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

More documents

Recommendations

Info

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

Ashley 2004 THA (Continued) 2. Parasite clearance Notes Country: Thailand Setting: 4 clinics on the Thai-Myanmar border Transmission: Unstable low and seasonal transmission Resistance: Multiple-drug resistance Dates: Apr 2003 to Apr 2004 Funding: Medicines for Malaria Venture, Wellcome Trust of Great Britain Risk of bias Item Authors’ judgement Description Adequate sequence generation? Yes ’The randomisation list was generated using STATA; version 7 (Stata)’. Randomized in blocks of 9. Allocation concealment? Yes ’The treatment allocation was concealed in sealed envelopes labelled with the study code’ Blinding? All outcomes Incomplete outcome data addressed? All outcomes No ’Laboratory staff reading the blood smears had no knowledge of the treatment received’. No other blinding described. Yes Losses to follow up were low in all groups (4.2% DHA-P vs 4.8% AS+MQ) Free of selective reporting? Yes All WHO outcomes reported. 2 patients were considered to be early treatment failures by the reviewers and reclassified as such. This was not clearly stated in the paper. Free of other bias? Yes No other sources of bias identified Ashley 2005 THA Methods Trial design: An open label randomized controlled trial Follow up: Temperature and blood smears daily until clearance of fever and parasites, then weekly attendance for clinical examination, symptom enquiry, malaria smear, and haematocrit until day 63 Adverse event monitoring: Adverse events were actively screened at each visit. Adverse events were defined as signs or symptoms that occurred or became more severe after treatment started. Participants Number: 500 randomized Inclusion criteria: Age 6 months to 65 yrs, weight > 5 kg, symptomatic P. falciparum mono-infection or mixed infections, informed consent Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 42
Ashley 2005 THA (Continued) Exclusion criteria: Pregnancy or lactation, signs or symptoms of severe malaria, > 4% of red blood cells parasitized, treatment with mefloquine in the previous 60 days, contraindication to mefloquine Interventions 1. Artesunate plus mefloquine, fixed-dose combination, adult tablets 100 mg/220 mg, paediatric tablets 25 mg/55 mg (Far-Manguinhos) • 5 to 8 kg 1 paediatric tablet per day • 9 to 17 kg 2 paediatric tablets per day • 18 to 29 kg 1 adult tablet per day • > 30 kg 2 adult tablets per day 2. Artesunate plus mefloquine, loose combination, (Arsumax: Sanofi-Synthelabo, Lariam: Roche) • AS 4 mg/kg once daily for 3 days • MQ 15 mg/kg on day 1 and 10 mg/kg on day 2 All doses supervized Outcomes 1. Cure rate at day 63, PCR adjusted and unadjusted 2. P. vivax during follow up, and median time to reappearance 3. Gametocyte development during follow up 4. Mean haematocrit during follow up 5. Adverse events Not included in this review: 1. Fever clearance 2. Parasite clearance Notes Country: Thailand Setting: 6 clinics on the Thai-Myanmar border Transmission: Unstable low and seasonal transmission Resistance: Multiple-drug resistance Dates: Nov 2004 to Jun 2005 Funding: DNDi, European Union International Co-operation programme, Médecins sans Frontières, WHO/TDR, Wellcome Trust of Great Britain Risk of bias Item Authors’ judgement Description Adequate sequence generation? Yes ’Randomised in blocks of 10 by a statistician using a computer-generated randomisation’ Allocation concealment? Yes ’The treatment allocation was concealed in numbered, sealed envelopes...opened only after enrolment in the study’ Blinding? All outcomes Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. No An open label study. ’50% of enrolment slides, 10% of follow up slides and all slides reported as showing recrudescence were subjected to a second blind reading’ 43
Page 1 and 2: Artemisinin-based combination thera
Page 3 and 4: Analysis 2.2. Comparison 2 Dihydroa
Page 5 and 6: Analysis 10.5. Comparison 10 Arteme
Page 7 and 8: [Intervention Review] Artemisinin-b
Page 9 and 10: B A C K G R O U N D Malaria is a di
Page 11 and 12: drugs and the treatment comparisons
Page 13 and 14: this analysis into participants who
Page 15 and 16: Figure 1. Methodological quality su
Page 17 and 18: confidence intervals of the estimat
Page 19 and 20: Anaemia Hasugian 2005 IDN found tha
Page 21 and 22: Three trials report significantly m
Page 23 and 24: or those treated for P. vivax at ba
Page 25 and 26: Early vomiting Not reported. D I S
Page 27 and 28: Figure 4. Olliaro-Vaillant plot. Da
Page 33 and 34: Figure 10. Olliaro-Vaillant plot. D
Page 35 and 36: of findings tables’. For these ta
Page 37 and 38: Huambo and Bie provinces, central A
Page 39 and 40: References to studies excluded from
Page 41 and 42: Adjuik 2004 Adjuik M, Babiker A, Ga
