來氟米特和甲氨蝶呤治療類風濕關節炎的Meta分析_《中國循證醫學雜志》

作者：

蘇冉 ¹ ,  魏麗 ¹ , 陳艷春 ² , 劉玉 ³

1. 新疆醫科大學第一附屬醫院風濕免疫科（烏魯木齊?830054）；2. 新疆醫科大學第一附屬醫院干部心血管一科（烏魯木齊?830054）；3. 新疆醫科大學第一附屬醫院循證醫學教研室（烏魯木齊?830054）;

關鍵詞：

來氟米特甲氨蝶呤類風濕關節炎 Meta分析系統評價隨機對照試驗

DOI：

10.7507/1672-2531.20110177

視頻：

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目的　系統評價來氟米特治療類風濕性關節炎的臨床療效和安全性，為來氟米特在我國的應用提供科學依據。
方法　在MEDLINE、EMbase、CNKI、萬方數據庫和CBM檢索1989.1～2011.1有關來氟米特治療類風濕關節炎的隨機對照試驗（RCT）。由兩位研究者按照納入與排除標準進行文獻篩選、資料提取和質量評價后，采用RevMan 5.0軟件進行Meta分析。
結果　共納入16個RCT，合計3 247例患者，其中來氟米特組1 711例，甲氨喋呤組1 536例。Meta分析結果顯示：來氟米特與甲氨蝶呤療效差異無統計學意義［RR=1.03，95%CI（0.94，1.11），P gt;0.05］，而副反應差異有統計學意義［RR=0.67，95%CI（0.49，0.94），P lt;0.05］。
結論　來氟米特治療類風濕性關節炎療效與甲氨喋呤相近且其安全性優于甲氨蝶呤，是一種比較安全、有效的改變病程的慢作用藥。由于受納入研究質量限制和可能存在的發表偏倚影響，其療效和安全性尚需更多高質量的隨機雙盲試驗加以驗證。

引用本文： 蘇冉,魏麗,陳艷春,劉玉. 來氟米特和甲氨蝶呤治療類風濕關節炎的Meta分析. 中國循證醫學雜志, 2011, 11(9): 1062-1069. doi: 10.7507/1672-2531.20110177 復制

