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

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(Continued)<br />

Mutabingwa 2004 TZA<br />

(1022 participants)<br />

Staedke 2003 UGA<br />

(268 participants)<br />

Yeka 2004 UGA<br />

(1461 participants)<br />

Footnotes<br />

AE = adverse event<br />

DHA-P = dihydroartemisinin-piperaquine<br />

AS = artesunate<br />

MQ = mefloquine<br />

AL = artemether-lumefantrine<br />

AQ = amodiaquine<br />

SP = sulfadoxine-pyrimethamine<br />

SAE = serious adverse event<br />

GI = gastrointestinal system<br />

CVS = cardiovascular system<br />

RS = respiratory system<br />

CNS = central nervous system<br />

ECG = electrocardiogram<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 with a<br />

standardized history and examination.<br />

Neurological assessment<br />

on days 0, 7, 14, and<br />

28. CBC, creatine and alanine<br />

transferase on days 0, 7, and 28.<br />

Adverse event monitoring not<br />

described<br />

QT = interval between the Q and T waves of an ECG<br />

U&E = urea and electrolytes<br />

FBC = full blood count<br />

LFT = liver function tests<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 />

Unclear SAE: 1 death in the AQ+SP<br />

group died on the day of randomization<br />

No other reporting of AE<br />

Single blind (outcome assessors)<br />

Single blind (outcome assessors)<br />

SAE: 16 serious adverse<br />

events (1/134 AS+AQ vs 6/134<br />

AQ+SP<br />

CNS: ‘No important neurological<br />

events were seen’<br />

Biochem: 1 severe anaemia with<br />

AS+AQ, 1 severe neutropenia<br />

with AQ+SP, 1 elevated alanine<br />

transaminase with AQ+SP<br />

No other comment on adverse<br />

events<br />

SAE: 4/731 AS+AQ vs 10/730<br />

AQ+SP. 2 additional patients<br />

died in the AQ+SP group<br />

No other reporting of AE<br />

236

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