依那西普治療強直性脊柱炎的系統評價_《中國循證醫學雜志》

作者：

1. 蘭州大學循證醫學中心，蘭州大學基礎醫學院（蘭州 730000）；2. 蘭州大學免疫學研究所（蘭州 730000）;

關鍵詞：

依那西普強直性脊柱炎安全性有效性系統評價

DOI：

10.7507/1672-2531.20090080

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目的　系統評價依那西普治療強直性脊柱炎的有效性和安全性。
方法　計算機檢索Cochrane Library（2008 年第4 期）、MEDLINE（1966 ～ 2008. 9）、EMbase（1974 ～ 2008. 9）、中國生物醫學文獻數據庫（1978 ～ 2008.9）、中國期刊全文數據庫（1994 ～ 2008. 9）、中文科技期刊全文數據庫（1989 ～ 2008. 9）。萬方數據庫，納入依那西普治療強直性脊柱炎的隨機對照試驗，由兩名評價員獨立提取資料，并對其方法學質量進行評價。對符合納入標準的研究用RevMan5.0 軟件進行Meta 分析。
結果　共納入7 個隨機對照試驗，949 例患者。Meta 分析結果顯示：依那西普組較安慰劑組能有效提高達到ASAS20 的病例數［OR=4.15，95% CI（2.90，5.93）］，達到ASAS50 例數［OR=6.88，95% CI（3.90，12.14）］，改善Bath 強直性脊柱炎活動指數［OR=6.52, 95%CI（3.18，13.37）］，降低紅細胞沉降率 [WMD=16.27，95%CI（11.80，20.74）］。依那西普組與安慰劑比較，在注射部位不良反應發生率方面，差異有統計學意義［OR=3.91，95%CI（2.47，6.20）］，但其他不良反應的差異無統計學意義；25 mg 依那西普組和50 mg依那西普組在療效和不良反應方面，差異無統計學意義。
結論依那西普較安慰劑能更有效地改善患者癥狀，緩解疾病的活動狀態，但同時會增加注射部位反應的發生率，但現有有限證據尚不能證明不同劑量依那西普的有效性和安全性有差異，尚需高質量、大樣本、長期的隨機對照試驗來驗證依那西普治療的最佳劑量。

引用本文： 李少紅,馬彬,譚繼英,楊克虎. 依那西普治療強直性脊柱炎的系統評價. 中國循證醫學雜志, 2009, 09(4): 423-429. doi: 10.7507/1672-2531.20090080 復制

