阿達木單抗治療斑塊型銀屑病的系統評價_《中國循證醫學雜志》

作者：

孫艷 ¹ , 吳嚴 ¹ , 陳良宏 ² , 劉宇博 ³ ,  高興華 ¹

1. 中國醫科大學附屬第一醫院皮膚科暨衛生部免疫皮膚病學重點實驗室（沈陽 110001）；2. 中國醫科大學附屬盛京醫院急診科（沈陽?110001）；3. 大連經濟技術開發區醫院皮膚科（大連 116600）;

關鍵詞：

斑塊型銀屑病阿達木單抗隨機對照試驗系統評價

DOI：

10.7507/1672-2531.20100549

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目的　系統評價阿達木單抗治療斑塊型銀屑病的療效與安全性。
方法　計算機檢索MEDLINE（1966～2009.12）、Cochrane圖書館（2009年第12期）、EMbase（1980～2009.12）、CBM（1978～2009.12）和CNKI（1979～2009.12），語種限于英、中文，收集所有關于阿達木單抗與其它治療方法比較的隨機對照試驗。根據納入與排除標準篩選文獻、評價質量、提取資料，采用RevMan 4.2軟件進行Meta分析。
結果　共納入3個隨機對照試驗，包括1?630例中重度斑塊型銀屑病患者。Meta分析結果顯示：① 阿達木單抗隔周皮下注射治療4周、8周、12周、16周時獲銀屑病皮損面積和嚴重性指數積分下降75%的患者例數（PASI 75）顯著多于安慰劑組及甲氨蝶呤口服組；但治療24周、60周時與安慰劑組比較并無顯著差異。② 阿達木單抗每周皮下注射組治療12周時獲PASI 75者顯著多于安慰劑組及阿達木單抗隔周組；但至24和60周時，與后兩組比較并無顯著性差異。③ 阿達木單抗隔周皮下注射組治療12～16周時，除注射部位疼痛、上呼吸道病毒感染的發生率顯著高于安慰劑組外，其它不良反應發生率與安慰劑比較并無顯著性差異。阿達木單抗每周皮下注射組治療12～60周時各種嚴重不良反應發生率均高于阿達木單抗隔周組及安慰劑繼以阿達木單抗隔周組，而其它不良反應發生率比較則無顯著性差異。
結論　現有證據表明，阿達木單抗隔周皮下注射治療12～16周對于中重度斑塊型銀屑病患者安全、有效，但延長治療時間至24周以上并不能進一步增強療效；阿達木單抗每周皮下注射方案較隔周皮下注射方案并無明顯優勢。受本系統評價納入研究數量和質量限制，上述結論尚需要更多高質量的隨機對照試驗驗證。

引用本文： 孫艷,吳嚴,陳良宏,劉宇博,高興華. 阿達木單抗治療斑塊型銀屑病的系統評價. 中國循證醫學雜志, 2010, 10(9): 1085-1095. doi: 10.7507/1672-2531.20100549 復制

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1. Krueger G, Koo J, Lebwohl M, et al. The impact of psoriasis on quality of life: results of a 1998 National Psoriasis Foundation patient-membership survey. Arch Dermatol, 2001, 137(3): 280-284.
2. Stern RS, Nijsten T, Feldman SR, et al. Psoriasis is common, carries a substantial burden even when not extensive, and is associated with widespread treatment dissatisfaction. J Investig Dermatol Symp Proc, 2004, 9(2): 136-139.
3. Christophers E, Griffiths CE, Gaitanis G, et al. The unmet treatment need for moderate to severe psoriasis: results of a survey and chart review. J Eur Acad Dermatol Venereol, 2006, 20(8): 921-925.
4. Arican O, Aeal M, Sasmaz S, et al. Serum levels of TNF-alpha, TNF-gamma, IL-6, IL-8, IL-12, IL-17, and IL-18 in patients with active psoriasis and correlation with disease severity. Mediators Inflamm, 2005, 2005(5): 273-279.
5. Mease PJ, Gladman DD, Ritchlin CT, et al. Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: results of a double-blind, randomized, placebo-controlled trial. Arthritis Rheum, 2005, 52(10): 3279-3289.
6. Gladman DD, Mease PJ, Ritchlin CT, et al. Adalimumab for long-term treatment of psoriatic arthritis: forty-eight week data from the adalimumab effectiveness in psoriatic arthritis trial. Arthritis Rheum, 2007, 56(2): 476-488.
7. Mease PJ, Ory P, Sharp JT, Ritchlin CT, et al. Adalimumab for long-term treatment of psoriatic arthritis: 2-year data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT). Ann Rheum Dis, 2009, 68(5): 702-709.
8. Ashcroft DM, Wan Po AL, Williams HC, et al. Clinical measures of disease severity and outcome in psoriasis: a critical appraisal of their quality. Br J Dermatol, 1999, 141(2): 185-191.
9. Gordon KB, Langley RG, Leonardi C, et al. Clinical response to adalimumab treatment in patients with moderate to severe psoriasis: Double-blind,randomized controlled trial and open-label extension study. J Am Acad Dermatol, 2006, 55(4): 598-606.
10. Menter A, Tyring SK, Gordon K, et al. Adalimumab therapy for moderate to severe psoriasis:A randomized, controlled phase III trial. J Am Acad Dermatol, 2008, 58(1): 106-115.
11. Saurat JH, Stingl G, Dubertret L, et al. Efficacy and safety results from the randomized controlled comparative study of adalimumab vs. methotrexate vs. placebo in patients with psoriasis (CHAMPION). Br J Dermatol, 2008, 158(3): 558-566.

《中國循證醫學雜志》

阿達木單抗治療斑塊型銀屑病的系統評價

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《中國循證醫學雜志》

阿達木單抗治療斑塊型銀屑病的系統評價

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