Introduction
Patients and methods
Study site and patient selection
Study and laboratory procedures
Drug regimens
Study outcomes
Assessment of adverse events
Data management and analysis
Results
Clinical and laboratory findings
Pre-treatment | Treatment Groups | |
---|---|---|
Total number recruited: 130 | ANQ | CQ + SP |
Numbers analyzed | 51 | 49 |
Male/female | 27/24 | 25/24 |
Age: median (range) | 27.5 (14–60) | 23.0 (14–60) |
Weight (Kg): median (range) | 60 (43.3–98) | 56.6 (42–79) |
Axillary temperature (°C) | 38.2 ± 1.2 | 38.2 ± 1.3 |
Mean parasitaemia* ± sd | 22228.1 ± 34567.2 | 19761.9 ± 36888.5 |
Laboratory parameters | Treatments | D0 | D3 | D7 | D14 | 21 | 28 |
---|---|---|---|---|---|---|---|
Biochemistry
| |||||||
Glucose
mm/L
| ANQ | 4.9 ± 0.9 | 5.5 ± 1.5 | 4.8 ± 0.8 | 4.5 ± 0.8 | 4.5 ± 0.5 | 5.0 ± 1.6 |
CQ+SP | 5.0 ± 1.0 | 5.5 ± 1.5 | 4.9 ± 0.8 | 4.5 ± 0.8 | 4.6 ± 0.5 | 5.2 ± 1.6 | |
Liver function
| |||||||
*AST
Units/L
| ANQ | 43.2 ± 16.4 | 43.7 ± 22.6 | 41.6 ± 32.1 | 35.7 ± 17.9 | 31.0 ± 10.4 | 33.4 ± 10.2 |
CQ+SP | 44.2 ± 16.4 | 43.2 ± 16.4 | 42.2 ± 32.1 | 35.2 ± 17.9 | 31.0 ± 10.4 | 35.4 ± 10.2 | |
**ALT
Units/L
| ANQ | 44.1 ± 20.9 | 47.9 ± 24.9 | 53.0 ± 49.2 | 57.3 ± 33.7 | 36.4 ± 14.8 | 36.3 ± 21.4 |
CQ+SP | 46.1 ± 20.9 | 47.9 ± 24.9 | 54.0 ± 49.2 | 57.3 ± 34.0 | 36.4 ± 14.9 | 35.3 ± 21.4 | |
Bilirubin
μm/L
| ANQ | 19.4 ± 14.3 | 12.1 ± 8.8 | 10.7 ± 5.0 | 8.3 ± 1.5 | 8.8 ± 1.3 | 8.8 ± 1.9 |
CQ+SP | 18.4 ± 14.3 | 12.1 ± 8.8 | 10.6 ± 5.0 | 8.3 ± 1.5 | 8.0 ± 1.3 | 8.8 ± 2.0 | |
Alkaline phosphatase
Units/L
| ANQ | 75.9 ± 18.6 | 81.8 ± 24.7 | 87.5 ± 27.5 | 91.3 ± 29.5 | 80.5 ± 24.3 | 95.1 ± 38.1 |
CQ+SP | 76.4 ± 20.2 | 83.4 ± 23.1 | 86.1 ± 25.2 | 91.8 ± 28.4 | 77.6 ± 21.5 | 84.0 ± 39.0 | |
#GGT
Units/L
| ANQ | 39.5 ± 22.7 | 40.3 ± 24.8 | 34.7 ± 22.3 | 29.5 ± 13.5 | 16.8 ± 11.9 | 22.5 ± 7.4 |
CQ+SP | 40.5 ± 22.7 | 40.3 ± 24.8 | 34.7 ± 22.3 | 29.5 ± 13.5 | 16.3 ± 12.9 | 22.5 ± 7.5 | |
Renal function
| |||||||
Creatinine
μm/L
| ANQ | 92.7 ± 19.4 | 91.8 ± 14.2 | 91.9 ± 18.1 | 87.9 ± 13.7 | 85.9 ± 10.9 | 79.3 ± 17.5 |
CQ+SP | 93.3 ± 19.3 | 92.8 ± 14.4 | 93.5 ± 19.1 | 88.9 ± 14.0 | 85.3 ± 11.5 | 80.4 ± 18.4 | |
Haematology
| |||||||
Haemoglobin
g/dl
| ANQ | 10.8 ± 2.3 | 10.6 ± 1.8 | 10.4 ± 1.2 | 10.7 ± 1.0 | 11.1 ± 1.7 | 11.6 ± 1.4 |
CQ+SP | 11.0 ± 2.3 | 10.7 ± 1.9 | 10.5 ± 1.3 | 11.0 ± 0.9 | 11.1 ± 1.6 | 11.6 ± 1.5 | |
WBC ×10
9
/L | ANQ | 5.2 ± 2.4 | 5.4 ± 1.7 | 5.5 ± 1.7 | 6.5 ± 2.5 | 6.6 ± 1.6 | 6.1 ± 1.7 |
CQ+SP | 5.4 ± 2.3 | 5.4 ± 1.6 | 5.8 ± 1.6 | 6.5 ± 2.3 | 6.6 ± 1.7 | 6.2 ± 1.8 | |
Electrolytes
| |||||||
Sodium
mm/L
| ANQ | 134.9 ± 5.6 | 138.2 ± 3.4 | 135.6 ± 7.6 | 137.2 ± 2.6 | 136.5 ± 3.1 | 139.6 ± 5.4 |
CQ+SP | 135.9 ± 5.5 | 138.3 ± 3.3 | 136.1 ± 7.1 | 137.2 ± 2.4 | 136.4 ± 2.9 | 140.0 ± 5.5 | |
Potassium
mm/L
| ANQ | 3.8 ± 0.7 | 4.1 ± 1.1 | 4.2 ± 0.8 | 4.1 ± 0.7 | 3.9 ± 0.3 | 4.0 ± 0.7 |
CQ+SP | 3.8 ± 0.7 | 4.1 ± 0.7 | 4.2 ± 0.7 | 4.0 ± 0.7 | 4.0 ± 0.7 | 4.1 ± 1.0 |