Fixed pigmented erythema to secnidazole / Eritema pigmentar fixo à secnidazol

Rare description of drug fixed eruption induced by secnidazole.

Descrição rara de eritema pigmentar fixo induzido por secnidazol.

Single dose secnidazole treatment efficiency against naturally occuring Giardia duodenalis infection in calves / Eficacia del tratamiento con secnidazol en dosis única contra la infección natural de Giardia duodenalis en terneros

Abstract Objective. In the present study the aim was to establish the efficacy of 30 mg/kg single dose secnidazol in calves naturally infected with Giardia duodenalis. Materials and methods. In an attempt to perform original study a total of 18 calves, from various breed, age and of both sexes were enrolled. Diagnosis was based on detection of trophozoit and/or cysts on fecal flotation among calves naturally infected with G. duodenalis, besides by use of rapid diagnostic test kits working with solid phase immunochromatographic principles and β-giardin nested- Polymerase Chain Reaction aplication. Cyst count per gram of feces were performed among days 0, 3, 7 and 10 in all cases. On days 0 and 10 hematological (WBC, RBC, HCT, MCHC, PLT) and serum biochemical (ALT, AST, creatinine, urea) values were determined. Results. Two different groups of calves composed of secnidazole group (n:9) and control group (n:9) were enrolled. Among calves enrolled in treatment group secnidazole was administered at a single dosage of 30 mg/kg perorally on day 0, whereas control group were left without any active ingredient. Cyst count per gram feces, hematological and serum biochemical values were analyzed among groups and intragroup comparisons. Giardia duodenalis assemblage A3 was detected in all 18 calves. On days 3, 7, and 10 there was significant (p˂0.001) reduction in cyst excretion; whereas evaluation of mean geometric cyst excretion revealed 100% reduction on days 7 and 10. Among two group statistical analysis of hematological and serumbiochemical variables revealed no statistical significance on days 0 and 10. Conclusions. In conclusion secnidazole at a single dose of 30 mg/kg might be practically appliable, reasonably priced, safety, completely effective and causing rapid recovery treatment protocole for therapy of calves with Giardiasis.

Resumen Objetivo. En el presente estudio se pretendía establecer la eficacia de 30 mg / kg de dosis única de secnidazol en terneros naturalmente infectados con Giardia duodenalis. Materiales y métodos. En un intento de realizar un estudio original, se matricularon 18 terneros, de distintas raza, edad y de ambos sexos. El diagnóstico se basó en la identificación de trofozoítos y /o quistes en la flotación fecal entre terneros naturalmente infectados con G. duodenalis, además de utilizar kits de diagnóstico rápido que funcionan con principios inmunocromatográficos en fase sólida y aplicación de Reacción en Cadena de Polimerasa anidada con β-giardina. El conteo de quistes por gramo de heces se realizó entre los días 0, 3, 7 y 10 en todos los casos. En los días 0 y 10 se determinaron los valores hematológicos (WBC, RBC, HCT, MCHC, PLT) y suero bioquímico (ALT, AST, creatinina, urea). Resultados. Se inscribieron dos grupos diferentes de terneros tratados con secnidazol (n: 9) y el grupo control (n: 9). Entre los becerros incluidos en el grupo de tratamiento se administró secnidazol en una dosis única de 30 mg/kg oralmente al día 0, mientras que el grupo de control se dejó sin ningún ingrediente activo. Se analizó el conteo de quistes por gramo de heces, valores hematológicos y bioquímicos de suero entre grupos y comparaciones intragrupo. Giardia duodenalis ensamblaje A3 se identificó en los 18 terneros. En los días 3, 7 y 10 hubo una reducción significativa (p˂0.001) en la excreción de quistes; Mientras que la evaluación de la excreción geométrica promedio de quistes reveló una reducción del 100% en los días 7 y 10. Entre los dos grupos de análisis estadístico de las variables hematológicas y sero-bioquímicas no reveló significación estadística en los días 0 y 10. Conclusión. En conclusión secnidazol en una dosis única de 30 mg/kg podría ser prácticamente aplicable, a un precio razonable, la seguridad, completamente eficaz y causando un tratamiento de recuperación rápida protocolo para la terapia de terneros con Giardiasis.

