支气管热成形术对第一秒用力呼气容积占预计值的百分比<60%重症哮喘患者的疗效及安全性

Analysis of the safety and efficacy of bronchial thermoplasty for severe asthma with the first second forced expiratory volume(FEV1)as a percentage of the predicted value(FEV1%pred)<60%

目的探讨支气管热成形术(BT)对第一秒用力呼气容积(FEV1)占预计值的百分比(FEV1%预计值)<60%重症哮喘患者的疗效及安全性。方法对2016年1月至2018年1月在中国科学院大学深圳医院行BT治疗的75例哮喘患者进行回顾性分析,患者根据治疗前的FEV1%预计值分为两组:FEV1%预计值<60%组(39例)、FEV1%预计值≥60%组(36例)。对两组患者治疗前后的激素用量、急性发作次数、哮喘控制测试(ACT)评分、肺功能改变及治疗后3周不良反应等进行比较。结果FEV1%预计值<60%组治疗前口服波尼松用量、吸入布地奈德罗用量、急性发作次数均>FEV1%预计值≥60%组,ACT评分低于FEV1%预计值≥60%组[M(Q1,Q3),10.00(0,20.00)比0(0,3.75)mg/d、960(320,960)比320(320,640)μg/d、5(4,8)比4(4,5)次/年,13(9,15)比17(13,19)分](P值均<0.05);其中BT治疗后1年FEV1%预计值<60%组口服泼尼松用量仍偏高外[0(0,5.00)比0(0,0)mg/d](P=0.009),其余各项指标在治疗后1年及治疗后2年两组间差异均无统计学意义(P值均>0.05);两组治疗后1、2年各项指标均好于治疗前(P值均<0.05),FEV1%预计值<60%组BT治疗后2年吸入布地奈德量、急性加重次数均少于治疗前1年[320(320,320)比320(320,640)μg/d、0(0,0)比0(0,1)次/年](P值均<0.05),其余指标差异均无统计学意义(P值均>0.05);FEV1%预计值≥60%组各指标治疗后2年与治疗后1年相比,除吸入布地奈德量外,差异均无统计学意义(P值均>0.05)。FEV1%预计值<60%组治疗前、治疗后1年、治疗后2年FEV1、FEV1%预计值均低于FEV1%预计值≥60%组[FEV1:(1.21±0.41)比(2.26±0.80)L、(1.84±0.73)比(2.30±0.78)L、(1.70±0.66)比(2.38±0.76)L;FEV1%预计值:46.2(38.5,53.7)%比80.8(66.5,93.6)%、60.1(48.2,71.6)%比87.4(68.5,96.5)%、58.5(48.6,74.8)%比86.6(73.0,97.3)%](P值均<0.05);FEV1%预计值<60%组治疗后1、2年的FEV1、FEV1%预计值均高于治疗前(P值均<0.05);FEV1%预计值≥60%组治疗前后各时点FEV1差异均无统计学意义(P值均>0.05),但治疗后2年FEV1%预计值高于治疗前(P<0.05);两组各项不良事件发生情况差异均无统计学意义(P值均>0.05)。结论BT可明显改善FEV1%预计值<60%的重症哮喘患者的肺功能,降低急性发作次数及激素用量,安全有效。

Objective To investigate the efficacy and safety of bronchial thermoplasty(BT)in severe asthma patients with the first second forced expiratory volume(FEV1)as a percentage of the predicted value(FEV1%pred)<60%.Methods A retrospective analysis was performed on 75 patients with asthma who were treated with BT at Shenzhen University Hospital of the Chinese Academy of Sciences from January 2016 to January 2018.The patients were divided into two groups based on the FEV1%pred before treatment:FEV1%pred<60%group(39 cases)and FEV1%pred≥60%group(36 cases).Comparative analysis of glucocorticoid consumption,times of acute attack,asthma control test(ACT)score,changes in lung function,and adverse reactions at 3 weeks after treatment were performed between the two groups of patients.Results Before BT treatment,the consumption of oral prednisone,the amount of budesonide inhaled,and the times of acute attack[M(Q1,Q3)]in the FEV1%pred<60%group were significantly greater than those in the FEV1%pred≥60%group,and the ACT score was significantly lower than the FEV1%pred≥60%group[10.00(0,20.00)vs 0(0,3.75)mg/d,960(320,960)vs 320(320,640)μg/d,5(4,8)vs 4(4,5)times/year,13(9,15)vs 17(13,19)scores](all P<0.05).Except that the oral prednisone dosage in the FEV1%pred<60%group was still higher 1 year after treatment[0(0,5.00)vs 0(0,0)mg/d](P=0.009),there was no significant difference in the remaining indicators between the two groups 1 year after treatment and 2 years after treatment(all P>0.05).After 1 year and 2 years of treatment,all indicators in the two groups were better than before treatment(all P<0.05).The inhaled budesonide amount and the times of acute exacerbation in the FEV1%pred<60%group 2 years after treatment were less than those 1 year after treatment[320(320,320)vs 320(320,640)μg/d,0(0,0)vs 0(0,1)times/year](all P<0.05),and there was no significant difference in the remaining indicators.In the FEV1%pred≥60%group,there was no significant difference between 2 years after treatment and 1 year after treatment in the above indicators except the amount of inhaled budesonide(all P>0.05).In the FEV1%pred<60%group,FEV1 and the FEV1%pred were significantly lower than the FEV1%pred≥60%group before treatment,1 year after treatment and 2 years after treatment[FEV1:(1.21±0.41)vs(2.26±0.80)L,(1.84±0.73)vs(2.30±0.78)L,(1.70±0.66)vs(2.38±0.76)L;FEV1%pred:46.2(38.5,53.7)%vs 80.8(66.5,93.6)%,60.1(48.2,71.6)%vs 87.4(68.5,96.5)%,58.5(48.6,74.8)%vs 86.6(73.0,97.3)%](all P<0.05).In the FEV1%pred<60%group,FEV1 and FEV1%pred 1 year after treatment and 2 years after treatment were all increased compared with before treatment(all P<0.05).In the FEV1%pred≥60%group,there was no statistical difference in FEV1 at each time point before and after treatment(all P>0.05),but the FEV1%pred at 2 years after treatment was higher than before treatment(P<0.05).There were no significant differences in adverse events between the two groups(all P>0.05).Conclusion BT can significantly improve the lung function,reduce the times of acute attack and the dosage of glucocorticoids in severe asthma patients with FEV1%pred<60%,which is safe and effective.