Ishibashi Toru, Sato Bunpei, Shibata Shinji, Sakai Takaaki, Hara Yuichi, Naritomi Yuji, Koyanagi Samon, Hara Hiroshi, Nagao Tetsuhiko
Haradoi Hospital, Department of Rheumatology and Orthopaedic Surgery, 6-40-8 Aoba, Higashi-ku, Fukuoka 813-8588, Japan.
MiZ Company, 16-5 Zengyo 1-chome, Fujisawa, Kanagawa 251-0871, Japan.
Int Immunopharmacol. 2014 Aug;21(2):468-73. doi: 10.1016/j.intimp.2014.06.001. Epub 2014 Jun 11.
The aim of this study was to demonstrate the safety and efficacy of H2-saline infusion for treatment of rheumatoid arthritis (RA). We conducted a randomized, double-blind, placebo-controlled investigation of the infusion of 1 ppm H2-dissolved saline (H2-saline) in 24 RA patients. Patients were randomized 1:1 to receive 500 ml of either H2-saline or placebo-saline, which was drop infused intravenously (DIV) daily for 5 days. The disease activity score in 28 joints (DAS28) was measured at baseline, immediately post infusion, and after 4 weeks. Therapeutic effects of H2-saline on joint inflammation were estimated by measuring serum biomarkers for RA, tumor necrosis factor-α (TNFα), interleukin-6 (IL-6), matrix metalloproteinase-3 (MMP-3), and urinary 8-hydroxydeoxyguanosine (8-OHdG). In the H2-infused group, average DAS28 decreased from 5.18 ± 1.16 to 4.02 ± 1.25 immediately post infusion and reached 3.74 ± 1.22 after 4 weeks. No significant decrease in DAS28 was observed in the placebo group throughout the study. IL-6 levels in the H2 group significantly decreased in 4 weeks by 37.3 ± 62.0% compared to baseline, whereas it increased by 33.6 ± 34.4% in the placebo group. TNFα levels did not change remarkably in the H2 or placebo groups in 4 weeks post-infusion compared to baseline. The relative ratio of 8-OHdG in the H2 group also significantly decreased by 4.7%. After 4 weeks, MMP3 was significantly reduced by 19.2% ± 24.6% in the H2 group, and increased by 16.9% ± 50.2% in the placebo group. Drop infusion of H2 safely and effectively reduced RA disease activity.
本研究的目的是证明氢生理盐水输注治疗类风湿性关节炎（RA）的安全性和有效性。我们对24例RA患者进行了一项随机、双盲、安慰剂对照研究，输注1 ppm氢溶解生理盐水（氢生理盐水）。患者按1:1随机分组，接受500 ml氢生理盐水或安慰剂生理盐水，每天静脉滴注（DIV）5天。在基线、输注后即刻和4周后测量28个关节的疾病活动评分（DAS28）。通过测量RA的血清生物标志物、肿瘤坏死因子-α（TNFα）、白细胞介素-6（IL-6）、基质金属蛋白酶-3（MMP-3）和尿8-羟基脱氧鸟苷（8-OHdG）来评估氢生理盐水对关节炎症的治疗效果。在氢输注组中，输注后即刻平均DAS28从5.18±1.16降至4.02±1.25，4周后降至3.74±1.22。在整个研究过程中，安慰剂组的DAS28没有显著下降。与基线相比，氢组的IL-6水平在4周内显著下降了37.3±62.0%，而安慰剂组则上升了33.6±34.4%。与基线相比，输注后4周氢组或安慰剂组的TNFα水平没有明显变化。氢组中8-OHdG的相对比例也显著下降了4.7%。4周后，氢组中MMP3显著降低了19.2%±24.6%，安慰剂组则增加了16.9%±50.2%。氢的静脉滴注安全有效地降低了RA疾病活动度。
