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 />
Fanello 2004 RWA<br />
(500 participants)<br />
Faye 2003 SEN<br />
(310 participants)<br />
Mutabingwa 2004 TZA<br />
(1026 participants)<br />
Zongo 2007 BFA<br />
(372 participants)<br />
All adverse events were recorded<br />
on the clinical record <strong>for</strong>m (days<br />
7, 14, 21, and 28) and a causality<br />
assessment was made<br />
PCV and WBC days 0 and 14<br />
All side effects were monitored<br />
actively (days 0, 1, 2, 7, 14, 21,<br />
and 28) and passively during<br />
the study<br />
25% were randomly selected <strong>for</strong><br />
blood counts, liver and renal<br />
function tests at days 0, 14, and<br />
28<br />
Parents or guardians were asked<br />
to report on side effects, tolerability,<br />
and usefulness of the<br />
treatment (days 0, 14, and 28)<br />
Assessed at each visit (days 0, 1,<br />
2, 3, 7, 14, 21, 28, 35, and 42)<br />
Adverse events defined as any<br />
untoward medical occurrence<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 />
rhoea.<br />
CVS/RS: No significant difference<br />
in cough<br />
CNS: Weakness more common<br />
with AQ+SP (P < 0.05). No<br />
other significant differences.<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: No comment on serious<br />
AE<br />
Overall comment: 251 patients<br />
reported one AE concomitant<br />
with administration of the drug<br />
with no differences between<br />
groups. AE possibly or probably<br />
related to the study drugs<br />
22/251 AL, 35/249 AQ+SP P =<br />
0.06<br />
Haem: Mean WBC count at<br />
day 14 was similar in both<br />
groups (data not shown).<br />
Open label SAE: No serious adverse events<br />
Overall comment: <strong>The</strong> side effects<br />
observed with each treatment<br />
<strong>combination</strong> were minor,<br />
mainly gastralgia, dizziness,<br />
pruritis, asthenia, and<br />
vomiting<br />
Biochemical: No severe alterations<br />
in renal or hepatic function<br />
were observed<br />
Unclear SAE: 1 death in each group<br />
No other reporting of AE<br />
Open label SAE: No serious adverse events<br />
GI: No significant difference in<br />
abdominal pain, vomiting, diarrhoea,<br />
or anorexia<br />
CVS/RS: No significant differ-<br />
232