1.	1 Barlett RR, Anagnostopulos H, Zielinski T, et al . Effects of leflunomide on immune responses and models of inflammation. Springer Semin Immunopathal , 1993, 14(4): 381-394.
2.	Mldenovic V, Domljan Z, Rozman B, et al . Safety and effectiveness of leflunomide in the treatment of patients with rheumatoidarthritis. Arthritis Rheumat , 1995, 38(11): 1596-1603.
3.	Smolen JS, Kalden JR, Scott DL, et al . Efficacy and safety of leflunomide compared with placebo and sulphasalazine in active rheumatoidarthritis: a double-blind, randomised, multicentre trial. Lancet , 1999, 353(9149): 259-266.
4.	Felson DT, Anderson JJ, Boers M, et al . American college of rheumatology preliminary definition of improvement in rheumatoid arthrit is. Arthritis Rheumat , 1995, 38(6): 727-735.
5.	孫凌云, 金歐, 王紅. 來氟米特治療類風濕關節炎的療效評價. 南京大學學報(自然科學), 2002, 38(5): 632-635.
6.	Jadad AR, Moore RA, Corral D, Assessing the quality of the reports of randomized clinical trials: is blinding necessary? control clin trials , 1996, 17(1): 1-12.
7.	呂隨峰, 肖飛, 何培根, 等. 愛若華治療類風濕性關節炎的療效及其安全性. 臨床內科雜志, 2000, 11(6): 375-376.
8.	李向培, 厲小梅, 汪國生, 等. 來氟米特治療類風濕性關節炎的臨床研究. 中國臨床藥理學與治療學, 200l, 6 (2): 142-144.
9.	張玲玲, 丁長海, 梁朝朝, 等. 來氟米特治療類風濕關節炎隨機雙盲平行對照臨床試驗. 中國臨床藥理學雜志, 2005, 9, (97): 341-343.
10.	Hu Y, Tu S, Liu P. A randomized, controlled, single-blind trial of leflunomide in the treatment of rheumatoid arthritis. J Tongji Med Univ , 2001, 21(1): 72-74.
11.	鐘清, 甘華, 陳恩靜, 等. 來氟米特治療類風濕性關節炎的臨床療效評價. 重慶醫科大學學報, 2003, 28 (4): 503-505, 524.
12.	帥宗文, 劉爽, 孫桂華, 等. 來氟米特治療類風濕性關節炎的Ⅱ期臨床試驗. 安徽醫科大學學報, 2002, 37 (1): 41-43.
13.	姜林銻, 於強, 梅振武. 來氟米特治療類風濕性關節炎的療效評價. 中國臨床醫學, 2000, 7 (4): 413-415.
14.	馬驥良. 來氟米特和甲氨喋呤治療活動性類風濕關節炎的對比觀察. 北京醫學, 2000, 22 (6): 342-345.
15.	Strand V, Cohen S, Schiff M, et al . Treatment of active rheumatoid arthritis with leflunomide compared with placebo and methotrexate. Arch Intern Med , 1999, 159 (21): 2542-2550.
16.	Fiehn C, Jacki S, Heilig B, et al . Eight versus 16-week re-evaluation period in rheumatoid arthritis patients treated with leflunomide or methotrexate accompanied by moderate dose prednisone. Rheumatol Int , 2007, 8(27): 975–979.
17.	Bao C, Chen S, Gu Y, et al . Leflunomide, a new disease-modifying drug for treating active rheumatoid arthritis in methotrexate-controlled phase II clinical trial. Chin Med J (Engl) , 2003, 116(8): 1228-1234.
18.	Emery P, Breedveld FC, Lemmel EM, et al . A comparison of the efficacy and safety of leflunomide and methotrexate for the treatment of rheumatoid arthritis. Rheumatology , 2000, 39: 655-665.
19.	Cohen S, Cannon GW, Schiff M, et al . Two-year, blinded, randomized, controlled trail of treatment of active rheumatoid arthritis with leflunomide compared with methotrexate. Arthritis Rheum , 2001, 44(9): 1984-1992.
20.	Ishaq M, Muhammad JS, Hameed K, et al . Leflunomide or methotrexate? Comparison of clinical efficacy and safety in low socio-economic rheumatoid arthritis patients. Mod Rheumatol , 2011, 1(7): 566-589.
21.	Peter T, George W, Andreas M, et al . Clinical improvement as peflected in measures of function and health-related quality of life following treatment with leflunomide compare wirh methotrexate in patients with rheumatoid arthritis. Arthritis & Rheumatism , 2000, 3(43): 506–514.
22.	Katayama K, Matsuno T. Long-term efficacy of leflunomide on disease activity and inhibition of joint damage: retrospective comparison with methotrexate for Japanese rheumatoid arthritis patients. Mod Rheumatol , 2009, 6(19): 513–521.
23.	李金鵬, 王搖瑞, 白人驍. 來氟米特和甲氨蝶呤治療類風濕關節炎療效及安全性的薈萃分析. 現代中西醫結合雜志, 2011, 2(6): 673-675.
24.	朱湘竹, 周興軍, 陸艾芹, 等. 來氟米特治療類風濕性關節炎療效的Meta分析. 現代預防醫學2007, 34(11): 2011-2014.

