论文部分内容阅读
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 clinical efficacy and safety of combined multivalent bacterial vaccine (Lactobacillus) in children with bronchial asthma and recurrent respiratory tract infections (RRI) who are not controlled by regular inhaled corticosteroids (ICS). Methods A randomized, double-blind trial of 48 patients with asthma complicated with RRI admitted to the First Affiliated Hospital of Guangzhou Medical College and the Institute of Respiratory Diseases from June 2001 to June 2002 was performed without systematic ICS treatment control Good children were divided into two groups, were given sublingual Ling Lan net or placebo treatment, the two groups of children with RRI and clinical symptoms of asthma, serum IgA and salivary secretion of IgA (sIgA) levels and possible adverse reaction. Serum IgA and salivary sIgA were detected by one-way immunodiffusion. Results Compared with the placebo group, the number of respiratory tract infections, days of fever, days of antibiotic use, days of cough and asthma attacks in Lan Lan net group decreased significantly (P <0.05). Serum IgA after treatment with Lan Jing net group and saliva sIgA at 1, 2, 3 months after treatment were significantly higher than those before treatment (all P <0.05), while sIgA and treatment of saliva 6 months after treatment Before the difference was not significant (P> 0.05). Serum IgA and salivary sIgA in the placebo group were not significantly different from those before treatment (all P> 0.05). No significant difference was found in the incidence and rate of adverse events between the two groups (all P> 0.05). Conclusions Asthma combined with RRI can effectively prevent RRI by combining polyvalent bacterial vaccine (Lactobacillus) with ICS uncontrolled children, so as to reduce the number of asthma attacks and the severity of asthma. Multivalent bacterial vaccine (Lan bacteria net) good safety, easy to use, it is worth promoting application.