肝性脳症の予防にリファキシミン

　リファキシミンrifaximinは、急性の肝性脳症で治療に用いられているが、予防効果がありそう、との報告です。

　リファキシミン550mgを１日２回投与（140名）と、プラセボ（159名）で６ヶ月間のランダム化二重盲検比較試験。第一のアウトカムは、初回の肝性脳症症状。リファキシミンが、肝性脳症のリスクを減少（ハザード比0.42; 95% confidence interval [CI], 0.28 to 0.64; P<0.001）。肝性脳症の発症は、リファキシミン投与群で22.1%、プラセボ群で45.9%。そのうち入院率は、リファキシミン投与群13.6%、プラセボ群で22.6%（ハザード比 0.50 (95% CI, 0.29 to 0.87; P=0.01)）。90%以上の患者が、ラクツロースの治療を行っていた。副作用は同等。

気づき）

　・リファキシミンはリファンピンの誘導体で，経口投与後の吸収は不良で，97％は糞便中に主として未変化で回収される

　・2010年4月5日付け「あすか製薬 非吸収性抗生物質リファキシミンの日本の開発・販売権取得」

　・これまではカナマイシンを適応外で処方していましたが、これからはリファキシミンでしょうか？

Rifaximin treatment in hepatic encephalopathy.

N Engl J Med. 2010 Mar 25;362(12):1071-81.

Background Hepatic encephalopathy is a chronically debilitating complication of hepatic cirrhosis. The efficacy of rifaximin, a minimally absorbed antibiotic, is well documented in the treatment of acute hepatic encephalopathy, but its efficacy for prevention of the disease has not been established.

Methods In this randomized, double-blind, placebo-controlled trial, we randomly assigned 299 patients who were in remission from recurrent hepatic encephalopathy resulting from chronic liver disease to receive either rifaximin, at a dose of 550 mg twice daily (140 patients), or placebo (159 patients) for 6 months. The primary efficacy end point was the time to the first breakthrough episode of hepatic encephalopathy. The key secondary end point was the time to the first hospitalization involving hepatic encephalopathy.

Results Rifaximin significantly reduced the risk of an episode of hepatic encephalopathy, as compared with placebo, over a 6-month period (hazard ratio with rifaximin, 0.42; 95% confidence interval [CI], 0.28 to 0.64; P<0.001). A breakthrough episode of hepatic encephalopathy occurred in 22.1% of patients in the rifaximin group, as compared with 45.9% of patients in the placebo group. A total of 13.6% of the patients in the rifaximin group had a hospitalization involving hepatic encephalopathy, as compared with 22.6% of patients in the placebo group, for a hazard ratio of 0.50 (95% CI, 0.29 to 0.87; P=0.01). More than 90% of patients received concomitant lactulose therapy. The incidence of adverse events reported during the study was similar in the two groups, as was the incidence of serious adverse events.

Conclusions Over a 6-month period, treatment with rifaximin maintained remission from hepatic encephalopathy more effectively than did placebo. Rifaximin treatment also significantly reduced the risk of hospitalization involving hepatic encephalopathy.

これから）長期実務実習第一期終了後のアンケート作成、MR面接、職員面接１名、職場会議、佐伯晴子氏（東京ＳＰ会代表）「患者の視点で考える医療コミュニケーション」講演会、朝から猛暑なので3kmランニング、脱水注意ですな。