沙美特罗与沙丁胺醇治疗轻至中度哮喘的比较。

A comparison of salmeterol with albuterol in the treatment of mild-to-moderate asthma.

作者信息

Pearlman D S, Chervinsky P, LaForce C, Seltzer J M, Southern D L, Kemp J P, Dockhorn R J, Grossman J, Liddle R F, Yancey S W

机构信息

Colorado Allergy and Asthma Clinic, Aurora 80012.

出版信息

N Engl J Med. 1992 Nov 12;327(20):1420-5. doi: 10.1056/NEJM199211123272004.

DOI:10.1056/NEJM199211123272004

PMID:1357554

Abstract

BACKGROUND

An effective, long-acting bronchodilator could benefit patients with asthma who have symptoms not controlled by antiinflammatory drugs. We compared a new long-acting, inhaled beta 2-adrenoceptor agonist, salmeterol, with a short-acting beta 2-agonist, albuterol, in the treatment of mild-to-moderate asthma.

METHODS

We randomly assigned 234 patients (150 male and 84 female patients 12 to 73 years old) to one of three treatment groups: one group received 42 micrograms of salmeterol twice daily, one received 180 micrograms of albuterol four times daily, and one received placebo. Treatment was assigned in a double-blind fashion, and all patients could use supplemental inhaled albuterol as needed during the 12-week treatment period.

RESULTS

Measurements of the forced expiratory volume in one second, performed hourly for 12 consecutive hours, showed that a single dose of salmeterol produced a greater mean area under the curve than two doses of albuterol taken 6 hours apart (6.3 vs. 4.9 liter.hr, P < 0.05). The difference was significant on day 1 and at week 4 of the study, but not at week 8 or 12. Salmeterol was also more effective than albuterol or placebo (with albuterol taken as needed) in increasing the morning peak expiratory flow rate: salmeterol induced a mean increase of 24 liters per minute over the pretreatment values, as compared with a decrease of 6 liters per minute with albuterol (P < 0.001) and an increase of 1 liter per minute with placebo (P = 0.002). The mean overall symptom score was improved most by salmeterol treatment (P < 0.05), with the number of days with symptoms and of nights with awakenings decreasing by 22 percent and 52 percent, respectively; there were no differences in results between albuterol treatment and placebo administration. We found no evidence of tolerance to the bronchodilating effects of salmeterol, and adverse reactions to all the treatments were infrequent and mild.

CONCLUSIONS

For the management of mild-to-moderate asthma, salmeterol given twice daily is superior to albuterol given either four times daily or as needed.

摘要

背景

一种有效的长效支气管扩张剂可能会使那些症状未被抗炎药物控制的哮喘患者受益。我们比较了一种新型长效吸入型β2肾上腺素能受体激动剂沙美特罗与一种短效β2激动剂沙丁胺醇在治疗轻至中度哮喘中的效果。

方法

我们将234例患者（150例男性和84例女性，年龄12至73岁）随机分为三个治疗组之一：一组每日两次吸入42微克沙美特罗，一组每日四次吸入180微克沙丁胺醇，一组接受安慰剂治疗。治疗采用双盲方式分配，所有患者在12周的治疗期间可根据需要使用补充吸入的沙丁胺醇。

结果

连续12小时每小时进行一次一秒用力呼气量测量，结果显示单剂量沙美特罗产生的曲线下平均面积大于相隔6小时服用的两剂沙丁胺醇（6.3对4.9升·小时，P<0.05）。该差异在研究的第1天和第4周时显著，但在第8周或第12周时不显著。在增加早晨呼气峰值流速方面，沙美特罗也比沙丁胺醇或安慰剂（按需服用沙丁胺醇）更有效：沙美特罗使平均流速比治疗前值增加24升/分钟，而沙丁胺醇使流速降低6升/分钟（P<0.001），安慰剂使流速增加1升/分钟（P = 0.002）。沙美特罗治疗使总体症状平均评分改善最为显著（P<0.05），有症状的天数和夜间醒来的次数分别减少了22%和52%；沙丁胺醇治疗和安慰剂给药的结果没有差异。我们没有发现对沙美特罗支气管扩张作用产生耐受性的证据，并且所有治疗的不良反应都很少且轻微。