STUDY ON THE EFFICACY AND SAFETY OF ARTEMETHER/LUMEFANTRINE IN THE TREATMENT OF UNCOMPLICATED PLASMODIUM FALCIPARUM MALARIA AMONGST CHILDREN IN KANO.
STUDY ON THE EFFICACY AND SAFETY OF ARTEMETHER/LUMEFANTRINE IN THE TREATMENT OF UNCOMPLICATED PLASMODIUM FALCIPARUM MALARIA AMONGST CHILDREN IN KANO.
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Date
2014-10
Authors
MUHAMMAD, MUHAMMAD AUWAL
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Abstract
Globally, malaria is a major health concern because it causes high morbidity and
mortality particularly in children under 5 years because of their low immunity. The
development of resistance to chloroquine and sulphodoxine/pyrimethamine in many
parts of the world has further worsened the disease. In 2001, WHO recommended the
use of artemisinin combination therapy for the treatment of uncomplicated Plasmodium
falciparum malaria in countries experiencing resistance to chloroquine and other
antimalarial monotherapies. In 2005, Nigeria made a shift in the policy of treatment and
adopted WHO Artemisinin Combination Therapy policy for the treatment of
uncomplicated Plasmodium falciparum malaria. The aim of the study was to assess the
therapeutic efficacy and safety of the artemether/lumefantrine supplied by the Kano
State Government for the treatment of uncomplicated Plasmodium falciparum malaria
following an observed increase in patients requiring retreatment. It was a prospective
evaluation of clinical and parasitological responses to directly observed treatment of
uncomplicated Plasmodium falciparum malaria using artemether/lumefantrine. Patients
of ages 6-59 months numbering 73 who met the inclusion criteria were enrolled into the
study after a written informed consent by their parents or guardians. The drug was
administered at 0, 8, 12, 24, 48, and 60 hr according to the ages of the patients. They
were followed-up on days 0, 1, 2,3,7,14,21, and 28 in which they were assessed
clinically and parasitologically. Data obtained were analyzed using the WHO malaria
drugs therapeutic efficacy Excel Data Sheet and Graphpad instat software.
The test drug was also subjected to qualitative tests such disintegration test, weight
uniformity test, hardness test and friability test to determine the quality of the drug.
The result of the study showed that 63 patients completed the 28 days follow-up period
while10 patients were lost to follow-up. There was no early treatment failure observed.
However, there was 1 late clinical failure, 8 late parasitological failures and 54
adequate clinical and parasitological response. The cure rate was 85.7% (PCR
uncorrected) and failure rate was 14.3% on day 28. The fever clearance time was found
to be 40.22 hrs while the parasite clearance time was 52.14 hrs. There was no serious
adverse drug reactions observed or reported during the course of the study. The results
of the qualitative tests using B.P. 2009 standards were all within the normal limit with a
disintegration time of 4.5min, average weight of 244.5 mg ± 1.1 hardness of 9.05 Kg
and the friability was 0.4%. When the above efficacy results are compared with
previous efficacy studies conducted in 2002, 2004 and more recently in 2009 it could
be seen that the efficacy of artemether/lumefantrine is gradually diminishing with time
though it is still within the acceptable limit.
The study showed that the standard six dose regime in malaria treatment with the brand
of artemether/lumefantrine was efficacious, safe and qualitative in the treatment of
uncomplicated Plasmodium falciparum malaria in children less than 5 years of age with
an efficacy of 85.7% PCR uncorrected in the 28 days per protocol analysis.
Description
A THESIS SUBMITTED TO THE SCHOOL OF POSTGRADUATE
STUDIES,
AHMADU BELLO UNIVERSITY, ZARIA
IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE
AWARD
OF A
MASTER DEGREE IN PHARMACOLOGY.
DEPARTMENT OF PHARMACOLOGY AND THERAPEUTICS,
FACULTY OF PHARMACEUTICAL SCIENCES
AHMADU BELLO UNIVERSITY, ZARIA
NIGERIA
OCTOBER, 2014.
Keywords
STUDY,, EFFICACY,, SAFETY,, ARTEMETHER/LUMEFANTRINE, TREATMENT,, UNCOMPLICATED,, PLASMODIUM FALCIPARUM, MALARIA,, AMONGST,, CHILDREN,, KANO.