摘要
目的观察联合吸入噻托溴铵和沙美特罗／氟替卡松治疗稳定期中重度慢性阻塞性肺疾病（chronicobstructivepulmonarydisease，COPD）的疗效。方法216例符合条件的中重度COPD患者纳入试验（男178例，女38例），按照随机数字表法分为4组：①联合治疗组56例（男46例，女10例），吸入沙美特罗／氟替卡松50／500μg每日2次，同时吸入噻托溴铵干粉胶囊1粒（18μg），每日1次；②沙美特罗／氟替卡松组54例（男46例，女8例），吸入沙美特罗／氟替卡松50／500μg，每日2次；③噻托溴铵组54例（男44例，女10例），吸入噻托溴铵干粉胶囊1粒（18μg），每日1次；④空白对照组52例（男42例，女10例），未应用胆碱能受体抑制剂、长效β2受体激动剂及糖皮质激素治疗。分别对四组患者治疗前和治疗后12个月肺功能指标、BODE（TheBody-MassIndex，AirflowObstruction，Dyspnea，andExerciseCapacity）指数、生活质量、药物不良反应进行观察对比，评价药物的疗效和安全性。结果共有176例患者完成了试验，其中联合治疗组48例（男40例，女8例），沙美特罗／氟替卡松组40例（男32例，女8例），噻托溴铵组46例（男36例，女10例），空白对照组42例（男32例，女10例）。治疗结束时各试验组FEV1明显高于试验前对应组（P〈0．01）。联合治疗组的FEV1（1．19±0．03）L，较沙美特罗／氟替卡松组（1．13±0．01）L、噻托溴铵组（1．15±0．01）L、空白对照组（1．07±0．02）L明显升高（P〈0．01）。急性发作次数和应用缓解药次数：联合治疗组的急性发作次数和应用缓解药次数中位数（四分位数间距）分别是[1．0（O-1）]、[1．0（0-1）]次，明显低于沙美特罗／氟替卡松组[1．0（O-2）]、[1．0（0-2）]次，噻托溴铵组[1．5（0-2）]、[1．0（0-2）]次，空白对照组[2．0（O-3）]、[2．0（O-4）]次，差异有统计学意义（P〈O．05）。联合治疗组试验后BODE指数（6．10±1．30）明显低于沙美特罗／氟替卡松组（6．51±1．32）、噻托溴铵组（6．61±1．23）、空白对照组（7．11±1．35），差异有统计学意义（P〈0．01）。结论噻托溴铵联合沙美特罗／氟替卡松治疗稳定期中重度COPD，疗效优于单独使用其中一种药物。
Objective To observe the effects of combining salmeterol/fluticasone and tiotropium in patients combination therapy with moderate-to-severe stable chronic obstructive pulmonary disease （COPD）. Methods Two hundreds and sixteen patients with moderate-to-severe stable COPI） received 12 months of treatment randomly in one of the four treatment groups： ①sa[meterol/fluticasone 50/500 μg twice daily and tiotropium 18 μg once daily （ n ： 56, M/F： 46/10）,②salmeterol/fluticasone 50/500μg twice daily （ n ： 54, M/F： 46/8）, ③tiotropium 18 μg once daily （ n ： 54, M/F： 44/10）, ④ the blank control group （n ： 52, M/F： 42/10）. Patients did not receive any inhaled anticholinergic drugs, long-acting beta2 agonists or glucocorticoid therapy. The lung function index, BODE index, quality of life, adverse drug reactions were observed to compare drug efficacy and safety before treatment and after treatment for 12 months. Results One hundred and seventy-six patients completed the 12-month treatment period： 48 patients receiving salmeterol/fluticasone ＋ tiotropium （M/F： 40/8）. 40 patients receiving salmeterol/fluticasone （M/F： 32/8）. 46 patients receiving tiotropium （M/F： 36/10）. 42 patients receiving nither salmeterol/fluticasone nor tiotropium （M/F： 32/10）. FEV1 in the three active treatments had improved significantly above baseline. FEV1 in the combination group after the trial before inhaling salbutamol was （1.19±0.03） L, which was significantly improved compared to that salmeterol/ fluticasone alone （1.13±0.01） L,tiotropium alone （1.15±0.01） L, and the blank group （1.07±0.02） L. （P 〈 0.01）. The frequency of exacerbations in the combination group was [1.0 （0-1）] times, significantly lower than that in the salmeterol/fluticasone alone[1.0 （0-2）] times, tiotropium alone [ 1.5 （0-2）] times, and blank group[2.0（0-3）] times （P 〈0.05）. The use of rescue medication in the combination group was [1.0（0-1）] times, significantly decreased compared with those in the salmeterol/ flutieasone alone [1.0（0-2）]times, tiotropium alone [1.0（0-2）] times, blank group [-2.0（0-4）] times （ P 〈0.05）. The BODE score in the combination group was （6. 10±_1.30）, significantly lower than that in the salmeterol/fluticasone alone （6.51 ± 1. 32）, tiotropium alone （6. 61 ± 1. 23） and blank group （7.11±1.35）. （ P 〈 0.01 ）. Conclusions Combination therapy with saimeterol/fluticasone and tiotropium may provide benefits, with no greater risk of side-effects in patients with moderate-to-severe stable COPD as compared to salmeterol/fluticasone or tiotropium alone in the treatment of COPD.
出处
《国际呼吸杂志》
2013年第1期1-5,共5页
International Journal of Respiration
基金
徐州市科技计划项目
