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1.
Clin Infect Dis ; 77(4): 574-582, 2023 08 22.
Article in English | MEDLINE | ID: mdl-37100061

ABSTRACT

BACKGROUND: Meglumine antimoniate (MA) remains the main treatment for cutaneous leishmaniasis (CL). Uncontrolled studies suggest that intralesional MA (IL-MA) may be noninferior and safer than systemic MA (S-MA). METHODS: Multicenter, randomized, controlled, open-label, phase 3 clinical trial to evaluate the efficacy and toxicity of IL-MA in 3 infiltrations at 14-day intervals compared with S-MA (10-20 mg Sb5+/kg/day, 20 days) for CL, with noninferiority margin of 20%. Primary and secondary outcomes were definitive cure at day 180 and epithelialization rate at day 90 of treatment, respectively. A 2-year follow-up was performed to assess relapses and emergence of mucosal lesions. Adverse events (AEs) were monitored according to the Division of AIDS AE grading system. RESULTS: We evaluated 135 patients. The cure rates (95% confidence interval) for IL-MA and S-MA treatment were, respectively, 82.8% (70.5-91.4) and 67.8% (53.3-78.3) per protocol (PP) and 70.6% (58.3-81.0) and 59.7% (47.0-71.5) per intention to treat (ITT). The epithelialization rates of the IL-MA and S-MA treatment were, respectively, 79.3% (66.6-88 + 8) and 71.2% (57.9-82.2) PP and 69.1% (55.2-78.5) and 64.2% (50.0-74.2) ITT. AEs in the IL-MA and S-MA groups were, respectively, clinical, 45.6% and 80.6%; laboratory, 26.5% and 73.1%; and electrocardiogram, 8.8% and 25.4%. Ten participants in the S-MA group and 1 in the IL-MA group were discontinued due to severe or persistent AEs. CONCLUSIONS: IL-MA provides a similar cure rate and results in less toxicity compared with S-MA and may be used as first-line therapy for CL patients. CLINICAL TRIALS REGISTRATION: REBEC: RBR-6mk5n4.


Subject(s)
Antiprotozoal Agents , Leishmaniasis, Cutaneous , Organometallic Compounds , Humans , Meglumine Antimoniate/therapeutic use , Meglumine Antimoniate/adverse effects , Antiprotozoal Agents/adverse effects , Meglumine/adverse effects , Brazil , Treatment Outcome , Organometallic Compounds/adverse effects , Leishmaniasis, Cutaneous/drug therapy
2.
Am J Trop Med Hyg ; 85(5): 818-9, 2011 Nov.
Article in English | MEDLINE | ID: mdl-22049033

ABSTRACT

Liposomal amphotericin B has been used as an alternative treatment of mucosal leishmaniasis, but the optimal dose is not established. We retrospectively reviewed the clinical outcome of eight patients with mucosal leishmaniasis treated with liposomal amphotericin B. The mean total dose was 35 mg/kg (range 24-50 mg/kg), which resulted in the healing of all the lesions in all patients and no recurrences were observed during the follow-up period (mean 25 months; range 7-40 months).


Subject(s)
Amphotericin B/administration & dosage , Amphotericin B/therapeutic use , Leishmaniasis, Mucocutaneous/drug therapy , Adult , Aged , Dose-Response Relationship, Drug , Humans , Male , Middle Aged , Retrospective Studies
3.
An. acad. bras. ciênc ; 83(3): 1007-1020, Sept. 2011. ilus, tab
Article in English | LILACS | ID: lil-595531

ABSTRACT

The Brazilian cerrado has undergone an intense process of fragmentation, which leads to an increase in the number of remnants exposed to edge effects and associated changes on environmental conditions that may affect the phenology of plants. This study aimed to verify whether the reproductive phenology of Xylopia aromatica (Lam.) Mart. (Annonaceae) differs under different light conditions in a cerrado sensu stricto (a woody savanna) of southeastern Brazil. We compared the reproductive phenology of X. aromatica trees distributed on east and south cardinal faces of the cerrado during monthly observations, from January 2005 to December 2008. The east face had a higher light incidence, higher temperatures and canopy openness in relation to south face. X. aromatica showed seasonal reproduction at both faces of the cerrado, but the percentage of individuals, the synchrony and duration of phenophases were higher at the east face. The study demonstrated the influence of the environmental conditions associated to the cardinal orientation of the cerrado faces on the phenological pattern of X. aromatica. Similar responses may be observed for other species, ultimately affecting patterns of floral visitation and fruit production, which reinforces the importance of considering the cardinal direction in studies of edge effects and fragmentation.


O cerrado brasileiro vem sofrendo um processo intenso de fragmentação, que levou ao aumento de remanescentes sujeitos aos efeitos de borda e a alterações nas condições ambientais que podem afetar a fenologia das plantas. O objetivo deste trabalho foi verificar se a fenologia reprodutiva de Xylopia aromatica (Lam.) Mart. (Annonaceae) difere sob diferentes condições de luz em um cerrado sensu stricto no sudeste do Brasil. Comparamos a fenologia reprodutiva de árvores de X. aromatica distribuídas nas faces leste e sul do cerrado, observadas mensalmente de janeiro de 2005 a dezembro de 2008. A face leste apresentou maior incidência de luz, temperaturas e aberturas do dossel em relação à face sul. X. aromatica apresentou reprodução sazonal em ambas as faces do cerrado, mas a porcentagem de indivíduos, sincronia e duração das fenofases foram maiores na face leste. O estudo demonstrou a influência das condições ambientais associadas à orientação cardeal das faces do cerrado no padrão fenológico de X. aromatica. Respostas similares poderão ser observadas em outras espécies de cerrado, afetando os padrões de visitação floral e produção de frutos, o que reforça a importância de considerarmos a orientação cardeal nos estudos de efeitos de borda e fragmentação.


Subject(s)
Xylopia/physiology , Brazil , Periodicity , Reproduction/physiology , Seasons , Trees , Xylopia/growth & development
4.
An Acad Bras Cienc ; 83(3): 1007-20, 2011 Sep.
Article in English | MEDLINE | ID: mdl-21779657

ABSTRACT

The Brazilian cerrado has undergone an intense process of fragmentation, which leads to an increase in the number of remnants exposed to edge effects and associated changes on environmental conditions that may affect the phenology of plants. This study aimed to verify whether the reproductive phenology of Xylopia aromatica (Lam.) Mart. (Annonaceae) differs under different light conditions in a cerrado sensu stricto (a woody savanna) of southeastern Brazil. We compared the reproductive phenology of X. aromatica trees distributed on east and south cardinal faces of the cerrado during monthly observations, from January 2005 to December 2008. The east face had a higher light incidence, higher temperatures and canopy openness in relation to south face. X. aromatica showed seasonal reproduction at both faces of the cerrado, but the percentage of individuals, the synchrony and duration of phenophases were higher at the east face. The study demonstrated the influence of the environmental conditions associated to the cardinal orientation of the cerrado faces on the phenological pattern of X. aromatica. Similar responses may be observed for other species, ultimately affecting patterns of floral visitation and fruit production, which reinforces the importance of considering the cardinal direction in studies of edge effects and fragmentation.


Subject(s)
Xylopia/physiology , Brazil , Periodicity , Reproduction/physiology , Seasons , Trees , Xylopia/growth & development
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