奧馬佐單抗治療過敏性支氣管哮喘療效與安全性的系統評價_《中國循證醫學雜志》

作者：

麥琳 , 孫蓉菲 ,  李為民

四川大學華西醫院呼吸內科（成都 610041）;

關鍵詞：

奧馬佐單抗抗IgE 過敏性支氣管哮喘系統評價 Meta分析隨機對照試驗

DOI：

10.7507/1672-2531.20130126

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目的　系統評價奧馬佐單抗治療過敏性支氣管哮喘的療效及安全性。
方法　計算機檢索MEDLINE、EMbase、The Cochrane Library、CBM、CNKI、VIP和WanFang Data等數據庫，收集奧馬佐單抗治療過敏性支氣管哮喘的隨機對照試驗（RCT），檢索時限均為從建庫至2013年4月，并追溯納入研究的參考文獻和手工檢索相關會議資料。由兩位研究者按照納入與排除標準獨立篩選文獻、提取資料和評價質量后，采用RevMan 5.1軟件進行Meta分析。
結果　共納入了13個RCT，4 195例患者。Meta分析結果顯示：① 試驗組與對照組比較，治療期間發生哮喘急性加重率降低［RR=0.71，95%CI（0.65，0.77），P lt;0.000 01］；而哮喘全球療效評估（GETE）達優/良的患者比例更高［RR=1.61，95%CI（1.32，1.97），P lt;0.000 01］；更多的患者可在治療期和之后的24周隨訪期達吸入性糖皮質激素（ICS）減量大于50%［分別為RR=1.40，95%CI（1.29，1.52）和RR=1.69, 95%CI（1.41，2.03）］；哮喘相關生存質量（AQLQ）總分提高0.5分和1.5分的患者比例也均明顯增高。② 兩組間總不良反應發生率相似［RR=1.01，95%CI（0.98，1.04）］，且嚴重不良反應發生率也無差異［RR=0.94，95CI（0.68，1.28）］。③ 對于能否減少急救藥物的使用和肺功能的改善，可能有一定作用，但目前觀察到的效果不明顯。
結論　奧馬佐單抗在哮喘治療中可降低哮喘急性加重率和ICS的使用，提高療效評估和生活質量，且有較好的安全性。

引用本文： 麥琳,孫蓉菲,李為民. 奧馬佐單抗治療過敏性支氣管哮喘療效與安全性的系統評價. 中國循證醫學雜志, 2013, 13(6): 709-716. doi: 10.7507/1672-2531.20130126 復制

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14.	Hanania NA, Alpan O, Hamilos DL, et al. Omalizumab in severe allergic asthma inadequately controlled with standard therapy: a randomized trial. Ann Intern Med, 2011, 154(9): 573-582.
15.	Hoshino M, Ohtawa J. Effects of adding omalizumab, an anti-immunoglobulin E antibody, on airway wall thickening in asthma. Respiration, 2012, 83(6): 520-528.
16.	Rubin AS, Souza-Machado A, Andradre-Lima M, et al. Effect of omalizumab as add-on therapy on asthma-related quality of life in severe allergic asthma: a Brazilian study (QUALITX). Journal of Asthma, 2012, 49(3): 288-293.
17.	Bardelas J, Figliomeni M, Kianifard F, et al. A 26-week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the effect of omalizumab on asthma control in patients with persistent allergic asthma. J Asthma, 2012, 49(2): 144-152.
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24.	Siergiejko Z, Swiebocka E, Smith N, et al. Oral corticosteroid sparing with omalizumab in severe allergic (IgE-mediated) asthma patients. Curr Med Res Opin, 2011, 27(11): 2223-2228.
25.	Milgrom H, Berger W, Nayak A, et al. Treatment of childhood asthma with anti-immunoglobulin E antibody (omalizumab). Pediatrics, 2001, 108(2): E36.
26.	Lanier B, Bridges T, Kulus M, et al. Omalizumab for the treatment of exacerbations in children with inadequately controlled allergic (IgE-mediated) asthma. J Allergy Clin Immunol, 2009, 124(6): 1210-1216.
27.	Busse WW, Morgan WJ, Gergen PJ, et al. Randomized trial of omalizumab (anti-IgE) for asthma in inner-city children. N Engl J Med, 2011, 364(11): 1005-1015.
28.	Bousquet J, Siergiejko Z, Swiebocka E, et al. Persistency of response to omalizumab therapy in severe allergic (IgE-mediated) asthma. Allergy, 2011, 66(5): 671-678.
29.	Menzella F, Facciolongo N, Piro R, et al. Clinical and pharmacoeconomic aspects of omalizumab: a 4-year follow-up. Therapeutic Advances in Respiratory Disease, 2012, 6(2): 87-95.
30.	Tzortzaki EG, Georgiou A, Kampas D, et al. Long-term omalizumab treatment in severe allergic asthma: The South-Eastern Mediterranean “real-life” experience. Pulmonary Pharmacology & Therapeutics, 2012, 25(1): 77-82.
31.	Grossman HL, Schlender A, Alperin P, et al. Modeling the effects of omalizumab over 5 years among patients with moderate-to-severe persistent allergic asthma. Current Medical Research & Opinion, 2010, 26(12): 2779-2793.
32.	Brown R, Turk F, Dale P, et al. Cost-effectiveness of omalizumab in patients with severe persistent allergic asthma. Allergy, 2007, 62(2): 149-153.
33.	Sthoeger ZM, Eliraz A, Asher I, et al. The beneficial effects of Xolair (omalizumab) as add-on therapy in patients with severe persistent asthma who are inadequately controlled despite best available treatment (GINA 2002 step IV)--the Israeli arm of the INNOVATE study. IMAJ, 2007, 9(6): 472-475.
34.	Oba Y, Salzman GA. Cost-effectiveness analysis of omalizumab in adults and adolescents with moderate-to-severe allergic asthma. J Allergy Clin Immunol, 2004, 114(2): 265-269.
35.	Slavin RG, Ferioli C, Tannenbaum SJ, et al. Asthma symptom re-emergence after omalizumab withdrawal correlates well with increasing IgE and decreasing pharmacokinetic concentrations. J Allergy Clin Immunol, 2009, 123(1): 107-113.
36.	Noga O, Hanf G, Brachmann I, et al. Effect of omalizumab treatment on peripheral eosinophil and T-lymphocyte function in patients with allergic asthma. J Allergy Clin Immunol, 2006, 117(6): 1493-1499.
37.	van Rensen EL, Evertse CE, van Schadewijk WA, et al. Eosinophils in bronchial mucosa of asthmatics after allergen challenge: effect of anti-IgE treatment. Allergy, 2009, 64(1): 72-80.

