原创力文档safety and efficacy of the 10-day melarsoprol schedule for the treatment of second stage rhodesiense sleeping sickness安全性和有效性的10天美拉胂醇安排第二阶段rhodesiense昏睡病的治疗.pdfVIP
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safety and efficacy of the 10-day melarsoprol schedule for the treatment of second stage rhodesiense sleeping sickness安全性和有效性的10天美拉胂醇安排第二阶段rhodesiense昏睡病的治疗
Safety and Efficacy of the 10-Day Melarsoprol Schedule
for the Treatment of Second Stage Rhodesiense Sleeping
Sickness
1,2 1,2 3 3 4
Irene Kuepfer *, Caecilia Schmid , Mpairwe Allan , Andrew Edielu , Emma P. Haary ,
5 6 1,2 1,2
Abbas Kakembo , Stafford Kibona , Johannes Blum , Christian Burri
1 Swiss Tropical and Public Heath Institute, Basel, Switzerland, 2 University of Basel, Basel, Switzerland, 3 Lwala Hospital, Lwala, Uganda, 4 Kaliua Health Centre, Kaliua,
Tanzaina, 5 Ministry of Health, Vector Control Division, Kampala, Uganda, 6 National Institute for Medical Research, Tabora Research Centre, Tabora, Tanzania
Abstract
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
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