利福昔明
医学
肝性脑病
内科学
胃肠病学
脑病
高氨血症
随机对照试验
不利影响
临床研究阶段
临床试验
外科
肝硬化
抗生素
化学
生物化学
作者
Kazuyuki Suzuki,Ryujin Endo,Yasuhiro Takikawa,Fuminori Moriyasu,Yoshinobu Aoyagi,Hisataka Moriwaki,Shuji Terai,Isao Sakaida,Yoshiyuki Sakai,Shuhei Nishiguchi,Toru Ishikawa,Hitoshi Takagi,Atsushi Naganuma,Takuya Genda,Takafumi Ichida,Koichi Takaguchi,Kazuhiro Miyazawa,Kiwamu Okita
摘要
Aim The efficacy and safety of rifaximin in the treatment of hepatic encephalopathy (HE) are widely known, but they have not been confirmed in Japanese patients with HE. Thus, two prospective, randomized studies (a phase II/III study and a phase III study) were carried out. Methods Subjects with grade I or II HE and hyperammonemia were enrolled. The phase II/III study, which was a randomized, evaluator‐blinded, active‐comparator, parallel‐group study, was undertaken at 37 institutions in Japan. Treatment periods were 14 days. Eligible patients were randomized to the rifaximin group (1200 mg/day) or the lactitol group (18–36 g/day). The phase III study was carried out in the same patients previously enrolled in the phase II/III study, and they were all treated with rifaximin (1200 mg/day) for 10 weeks. Results In the phase II/III study, 172 patients were enrolled. Blood ammonia (B‐NH 3 ) concentration was significantly improved in the rifaximin group, but the difference between the two groups was not significant. The portal systemic encephalopathy index (PSE index), including HE grade, was significantly improved in both groups. In the phase III study, 87.3% of enrolled patients completed the treatment. The improved B‐NH 3 concentration and PSE index were well maintained from the phase II/III study during the treatment period of the phase III study. Adverse drug reactions (ADRs) were seen in 13.4% of patients who received rifaximin, but there were no severe ADRs leading to death. Conclusion The efficacy of rifaximin is sufficient and treatment is well tolerated in Japanese patients with HE and hyperammonemia.
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