哮喘联盟

   摘要
   研究背景：舌下免疫疗法治疗屋尘螨诱发哮喘的安全性及有效性尚待明确。本文将报道中国大陆一项双盲、对照、随机临床试验的结果。
   研究方法：三个月基线期后，484名成年哮喘患者以2：1的比例被随机分为两组，一组每天给予300单位欧洲屋尘螨和美洲屋尘螨的活性提取混合物，另一组给予安慰剂，治疗时间12个月。主要疗效指标为哮喘有效控制率（治疗最后20周内，哮喘有效控制时间≥16周）。
   研究结果：治疗组（308名患者）和安慰剂组（157名患者）的哮喘有效控制率分别为85.4%及81.5%（P=0.244）。随后的哮喘严重性分析显示，治疗组患者中，基线中度持续性哮喘患者[401-800微克布地奈德/天，175名患者]临床获益显著，哮喘有效控制率（治疗组与安慰机组分别为80.5%和66.1%，P=0.021）和哮喘完全控制率（54%和33.9%，P=0.008）显著提高，哮喘控制问卷得分小于0.75的患者比例更高（56.6%和40.0%，P=0.039），糖皮质激素平均吸入量显著降低（218.5微克和126.2微克，P=0.004）。对轻度持续性哮喘患者，治疗组与安慰机组在病情控制及糖皮质激素使用量上无明显差异。本研究中无治疗相关不良反应报告。
   结论：屋尘螨舌下免疫疗法在成年哮喘患者中耐受性良好，可有效控制中度（但不包括轻度）持续性哮喘。

 

（刘国梁 审校）
Allergy. 2014 Sep;69(9):1181-1188. doi: 10.1111/all.12188. Epub 2014 Jul 24.

 

House dust mite sublingual immunotherapy is safe and appears to be effective in moderate, persistent asthma.
 

Wang L1, Yin J, Fadel R, Montagut A, de Beaumont O, Devillier P.
 

ABSTRACT
BACKGROUND: The efficacy and safety of sublingual immunotherapy in house dust mite-induced asthma have yet to be firmly established. We report the results of a double-blind, placebo-controlled, randomized clinical trial performed in mainland China.
METHODS: After a three-month baseline period, 484 asthmatic adults were randomized 2 : 1 to 12 months of daily treatment with either an aqueous, standardized, 300 index of reactivity mixture of Dermatophagoidespteronyssinus and Dermatophagoidesfarinae extracts or a placebo. The primary efficacy criterion was well-controlled asthma for at least 16 of the last 20 weeks of treatment.
RESULTS: In the active (n = 308) and placebo (n = 157) groups, well-controlled asthma was achieved by 85.4% and 81.5% of the patients, respectively (P = 0.244). A subsequent post hoc analysis by asthma severity revealed significant clinical benefits in actively treated subjects with moderate, persistent asthma at baseline [401-800 μg budesonide/day (n = 175)], with greater achievement of well-controlled asthma (80.5% and 66.1% for the active treatment and placebo groups, respectively; P = 0.021) and totally controlled asthma (54.0% and 33.9%, respectively, P = 0.008), a higher percentage of patients with an asthma control questionnaire score < 0.75 (56.6% and 40.0%, respectively; P = 0.039) and a greater mean reduction in inhaled corticosteroid use (218.5 μg and 126.2 μg, respectively; P = 0.004). The active vs placebo differences in disease control and corticosteroid use were not significant for mild, persistent asthma. No treatment-related serious adverse events were reported.
CONCLUSIONS: Sublingual mite allergen immunotherapy was well tolerated in adult asthmatics and effectively controlled disease in patients with moderate (but not mild) persistent asthma
 

Allergy. 2014 Sep;69(9):1181-1188. doi: 10.1111/all.12188. Epub 2014 Jul 24.