Page 43 and 44: C H A R A C T E R I S T I C S O F S
Page 45 and 46: Ashley 2003a THA (Continued) Outcom
Page 47: Ashley 2003b THA (Continued) Alloca
Page 51 and 52: Bonnet 2004 GIN (Continued) Item Au
Page 53 and 54: Bukirwa 2005 UGA Methods Trial desi
Page 55 and 56: Djimde 2004 MLI (Continued) • AS
Page 57 and 58: Dorsey 2006 UGA (Continued) Item Au
Page 59 and 60: Fanello 2004 RWA Methods Trial desi
Page 61 and 62: Faye 2003 SEN (Continued) Outcomes
Page 63 and 64: Grande 2005 PER (Continued) Allocat
Page 65 and 66: Guthmann 2004 AGO (Continued) All d
Page 67 and 68: Hasugian 2005 IDN Methods Trial des
Page 69 and 70: Hutagalung 2002 THA (Continued) 5.
Page 71 and 72: Janssens 2003 KHM (Continued) Free
Page 73 and 74: Karema 2004 RWA (Continued) Interve
Page 75 and 76: Karunajeewa 2007 PNG (Continued) Ri
Page 77 and 78: Kobbe 2007 GHA (Continued) Exclusio
Page 79 and 80: Koram 2003 GHA (Continued) Adequate
Page 81 and 82: Martensson 2003 TZA Methods Trial d
Page 83 and 84: Mayxay 2003 LAO (Continued) 1. Feve
Page 85 and 86: Menard 2006 MDG Methods Trial desig
Page 87 and 88: Mens 2007 KEN (Continued) Risk of b
Page 89 and 90: Mutabingwa 2004 TZA (Continued) •
Page 91 and 92: Owusu-Agyei 2006 GHA (Continued) Fr
Page 93 and 94: Sagara 2005b MLI (Continued) • 25
Page 95 and 96: Smithuis 2004 MMR (Continued) Risk
Page 97 and 98: Stohrer 2003 LAO Methods Trial desi
Page 99 and 100:
Swarthout 2004 ZAR (Continued) Note
Page 101 and 102:
Tran 2002 VNM Methods Trial design:
Page 103 and 104:
Van den Broek 2003a BGD (Continued)
Page 105 and 106:
Van Vugt 1998 THA Methods Trial des
Page 107 and 108:
Yeka 2004 UGA (Continued) Risk of b
Page 109 and 110:
Yeka 2007 UGA (Continued) Free of o
Page 111 and 112:
Zongo 2007 BFA (Continued) Novartis
Page 113 and 114:
(Continued) Fofana 2005 Conference
Page 115 and 116:
D A T A A N D A N A L Y S E S Compa
Page 117 and 118:
2.2 Asia 1 317 Risk Ratio (M-H, Fix
Page 119 and 120:
Comparison 5. Dihydroartemisinin-pi
Page 121 and 122:
Comparison 8. Artesunate plus meflo
Page 123 and 124:
Comparison 10. Artemether-lumefantr
Page 125 and 126:
Comparison 12. Artesunate plus amod
Page 127 and 128:
5.2 DHA-P 3 doses 3 1116 Risk Ratio
Page 129 and 130:
Comparison 21. How does Artesunate
Page 131 and 132:
Analysis 1.3. Comparison 1 Dihydroa
Page 133 and 134:
Page 135 and 136:
Page 137 and 138:
(... Continued) Study or subgroup D
Page 139 and 140:
Analysis 1.12. Comparison 1 Dihydro
Page 141 and 142:
Page 143 and 144:
Page 145 and 146:
Page 147 and 148:
Page 149 and 150:
Page 151 and 152:
Page 153 and 154:
Page 155 and 156:
Page 157 and 158:
Page 159 and 160:
Page 161 and 162:
Page 163 and 164:
(... Continued) Study or subgroup A
Page 165 and 166:
Analysis 6.6. Comparison 6 Artesuna
Page 167 and 168:
Page 169 and 170:
Page 171 and 172:
Page 173 and 174:
Analysis 9.2. Comparison 9 Artemeth
Page 175 and 176:
Page 177 and 178:
Analysis 9.8. Comparison 9 Artemeth
Page 179 and 180:
Page 181 and 182:
Page 183 and 184:
Analysis 10.2. Comparison 10 Arteme
Page 185 and 186:
Page 187 and 188:
Page 189 and 190:
Page 191 and 192:
Page 193 and 194:
Page 195 and 196:
Page 197 and 198:
Analysis 12.2. Comparison 12 Artesu
Page 199 and 200:
Page 201 and 202:
Page 203 and 204:
Page 205 and 206:
Page 207 and 208:
Analysis 14.2. Comparison 14 Dihydr
Page 209 and 210:
Page 211 and 212:
Page 213 and 214:
Page 215 and 216:
Page 217 and 218:
Page 219 and 220:
Analysis 20.1. Comparison 20 How do
Page 221 and 222:
Analysis 21.1. Comparison 21 How do
Page 223 and 224:
(Continued) 2. How does artesunate
Page 225 and 226:
(Continued) Sensitivity analysis 1
Page 227 and 228:
(Continued) Smithuis 2004 MMR (652
Page 229 and 230:
Dihydroartemisinin-piperaquine vs A
Page 231 and 232:
(Continued) Mayxay 2003 LAO (220 pa
Page 233 and 234:
Artesunate plus mefloquine vs Amodi
Page 235 and 236:
(Continued) Faye 2003 SEN (509 part
Page 237 and 238:
Artemether-lumefantrine vs Artesuna
Page 239 and 240:
(Continued) Zongo 2005 BFA (521 par
Page 241 and 242:
(Continued) Faye 2003 SEN (521 part
Page 243 and 244:
PCR = polymerase chain reaction PCV
Page 245 and 246:
(Continued) Proportion with anaemia
Page 247 and 248:
(Continued) Vivax efficacy: P. viva
Page 249 and 250:
(Continued) Efficacy: Total Failure
Page 251 and 252:
(Continued) Outcomes Illustrative c
Page 253 and 254:
Page 255 and 256:
(Continued) GRADE Working Group gra
Page 257 and 258:
Footnotes 1 Data were also availabl
Page 259 and 260:
8 Very serious imprecision: There w
Page 261 and 262:
Page 263 and 264:
(Continued) justed Vivax efficacy:
Page 265 and 266:
(Continued) Harms: Serious adverse
Page 267 and 268:
(Continued) Harms: Early vomiting -
Page 269 and 270:
1 Dorsey 2006 UGA; Faye 2003 SEN; K
show all

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

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?