Table 1.
Adverse effects in 50 patients
| Mild* | Moderate* | Severe* | |
|---|---|---|---|
| Local reactions | |||
| Erythema | 45 | 5 | 0 |
| Edema | 37 | 0 | 0 |
| Hard edema | 27 | 2 | 0 |
| Pruritus | 11 | 4 | 0 |
| Pain | 20 | 3 | 0 |
| Systemic reactions | |||
| Nausea | 25 | 3 | 0 |
| Vomiting | 14 | 1 | 0 |
| Diarrhea | 11 | 0 | 0 |
| Hypotension | 2 | 0 | 0 |
| Laboratory parameters† | |||
| Blood glucose change | 3 | 0 | 0 |
| AST | 16 | 3 | 0 |
| Creatinine | 6 | 1 | 0 |
AST = aspartate transaminase.
Number of patients with grade of adverse effect. Each local and systemic reaction other than pain was graded on a 0–3 scale defined as follows: 0 = absent, 1 = mild (present but treatment not required), 2 = moderate (present and needed specific treatment), and 3 = severe (present with such intensity that antileishmanial therapy had to be stopped). The 0–3 scale for pain was as follows: 0 = absent, 1 = mild (present but expected with injections, treatment not required), 2 = moderate (present and more than expected with injections, treatment not required), and 3 = severe (present with such intensity that analgesics were required).
Laboratory parameters were graded according to the common toxicity criteria scale.11 Of the three blood glucose abnormalities, two were first seen on day 14 and one on day 28. For AST, 14 were first seen on day 14 and 5 on day 28. For creatinine, four were first seen on day 14 and three on day 28. The mean (standard deviation) [range] for the laboratory abnormalities were as follows: glucose—104 (14) [88–114] mg/dL, AST—89 (33) [51–169] U/L, and creatinine—1.5 (2.0) [1.3–1.9] mg/dL. The upper limits of normal for our laboratory are as follows: glucose—100 mg/dL, AST—45 U/L, and creatinine—1.2 mg/dL.