Pollak Mordechai, Gambazza Simone, Orenti Annalisa, De Rose Virginia, Prais Dario, Kerem Eitan, Mei Zahav Meir
The Adelson School of Medicine, Ariel University, Ariel, Israel.
Pediatric Pulmonology Institute, Schneider's Children's Hospital, Petah Tikvah, Israel.
ERJ Open Res. 2025 Aug 4;11(4). doi: 10.1183/23120541.01248-2024. eCollection 2025 Jul.
Elexacaftor/tezacaftor/ivacaftor (ETI) has improved outcomes for people with cystic fibrosis (pwCF). This study evaluated changes in airway microbiological infection status after initiating ETI.
Using the European Cystic Fibrosis Society registry, pwCF who started ETI between 2019 and 2021 were identified. The changes in microbiological status from 1 year before to 1 year after ETI initiation, were compared with the changes seen from 3 to 1 years before starting ETI. Mixed-effect regression models were used to analyse changes. Data from 2 years after initiation were examined for those starting ETI in 2019-2020.
Included were 15 739 pwCF from 30 countries. In the year before ETI, 38.4% were positive for (PsA) and 36.4% for methicillin-sensitive (MSSA). After ETI, 38.7% of PsA-positive and 47.2% of MSSA-positive patients transitioned to negative status, compared with 14.8% and 29.1%, respectively, in the previous years. The adjusted difference in transitioning to negative was 14.6% (PsA) and 17.1% (MSSA), both p<0.001. Similar improvements were seen for complex and . For those starting ETI in 2019-2020, PsA positivity remained low over 2 years, decreasing from 46.8% pre-ETI to 30.4% and 27.7% at 1 and 2 years after ETI treatment.
One year after starting ETI, many pwCF who were initially positive for various CF-related pathogens, shifted to a negative status, a change less common before ETI. These findings suggest that ETI reduces airway infections, with benefits extending into the second year of treatment, although some pwCF continue to carry these pathogens despite treatment.
依列卡福妥/替扎卡福妥/依伐卡托（ETI）改善了囊性纤维化患者（pwCF）的治疗效果。本研究评估了开始使用ETI后气道微生物感染状态的变化。
利用欧洲囊性纤维化协会登记处的数据，确定了2019年至2021年间开始使用ETI的pwCF。将ETI开始前1年至开始后1年的微生物状态变化与开始ETI前3年至1年的变化进行比较。使用混合效应回归模型分析变化情况。对2019 - 2020年开始使用ETI的患者，检查了开始治疗后2年的数据。
纳入了来自30个国家的15739名pwCF。在使用ETI前一年，38.4%的患者肺炎链球菌（PsA）检测呈阳性，36.4%的患者对甲氧西林敏感的金黄色葡萄球菌（MSSA）检测呈阳性。使用ETI后，38.7%的PsA阳性患者和47.2%的MSSA阳性患者转为阴性状态，而前几年这一比例分别为14.8%和29.1%。转为阴性的调整差异为14.6%（PsA）和17.1%（MSSA），两者p<0.001。对于肺炎克雷伯菌复合菌和铜绿假单胞菌也观察到了类似的改善。对于2019 - 2020年开始使用ETI的患者，PsA阳性率在2年内一直较低，从ETI治疗前的46.8%降至ETI治疗后1年和2年的30.4%和27.7%。
开始使用ETI一年后，许多最初对各种与CF相关病原体检测呈阳性的pwCF转为阴性状态，这种变化在使用ETI之前不太常见。这些发现表明ETI可减少气道感染，其益处可延续至治疗的第二年，尽管一些pwCF在治疗后仍携带这些病原体。
