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目的探讨沙美特罗/丙酸氟替卡松吸入治疗稳定期中重度慢性阻塞性肺疾病(COPD)患者的临床疗效与安全性。方法将160例稳定期中重度COPD患者随机分为观察组和对照组,每组各80例。对照组予以常规治疗,观察组在对照组治疗的基础上吸入沙美特罗/丙酸氟替卡松干粉剂,规律治疗3个月,于治疗前、治疗过程中及治疗结束后分别观察圣.乔治呼吸疾病问卷(SGRQ)评分、6 min步行距离(6MWT)、肺功能指标及药物不良反应等。结果观察组70例、对照组63例获有效随访。治疗8周后,观察组与对照组均显示出一定的临床效果,2组SGRQ总分、6MWT、肺功能(FEV1及FEV1%Pred)、血气分析指标PaO2较治疗前均有改善(P均<0.05),血气分析指标PaCO2未见明显变化。2组治疗后SGRQ总分、6MWT、血气分析指标PaCO2、急性加重住院患者比例等比较,观察组优于对照组,差异均具有统计学意义(P均<0.05),肺功能(FEV1、FEV1%Pred)2组比较差异无统计学意义(P>0.05)。结论在常规诊疗措施的基础上,规律吸入沙美特罗/丙酸氟替卡松治疗稳定期中重度COPD具有较好的临床疗效和较高的临床安全性,适合于患者的长期、持续治疗。
Objective To investigate the clinical efficacy and safety of salmeterol / fluticasone propionate inhalation in patients with stable chronic obstructive pulmonary disease (COPD). Methods 160 patients with moderate-to-severe COPD were randomly divided into observation group and control group, 80 cases in each group. The control group was given conventional treatment. The observation group was given inhaled salmeterol / fluticasone propionate dry powder for 3 months on the basis of the control group. Before and after treatment, St. George’s respiratory disease Questionnaire (SGRQ) score, 6 min walking distance (6MWT), pulmonary function indicators and adverse drug reactions. Results The observation group of 70 cases, 63 cases of the control group were effectively followed up. After 8 weeks of treatment, both the observation group and the control group showed certain clinical effects. The SGRQ score, 6MWT, FEV1 and FEV1% Pred and PaO2 in both groups were significantly improved (P < 0.05), PaCO2 blood gas analysis showed no significant change. The total score of SGRQ, 6MWT, PaCO2, acute exacerbation rate of hospitalized patients in the two groups were significantly higher than those in the control group (P <0.05), and pulmonary function (FEV1, FEV1% There was no significant difference between the two groups (P> 0.05). Conclusion Conventional salmeterol / fluticasone propionate has a good clinical efficacy and high clinical safety in the treatment of stable COPD. It is suitable for long-term and continuous treatment of patients.