Desenlaces clínicos en una cohorte colombiana de pacientes con síndrome de flujo vaginal tratadas con antimicóticos y antibióticos / Clinical outcomes in a Colombian cohort of patients with vaginal discharge syndrome treated with antifungals and antibiotics

Resumen Objetivo: Reportar el desempeño clínico de dos medicamentos indicados para tratamiento del síndrome de flujo vaginal (fluconazol, secnidazol y terconazol, clindamicina) y comparar el efecto clínico. Materiales y métodos: Estudio observacional, comparativo y analítico de cohortes al que se incluyeron pacientes con diagnóstico de síndrome de flujo vaginal susceptibles de ser tratadas con fluconazol-secnidazol o terconazol-clindamicina en 12 ciudades de Colombia, con seguimiento de 8 días (± 3 días). Este proyecto fue aprobado por un comité de ética en investigación con seres humanos. Resultados: Se incluyeron 176 pacientes, pero solo 153 (87%) completaron el seguimiento. Los límites de edad fueron 18 y 67 años; 134 (76%) iniciaron con fluconazol-secnidazol y 42 (24%) con terconazol-clindamicina. Por lo que se refiere a la comparación en disminución de los síntomas, fluconazol-secnidazol y terconazol-clindamicina: flujo (p = 0.0000), prurito (p = 0.002), irritación (p = 0.0000), mal olor (p = 0.001) y dispareunia (p = 0.4). Conclusión: La prescripción de la combinación fluconazol-secnidazol fue más frecuente. El apego al tratamiento fue de 86%. La proporción de disminución de los síntomas tuvo límites de 15 y 40%; para el flujo vaginal fue superior a 70% (fluconazol-secnidazol: 115 de 121 y terconazol-clindamicina: 29 de 41).

Abstract Objective: To know the real life clinical performance of the prescription of two drugs for the treatment of vaginal discharge syndrome (Fluconazole-Secnidazole and Terconazole-Clindamycin) and to compare the clinical outcomes. Materials and methods: An analytical cohort study was conducted. We included women older than 18 years with a diagnosis of vaginal discharge syndrome who were candidates to be treated with Fluconazole-Secnidazole or Terconazole-Clindamycin with 8 days (±3) of follow-up, in 12 cities of Colombia. This project was approved by a research with human being's ethics committee. Results: 176 patients were included, 153 (86.9%) completed the follow-up, their age ranged between 18 and 67 years. 134 (76.1%) started treatment with Fluconazole-Secnidazole and 42 (23.8%) Terconazole-Clindamycin. Symptoms improvement was compared (Enrollment vs. Control), finding for Fluconazole-Secnidazole and Terconazole-Clindamycin: discharge (p=0.0000), pruritus (p=0.002), irritation (p=0.0000), bad smell (p=0.001) and dyspareunia (p=0.4). Conclusions: The prescription of the combination Fluconazole-Secnidazole was more frequent. The adherence to treatment was 86%. The proportion of improvement in symptoms ranged between 15% and 40%, however, for the case of vaginal discharge it was greater than 70% (Fluconazole-Secnidazole: 115/121 and Terconazole-Clindamycin: 29/41).

Determination and validation of secnidazole in tablets by UV spectrophotometric / Determinação e validação do secnidazol em comprimidos por espectrofotometria na região do ultravioleta

Secnidazole, a 5-nitroimidazole, is a drug used in the treatment against protozoa, and several bacterial infections. This study purpose was to develop and validate a UV spectrophotometric method to determine secnidazole in pharmaceutical tablet dosage forms once there is no method reported in the pharmacopoeia yet. The quantification was performed using methanol as solvent at 325 nm (maximum wavelength) and three kinds of products marketed in Brazil (reference, generic and similar tablets) containing 1g of secnidazole. The method obeyed Beer's law in the concentration range of 4 - 20 µgmL-1 respectively. The method was validated according to the International Conference on Harmonization (ICH) and Brazil National Health Surveillance Agency (ANVISA) guidelines, showing accuracy, precision, selectivity, robustness and linearity. Tests such as weight range, friability, disintegration, hardness and dissolution were carried out to check tablets' quality and all the trials showed to be in accordance with the general test guidelines of the Brazilian Pharmacopoeia. The dissolution test was carried out and the developed method was applied. The method developed is suitable for the estimation of secnidazole in tablets without any interference from the excipients and can be used for routine in quality control. Still, it's a simple, fast and low cost method.

