Table 2. Baseline biological markers.
AmBisome + SSG | AmBisome + miltefosine | Miltefosine | ||
---|---|---|---|---|
N = 51 | N = 49 | N = 51 | ||
Weight | mean (SD) | 35.2 (14.5) | 34.3 (13.4) | 36.7 (13.4) |
(kg) | median (range) | 31 (15–69) | 30 (15–59) | 31 (16–65) |
Temperature | mean (SD) | 37.5 (1.1) | 37.5 (1.1) | 37.6 (1.3) |
(°C) | median (range) | 37.3 (35.7–40) | 37.5 (36–40.1) | 37.6 (35.8–40.2) |
Heart Rate | mean (SD) | 100.9 (10.6) | 103 (13.7) | 99.1 (11.4) |
(beats/min) | median (range) | 100 (80–130) | 100 (68–130) | 100 (80–128) |
Spleen Size | mean (SD) | 8.5 (4.4) | 8.4 (5.6) | 8.2 (3.9) |
(cm) | median (range) | 8 (0–18) | 7 (0–22) | 8 (0–18) |
Liver Size*** | mean (SD) | 2.3 (2.4) | 2.5 (2.3) | 2.7 (2.4) |
(cm) | median (range) | 2 (0–10) | 2 (0–8) | 2 (0–10) |
Systolic BP | mean (SD) | 100.9 (10.4) | 95.7 (9.5) | 99.4 (7.7) |
(mm Hg) | median (range) | 100 (80–130) | 90 (80–120) | 100 (85–120) |
Diastolic BP | mean (SD) | 62.2 (7) | 61.2 (7.1) | 63 (7.3) |
(mm Hg) | median (range) | 60 (50–80) | 60 (50–80) | 60 (50–80) |
Nutritional Status n (%) | Severely underweight (BMI*< 15) | 5 (10)** | 9 (18)** | 8 (16)** |
Underweight (BMI 15–18.4) | 23 (45) | 18 (37) | 16 (31) | |
Normal (BMI 18.5–24.9) | 22 (43) | 22 (45) | 27 (53) | |
Obese/overweight (BMI > 24.9) | 1 (2) | 0 (0) | 0 (0) |
*BMI in kg/m2
**nutritional status categorization derived by post-hoc determination of WHO standardized value, as opposed to the BMI threshold in the severely underweight exclusion criterion.
*** Liver size was measured below right costal margin