探索雾化抗菌药物治疗伴铜绿假单胞菌感染的支气管扩张症急性加重患者的疗效和安全性  

Efficacy of nebulized antibacterial therapy for acute exacerbations of bronchiectasis with Pseudomonas aeruginosa infection

作　　者：邓文静[1] 缑剑 兀威[3] 孙锎 陈旻旻 韦永刚 张明川 张秋红[1] 杨拴盈[1] Deng Wenjing;Gou Jian;Wu Wei;Sun Kai;Chen Minmin;Wei Yonggang;Zhang Mingchuan;Zhang Qiuhong;Yang Shuanying(Department of Respiratory and Critical Care Medicine,the Second Affiliated Hospital of Xi′an Jiaotong University,Xi′an 710004,China;Pulmonary and Critical Care Medicine,the First People′s Hospital of Xianyang,Xianyang 712000,China;Pulmonary and Critical Care Medicine,the Second Affiliated Hospital of Xi′an Medical,Xi′an 710000,China;Pulmonary and Critical Care Medicine,Chongqing University Three Gorges Hospital,Chongqing 404000,China;Department of Pneumology,Songshan Hospital,Chongqing 401147,China;Pulmonary and Critical Care Medicine,The People′s Hospital of Kaizhou District in Chongqing,Chongqing 405400,China;Pulmonary and Critical Care Medicine,The People′s Hospital of Tongliang District in Chongqing,Chongqing 402560,China)

机构地区：[1]西安交通大学第二附属医院呼吸与危重症医学科,西安710004 [2]咸阳市第一人民医院呼吸与危重症医学科,咸阳712000 [3]西安医学院第二附属医院呼吸与危重症医学科,西安710000 [4]重庆大学附属三峡医院呼吸与危重症医学科,重庆404000 [5]重庆松山医院呼吸科,重庆401147 [6]重庆市开州区人民医院呼吸与危重症医学科,重庆405400 [7]重庆市铜梁区人民医院呼吸与危重症医学科,重庆402560

出　　处：《国际呼吸杂志》2024年第6期706-711,共6页International Journal of Respiration

基　　金：陕西省自然科学基金(2022JM-509);陕西省重点研发计划(2020GXLH-Y-010)。

摘　　要：目的比较妥布霉素吸入溶液(TIS)和多黏菌素E甲磺酸钠(CMS)治疗支气管扩张症急性加重患者伴铜绿假单胞菌(PA)感染的疗效和安全性。方法本研究为多中心、前瞻、随机对照研究,采用简单随机的方法纳入2023年2月至9月7家研究中心筛选的支气管扩张症急性加重患者37例,简单随机分为TIS组(19例)和CMS组(18例)。2组患者均接受5 d的吸入抗菌药物治疗,比较2组患者的临床肺部感染评分(CPIS)、支气管扩张症急性加重与症状评估工具(BEST)评分、欧洲五维健康量表(EQ-5D-5L)、住院时间、住院总费用等指标。结果最终32例患者完成治疗和随访,TIS组16例,男7例,女9例,年龄(64.00±6.99)岁;CMS组16例,男3例,女13例,年龄(66.56±7.30)岁,2组性别、年龄差异均无统计学意义(均P>0.05)。治疗5 d后,TIS组和CMS组CPIS评分均较治疗前降低,分别为[(2.47±1.19)分比(4.73±1.83)分、(2.94±1.95)分比(4.56±1.79)分],差异有统计学意义(均P<0.05),但治疗后2组差异均无统计学意义[(2.47±1.19)分比(2.94±1.95)分],t=0.82,P=0.417;TIS组BEST评分均较治疗前降低(5.78±2.05)分比(10.78±4.41)分,差异有统计学意义(P<0.05),治疗后TIS组低于CMS组,(5.78±2.05)分比(9.17±6.22)分,治疗后,2组差异有统计学意义(t=2.07,P=0.047);治疗后TIS组EQ-5D-5L效用值较治疗前升高,(0.80±0.19)比(0.60±0.27),差异有统计学意义(P<0.05),治疗后2组差异无统计学意义,[(0.80±0.19)比(0.64±0.41),(t=1.42,P=0.167)]。TIS组和CMS组PA转阴率、治疗5 d出院率、住院时间和总住院费用差异均无统计学意义(均P>0.05)。没有发现与TIS和CMS有关的不良事件发生。结论雾化TIS和CMS均可有效改善支气管扩张症急性加重患者的临床症状,两种药物均无明显不良反应,应用安全。ObjectiveTo evaluate the efficacy and safety of tobramycin inhalation solution(TIS)and colistimethate sodium(CMS)in treating patients with acute exacerbations of bronchiectasis with Pseudomonas aeruginosa(P.aeruginosa,PA)infection.MethodsThis multicenter,prospective,randomized controlled study enrolled 37 patients with acute exacerbation of bronchiectasis,recruited from seven centers between February 2023 and September 2023.Patients were randomly assigned to receive either TIS(19 patients)or CMS(18 patients).Both groups underwent a five-day inhalational antimicrobial therapy.Clinical outcomes assessed included Clinical Pulmonary Infection Score(CPIS),Bronchiectasis Exacerbation and Symptom Tool(BEST),the EuroQol five-dimension five-level questionnaire(EQ-5D-5L),length of hospital stay,total hospitalization cost,etc.ResultsOf the initially enrolled patients,32 completed the treatment and follow-up.In the TIS group,there were 16 patients(7 males,9 females,average age 64.00±6.99 years);in the CMS group,there were 16 patients(3 males,13 females,average age 66.56±7.30 years).No significant differences in gender or age were observed between the groups.After 5 days of treatment,both groups showed a significant reduction in CPIS scores from baseline([2.47±1.19]vs[4.73±1.83]for TIS,[2.94±1.95]vs[4.56±1.79]for CMS),with significant differences(both P<0.05);but no significant differences were found between the groups after treatment([2.47±1.19]vs[2.94±1.95];t=0.82,P=0.417).BEST scores in the TIS group also decreased significantly after treatment,from(10.78±4.41)to(5.78±2.05)(P<0.05),lower than in the CMS group after treatment(9.17±6.22),with significant difference(t=2.07,P=0.047).The EQ-5D-5L utility scores in the TIS group increased from(0.60±0.27)to(0.80±0.19)after treatment,showing a statistically significant improvement(P<0.05),with no significant differences between the two groups post-treatment([0.80±0.19]vs[0.64±0.41];t=1.42,P=0.167).There were no significant differences in PA clearance rates,discharge

关 键 词：支气管扩张症 妥布拉霉素 多黏菌素E甲磺酸钠 铜绿假单胞菌 

分 类 号：R562.22[医药卫生—呼吸系统]