randomized clinical trial on ivermectin versus thiabendazole for the treatment of strongyloidiasis随机临床试验对伊维菌素与噻苯咪唑类圆线虫病的治疗.pdfVIP

Randomized Clinical Trial on Ivermectin versus Thiabendazole for the Treatment of Strongyloidiasis 1 1 1 1 1 Zeno Bisoffi *, Dora Buonfrate , Andrea Angheben , Marina Boscolo , Mariella Anselmi , Stefania 1 1 1 2 1 Marocco , Geraldo Monteiro , Maria Gobbo , Giulia Bisoffi , Federico Gobbi 1 Centre for Tropical Diseases, S. Cuore Hospital, Negrar (Verona), Italy, 2 Biostatistic Unit, University Hospital, Verona, Italy Abstract Background: Strongyloidiasis may cause a life-threatening disease in immunosuppressed patients. This can only be prevented by effective cure of chronic infections. Direct parasitologic exams are not sensitive enough to prove cure if negative. We used an indirect immune fluorescent antibody test (IFAT) along with direct methods for patient inclusion and efficacy assessment. Methodology/Principal Findings: Prospective, randomized, open label, phase III trial conducted at the Centre for Tropical Diseases (Verona, Italy) to compare efficacy and safety of ivermectin (single dose, 200 mg/kg) and thiabendazole (two daily doses of 25 mg/Kg for two days) to cure strongyloidiasis. The first patient was recruited on 6th December, 2004. Follow-up visit of the last patient was on 11th January, 2007. Consenting patients responding to inclusion criteria were randomly assigned to one of the treatment arms. Primary outcome was: negative direct and indirect (IFAT) tests at follow-up (4 to 6 months after treatment) or subjects with negative direct test and drop of two or more IFAT titers. Considering 198 patients who concluded follow-up, efficacy was 56.6