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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SPSS12.0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。
Objective To observe the efficacy and safety of formoterol fumarate powder inhalation combined with budesonide inhaler and formoterol fumarate powder inhaler in children with asthma. Methods Eighty patients with moderate asthma were randomly divided into treatment group and control group using a randomized, open and parallel controlled study. The treatment group received budesonide formoterol powder inhalation for 12 months and the control group received budesonide powder inhaler plus formoterol fumarate powder inhalation for 12 months. The patients were followed up for 1 month, 3 months, 6 months, 9 months and 12 months respectively. During the observation period, the parents of the children were recorded asthma diarrhea, including cough symptom scores during the day and night. Calculate daytime and nighttime cough symptom scores based on parental records of children. At the same time, the maximum expiratory flow rate (PEF) in children was measured. Children’s asthma control test (C-ACT) was conducted once a month. The incidence of adverse reactions was also observed. Application SPSS12.0 software for statistical analysis. Results The clinical control rate in the treatment group was significantly better than that in the control group. The total effective rate in the two groups was significantly different (P <0.05). The cough score, PEF score and C-ACT score of the treatment group and the control group were significantly improved after treatment for 1 month, 3 months, 6 months, 9 months and 12 months. All were statistically significant (Pa <0.05). The scores of postoperative day, night symptom scores and PEF in the treatment group were significantly lower than those in the control group (P <0.05), but there was no significant difference in the C-ACT score between the two groups (Pa> 0.05). Conclusion Both budesonide formoterol powder inhalation and budesonide powder inhalation combined with formoterol fumarate powder inhalation have good curative effect and safety, but budesonide formoterol powder inhalation Agent effect better.