CIOMS/RUCAM scale
The CIOMS/RUCAM scale is a tool to predict whether liver damage can be attributed to a particular medication.
Hepatotoxicity
Determining hepatotoxicity (toxic effects of a substance on the liver) remains a major challenge in clinical practice due to lack of reliable markers.[1] Many other conditions lead to similar clinical as well as pathological picture. To diagnose hepatotoxicity, a causal relationship between the use of the toxin or drug and subsequent liver damage has to be established, but might be difficult, especially when idiosyncratic reaction is suspected.[2] Simultaneous use of multiple drugs may add to the complexity. As in acetaminophen toxicity, well established dose dependent pharmacological hepatotoxicity is easier to spot.
Interpretation
The CIOMS/RUCAM scale has been proposed to establish causal relationship between offending drug and liver damage. The CIOMS/RUCAM scale involves a scoring system which categorizes the suspicion into "definite or highly probable" (score > 8), "probable" (score 6-8), "possible" (score 3-5), "unlikely" (score 1-2) and "excluded" (score ≤ 0). In clinical practice physicians put more emphasis on the presence or absence of similarity between the biochemical profile of the patient and known biochemical profile of the suspected toxicity ( e.g. cholestatic damage in amoxycillin-clauvonic acid ).[1]
Elements of the scale
| Type of liver injury | Hepatocellular | Cholestatic/mixed | Points | ||
|---|---|---|---|---|---|
| Time of onset of the event | first exposure | second exposure | first exposure | second exposure | — |
| Time from drug intake until reaction onset |
5 to 90 days | 1 to 15 days | 5 to 90 days | 1 to 90 days | +2 |
| <5 or >90 days | >15 days | <5 or >90 days | >90 days | +1 | |
| Time from drug withdrawal until reaction onset |
≤15 days | ≤15 days | ≤30 days | ≤30 days | +1 |
| Risk factors | Alcohol | Alcohol or pregnancy | +1 | ||
| Age ≥ 55 years | Age ≥ 55 years | +1 | |||
| Course of the reaction | >50% improvement 8 days | — | +3 | ||
| >50% improvement 30 days | >50% improvement 180 days | +2 | |||
| — | <50% improvement 180 days | +1 | |||
| Lack of information or no improvement | Lack of information or no improvement | +0 | |||
| Worsening or <50% improvement 30 days |
— | -1 | |||
- Concomitant therapy:
- Time to onset incompatible: +0
- Time to onset compatible but with unknown reaction: -1
- Time to onset compatible but known reaction: -2
- Role proved in this case: -3
- None or information not available: +0
- Exclusion of nondrug-related causes:
- Rule out: +2
- “Possible” to “not investigated”: -2 to +1
- Probable: -3
- Previous information on hepatotoxicity:
- Reaction unknown: +0
- Reaction published but unlabeled: +1
- Reaction labeled in the product's characteristics: +2
- Response to re-administration:
- Positive: +3
- Compatible: +1
- Negative: -2
- Not available or not interpretable: +0
- or plasma concentration of drug known as toxic: +3
- or validated laboratory test with high specificity, sensitivity, and predictive values:
- Positive: +3
- Negative: -3
- Not interpretable or not available: +0
Score analysis
Points are summed and the total compared to this chart:
- 0 or lower: relationship with the drug excluded
- 1-2: unlikely
- 3-5: possible
- 6-8: probable
- >8: highly probable
If the results are incompatible with a connection, then the case is considered "unrelated". In some cases, insufficient information is available; these cases are recorded as "insufficiently documented".
See also
References
- ↑ 1.0 1.1 Andrade RJ, Robles M, Fernández-Castañer A, López-Ortega S, López-Vega MC, Lucena MI (2007). "Assessment of drug-induced hepatotoxicity in clinical practice: a challenge for gastroenterologists". World J. Gastroenterol. 13 (3): 329–40. PMID 17230599.
- ↑ Arundel C, Lewis JH (2007). "Drug-induced liver disease in 2006". Curr. Opin. Gastroenterol. 23 (3): 244–54. doi:10.1097/MOG.0b013e3280b17dfb. PMID 17414839.