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

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$Interventions for treating proximal humeral fractures in adults (Review)$

(Continued) Fanello 2004 RWA (500 participants) Faye 2003 SEN (310 participants) Mutabingwa 2004 TZA (1026 participants) Zongo 2007 BFA (372 participants) All adverse events were recorded on the clinical record form (days 7, 14, 21, and 28) and a causality assessment was made PCV and WBC days 0 and 14 All side effects were monitored actively (days 0, 1, 2, 7, 14, 21, and 28) and passively during the study 25% were randomly selected for blood counts, liver and renal function tests at days 0, 14, and 28 Parents or guardians were asked to report on side effects, tolerability, and usefulness of the treatment (days 0, 14, and 28) Assessed at each visit (days 0, 1, 2, 3, 7, 14, 21, 28, 35, and 42) Adverse events defined as any untoward medical occurrence Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. rhoea. CVS/RS: No significant difference in cough CNS: Weakness more common with AQ+SP (P < 0.05). No other significant differences. Biochemical: Elevated liver enzymes occurred in 7 patients, all were attributed to other causes (6 viral hepatitis and 1 Salmonella bacteraemia) Other: No significant difference in pruritis Open label SAE: No comment on serious AE Overall comment: 251 patients reported one AE concomitant with administration of the drug with no differences between groups. AE possibly or probably related to the study drugs 22/251 AL, 35/249 AQ+SP P = 0.06 Haem: Mean WBC count at day 14 was similar in both groups (data not shown). Open label SAE: No serious adverse events Overall comment: The side effects observed with each treatment combination were minor, mainly gastralgia, dizziness, pruritis, asthenia, and vomiting Biochemical: No severe alterations in renal or hepatic function were observed Unclear SAE: 1 death in each group No other reporting of AE Open label SAE: No serious adverse events GI: No significant difference in abdominal pain, vomiting, diarrhoea, or anorexia CVS/RS: No significant differ- 232
(Continued) Zongo 2005 BFA (521 participants) Assessed at each visit (days 0, 1, 2, 3, 7, 14, 21, and 28) Adverse events defined as any untoward medical occurrence Artesunate plus amodiaquine vs Artesunate plus sulfadoxine-pyrimethamine ence in cough CNS: No significant difference in headache or weakness. Other: Pruritis more common with AQ+SP (P < 0.05) Double blind SAE: 1 serious AE in each group (severe anaemia) GI: No significant difference in abdominal pain, vomiting, diarrhoea, or anorexia CVS/RS: No significant difference in cough or coryza CNS: No significant difference in headache or weakness Other: Pruritis more common with AQ+SP (P < 0.0001) Study ID Adverse event monitoring Blinding Adverse events Bonnet 2004 GIN (220 participants) Djimde 2004 MLI ( participants) Guthmann 2003 AGO (187 participants) Adverse event monitoring not described Haemoglobin, glucose, complete blood count, liver enzymes, and creatinine were measured on days 0, 7, 14, and 28 Adverse event monitoring not described Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Open label AE not reported Single blind (details not given) SAE: One with AS+AQ. Overall comment: Adverse event distribution was unremarkable. Haematological: All treatment decreased the prevalence of abnormal values of leucocytes and platelets (figures not given) Biochemical: At day 14 the prevalence of grade 1 ALT toxicity was 9.7% AS+AQ vs 2.5% AS+SP (figures not given). These changes not thought to be clinically significant. Open label AE not reported 233
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Artemisinin-based combination thera
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Analysis 2.2. Comparison 2 Dihydroa
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Analysis 10.5. Comparison 10 Arteme
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[Intervention Review] Artemisinin-b
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B A C K G R O U N D Malaria is a di
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drugs and the treatment comparisons
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this analysis into participants who
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Figure 1. Methodological quality su
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confidence intervals of the estimat
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Anaemia Hasugian 2005 IDN found tha
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Three trials report significantly m
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or those treated for P. vivax at ba
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Early vomiting Not reported. D I S
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Figure 4. Olliaro-Vaillant plot. Da
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Figure 10. Olliaro-Vaillant plot. D
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of findings tables’. For these ta
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Huambo and Bie provinces, central A
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References to studies excluded from
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Adjuik 2004 Adjuik M, Babiker A, Ga
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C H A R A C T E R I S T I C S O F S
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Ashley 2003a THA (Continued) Outcom
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Ashley 2003b THA (Continued) Alloca
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Ashley 2005 THA (Continued) Exclusi
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Bonnet 2004 GIN (Continued) Item Au
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Bukirwa 2005 UGA Methods Trial desi
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Djimde 2004 MLI (Continued) • AS
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Dorsey 2006 UGA (Continued) Item Au
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Fanello 2004 RWA Methods Trial desi
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Faye 2003 SEN (Continued) Outcomes
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Grande 2005 PER (Continued) Allocat
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Guthmann 2004 AGO (Continued) All d
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Hasugian 2005 IDN Methods Trial des
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Hutagalung 2002 THA (Continued) 5.
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Janssens 2003 KHM (Continued) Free
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Karema 2004 RWA (Continued) Interve
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Karunajeewa 2007 PNG (Continued) Ri
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Kobbe 2007 GHA (Continued) Exclusio
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Koram 2003 GHA (Continued) Adequate
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Martensson 2003 TZA Methods Trial d
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Mayxay 2003 LAO (Continued) 1. Feve
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Menard 2006 MDG Methods Trial desig
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Mens 2007 KEN (Continued) Risk of b
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Mutabingwa 2004 TZA (Continued) •
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Owusu-Agyei 2006 GHA (Continued) Fr
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Sagara 2005b MLI (Continued) • 25
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Smithuis 2004 MMR (Continued) Risk
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Stohrer 2003 LAO Methods Trial desi
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Swarthout 2004 ZAR (Continued) Note
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Tran 2002 VNM Methods Trial design:
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Van den Broek 2003a BGD (Continued)
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Van Vugt 1998 THA Methods Trial des
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Yeka 2004 UGA (Continued) Risk of b
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Yeka 2007 UGA (Continued) Free of o
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Zongo 2007 BFA (Continued) Novartis
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(Continued) Fofana 2005 Conference
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D A T A A N D A N A L Y S E S Compa
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2.2 Asia 1 317 Risk Ratio (M-H, Fix
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Comparison 5. Dihydroartemisinin-pi
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Comparison 8. Artesunate plus meflo
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Comparison 10. Artemether-lumefantr
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Comparison 12. Artesunate plus amod
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5.2 DHA-P 3 doses 3 1116 Risk Ratio
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Comparison 21. How does Artesunate
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(... Continued) Study or subgroup D
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