Walters AS, Allen RP, et al. Impact, diagnosis and treatment of restless legs syndrome (RLS) in a primary care population: the REST (RLS epidemiology, symptoms, and treatment) primary care study. Sleep Med, 2004, 5(3): 237-246.
8. Trenkwalder C, Paulus W, Walters AS. The restless legs syndrome. Lancet Neurol, 2005, 4(8): 465-475.
9. Trenkwalder C, Hening WA, Montagna P, et al. Treatment of restless legs syndrome: an evidence-based review and implications for clinical practice. Mov Disord, 2008, 23(16): 2267-2302.
10. Conti CF, Oliveira MM, Valbuza JS, et al. Anticonvulsants to treat idiopathic restless legs syndrome: systematic review. Arq Neuropsiquiatr, 2008, 66(2b): 431-435.
11. Walters AS, Lebrocq C, Dhar A, et al. Validation of the International Restless Legs Syndrome Study Group rating scale for restless legs syndrome. Sleep Med, 2003, 4(2): 121-132.
12. National Institute of Medtal Health. Early Clinical Drug Evaluation Unit (ECDEU). Clinical Global Impressions. In: Guy W, ed ECDEU Assessment Manual for Psychopharmacology Rockville, MD: NIMH, USA, 1976, 218-222.
13. Higgins J, Altman DG. Assessing risk of bias in included studies. In: Cochrane Handbook for Systematic Reviews of Interventions Version 510 [updated March 2011], 2011, Chapter 8.
14. Micozkadioglu H, Ozdemir FN, Kut A, et al. Gabapentin versus levodopa for the treatment of restless legs syndrome in hemodialysis patients: An open-label study. Renal Failure, 2004, 26(4): 393-397.
15. Thorp ML, Morris CD, Bagby SP. A crossover study of gabapentin in treatment of restless legs syndrome among hemodialysis patients. American Journal of Kidney Diseases, 2001, 38(1): 104-108.
16. 石強, 黃旭升, 崔芳, 等. 加巴噴丁治療不安腿綜合征的療效觀察. 中國臨床神經科學, 2008, 16(6): 627-629.
17. Happe S, Sauter C, Klosch G, et al. Gabapentin versus ropinirole in the treatment of idiopathic restless legs syndrome. Neuropsychobiology, 2003, 48(2): 82-86.
18. Adler CH. Treatment of restless legs syndrome with gabapentin. Clin Neuropharmacol, 1997, 20(2): 148-151.
19. Saletu M, Anderer P, Saletu-Zyhlarz GM, et al. Comparative placebo-controlled polysomnographic and psychometric studies on the acute effects of gabapentin versus ropinirole in restless legs syndrome. Journal of Neural Transmission, 2010, 117(4): 463-473.
20. Winkelman JW, Bogan RK, Schmidt MH, et al. Randomized polysomnography study of gabapentin enacarbil in subjects with restless legs syndrome. Mov Disord, 2011, 26(11): 2065-2072.
21. Lee DO, Ziman RB, Perkins AT, et al. A randomized, double-blind, placebo-controlled study to assess the efficacy and tolerability of gabapentin enacarbil in subjects with restless legs syndrome. J Clin Sleep Med, 2011, 7(3): 282-292.
22. Bogan RK, Bornemann MA, Kushida CA, et al. Long-term maintenance treatment of restless legs syndrome with gabapentin enacarbil: a randomized controlled study. Mayo Clin Proc, 2010, 85(6): 512-521.
23. Walters AS, Ondo WG, Kushida CA, et al. Gabapentin enacarbil in restless legs syndrome: A phase 2b, 2-week, randomized, double-blind, placebo-controlled trial. Clinical Neuropharmacology, 2009, 32(6): 311-320.
24. Kushida CA, Walters AS, Becker P, et al. A randomized, double-blind, placebo-controlled, crossover study of XP13512/GSK1838262 in the treatment of patients with primary restless legs syndrome. Sleep, 2009, 32(2): 159-168.
25. Kushida CA, Becker PM, Ellenbogen AL, et al. Randomized, double-blind, placebo-controlled study of XP13512/GSK1838262 in patients with RLS. Neurology, 2009, 72(5): 439-446.
26. Garcia-Borreguero D, Larrosa O, De La Llave Y, et al. Treatment of restless legs syndrome with gabapentin: A double-blind, cross-over study. Neurology, 2002, 59(10): 1573-1579.
27. Ondo W, Jankovic J. Restless legs syndrome: clinicoetiologic correlates. Neurology, 1996, 47(6): 1435-1441.
28. Pugsley TA, Whetzel SZ, Dooley DJ. Reduction of 3,4-diaminopyridine-induced biogenic amine synthesis and release in rat brain by gabapentin. Psychopharmacology (Berl), 1998, 137(1): 74-80.
29. Fulda S, Wetter TC. Dopamine agonists for the treatment of restless legs syndrome. Expert Opin Pharmacother, 2005, 6(15): 2655-2666.
30. Telstad W, Sorensen O, Larsen S, et al. Treatment of the restless legs syndrome with carbamazepine: a double blind study. Br Med J (Clin Res Ed), 1984, 288(6415): 444-446.
31. Lundvall O, Abom PE, Holm R. Carbamazepine in restless legs. A controlled pilot study. European Journal of Clinical Pharmacology, 1983, 25(3): 323-324.
32. Eisensehr I, Ehrenberg BL, Solti SR, et al. Treatment of idiopathic restless legs syndrome (RLS) with slow-release valproic acid compared with slow-release levodopa/benserazid: A randomized, placebo-controlled, double-blind, cross-over study. Journal of Neurology, 2004, 251(5): 579-583.
33. Allen R, Chen C, Soaita A, et al. A randomized, double-blind, 6-week, dose-ranging study of pregabalin in patients with restless legs syndrome. Sleep Med, 2010, 11(6): 512-519.
34. Partinen M, Hirvonen K, Jama L, et al. Efficacy and safety of pramipexole in idiopathic restless legs syndrome: a polysomnographic dose-finding study--the PRELUDE study. Sleep Med, 2006, 7(5): 407-417.
35. Bliwise DL, Freeman A, Ingram CD, et al. Randomized, double-blind, placebo-controlled, short-term trial of ropinirole in restless legs syndrome. Sleep Med, 2005, 6(2): 141-147.
36. Hogl B, Garcia-Borreguero D, Kohnen R, et al. Progressive development of augmentation during long-term treatment with levodopa in restless legs syndrome: results of a prospective multi-center study. J Neurol, 2010, 257(2): 230-237.

《中國循證醫學雜志》

加巴噴丁治療不寧腿綜合征的系統評價

摘要 全文 圖表 視頻 參考文獻 施引文獻 補充材料

上一篇

下一篇

Format

Content

《中國循證醫學雜志》

加巴噴丁治療不寧腿綜合征的系統評價

摘要 全文 圖表 視頻 參考文獻 施引文獻 補充材料

上一篇

下一篇

Format

Content

摘要全文圖表視頻參考文獻施引文獻補充材料