Le Bourgeois M, de Blic J, Chauvin J P, Scheinmann P, Paupe J
Pediatric Pneumology and Allergology Department, Sick Children Hospital, Paris, France.
Clin Ther. 1990 Nov-Dec;12(6):513-9.
The subjects were 40 children aged 6 to 16 years with stable chronic asthma; 20 were randomly assigned to receive 40 micrograms/kg of tulobuterol twice daily and 20 received 100 micrograms/kg of albuterol three times daily for three months. Patients were assessed by spirometry after the morning dose of medication at 0, 2, 4, 8, and 12 weeks of treatment. After initial dosing, the mean percentage increases in forced expiratory volume in one second (FEV1) were significantly higher in the tulobuterol-treated patients than in the albuterol-treated patients: at 30 minutes after dosing, the mean increase was 17.2% in the tulobuterol group and 5% in the albuterol group; at one hour, 20.3% and 6.8%. Similar results were found at 12 weeks. Mean changes in forced vital capacity and peak expiratory flow rate were similar to the changes in FEV1. Treatment side effects were reported by seven tulobuterol-treated patients and by four albuterol-treated patients. Tulobuterol treatment was withdrawn in one patient because of severe vomiting and headache of unknown cause. No changes in cardiovascular function were found in any patient. It is concluded that tulobuterol taken twice daily was more effective than albuterol taken three times daily in the treatment of asthma in children.
研究对象为40名6至16岁患有稳定型慢性哮喘的儿童;20名儿童被随机分配接受每日两次、每次40微克/千克的妥洛特罗治疗,另外20名儿童接受每日三次、每次100微克/千克的沙丁胺醇治疗,为期三个月。在治疗的第0、2、4、8和12周,于早晨服药后通过肺活量测定法对患者进行评估。初次给药后,妥洛特罗治疗组患者一秒用力呼气量(FEV1)的平均增加百分比显著高于沙丁胺醇治疗组患者:给药后30分钟,妥洛特罗组的平均增加量为17.2%,沙丁胺醇组为5%;一小时时,分别为20.3%和6.8%。在第12周时也发现了类似结果。用力肺活量和呼气峰值流速的平均变化与FEV1的变化相似。7名接受妥洛特罗治疗的患者和4名接受沙丁胺醇治疗的患者报告了治疗副作用。一名接受妥洛特罗治疗的患者因不明原因的严重呕吐和头痛而停药。未发现任何患者的心血管功能有变化。结论是,在儿童哮喘治疗中,每日服用两次妥洛特罗比每日服用三次沙丁胺醇更有效。