Table III.
Morbidity and mortality (no. [%] of patients) over the 9-month treatment period, by treatment group.
| Morbidity/Mortality | Pyrimethamine (n = 36) | Proguanil (n = 32) | Placebo (n = 29) | Chi-Square |
|---|---|---|---|---|
| Organ enlargement | ||||
| Hepatomegaly | 26 (72.2) | 23(71.9) | 20(69.0) | 1.1 |
| Splenomegaly | 6 (16.7)∗ | 15 (46.9)† | 16 (55.2) | 16.1 |
| SCD-related events | ||||
| Symptomatic malarial infection | 14 (38.9) | 5 (15.6) | 9 (31.0) | 3.8 |
| Bone pain crisis | 2 (5.6) | 0 (0.0) | 5 (17.2) | 1.8 |
| Hemolytic crisis | 0 (0.0) | 3 (9.4) | 7 (24.1) | 2.6 |
| Hospitalizations‡ | 2 (5.6) | 5 (15.6) | 11 (37.9) | 3.3 |
| Blood transfusions | 0 (0.0)∗ | 3 (9.4)† | 8 (27.6) | 6.6 |
| Deaths | 0 (0.0) | 0 (0.0) | 1 (3.4)§ | 0.3 |
SCD = sickle cell disease.
P<0.05 versus proguanil and versus placebo, with Yates correction.
P<0.05 versus placebo, with Yates correction.
Reasons for hospitalization were as follows: pyrimethamine group: severe malaria with bone pain crises (2 patients [5.6%]); proguanil group: severe malaria with anemia requiring blood transfusion (3 [9.4%]), and cellulitis of the right upper arm and typhoid septicemia (1 [3.1%] each); and placebo group: severe malaria with anemia (3 [10.3%]), dactylitis with anemia and anemia alone (2 [6.9%] each), and bronchopneumonia with anemia, hepatitis, chronic osteomyelitis, and bone pain crisis (1 [3.4%] each).
Cause of death: viral hepatitis and presumed overwhelming septicemia.