沙美特罗替卡松联合噻托溴铵治疗稳定期老年COPD患者的临床研究OA北大核心CSTPCD
Clinical trial of salmeterol and fluticasone propionate combined with tiotropium in treatment of elderly patients with stable COPD
目的 分析沙美特罗替卡松联合噻托溴铵治疗稳定期老年慢性阻塞性肺疾病(COPD)患者疗效及对血清降钙素原(PCT)、淀粉样蛋白A(SAA)和白蛋白与纤维蛋白原比值(AFR)水平的影响.方法 将稳定期老年COPD患者分为对照组和试验组.对照组给予沙美特罗替卡松吸入粉雾剂治疗,每次1吸,bid;试验组在对照组治疗的基础上,给予噻托溴铵吸入粉雾剂治疗,每次1吸,qd,2组患者均治疗3个月.比较2组患者的临床疗效、肺功能[1s用力呼气容积(FEV1)、FEV1/用力肺活量(FEV1/FVC)、呼气峰流速(PEF)]、改良英国医学研究委员会呼吸问卷(mMRC)评分、COPD患者自我评估测试问卷(CAT)评分、血清PCT、SAA和AFR水平的差异,并进行安全性评价.结果 试验组和对照组分别纳入52例和58例患者.治疗后,试验组和对照组的总有效率分别为90.38％(47例/52例)和75.86％(44例/58例),在统计学上差异有统计学意义(P＜0.05).治疗后,试验组和对照组的FEV1分别为(1.49±0.33)和(1.36±0.29)L,FEV1/FVC 分别为(61.28±10.56)％和(57.41±10.03)％,PEF 分别为(5.32±0.88)和(4.93±0.75)L·s-1,mMRC 评分分别为(0.99±0.24)和(1.21±0.27)分,CAT 评分分别为(11.58±3.02)和(14.26±3.71)分,PCT 分别为(0.76±0.11)和(0.85±0.18)μg·L-1,SAA 分别为(34.59±4.15)和(37.66±5.34)mg·L-1,AFR 分别为(5.97±1.12)和(5.53±1.06),试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(均P＜0.05).试验组的药物不良反应主要有口干、便秘、头晕、恶心,对照组的药物不良反应主要有口干、便秘、头晕、恶心.试验组和对照组的总药物不良反应发生率分别为21.15％(11例/52例)和13.79％(8例/58例),在统计学上差异无统计学意义(P＞0.05).结论 沙美特罗替卡松吸入粉雾剂联合噻托溴铵吸入粉雾剂能有效提升稳定期老年COPD患者的临床疗效,改善患者的肺功能,减轻机体炎症,促进患者病情好转,安全性较好.
Objective To analyze the efficacy of salmeterol rotticasone combined with tiotropium bromide in the treatment of elderly patients with stable chronic obstructive pulmonary disease(COPD)and its influence on serum procalcitonin(PCT),serum amyloid A(SAA)and albumin-to-fibrinogen ratio(AFR)levels.Methods The elderly patients with stable COPD were divided into control group and treatment group.The control group was treated with salmeterol rotticasone inhalation powder(1 inhalation each time,twice a day),while the treatment group was given tiotropium bromide inhaled powder aerosol treatment(1 inhalation each time once a day)on the basis of the control group.Patients in two groups were treated for 3 months.The clinical efficacy and differences in pulmonary function[forced expiratory volume in one second(FEV1),FEV1/forced vital capacity(FEV1/FVC),peak expiratory flow(PEF)],modified British Medical Research Council respiratory questionnaire(mMRC)score,COPD Assessment Test(CAT)score and serum PCT,SAA and AFR levels were compared;and the safety was evaluated.Results Fifty-two patients and fifty-eight patients were included in treatment group and control group,respectively.After treatment,the total effective rates in treatment group and control group were 90.38％(47 cases/52 cases)and 75.86％(44 cases/58 cases)(P＜0.05).The FEV1 values in treatment group and control group were(1.49±0.33)and(1.36±0.29)L;the FEV1/FVC values were(61.28±10.56)％and(57.41±10.03)％;PEF values were(5.32±0.88)and(4.93±0.75)L·s-1;mMRC scores were(0.99±0.24)and(1.21±0.27)points;the CAT scores were(11.58±3.02)and(14.26±3.71)points;PCT levels were(0.76±0.11)and(0.85±0.18)µg·L-1;SAA levels were(34.59±4.15)and(37.66±5.34)mg·L-1;AFR levels were 5.97±1.12 and 5.53±1.06,respectively.Compared with the control group,the above indexes in the treatment group were statistically significant(all P＜0.05).The main adverse drug reactions in treatment group were dry mouth,constipation and dizziness and nausea,and the main adverse drug reactions in control group were dry mouth,constipation,and dizziness and nausea.The total incidence rates of adverse drug reactions in treatment group and control group were 21.15％(11 cases/52 cases)and 13.79％(8 cases/58 cases)respectively,with no statistical significance(P＞0.05).Conclusion Salmeterol ticasone inhalation powder and tiotropium bromide inhaled powder aerosol can effectively enhance the clinical efficacy of elderly patients with stable COPD,improve the pulmonary function,relieve the body's inflammation,and promote the improvement of disease condition,with good safety.
周霞;娄丽丽;杨柳;程慧鑫
大庆龙南医院老年病科,黑龙江大庆 163000
药学
沙美特罗替卡松吸入粉雾剂噻托溴铵吸入粉雾剂慢性阻塞性肺疾病稳定期老年疗效炎症反应
salmeterol rotticasone inhalation powdertiotropium bromide inhaled powder aerosolchronic obstructive pulmonary diseasestable periodold agecurative effectinflammatory response
《中国临床药理学杂志》 2024 (017)
2459-2463 / 5
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