臨牀消化器内科 Vol.23 No.13(3-1)


特集名 急性肝不全と再生医療
題名 肝不全と再生医療 (1) 劇症肝炎症例への組換えヒト肝細胞増殖因子の投与
発刊年月 2008年 12月
著者 森内 昭博 鹿児島大学大学院医歯学総合研究科消化器疾患・生活習慣病学
著者 井戸 章雄 鹿児島大学大学院医歯学総合研究科消化器疾患・生活習慣病学
著者 坪内 博仁 鹿児島大学大学院医歯学総合研究科消化器疾患・生活習慣病学
【 要旨 】 劇症肝炎患者血漿から単離・生成された肝細胞増殖因子(hepatocyte growth factor;HGF)には多彩な生理作用があり,劇症肝炎をはじめとする難治性疾患の新規治療薬として期待されてきた.2002年に京都大学医学部附属病院探索医療センターに「HGF肝再生プロジェクト」として採択され,2005年から医師主導治験を実施した.劇症肝炎亜急性型および遅発性肝不全の4例に組換えヒトHGFを投与し2例が生存したが,被験者リクルートに難渋し4例で治験を終了したため臨床効果について結論を出すことはできなかった.一方,重篤な副作用が認められなかったことは,組換えヒトHGFの実用化へ向けた大きな一歩と考えられ,今後の臨床開発が加速されることが期待される.
Theme Acute Liver Failure and Regenerative Medicine of the Liver
Title Recombinant Human HGF for Treatment of Fulminant Hepatic Failure
Author Akihiro Moriuchi Department of Digestive and Life-style Related Disease, Kagoshima University Graduate School of Medical and Dental Sciences
Author Akio Ido Department of Digestive and Life-style Related Disease, Kagoshima University Graduate School of Medical and Dental Sciences
Author Hirohito Tsubouchi Department of Digestive and Life-style Related Disease, Kagoshima University Graduate School of Medical and Dental Sciences
[ Summary ] Hepatocyte growth factor (HGF) is apotential therapeutic agent for treating intractable liver diseases including fulminant hepaticfailure (FHF). In 2005, after performing a number of preclinical tests with recombinant human HGF (rh-HGF), we started a phase I/II study of patients with FHF or late-onset hepatic failure (LOHF) to examine the safety and clinical efficacy of rh-HGF. To date, we have administered rh-HGF to three patients with FHF and one with LOHF; two of the four patients recovered. The data from our clinical trial that examined the effects of rh-HGF in patients with FHF or LOHF were reviewed by an independent data monitoring committee. Because only four patients were investigated, it is difficult to confirm any effects of rh-HGF with certainty. However, rh-HGF, as administered here, did not produce any severe side effects, although a decrease in systolic blood pressure and reversible albuminuria occurred in the preclinical tests. We hope that these results will help hasten the future use of rh-HGF for patients with intractable liver diseases.
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