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

Tangpukdee 2005 THA (Continued)
Interventions 1. Dihydroartemisinin-piperaquine, fixed dose combination, 40 mg/320 mg tablets
(Artekin: Holleykin)
• Total dose: DHA 6 mg/kg + P 45 mg/kg in 3 divided doses, given once daily for 3
days
2. Artesunate plus mefloquine, loose combination
• AS 4 mg/kg once daily for 3 days
• MQ 8 mg/kg once daily for 3 days
All doses supervized
Outcomes 1. Cure rate at day 28. PCR analysis not performed as all patients hospitalised for
duration of follow up, so all recurrent parasitaemias presumed to be recrudescence
2. Adverse events
Not included in the review:
1. Fever clearance time
2. Parasite clearance time
Notes Country: Thailand
Setting: Bangkok Hospital for Tropical Diseases
Transmission: Low
Resistance: Multiple-drug resistance
Dates: Not given
Funding: Mahidol University Research Grant, Artekin supplied by Holleykin Pharmaceuticals
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Unclear ’Randomly treated at a ratio of 1:2’. No
further details given.
Allocation concealment? No None described
Blinding?
All outcomes
Incomplete outcome data addressed?
All outcomes
No An open label trial. No comment on blinding
of laboratory staff.
Yes Losses to follow up were low and similar
between groups (10.8% DHA-P vs 10%
AS+MQ)
Free of selective reporting? Yes Day 28 outcomes may overestimate the efficacy
of drugs with long half-lives such as
AS+MQ and DHA-P
Free of other bias? Yes No other sources of bias identified
Artemisinin-based combination therapy for treating uncomplicated malaria (Review)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
94