Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 2 de 2
Filtrar
Mais filtros










Base de dados
Intervalo de ano de publicação
1.
PLoS Negl Trop Dis ; 6(8): e1695, 2012 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-22970329

RESUMO

OBJECTIVE: Assessment of the safety and efficacy of a 10-day melarsoprol schedule in second stage T.b. rhodesiense patients and the effect of suramin-pretreatment on the incidence of encephalopathic syndrome (ES) during melarsoprol therapy. DESIGN: Sequential conduct of a proof-of-concept trial (n = 60) and a utilization study (n = 78) using historic controls as comparator. SETTING: Two trial centres in the T.b. rhodesiense endemic regions of Tanzania and Uganda. PARTICIPANTS: Consenting patients with confirmed second stage disease and a minimum age of 6 years were eligible for participation. Unconscious and pregnant patients were excluded. MAIN OUTCOME MEASURES: The primary outcome measures were safety and efficacy at end of treatment. The secondary outcome measure was efficacy during follow-up after 3, 6 and 12 months. RESULTS: The incidence of ES in the trial population was 11.2% (CI 5-17%) and 13% (CI 9-17%) in the historic data. The respective case fatality rates were 8.4% (CI 3-13.8%) and 9.3% (CI 6-12.6%). All patients discharged alive were free of parasites at end of treatment. Twelve months after discharge, 96% of patients were clinically cured. The mean hospitalization time was reduced from 29 to 13 days (p<0.0001) per patient. CONCLUSIONS: The 10-day melarsoprol schedule does not expose patients to a higher risk of ES or death than does treatment according to national schedules in current use. The efficacy of the 10-day melarsoprol schedule was highly satisfactory. No benefit could be attributed to the suramin pre-treatment. TRIAL REGISTRATION: Current Controlled Trials ISRCTN40537886.


Assuntos
Melarsoprol/administração & dosagem , Melarsoprol/efeitos adversos , Tripanossomicidas/administração & dosagem , Tripanossomicidas/efeitos adversos , Trypanosoma brucei rhodesiense , Tripanossomíase Africana/tratamento farmacológico , Adolescente , Adulto , Idoso , Encefalopatias/etiologia , Criança , Esquema de Medicação , Doenças Endêmicas , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Suramina/uso terapêutico , Tanzânia/epidemiologia , Tripanossomíase Africana/complicações , Tripanossomíase Africana/epidemiologia , Uganda/epidemiologia
2.
PLoS Negl Trop Dis ; 5(3): e968, 2011 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-21407802

RESUMO

BACKGROUND: A wide spectrum of disease severity has been described for Human African Trypanosomiasis (HAT) due to Trypanosoma brucei rhodesiense (T.b. rhodesiense), ranging from chronic disease patterns in southern countries of East Africa to an increase in virulence towards the north. However, only limited data on the clinical presentation of T.b. rhodesiense HAT is available. From 2006-2009 we conducted the first clinical trial program (Impamel III) in T.b. rhodesiense endemic areas of Tanzania and Uganda in accordance with international standards (ICH-GCP). The primary and secondary outcome measures were safety and efficacy of an abridged melarsoprol schedule for treatment of second stage disease. Based on diagnostic findings and clinical examinations at baseline we describe the clinical presentation of T.b. rhodesiense HAT in second stage patients from two distinct geographical settings in East Africa. METHODOLOGY/PRINCIPAL FINDINGS: 138 second stage patients from Tanzania and Uganda were enrolled. Blood samples were collected for diagnosis and molecular identification of the infective trypanosomes, and T.b. rhodesiense infection was confirmed in all trial subjects. Significant differences in diagnostic parameters and clinical signs and symptoms were observed: the median white blood cell (WBC) count in the cerebrospinal fluid (CSF) was significantly higher in Tanzania (134 cells/mm(3)) than in Uganda (20 cells/mm(3); p<0.0001). Unspecific signs of infection were more commonly seen in Uganda, whereas neurological signs and symptoms specific for HAT dominated the clinical presentation of the disease in Tanzania. Co-infections with malaria and HIV did not influence the clinical presentation nor treatment outcomes in the Tanzanian study population. CONCLUSIONS/SIGNIFICANCE: We describe a different clinical presentation of second stage T.b. rhodesiense HAT in two distinct geographical settings in East Africa. In the ongoing absence of sensitive diagnostic tools and safe drugs to diagnose and treat second stage T.b. rhodesiense HAT an early identification of the disease is essential. A detailed understanding of the clinical presentation of T.b. rhodesiense HAT among health personnel and affected communities is vital, and awareness of regional characteristics, as well as implications of co-infections, can support decision making and differential diagnosis.


Assuntos
Trypanosoma brucei rhodesiense/isolamento & purificação , Tripanossomíase Africana/diagnóstico , Tripanossomíase Africana/patologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Sangue/parasitologia , Líquido Cefalorraquidiano/citologia , Criança , Ensaios Clínicos como Assunto , Feminino , Geografia , Humanos , Contagem de Leucócitos , Masculino , Pessoa de Meia-Idade , Tanzânia , Tripanossomíase Africana/parasitologia , Uganda , Adulto Jovem
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA
...