D'Alonzo G E, Nathan R A, Henochowicz S, Morris R J, Ratner P, Rennard S I
University of Texas Health Science Center, Houston.
JAMA. 1994 May 11;271(18):1412-6.
To compare the efficacy and safety of inhaled salmeterol xinafoate, a long-acting beta 2-adrenoceptor agonist, with that of albuterol, a short-acting inhaled beta 2-agonist, in the treatment of asthma.
Randomized, double-blind, placebo-controlled, parallel-group study.
Eleven outpatient clinical centers.
A total of 322 male and female patients at least 12 years of age with chronic symptomatic asthma requiring daily therapy.
Patients were treated with salmeterol xinafoate (42 micrograms inhaled twice daily), albuterol (180 micrograms inhaled four times daily), or placebo (four times a day) for 12 weeks; patients in all three groups could use inhaled albuterol as backup medication for breakthrough symptoms.
Serial 12-hour forced expiratory flow in 1 second (FEV1), peak expiratory flow (PEF), asthma symptoms, nocturnal awakenings due to asthma, episodes of asthma exacerbations, and electrocardiography.
The mean area under the curve for FEV1 throughout each 12-hour period was consistently greater after a single dose of salmeterol than after two doses of albuterol administered 6 hours apart (P < .001), with the difference ranging from 3.1 to 4.3 L.h. Salmeterol produced an average increase in morning and evening PEF of 26 and 29 L/min, respectively, over pretreatment values compared with decreases of -13 and -3 L/min, respectively, in the albuterol group and -2 L/min both in the morning and evening in the placebo group (P < .001). Patients in the salmeterol group had significantly fewer days and nights with symptoms than did either the albuterol or placebo group (P < .001). Responses to salmeterol were similar at day 1 and at week 12. Adverse events in all treatment groups were equally infrequent, and no clinically significant change in cardiac rhythm was observed with salmeterol treatment.
Salmeterol inhaled twice daily is more effective than albuterol inhaled four times a day (or as needed) in patients with asthma requiring maintenance therapy. No deterioration of asthma control was observed with the use of salmeterol over a 3-month period.
比较长效β2肾上腺素受体激动剂昔萘酸沙美特罗吸入剂与短效吸入型β2激动剂沙丁胺醇治疗哮喘的疗效和安全性。
随机、双盲、安慰剂对照、平行组研究。
11个门诊临床中心。
总共322例年龄至少12岁、患有慢性症状性哮喘且需要每日治疗的男性和女性患者。
患者接受昔萘酸沙美特罗（每日两次吸入42微克）、沙丁胺醇（每日四次吸入180微克）或安慰剂（每日四次）治疗12周；三组患者均可使用吸入型沙丁胺醇作为突破性症状的备用药物。
连续12小时的1秒用力呼气流量（FEV1）、呼气峰值流量（PEF）、哮喘症状、因哮喘导致的夜间觉醒、哮喘加重发作次数以及心电图。
单剂量沙美特罗后，每个12小时间隔内FEV1的平均曲线下面积始终大于间隔6小时给予的两剂沙丁胺醇后（P < 0.001），差异范围为3.1至4.3L·h。与沙丁胺醇组分别下降-13和-3L/min以及安慰剂组早晚均下降-2L/min相比，沙美特罗使早晨和晚上的PEF较治疗前值分别平均增加26和29L/min（P < 0.001）。沙美特罗组出现症状的白天和夜晚明显少于沙丁胺醇组或安慰剂组（P < 0.001）。第1天和第12周时沙美特罗的反应相似。所有治疗组的不良事件发生率相同，沙美特罗治疗未观察到临床上显著的心律变化。
对于需要维持治疗的哮喘患者，每日两次吸入沙美特罗比每日四次吸入沙丁胺醇（或按需使用）更有效。使用沙美特罗3个月期间未观察到哮喘控制情况恶化。
