PULMOZYME dornase alfa
Drug Class
Recombinant human deoxyribonuclease I (rhDNase)重组人脱氧核糖核酸酶I
Mechanism
Cleaves extracellular DNA in the purulent secretions of cystic fibrosis patients, reducing sputum viscoelasticity and improving airway clearance.通过特异性水解积聚在囊性纤维化患者脓性分泌物中的游离DNA，降低痰液的粘弹性，从而改善气道清除能力。
Approved Indication
In conjunction with standard therapies for the management of cystic fibrosis patients to improve pulmonary function.联合标准疗法，用于治疗囊性纤维化患者，以改善肺部功能。
What This Means For Patients
Pulmozyme (dornase alfa) is an inhaled enzyme approved by the FDA for patients with cystic fibrosis. It works by breaking down the thick DNA accumulation in mucus, making it thinner and easier to clear from the lungs. Eligible patients can access this therapy under special import pathways in the Boao Lecheng pilot zone.Pulmozyme（阿法妥拉酶）是一种吸入型重组酶制剂，获得美国FDA批准用于囊性纤维化患者的治疗。它能降解呼吸道粘液中积聚的游离DNA，稀释痰液，使其更容易被咳出。符合条件的患者可通过海南博鳌乐城先行区特药进口通道申请评估使用。
Regulatory Approvals
- FDA — approved (1993) — label
Pivotal Clinical Evidence
- Fuchs et al., 1994 — Fuchs et al., N Engl J Med 1994 — DOI
This page provides regulatory and mechanism-of-action information for reference only. It is not medical advice, a treatment recommendation, or a guarantee of outcome. Availability is subject to individual clinical review.