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

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

(Continued) Ashley 2003b THA (356 participants) Ashley 2004 THA (499 participants) Grande 2005 PER (522 participants) Janssens 2003 KHM (464 participants) Mayxay 2004 LAO (220 participants) Daily review until parasites cleared then weekly until day 63 A subset of patients in the DHA-P group had FBC, U&E and LFT on days 0 and 7 and ECG monitoring before and after treatment Clinical examination, symptom enquiry, and haematocrit daily until parasites cleared then weekly until day 63 Clinical assessment daily until day 3 then weekly until day 63 FBC, U&E, LFT, and PCV days 0 and 7, PCV days 14 and 63 Clinical examination and symptom questionnaire days 0, 1, 2, 3. Only adverse events occurring in these 3 days are reported. Daily review until parasites cleared then weekly until day 42 Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Open label SAE: No serious adverse events observed GI: More abdominal pain reported with DHA-P (P = 0.025) Nausea, vomiting, and diarrhoea not significantly different CNS: More sleep disturbance with AS+MQ (P = 0.008) Dizziness not significantly different Biochemical: Some minor fluctuations in LFTs CVS: No comment Open label SAE: 4 serious events with AS+MQ (death, severe anaemia, febrile convulsion, coagulopathy) and 11 with DHA-P (2 deaths, bacterial sepsis, febrile convulsion, leptospirosis, haematemesis, nephritic syndrome, severe anaemia, respiratory infection, epigastric pain and vomiting). All except the one case of severe vomiting were judged to be unrelated or unlikely to be due to the study treatment GI: More diarrhoea with DHA-P (P = 0.026); nausea, vomiting, and abdominal pain not significantly different CNS: No significant difference in dizziness or sleep disturbance Other: Urticaria occurred in 1 patient with DHA- P but none with AS+MQ Open label SAE: 3 serious drug related events with AS+MQ requiring stopping treatment (encephalopathy, anxiety and arrhythmia, palpitations, and chest pain) GI: More nausea and vomiting with AS+MQ in adults (P = 0.02) but not significantly different in children. Abdominal pain and anorexia not significantly different CNS: More insomnia, dizziness and anxiety with ASMQ in adults (P = < 0.001) and more insomnia and anxiety with AS+MQ in children (P = < 0.001, 0.02). More somnolence with DHA-P (P = 0.02) Biochemical: No clinically significant abnormal renal or liver test results Open label SAE: No serious adverse events observed GI: More nausea, vomiting, and anorexia with AS+MQ, only vomiting was significant (P = 0.03) CNS: More dizziness and sleep disturbance with AS+MQ (P = 0.002, 0.03) CVS: More palpitations with AS+MQ (P = 0.04) Open label SAE: One neuropsychiatric reaction in AS+MQ group GI: More nausea and vomiting with AS+MQ (P = 220
(Continued) Smithuis 2004 MMR (652 participants) Tangpukdee 2005 THA (180 participants) Tran 2002 VNM (243 participants) Symptom questionnaire at days 0, 1, 2, 3 and 7. Only adverse events occurring in the first 7 days are reported. Inpatient monitoring until day 28. Assessed using non-suggestive questioning. Review at days 0, 2 and 7 LFTs on days 3, 7 and 28. Further follow-up is unclear. Dihydroartemisinin-piperaquine vs Artemether-lumefantrine Study ID Adverse event monitoring Blinding Adverse events Kamya 2006 UGA (421 participants) Karunajeewa 2007 PNG (250 participants) Assessed daily until day 3 then weekly until day 42. A standardized history, physical exam, including neurological assessment at each visit. Haemoglobin was checked at baseline and last day of follow up. Standardized follow up on days 0, 1, 2, 3, 7, 14, 28, and 42. Ad- Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. < 0.001, 0.02), abdominal pain and diarrhoea not significantly different CNS: More dizziness, sleep disturbance, nightmares, headache and weakness with AS+MQ (P = < 0.001, 0.02, 0.003, 0.001, 0.009) CVS/RS: More palpitations and dyspnoea with AS+MQ (P = 0.002, 0.04) Open label SAE: No serious adverse events reported in the first 7 days GI: More nausea with AS+MQ but only significant in the group having supervised treatment (P = 0.05), diarrhoea, vomiting, and abdominal pain were not significantly different CNS: More dizziness with AS+MQ but only significant in the group having unsupervised treatment (P = 0.03), no other symptoms reported Open label SAE: No serious adverse events observed Other: Reported as minor. No differences between groups reported Open label SAE: 12 events (10 vomiting, 2 dizziness) described as significant in AS+MQ group and none with DHA-P (P = 0.002) Biochemical: No significant differences Other: All other adverse events described as minor with no differences between groups reported Double-blind SAE: four with DHA-P, 2 with AL, all judged to be unrelated to study meds (3 febrile convulsions, otitis media, asthma attack, pyomyositis) GI: No difference in vomiting, diarrhoea, abdominal pain, or anorexia CNS: No differences presented CVS/RS: No difference in cough Open label Overall comment: No treatment withdrawals were attributable to adverse events related to a 221
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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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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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Analysis 1.12. Comparison 1 Dihydro
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Analysis 6.6. Comparison 6 Artesuna
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Analysis 9.2. Comparison 9 Artemeth
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