1 Department of Pediatrics, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colorado.
2 Cystic Fibrosis Foundation Therapeutics Development Network Coordinating Center, Seattle Children's Research Institute, Seattle, Washington.
Am J Respir Crit Care Med. 2018 Sep 1;198(5):639-647. doi: 10.1164/rccm.201801-0105OC.
Cystic fibrosis (CF) is characterized by dietary antioxidant deficiencies, which may contribute to an oxidant-antioxidant imbalance and oxidative stress.
Evaluate the effects of an oral antioxidant-enriched multivitamin supplement on antioxidant concentrations, markers of inflammation and oxidative stress, and clinical outcomes.
In this investigator-initiated, multicenter, randomized, double-blind, controlled trial, 73 pancreatic-insufficient subjects with CF 10 years of age and older with an FEV between 40% and 100% predicted were randomized to 16 weeks of an antioxidant-enriched multivitamin or control multivitamin without antioxidant enrichment. Endpoints included systemic antioxidant concentrations, markers of inflammation and oxidative stress, clinical outcomes (pulmonary exacerbations, anthropometric measures, pulmonary function), safety, and tolerability.
Change in sputum myeloperoxidase concentration over 16 weeks, the primary efficacy endpoint, was not significantly different between the treated and control groups. Systemic antioxidant (β-carotene, coenzyme Q10, γ-tocopherol, and lutein) concentrations significantly increased in the antioxidant-treated group (P < 0.001 for each), whereas circulating calprotectin and myeloperoxidase decreased in the treated group compared with the control group at Week 4. The treated group had a lower risk of first pulmonary exacerbation requiring antibiotics than the control group (adjusted hazard ratio, 0.50; P = 0.04). Lung function and growth endpoints did not differ between groups. Adverse events and tolerability were similar between groups.
Antioxidant supplementation was safe and well tolerated, resulting in increased systemic antioxidant concentrations and modest reductions in systemic inflammation after 4 weeks. Antioxidant treatment was also associated with a lower risk of first pulmonary exacerbation. Clinical trial registered with www.clinicaltrials.gov (NCT01859390).
囊性纤维化（CF）的特点是饮食中抗氧化剂缺乏，这可能导致氧化剂-抗氧化剂失衡和氧化应激。
评估富含抗氧化剂的多种维生素补充剂对抗氧化浓度、炎症和氧化应激标志物以及临床结果的影响。
在这项由研究者发起的、多中心、随机、双盲、对照试验中，将 73 名年龄在 10 岁及以上且肺功能 FEV1 占预计值的 40%至 100%之间的胰腺功能不全 CF 患者随机分为 16 周富含抗氧化剂的多种维生素组或不含抗氧化剂富集的对照多种维生素组。终点包括系统抗氧化浓度、炎症和氧化应激标志物、临床结果（肺部恶化、人体测量指标、肺功能）、安全性和耐受性。
16 周时痰髓过氧化物酶浓度的变化（主要疗效终点）在治疗组和对照组之间无显著差异。抗氧化治疗组的系统抗氧化剂（β-胡萝卜素、辅酶 Q10、γ-生育酚和叶黄素）浓度显著增加（P<0.001），而治疗组在第 4 周时与对照组相比，循环钙卫蛋白和髓过氧化物酶减少。与对照组相比，治疗组首次需要抗生素治疗的肺部恶化风险较低（调整后的危险比为 0.50；P=0.04）。两组的肺功能和生长终点无差异。两组之间的不良事件和耐受性相似。
抗氧化剂补充是安全且耐受良好的，可导致系统抗氧化浓度增加，并在 4 周后适度降低全身炎症。抗氧化治疗也与首次肺部恶化的风险降低相关。该临床试验已在 www.clinicaltrials.gov 上注册（NCT01859390）。
