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

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 rate within 5 days of treatment,duration of hospital stay,or total hospital costs between the TIS and CMS groups(all P>0.05).No adverse events related to TIS or CMS were reported.ConclusionsBoth nebulized TIS and CMS can effectively improve clinical symptoms in patients with acute exacerbations of bronchiectasis,with no significant adverse reactions,indicating safe application of those therapies.