Artemisinin-based combination therapy for ... - The Cochrane Library
Artemisinin-based combination therapy for ... - The Cochrane Library
Artemisinin-based combination therapy for ... - The Cochrane Library
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(Continued)<br />
Bukirwa 2005 UGA<br />
(408 participants)<br />
Dorsey 2006 UGA<br />
(434 participants)<br />
Falade 2005 NGA<br />
(132 participants)<br />
Assessed at each follow-up visit<br />
(days 0, 1, 2, 3, 7, 14, and<br />
28), including neurological assessment<br />
An adverse event defined as any<br />
untoward medical occurrence<br />
Assessed at each follow-up visit<br />
(days 0, 1, 2, 3, 7, 14, and 28)<br />
An adverse event defined as any<br />
untoward medical occurrence<br />
Complete blood count and liver<br />
enzymes on days 0 and 14<br />
Assessed at each visit (days 0 to<br />
7, 14, 21, and 28)<br />
<strong>Artemisinin</strong>-<strong>based</strong> <strong>combination</strong> <strong>therapy</strong> <strong>for</strong> treating uncomplicated malaria (Review)<br />
Copyright © 2009 <strong>The</strong> <strong>Cochrane</strong> Collaboration. Published by John Wiley & Sons, Ltd.<br />
Single blind (outcome assessors)<br />
Single blind (outcome assessors)<br />
groups throughout follow up<br />
but there was no significant difference<br />
between groups. <strong>The</strong>re<br />
was no significant difference in<br />
the incidence of neutropenia<br />
between groups (14/111 AL vs<br />
13/116)<br />
Biochemical: No difference in<br />
liver enzymes were observed between<br />
groups. Liver enzymes<br />
were not observed to increase in<br />
response to treatment.<br />
SAE: One serious adverse event<br />
in each group (AL6 convulsion;<br />
AS+AQ pneumonia) both<br />
judged unlikely to be related to<br />
study meds<br />
CNS: No abnormalities in hearing<br />
or fine finger dexterity<br />
Overall comment:<br />
Adverse events of at least<br />
moderate severity: 125/202 AL<br />
vs 136/201 ASAQ (P = 0.25)<br />
SAE: 29 serious adverse events<br />
(14/202 AL vs 15/232 ASAQ).<br />
Majority were seizures associated<br />
with fever. None considered<br />
probably or definitely related<br />
to study meds<br />
GI: Anorexia more common<br />
with ASAQ (P < 0.05). No significant<br />
difference in abdominal<br />
pain, vomiting or diarrhoea<br />
CVS/RS: No significant difference<br />
in cough<br />
CNS: No other significant differences<br />
in weakness<br />
Biochemical: Elevated liver enzymes<br />
occurred in 7 patients,<br />
all were attributed to other<br />
causes (6 viral hepatitis and 1<br />
Salmonella bacteraemia)<br />
Other: No significant difference<br />
in pruritis<br />
Open label SAE: <strong>The</strong>re were no serious adverse<br />
events<br />
228