Effect of Immunozin™ therapy on hematological and biochemical parameters of Sickle Cell Disease patients who presented with fatigue, acute bone pain, and acute chest syndrome in Nigeria

Abstract

Introduction: Painful vaso-occlusive crises are frequent complications of sickle cell disease (SCD),
which affects about 3% of the Nigerian population with a high mortality in children. Relevance of
hematological and biochemical parameters to clinical symptoms of SCD are not often documented.
Aims and Objective: This study aimed at determining the prevalence of fatigue, acute bone pains
(ABP) and acute chest syndrome (ACS) and to assess the associating hematological and biochemical
parameters before and after administration of ImmunozinTM. Materials and Method: This study was
a double-blind, two-arm, randomized control pilot study with 30 SCD patients presenting with fatigue,
acute bone pains (ABP) and ACS, each of whom was given the study agent. At the first visit, after
thorough assessment of each patient had been undertaken and hematological parameters were measured,
the study drug was administered to each patient accordingly. This process was repeated monthly for
five more monthly visits when the study concluded. At each visit, venous blood sample was collected
for hematological parameters, electrolytes, urea and creatinine analyses within 2 hours of collection.
Results: Means (±sd) of age and BMI (Kg/m2) of the study subjects were 13.0 (5.6) and 16.1 (1.9)
respectively with 26 (86.7%) of the patients underweight. At enrollment into the study, 25 (83.3%), 18
(60.0%) and 10 (33.3%) of the patients presented with ABP, fatigue and ACS respectively but at the end
of study, post administration of study drug, 11 (36.7%), 8 (26.7%) and 7 (23.3%) presented with ABP,
fatigue and ACS. At enrollment, females were less likely to present with moderate fatigue (χ²=2.03,
P-value=0.15, OR=0.23, 95% CI: 0.05, 1.18), moderate ABP (χ²=0.09, P-value=0.77, OR=0.80, 95%
CI: 0.18, 3.46) and moderate ACS (χ²=0.01, P-value=0.90, OR=0.40, 95% CI: 0.03, 4.96) compared to
males. Only one patient each presented with fatigue and ABP at the end of study. The values of many
hematological parameters, electrolytes, urea and creatinine significantly varied at the end of the study
compared with enrollment values. A significant positive correlation (Pearson’s r=0.40, P-value=0.031)
was observed between serum urea and ACS at enrollment, and astonishingly between fatigue and ABP
(r=0.52, P-value=0.003) but no notable correlation between any of the clinical symptoms and other
variables at the end of study. Conclusion: The significant reduction in proportion of patients with
fatigue, ABP and ACS at the end of study, after administration of test drug may suggest the therapeutic
consequence of the test drug among SCD patients. There is urgent need to conduct multi-center and
multi-disciplinary studies to corroborate these findings.