Ruffin R E, Latimer K M
Dept of Respiratory Medicine, Flinders Medical Centre, Bedford Park, South Australia.
Eur Respir J. 1991 May;4(5):575-9.
Ten patients with stable chronic asthma completed a randomized double-blind placebo controlled crossover study examining the effect of 120mg terfenadine twice daily for 4 weeks on bronchial responsiveness. Bronchial responsiveness was measured by methacholine inhalation tests performed by the tidal breathing technique at 0, 2 and 4 weeks of active and placebo treatment periods separated by a one week washout period. There were no significant differences in mean baseline forced expired volume in 1 sec (FEV1) for placebo and terfenadine treatments (p greater than 0.05) and there were no differences between geometric mean provocative concentrations of methacholine to cause a 20% fall in FEV1 (PC20M) at 2 and 4 weeks of terfenadine (0.89 and 0.99 mg.ml.1) from placebo (0.94 and 0.84 mg.ml.1) (p greater than 0.05). Examination of individual PC20M values during terfenadine treatment showed that 5 patients had PC20M's outside their 95% confidence interval; 2 increased both 2 and 4 week values, 1 increased one value and 2 decreased one value each. It is concluded that terfenadine does not produce clinically significant changes in stable asthmatics.
十名患有稳定型慢性哮喘的患者完成了一项随机双盲安慰剂对照交叉研究,该研究考察了每日两次服用120毫克特非那定,持续4周对支气管反应性的影响。支气管反应性通过在主动治疗期和安慰剂治疗期的第0、2和4周采用潮气呼吸技术进行的乙酰甲胆碱吸入试验来测量,两个治疗期之间有一周的洗脱期。安慰剂和特非那定治疗组的平均基线一秒用力呼气量(FEV1)无显著差异(p大于0.05),特非那定治疗2周和4周时引起FEV1下降20%的乙酰甲胆碱几何平均激发浓度(PC20M)与安慰剂组(0.94和0.84毫克/毫升)相比无差异(0.89和0.99毫克/毫升)(p大于0.05)。对特非那定治疗期间个体PC20M值的检查显示,5名患者的PC20M值超出其95%置信区间;2名患者在第2周和第4周的值均升高,1名患者升高了一个值,2名患者各降低了一个值。得出的结论是,特非那定对稳定型哮喘患者不会产生具有临床意义的变化。