TABLE 3.
Possible ADRs due to antibiotic use between treatment arms
| Group or ADR | No. (%) of patients in the following polymyxin treatment arm: |
P value | ||
|---|---|---|---|---|
| MT (n = 58) | NVCT (n = 203) | VCT (n = 30) | ||
| All patients with an ADR | 18 (31.0) | 89 (43.8) | 12 (40.0) | 0.215 |
| Patients in which the ADR resolveda | 14 (77.8) | 63 (70.8) | 10 (83.3) | 0.545 |
| Nephrotoxicity based on RIFLE criteria | 16 (27.6) | 74 (36.5) | 8 (26.7) | 0.313 |
| Risk of renal dysfunction | 8 (13.8) | 20 (9.9) | 4 (13.3) | 0.637 |
| Injury to the kidney | 5 (8.6) | 31 (15.3) | 0 (0.0) | 0.038 |
| Failure of kidney function | 3 (5.2) | 22 (10.8) | 3 (10.0) | 0.434 |
| Loss of kidney function | 0 (0.0) | 0 (0.0) | 1 (3.3) | 0.013 |
| End-stage kidney disease | 0 (0.0) | 1 (0.5) | 0 (0.0) | 0.805 |
| Nephrotoxicity not included in the RIFLE criteriab | 0 (0.0) | 4 (2.0) | 1 (3.3) | 0.460 |
| Total incidence of nephrotoxicityc | 16 (27.6) | 78 (38.4) | 9 (30.0) | 0.254 |
| Neurotoxicity | 1 (1.7) | 10 (4.9) | 1 (3.3) | 0.543 |
| Hepatotoxicity | 2 (3.4) | 8 (3.9) | 0 (0.0) | 0.542 |
| Othersd | 2 (3.4) | 13 (6.4) | 3 (10.0) | 0.468 |
The percentages in parentheses refer to the percentage of patients who experienced a resolution of the adverse drug reactions among all patients who experienced adverse drug reactions.
These patients experienced electrolyte imbalances due to nephropathy without a concomitant rise in the serum creatinine level of ≥1.5 times the baseline level (a requisite for the least severe grade of nephrotoxicity under the RIFLE criteria).
Includes incidences of nephrotoxicity classified under the RIFLE criteria and those that do not meet its requirements.
Others included hyperpigmentation (n = 2), drug-related exanthem (n = 5), drug-related fever (n = 1), bronchospasm (n = 1), phlebitis (n = 1), nausea and vomiting (n = 3), diarrhea (n = 3), abdominal pain (n = 1), thrombocytopenia (n = 1), leukopenia (n = 1), and pancytopenia (n = 1).