1.	donors. Arthritis Rheum, 1998, 41: 58-67.
2.	assessment group preliminary definition of short-term improvement in ankylosing spondylitis. Arthritis Rheum, 2001, 44: l876-1886.
3.	Sieper J, Braun J, Rudwaleit M, et al. Ankylosing spondylitis: an overview. Ann Rheum Dis, 2002, 61(Suppl 3): iii8–iii18.
4.	Br aun J , Bol low M, Remlinge r G, etal . Prevalenc e of spondylarthropathies in HLA-B27 positive and negative blood.
5.	Gran JT, Husby G, Hordvik M. Prevalence of ankylosing spondylitis in males and females in a young middle-aged population of Tromso, northern Norway. Ann Rheum Dis, 1985, 44: 359-67.
6.	Braun J, Listing J, Sieper J. Reply. Arthritis Rheum, 2005, 52: 4049-4059.
7.	Toussirot E, Wendling D. Current guidelines for the drug treatment of ankylosing spondylitis. Drugs, 1998, 56: 225-240.
8.	Immunex Corporation. Enbrel (etanercept) for subcutaneous injection (2006). Available from URL: http://www.amgen.com/pdfs/misc/enbrel_pi.pdf .
9.	Braun J, Heijde VD. Novel approaches in the treatment of ankylosing spondylitis and other spondyloarthritides. Expert Opin Investing Drugs, 2003, 12(7): 1097-1109.
10.	Linden S, Valkenburg HA, Cats A. Evaluation of diagnostic criteria for ankylosing spondylitis. Arthritis Rheum, 1984, 27: 361-368.
11.	Heijde VD, Linden S, Ballamy N, et a1. Which domains should be included in a core set for endpoints in ankylosing spondylitis? Introduction to the ankylosing spondylitis module of omeractive. The Journal of Rheumatology, l999, 26(76): 495-497.
12.	Heijde VD, Braun J, McGonagle D, et a1.Treatment trials in ankylosing spondylitis: current and future considerations. Ann Rheum Dis, 2002, 6 l(Suppl 3): iii24-iii32.11 Anderson JJ, Baron G, Heijde VD, et a1．Ankylosing spondylitis.
13.	Millicent A, Stone SD, Robert D, et a1．Validation exercise of the ankylosing spondylitis assessment study (ASAS)group response criteria in ankylosing spondylitis patients treated with biologics. Arthritis Rheum, 2004, 51: 316-320.
14.	Heijde DV, Silva JC, Dougados M, et al. Etanercept 50 mg once weekly is as effective as 25 mg twice weekly in patients with ankylosing spondylitis. Ann Rheum Dis, 2006, 65(12): 1572-1577.
15.	Braun J, McHugh N, Singh A, et al. Improvement in patientreported outcomes for patients with ankylosing spondylitis treated with etan- ercept 50 mg once-weekly and 25 mg twice weekly. Rheumatology, 2007, 46: 999-1004.
16.	Davis JC, Heijde VD, Braun J, et al. Recombinant Human Tumor Necrosis Factor Receptor (Etanercept) for Treating Ankylosing Spondylitis. Arthritis Rheum, 2003, 48(11): 3230-3236.
17.	Davis JC, Heijde VD, Braun J, et al. Sustained durability and tolerability of etanercept in ankylosing spondylitis for 96 weeks. Ann Rheum Dis, 2005, 64(11): 1557-1562.
18.	Davis JC, Heijde VD, Braun J, et al. Efficacy and safety of up to 192 weeks of etanercept therapy in patients with ankylosing spondylitis. Ann Rheum Dis, 2008, 67: 346-352.
19.	Brandt J, Khariouzov A, Listing J, et al. Six-Month Results of a Double-Blind, Placebo-Controlled Trial of Etanercept Treatment in Patients With Active Ankylosing Spondylitis. Arthritis Rheum, 2003, 48(6): 1667-1675.
20.	Brandt J, Listing J, Haibel H, et al. Long-term efficacy and safety of etanercept after readministration in patients with active ankylosing spondylitis .Rheumatology, 2005, 44(3): 342-348.
21.	Jennifer D, Gorman, Kenneth E, et al. Treatment of ankylosing spondylitis by inhibition of tumor necrosis factors a. N Engl J Med, 2002, 346(18): 1349-1356.
22.	Calin A, Dijkmans B, Emery P, et al. Outcomes of a multicentre randomised clinical trial of etanercept to treat ankylosing spondylitis. Ann Rheum Dis, 2004, 63(12): 1594-1600.
23.	王莉莎, 黃烽, 張江林, 等. 腫瘤壞死因子拮抗劑在治療強直性脊柱炎中的安全性分析. 中國新藥雜志, 2007, 16(7): 556-561.
24.	郝慧琴, 黃烽, 鄧小虎, 等. 依那西普不同用藥方案治療強直性脊柱炎療效比較. 中國藥物與臨床, 2008, 8(6): 432-436.

