氟替卡松联合细菌溶解产物对儿童哮喘的疗效观察

Clinical Efficacy of Fluticasone Plus Combied with Bacterial Lysates in Treatment of Children with Asthma

目的探讨丙酸氟替卡松吸入气雾剂联合细菌溶解产物(泛福舒)对间歇发作的支气管哮喘儿童的临床疗效和安全性。方法 2009年2～6月收治的支气管哮喘患儿93例随机分为两组:实验组47例在吸入丙酸氟替卡松的基础上加用细菌溶解产物胶囊,口服3个月;对照组46例仅给予丙酸氟替卡松吸入治疗。两组均随访12个月,记录两组患儿临床表现、血清细胞因子、免疫球蛋白及不良反应。结果 与对照组比较,治疗后实验组的上呼吸道感染次数(t=10.731)、下呼吸道感染次数(Z=3.548)、哮喘发作次数(t=4.758)、每次发作的咳嗽天数(Z=3.267)、发热天数(t=2.401)和抗生素使用天数(t=2.079)均少于对照组,差异均有统计学意义(均P<0.05)。与对照组比较,实验组在治疗后3个月时血清IFN-γ(χ2=10.417)、血清IgA(t=5.928)和唾液sIgA(t=13.627)高于对照组,血清IL-4(χ2=6.106)低于对照组,差异有统计学意义(均P<0.05)。两组不良反应发生率差异无统计学意义(χ2=2.601,P>0.05)。结论 间歇发作的支气管哮喘患儿在使用丙酸氟替卡松吸入的基础上加用细菌溶解产物口服,可显著减少哮喘发作次数,疗效明显优于单独使用丙酸氟替卡松组,两药联合使用无明显不良反应。

Objective To investigate the clinical efficacy of fluticasone plus combined with bacterial lysates in treatment of children with asthma and security. Methods A randomized and controlled trial was made. Nighty-three children aged 5-12 years old with intermittent asthma were enrolled and randomly divided into two groups：the experimental group （47 cases） received fluticasone plus bacterial lysates,control group （46 cases） received fluticasone only. The episodes of respiratory tract infection and asthma, cytokine levels,immunoglobulin in serum and the adverse events were recorded in the following 12 months. Results Compared with control group,the frequencies of asthma exacerbation （t=4.758,P〈0.01）,upper respiratory tract infection （t=-10.731 ,P〈0.01 ）,lower respiratory tract infection （Z=3.548,P〈0.05）significantly reduced;the days of fever （t=-2.401,P〈0.05）,cough （Z=3.267,P〈0.05）,antibiotics usage （t=2.079,P〈0.05）significantly reduced too in the experimental group. There was significant difference in all index. Compared with control group, at the end of three months after treatment, serum IFN-γ （χ2=10.417,P〈0.01）,serum IgA （t=5.928,P〈0.01） and salivary slgA（t=13.627,P〈：0.01）significantly increased with a significate difference,while serum IL-4 decreased（χ2=6.106,P〈0.05） in the experimental group. There was no significantly difference in the adverse events between two groups （χ2=-2.601,P〉0.05）. Conclusion A better control was observed in children receiving inhaled fluticasone and bacterial lysates, compared to those who were treated with inhaled flutieasone only. Inhaled fluticasone plus bacterial lysates is a good choice for children with intermittent asthma.