Secnidazol, um nitroimidazólico, é um fármaco utilizado no tratamento para protozoários, e várias infecções bacterianas. Este trabalho propôs o desenvolvimento e validação de um método espectrofotométrico na região do ultravioleta para a determinação de Secnidazol na forma farmacêutica de comprimidos, uma vez que não há nenhum método relatado nas farmacopeias. A quantificação foi realizada utilizando metanol como solvente a 325 nm (máximo de comprimento de onda) e usando três tipos de produtos comercializados no Brasil (de referência, genéricos e comprimidos similares) contendo 1g de Secnidazol. O método obedeceu a lei de Beer no intervalo de concentração de 4 - 20 µgmL-1, respectivamente. O método foi validado de acordo com a Conferência Internacional de Harmonização (ICH) e diretrizes da Agência Nacional de Vigilância Sanitária do Brasil (ANVISA), apresentando exatidão, precisão, seletividade, robustez e linearidade. Testes como variação de peso, friabilidade, desintegração, dureza e dissolução foram realizados para verificar a qualidade de comprimidos e mostrou-se de acordo com os testes gerais da Farmacopeia Brasileira. O teste de dissolução realizado e o método desenvolvido pode ser aplicado. O método desenvolvido é adequado para a estimativa de secnidazole em comprimidos sem qualquer interferência dos excipientes e pode ser usado para a rotina de controlo de qualidade. Ainda, é um método simples, rápido e de baixo custo.

Efectividad y seguridad de la combinación fluconazol más secnidazol para el tratamiento de flujo vaginal sintomático: Bogotá, Colombia / Effectiveness and safety of the combination of fluconazole and secnidazole for the treatment of symptomatic vaginal discharge: Bogotá, Colombia

Objectives: To describe the safety and the clinical and microbiological efficacy of a single oral dose of a combined treatment with secnidazole plus fluconazole for the syndromic management of symptomatic vaginal discharge.Materials and methods: A clinical trial without control group study was conducted including women with symptomatic vaginal discharge who assisted to a secondary level hospital in Bogota, Colombia. 118 women were included in a consecutive convenience sample who received the study treatment according to syndromic diagnosis approach. Microbiological diagnosis of bacterial vaginosis (BV) was confirmed by Nugent score, yeast infection by candida culture and trichomoniasis by wet mount. Prevalence, clinical and microbioogical efficacy and safety of the secnidazole and fluconazole combination pill was determined and a sensitivity analysis for treatment efficacy was performed.Results: The following infections were found: BV in 57.1%, candidiasis in 28.8%, and mixed infections in 10.8%. In 8.5% of the patients, the microbiology tests were negative. No trichomonas were found. The clinical cure rate was 90.4%, and the microbiological cure rate was 94.1% with the study medication. Twelve cases (12.90%) presented drug-related non serious adverse events.Conclusion: The most prevalent infection was BV, followed by candidiasis and mixed infection. The combination of a single dose of secnidazole plus fluconazole combined pill had an efficacy rate over 90% and was safe for the treatment of symptomatic women with vaginal discharge.

