水素療法は、進行性非小細胞肺がん患者さんの腫瘍の進行を抑制し、薬物療法の有害事象を緩和するために使用することができます

Hydrogen therapy can be used to control tumor progression and alleviate the adverse events of medications in patients with advanced non-small cell lung cancer.

抄録

進行性非小細胞肺がんに対しては、化学療法、分子標的治療、免疫療法などが行われています。このような治療に伴う有害事象を緩和する臨床的に有効な方法が不足しています。そこで、肺の症状や薬物による有害事象を緩和するために、成人患者58名を対象とした臨床試験を実施した。薬物治療を拒否した20名の患者を、水素（H）単独群と対照群に等しく無作為に割り付けた。腫瘍遺伝子変異や薬剤感受性検査の結果、化学療法群、標的療法群、免疫療法群にそれぞれ10名、18名、10名が登録され、これらの療法に水素療法が併用された。患者は1日4〜5時間のH吸入を5ヶ月間受けるか、がんが再発した時点で中止した。試験開始前、5群の人口統計学（腫瘍変異遺伝子を除く）および肺症状（中程度の咳を除く）に有意差はなかった。治療開始後5ヶ月間、対照群の症状の有病率は徐々に増加したが、4つの治療群の症状の有病率は徐々に減少した。16 ヵ月の追跡調査後、対照群の無増悪生存期間は、H-only 群より短く、H＋化学療法群、H＋標的療法群、H＋免疫療法群より有意に短かかった。併用療法群では、ほとんどの薬物関連有害事象は徐々に減少し、あるいは消失した。H吸入は、進行した非小細胞肺がん患者の腫瘍の進行を抑制し、薬物による有害事象を緩和するために使用できることが、臨床で初めて発見されました。本研究は、2018年12月7日に済南大学福田癌病院倫理委員会の承認を受け（承認番号：Fuda20181207）、2019年1月28日に ClinicalTrials.gov に登録されました（識別番号：NCT03818347）。

Chemotherapy, targeted therapy, and immunotherapy are used against advanced non-small cell lung cancer. A clinically efficacious method for relieving the adverse events associated of such therapies is lacking. Fifty-eight adult patients were enrolled in our trial to relieve pulmonary symptoms or the adverse events of drugs. Twenty patients who refused drug treatment were assigned equally and randomly to a hydrogen (H)-only group and a control group. According to the results of tumor-gene mutations and drug-sensitivity tests, 10, 18, and 10 patients were enrolled into chemotherapy, targeted therapy, and immunotherapy groups in which these therapies were combined with H-therapy, respectively. Patients underwent H inhalation for 4-5 hours per day for 5 months or stopped when cancer recurrence. Before study initiation, the demographics (except for tumor-mutation genes) and pulmonary symptoms (except for moderate cough) of the five groups showed no significant difference. During the first 5 months of treatment, the prevalence of symptoms of the control group increased gradually, whereas that of the four treatment groups decreased gradually. After 16 months of follow-up, progression-free survival of the control group was lower than that of the H-only group, and significantly lower than that of H + chemotherapy, H + targeted therapy, and H + immunotherapy groups. In the combined-therapy groups, most drug-associated adverse events decreased gradually or even disappeared. H inhalation was first discovered in the clinic that can be used to control tumor progression and alleviate the adverse events of medications for patients with advanced non-small cell lung cancer. This study was approved by the Ethics Committee of Fuda Cancer Hospital of Jinan University on December 7, 2018 (approval No. Fuda20181207), and was registered at ClinicalTrials.gov (Identifier: NCT03818347) on January 28, 2019.