Double-blind and placebo-controlled study to assess efficacy and safety of a modified allergen extract of Dermatophagoides pteronyssinus in allergic asthma
Double-blind and placebo-controlled study to assess efficacy and safety of a modified allergen extract of Dermatophagoides pteronyssinus in allergic asthma
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DOI：
10.1111/j.1398-9995.2005.00862.x
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发表时间：
2005-09-01
期刊：
影响因子：
12.4
通讯作者：
García-González, JJ
中科院分区：
文献类型：
--
作者：
Ameal, A;Vega-Chicote, JM;García-González, JJ
背景：采用随机、双盲、安慰剂对照的研究方法，对屋尘螨致敏的过敏性哮喘患者进行研究。目的：与安慰剂对照，评价改良屋尘螨提取物免疫治疗1年后的疗效和安全性。材料与方法：55例患者随机分为主动治疗组(n=29)和安慰剂组(n=26)。主要结果为特异性支气管激发试验(BPT)。其他参数分析包括剂量-反应皮肤点刺试验、症状和药物评分以及哮喘生活质量。结果：研究结束时，活动组的PD20FEV1显著高于安慰剂组(P=0.0029)。活动组中有19名患者比安慰剂组中的10名患者需要两倍以上的变应原提取物才能出现阳性反应(P=0.0293)；安慰剂组中有7名患者比活动组中的1名患者所需的变应原提取物量少于一半(P=0.0137)。在SPT中，活动组有显著改善(P=0.0049)。这组患者症状评分的中位数降低了91.5%，而安慰剂组增加了86%。两组患者的用药分数都有所下降(积极组为56%，安慰剂组为11.4%)。治疗结束时，两组患者的生活质量差异有统计学意义(P=0.0234)。结论：经1年的治疗，改良的屋尘螨提取物对哮喘和过敏性鼻结膜炎患者安全有效。
Background: A randomized double-blind, placebo-controlled study was conducted in patients allergic asthma sensitized to Dermatophagoides pteronyssinus.Objective: To evaluate the efficacy and safety after 1-year of immunotherapy with a modified D. pteronyssinus extract compared with placebo.Material and methods: Fifty-five patients were randomly allocated to receive the active treatment (n = 29), or placebo (n = 26). The main outcome was the specific bronchial provocation test (BPT). Other parameters analysed were dose-response skin prick test (SPT), symptom and medication scores and asthma quality of life (AQLQ).Results: At the end of the study, the active group showed a significant increase in the PD20FEV1 compared with placebo (P = 0.0029). Nineteen patients of the active vs 10 of the placebo group needed more than twice the initial amount of allergen extract to have a positive BPT (P = 0.0293); seven patients in the placebo vs one in the active group needed less than half (P = 0.0137). In SPT, a significant improvement (P = 0.0049) was found in the active group. This group also had a median reduction of 91.5% in symptom scores, whereas the placebo group increased by 86%. Medication scores decreased in both groups (56% in the active and 11.4% in the placebo). In AQLQ, the differences between both groups were significant (P = 0.0234) at the end of the study.Conclusions: After 1 year of treatment, the modified extract of D. pteronyssinus demonstrated to be safe and efficacious to treat patients with asthma and allergic rhinoconjunctivitis sensitized to this mite.