Campbell L M, Anderson T J, Parashchak M R, Burke C M, Watson S A, Turbitt M L
Southbank Surgery, Glasgow, U.K.
Respir Med. 1999 Jul;93(7):236-44.
Four hundred and sixty nine patients were randomized to receive either 12 micrograms bd of eformoterol (Oxis, Astra Pharmaceuticals Ltd., Kings Langley, U.K.) delivered via Turbohaler or 50 micrograms bd salmeterol (Serevent, Glaxo-Wellcome Ltd., Uxbridge, U.K.) via either the Accuhaler (Glaxo-Wellcome Ltd.) or pressurized metered dose inhaler (pMDI, Glaxo-Wellcome Ltd.) for 8 weeks. This was followed by a 4-week cross-over period when patients who had received salmeterol in the previous 8 weeks were given eformoterol and patients who had received eformoterol were given either salmeterol via the Accuhaler or pMDI to assess patient device and treatment preference. For the primary efficacy variable, the increase in peak expiratory flow (PEF) rate from run-in to 8 weeks, similar significant improvements were seen in all three treatment groups. Eformoterol Turbohaler (FT) achieved a greater increase in morning PEF than salmeterol Accuhaler (SA) from randomisation to 4 weeks; the increase shown in the eformoterol Turbohaler group was 28.9 1 min-1 compared to 19.91 min-1 for the salmeterol Accuhaler group. The addition of eformoterol Turbohaler 12 micrograms bd, to patients' existing asthma therapy was found to have a significantly more beneficial effect on the severity of patients' daytime asthma symptoms than had salmeterol Accuhaler 50 micrograms bd (P = 0.014). Eformoterol Turbohaler reduced the severity of daytime asthma symptoms by 42% after only 4 weeks of treatment. The patients in the eformoterol Turbohaler treated group experienced a higher percentage of days when they were symptom-free and did not use their short-acting bronchodilator to relieve symptoms (32.8, 24.1 and 28.0% in the FT, SA and SM groups, respectively). At 8 weeks there were no significant differences in any of these variables between the three groups. Patients in all the treatment groups gained an additional 1-1.5 nights undisturbed by asthma per week. The changes in sleep disturbance were not significantly different between the three treatment groups. In addition to the therapeutic benefits provided by eformoterol Turbohaler the device (Turbohaler) was the significant preference of patients given both Turbohaler and pMDI (P = 0.0168) and was also considered to be significantly more convenient to carry around than the Accuhaler (P < 0.0001). No other differences were found between the three devices. The results of this study demonstrate that the addition of a long-acting beta 2-agonist is an effective tool for achieving the goals of asthma treatment. Eformoterol via the Turbohaler is at least as effective as salmeterol via either the Accuhaler or the pMDI in achieving these goals.
469名患者被随机分为两组，一组通过都保装置（英国国王兰利阿斯特拉制药有限公司生产的奥克斯都保）每日两次吸入12微克的福莫特罗，另一组通过准纳器（葛兰素威康有限公司生产）或压力定量气雾剂（pMDI，葛兰素威康有限公司生产）每日两次吸入50微克的沙美特罗，治疗8周。接下来是为期4周的交叉治疗期，在此期间，前8周接受沙美特罗治疗的患者改用福莫特罗，而接受福莫特罗治疗的患者则通过准纳器或pMDI吸入沙美特罗，以评估患者对装置和治疗方法的偏好。对于主要疗效变量，即从导入期到8周时呼气峰值流速（PEF）的增加，在所有三个治疗组中都观察到了类似的显著改善。从随机分组到4周期间，福莫特罗都保（FT）使早晨PEF的增加幅度大于沙美特罗准纳器（SA）；福莫特罗都保组的增加幅度为28.9升/分钟，而沙美特罗准纳器组为19.9升/分钟。研究发现，在患者现有的哮喘治疗方案中添加每日两次12微克的福莫特罗都保，对患者白天哮喘症状的严重程度的改善作用明显大于每日两次50微克的沙美特罗准纳器（P = 0.014）。仅治疗4周后，福莫特罗都保就使白天哮喘症状的严重程度降低了42%。福莫特罗都保治疗组的患者无症状且无需使用短效支气管扩张剂缓解症状的天数百分比更高（FT组、SA组和SM组分别为32.8%、24.1%和28.0%）。在8周时，三组之间在这些变量上均无显著差异。所有治疗组的患者每周因哮喘而未受干扰的夜晚数都额外增加了1 - 1.5个。三个治疗组之间睡眠干扰的变化无显著差异。除了福莫特罗都保带来的治疗益处外，在同时提供都保装置和pMDI的患者中，都保装置（都保）是患者的显著偏好选择（P = 0.0168），并且还被认为比准纳器更便于携带（P < 0.0001）。在这三种装置之间未发现其他差异。本研究结果表明，添加长效β2激动剂是实现哮喘治疗目标的有效手段。通过都保装置吸入的福莫特罗在实现这些目标方面至少与通过准纳器或pMDI吸入的沙美特罗一样有效。
