11.11.2012 Views

Artemisinin-based combination therapy for ... - The Cochrane Library

Artemisinin-based combination therapy for ... - The Cochrane Library

Artemisinin-based combination therapy for ... - The Cochrane Library

SHOW MORE
SHOW LESS

You also want an ePaper? Increase the reach of your titles

YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.

(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

Hooray! Your file is uploaded and ready to be published.

Saved successfully!

Ooh no, something went wrong!