ZuWallack R L, Mahler D A, Reilly D, Church N, Emmett A, Rickard K, Knobil K
Section of Pulmonary Medicine, St. Francis Hospital and Medical Center, Hartford, CT 06105, USA.
Chest. 2001 Jun;119(6):1661-70. doi: 10.1378/chest.119.6.1661.
Patients with COPD often require multiple therapies to improve lung function and decrease symptoms and exacerbations. Salmeterol and theophylline are indicated for the treatment of COPD, but the use of these agents in combination has not been extensively studied.
To compare the efficacy and safety of salmeterol plus theophylline vs either agent alone in COPD.
Randomized, double-blind, double-dummy, parallel-group trial in 943 patients with COPD. After an open-label theophylline titration period (serum levels, 10 to 20 microg/mL), patients were randomly assigned to receive salmeterol (42 microg bid) plus theophylline, salmeterol (42 microg bid), or theophylline for 12 weeks. Serial pulmonary function tests were completed on day 1 and treatment week 12. Patients kept diary cards and noted their peak flow rates, symptom scores, and albuterol use, and periodically completed quality-of-life and dyspnea questionnaires.
All three groups significantly improved compared with baseline. Combination treatment with salmeterol plus theophylline provided significantly (p < or = 0.045) greater improvements in pulmonary function; significantly (p < or = 0.048) greater decreases in symptoms, dyspnea, and albuterol use; and significantly fewer COPD exacerbations (p = 0.023 vs theophylline). In general, treatment with salmeterol provided greater improvement in lung function and satisfaction with treatment compared with theophylline. Salmeterol treatment was also associated with significantly fewer drug-related adverse events (p < or = 0.042) than either treatment that included theophylline. The safety profile (adverse events, vital signs, and ECG findings) of the two treatments that included theophylline were similar.
Patients with COPD may benefit from combination treatment with salmeterol plus theophylline, without a resulting increase in adverse events or other adverse sequelae.
慢性阻塞性肺疾病（COPD）患者通常需要多种治疗方法来改善肺功能、减轻症状并减少病情加重。沙美特罗和茶碱可用于治疗COPD，但这两种药物联合使用尚未得到广泛研究。
比较沙美特罗加茶碱与单独使用任一药物治疗COPD的疗效和安全性。
对943例COPD患者进行随机、双盲、双模拟、平行组试验。在开放标签的茶碱滴定期（血清水平为10至20μg/mL）后，患者被随机分配接受沙美特罗（42μg，每日两次）加茶碱、沙美特罗（42μg，每日两次）或茶碱治疗12周。在第1天和治疗第12周完成系列肺功能测试。患者记录日记卡，记录其峰值流速、症状评分和沙丁胺醇使用情况，并定期完成生活质量和呼吸困难问卷调查。
与基线相比，所有三组均有显著改善。沙美特罗加茶碱联合治疗在肺功能改善方面显著更大（p≤0.045）；在症状、呼吸困难和沙丁胺醇使用减少方面显著更大（p≤0.048）；COPD病情加重显著更少（与茶碱相比，p = 0.023）。总体而言，与茶碱相比，沙美特罗治疗在肺功能改善和治疗满意度方面更大。沙美特罗治疗还与药物相关不良事件显著更少（p≤0.042）相关，比包括茶碱的任何一种治疗都少。包括茶碱的两种治疗的安全性概况（不良事件、生命体征和心电图结果）相似。
COPD患者可能从沙美特罗加茶碱联合治疗中获益，且不会导致不良事件或其他不良后果增加。
