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RECAM-J 2023-Validation and development of the Japanese version of RECAM for the diagnosis of drug-induced liver injury.
Tanaka, Atsushi; Tsuji, Keiji; Komiyama, Yasuyuki; Tsuruya, Kota; Kakisaka, Keisuke; Tsutsui, Akemi; Ichimoto, Keiko; Ueno, Masayuki; Okazaki, Yuki; Kamimura, Hiroteru; Takai, Atsushi; Yamashiki, Noriyo; Ito, Takanori; Watanabe, Masaaki; Abe, Masanori; Harada, Ken-Ichi; Kagawa, Tatehiro.
Afiliación
  • Tanaka A; Department of Medicine, Teikyo University School of Medicine, Tokyo, Japan.
  • Tsuji K; Department of Gastroenterology, Hiroshima Red Cross Hospital and Atomic-Bomb Survivors Hospital, Hiroshima, Japan.
  • Komiyama Y; Gastroenterology and Hepatology, Department of Internal Medicine, Faculty of Medicine, University of Yamanashi, Yamanashi, Japan.
  • Tsuruya K; Division of Gastroenterology and Hepatology, Department of Internal Medicine, Tokai University School of Medicine, Kanagawa, Japan.
  • Kakisaka K; Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, Iwate Medical University, Iwate, Japan.
  • Tsutsui A; Department of Hepatology, Kagawa Prefectural Central Hospital, Kagawa, Japan.
  • Ichimoto K; Department of Metabolism, Chiba Children's Hospital, Chiba, Japan.
  • Ueno M; Department of Gastroenterology and Hepatology, Kurashiki Central Hospital, Okayama, Japan.
  • Okazaki Y; Department of Gastroenterology and Hepatology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
  • Kamimura H; Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, Ehime, Japan.
  • Takai A; Division of Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences, Niigata University, Niigata, Japan.
  • Yamashiki N; Department of Gastroenterology and Hepatology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
  • Ito T; Department of Gastroenterology and Hepatology, Kansai Medical University Medical Center, Osaka, Japan.
  • Watanabe M; Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
  • Abe M; Department of Gastroenterology, Tosenen Kitamoto Hospital, Saitama, Japan.
  • Harada KI; Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, Ehime, Japan.
  • Kagawa T; Department of Human Pathology, Kanazawa University Graduate School of Medicine, Kanazawa, Japan.
Hepatol Res ; 54(6): 503-512, 2024 Jun.
Article en En | MEDLINE | ID: mdl-38642343
ABSTRACT

AIM:

The diagnosis of drug-induced liver injury (DILI) is challenging. We modified the revised electronic version of the Roussel Uclaf Causality Assessment Method (RUCAM) for the diagnosis of DILI (RECAM), the scoring system developed in US and Spanish cohorts in 2022, and developed RECAM-J 2023 to align with the clinical practice in Japan. In the current study, we introduce RECAM-J 2023 and verify its performance in the context of Japanese patients with DILI.

METHODS:

After translation of RECAM into Japanese, modifications were made to develop RECAM-J 2023 without any alteration to the scores. To examine the validity and performance of RECAM-J 2023, clinical information on DILI and non-DILI cases in Japan were retrospectively collected. The diagnosis of DILI was made by expert's decision. Then we scored each case using RECAM-J 2023, and calculated area under curve (AUC) values for identification for DILI.

RESULTS:

We collected data from 538 DILI and 128 non-DILI cases. The sum of highly probable (HP) and probable (PR) cases categorized by RECAM-J 2023 were only 206 (38%) in DILI cases. As the primary cause of low scores was the deduction with missing hepatitis virus markers, which is unlikely to be an issue in prospective applications, we rescored without these deductions. At this time, the sum of HP and PR was raised to 421 (78%). The AUCs of RECAM-J 2023 without deductions were 0.70 and 0.88 for identifying at least HP, and at least PR, respectively.

CONCLUSION:

RECAM-J 2023, when prospectively used without any missing hepatitis virus markers, provides acceptable performance for identifying at least PR DILI cases in Japanese daily clinical practice.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Hepatol Res Año: 2024 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Países Bajos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Hepatol Res Año: 2024 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Países Bajos