Score results of the present case according to the updated RUCAM for hepatocellular injury
| Items for hepatocellular injury score result | Score | Results |
|---|---|---|
| 1. Time to onset from the beginning of the drug/herb | ||
| • 5–90 days (rechallenge: 1–15 days) | +2 | +2 |
| • < 5 or > 90 days (rechallenge: > 15 days) | +1 | |
| Alternative: time to onset from cessation of the drug/herb | ||
| • 15 days (except for slowly metabolized chemicals: > 15 days) | +1 | |
| 2. Course of ALT after cessation of the drug/herb. % difference between ALT peak & N | ||
| • Decrease ≥50% within 8 days | +3 | +3 |
| • Decrease ≥50% within 30 days | +2 | |
| • No information or continued drug use | 0 | |
| • Decrease ≥50% after the 30th day | 0 | |
| • Decrease < 50% after the 30th day or recurrent increase | −2 | |
| 3. Risk factors | ||
| • Alcohol use (current drinks/d: > 2 for women, > 3 for men) | +1 | |
| • Alcohol use (current drinks/d: ≤2 for women, ≤3 for men) | 0 | |
| • Age ≥55 years | +1 | +1 |
| • Age < 55 years | 0 | |
| 4. Concomitant drug(s)/herb(s) | ||
| • None or no information | 0 | 0 |
| • Concomitant drug/herb with incompatible time to onset | 0 | |
| • Concomitant drug/herb with compatible or suggestive time to onset | −1 | |
| • Concomitant drug/herb known as hepatotoxin and with compatible or suggestive time to onset | −2 | |
| • Concomitant drug/herb with evidence for its role in this case (positive rechallenge or validated test) | −3 | |
| 5. Search for alternative causes | ||
| Group I (7 causes) | ||
| • HAV: Anti-HAV-IgM | ||
| • Hepatobiliary sonography/colour Doppler | ||
| • HCV: Anti-HCV, HCV-RNA | ||
| • HEV: Anti-HEV-IgM, anti-HEV-IgG, HEV-RNA | ||
| • Hepatobiliary sonography/colour Doppler sonography of liver vessels/endosonography/CT/MRC | ||
| • Alcoholism (AST/ALT ≥2) | ||
| • Acute recent hypotension history (particularly if underlying heart disease) | ||
| Group II (5 causes) | ||
| • Complications of underlying disease(s) such as sepsis, metastatic malignancy, autoimmune hepatitis, chronic hepatitis B or C, PBC or PSC, genetic liver diseases (-) | ||
| • Infection suggested by PCR and titer change for | ||
| • CMV (anti-CMV-IgM, anti-CMV-IgG) | ||
| • EBV (anti-EBV-IgM, anti-EBV-IgG) | ||
| • HSV (anti-HSV-IgM, anti-HSV-IgG) | ||
| • VZV (anti-VZV-IgM, anti-VZV-IgG) | ||
| Evaluation of groups I and II | ||
| • All causes-groups I and II—reasonably ruled out | +2 | |
| • The 7 causes of group I ruled out | +1 | +1 |
| • 6 or 5 causes of group I ruled out | 0 | |
| • Less than 5 causes of group I ruled out | −2 | |
| • Alternative cause highly probable | −3 | |
| 6. Previous hepatotoxicity of the drug/herb | ||
| • Reaction labelled in the product characteristics | +2 | |
| • Reaction published but unlabelled | +1 | +1 |
| • Reaction unknown | 0 | |
| 7. Response to unintentional reexposure | ||
| • Doubling ALT with the drug/herb alone, provided ALT below 5N before reexposure | +3 | |
| • Doubling of ALT with the drug(s)/herb(s) already given at the time of first reaction | +1 | |
| • Increase of ALT but less than N in the same conditions as for the first administration | −2 | |
| • Other situations | 0 | 0 |
| Total score for the case | +8 |
Individual items related to the case and corresponding results are shown in bold font; CMV: cytomegalovirus; EBV: Epstein-Barr virus; HAV: hepatitis A virus; HCV: hepatitis C virus; HEV: hepatitis E virus; HSV: herpes simplex virus; IgG: immunoglobulin G; IgM: immunoglobulin M; MRC: magnetic resonance cholangiography; N: upper limit of the normal range; PBC: primary biliary cholangitis; PCR: polymerase chain reaction; PSC: primary sclerosing cholangitis; VZV: varicella zoster virus
