Archives of dermatology · 2006
Imiquimod in combination with meglumine antimoniate for cutaneous leishmaniasis: a randomized assessor-blind controlled trial.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Firooz Alireza, Khamesipour Ali, Ghoorchi Mohammad H, Nassiri-Kashani Mansour, Eskandari S Ebrahim, Khatami Alireza, Hooshmand Badakhshan, Gorouhi Farzam, Rashighi-Firoozabadi Mehdi, Dowlati Yahya
Аннотация
OBJECTIVE: To determine the efficacy and safety of imiquimod in combination with meglumine antimoniate in treating cutaneous leishmaniasis.
DESIGN: Prospective, randomized, assessor-blind, parallel-design, placebo-controlled trial.
SETTING: Two primary care health clinics.
PATIENTS: One hundred nineteen patients (59 patients in the imiquimod group and 60 in the placebo group) were included in the study.
INTERVENTIONS: Patients were randomly assigned to receive a combined 4-week course of imiquimod or placebo with meglumine antimoniate treatment (20 mg/kg of pentavalent antimony daily for 2 weeks) in an endemic area of Leishmania tropica.
MAIN OUTCOME MEASURES: The primary end point was clinical cure, defined as more than 75% reduction in the size of lesions compared with baseline at week 8.
RESULTS: At the end of the 4-week treatment period, clinical cure was similar in both groups (11 patients [18.6%] in the imiquimod-treated group vs 18 patients [30.0%] in the placebo group) (P = .15). Four weeks after the end of treatment, 26 patients (44.1%) and 29 patients (48.3%) in the imiquimod-treated and placebo groups, respectively, were cured (P = .64). Pruritus and burning sensation were reported by 3 patients treated with imiquimod and by no patients treated with placebo.
CONCLUSION: This study showed no beneficial effect of combining a 4-week course of treatment with 5% imiquimod cream and a standard course of treatment with meglumine antimoniate in patients with cutaneous leishmaniasis in an endemic area of L tropica.
TRIAL REGISTRATION: isrctn.org Identifier:ISRCTN77659407 and Cochrane Skin Group Identifier: CSG Trial No. 32.
DESIGN: Prospective, randomized, assessor-blind, parallel-design, placebo-controlled trial.
SETTING: Two primary care health clinics.
PATIENTS: One hundred nineteen patients (59 patients in the imiquimod group and 60 in the placebo group) were included in the study.
INTERVENTIONS: Patients were randomly assigned to receive a combined 4-week course of imiquimod or placebo with meglumine antimoniate treatment (20 mg/kg of pentavalent antimony daily for 2 weeks) in an endemic area of Leishmania tropica.
MAIN OUTCOME MEASURES: The primary end point was clinical cure, defined as more than 75% reduction in the size of lesions compared with baseline at week 8.
RESULTS: At the end of the 4-week treatment period, clinical cure was similar in both groups (11 patients [18.6%] in the imiquimod-treated group vs 18 patients [30.0%] in the placebo group) (P = .15). Four weeks after the end of treatment, 26 patients (44.1%) and 29 patients (48.3%) in the imiquimod-treated and placebo groups, respectively, were cured (P = .64). Pruritus and burning sensation were reported by 3 patients treated with imiquimod and by no patients treated with placebo.
CONCLUSION: This study showed no beneficial effect of combining a 4-week course of treatment with 5% imiquimod cream and a standard course of treatment with meglumine antimoniate in patients with cutaneous leishmaniasis in an endemic area of L tropica.
TRIAL REGISTRATION: isrctn.org Identifier:ISRCTN77659407 and Cochrane Skin Group Identifier: CSG Trial No. 32.
Предметные рубрики MeSH
Adjuvants, ImmunologicAdolescentAdultAminoquinolinesAnimalsAntimonyAntiprotozoal AgentsChildDrug Therapy, CombinationFemaleFollow-Up StudiesHumansImiquimodLeishmania tropicaLeishmaniasis, CutaneousMaleMeglumineMeglumine AntimoniateMiddle AgedOrganometallic CompoundsProspective StudiesSingle-Blind MethodTreatment Outcome