罗氟司特片联合沙美特罗替卡松吸入气雾剂治疗中/重度慢性阻塞性肺疾病患者的临床研究  

Clinical trial of roflumilast tablets combined with salmeterol xinafoate and fluticasone propionate inhalation aerosol in the treatment of moderate/severe chronic obstructive pulmonary disease

作　　者：徐琳琳[1] 周瑞清[1] XU Lin-lin;ZHOU Rui-qing(Department of Respiratory Medicine,Fuyang People’s Hospital,Fuyang 236000,Anhui Province,China)

机构地区：[1]阜阳市人民医院呼吸内科,安徽阜阳236000

出　　处：《中国临床药理学杂志》2021年第11期1318-1321,共4页The Chinese Journal of Clinical Pharmacology

基　　金：安徽省公益性技术应用研究联动计划基金资助项目(1604f0804008)。

摘　　要：目的观察罗氟司特片联合沙美特罗替卡松吸入气雾剂治疗中/重度慢性阻塞性肺疾病(COPD)患者的临床疗效及安全性。方法将110例中/重度COPD患者随机分为对照组60例和试验组50例。2组患者均给予常规治疗。在此基础上,对照组给予沙美特罗替卡松吸入气雾剂治疗每次1吸,bid;试验组在对照组治疗的基础上,给予罗氟司特每次0.5 mg,qd,口服。2组患者均持续治疗3个月。比较2组患者的临床疗效、肺功能,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90.00%(45例/50例)和71.67%(43例/60例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的第1秒用力呼气容积(FEV_(1))分别为(2.24±0.29)和(1.87±0.24)L,FEV_(1)/用力肺活量(FVC)分别为(65.76±5.09)%和(58.23±5.33)%,FEV_(1)占预计值百分比分别为(64.38±7.00)%和(57.12±4.27)%,差异均有统计学意义(P<0.05)。试验组发生的药物不良反应以头晕头痛、失眠和恶心呕吐为主,对照组发生的药物不良反应以头晕头痛为主。试验组和对照组的总药物不良反应发生率分别为6.00%和3.33%,差异无统计学意义(P>0.05)。结论罗氟司特片联合沙美特罗替卡松吸入气雾剂治疗中/重度COPD患者的临床疗效确切,其能有效地改善患者的肺功能,且不增加药物不良反应的发生率。Objective To observe the clinical efficacy and safety of roflumilast tablets combined with salmeterol xinafoate and fluticasone propionate inhalation aerosol in the treatment of moderate/severe chronic obstructive pulmonary disease(COPD).Methods A total of 110 patients with moderate/severe COPD were randomly divided into control group(n=60 cases)and treatment group(n=50 cases).The two groups were given conventional treatment.On this basis,the control group was treated with seretide,1 suction per time,bid.On the basis of control group,the treatment group was given roflumilast 0.5 mg per time,qd,orally.Two groups were treated for 3 months.The clinical efficacy,lung function and adverse drug reactions were compared between two groups.Results After treatment,the total effective rates of treatment and control groups were 90.00%(45 cases/50 cases)and 71.67%(43 cases/60 cases)with statistically significant difference(P<0.05).After treatment,the main indexes of treatment and control groups were compared:forced expiratory volume in the first second(FEV_(1))were(2.24±0.29)and(1.87±0.24)L,the FEV_(1)/forced vital capacity(FEV_(1)/FVC)were(65.76±5.09)%and(58.23±5.33)%,the predicted value of the FEV_(1)were(64.38±7.00)%and(57.12±4.27)%,the differences were statistically significant(all P<0.05).The adverse drug reactions of treatment group were dizziness and headache,insomnia and nausea and vomiting,while those in the control group were dizziness and headache.The incidences of total adverse drug reactions in the treatment and control groups were 6.00%and 3.33%without significant difference(P>0.05).Conclusion Roflumilast tablets combined with salmeterol xinafoate and fluticasone propionate inhalation aerosol have a definitive clinical efficacy in the treatment of moderate/severe COPD,which can effectively improve the lung function,without increasing the incidence of adverse drug reactions.

关 键 词：罗氟司特片 沙美特罗替卡松吸入气雾剂 慢性阻塞性肺疾病 肺功能 安全性评价 

分 类 号：R97[医药卫生—药品]