Davies B, Brooks G, Devoy M
Llandough Hospital, Penarth, South Glamorgan, U.K.
Respir Med. 1998 Feb;92(2):256-63. doi: 10.1016/s0954-6111(98)90105-6.
The aim of this study was to compare the efficacy and safety of salmeterol vs theophylline in asthma management using meta-analysis of clinical trials. Nine clinical studies, containing a total of 1330 patients, met meta-analysis inclusion criteria: randomized, controlled study, minimum 2-week treatment duration with either salmeterol or theophylline. The main outcome measurements were morning and evening peak expiratory flow rate (PEFR), morning and evening symptom scores, use of salbutamol as rescue medication, and withdrawal from treatment for any cause. During the second week of treatment, salmeterol patients had a 10 l min-1 greater increase in mean morning PEFR from baseline than theophylline patients (P < 0.001). Similarly, in the second week, the increase in mean evening PEFR from baseline observed with salmeterol was significantly greater (P < 0.01) than that observed with theophylline. Salmeterol also produced a significantly greater increase in mean morning and evening PEFR than theophylline at weeks 3 and 4. Patients receiving salmeterol were free from daytime symptoms for a mean of 51% of days in the second week compared to 39% for theophylline patients (P < 0.001). Salmeterol patients experienced a mean of 63% symptom-free nights compared to 52% for theophylline patients (P < 0.001). Rescue medication with salbutamol was not required on 49% of days for salmeterol patients and 34% of days for theophylline patients. All results were maintained in the third and fourth weeks of treatment. Withdrawal and incidence of adverse events leading to withdrawal were significantly less frequent in patients receiving salmeterol (P < 0.001). Thus, this meta-analysis suggests that salmeterol has a superior safety and efficacy profile to theophylline in the management of symptoms of chronic asthma.
本研究旨在通过对临床试验的荟萃分析，比较沙美特罗与茶碱在哮喘管理中的疗效和安全性。九项临床研究共纳入1330例患者，符合荟萃分析纳入标准：随机对照研究，沙美特罗或茶碱治疗至少2周。主要观察指标为早晚呼气峰值流速（PEFR）、早晚症状评分、使用沙丁胺醇作为急救药物以及因任何原因退出治疗的情况。在治疗的第二周，沙美特罗组患者的平均晨间PEFR较基线的增加幅度比茶碱组患者大10 l/min（P<0.001）。同样，在第二周，沙美特罗组患者平均夜间PEFR较基线的增加幅度显著大于茶碱组（P<0.01）。在第3周和第4周，沙美特罗组患者的平均早晚PEFR较茶碱组也有显著更大幅度的增加。在第二周，接受沙美特罗治疗的患者白天无症状天数平均占51%，而茶碱组患者为39%（P<0.001）。沙美特罗组患者夜间无症状的平均比例为63%，而茶碱组患者为52%（P<0.001）。沙美特罗组患者49%的天数无需使用沙丁胺醇作为急救药物，而茶碱组患者为34%。所有结果在治疗的第三周和第四周均得以维持。接受沙美特罗治疗的患者退出治疗及因不良事件导致退出治疗的发生率显著更低（P<0.001）。因此，这项荟萃分析表明，在慢性哮喘症状管理方面，沙美特罗的安全性和疗效优于茶碱。
