目的 評價在糖皮質(zhì)激素基礎上使用霉酚酸酯治療增生性狼瘡腎炎的有效性和安全性。
方法 計算機檢索中國生物醫(yī)學文獻光盤數(shù)據(jù)庫(1979.11~2006.2)、中國循證醫(yī)學/ Cochrane 中心數(shù)據(jù)庫(2005年)、Cochrane圖書館臨床對照試驗資料庫(2005年第4期)、MEDLINE(1966.11~2006.2)、EMbase(1975~2006.2)和SCI(1985~2006.2)等數(shù)據(jù)庫,收集霉酚酸酯治療增生性狼瘡腎炎的隨機對照試驗, 對納入研究的方法學質(zhì)量進行評價。選擇臨床總有效率及完全緩解率作為近期療效指標,腎臟存活率、患者生存率及狼瘡腎炎復發(fā)率作為遠期療效指標,治療期及隨訪期發(fā)生感染、閉經(jīng)、白細胞減少、腹瀉等副作用的患者比例作為安全性評價指標,提取數(shù)據(jù)并采用Cochrane 協(xié)作網(wǎng)推薦的RevMan 4.2.7軟件進行統(tǒng)計分析。
結(jié)果 共檢索到符合納入標準的隨機對照試驗9篇(512例)。對近期療效指標的Meta分析結(jié)果顯示,霉酚酸酯與環(huán)磷酰胺/硫唑嘌呤比較治療臨床療效差異無統(tǒng)計學意義。腎臟存活率、腎病復發(fā)率的Meta分析結(jié)果顯示,霉酚酸酯與環(huán)磷酰胺/硫唑嘌呤比較,其臨床療效差異無統(tǒng)計學意義。遠期療效指標和安全性評價各項指標的Meta分析提示,霉酚酸酯優(yōu)于環(huán)磷酰胺/硫唑嘌呤。
結(jié)論 霉酚酸酯在改善增生性狼瘡腎炎患者的近期療效、腎臟存活率及防止腎病復發(fā)方面并不優(yōu)于目前常規(guī)的環(huán)磷酰胺/硫唑嘌呤治療,但在提高患者生存率及藥物安全性方面可能優(yōu)于后者。由于本系統(tǒng)評價納入文獻的方法學質(zhì)量不夠高,加之例數(shù)有限,尚需開展多中心、大樣本隨機雙盲試驗進一步證實霉酚酸酯的療效和安全性。
引用本文: 歐三桃,鐘利春,杜 新,黃頌敏,劉 琦,趙安菊,陳澤君. 霉酚酸酯治療增生性狼瘡腎炎的系統(tǒng)評價. 中國循證醫(yī)學雜志, 2006, 06(10): 712-720. doi: 復制
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4. | 朱彬, 周振安, 劉子棟, 等. 霉酚酸酯與環(huán)磷酰胺治療IV型狼瘡性腎炎的療效比較. 山東大學學報 (醫(yī)學版), 2003; 41(6): 692~694. |
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13. | Chan TM, Tse KC, Tang CS, et al. Long-term study of mycophenolate mofetil as continuous induction and maintenance treatment for diffuse proliferative lupus nephritis. J Am Soc Nephrol, 2005; 16(4): 1076–1084. |
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- 1. 蔣文功, 肖笑, 方敬愛. 霉酚酸酯治療彌漫增生性狼瘡腎炎的臨床觀察. 中國中西醫(yī)結(jié)合腎病雜志, 2002; 3(4): 218–221.
- 2. 劉國平, 黃九香, 林琳. 霉酚酸酯對彌漫增生型狼瘡性腎炎患者的療效觀察. 中國中西醫(yī)結(jié)合腎病雜, 2003; 4(7): 386~388.
- 3. 張江林, 張火亙, 馬麗等. 嗎替麥考酚酯治療系統(tǒng)性紅斑狼瘡的多中心前瞻性研究. 中華風濕病學雜志, 2002; 6(6): 406~410.
- 4. 朱彬, 周振安, 劉子棟, 等. 霉酚酸酯與環(huán)磷酰胺治療IV型狼瘡性腎炎的療效比較. 山東大學學報 (醫(yī)學版), 2003; 41(6): 692~694.
- 5. Boumpas DT, Austin HA III, Vaughn EM, et al. Controlled trial of pulse methylprednisolone versus two regimens of pulse cyclophosphamide in severe lupus nephritis.Lancet, 1992; 340: 741–745.
- 6. Dooley MA, Cosio FG, Nachman PH, et al. Mycophenolate mofetil therapy in lupus nephritis: clinical observations. J Am Soc Nephml, 1999;10(4): 833–839.
- 7. Tan EM, Cohen AS, Fries JF, et al. The1982 revised criteria for the classification of systemic lupus erythematosus. Arthritis Rheum, 1982; 25: 1271–1277.
- 8. Egger M, Smith GD, Altman DG. Systematic Reviews in Heath Care. London: Tavistock Square, Second edition, 2001. 73-78.
- 9. Jadad AR ,Moore A ,Carrol D, et al. Assessing the quality of reports of randomized clinical trials: Is blinding necessary. Control Clin Trials, 1996 ; 17: 1–12.
- 10. Cochrane Reviewer’s Handbook 4.2.2. The Cochrane Collaboration, 2000.
- 11. Schulz KF, Chalmers I, Hayes RJ. Empirical evidence of bias .JAMA, 1995; 273: 408–412.
- 12. Chan TM, Li FK, Tang CS, et al. Efficacy of mycophenolate mofetil in patients with diffuse proliferative lupus nephritis. N Engl J Med, 2000; 343(16): 1156–1162.
- 13. Chan TM, Tse KC, Tang CS, et al. Long-term study of mycophenolate mofetil as continuous induction and maintenance treatment for diffuse proliferative lupus nephritis. J Am Soc Nephrol, 2005; 16(4): 1076–1084.
- 14. Contreras G, Pardo V, Leclercq B, et al. Sequential therapies for proliferative lupus nephritis. N Engl J Med, 2004; 350(10): 971–980.
- 15. Ginzler EM, Dooley MA, Aranow C, et al. Mycophenolate mofetil or intravenous cyclophosphamide for lupus nephritis. N Eng J Med, 2005; 353(21): 2219–2228.
- 16. Jiang WG,Xiao X,Fang JA. Eff icacy of Mycophenolate Mofetil in Patients with Diffuse Prol -iferative Lupus Nephritis. Chinese Journal of Integrated Traditional and Western Nephrology, 2002; 3(4): 218–221.
- 17. Liu GP, Huang JX, Gui L. Clinical Study of Mycophenolate Mofetil in Patients with Diffuse Proliferative Lupus Nephritis.Chinese Journal of Integrated Traditional and Western Nephrology, 2003; 4(7): 386–388.
- 18. Ong LM, Hooi LS, Lim TO, et al. Randomized controlled trial of pulse intravenous cyclophosphamide versus mycophenolate mofetil in the induction therapy of proliferative lupus nephritis. Nephrology, 2005; 10(5): 504–510.
- 19. Zhang JL, Zhang HH, Ma L, et al. A multicentric and prospective study on mycophenolate mofetil in the treatment of systemic lupus erythematosus. Chinese Journal of Rheumatology, 2002; 6(6): 406–410.
- 20. Zhu B, Zhou ZA, Liu ZD, et al. Comparision of mycophenolate mofetil therapy versus cyclophosphamide treatment of proliferative lupus nephritis. Journal of Shandong Univenity (health sciences), 2003; 41(6): 692–694.