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临床试验/NCT01247259
NCT01247259已完成不适用

Efficacy of Sublingual Immunotherapy With House Dust Mite Extract in Poly-allergen-sensitized Allergic Rhinitis Patients

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2007年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
134
试验地点
1
主要终点
total nasal symptom score (TNSS) and anti-allergic medication score (AMS)

研究概览

简要总结

Recently, interest has increased in sublingual immunotherapy (SLIT) for treating allergic rhinitis. It is often suggested that polysensitized patients might not benefit from specific immunotherapy as much as monosensitized patients, although further research on this subject is needed. This study compared the efficacy of SLIT with standardized house dust mite extract in mono- and polysensitized allergic rhinitis patients.

Patients who were sensitized to house dust mites and treated with SLIT for house dust mites for at least 1 year between November 2007 and March 2010 were included. The mono-allergen sensitized group (Mgr) was defined as the patients who were sensitized to Dermatophagoides pteronyssinus (Dp) or D. farinae (Df; n = 70). The poly-allergen sensitized group (Pgr) was defined as the patients who were simultaneously sensitized to house dust mites and other allergens (n = 64). A standardized extract of house dust mites was used for immunotherapy. Anti-allergic medication and the total nasal symptom score (TNSS), including rhinorrhea, sneezing, nasal obstruction, and itchy nose, were evaluated before and 1 year after SLIT.

This study enrolled 134 patients. The TNSS improved significantly after SLIT in both groups, while the change in the TNSS did not differ significantly between the groups. The anti-allergic medication scores also decreased significantly in both groups, but there was no significant difference between the groups.

In polysensitized allergic rhinitis patients, SLIT for Dp/Df gave comparable improvements in both nasal symptoms and rescue medication scores to those in monosensitized patients, regardless of other positive allergens. SLIT for Dp/Df might be considered in polysensitized allergic rhinitis patients.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
4 Years 至 53 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who had sneezing, itching, rhinorrhea, and nasal congestion with or without eye symptoms
  • patients who were sensitized to Dermatophagoides pteronyssinus (Dp) or D. farinae (Df), as confirmed by skin prick testing (A/H ratio ≥ 1) or MAST

排除标准

  • Patients who had immunotherapy in the preceding 3 years
  • Patients who had systemic immunological disorders

研究组 & 干预措施

SLIT-mono

Active Comparator

干预措施: Pangramin® (Drug)

SLIT-poly

Active Comparator

干预措施: Pangramin® (Drug)

结局指标

主要结局

total nasal symptom score (TNSS) and anti-allergic medication score (AMS)

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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