Clinical efficacy of sublingual and subcutaneous birch pollen allergen-specific immunotherapy:: a randomized, placebo-controlled, double-blind, double-dummy study
Clinical efficacy of sublingual and subcutaneous birch pollen allergen-specific immunotherapy:: a randomized, placebo-controlled, double-blind, double-dummy study
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DOI：
10.1046/j.1398-9995.2003.00387.x
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发表时间：
2004-01-01
期刊：
影响因子：
12.4
通讯作者：
Malling, HJ
中科院分区：
文献类型：
--
作者：
Khinchi, MS;Poulsen, LK;Malling, HJ
背景资料：舌下变应原特异性免疫疗法（SLIT）和皮下免疫疗法（SCIT）均有临床疗效，但比较研究较少。目的：探讨SLIT与SCIT的临床疗效，并与安慰剂进行比较，评价SLIT和SCIT的相对临床疗效和全身副作用。一项为期3年的随机、安慰剂对照、双盲、双模拟研究，包括71名成年桦树花粉花粉症患者，在基线年后连续治疗两年。治疗组的分配是基于疾病的严重程度在基线季节，性别和age.Results：临床疗效估计在58例患者完成的第一个治疗年减去基线数据，并通过计算第一个治疗季节与基线的比率。SLIT将中位疾病严重程度降低至安慰剂治疗的一半，SCIT降低至安慰剂治疗的三分之一。两组间无统计学显著差异。与安慰剂相比，积极治疗患者的症状和药物评分均显示出统计学显著性和临床相关疗效。SLIT治疗仅导致局部轻微的副作用，而SCIT导致很少的严重全身性副作用。结论：根据有限的患者人数，SLIT的临床疗效与SCIT无统计学差异，与安慰剂相比，两种治疗方法在治疗桦树花粉鼻结膜炎方面均具有临床有效性。两种治疗之间缺乏显著差异并不表明疗效等同，但为了检测微小差异，需要对更大的组进行研究。由于有利的安全特性，SLIT可能是有利的。
Background: Both sublingual allergen-specific immunotherapy (SLIT) and subcutaneous immunotherapy (SCIT) have a documented clinical efficacy, but only few comparative studies have been performed.Objective: To investigate the clinical efficacy of SLIT vs SCIT and secondary to compare SLIT and SCIT with placebo and to evaluate the relative clinical efficacy in relation to systemic side-effects.Methods: A 3-year randomized, placebo-controlled, double-blind, double-dummy study including 71 adult birch pollen hay fever patients treated for two consecutive years after a baseline year. Allocation to treatment groups was based on disease severity in the baseline season, gender and age.Results: Clinical efficacy was estimated in 58 patients completing the first treatment year by subtracting baseline data and by calculating the ratio first treatment season vs baseline. SLIT diminished the median disease severity to one-half and SCIT to one-third of placebo treatment. No statistical significant difference between the two groups was observed. Both for symptoms and medication scores actively treated patients showed statistically significant and clinical relevant efficacy compared with placebo. SLIT treatment only resulted in local mild side-effects, while SCIT resulted in few serious systemic side-effects.Conclusion: Based on the limited number of patients the clinical efficacy of SLIT was not statistically different from SCIT, and both treatments are clinically effective compared with placebo in the treatment of birch pollen rhinoconjunctivitis. The lack of significant difference between the two treatments does not indicate equivalent efficacy, but to detect minor differences necessitates investigation of larger groups. Due to the advantageous safety profile SLIT may be favored.