FTY720治療多發性硬化的療效與安全性系統評價_《中國循證醫學雜志》

作者：

 鮑春 ^1,2 , 周建華 ¹

1. 華中科技大學同濟醫學院附屬同濟醫院兒科學系（武漢 430030）；2. 湖北襄陽市中醫醫院（襄陽 441000）;

關鍵詞：

FTY720 多發性硬化/復發緩解型 Meta分析系統評價隨機對照試驗

DOI：

10.7507/1672-2531.20120071

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目的　系統評價FTY720治療復發緩解型多發性硬化（RRMS）的療效與安全性，為臨床應用提供參考。
方法　計算機檢索MEDLINE、EMbase、Cochrane Liabrary、CBM、CNKI，查找有關FTY720治療復發緩解型多發性硬化的隨機對照試驗（RCT），檢索時限均為從2001年1月1日至2010年12月31日。按納入排除標準選擇文獻、提取資料，并以改良Jadad量表評價納入研究的質量后，采用RevMan 5.1軟件進行Meta分析。
結果　共納入3個高質量RCT。Meta分析結果顯示：① 與對照組相比，口服FTY720可顯著降低和減少年化復發率［OR= –6.67，95%CI （–10.75，–2.60），P=0.001］、殘疾惡化進展患者比例［OR=0.64，95%CI（0.47，0.87），P=0.004］和核磁共振腦部釓強化病變的患者比例［OR=0.28，95%CI（0.21，0.37），P lt;0.000 01］。② 0.5 mg/d和1.25 mg/d FTY720組間療效差異無統計學意義（P=0.55）。③ 3種不同劑量（5 mg/d、1.25 mg/d、0.5 mg/d）的FTY720的安全性比較，FTY720 0.5 mg/d組安全性最好。
結論　FTY720治療RRMS的安全性好，可顯著降低RRMS患者的年化復發率，減少殘疾惡化進展和核磁共振腦部釓強化病變。不同劑量的FTY720治療RRMS無劑量-效應關系，其中以口服0.5 mg/d FTY720安全性最好。

引用本文： 鮑春 ,周建華. FTY720治療多發性硬化的療效與安全性系統評價. 中國循證醫學雜志, 2012, 12(4): 445-450. doi: 10.7507/1672-2531.20120071 復制

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8.	Rommer PS, Patejdl R, Winkelmann A, et al. Rituximab for secondary progressive multiple sclerosis: a case series. CNS Drugs, 2011, 25(7): 607-613.
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11.	Fassas A, Kimiskidis VK, Sakellari I, et al. Long-term results of stem cell transplantation for MS: a single-center experience. Neurology, 2011, 76(12): 1066-1070.
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13.	Chun J, Hartung HP. Mechanism of action of oral Fingolimod (FTY720) in multiple sclerosis. Clinical Neuropharmacol, 2010, 33(2): 91-101.
14.	Horga A, Montalban X. FTY720 (fingolimod) for relapsing multiple sclerosis. Expert Rev Neurother, 2008, 8(5): 699-714.
15.	鄧可剛. 循證醫學證據的檢索步驟與檢索系統的選擇. 中國循證醫學雜志, 2004, 4(9): 634-637.
16.	郭新峰, 溫澤淮, 老鷹榮, 等. 臨床試驗質量評價工具及其應用. 中國循證醫學雜志, 2004, 4(7): 484-487.
17.	Polman CH, Reingold SC, Banwell B, et al. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol, 2011, 69(2): 292-302.
18.	Kappos L, Radue EW, O’connor P, et al. A placebo-controlled trial of oral fingonimod in relapsing multiple Sclerosis. N Engl J Med, 2010, 362(5): 387-401.
19.	Kappos L, Antel J, Comi G, et al. Oral fingolimod (FTY720) for relapsing multiple Sclerosis. N Engl J Med, 2006, 355(11): 1124-1140.
20.	Cohen JA, Barkhof F, Comi G, et al. Oral Fingolimod or Intramuscular. Interferon for relapsing multiple Sclerosis. N Engl J Med, 2010, 362(10): 402-415.
21.	Comi G, O’connor P, Montalban X, et al. Phase Ⅱ study of oral fingolimod (FTY720) in multiple sclerosis:3-year results. Mult Scler, 2010, 16(2): 197-207.
22.	Doggrell SA. Is fingolimod an advancement in the treatment of multipie sclerosis? Expert Opin.Pharmacother, 2007, 8(3): 383-386.
23.	Brown BA, Kantesaria PP, McDevitt LM. Fingolimod: A Novel Immunosuppressant for Multiple sclerosis. Ann Pharmacother, 2007, 41(10): 1660-1668.
24.	Aktas O, Küry P, Kieseier B, et al. Fingolimod is a potential novel therapy for multiple sclerosis. Nat Rev Neurol, 2010, 6(7): 373-382.

