沙美特罗替卡松联合治疗儿童中重度哮喘的临床研究

Clinical study of salmeterol/fluticasone propionate combination in therapy of moderate to severe asthma in children

目的观察吸入沙美特罗替卡松干粉剂6个月联合防治中、重度儿童哮喘的疗效和安全性。方法4～14岁中、重度哮喘患儿145例,按病情轻重分别给予沙美特罗替卡松,中度组50/100μg2吸/日,重度组50/100μg3吸/日,疗程6个月。记录治疗前、后2周、1月、2月、4月、6月时的临床症状评分、清晨呼气峰流速(PEFam)、使用缓解药物情况及不良反应。结果145例患儿的临床症状评分、PEFam在治疗后2周、1月、2月、4月、6月与治疗前比较均有显著改善(P<0.001),不良反应发生率仅1.4%。结论沙美特罗替卡松联合防治儿童中、重度哮喘,能有效改善患儿PEFam及临床症状,临床应用安全。

Objective:To investigate the efficacy and safety of 6 months inhalation of(SM/FP) among children.with moderate to severe asthma.Methods:145 children with moderate-severe asthma,aged between 4 and 14 years,were given SM/FP at the dose of 50/100μg twice daily in moderate group and 50/100μg 3 times every day in severe group for 6 months.The PEFam,symptom scores and the as-needed beta2 agonists were recorded at the beginning,2 weeks,1 month,2 months,4 months and 6 months after treatment.And the side effects were recorded also during the therapy.Results:Outcomes of clinical symptoms, PEFam and as-needed beta2 agomsts in all 145 cases improved significantly since 2 week ( P <0.001) after treatment and maintained throughout the therapy in the two groups.There was a very significant difference between the baseline and post-treatment ( P <0.001).The percentage suffering from side effects was 1.4%.Conclusion:SM/FP is an effective and safe medication for moderate-severe asthma in children.It could improve the PEFam and clinical symptoms obviously and rapidly.