Ahn et al. (2020)22
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N = 15 Healthy male volunteers (Vietnam) |
To evaluate whether MB can alter the pharmacokinetics of artesunate-amodiaquine (AS-AQ) and increase its antimalarial activity. |
After the drugs were administered, blood samples from 7 patients were evaluated for ex vivo antimalarial activity against artemisinin-sensitive (MRA1239) and -resistant (MRA1240) P. falciparum lines. Randomization: Group 1: single dose of AS-AQ (200 mg AS + 540 mg AQ). Group 2: single dose of MB (325 mg) + AS-AQ (200 mg AS + 540 mg AQ). Oral administration |
MB increased the antimalarial activity of AS-AQ, suggesting that the triple-drug tested may can be recommended to treat artemisinin-resistant malaria. |
Jorge et al. (2019)35
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N = 100 Children with uncomplicated falciparum malaria (Burkina Faso) |
To evaluate the efficacy of MB and primaquine (PQ) combined with AS-AQ in the treatment of uncomplicated falciparum malaria. |
Patients received weight-adjusted doses. Haematological recovery was assed at day seven. Group 1: AS-AQ (6.0-8.9 kg = 25 mg AS + 67.5 mg AQ; 9.0-17.9 kg = 50 mg AS + 135 mg AQ; >17.9 kg = 100 mg AS + 270 mg AQ). Group 2: daily dose of MB (15 mg/kg) for 3 days + AS-AQ (6.0-8.9 kg = 100 mg; 9.0-12.9 kg = 150 mg; 13.0-16.9 kg = 200 mg; 16.9 kg = 250 mg) PQ was administered at the last day of AS-AQ (day 2) (6.0-8.9 kg = 2 mg; 9.0-12.9 kg = 3 mg; 13.0-16.9 kg= 4 mg; 16.9 kg = 5 mg). Oral administration |
Although non-inferiority could not be observed, MB combination exhibited significant secondary benefits and thus may be useful to reduce the transmission and risk for development of resistant falciparum malaria. |
Coulibaly et al. (2015)36
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N = 221 Children aged 6-59 months with uncomplicated falciparum malaria (Burkina Faso) |
To assess the gametocytocidal effect, safety, and efficacy of AS-AQ combined with MB therapy in the treatment of uncomplicated falciparum malaria |
Patients were randomly assigned to two groups and received weight-adjusted doses once a day for 3 days. Randomization: Group 1: AS-AQ (6.0-8.9 kg = 25 mg AS + 67.5 mg AQ; 9.0-17.9 kg = 50 mg AS + 135 mg AQ; >17.9 kg = 100 mg AS + 270 mg AQ). Group 2: AS-AQ (aforementioned weight-adjusted doses) + MB (15 mg/kg) (6.0-8.9 kg =100 mg MB; 9.0-12.9 kg = 150 mg MB; 13.0-16.9 kg = 200 mg MB; 6.9 kg = 250 mg MB). Oral administration |
Gametocytes prevalence was significantly lower in patients treated with AS-AQ + MB compared to only AS-AQ and thus indicate that the combination may be useful for the treatment of falciparum malaria. |
Study |
Population (n) / Country |
Aim |
Intervention / Administration route |
Outcomes |
Bountogo et al. (2010)7
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N = 60 Semi-immune adults with uncomplicated falciparum malaria (Burkina Faso) |
To evaluate the efficacy of the therapy with MB in different dosing regimens in semi-immune adults with uncomplicated falciparum malaria. |
Patients received MB monotherapy (390 mg) twice a day (after breakfast and supper). Clinical and parasitological responses were evaluated on day 28. Randomization: Group 1: MB administered for 7 days. Group 2: MB administered for 5 days. Group 3: MB administered for 3 days. Oral administration |
MB activity against P. falciparum is slow; however, it appears to be effective following a seven-day administration. Therefore, MB should be combined with efficacious and rapidly drugs for the treatment of falciparum malaria. |
Dicko et al. (2018)28
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N = 80 Males aged 5 to 50 years with asymptomatic falciparum malaria (Mali) |
To evaluate the efficacy and safety of PQ and MB for the prevention of human to mosquito transmission of P. falciparum.
|
Patients were randomly assigned to two groups and received weight-adjusted doses. Randomization: Group 1: single dose of sulfadoxine (500 mg)-pyrimethamine (25 mg) + amodiaquine (150 mg) for 3 days. Group 2: single dose of sulfadoxine (500 mg)-pyrimethamine (25 mg) + amodiaquine (150 mg) for 3 days + single low-dose of primaquine (0.25 mg/kg). Group 3: standard doses of dihydroartemisinin-piperaquine. Group 4: standard doses of dihydroartemisinin-piperaquine + MB (15 mg/kg) for 3 days. Oral administration |
The combination of sulfadoxine-pyrimethamine with amodiaquine, as well as the combination of dihydroartemisinin-piperaquine with MB were highly effective to prevent the transmission of P. falciparum.
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Juffermans et al. (2010)29
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N = 15 Mechanically ventilated patients with septic shock (Netherlands) |
To assess the risk-ratio of using MB as an adjuvant in the treatment of human septic shock. |
Prior the study, patients received a standard protocol treatment, which included resuscitation with infusion of colloid fluids and administration of broad-spectrum antibiotics. Dose-finding investigation, global hemodynamics measurements, gasometrics, and gastric PCO2 were assessed before and after 20 minutes of MB administration. Randomization: Group 1: 1 mg / kg de AM. Group 2: 3 mg / kg de AM. Group 3: 7 mg / kg de AM. Intravenous administration |
MB administered at a dosage of 1-3 mg/kg in patients with septic shock is adequate to transiently elevate arterial pressure. It is attributed to an increase in cardiac index and vascular resistance. High doses of MB, such as 7 mg/kg may compromise splanchnic perfusion adequacy. |
Arzápalo et al. (2016)30
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N = 60 Patients with septic shock (Mexico) |
To assess the efficacy of MB as an adjuvant in the treatment of septic shock. |
Blood pressure, lactate, base deficit, central venous oxygen saturation, and CO2 delta were assessed at baseline and after every hour. Noradrenaline dosage (mg), length of stay and mechanical ventilation, and mortality were evaluated. Group A: Single dose of MB (2 mg/kg) in 100 mL of 5% dextrose over 60 minutes. Group C: 100 mL of 5% dextrose over 60 minutes. Intravenous administration |
MB may be used as a valuable adjuvant in the treatment of human septic shock. |