| dc.description.abstract | From July 1989 to February 1990 inclusive, an eight-month
controlled clinical trial study was conducted at Kenyatta National
Hospital aiming at evaluating the efficacy of quinine in severe
falciparum malaria and tolerability of quinine loading dose in
adults.
Thirty-three patients aged 14 years and over, exc luding
pregnant mothers, were recruited into the study after obtaining
wr itten informed consen t. The study group was treated with
intravenous quinine starting with an initial loading dose of 20
mg/kg diluted in 500 mls of normal saline or 51. dextrose and
infused over 4 hours followed by 10 mg/kg similarly infused every
8 hours. The control group was similarly treated but without an
initial loading dose. Oral quinine bisulfate 10 mg/kg exery 8
hours was substituted when the patients were well enough to take
orally.
Seventeen patients were enrolled in the study group and 16
in the control group. The age in years for the study group ranged
from 14 to 50 (27.47 + 9.32, mean + S.D.). 6 (351.) were males and
11 (651.) ""ere fema Ies. The age in years for the control group
ranged from 14 to 89 (30.63 ~ 11.52, mean + S.D.). 7 (441.) were
males and 9 (561.) were females. The age distribution and the sex
ratios in the two groups were not statistically different (P >
0.05) . The two groups were also comparable in history of travel
outside Nairobi; history of antimalarial ingestion prior to
admission and severity of the illness. Only one patient presented
with an unarousable coma.
There was no statistically significant difference in fever
clearance times and parasite clearance times in the 2 groups (P
> 0.05 respectively). Thus, fever clearance time in hours was
44.00 + 13.92 (mean + S.D.) in the study group and 51.43 ~ 19.62
(mean + S.D.) in the control group. The parasite clearance time
in hours was 42.40 + 9.75 (mean + S.D.) for the study group and
47.05 + 7.69 (mean + S.D.) for the control group. One patient
(6%),from each group died. Thirteen patients from the study and
11 from the control groups were seen on day 15 while one patient
in the study and 5 in the control groups were seen on day 28.
None of those patients had a positive blood slide for malaria
parasites.
Mild toxic effects were fairly common in both groups.
Transient partial hearing loss occurred significantly more in the
study than in the control group (P < 0.05). Hypoglycaemia during
treatment occurred in 3 (181.) patients in the study group and in
1 (61.) patient in the control group.
The mean trough quinine concentrations in mg/l for the 3
patients in the study group ranged from 9.44 + 0.63 (mean + S.E.)
to 10.4 + 1.68 (mean + S.E.) while in the 3 control patients, it
ranged from 10.8 + 2.1 (mean + S.E.) to 11.1 ~ 0.38 (mean + S.E.)
On the other hand, the mean peak concentrations in mg/l ranged
from 10.1 + 0.87 (mean + S.E.) to 10.7 + 0.35 (mean + S.E.) for
the study group and from 9.4 +-1.77 (mean + S.E.) to 11.8 + 0.87
(mean + S.E.) for the control group. The mean trough and mean
peak plasma quinine concentrations were persistently higher than
9 mg/l in both groups.
In conclusion therefore, quinine was found to be so effective
in the management of severe falciparum malaria in Nairobi that
therei was no advantage of an initial loading dose over the
standard regimen as measured by fever clearance time, parasite
clearance time and mortality . | en |