Objetivos: describir la seguridad y la eficacia clínica y microbiológica del tratamiento combinado de secnidazol mas fluconazol oral, dosis única, para el manejo del flujo vaginal sintomático.Materiales y métodos: ensayo clínico sin grupo control, realizado en mujeres sintomáticas con flujo vaginal en un hospital de mediana complejidad localizado en la ciudad de Bogotá, Colombia. Se incluyeron 118 mujeres por muestreo consecutivo por conveniencia quienes recibieron el tratamiento de acuerdo con el diagnóstico sindrómico. El diagnóstico microbiológico se estableció usando el puntaje de Nugent para vaginosis bacteriana (VB), el cultivo para cándida y el frotis directo en fresco para tricomonas. Se estimaron la prevalencia, la efectividad clínica y microbiológica, y la seguridad del tratamiento combinado de secnidazol con fluconazol en mono dosis, y se realizó un análisis de sensibilidad para la eficacia del tratamiento.Resultados: la prevalencia de VB fue del 57,1%, de candidiasis fue del 28,8% y de la infección mixta 10,8%. No se encontró infección por tricomonas. En 8,5% de las pacientes los resultados microbiológicos fueron negativos. La tasa de curación clínica con secnidazol más fluconazol fue de 90,4%, y la tasa de curación microbiológica fue de 94,1%. Doce pacientes (12,90%) presentaron eventos adversos no serios relacionados con el medicamento.Conclusión: la VB fue la infección más común en este estudio, seguida por la candidiasis y las infecciones mixtas. La combinación secnidazol más fluconazol es una intervención efectiva para alcanzar la cura clínica y microbiológica en las pacientes con síndrome de flujo vaginal, con una baja frecuencia de eventos adversos no serios.

Single dose of secnidazole treatment against naturally occuring Giardia duodenalis infection in Sakiz lambs / Tratamiento con dosis única con secnidazol en corderos naturalmente infectados con Giardia duodenalis

Objetive. The purposes of this study were to determine whether secnidazole administered at a single dose of 10 mg/kg, orally, lessens or eliminates Giardia cyst shedding, and to validate the benefit of secnidazole treatment on clinical signs and faecal consistency in lambs naturally infected with Giardia duodenalis. Materials and methods. To this extent weaned 12 weeks of age lambs were selected and randomly assigned into two groups based on placebo (group C, n=7 untreated control group) or treatment (group S, n=10 lambs treated with a single dose of secnidazole at 10 mg/kg). Results. On days 0 and 10, before and after treatment, respectively, reduction in cyst excretion was determined. The faecal consistency and general health were recorded at each sampling day. Conclusions. During the study there was a high (99.98%) reduction in cyst excretion in the secnidazol treatment group compared to the positive control group on day 10, resulting in a significant (p<0.001) reduction, making secnidazole highly effective treatment option.

Objetivo. El objetivo de este estudio fue determinar si la administración oral de una dosis única de secnidazol de 10mh/kg reduce o elimina la presencia de quistes de Giardia y validar el beneficio del tratamiento con secnidazol en los signos clínicos y la consistencia fecal de corderos infectados naturalmente con Giardia duodenalis. Materiales y métodos. Se seleccionaron corderos destetados de 12 semanas de edad que fueron asignados al azar a dos grupos con base a placebo (grupo C, n=7, grupo de control sin tratar) o tratamiento (grupo S, n=10 corderos con tratamiento de dosis única de secnidazol de 10 mg/kg). Resultados. En los días 0 y 10, antes y después del tratamiento, respectivamente, se determinó una merma en la excreción de quistes. La consistencia de la materia fecal y el estado general de salud fue registrado en cada muestreo diario. Conclusiones. Durante el estudio hubo una alta reducción en la excreción de quistes (99.98%) en el grupo tratado con secnidazol comparado con el grupo control positivo en el día 10, resultando en una disminución significativa (p<0.001), haciendo del tratamiento con secnizadol una opción altamente efectiva.

Bioavailability of two oral formulas of secnidazole in healthy volunteers / Biodisponibilidade de duas fórmulas de secnidazol oral em voluntários saudáveis

Secnidazole is an antimicrobial agent used primarily in the treatment of amoebiasis. For this bioequivalence study of secnidazole, twenty-eight healthy female volunteers were enrolled in a randomized crossover study. Each volunteer was given a single oral dose of secnidazole test preparation and then the reference preparation, or vice versa, with a wash out interval of two weeks. The plasma concentrations of secnidazole were determined by HPLC, and the samples were extracted with tert-butyl-methyl-ether: dicloromethane (60:40, v/v). Secnidazole and its parent compound metronidazole were separated on a C18 column with water:acetonitrile (85:15, v/v) as the mobile phase, and monitored at 310 nm. The ratio of mean Cmax, AUC0-t and AUC0-∞ values for the test and reference products were within the predetermined range established by ANVISA, demonstrating that the two formulations are bioequivalent in rate and extent of absorption.

