Objective To observe the effects of salmeterol / fluticasone combined with tiotropium in the treatment of sever to very sever COPD. Methods Eighty patients with severe to very severe stable COPD were recruited from outpatient of Central Hospital of Cangzhou between May 2008 and October 2009. The subjects were randomly divided into a salmeterol /fluticasone group and a combination group. The salmeterol / fluticasone group received salmeterol / fluticasone propionate, and the combination group received the combination therapy of tiotropium and salmeterol / fluticasone propionate. All patients had received the treatment for 12 months. At baseline and at the end of 1-month, 3-month, 6-month, 12-month, lung function ( FEV1 , IC and FVC) , six-minute walk distance and the St. George’s Respiratory Questionnaire ( SGRQ) score were assessed. The number of exacerbations and the time to the first exacerbation were also recorded. Results At every visit, lung function ( FEV1 , IC and FVC) , six-minute walk distance and the SGRQ score were improved in both groups compared with baseline ( Plt;0. 05) , especially in the combination group ( Plt;0.05) . Compared with the salmeterol /fluticason, the combination therapy with tiotropium significantly decreased the incidence of exacerbations and prolonged the time to the first exacerbation ( Plt;0.05) . And there was no significant difference between two groups in adverse effects ( Pgt;0.05) . Conclusions The combination therapy with salmeterol / fluticasone propionate and tiotropium was superior to salmeterol / fluticasone propionate in treatment of sever to very severe stable COPD patients in improving lung function, exercise tolerance, and quality of life, without additional adverse effects.
【摘要】 目的 观察沙美特罗替卡松粉吸入剂（沙美特罗50 μg/氟替卡松500 μg）治疗稳定期Ⅲ~Ⅳ级慢性阻塞性肺疾病（COPD）的疗效及安全性。 方法 将2008年1-12月就诊的62例稳定期Ⅲ~Ⅳ级COPD患者随机分成对照组和治疗组。对照组采用常规传统治疗方法，口服茶碱缓释片、祛痰剂；治疗组在常规传统治疗的基础上，加用沙美特罗替卡松粉吸入剂。6个月后评估两组患者肺功能、血气分析、呼吸困难程度及不良反应。治疗过程中，两组各有2例患者因失访退出研究。 结果 治疗前，对照组、治疗组1 s用力呼气量（FEV1）和FEV1%预计值比较，无统计学意义（Pgt;0.05）；治疗后，治疗组FEV1和FEV1%预计值明显增加，有统计学意义（Plt;0.05）。对照组治疗前后比较无改变（Pgt;0.05），治疗组较对照组呼吸困难程度明显好转，临床症状评分明显下降，两组间差异有统计学意义（Plt;0.05）。治疗结束时两组上述各指标比较，差异有统计学意义 （Plt;0.05）。两组均有少数出现咽喉不适，患者耐受好。 结论 沙美特罗替卡松粉吸入剂治疗稳定期Ⅲ~Ⅳ级COPD患者有效。【Abstract】 Objective To observe the efficacy and safety of inhaled formulations of Seretide (salmeterol 50 μg / fluticasone 500 μg) on grade Ⅲ ~ Ⅳ stable chronic obstructive pulmonary disease (COPD). Methods Sixty-two patients of grade Ⅲ-Ⅳ stable COPD were randomly divided into control group and treatment group. The control group was treated by conventional methods, oral theophylline and expectorant agents,while the treatment group was treated by inhalation of large dosage Seretide be added in the conventional treatment based on traditional. After six months, the lung function, blood gas analysis, respiratory difficulty and adverse effects were assessed. Results Before the treatment, the differences of forced expiratory volume in one second (FEV1) and FEV1% predicted value in the two groups were not statistically significant (Pgt;0.05). After treatment, FEV1 and FEV1% predicted value of treatment group were increased significantly(Plt;0.05). The control group showed no significant change before and after treatment(Pgt;0.05). The respiratory difficulty imprvoved significantly,while clinical symptom score decreased significantly in the treatment group,which compared with the control group (Plt;0.05). A few appeared thoat discomfort in the two groups. Well tolerated in patients. Conclusion Inhaled formulations of Seretide was effective and safty on stable period COPD patients with grade Ⅲ-Ⅳ.
Objective To systematically evaluate the efficacy and safety of salmeterol/fluticasone combined with tiotropium versus salmeterol/fluticasone alone for Chinese patients with chronic obstructive pulmonary disease (COPD). Methods The databases including PubMed, EMbase, The Cochrane Library (Issue 4, 2017), CNKI, VIP and WanFang Data were electronically searched to collect randomized controlled trials (RCTs) about salmeterol/fluticasone combined with tiotropium vs. salmeterol/fluticasone alone for Chinese COPD patients from inception to April 2017. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then meta-analysis was conducted by RevMan 5.3 software. Results A total of 30 RCTs involving 3 121 Chinese patients were included. The results of meta-analysis showed that, compared with the salmeterol/fluticasone alone group, the salmeterol/fluticasone plus tiotropium group could significantly improve the levels of FEV1[MD=0.30, 95%CI(0.22, 0.39), P<0.000 01], FVC [MD=0.31, 95%CI (0.23, 0.40), P<0.000 01] and FEV1/FVC [MD=9.07, 95%CI (6.69, 11.44), P<0.000 01]. While there was no significant difference in adverse reaction rates between the two groups [OR=1.17, 95%CI (0.83, 1.66), P=0.37]. Conclusions Current evidence shows that salmeterol/fluticasone plus tiotropium can improve lung function in Chinese patients with COPD. Due to the limited quality and quantity of included studies, more high quality studies are needed to verify the above conclusion.