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一项随机、双盲、安慰剂对照试验:间断和发作时使用普鲁司特降低过敏性儿童的喘息的发生频率

2015/06/18

   摘要
   背景:
使用白三烯受体拮抗剂(LTRA)治疗能够减少2岁以上哮喘患儿的哮喘急性加重。然而,1~2岁有喘息发作的过敏性儿童早期使用LTRA治疗是否能够减少喘息的发生频率仍不清楚。
   方法:随机、双盲、安慰剂对照、多中心试验,纳入2岁以下之前发生过2次(不超过2次)的喘息发作,并对过敏原特异性Ig阳性的儿童(≥2级),接受LTRAs普鲁司特治疗12个月,在喘息发作间断时使用。主要终点为3个月内每月喘息发作超过一次的发生率。
   结果:77例儿童随机接受普鲁司特(n=37)或安慰剂治疗(n=40)。普鲁司特组主要终点发生率为10/36(28%),安慰剂组发生率为14/39(36%),两组比较无显著差异(P=0.45)。即使本项研究的时间最长延长到>5年,但是两组主要终点的Kaplan-Meier曲线仍无显著差异。
   结论:这些结果表明,有喘息和特异性过敏病史的儿童间断和发作时使用普鲁司特可能不会降低后续生活中喘息的发生频率。然而,由于样本量太小还不能得出确定的结论。

 

(杨冬 审校)
World Allergy Organ J. 2015 Apr 2;8(1):11. doi: 10.1186/s40413-015-0062-3. eCollection 2015.

 

 

Intermittent and episode-driven use of pranlukast to reduce the frequency of wheezing in atopic children: a randomized, double-blind, placebo-controlled trial.
 

Ebisawa M1, Terada A2, Sato K3, Kurosaka F4, Kondo N5, Sugizaki C1, Morikawa A6, Nishima S7, Urashima M8.

Author information
 

Abstract
BACKGROUND:
Leukotriene receptor antagonist (LTRA) therapy reduces asthma exacerbations in children older than 2 years. However, whether early intervention using LTRA in atopic smaller children aged 1 to 2 years who had experienced episodic wheezing can reduce the frequency of wheezing is unknown.
METHODS:A randomized, double-blind, placebo-controlled, multi-center trial of episode-driven intermittent use of pranlukast for 12 months, one of the LTRAs, was conducted by enrolling children who had two, but not more than two, episodes of wheezing prior to entry and were allergen-specific IgE-positive (≥class 2). The primary outcome was increased episodes of wheezing more than once a month for 3 months.
RESULTS:Seventy-seven children were randomly assigned to receive pranlukast (n = 37) or placebo (n = 40). The primary outcome occurred in 10 of 36 (28%) of the pranlukast group and 14 of 39 (36%) in the placebo group, which was not significantly different (P = 0.45). Even though the study period was extended to a maximum of >5 years, there was no significant difference in the Kaplan-Meier curves in the occurrence of the primary outcome between the two groups.
CONCLUSIONS:These results suggest that intermittent and episode-driven use of pranlukast in small children with a prior history of wheezing and atopic sensitization may not reduce the frequency of wheezing later in life. However, the sample size was too small to make a definitive conclusion.

 

WorldAllergyOrganJ. 2015Apr2;8(1):11.doi:10.1186/s40413-015-0062-3.eCollection 2015.

 


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