吸入型沙美特罗/丙酸氟替卡松与异丙托溴铵/沙丁胺醇治疗慢性阻塞性肺疾病患者的疗效及安全性的比较研究

目的比较沙美特罗/丙酸氟替卡松与异丙托溴铵/沙丁胺醇治疗稳定期中重度慢性阻塞性肺疾病(chronic obstruchive pulmonary disease,COPD)患者的疗效及安全性。方法 21例确诊为中、重度COPD患者随机分为:①沙美特罗/丙酸氟替卡松组(10例):予50/500μg,1吸/次,2次/d;②异丙托溴铵/沙丁胺醇组(11例):20/120μg,2吸/次,4次/d;共用12周。测定治疗前后4周、12周的临床症状变化、英国医学研究委员会(modified medical research council,MMRC)呼吸困难评分、多因素分级系统(body mass,airflow obstruction,dyspnea,and exercise cqpacity,BODE)指数评分、圣乔治医院呼吸问题调查问卷(St.George's Hospital respiratory questionaire,SGRQ)得分、肺功能相关指标使用支气管扩张剂后的第一秒用力呼气容积(forced expiratory vohime in one second,FEV1)、FEV1占预计值百分比(FEV1%)、FEV1/FVC%、最大呼气峰流速值(peak expiratory flow,PEF)及PEF占预计值百分比(PEF%)],记录药物不良反应及患者急性加重的发生率。结果治疗12周后两组患者肺功能有所改善,其中FEV1沙美特罗/丙酸氟替卡松组治疗后与治疗前行配对t检验的P=0.03,异丙托溴铵/沙丁胺醇组治疗后与治疗前行配对t检验的P=0.09,两组间配对t检验4周时P=0.04,12周时P0.05。各项评分包括MMRC、BODE、SGRQ等两组治疗前后相比较无明显差异(P0.05)。结论沙美特罗/丙酸氟替卡松和异丙托溴铵/沙丁胺醇治疗稳定期中重度COPD患者12周后在疗效上无显著差异。可能仍需更多大规模、随访时间长的临床实验加以验证。

The efficacy and safety of inhaled Salmeterol/fluticasone propionate and Ipratropium Bromide/Salbutamol in chronic obstructive pulmonary disease, a comparative study

Objective To compare the efficacy and safety of inhaled Salmeterol/fluticasone propionate and Ipratropium Bromide/Salbutamol in chronic obstructive pulmonary disease （COPD）patients. Methods A randomized, open, parallelPgroup study. Twenty-one patients with clinically stable moderate to severe COPD were randomized to one of two treatment groups ： 10 patients received the salmeterol/flutica- sone combination 50/500 μg one suction, twice daily and 11 received Ipratropium Bromide/Salbutamol 20/ 120 μg two suction, 4 times daily for 12 weeks. Forced expiratory volume in one second（FEVl ）, FEV1%, FEVI/FVC%, peak expiratory flow（PEF）, PEF%, MMRC, BODE, SGRQ, exacerbation rates and adverse reactions of drug were observed. Results After 12 weeks of treatment, both groups had pulmonary function （salmeterol/fluticasone group＇s t-test： P = 0.03, Ipratropium Bromide/Salbutamol group＇s t-test： P = 0.09） and the MMRC, BODE, SGRQ scores all improved, but there was no significant difference in pulmonary function（ P = 0.04 at 4 weeks, P 〉 0.05 at 12 weeks） and all the scores （ P 〉 0.05 ） between the two groups after treatment. Conclusion Salmeterol/fluticasone propionate and ipratropium bromide/ albuterol were used in patients with stable moderate to severe COPD who had no obvious adverse reactions aftertreatment for 12 weeks, the two groups had no significant differences in efficacy by this study There ohould be bigger and longer trials to testify the resuh.