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沙美特罗替卡松粉吸入剂治疗慢性阻塞性肺疾病的临床研究 被引量:27

Clinical trial of salmeterol xinafoate and fluticasone propionate powder for inhalation in the treatment of chronic obstructive pulmonary disease
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摘要 目的观察沙美特罗替卡松治疗慢性阻塞性肺疾病(COPD)临床疗效及安全性。方法将70例COPD患者随机分为对照组35例与试验组35例。2组均予以常规治疗以及对症治疗;对照组予以噻托溴铵粉雾剂,每次一吸(18μg),qd;试验组予以沙美特罗替卡松粉吸入剂,每次一吸(50μg),qd。2组患者一个周期均为28 d,共治疗3个周期。比较2组患者的临床疗效、治疗前后用力肺活量(FVC)、一秒用力呼气容积(FEV1)、最大呼气峰流速值(PEF)、FEV1/FVC、FEV1及PEF占预计值百分比、圣·乔治医院呼吸问题调查问卷(SGRQ)、多因素分级系统(BODE)指数评分,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为91.43%(32/35例)和77.14%(27/35例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的FEV1分别为(1.86±0.19),(1.42±0.17)L;FEV1/FVC分别为(42.93±4.25)%,(39.73±3.68)%;PEF分别为(3.69±0.37),(3.11±0.35)L;FEV1/预计值分别为(48.57±4.97)%,(44.47±4.51)%;PEF/预计值分别为(48.92±5.05)%,(41.53±4.55)%;SGBQ分别为(44.97±4.96),(42.01±4.67)分;BODE分别为(5.98±0.59),(5.67±0.59)分,差异均有统计学意义(均P<0.05)。试验组出现头痛1例,震颤1例,心悸1例,总药物不良反应发生率为8.57%(3/35例),对照组出现头痛2例,心悸1例,声音嘶哑2例,总药物不良反应发生率为14.29%(5/35例),2组患者的药物不良反应发生率比较,差异无统计学意义(P>0.05)。结论沙美特罗替卡松治疗COPD的临床疗效显著,安全性高。 Objective To investigate the clinical efficacy and safety of salmeterol xinafoate/fluticasone propionate in the treatment of chronic obstructive pulmonary disease(COPD).Methods A total of 70 patients with COPD were randomly divided into control group and treatment group,35 cases in each group.Patients in the two groups were all given regular treatment.Patients in the control group were given inhalation treatment with 18 μg tiotropium bromide powder inhalation,qd.Patients in the treatment group were given 50 μg salmeterol fluticasone propionate powder,qd.Patients in the two groups were treated for three cycles(28 days per cycle).The clinical efficacy,pre-and post-treatment of forced vital capacity(FVC), one second forced expiratory volume(FEV1),peak expiratory flow rate value(PEF),FEV1/FVC,the predicted percentage of FEV1 and PEF value,St.George Hospital Respiratory Questionnaire(SGRQ),multi factor grading system(BODE: body mass index,airflow obstruction,dyspnea and exercise capacity) index score and the incidence of adverse reaction were compared between the two groups.Results After treatment,the total clinical effective rates in the treatment group and the control group were 91.43%(32/35 cases) and 77.14%(27/35 cases), respectively, with statistically significant difference(P 〈 0.05).After treatment,the FEV1 in the treatment group and the control group were(1.86 ± 0.19) L and(1.42 ± 0.17) L,respectively.The FEV1/FVC were(42.93 ± 4.25) % and(39.73 ± 3.68) %,respectively.The PEF were(3.69 ± 0.37) L and(3.11 ± 0.35) L,respectively.The FEV1/Predicted value were(48.57 ± 4.97) % and(44.47 ± 4.51) %,respectively.The PEF/Predicted value were(48.92 ± 5.05) % and(41.53 ± 4.55) %,respectively.The SGBQ score were(44.97 ± 4.96) and(42.01 ± 4.67) points,respectively.The BODE score were(5.98 ± 0.59) and(5.67 ± 0.59) points.There were statistically significant differences in all the items above between the two gro
出处 《中国临床药理学杂志》 CAS CSCD 北大核心 2017年第11期966-969,共4页 The Chinese Journal of Clinical Pharmacology
基金 山东省医药卫生科技发展计划基金资助项目(2015ws0363)
关键词 沙美特罗替卡松 慢性阻塞性肺疾病 噻托溴铵粉雾剂 肺活量 salmeterol xinafoate and fluticasone propionate chronic obstructive pulmonary disease tiotropium bromide powder inhalation forced vital capacity
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