Objective To observe the therapeutic effect and safety of budesonide and formoterol fumarate powder for inhalation and budesonide powder for inhalation plus formoterol fumarate powder for inhalation in the treatment of children with asthma. Methods An open,randomized and control study was carried out in the 80 children with moderate asthma. All the children were randomly divided into treatment group and control group. Budesonide and formoterol fumarate powder for inhalation was given to children in the treatment group for 12 months,while budesonide powder for inhalation plus formoterol fumarate powder for inhalation was given to children in the control group for 12 months.All the children were regularly followed up before the treatment and 1 month,3 months,6 months,9 months, 12 months after the treatment, respectively. Their parents were asked to observe and record asthmatic diary ,including the frequencies of cough during day and night. Day - and -night time coughs were scored on the basis of the diaries. The peak expiratory flow (PEF) was measured at the same time. The scores of asthma control test(C-ACT) was done once every month and any adverse events were observed. SPSS 12.0 software was used to analyze the data.Results Compared with those before the treatment, the day - and - night cough scores, PEF values and C-ACT scores in 1 month,3 months,6 months,9 months and 12 months after the treatment in both control group and treatment group were significantly improved, and the differences were significant ( Pa ＜ 0. 05 ). The day - and - night cough scores and PEF values in the treatment group were significantly lower than those in the control group (Pa ＜0.05) ,but C-ACT scores had no significant differences between the 2 groups(Pa ＞0.05). No adverse reaction was observed in both groups. Conclusions Both budesonide and formoterol fumarate powder for inhalation and budesonide powder for inhalation plus formterol fumarate powder for inhalation have good efficacy and safety in the treatment of children with asthma, but budesonide and formoterol fumarate powder for inhalation has better effects than budesonide powder for inhalation plus formoterol fumarate powder for inhalation.%目的 观察布地奈德福莫特罗粉吸入剂与布地奈德粉吸入剂联合富马酸福莫特罗粉吸入剂治疗儿童哮喘的疗效及安全性.方法 采用随机、开放、平行对照研究方法 ,将80例中度哮喘患儿随机分为治疗组和对照组.治疗组应用布地奈德福莫特罗粉吸入剂治疗12个月,对照组应用布地奈德粉吸入剂加富马酸福莫特罗粉吸入剂治疗12个月.分别于治疗前及治疗1个月、3个月、6个月、9个月、12个月进行随访,观察期内由患儿家长记录哮喘日记,包括日间和夜间咳嗽症状评分.根据患儿家长记录计算日间和夜间咳嗽症状评分.同时测量患儿最大呼气流量(PEF),每月进行一次儿童哮喘控制测试(C-ACT),并观察不良反应发生情况.应用SPSS 12.0软件进行统计学分析.结果 治疗组临床控制率明显优于对照组,二组总有效率比较差异有统计学意义(P<0.05).治疗1个月、3个月、6个月、9个月、12个月,治疗组和对照组与治疗前比较,日、夜间咳嗽情况评分、PEF值及C-ACT评分均明显改善,差异均有统计学意义(Pa<0.05).治疗组治疗后日、夜间症状评分、PEF值均显著低于对照组,差异均有统计学意义(Pa<0.05),但C-ACT评分比较差异无统计学意义(Pa>0.05).结论 布地奈德福莫特罗粉吸入剂与布地奈德粉吸入剂联合富马酸福莫特罗粉吸入剂治疗均具有良好的疗效及安全性,但应用布地奈德福莫特罗粉吸入剂效果更好.
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