1. Trojano M, Paolicelli D, Tortorella C, et al. Natural history of multiple sclerosis: have available therapies impacted long-term prognosis? Neurol Clin, 2011, 29(2): 309-321.
2. Cheng XJ, Xu LZ. Review of the diagnosis and clinical features of multiple sclerosis in China. Neurosci Bull, 2009, 25(1): 38-42 .
3. Sanford M, Lyseng-Williamson KA. Subcutaneous recombinant interferon-β-1a (Rebif?): a review of its use in the treatment of relapsing multiple sclerosis. Drugs, 2011, 71(14): 1865-1891.
4. Ravnborg M, Sørensen PS, Andersson M, et al. Methylprednisolone in combination with interferon beta-1a for relapsing-remitting multiple sclerosis (MECOMBIN study): a multicentre, double-blind, randomised,placebo-controlled, parallel-group trial. Lancet Neurol, 2010, 9(7): 672-680.
5. Vollmer T, Panitch H, Bar-Or A, et al. Glatiramer acetate after induction therapy with mitoxantrone in relapsing multiple sclerosis. Mult Scler, 2008, 14 (5): 663-670.
6. Le Page E, Leray E, Taurin G, et al. Mitoxantrone as induction treatment in aggressive relapsing remitting multiple sclerosis: treatment response factors in a 5 year follow-up observational study of 100 consecutive patients. J Neurol Neurosurg Psychiatry, 2008, 79(1): 52-56.
7. Belachew S, Phan-Ba R, Bartholomé E, et al. Natalizumab induces a rapid improvement of disability status and ambulation after failure of previous therapy in relapsing-remitting multiple sclerosis. Eur J Neurol, 2011, 18(2): 240-245.
8. Rommer PS, Patejdl R, Winkelmann A, et al. Rituximab for secondary progressive multiple sclerosis: a case series. CNS Drugs, 2011, 25(7): 607-613.
9. Stein MS, Liu Y, Gray OM, et al. A randomized trial of high-dose vitamin D2 in relapsing-remitting multiple sclerosis. Neurology, 2011, 77(17): 1611-1618.
10. Papadopoulos D, Mitsikostas DD. Nocebo effects in multiple sclerosis trials: a meta-analysis. Mult Scler, 2010 , 16(7): 816-828.
11. Fassas A, Kimiskidis VK, Sakellari I, et al. Long-term results of stem cell transplantation for MS: a single-center experience. Neurology, 2011, 76(12): 1066-1070.
12. Matzke B, Metze C, Winkelmann A, et al. Severe relapse of multiple sclerosis during plasma exchange treatment. Mult Scler, 2011, 17(6): 759-762.
13. Chun J, Hartung HP. Mechanism of action of oral Fingolimod (FTY720) in multiple sclerosis. Clinical Neuropharmacol, 2010, 33(2): 91-101.
14. Horga A, Montalban X. FTY720 (fingolimod) for relapsing multiple sclerosis. Expert Rev Neurother, 2008, 8(5): 699-714.
15. 鄧可剛. 循證醫學證據的檢索步驟與檢索系統的選擇. 中國循證醫學雜志, 2004, 4(9): 634-637.
16. 郭新峰, 溫澤淮, 老鷹榮, 等. 臨床試驗質量評價工具及其應用. 中國循證醫學雜志, 2004, 4(7): 484-487.
17. Polman CH, Reingold SC, Banwell B, et al. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol, 2011, 69(2): 292-302.
18. Kappos L, Radue EW, O’connor P, et al. A placebo-controlled trial of oral fingonimod in relapsing multiple Sclerosis. N Engl J Med, 2010, 362(5): 387-401.
19. Kappos L, Antel J, Comi G, et al. Oral fingolimod (FTY720) for relapsing multiple Sclerosis. N Engl J Med, 2006, 355(11): 1124-1140.
20. Cohen JA, Barkhof F, Comi G, et al. Oral Fingolimod or Intramuscular. Interferon for relapsing multiple Sclerosis. N Engl J Med, 2010, 362(10): 402-415.
21. Comi G, O’connor P, Montalban X, et al. Phase Ⅱ study of oral fingolimod (FTY720) in multiple sclerosis:3-year results. Mult Scler, 2010, 16(2): 197-207.
22. Doggrell SA. Is fingolimod an advancement in the treatment of multipie sclerosis? Expert Opin.Pharmacother, 2007, 8(3): 383-386.
23. Brown BA, Kantesaria PP, McDevitt LM. Fingolimod: A Novel Immunosuppressant for Multiple sclerosis. Ann Pharmacother, 2007, 41(10): 1660-1668.
24. Aktas O, Küry P, Kieseier B, et al. Fingolimod is a potential novel therapy for multiple sclerosis. Nat Rev Neurol, 2010, 6(7): 373-382.

《中國循證醫學雜志》

FTY720治療多發性硬化的療效與安全性系統評價

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《中國循證醫學雜志》

FTY720治療多發性硬化的療效與安全性系統評價

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