コルチコステロイド抵抗性・依存性慢性移植片対宿主病患者における水素の効果：単群・多施設・非盲検・第2相試験
Chronic graft-versus-host disease (cGVHD) following allogeneic hematopoietic stem cell transplantation remains a major cause of late non-relapse mortality, with no established approach for corticosteroid-refractory or corticosteroid-dependent cases. This prospective, open-label, multicenter phase 2 study enrolled 24 patients (median age 27 years) who received hydrogen-rich water orally at 4 ml/kg three times daily. Organ responses were evaluated every 3 months across skin, mouth, gastrointestinal tract, liver, eyes, lungs, and joints. An objective response was observed in 18 of 24 patients (75%; 95% CI: 55.1–88%). The estimated 4-year overall survival rate reached 74.7% (95% CI: 54.9–94.5%), and the response group demonstrated significantly superior 4-year survival compared with non-responders (86.6% vs. 0%; p=0.000132). No significant adverse effects were associated with long-term hydrogen-rich water administration. The trial was registered at ClinicalTrials.gov (NCT02918188).
Hydrogen's selective scavenging of reactive oxygen species and its anti-inflammatory properties are proposed to reduce immune-mediated tissue damage characteristic of cGVHD.
Hydrogen-rich water is a low-risk delivery route, but the achievable systemic hydrogen dose is bounded. For clinical applications, inhalation is the most efficient route; inhalation, however, carries explosion risk, and concentration matters (empirical LFL of 10% applies to inhalation environments; high-concentration devices are documented in the Consumer Affairs Agency accident database and are not recommended).
See also:
https://h2-papers.org/en/papers/33324415