Meta AnalysisID 2323

双氢青蒿素-哌喹对比蒿甲醚-本芴醇治疗乌干达儿童无并发症恶性疟的疗效与安全性:随机对照试验的系统评价与Meta分析

CRD42020182354

What is the efficacy of dihydroartemisinin-piperaquine and artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in children in Uganda? What is the safety of dihydroartemisinin-piperaquine and art

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Record Fields

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Meta Analysis Id
2323
Evidence Id
10881
Core Evidence Id
10881
Source Meta Analysis Id
2272
Herb2 Meta Analysis Id
HBMA002272
Crd Id
CRD42020182354
Title
Efficacy and safety of dihydroartemisinin-piperaquine versus artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in children in Uganda: A systematic review and meta-analysis of randomized control trial.
Review Question
What is the efficacy of dihydroartemisinin-piperaquine and artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in children in Uganda? What is the safety of dihydroartemisinin-piperaquine and artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in children in Uganda?
Study Type Included
Randomized control trials.
Condition Being Studied
Uncomplicated falciparum malaria
Participant
Children having uncomplicated falciparum malaria residing in Uganda regardless of gender will be included. Uncomplicated malaria caused by the P. falciparum parasite in this study is defined as patients having symptoms that are non-specific in the presence of P. falciparum but in the absence of clinical or laboratory findings of severe organ dysfunction.
Animal
Human Disease Modelled
Intervention
Three days multiple doses of dihydroartemisinin-piperaquine. Different dosages of an antimalarial regimen will be considered as individual treatments.
Comparator Control
A three-day course of artemether-lumefantrine. Different dosages of an antimalarial regimen will be considered as individual treatments.
Main Outcome
Total failure at days 28, 42/63; PCR-adjusted and PCR unadjusted. Our primary analysis will be drawn on the WHO protocol for assessing and monitoring antimalarial drug efficacy (Bloland 2003) and WHO Methods and techniques for clinical trials on antimalarial drug efficacy: genotyping to identify parasite populations (2008). Measures of effect For dichotomous outcomes, we will record the number of participants experiencing the event and the number of participants in each treatment group, and our effect measure will be a risk ratio.
Outcome Measure
Additional Outcome
Fever clearance: the proportion of patients febrile on each day within three days Parasite clearance: the proportion of patients clear of parasites on each day within three days, Gametocyte carriage at Baseline and Day 14 or 28 or 42, and Changes in serum hemoglobin level from baseline (minimum 28 days and 42 days follow-up) will also be evaluated. Adverse events: Serious adverse events that require patients to stop treatment or be admitted to hospital, and any other adverse events Measures of effect For dichotomous outcomes, we will record the number of participants experiencing the event and the number of participants in each treatment group, and our effect measure will be a relative risk. For continuous outcomes, we will extract the arithmetic means and standard deviations for each treatment group together with the numbers of participants in each group, and our effect measure will be the mean difference.
Study Method
Meta-analysis, Systematic review
Keyword
Antimalarials; Artemether; Artemether, Lumefantrine Drug Combination; Artemisinins; Child; Humans; Infant; Malaria, Falciparum; Quinolines; Uganda; dihydroartemisinin; piperaquine
Contact
Dawit Getachew Assefa [email protected]
Organisational Affiliation
Dilla University http://www.du.edu.et/
Funding Source
Other Selection Criteria
Final Publication
Results Eleven trials were included in this review and two of them only included under safety outcome. Total 3798 participants were enrolled. The PCR unadjusted treatment failure was significantly lower with DHA–PQ at day 28 (RR 0.30, 95% CI 0.19–0.49; participants = 7863; studies = 5; I² = 93%, low quality evidence) and at day 42 (RR 0.53, 95% CI 0.38–0.76; participants = 1618; studies = 4; I² = 79%, moderate quality of evidence). The PCR adjusted treatment failure at day 42 was significantly lower with DHA–PQ treatment group (RR 0.45, 95% CI 0.28 to 0.72; participants = 1370; studies = 5, high quality of evidence), and it was below 5% in both arms at day 28 (moderate quality of evidence). AL showed a longer prophylactic effect on new infections which may last for up to 63 days (PCR-adjusted treatment failure: RR 2.04, 95% CI 1.13–3.70; participants = 1311; studies = 2, moderate quality of evidence). Compared to AL, DHA–PQ was associated with a slightly higher frequency of cough (RR 1.07, 95% CI 1.01 to 1.13; 2575 participants; six studies; high quality of evidence). In both treatment groups, the risk of recurrent parasitaemia due to possible recrudescence was less than 5% at day 28. The appearance of gametocyte between 29 and 42 days was also significantly lower in DHA–PQ than AL (RR 0.26, 95% CI 0.12 to 0.56; participants = 623; studies = 2; I² = 0%). Conclusion Compared to AL, DHA–PQ appeared to reduce treatment failure and gametocyte carriage in Ugandan children. This may trigger DHA–PQ to become the first-line treatment option. Both treatments were safe and well-tolerated. https://doi.org/10.1186/s12936-021-03711-4
Same Topic Review
Published Protocol
Review Type
Language
English
Country
Ethiopia
Review Stage
Review Completed published
First Submission Date
2020-04-26
Registration Date
2020-07-05
Anticipated Start Date
2020-05-10
Anticipated Completion Date
2020-09-30
Title Cn
双氢青蒿素-哌喹对比蒿甲醚-本芴醇治疗乌干达儿童无并发症恶性疟的疗效与安全性:随机对照试验的系统评价与Meta分析
Title En
Efficacy and safety of dihydroartemisinin-piperaquine versus artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in children in Uganda: A systematic review and meta-analysis of randomized control trial.
Bilingual Status
complete