奥马佐单抗治疗过敏性支气管哮喘疗效与安全性的系统评价_《中国循证医学杂志》

作者：

麦琳 , 孙蓉菲 ,  李为民

四川大学华西医院呼吸内科（成都 610041）;

关键词：

奥马佐单抗抗IgE 过敏性支气管哮喘系统评价 Meta分析随机对照试验

DOI：

10.7507/1672-2531.20130126

视频：

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摘要 全文 图表 视频 参考文献 施引文献 补充材料

目的　系统评价奥马佐单抗治疗过敏性支气管哮喘的疗效及安全性。
方法　计算机检索MEDLINE、EMbase、The Cochrane Library、CBM、CNKI、VIP和WanFang Data等数据库，收集奥马佐单抗治疗过敏性支气管哮喘的随机对照试验（RCT），检索时限均为从建库至2013年4月，并追溯纳入研究的参考文献和手工检索相关会议资料。由两位研究者按照纳入与排除标准独立筛选文献、提取资料和评价质量后，采用RevMan 5.1软件进行Meta分析。
结果　共纳入了13个RCT，4 195例患者。Meta分析结果显示：① 试验组与对照组比较，治疗期间发生哮喘急性加重率降低［RR=0.71，95%CI（0.65，0.77），P lt;0.000 01］；而哮喘全球疗效评估（GETE）达优/良的患者比例更高［RR=1.61，95%CI（1.32，1.97），P lt;0.000 01］；更多的患者可在治疗期和之后的24周随访期达吸入性糖皮质激素（ICS）减量大于50%［分别为RR=1.40，95%CI（1.29，1.52）和RR=1.69, 95%CI（1.41，2.03）］；哮喘相关生存质量（AQLQ）总分提高0.5分和1.5分的患者比例也均明显增高。② 两组间总不良反应发生率相似［RR=1.01，95%CI（0.98，1.04）］，且严重不良反应发生率也无差异［RR=0.94，95CI（0.68，1.28）］。③ 对于能否减少急救药物的使用和肺功能的改善，可能有一定作用，但目前观察到的效果不明显。
结论　奥马佐单抗在哮喘治疗中可降低哮喘急性加重率和ICS的使用，提高疗效评估和生活质量，且有较好的安全性。

引用本文： 麦琳,孙蓉菲,李为民. 奥马佐单抗治疗过敏性支气管哮喘疗效与安全性的系统评价. 中国循证医学杂志, 2013, 13(6): 709-716. doi: 10.7507/1672-2531.20130126 复制

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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.
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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.

《中国循证医学杂志》

奥马佐单抗治疗过敏性支气管哮喘疗效与安全性的系统评价

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《中国循证医学杂志》

奥马佐单抗治疗过敏性支气管哮喘疗效与安全性的系统评价

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