Cohort event monitoring of patients treated for uncomplicated malaria with artemisinin-based combination therapies in selected hospitals and community pharmacies in Nigeria.

AIMS AND OBJECTIVES: The study was designed with the broad objective of determining the safety profile of artemisinin-based combination therapies amongst Nigerian population. PATIENTS AND METHODS: This was a cohort event monitoring (CEM) programme involving monitoring adverse events (AEs) in malaria patients treated with either artemether-lumefantrine (AL) or artesunate-amodiaquine (AA) in healthcare facilities in Nigeria. The study involved continuous enrolment of patients with malaria and treated with either AL or AA at the various sites until a total cohort of 600 patients were enrolled at each site. Patients were monitored from the onset of therapy, and on days 3 and 7 from the first day of treatment to identify AEs that may occur. RESULTS: A total of 6102 AEs were recorded in 10,259 patients monitored during the programme. Of 4896 patients who received AA, 4233 (86.5%) patients reported at least one AE while 1869 (34.8%) AEs out of 5363 patients who received AL were reported (P = 0.010). The predominant incidence of each specific AE reported in each group among the patients who received AA and AL includes body weakness 30.8%/7.5%, dizziness 10.3%/3.9%, restlessness 5.02/1.12%, vomiting 3.5/1.03% and drowsiness 3.1/1.5% for AA and AL, respectively. There were more AEs among patients with co-morbid conditions and patients in the younger age groups (9-<15 years), P = 0.000. CONCLUSIONS: Various types of AEs were seen and documented during the CEM programme. The findings suggested that the AA/AL monitored during this programme was generally safe and remarkably well tolerated among the Nigerian populations.

The evaluation of non-specific cellular immunological parameters amongst children with Schistosoma haematobium infection in Nigeria.

This study used the leucocyte migration index to assess cellular immune function in children with urinary schistosomiasis. Migration inhibitory factor was produced (with other lymphokines) by sensitizing mitogens. The production of antigen-induced migration inhibitory factor in vitro correlated with the in vivo state of cellular hypersensitivity of the lymphocyte donor. The percentage positive leucocyte migration rate using three mitogens was least with inactivated measles haemagglutinin virus (IMV) and highest with Bacillus Calmette-Guerin (BCG) in the control group, while highest with tuberculin purified protein derivative (PPD) and least with IMV in the test group. The measurement of the migration index of leucocytes comparing the control with lightly- and heavily-infected children on activation using three mitogens was significantly reduced, except in the case of the control versus lightly-infected children using IMV. Using IMV, the leucocyte migration index for control versus lightly-infected children and heavily-infected children was significant (p > 0.002 and p < 0.001, respectively). Using BCG the difference between controls and lightly- and heavily-infected children were significant (p < 0.02). PPD showed no significant difference in leucocyte migration between control and the lightly- or heavily-infected children. In all leucocyte migration index decreased with intensity of infection except in the case of PPD (p < 0.002 for BCG; p < 0.001 for the IMV). There was a significant correlation between egg count and leucocyte migration index; for BCG (r = -0.20, p < 0.005); for IMV (r = -0.3, p < 0.001); for PPD (r = -0.38,p < 0.001). Patients with schistosomiasis infection can express normal and effective cellular immune responses to non-schistosomal antigens and also have equal immunological ability to combat pathogens as S. haematobium-free controls.