Chemotherapy of human intestinal parasitic diseases.
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Biomedical subjects
Publications and source records attributed to D Botero.
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A dose range study in 18 patients suffering from intestinal amoebiasis and treated with doses of panidazole between 1.0 and 2.0 g per day for six days revealed that the best therapeutic results were obtained with the higher dose. This dose was then compared with metronidazole, at the same dose, in a clinical trial in 100 patients with intestinal amoebiasis. Cure rates were 68% and 80% for the two drugs respectively. In 100 cases of vaginal trichomoniasis treated with panidazole at the dose of 1.0 g per day for seven days in half of the patients and for 10 days in the other half, we obtained 50% and 60% cure rates. The results of our studies with both amoebiasis and trichomoniasis were not superior to those obtained with metronidazole and other nitroimidazole derivatives. Side effects were found in 74% of the patients treated for amoebiasis and in 46% of the cases treated for trichomoniasis. No toxic effects were revealed by haematological, biochemical and renal function tests nor by cardiovascular studies.
The high prevalence of intestinal parasitic infections as an index of underdevelopment, especially in tropical countries, is related to poverty, poor housing, lack of sanitation, malnutrition, and ignorance. The effects are lowered work capacity, physical and mental retardation, leading to recurrences and exacerbations of the parasitism and malnutrition. The most prevalent parasites, methods of detection by specific tests in patients in clinical trials involving antiparasitic drugs are dealt with. How and by whom investigations of new drugs should be undertaken, the need for a basic knowledge of parasitology and techniques of the discipline, of biostatistics, and use of such controls as randomized allotment to treatment groups, placebo administration, and double-blind assessments are emphasized. The justification for undertaking an evaluation of an antiparasitic drug is predicated on the demonstration of safety in exhaustive in vitro and animal studies and of the drug's potential superiority as to efficacy and lower incidence of unwanted side effects, as compared with existing agents. Tolerance and dose-range studies should be conducted in male adult hospitalized patients under close supervision. The evaluation of amebicides in clinical trials, as well as of anthelmintics, is considered in terms of differentiation and reproductive habits of specific causative agents and tests for detecting their elimination to determine improvement under drug therapy. The problem of reinfection, particuarly of nonhospitalized patients under the adverse conditions of life, is stressed.
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Of 115 patients with symptomatic intestinal amebiasis, 56 were treated with Ro 7-0207 and 59 with metronidazole in a double blind study. Results of treatment were similar in the two groups and side effects were of low intensity except in one patient who received Ro 7-0207 and developed numbness of hands and tongue, difficulty in speaking, and headache. These symptoms disappeared after termination of treatment.
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The efficacy of albendazole was evaluated in 20 Colombian patients with neurocysticercosis showing neurological symptoms. All had parenchymal non-enhancing cystic images by computerized tomography and a positive enzyme-linked immunosorbent assay for cysticercus antibodies in serum or cerebrospinal fluid. They stayed in hospital for 8 d during treatment with albendazole, 15 mg/kg/d in 2 divided doses, and were then followed for at least 6 months after treatment. The number of cysts was reduced by 50% after 6 months. In 7 (35%) all cysts disappeared, in 7 (35%) the number was reduced, and in the remaining 6 (30%) the number was unchanged. In the 13 patients who still had cysts at 6 months, 11 showed a moderate decrease in average cyst size and in 2 the size was unchanged. Side effects during treatment were observed in 60% of the cases, but only 3 required corticosteroids.
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