Abstract
Introduction: Therapeutic management of sickle cell disease (SCD) has proven to be a major task to both patients and clinicians in Africa. Investigation of blood and serum parameters are essential tools for assessing efficacy of medical interventions and eventual outcome of the disease. There is paucity of studies on modern African medicinal treatment and resulting post-intervention hematological parameters of SCD in Nigeria. This study aimed at determining serum electrolytes and urea and some hematological parameters among SCD patients who were treated with a study agent compared to SCD patients who were not treated with the study agent but given normal hospital care.
Objective: The objective of this study was to assess the differences in reticulocytes, thrombocytes, and serum electrolytes, urea and creatinine of pediatric and adult SCD patients on the study agent and in control patients.
Materials and Method: This was a double-blind, two-arm, randomized control pilot study involving a total of 62 subjects, including 33 cases with SCD who were given the study agent and 29 controls with SCD who were not given the study agent. After preliminary evaluation, the study drug was administered at enrollment into the study on Day 1 and each study participant was re-evaluated at each monthly administration of the test drug for 6 consecutive visits conducted monthly. Study drug was administered one month after enrolment on each subsequent month for 5 months. Venous blood sample was collected and all other variables were investigated at each visit. A full blood count (hemoglobin (Hb) concentration, packed cell volume (PCV), white blood cells (WBC), reticulocytes (RTC), platelets (PLT) counts were done within 2 hours of collection, and were recorded. Serum electrolytes and urea, liver enzymes were also investigated. NCSS statistical software was used for analysis.
Results: At the end of study, mean (?ñsd) reticulocyte count of pediatric cases (1.54 [1.00]) was significantly lower (t-test=4.19, P-value=0.0002) than the enrolment value (2.44 [0.77]) and greater drop in reticulocyte count occurred among pediatric cases than among control subjects. A significant decrease (t-test=2.07, P-value=0.02) in the mean (?ñsd) thrombocyte count of adult controls at enrolment (515.0 [77.9]) compared to the value at the end of the study (432.3 [29.4]) was observed. The mean (?ñsd) creatinine blood level of pediatric cases at enrolment was significantly lower (t-test = -3.12, P-value = 0.002) than that at end of study (49.5 [11.2]). Serum potassium levels were elevated in all cases and controls at the end of the study. Simple linear regression analysis showed that the estimated change in total thrombocyte count per unit change in reticulocyte count varied between pediatric and adult case and control subjects.
Conclusion: The significant reduction in mean reticulocyte count of pediatric SCD patients on test drug and the difference in the slope of the equation of straight line relating thrombocyte count and reticulocyte count may reflect the therapeutic effect of the test drug among pediatric patients. Clinicians should monitor serum potassium level when managing sickle cell disease patients for cardiac response to hyperkalaemia. Further studies are needed to confirm these findings.
Keywords