复方舒利迭治疗儿童重度哮喘的剂量及安全性

目的探讨吸入复方舒利迭(沙美特罗/丙酸氟替卡松,SM/FP简称舒利迭)治疗儿童重度哮喘的适宜剂量、疗程和安全性。方法将5～14岁重度哮喘患者52例随机分为A、B两组,均给予舒利迭早晚各1吸,2次/d,但A组每1吸50/250μg,B组每1吸50/100μg。缓解期维持原剂量3个月不变,继之,A、B两组均减为相同剂量每晚1次,每1吸50/100μg,直到哮喘达到完全控制持续3个月即停药,总疗程6～18个月。观察两组控制率、两组50%患者达到控制标准所需时间、两组在6、12、18个月达到停药标准的累计例数百分比及其停药后的复发率进行统计学分析。结果总控制率(良好控制率+完全控制率)A组为96.2%高于B组的76.9%(P<0.05),两组50%患者达到控制标准所需时间A组良好控制为(3±0.92)周,全面控制为(6±1.30)周,短于B组的(5±0.82)、(8±2.02)周(P<0.01),两组在不同疗程达到停药标准例数的累计率A组高于B组(P<0.05),停药后复发率A组为7.8%,低于B组的15.4%。结论儿童重度哮喘初始治疗阶段每天用舒利迭剂量50/500μg效果优于50/200μg,无严重不良反应;儿童哮喘吸入ICS应采用个体化治疗剂量及疗程。

Clinical study on the dosage and safety of Seretide in the control of severe child asthma

Objective To explore the proper dose and the time needed on seretide(salmeteral/fluticasone)(SM/FP) in the control of severe child asthma.Methods The 52 children between 5 and 14 years old who suffered from severe asthma were divided randomly into two groups: A group was given SM/FP (each,50/250μg),twice daily,B group was give SM/FP (50/100μg,each) twice daily. Original dose still were given in two groups for 3 months at relief-stage,then both groups received SM/FP at the dose of equal amounts(50/100μg) 1 times per day until condition was getting completely controlled for 3 months,total treatment course was 6-18 monthes. The numbers of the patients in each group whose condition got well controlled or completely controlled were observed; and the time needed was also observed for half of them.The number of patients stopping inhalation were observed between two groups in various time. Results The number of A group whose got well controlled and completely controlled were more ,which differs greatly from B group (46.2% vs 76.9%,P<0.05).The time needed for that in A group was shorter than that of B group(P<0.01).There was an obvious difference between two groups in the number of patients stopping inhalation in various time(P<0.05).Conclusion The use of greater dose(50/500μg) of SM/FP is a better choice and safe for the control of child severe asthma and without any severe adverse reaction. The time needed is different for each child of severe asthma,thus individualization should be adopted.