沙美特罗替卡松单用与丙酸氟替卡松联合孟鲁司特钠治疗儿童中度持续哮喘的疗效比较

Comparison of Efficacy of Salmeterol-flutiacasone Alone versus Fluticasone Propionate Combined with Montelukast Sodium in the Treatment of Children with Moderate Persistent Asthma

目的:比较沙美特罗替卡松单用与丙酸氟替卡松联合孟鲁司特钠两种方案治疗中度持续哮喘患儿的疗效及安全性。方法:将275例中度持续哮喘患儿按照随机数字表法分为吸入性糖皮质激素(ICS)+长效β2受体激动药(LABA)组(139例)和ICS+白三烯受体拮抗药(LTRA)组(136例)。ICS+LABA组患儿给予沙美特罗替卡松粉吸入剂1吸,bid;ICS+LTRA组患儿给予丙酸氟替卡松吸入气雾剂1吸,bid+孟鲁司特钠咀嚼片5 mg,睡前嚼服,qd。两组患儿均治疗>12周。观察两组患儿哮喘控制程度分级、哮喘评分、最大呼气流量(PEF)占预计值百分比、PEF变异率、外周血嗜酸性粒细胞阳离子蛋白(ECP)和白三烯E4(LTE4)水平、治疗期间短效β2受体激动药(SABA)使用次数、无症状天数、依从性以及不良反应发生情况。结果:ICS+LABA组患儿治疗4周的哮喘总控制率(86.33%)明显高于ICS+LTRA组(58.09%),差异有统计学意义(P<0.05);ICS+LABA组患儿治疗12周的哮喘总控制率(99.28%)高于ICS+LTRA组(98.53%),但差异无统计学意义(P>0.05)。两组患儿治疗后日间、夜间哮喘评分均明显下降,PEF占预计值百分比明显上升,与治疗前比较差异均有统计学意义(P<0.05),但治疗后两组患儿以上指标比较,差异均无统计学意义(P>0.05)。两组患儿治疗后ECP、LTE4水平均明显下降,与治疗前比较差异均有统计学意义(P<0.05);且ICS+LTRA组患儿较ICS+LABA组下降更明显,组间比较差异均有统计学意义(P<0.05)。两组患儿治疗后PEF变异率及治疗期间SABA使用次数、无症状天数、依从性和不良反应发生率等方面比较,差异均无统计学意义(P>0.05)。结论:沙美特罗替卡松单用与丙酸氟替卡松联合孟鲁司特钠两种给药方案均有较好的疗效和安全性,但后者对ECP和LTE4的抑制作用更强,控制哮喘症状更为迅速。

OBJECTIVE：To compare the clinical efficacy and safety of salmeterol-fluticasone alone versus fluticasone propionate combined with montelukast sodium in the treatment of children with moderate persistent asthma. METHODS：275 children with moderate persistent asthma were randomly divided into inhaled corticosteroids（ICS）＋ long acting β2receptor agonist（LABA）group（139 cases）and ICS＋ leukotriene receptor antagonists（LTRA）group（136 cases）. ICS＋LABA group was given Salmeterol-fluticasone powder inhalant,1 inhalation,bid;ICS ＋ LTRA was given Fluticasone propionate inhalation aerosol,bid ＋ Montelukast sodium chewable tablet 5 mg,before bedtime,qd. Both groups received more than 12 weeks of treatment. Body indexes of 2groups were observed after treatment,such as asthma control degree,asthma score,the percentage of peak expiratory flow（PEF）in estimated value,aberration rate of PEF,the levels of eosinophi cationic protein（ECP）and leukotrienes E4（LTE4）in peripheral blood,the times of taking short acting β2receptor agonist（SABA） during treatment,asymptomatic days,compliance,the incidence of ADR,etc. RESULTS：Total effective rate of ICS＋LABA group（86.33%）after 4 weeks treatment was higher than that of ICS＋LTRA group（58.09%）,with statistical significance（P〈0.05）;that of ICS＋LABA（99.28%）after 12 weeks treatment was higher than that of ICS＋LTRA group（98.53%）,without statistical significance（P〈0.05）. The day and night asthma score of 2groups decreased significantly and the percentage of PEF in estimated value increased significantly after treatment,there was statistical significance compared to before treatment（P〈0.05）. There was no statistical significance in above indexes between 2 groups after treatment（P〈0.05）. The levels of ECP and LTE4 decreased significantly in 2 groups after treatment,there was statistical significance compared to before treatment（P〈0.05）;those of ICS＋LTRA group decreased significantly compared to ICS＋LABA group,there was statistical significance between 2 groups（P〈0.05）. There was no statistical significance in the aberration rate of PEF after treatment,the times of taking SABA,asymptomatic days,compliance and the incidence of ADR between 2 groups during treat-ment（P〉0.05）. CONCLUSIONS：Salmeterol-fluticasone alone versus fluticasone propionate combined with montelukast sodium in the treatment of children with moderate persistent asthma both have good therapeutic efficacy and safety,while thelatter one has stronger inhibition effect on ECP and LTE4,and to control asthma symptoms more rapidly.