Shakya K N, Joshi P, Piya A, Baral M R
Kathmandu Medical College, Teaching Hospital, Sinamangal, Kathmandu, Nepal.
Kathmandu Univ Med J (KUMJ). 2003 Oct-Dec;1(4):242-7.
To assess the efficacy of Ketotifen in asthmatic children and to record its adverse effects, if any.
Prospective clinical trial.
Pediatric asthma follow up clinic of a teaching hospital.
23 asthmatic children between 3 and 15 years; 100% completed the trial on full protocol.
Ketotifen 1mg (adjusted according to body weight, 50 mcg/kg/dose) orally twice daily for 9 months.
Decrease in frequency of asthmatic attacks and severity of exacerbations with improvements in peak expiratory flow rates (PEFR). Other measures included decrease in bronchodilator requirement, steroid doses and parental perception regarding patient quality of life.
34.78% children were symptom free by the end of 2nd 3 months and 65.21% had no further attack by the end of 3rd 3 months of Ketotifen prophylaxis. Those children with activity and sleep 'affected' (8.69%) and 'may be affected' (30.43%) together improved to 'may be affected' group (21.73%) by the end of 2nd 3 months and further reduced to 8.69% by the conclusion of 3rd 3 months. The duration of exacerbations was reduced in the remaining cases. Variability of PEFR decreased from 26.08% to 8.69% of children after the 3rd 3 months of Ketotifen prophylaxis. No significant adverse effect of therapy was observed during the study.
Oral Ketotifen is effective and well tolerated for use in prophylactic treatment of bronchial asthma in children.
评估酮替芬对哮喘儿童的疗效，并记录其不良反应（如有）。
前瞻性临床试验。
一家教学医院的儿科哮喘随访诊所。
23名3至15岁的哮喘儿童；100%按完整方案完成试验。
酮替芬1毫克（根据体重调整，50微克/千克/剂量），口服，每日两次，共9个月。
哮喘发作频率降低，病情加重的严重程度减轻，同时呼气峰值流速（PEFR）有所改善。其他指标包括支气管扩张剂需求减少、类固醇剂量降低以及家长对患儿生活质量的认知。
在酮替芬预防治疗的第2个3个月结束时，34.78%的儿童无症状，在第3个3个月结束时，65.21%的儿童未再发作。那些活动和睡眠“受影响”（8.69%）以及“可能受影响”（30.43%）的儿童，在第2个3个月结束时，合并改善至“可能受影响”组（21.73%），到第3个3个月结束时进一步降至8.69%。其余病例的病情加重持续时间缩短。在酮替芬预防治疗3个3个月后，儿童PEFR的变异性从26.08%降至8.69%。研究期间未观察到治疗的显著不良反应。
口服酮替芬用于儿童支气管哮喘的预防性治疗有效且耐受性良好。
