Department of Pneumology, Second Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czechia.
Faculty of Medicine, Masaryk University, Brno, Czechia.
Dig Dis. 2024;42(4):361-368. doi: 10.1159/000538606. Epub 2024 Apr 3.
Cystic fibrosis transmembrane conductance regulator modulator therapy improves nutritional status and quality of life. Clinical trials have shown pancreatic insufficiency conversion, mostly in pediatric patients treated with ivacaftor. Studies with elexacaftor/tezacaftor/ivacaftor (ETI) in older patients have not suggested restoration of exocrine pancreas function, but quality data in adults are lacking. Our aim was to show the effect of ETI in adults with cystic fibrosis (CF) on nutritional status and digestive function. We hypothesized improvement of nutritional parameters and gastrointestinal symptoms, reduction of pancreatic enzyme replacement therapy, but uncertain improvement in exocrine pancreatic function.
We prospectively enrolled adults with CF treated with ETI from August 2021 to June 2022. We measured anthropometric parameters, laboratory nutritional markers, change of fecal elastase, pancreatic enzymes replacement therapy needs, and gastrointestinal symptoms.
In the cohort of 29 patients (mean age 29.1 years), 82.8% suffered exocrine pancreatic insufficiency. After ETI, mean BMI increased by 1.20 kg/m2 (p < 0.001), mean body weight by 3.51 kg (p < 0.001), albumin by 2.81 g/L, and prealbumin by 0.06 (both p < 0.001). Only 1 patient, initially pancreatic insufficient (4.5%, p < 0.001), developed pancreatic sufficiency, indicated by increased fecal elastase from 45 μg/g to 442.1 μg/g. Mean change in lipase substitution decreased by 1,969 units/kg/day (p < 0.001) and stools frequency by 1.18 per day (p < 0.001).
Our data suggest increased nutritional parameters, lower pancreatic substitution requirements, and improved defecation in adult CF patients on ETI. Improvement in exocrine pancreatic function might be mutation-specific and needs further study.
囊性纤维化跨膜电导调节剂治疗可改善营养状况和生活质量。临床试验表明,伊伐卡托治疗的大多数儿科患者胰腺功能不全得到转化。在老年患者中进行的 elexacaftor/tezacaftor/ivacaftor(ETI)研究并未提示外分泌胰腺功能恢复,但成人缺乏质量数据。我们的目的是展示 ETI 对囊性纤维化(CF)成年患者的营养状况和消化功能的影响。我们假设营养参数和胃肠道症状得到改善,胰腺酶替代治疗减少,但外分泌胰腺功能不确定得到改善。
我们前瞻性地招募了 2021 年 8 月至 2022 年 6 月接受 ETI 治疗的 CF 成年患者。我们测量了人体测量参数、实验室营养标志物、粪便弹性蛋白酶的变化、胰腺酶替代治疗需求以及胃肠道症状。
在 29 例患者的队列中(平均年龄 29.1 岁),82.8%的患者患有外分泌胰腺功能不全。ETI 后,平均 BMI 增加 1.20kg/m2(p < 0.001),平均体重增加 3.51kg(p < 0.001),白蛋白增加 2.81g/L,前白蛋白增加 0.06g/L(均 p < 0.001)。只有 1 名最初胰腺功能不全(4.5%,p < 0.001)的患者发展为胰腺功能正常,粪便弹性蛋白酶从 45μg/g 增加到 442.1μg/g。脂肪酶替代的平均变化减少了 1,969 单位/kg/天(p < 0.001),粪便频率每天减少 1.18 次(p < 0.001)。
我们的数据表明,ETI 治疗可使 CF 成年患者的营养参数增加,胰腺替代需求减少,排便改善。外分泌胰腺功能的改善可能是突变特异性的,需要进一步研究。