口服抗真菌药物治疗真菌致敏性严重哮喘的随机对照研究—FAST
2009/05/18
理论依据：某些严重哮喘患者对一种或多种真菌有免疫致敏性，临床上称为“真菌致敏性严重哮喘（SAFS）”。
目的：为了评价口服抗真菌药物-伊曲康唑治疗SAFS的反应。
方法：研究纳入了58例真菌致敏性严重哮喘患者，将其随机分为两组，口服伊曲康唑200mg（2次/日）或安慰剂治疗32周，随访16周。所有患者总IgE水平低于1000IU/ml，曲霉菌沉淀素试验阴性。主要终点指标是哮喘生活质量问卷（AQLQ）评分，血浆总IgE水平与肺功能检查等。
主要结果：与基线时相比，伊曲康唑组的AQLQ平均评分增加0.85分，鼻炎评分减少0.43分。上述改善与安慰剂组相比有显著差异（P=0.014和P=0.013）。伊曲康唑组的早晨最大呼气流量改变（P=0.028），血浆总IgE水平下降（P=0.001）。7例患者因不良反应退出研究（5例为伊曲康唑组患者），未见严重不良反应。
结论：60%的患者生活质量获得较大改善，证明抗真菌治疗SAFS有效。
（苏楠 卫生部中日友好医院呼吸内科 100029 摘译）
（Am J Respir Crit Care Med. 2009 Jan 1;179(1):11-18）
Am J Respir Crit Care Med. 2009 Jan 1;179(1):11-8.
Am J Respir Crit Care Med. 2009 Feb 15;179(4):330-1.
Randomized controlled trial of oral antifungal treatment for severe asthma with fungal sensitization: The Fungal Asthma Sensitization Trial (FAST) study.
Denning DW, O’Driscoll BR, Powell G, Chew F, Atherton GT, Vyas A, Miles J, Morris J, Niven RM.
School of Translational Medicine, University of Manchester, Manchester, UK. ddenning@manchester.ac.uk
RATIONALE: Some patients with severe asthma are immunologically sensitized to one or more fungi, a clinical entity categorized as severe asthma with fungal sensitization (SAFS). It is not known whether SAFS responds to antifungal therapy.
OBJECTIVES: To evaluate the response of SAFS to oral itraconazole.
METHODS: Patients with severe asthma sensitized to at least one of seven fungi by skin prick or specific IgE testing were recruited. All had total IgE less than 1,000 IU/ml and negative Aspergillus precipitins. They were treated with oral itraconazole (200 mg twice daily) or placebo for 32 weeks, with follow-up for 16 weeks.
MEASUREMENTS AND MAIN RESULTS: The primary end point was change in the Asthma Quality of Life Questionnaire (AQLQ) score, with rhinitis score, total IgE, and respiratory function as secondary end points. Fifty-eight patients were enrolled, of whom 41% had been hospitalized in the previous year. Baseline mean AQLQ score was 4.13 (range, 1-7). At 32 weeks, the improvement (95% confidence interval) in AQLQ score was +0.85 (0.28, 1.41) in the antifungal group, compared with a -0.01 (-0.43, 0.42) change in the placebo group (P = 0.014). Rhinitis score improved (-0.43) in the antifungal, and deteriorated (+0.17) in the placebo group (P = 0.013). Morning peak flow improved (20.8 L/minute, P = 0.028) in the antifungal group. Total serum IgE decreased in the antifungal group (-51 IU/ml) but increased in placebo group (+30 IU/ml) (P = 0.001). No severe adverse events were observed, but seven patients developed adverse events requiring discontinuation, five in the antifungal group.
CONCLUSIONS: SAFS responds to oral antifungal therapy as judged by large improvements in quality of life in about 60% of patients.
目的：为了评价口服抗真菌药物-伊曲康唑治疗SAFS的反应。
方法：研究纳入了58例真菌致敏性严重哮喘患者，将其随机分为两组，口服伊曲康唑200mg（2次/日）或安慰剂治疗32周，随访16周。所有患者总IgE水平低于1000IU/ml，曲霉菌沉淀素试验阴性。主要终点指标是哮喘生活质量问卷（AQLQ）评分，血浆总IgE水平与肺功能检查等。
主要结果：与基线时相比，伊曲康唑组的AQLQ平均评分增加0.85分，鼻炎评分减少0.43分。上述改善与安慰剂组相比有显著差异（P=0.014和P=0.013）。伊曲康唑组的早晨最大呼气流量改变（P=0.028），血浆总IgE水平下降（P=0.001）。7例患者因不良反应退出研究（5例为伊曲康唑组患者），未见严重不良反应。
结论：60%的患者生活质量获得较大改善，证明抗真菌治疗SAFS有效。
（苏楠 卫生部中日友好医院呼吸内科 100029 摘译）
（Am J Respir Crit Care Med. 2009 Jan 1;179(1):11-18）
Am J Respir Crit Care Med. 2009 Jan 1;179(1):11-8.
Am J Respir Crit Care Med. 2009 Feb 15;179(4):330-1.
Randomized controlled trial of oral antifungal treatment for severe asthma with fungal sensitization: The Fungal Asthma Sensitization Trial (FAST) study.
Denning DW, O’Driscoll BR, Powell G, Chew F, Atherton GT, Vyas A, Miles J, Morris J, Niven RM.
School of Translational Medicine, University of Manchester, Manchester, UK. ddenning@manchester.ac.uk
RATIONALE: Some patients with severe asthma are immunologically sensitized to one or more fungi, a clinical entity categorized as severe asthma with fungal sensitization (SAFS). It is not known whether SAFS responds to antifungal therapy.
OBJECTIVES: To evaluate the response of SAFS to oral itraconazole.
METHODS: Patients with severe asthma sensitized to at least one of seven fungi by skin prick or specific IgE testing were recruited. All had total IgE less than 1,000 IU/ml and negative Aspergillus precipitins. They were treated with oral itraconazole (200 mg twice daily) or placebo for 32 weeks, with follow-up for 16 weeks.
MEASUREMENTS AND MAIN RESULTS: The primary end point was change in the Asthma Quality of Life Questionnaire (AQLQ) score, with rhinitis score, total IgE, and respiratory function as secondary end points. Fifty-eight patients were enrolled, of whom 41% had been hospitalized in the previous year. Baseline mean AQLQ score was 4.13 (range, 1-7). At 32 weeks, the improvement (95% confidence interval) in AQLQ score was +0.85 (0.28, 1.41) in the antifungal group, compared with a -0.01 (-0.43, 0.42) change in the placebo group (P = 0.014). Rhinitis score improved (-0.43) in the antifungal, and deteriorated (+0.17) in the placebo group (P = 0.013). Morning peak flow improved (20.8 L/minute, P = 0.028) in the antifungal group. Total serum IgE decreased in the antifungal group (-51 IU/ml) but increased in placebo group (+30 IU/ml) (P = 0.001). No severe adverse events were observed, but seven patients developed adverse events requiring discontinuation, five in the antifungal group.
CONCLUSIONS: SAFS responds to oral antifungal therapy as judged by large improvements in quality of life in about 60% of patients.
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