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目的研究布地奈德雾化液(BIS)吸入治疗儿童咳嗽变异性哮喘(CVA)的疗效。方法 2008-04-04—2009-03-22期间,采用开放性、多中心非干预性调研,在全国39个中心入选了903例5岁及5岁以下CVA患儿。雾化吸入(BIS)1～2mg/d,共7周。研究期间共有5次访视,评估雾化吸入BIS治疗后CVA患儿症状评分改变、缓解药物的使用、依从性和疾病控制情况等。结果 7周的观察期间,患儿总退出率8.97%(81/903)。雾化吸入BIS治疗后患儿的症状总评分(第1周4.0分vs第7周0.5分),白天症状评分(第1周2.4分vs第7周0.3分),夜间症状评分(第1周1.5分vs第7周0.2分)均明显下降(P均<0.0001)。使用支气管舒张剂的患儿比例明显降低(第1周39.42%vs第7周2.99%,P<0.0001),使用支气管舒张剂的中位数从第1周的5.8d/周减少到治疗终点时的3.9d/周。第7周时仍有87.49%的患儿依从性良好。依从性良好的患儿达到有效控制的可能性是依从性较差患儿的2.698倍,而且CVA复发可能性较低(OR=0.439)。没有自发不良事件报告。结论 BIS雾化吸入治疗能改善CVA患儿的症状评分,减少支气管舒张剂的应用,患儿依从性和安全性良好。

A study of cough variant asthma treated with budesonide suspension nebulization in childhood.

Objectives To study the efficacy of budesonide inhalation suspension(BIS) nebulization in cough variant asthma(CVA) patients aged 5 years or younger.Methods In an open-label,multicenter,non-interventional study,903 CVA patients aged 5 years or younger(male:536,female:367,mean age 2.8±1.2a) were recruited and prescribed for BIS(1～2mg/d for 7 weeks).There were 5 visits during the study.Changes of symptom scores,bronchodilator usage,compliace and disease control level were analized after treatment.Results The withdraw rate was 8.97%(81/903).About 42.64% of the total 903 patients were with at least one other allergic disease,such as allergic rhinitis,allergic dermatitis and allergic conjunctivitis.After 7-week BIS nebulization,the total symptom score(4.0 at week 1 vs 0.5 at week 7),daytime symptom score(2.4 at week 1 vs 0.3 at week 7),nocturnal symptom score(1.5 at week 1 vs 0.2 at week 7) decreased significantly in CVA children(P < 0.001,respectively).The ratio of CVA children who had used brochodilator for symptom relief decreased significantly(39.42% at week 1 vs 2.99% at week 7,P < 0.001).The median number of days for as-needed bronchodilator usage at week 1 was 5.8 days,while at the end of the study it reduced to 3.9 days.At week 7,87.49% of children still had good compliance.In CVA children,the effective control rate increased(34% at screening vs 89.92% at week 7,P < 0.001).No spontaneous adverse events were reported.Conclusion BIS nebulization improves the symptom scores and reduces as-needed bronchodilator usage with good compliance and safety profile in young children with CVA.