De Oliveira M A, Jardim J R, Faresin S M, Lucas S R, Nery L E
Universidade Federal de São Paulo.
Rev Assoc Med Bras (1992). 1998 Jul-Sep;44(3):169-75.
Beta 2-agonists are considered one of the cornerstones of the asthma therapy, but their short action requires frequent administration and an association with other broncodilators. The development of long-acting beta 2-agonists may represent an important improvement in asthma treatment.
The present study was designed to assess the efficacy and safety of inhaled salmeterol compared to salbutamol in patients with mild-to-moderate asthma.
After the two run-in weeks, the patients received either salmeterol 50 mg twice a day or salbutamol 200 mg four times a day, over a four week period, following a double blind, parallel group study. Sixty patients had the following inclusion criteria: FEV1 > 50% or PEFR over the past seven days > 50% of predicted normal; reversibility of FEV1 > 15%; symptoms scores > 2 (score 0 and 5) in 4 of the last seven days or PEFR variation > 15%.
Seven patients discontinued the protocol (see methods). Of the 53 analyzable patients, 25 were of the salmeterol group and 28 of the salbutamol group. Our results showed that in the run-in period there were not differences among the groups comparing the values of FEV1 in % predicted, morning PEFR and asthma symptoms scores. The improvement rate of morning FEV1 and PEFR in patients who received salmeterol was significantly higher (p < 0.05) compared to the patients who received salbutamol, for two and four weeks of treatment. Also, the salmeterol group have shown reduction of the symptoms in the nocturnal period(significantly in the first fortnight of treatment) demonstrated by the significative increase in the symptoms improvement rate when compared salmeterol and to salbutamol groups. The number of rescue medication inhaled, side effects, heart rate, blood pressure, serum potassium dosage and electrocardiograms, did no show significative differences between the groups.
This study showed that in mild to moderate asthmatic patients, salmeterol in the dosage of 100 mg/day raised the FEV1 and the morning PEF and led to pronounced decrease in the nocturnal symptoms as compared to salbutamol. The side effects were similar.
β2 激动剂被认为是哮喘治疗的基石之一，但其作用时间短，需要频繁给药，且常与其他支气管扩张剂联合使用。长效β2 激动剂的研发可能代表了哮喘治疗的一项重要进展。
本研究旨在评估吸入沙美特罗与沙丁胺醇相比，在轻至中度哮喘患者中的疗效和安全性。
经过两周的导入期后，患者按照双盲、平行组研究，在四周时间内，每天两次接受 50 毫克沙美特罗或每天四次接受 200 毫克沙丁胺醇治疗。60 名患者符合以下纳入标准：第一秒用力呼气容积（FEV1）>50%或过去七天的呼气峰值流速（PEFR）>预测正常值的 50%；FEV1 的可逆性>15%；在过去七天中的四天症状评分>2（评分范围为 0 至 5）或 PEFR 变化>15%。
7 名患者退出研究方案（见方法）。在 53 名可分析的患者中，沙美特罗组 25 名，沙丁胺醇组 28 名。我们的结果显示，在导入期，比较预测值百分比的 FEV1、早晨 PEFR 和哮喘症状评分，各组之间没有差异。在治疗两周和四周时，接受沙美特罗的患者早晨 FEV1 和 PEFR 的改善率显著高于接受沙丁胺醇的患者（p<0.05）。此外，沙美特罗组在夜间症状有所减轻（在治疗的头两周显著），与沙丁胺醇组相比，症状改善率有显著提高。吸入急救药物的次数、副作用、心率、血压、血清钾剂量和心电图，两组之间没有显著差异。
本研究表明，在轻至中度哮喘患者中，每天 100 毫克剂量的沙美特罗与沙丁胺醇相比，可提高 FEV1 和早晨 PEF，并显著减轻夜间症状。副作用相似。
