IJCCR 2013, Vol.3, No.3, 17
-
25
http://ijccr.sophiapublisher.com
23
a part of our ongoing non-funded prospective
observational study on malaria. The vivax, falciparum,
and mixed malaria arm of the study had already been
reported earlier that showed severe malaria in all the
three groups (Mohapatra et al., 2002; Mohapatra and
Das, 2009; Mohaptra, 2006; Mohapatra et al., 2012).
The present one is the severe vivax malaria arm of the
above study, in which data from March 2007 to
February 2012 are included. It comprised of two
parallel sub studies, i.e. one evaluating the risk factors
and outcome (Study
-
1),
and the other investigating
the efficacy of Artesunate for treatment of severe
vivax malaria (Study
-
2).
3.1
Sub-study
-
1
It is a prospective observational study in which adult
patients of vivax malaria were included. The patients
were grouped into uncomplicated vivax malaria
(
UVM) and severe vivax malaria (SVM). All patients
of SVM were admitted to the indoor. On admission
clinical work up was done in accordance with the
proforma designed for the study. It also included
history of antimalarial drugs consumed, body mass
index (BMI), associated infections, and co-morbid
conditions.
The diagnosis of vivax malaria was made with
detection of asexual form of the parasite in the Giemsa
stained peripheral blood smears (PBS). Parasite counts
were expressed as numbers of asexual parasites per
micro liter of blood and were calculated from the
numbers of parasitized cells per 200 leukocytes in a
thick film stained with Giemsa stain i.e. No. of
parasites X total leukocyte count/200.
Severe malaria was diagnosed according to the
guidelines of World Health Organization (World
Health Organization, 2000). Earlier we did a
longitudinal analysis to find out the criteria for
definition of organ dysfunction of severe malaria and
a scoring system for assessment of severity known as
Malaria Severity Score (MSS) (Mohapatra and Das,
2009).
Accordingly, we defined the organ dysfunction
and assessed the severity by calculating MSS. The
laboratory investigations done were: complete blood
count (CBC), blood glucose, blood urea, serum
creatinine, serum bilirubin, alanine-amino transferase
(
ALT), aspartate-amino transferase (AST), alkaline
phosphatase and glucose-6-phosphate dehydrogenase
(
G-6
-
PD), serum sodium, and potassium. Lumbar
puncture was done to study cerebrospinal fluid (CSF)
in unconscious patient.
To find out the risk factors of development of SVM
we have included all patients with different co-morbid
conditions and investigate also for different infections.
For detection of infections throat culture, urinalysis
with culture, X-Ray chest PA view, Widal test were
done.
Temperature was recorded and PBS was examined 12
hourly to determine fever resolution and parasitic
clearance time. Patients who lost follow up were
excluded from the study.
The study protocol was approved by the ethics
committee and written informed consent was obtained
from all the patients.
3.2
Sub-study
-
2
It is an open label and non-randomized trial. In this
part of study we included the patients of SVM and
treated with injection Artesunate 2.4 mg/kg at 0 h, 12 h,
24
h then once daily for 7 days or continued until they
were able to tolerate drugs orally according to WHO
guidelines (World Health Organization, 2010). Then
mefloquine was given orally. Supportive treatment
was given as per requirement. Oliguric acute renal
failure i.e. urine output <400 mL/24 hours associated
with rising serum creatinine despite rehydration and a
trial of diuretics; was treated with haemodialysis.
Patients who developed adult respiratory distress
syndrome were intubated and ventilated with positive
end expiratory pressure if indicated.
Radical treatment was administered with primaquin
0.25
mg base/kg bw for 14 days to the patients
without G6PD deficiency. Intermittent primaquin
regimen of 0.75 mg/kg bw weekly for 8 weeks was
given with supervision to patients with G6PD
deficiency.
The outcomes of therapeutic efficacy of artesunate in
SVM were assessed as per the WHO standard protocol
for monitoring drug resistance for falciparum malaria
(
World Health Organization, 2003). Accordingly the
therapeutic responses were grouped into four
categories:
i) Early treatment failure (if the patient develops