1. GINA report, global strategy for asthma management and prevention. www.ginasthma.com, 2010. Accessed February 25, 2012.
2. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. Issued 1995 (NIH pub no. 02–3659); Accessed December 2011.
3. Prussin C, Metcalfe DD. IgE, mast cells, basophils, and eosinophils. J Allergy Clin Immunol, 2003, 111(2): S486-494.
4. Chanez P, Contin-Bordes Cc, Garcia G, et al. Omalizumab-induced decrease of FcεRI expression in patients with severe allergic asthma. Respir Med, 2010, 104(11): 1608-1617.
5. Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1 [updated March 2011]. The Cochrane Collaboration, 2011. Available from: http:// www.cochrane-handbook.org.
6. Soler M, Matz J, Townley R, et al. The anti-IgE antibody omalizumab reduces exacerbations and steroid requirement in allergic asthmatics. Official Journal of the European Society for Clinical Respiratory Physiology, 2001, 18(2): 254-261.
7. Busse W, Corren J, Lanier BQ, et al. Omalizumab, anti-IgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma. The Journal of Allergy and Clinical Immunology, 2001, 108(2): 184-190.
8. Holgate ST, Chuchalin AG, Hebert J, et al. Efficacy and safety of a recombinant anti-immunoglobulin E antibody (omalizumab) in severe allergic asthma. Clin Exp Allergy, 2004, 34(4): 632-638.
9. Ayres JG, Higgins B, Chilvers ER, et al. Efficacy and tolerability of anti-immunoglobulin E therapy with omalizumab in patients with poorly controlled (moderate-to-severe) allergic asthma. Allergy, 2004, 59(7): 701-708.
10. Vignola AM, Humbert M, Bousquet J, et al. Efficacy and tolerability of anti-immunoglobulin E therapy with omalizumab in patients with concomitant allergic asthma and persistent allergic rhinitis: SOLAR. Allergy, 2004, 59(7): 709-717.
11. Humbert M, Beasley R, Ayres J, et al. Benefits of omalizumab as add-on therapy in patients with severe persistent asthma who are inadequately controlled despite best available therapy (GINA 2002 step 4 treatment): INNOVATE. Allergy, 2005, 60(3): 309-316.
12. Kopp MV, Hamelmann E, Zielen S, et al. Combination of omalizumab and specific immunotherapy is superior to immunotherapy in patients with seasonal allergic rhinoconjunctivitis and co-morbid seasonal allergic asthma. Clin Exp Allergy, 2009, 39(2): 271-279.
13. Ohta K, Miyamoto T, Amagasaki T, et al. Efficacy and safety of omalizumab in an Asian population with moderate-to-severe persistent asthma. Respirology, 2009, 14(8): 1156-1165.
14. Hanania NA, Alpan O, Hamilos DL, et al. Omalizumab in severe allergic asthma inadequately controlled with standard therapy: a randomized trial. Ann Intern Med, 2011, 154(9): 573-582.
15. Hoshino M, Ohtawa J. Effects of adding omalizumab, an anti-immunoglobulin E antibody, on airway wall thickening in asthma. Respiration, 2012, 83(6): 520-528.
16. Rubin AS, Souza-Machado A, Andradre-Lima M, et al. Effect of omalizumab as add-on therapy on asthma-related quality of life in severe allergic asthma: a Brazilian study (QUALITX). Journal of Asthma, 2012, 49(3): 288-293.
17. Bardelas J, Figliomeni M, Kianifard F, et al. A 26-week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the effect of omalizumab on asthma control in patients with persistent allergic asthma. J Asthma, 2012, 49(2): 144-152.
18. Buhl R, Soler M, Matz J, et al. Omalizumab provides long-term control in patients with moderate-to-severe allergic asthma. Eur Respir J, 2002, 20(1): 73-78.
19. Lanier BQ, Corren J, Lumry W, et al. Omalizumab is effective in the long-term control of severe allergic asthma. Ann Allergy Asthma Immunol, 2003, 91(2): 154-159.