1. 1 Barlett RR, Anagnostopulos H, Zielinski T, et al . Effects of leflunomide on immune responses and models of inflammation. Springer Semin Immunopathal , 1993, 14(4): 381-394.
2. Mldenovic V, Domljan Z, Rozman B, et al . Safety and effectiveness of leflunomide in the treatment of patients with rheumatoidarthritis. Arthritis Rheumat , 1995, 38(11): 1596-1603.
3. Smolen JS, Kalden JR, Scott DL, et al . Efficacy and safety of leflunomide compared with placebo and sulphasalazine in active rheumatoidarthritis: a double-blind, randomised, multicentre trial. Lancet , 1999, 353(9149): 259-266.
4. Felson DT, Anderson JJ, Boers M, et al . American college of rheumatology preliminary definition of improvement in rheumatoid arthrit is. Arthritis Rheumat , 1995, 38(6): 727-735.
5. 孫凌云, 金歐, 王紅. 來氟米特治療類風濕關節炎的療效評價. 南京大學學報(自然科學), 2002, 38(5): 632-635.
6. Jadad AR, Moore RA, Corral D, Assessing the quality of the reports of randomized clinical trials: is blinding necessary? control clin trials , 1996, 17(1): 1-12.
7. 呂隨峰, 肖飛, 何培根, 等. 愛若華治療類風濕性關節炎的療效及其安全性. 臨床內科雜志, 2000, 11(6): 375-376.
8. 李向培, 厲小梅, 汪國生, 等. 來氟米特治療類風濕性關節炎的臨床研究. 中國臨床藥理學與治療學, 200l, 6 (2): 142-144.
9. 張玲玲, 丁長海, 梁朝朝, 等. 來氟米特治療類風濕關節炎隨機雙盲平行對照臨床試驗. 中國臨床藥理學雜志, 2005, 9, (97): 341-343.
10. Hu Y, Tu S, Liu P. A randomized, controlled, single-blind trial of leflunomide in the treatment of rheumatoid arthritis. J Tongji Med Univ , 2001, 21(1): 72-74.
11. 鐘清, 甘華, 陳恩靜, 等. 來氟米特治療類風濕性關節炎的臨床療效評價. 重慶醫科大學學報, 2003, 28 (4): 503-505, 524.
12. 帥宗文, 劉爽, 孫桂華, 等. 來氟米特治療類風濕性關節炎的Ⅱ期臨床試驗. 安徽醫科大學學報, 2002, 37 (1): 41-43.
13. 姜林銻, 於強, 梅振武. 來氟米特治療類風濕性關節炎的療效評價. 中國臨床醫學, 2000, 7 (4): 413-415.
14. 馬驥良. 來氟米特和甲氨喋呤治療活動性類風濕關節炎的對比觀察. 北京醫學, 2000, 22 (6): 342-345.
15. Strand V, Cohen S, Schiff M, et al . Treatment of active rheumatoid arthritis with leflunomide compared with placebo and methotrexate. Arch Intern Med , 1999, 159 (21): 2542-2550.
16. Fiehn C, Jacki S, Heilig B, et al . Eight versus 16-week re-evaluation period in rheumatoid arthritis patients treated with leflunomide or methotrexate accompanied by moderate dose prednisone. Rheumatol Int , 2007, 8(27): 975–979.
17. Bao C, Chen S, Gu Y, et al . Leflunomide, a new disease-modifying drug for treating active rheumatoid arthritis in methotrexate-controlled phase II clinical trial. Chin Med J (Engl) , 2003, 116(8): 1228-1234.
18. Emery P, Breedveld FC, Lemmel EM, et al . A comparison of the efficacy and safety of leflunomide and methotrexate for the treatment of rheumatoid arthritis. Rheumatology , 2000, 39: 655-665.
19. Cohen S, Cannon GW, Schiff M, et al . Two-year, blinded, randomized, controlled trail of treatment of active rheumatoid arthritis with leflunomide compared with methotrexate. Arthritis Rheum , 2001, 44(9): 1984-1992.
20. Ishaq M, Muhammad JS, Hameed K, et al . Leflunomide or methotrexate? Comparison of clinical efficacy and safety in low socio-economic rheumatoid arthritis patients. Mod Rheumatol , 2011, 1(7): 566-589.
21. Peter T, George W, Andreas M, et al . Clinical improvement as peflected in measures of function and health-related quality of life following treatment with leflunomide compare wirh methotrexate in patients with rheumatoid arthritis. Arthritis & Rheumatism , 2000, 3(43): 506–514.
22. Katayama K, Matsuno T. Long-term efficacy of leflunomide on disease activity and inhibition of joint damage: retrospective comparison with methotrexate for Japanese rheumatoid arthritis patients. Mod Rheumatol , 2009, 6(19): 513–521.
23. 李金鵬, 王搖瑞, 白人驍. 來氟米特和甲氨蝶呤治療類風濕關節炎療效及安全性的薈萃分析. 現代中西醫結合雜志, 2011, 2(6): 673-675.
24. 朱湘竹, 周興軍, 陸艾芹, 等. 來氟米特治療類風濕性關節炎療效的Meta分析. 現代預防醫學2007, 34(11): 2011-2014.

《中國循證醫學雜志》

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《中國循證醫學雜志》

來氟米特和甲氨蝶呤治療類風濕關節炎的Meta分析

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