TABLE 2.
Study design characteristics and outcomes of 13 prospective studies included in the analysis.
| Author (year)Country | Study design/patient numberAge Sex (male %) | Intervention | Mortality, OLT (N, %) | Hepatotoxicity (N/Tot) | AEs (N, %) |
|---|---|---|---|---|---|
| Smilkstein et al. (1988) | Multicenter study involving 2540 patients | NAC oral | 28/2540 (1, 1%) | 611/2540 (24%) | NR |
| Colorado, United States | 10–30 years | ||||
| Male 30% | 140 → 70 mg/kg 10–24 h | ||||
| Rigges et al. (1989) | Prospective study of 60 patients | NAC oral | 1/60 (1.6%) | 24/60 (49%) | NR |
| Colorado, United States | Adults (>18 years) | ||||
| Female 100% pregnant | 140 mg/kg→ 70 mg/kg 72 h | ||||
| Smilkstein et al. (1991) | Non-RCT of 179 patients | NAC I.V. | 2/179 (1.11%) | 39/179 (21%) | 32 (17%) AEs (erythema, urticaria) |
| Colorado, United States | Adult (>18 years) | ||||
| Children <5–10 years | 48 h:140 mg/kg→ 70 mg/kg | ||||
| Male 33% | |||||
| Perry and Shannon, (1998) | Prospective with historical controls | NAC I.V. vs. oral | 0 | 6/54 (11%) | 2 (7%) NAC I.V. |
| Massachusetts, United States | 54 patients | 25 with NAC I.V. | 2 (6%) oral | ||
| Pediatric (<18 years) | 29 with NAC oral (controls) | (rash, urticaria, fever, anaphylaxis) | |||
| Female 90% | 28 (vomiting) | ||||
| Schmidt et al. (2002) | Prospective study of 645 patients | NAC I.V. | 51/645 (7.9%) | 28/645 (4.3%) | NR |
| Denmark | 12–86 years | ||||
| Male 44% | 150 mg/kg→ 50 mg/kg > 100 mg/kg (<12, 24, 48 h) | ||||
| Betten (2007) | Prospective observational, 205 patients | NAC oral <48 h | 0 | 0 | 8 (4%) AEs, abdominal pain and vomiting |
| United States | 1–81 years | ||||
| Male 33% | |||||
| Waring et al. (2008) | Prospective, 362 patients | NAC I.V. | 0 | 194/362 (53%) | 147 (40, 6%) with 54 (14.9%) anaphylactic reactions |
| Adults (>18 years, mean age 35 years) | |||||
| United Kingdom | Male 34% | 150 mg/kg→ 50 mg/kg > 100 mg/kg | |||
| Doyon and Klein-Schwartz (2009) | Prospective, cohort, 77 patients | NAC I.V. | 2/77 (2.5%) | 4/77 (5%) | NR |
| 13–75 years | |||||
| Male 33% | |||||
| United States | |||||
| Horowitz et al. (1997) | Case series involving 4 patients | NAC oral and I.V. | 0 | 2/4 (50%) | NR |
| Colorado, United States | Adult (>18 years) | ||||
| Female 100% pregnant | |||||
| Heard et al. (2014) | Multicenter, single-arm, open-label clinical trial of 309 young patients and children (mean age 21 years) | NAC I.V. | 1/309 (0.3%) | (56/309) 18% | 28, 8% |
| United States | Male 33% | 140 mg/kg→ 70 mg/kg | Overall | Nausea, vomiting, flushing | |
| Every 4 h for 12 doses | 3.4% patients treated within 10 h | ||||
| Gheshlaghi (2006) | Case series and descriptive analytic study of 173 patients | NAC I.V. | 0 | - | 44, 5% anaphylactoid reaction, 63% nausea and vomiting, 30% flashing, 26% bronchospasm, 23% vertigo, 32% skin rash |
| Iran | 15–30 years | ||||
| Male 40% | 150 mg/kg→ 50 mg/kg→100 mg/kg | ||||
| Larson et al. (2005) | Prospective study | NAC | 74 (26%) died without OLT | 250 (91%) | NR |
| Pennsylvania, United States | Involving 275 patients | In 231 patients | 18 (6%) lived with OLT | ||
| Adult (>18 years) | 5 (2%) died with OLT | ||||
| Male 36% | |||||
| Rumack (1984) | Multicenter, open, prospective study of 417 patients | NAC os | 0 | 3/417 (0, 71%) | NR |
| Colorado, United States | Pediatric | 140 mg/kg--> 70 mg/kg | |||
| Less than 5 years | Every 4 h for 17 doses |