2021 年第 1 期 第 16 卷

布地奈德/福莫特罗维持和缓解方案对哮喘患者的疗效

The efficacy of budesonide/formoterol maintenance and reliever regimen on patients with asthma

作者：李双双1刘晖1王晶1文进2张莹1

英文作者：Li Shuangshuang1 Liu Hui1 Wang Jing1 Wen Jin2 Zhang Ying1

单位：1新疆医科大学第一附属医院呼吸中心，乌鲁木齐830011；2新疆医科大学第二附属医院重症医学科，乌鲁木齐830011

英文单位：1Respiratory Center the First Affiliated Hospital of Xinjiang Medical University Urumqi 830011 China; 2Department of Critical Care Medicine the Second Affiliated Hospital of Xinjiang Medical University Urumqi 830011 China

关键词：哮喘；肺功能；布地奈德/福莫特罗

英文关键词：Asthma;Lungfunction;Budesonide/formoterol

• 摘要：

• 目的 探讨布地奈德/福莫特罗维持和缓解方案对哮喘患者的疗效。方法 选取2017年3月至2018年11月来新疆医科大学第一附属医院诊治的哮喘患者（年龄＞16岁）404例。根据患者既往吸入药物情况分为布地奈德/福莫特罗维持和缓解组（198例）和沙美特罗/丙酸氟替卡松加按需沙丁胺醇组（206例），比较2组患者的基线特征，运用Kaplan-Meier生存分析和Log-rank检验比较2组患者哮喘首次加重出现时间，同时使用泊松回归模型比较2组急性加重年发生率，采用两因素两水平重复测量协方差分析比较2组治疗前后肺功能改善情况，哮喘控制和生活质量改善情况。结果 2组患者的基线特征差异无统计学意义(P＞0.05)。与使用沙美特罗/丙酸氟替卡松加按需沙丁胺醇组相比，布地奈德/福莫特罗维持和缓解组的哮喘患者首次急性加重出现时间显著后延［5.2(2.4,7.8)d比2.0(1.6,2.4)d，Log-rank P=0.024］，首次恶化的风险降低了44.0%（比值比=0.56，95%置信区间：0.32～0.95，P=0.033），急性加重年发生率也显著较低（16.0%比26.0%，比值比=0.62，95%置信区间：0.41～0.94，P=0.024）。与基线相比，布地奈德/福莫特罗维持和缓解组及沙美特罗/丙酸氟替卡松加按需沙丁胺醇组两种方案均可达到哮喘控制，组间差异无统计学意义［哮喘控制问卷评分变化（-0.70±0.37）分比（-0.66±0.29）分，P=0.422］；2组标准化哮喘患者生活质量问卷评分变化［（0.84±0.30）分比（0.73±0.31）分，P=0.164］和使用支气管扩张剂前后第1秒用力呼气容积［（74±58）ml比（46±31）ml，P=0.285；（196±121）ml 比（173±104）ml，P=0.441］的差异均无统计学意义；2组各不良反应及总不良反应发生率差异均无统计学意义（均P>0.05）。结论 布地奈德/福莫特罗维持和缓解治疗方案较沙美特罗/丙酸氟替卡松加按需沙丁胺醇治疗方案明显降低哮喘患者急性加重风险，但二者在哮喘控制、生活质量和第1秒用力呼气容积的改善方面具有相同的疗效。

• Objective To investigate the efficacy of budesonide/formoterol maintenance and reliever regimen on patients with asthma. Methods A total of 404 adult patients with asthma(>16 years) admitted to the First Affiliated Hospital of Xinjiang Medical University from March 2017 to November 2018 were enrolled. According to the prior inhaled medication， they were divided into budesonide/formoterol maintenance and reliever group (198 cases) and salmeterol/fluticasone propionate plus on-demand salbutamol group (206 cases). The baseline characteristics of the two groups were compared. Kaplan-Meier survival analysis and Log-rank test were used to compare the first exacerbation time of asthma between the two groups. Poisson regression model was used to compare the  annual incidences of acute exacerbation between the two groups. Two-way repeated measures ANOVA was used to compare the improvement of lung function, asthma control and quality of life between the two groups before and after treatment. Results There was no significant difference in baseline characteristics between the two groups(P＞0.05). Compared with salmeterol/fluticasone propionate plus on-demand salbutamol group, the first acute exacerbation time of asthma patients in budesonide/formoterol maintenance and reliever group was significantly delayed［5.2(2.4,7.8)d vs 2.0(1.6,2.4)d， Log-rank P=0.024］, the risk of the first exacerbation was reduced by 44.0%(odds ratio=0.56, 95% confidence interval: 0.32-0.95, P=0.033), and the acute exacerbation annual incidence was also significantly reduced(16.0% vs 26.0%, odds ratio=0.62, 95% confidence interval: 0.41-0.94, P=0.024). Compared with baseline, the two regimens of budesonide/formoterol maintenance and reliever group and salmeterol/fluticasone propionate plus on-demand salbutamol group could achieve the improvement of asthma control, and there wasn′t significant difference between two groups［（-0.70±0.37） vs （-0.66±0.29）, P=0.422］; there were no significant differences in the clinical related improvement of quality of life［（0.84±0.30） vs （0.73±0.31）, P=0.164］and the forced expiratory volume in the first second(FEV1) before and after using bronchodilator［（74±58）ml vs （46±31）ml, P=0.285; （196±121）ml vs （173±104）ml, P=0.441］; there were no significant differences in the incidences of each adverse reaction and total adverse reactions between the two groups(all P>0.05). Conclusions  Budesonide/formoterol maintenance and reliever therapy regimen significantly reduces the risk of acute exacerbation of asthma compared with salmeterol/fluticasone propionate plus on-demand salbutamol regimen. However, both regimens have the same efficacies in improvement of asthma control, quality of life and FEV1.