Archives of dermatology · 1999
Equivalent therapeutic efficacy and safety of ivermectin and lindane in the treatment of human scabies.
Клиническое исследованиеСтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Chouela E N, Abeldaño A M, Pellerano G, La Forgia M, Papale R M, Garsd A, Balian M C, Battista V, Poggio N
Аннотация
OBJECTIVE: To compare the therapeutic efficacy and safety of ivermectin and lindane for the treatment of human scabies.
DESIGN: Randomized, prospective, controlled, double-blind, "double-dummy," and parallel clinical study.
SETTING: A single department of dermatology at a hospital in Buenos Aires, Argentina.
PATIENTS: Patients were outpatients, hospitalized patients, and those referred to our hospital from nursing homes and asylums. Fifty-three patients had clinical signs and symptoms compatible with scabies.
INTERVENTION: Patients received either a single oral dose of ivermectin (150-200 microg/kg of body weight) or a topical application of 1% lindane solution. Treatment was repeated after 15 days if clinical cure had not occurred.
MAIN OUTCOME MEASURES: Clinical healing and adverse effects.
RESULTS: Of 53 patients, 43 (81%) completed the study, 19 in the group treated with ivermectin and 24 in the group treated with lindane. At day 15, 14 patients (74%; 95% confidence interval, 48.8%-90.8%) in the group receiving ivermectin showed healing of their scabies and 13 patients (54%; 95% confidence interval, 32.8%-74.4%) in the group treated with lindane were healed. At 29 days, both treatments resulted in statistically equivalent therapeutic efficacy: 18 patients (95%; 95% confidence interval, 74.0%-99.9%) were healed with ivermectin and 23 patients (96%; 95% confidence interval, 78.9%, 99.9%) were healed with lindane (P<.02). Adverse effects from the treatments were few, mild, and transient. Results from laboratory tests showed no major abnormalities and no difference between treatments.
CONCLUSIONS: Ivermectin is as effective as lindane for the treatment of scabies. Ivermectin is simpler to use and, therefore, is a promising tool to improve compliance and to control infestations.
DESIGN: Randomized, prospective, controlled, double-blind, "double-dummy," and parallel clinical study.
SETTING: A single department of dermatology at a hospital in Buenos Aires, Argentina.
PATIENTS: Patients were outpatients, hospitalized patients, and those referred to our hospital from nursing homes and asylums. Fifty-three patients had clinical signs and symptoms compatible with scabies.
INTERVENTION: Patients received either a single oral dose of ivermectin (150-200 microg/kg of body weight) or a topical application of 1% lindane solution. Treatment was repeated after 15 days if clinical cure had not occurred.
MAIN OUTCOME MEASURES: Clinical healing and adverse effects.
RESULTS: Of 53 patients, 43 (81%) completed the study, 19 in the group treated with ivermectin and 24 in the group treated with lindane. At day 15, 14 patients (74%; 95% confidence interval, 48.8%-90.8%) in the group receiving ivermectin showed healing of their scabies and 13 patients (54%; 95% confidence interval, 32.8%-74.4%) in the group treated with lindane were healed. At 29 days, both treatments resulted in statistically equivalent therapeutic efficacy: 18 patients (95%; 95% confidence interval, 74.0%-99.9%) were healed with ivermectin and 23 patients (96%; 95% confidence interval, 78.9%, 99.9%) were healed with lindane (P<.02). Adverse effects from the treatments were few, mild, and transient. Results from laboratory tests showed no major abnormalities and no difference between treatments.
CONCLUSIONS: Ivermectin is as effective as lindane for the treatment of scabies. Ivermectin is simpler to use and, therefore, is a promising tool to improve compliance and to control infestations.