缓解期重度COPD患者联合使用噻托溴铵与沙美特罗/丙酸氟替卡松的临床研究

Tiotropium Bromide Combined with Salmeterol/Fluticasone Propionate for Severe COPD at Remission Stage:A Clinical Study

目的探讨缓解期重度COPD患者联合使用噻托溴铵与沙美特罗/丙酸氟替卡松治疗的临床疗效与安全性。方法将156例缓解期重度COPD患者随机分为观察组96例和对照组60例,在常规治疗的基础上,对照组吸入沙美特罗/丙酸氟替卡松干粉剂;观察组在对照组的基础上联合吸入噻托溴铵干粉剂,规律治疗12周,于治疗前、治疗过程中及治疗结束后分别观察SGRQ评分、6MWT、肺功能指标及药物不良反应等。结果治疗4～8周后,观察组与对照组均显示出一定的临床效果,且观察组优于对照组,治疗后SGRQ总分、6MWT、肺功能、急性加重住院比较,差异均具有统计学意义(P<0.05),但血气分析指标中,PaCO2未见显著性变化。结论在常规诊疗措施的基础上,联合使用噻托溴铵与沙美特罗/丙酸氟替卡松治疗缓解期重症COPD患者具有较好的临床疗效和较高的临床安全性,适宜于缓解期重症COPD患者的长期、持续治疗。

Objective To explore the curative effect and safety of treating severe COPD patients in remission stage by Tiotropium Bromide combined with Salmeterol/Fluticasone Propionate. Methods One hundred and fifty-six cases severe COPD patients in remission stage were randomly divided into observation group with 96 cases and control group with 60 cases. Patients in control group were given Salmeterol/Fluticasone Propionate on the basis of routine therapy, and patients in observation group were given Tiotropium Bromide on the basis of control group. Patients in two groups were regularly treated for 12 weeks, and recorded SGRQ mark, 6MWT, pulmonary function index and adverse drug reactions before treatment, in healing process and after treatment respectively. Results Patients in observation group and control group were all showed some clinical effect 4 to 8 weeks later after treatment, and observation group were superior than control group in SGRQ total score, 6MWT, pulmonary function and acute exacerbations hospitalization, and there were statistical differences （ P 〈 0.05 ） among the above marks, yet there were no obvious changes of PaCO2 in blood gas analysis. Conclusion It has good clinical curative effect and high safety of treating severe COPD patients in remission stage by Tiotrupium Bromide combined with Salmeterol/Fluticasone on the basis of conventional treatment measures, so it is suitable for long-term and sustained treatment for severe COPD patients in remission stage.