1. donors. Arthritis Rheum, 1998, 41: 58-67.
2. assessment group preliminary definition of short-term improvement in ankylosing spondylitis. Arthritis Rheum, 2001, 44: l876-1886.
3. Sieper J, Braun J, Rudwaleit M, et al. Ankylosing spondylitis: an overview. Ann Rheum Dis, 2002, 61(Suppl 3): iii8–iii18.
4. Br aun J , Bol low M, Remlinge r G, etal . Prevalenc e of spondylarthropathies in HLA-B27 positive and negative blood.
5. Gran JT, Husby G, Hordvik M. Prevalence of ankylosing spondylitis in males and females in a young middle-aged population of Tromso, northern Norway. Ann Rheum Dis, 1985, 44: 359-67.
6. Braun J, Listing J, Sieper J. Reply. Arthritis Rheum, 2005, 52: 4049-4059.
7. Toussirot E, Wendling D. Current guidelines for the drug treatment of ankylosing spondylitis. Drugs, 1998, 56: 225-240.
8. Immunex Corporation. Enbrel (etanercept) for subcutaneous injection (2006). Available from URL: http://www.amgen.com/pdfs/misc/enbrel_pi.pdf .
9. Braun J, Heijde VD. Novel approaches in the treatment of ankylosing spondylitis and other spondyloarthritides. Expert Opin Investing Drugs, 2003, 12(7): 1097-1109.
10. Linden S, Valkenburg HA, Cats A. Evaluation of diagnostic criteria for ankylosing spondylitis. Arthritis Rheum, 1984, 27: 361-368.
11. Heijde VD, Linden S, Ballamy N, et a1. Which domains should be included in a core set for endpoints in ankylosing spondylitis? Introduction to the ankylosing spondylitis module of omeractive. The Journal of Rheumatology, l999, 26(76): 495-497.
12. Heijde VD, Braun J, McGonagle D, et a1.Treatment trials in ankylosing spondylitis: current and future considerations. Ann Rheum Dis, 2002, 6 l(Suppl 3): iii24-iii32.11 Anderson JJ, Baron G, Heijde VD, et a1．Ankylosing spondylitis.
13. Millicent A, Stone SD, Robert D, et a1．Validation exercise of the ankylosing spondylitis assessment study (ASAS)group response criteria in ankylosing spondylitis patients treated with biologics. Arthritis Rheum, 2004, 51: 316-320.
14. Heijde DV, Silva JC, Dougados M, et al. Etanercept 50 mg once weekly is as effective as 25 mg twice weekly in patients with ankylosing spondylitis. Ann Rheum Dis, 2006, 65(12): 1572-1577.
15. Braun J, McHugh N, Singh A, et al. Improvement in patientreported outcomes for patients with ankylosing spondylitis treated with etan- ercept 50 mg once-weekly and 25 mg twice weekly. Rheumatology, 2007, 46: 999-1004.
16. Davis JC, Heijde VD, Braun J, et al. Recombinant Human Tumor Necrosis Factor Receptor (Etanercept) for Treating Ankylosing Spondylitis. Arthritis Rheum, 2003, 48(11): 3230-3236.
17. Davis JC, Heijde VD, Braun J, et al. Sustained durability and tolerability of etanercept in ankylosing spondylitis for 96 weeks. Ann Rheum Dis, 2005, 64(11): 1557-1562.
18. Davis JC, Heijde VD, Braun J, et al. Efficacy and safety of up to 192 weeks of etanercept therapy in patients with ankylosing spondylitis. Ann Rheum Dis, 2008, 67: 346-352.
19. Brandt J, Khariouzov A, Listing J, et al. Six-Month Results of a Double-Blind, Placebo-Controlled Trial of Etanercept Treatment in Patients With Active Ankylosing Spondylitis. Arthritis Rheum, 2003, 48(6): 1667-1675.
20. Brandt J, Listing J, Haibel H, et al. Long-term efficacy and safety of etanercept after readministration in patients with active ankylosing spondylitis .Rheumatology, 2005, 44(3): 342-348.
21. Jennifer D, Gorman, Kenneth E, et al. Treatment of ankylosing spondylitis by inhibition of tumor necrosis factors a. N Engl J Med, 2002, 346(18): 1349-1356.
22. Calin A, Dijkmans B, Emery P, et al. Outcomes of a multicentre randomised clinical trial of etanercept to treat ankylosing spondylitis. Ann Rheum Dis, 2004, 63(12): 1594-1600.
23. 王莉莎, 黃烽, 張江林, 等. 腫瘤壞死因子拮抗劑在治療強直性脊柱炎中的安全性分析. 中國新藥雜志, 2007, 16(7): 556-561.
24. 郝慧琴, 黃烽, 鄧小虎, 等. 依那西普不同用藥方案治療強直性脊柱炎療效比較. 中國藥物與臨床, 2008, 8(6): 432-436.

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依那西普治療強直性脊柱炎的系統評價

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依那西普治療強直性脊柱炎的系統評價

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