20. Juniper EF, Guyatt GH, Epstein RS, et al. Evaluation of impairment of health related quality of life in asthma: development of a questionnaire for use in clinical trials. Thorax, 1992, 47(2): 76–83.
21. Buhl R, Hanf G, Soler M, et al. The anti-IgE antibody omalizumab improves asthma-related quality of life in patients with allergic asthma. Eur Respir J, 2002, 20(5): 1088-1094.
22. Finn A, Gross G, van Bavel J, et al. Omalizumab improves asthma-related quality of life in patients with severe allergic asthma. J Allergy Clin Immunol, 2003, 111(2): 278-284.
23. Hendeles L, Sorkness CA. Anti-immunoglobulin E therapy with omalizumab for asthma. The Annals of Pharmacotherapy, 2007, 41(9): 1397-1410.
24. Siergiejko Z, Swiebocka E, Smith N, et al. Oral corticosteroid sparing with omalizumab in severe allergic (IgE-mediated) asthma patients. Curr Med Res Opin, 2011, 27(11): 2223-2228.
25. Milgrom H, Berger W, Nayak A, et al. Treatment of childhood asthma with anti-immunoglobulin E antibody (omalizumab). Pediatrics, 2001, 108(2): E36.
26. Lanier B, Bridges T, Kulus M, et al. Omalizumab for the treatment of exacerbations in children with inadequately controlled allergic (IgE-mediated) asthma. J Allergy Clin Immunol, 2009, 124(6): 1210-1216.
27. Busse WW, Morgan WJ, Gergen PJ, et al. Randomized trial of omalizumab (anti-IgE) for asthma in inner-city children. N Engl J Med, 2011, 364(11): 1005-1015.
28. Bousquet J, Siergiejko Z, Swiebocka E, et al. Persistency of response to omalizumab therapy in severe allergic (IgE-mediated) asthma. Allergy, 2011, 66(5): 671-678.
29. Menzella F, Facciolongo N, Piro R, et al. Clinical and pharmacoeconomic aspects of omalizumab: a 4-year follow-up. Therapeutic Advances in Respiratory Disease, 2012, 6(2): 87-95.
30. Tzortzaki EG, Georgiou A, Kampas D, et al. Long-term omalizumab treatment in severe allergic asthma: The South-Eastern Mediterranean “real-life” experience. Pulmonary Pharmacology & Therapeutics, 2012, 25(1): 77-82.
31. Grossman HL, Schlender A, Alperin P, et al. Modeling the effects of omalizumab over 5 years among patients with moderate-to-severe persistent allergic asthma. Current Medical Research & Opinion, 2010, 26(12): 2779-2793.
32. Brown R, Turk F, Dale P, et al. Cost-effectiveness of omalizumab in patients with severe persistent allergic asthma. Allergy, 2007, 62(2): 149-153.
33. Sthoeger ZM, Eliraz A, Asher I, et al. The beneficial effects of Xolair (omalizumab) as add-on therapy in patients with severe persistent asthma who are inadequately controlled despite best available treatment (GINA 2002 step IV)--the Israeli arm of the INNOVATE study. IMAJ, 2007, 9(6): 472-475.
34. Oba Y, Salzman GA. Cost-effectiveness analysis of omalizumab in adults and adolescents with moderate-to-severe allergic asthma. J Allergy Clin Immunol, 2004, 114(2): 265-269.
35. Slavin RG, Ferioli C, Tannenbaum SJ, et al. Asthma symptom re-emergence after omalizumab withdrawal correlates well with increasing IgE and decreasing pharmacokinetic concentrations. J Allergy Clin Immunol, 2009, 123(1): 107-113.
36. Noga O, Hanf G, Brachmann I, et al. Effect of omalizumab treatment on peripheral eosinophil and T-lymphocyte function in patients with allergic asthma. J Allergy Clin Immunol, 2006, 117(6): 1493-1499.
37. van Rensen EL, Evertse CE, van Schadewijk WA, et al. Eosinophils in bronchial mucosa of asthmatics after allergen challenge: effect of anti-IgE treatment. Allergy, 2009, 64(1): 72-80.

《中國循證醫學雜志》

奧馬佐單抗治療過敏性支氣管哮喘療效與安全性的系統評價

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《中國循證醫學雜志》

奧馬佐單抗治療過敏性支氣管哮喘療效與安全性的系統評價

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