舌下滴入多价细菌疫苗对支气管哮喘合并反复呼吸道感染儿童疗效观察

Efficacy of polyvalent bacterial vaccine in asthma with recurrent respiratory infections in children.

目的 探讨支气管哮喘合并反复呼吸道感染(RRI)经规律吸入糖皮质激素(ICS)控制不理想的儿童联用多价细菌疫苗(兰菌净)的临床疗效及安全性。方法 采用随机、双盲法将2 0 0 1年6月至2 0 0 2年6月在广州医学院第一附属医院及呼吸病研究所收治的4 8例哮喘合并RRI经系统ICS治疗控制不佳的患儿分为2组,分别给予舌下滴入兰菌净或安慰剂治疗,观察两组患儿RRI及哮喘临床症状、血清IgA及唾液分泌型IgA(sIgA)水平及可能出现的不良反应。血清IgA及唾液sIgA采用单向免疫扩散法检测。结果 与安慰剂组比较,兰菌净组呼吸道感染次数、发热天数、抗生素使用天数、咳嗽及气喘发作天数均减少,差异有显著性(P均<0 0 5 )。兰菌净组治疗后血清IgA及治疗后第1、2、3个月唾液sIgA与治疗前比较均显著升高(均P <0 . 0 5 ) ,而治疗后第6个月唾液sIgA与治疗前比较差异无显著性(P >0 .0 5 )。安慰剂组治疗后血清IgA及唾液sIgA与治疗前比较差异均无显著性(均P >0 . 0 5 )。两组不良事件发生率及脱落率差异均无显著性(均P >0. 0 5 )。结论 哮喘合并RRI经ICS控制不理想儿童联用多价细菌疫苗(兰菌净)能有效预防RRI ,从而减少哮喘发作的次数,减轻哮喘严重程度。多价细菌疫苗(兰菌净)安全性好、使用方便,值得推广应用。

Objective To investigate the efficacy and safety of a polyvalent bacterial vaccine (Lantigen B) in asthma with recurrent respiratory infections(RRI) in children.Methods 48 children with asthma and RRI received Lantigen B or placebo randomizedly in a parallel,double-blind study.The main outcomes included:incidence of RRI,days with fever,cough or wheeze,consumption of antibiotics and levels of serum IgA and salivary secretary IgA(sIgA).Results After treatment with Lantigen B,it was showed that there were remarkable clinical responses with reductions in the number of infective episodes,days of fever,antibiotics consumption,and days of cough and wheeze;these differences were all statistically significant( P <0.05).After treatment with Lantigen B,the salivary sIgA concentration increased significantly in 1,2 and 3 months of observation period( P <0.05),but there were no significant changes in placebo group( P >0.05).There was significant increase of serum concentration of IgA in Lantigen B group( P <0.05),but not in the placebo group( P >0.05).The clinical tolerability was very good and there was no difference in the adverse events between the Lantigen B and placebo group( P >0.05).Conclusion The present data shows that sublingually administered Lantigen B has significant clinical efficacy and very good tolerability in asthma with RRI in children,which is associated with increases of serum IgA and salivary sIgA levels.