TABLE 3.
Study design characteristics and outcomes of three clinical trials included in the analysis.
| Author (Year)Country | Study design/patient number Age Sex (male %) | Intervention | Mortality, OLT (N, %) | Hepatotoxicity (N/Tot) | AEs (N, %) |
|---|---|---|---|---|---|
| Keays et al. (1991) | Prospective RCT involving 50 patients: 25 NAC vs. 25 control | NAC I.V. 150 mg/kg →50 mg/kg + intensive care | 13/25 NAC (52%) | - | 0 |
| London | Adult (>18 years) | Control group dextrose 5% + intensive care | 20/25 control group (80%) | ||
| Male 48% | |||||
| Bateman et al. (2014) | Double-blind, randomized study involving 222 patients | NAC I.V. | 0 | 13/101 | Vomiting: 71/109 |
| United Kingdom | 110 standard | Standard: 150 mg/kg→ 50 mg/kg→100 mg/kg (20–25 h) | Standard vs. | Standard vs. 39/108 shorter | |
| 112 shorter | Shorter: 100 mg/kg → 200 mg/kg (12 h) | 9/100 shorter | 45/109 ondansetronVs. 65/108 placebo | ||
| Adult (>18 years) | With or without I.V. ondansetron pre-treatment or placebo | 16/100 ondansetron | |||
| Male 40% | vs. 6/100 placebo | Anaphylactoid reactions: 31 standard vs. 5 shorter | |||
| Morrison et al. (2019) | Randomized study involving 24 patients | 6: NAC alone | 0 | 2/6 (NAC alone) | Serious adverse events |
| United Kingdom | Adult (>18 years) | 6: NAC I.V. + calmangafodipir 2 mmol/kg | vs. | 2/6 (NAC alone) | |
| Male 45% | 6: NAC + calmangafodipir 5 mmol/kg | 0/18 (NAC + calmangafodipir) | vs. | ||
| 6: NAC + calmangafodipir 10 mmol/kg | 4/6 (NAC +calmangafodipir 2) vs. | ||||
| 2/6 (NAC + calmangafodipir 5) vs. | |||||
| 3/6 (NAC + calmangafodipir 10) |
NAC, N-acetylcysteine; AE, adverse events; LT, liver transplantation; I.V., intravenous; DILI, drug-induced liver injury; NR, not reported.