BAMBUTEROL IN THE TREATMENT OF ASTHMA - A PLACEBO-CONTROLLED COMPARISON OF ONCE-DAILY MORNING VS EVENING ADMINISTRATION
BAMBUTEROL IN THE TREATMENT OF ASTHMA - A PLACEBO-CONTROLLED COMPARISON OF ONCE-DAILY MORNING VS EVENING ADMINISTRATION
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DOI：
10.1378/chest.107.2.406
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发表时间：
1995-02-01
期刊：
影响因子：
9.6
通讯作者：
KARLSSON, K
中科院分区：
文献类型：
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作者：
DALONZO, GE;SMOLENSKY, MH;KARLSSON, K
在一项双盲、交叉、随机和安慰剂对照研究中，对特布他林前药班布特罗（20 mg片剂剂量）每天早晨（7 AM）与晚上（10 PM）给药一次进行了研究，该研究涉及29例日常活动性哮喘患者。特布他林血药浓度，肺功能测定和药物耐受性进行了评估，在39小时的住院研究。每次给药间隔7天洗脱期。班布特罗早晨和晚上的平均24小时血浆浓度相当（13.2 vs 14.0 nmol/L）。晚上与早晨给药的Cmax为17.2 vs 15.5 nmol/L（p < 0.02）。班布特罗（早上：3.2 L;晚上：3.4 L）与安慰剂（2.9 L）相比，24小时平均FEV（1）更大（p < 0.001），就像FVC、FEF 25 - 75%和峰值呼气流速（PEER）一样，凌晨4点效果最大，与用药时间无关。然而，晚上给药导致最大的7 AM（觉醒）FEV（1），FEV 25 -75和PEER（p < 0.03）。参照相应的安慰剂值，在24小时给药间隔结束时，晚上和早上班布特罗给药后FEV（1）的改善分别为0.34 L（13.5%）（p < 0.0004）和0.35 L（15.9%）（p < 0.0012）。班布特罗的副作用大于安慰剂，但并不显著。每天一次班布特罗治疗被证明是一种有效的治疗哮喘，无论是在晚上或早上。夜间给药似乎对夜间哮喘最好，因为夜间气道通畅和早上7点醒来时改善最多。
Once-daily morning (7 AM) vs evening (10 PM) administration of the terbutaline prodrug bambuterol (20-mg tablet dose) was investigated in a double-blind, crossover, randomized, and placebo-controlled study involving 29 diurnally active patients with asthma. Terbutaline plasma concentration, spirometry, and drug tolerance were assessed during 39-h inpatient studies. A 7-day washout period separated each treatment. Mean 24-h plasma concentration was comparable for morning and evening bambuterol (13.2 vs 14.0 nmol/L). The Cmax for evening vs morning dosing was 17.2 vs 15.5 nmol/L (p < 0.02). The 24-h mean FEV(1) was greater (p < 0.001) for bambuterol (morning: 3.2 L; evening: 3.4 L) vs placebo (2.9 L) as it was for FVC, FEF25-75%, and peak expiratory now rate (PEER), with the maximum effect at 4 AM independent of medication time. Evening dosing, however, resulted in greatest 7 AM (awakening) FEV(1), FEV25-75, and PEER (p < 0.03). With reference to corresponding-in-time placebo values, improvement in FEV(1) at the end of the 24-h dosing intervals amounted to 0.34 L (13.5%) (p < 0.0004) and 0.35 L (15.9%) (p < 0.0012) with evening and morning bambuterol dosing, respectively. Side effects were greater for bambuterol than placebo, but not significantly so. Once-daily bambuterol therapy proved to be an effective treatment for asthma, whether administered in the evening or morning. Evening dosing seems best for nocturnal asthma since airway patency overnight and on awakening at 7 AM is most improved.