Secnidazol é um agente antimicrobiano utilizado principalmente no tratamento da amebíase. Para este estudo de bioequivalência de secnidazol em voluntários saudáveis, foram incluídos vinte e oito voluntárias mulheres no estudo randomizado cruzado. Cada voluntária recebeu uma única dose oral de secnidazol do produto teste e referência para comparação, com um intervalo de wash-out de duas semanas. As concentrações plasmáticas de secnidazol foram determinados por CLAE, as amostras foram extraídas com terc-butil-metil-éter: dicloromethano (60:40, v/v). O secnidazol e seu padrão interno metronidazol foram separados em uma coluna (C18 ) com fase móvel água ultra-pura:acetonitrila (85:15, v/v) e monitorado em 310 nm. As razões entre as médias geométricas de Cmáx, ASC0-t e ASC0-∞, encontraram-se dentro do estabelecido pela ANVISA, demonstrando que as formulações são bioequivalentes quanto à taxa e extensão de absorção.

Comportamiento biológico de Blastocystis hominis en pacientes tratados con Secnidazol (Unidazol®) / Biological behavior of Blastocystis hominis in patients treated with Secnidazol (Unidazol®)

Blastocystis hominis, clasificado como Stramenopile, es el parásito intestinal más frecuente en el hombre. En las heces y cultivos se observan formas con cuerpo central (FCC), granulosas (FGra), globulosas, ameboides, en división binaria y quistes. Su elevada prevalencia, asociación con síntomas en el humano y carencia de tratamiento efectivo, justificó la evaluación del Secnidazol (Unidazol® ZUOZ-PHARMA) en 14 individuos (7 varones y 7 hembras), infectados con B. hominis, con edades entre 5-79 años, quienes fueron evaluados clínica y parasitológicamente antes y después del tratamiento, con una dosis del medicamento: 2g (adultos) y 30 mg/Kg/peso (niños). En el examen seriado de heces (3 muestras), se evaluó la morfología, número por campo microscópico (400X), formas de reproducción y crecimiento en el cultivo. En 14,3% (2/14) de los pacientes se eliminó el parásito y en el resto, se observó disminución significativa del número por campo (p< 0,05), de la frecuencia de FCC (p=0,001) y FGra (p<0,05) y disminuyó la positividad del examen directo (p<0,001). Estos resultados demuestran que el fármaco en dosis única, ocasionalmente erradicó a B. hominis, disminuyó la excreción de las formas vegetativas e indujo la aparición de quistes. Estos estudios deben continuarse.

Blastocystis hominis, classified as Stramenopile, is the most frequent intestinal parasite in humans. In feces and cultures, forms with a central body (FCB), granulose forms (GraF), as well as globulous and ameboid forms in binary division or in cysts are seen. Its elevated prevalence, association with symptoms in humans, and lack of effective treatment, justified the evaluation of secnidazol (Unidazol ® ZOUZ-PHARMA) in 14 individuals (7 males and 7 females) infected with B. hominis, with ages between 5-79 years, who were clinically and parasitologically evaluated before and after treatment; with one dose of the drug: 2 g for adults and 30 mg/Kg body weight for children. In feces serial examinations we evaluated morphology, number of parasites per microscopic field (400X), reproductive forms, and growth in culture. The study showed that in 14.3% (2/14) of patients the parasite was eliminated, and there was a significant decrease of the number per field (p< 0.05), of the FCB (p= 0.001) and of GraF (p< 0.05) frequency in the rest, as well as a decrease of positive direct examinations (p< 0.001). These preliminary results show that the drug in a single dose occasionally eradicated B. hominis, decreased the excretion of vegetative forms and induced the occurrence of cysts.These studies should be continued.

Secnidazole for metronidazole-resistant amebiasis

It is presented the case of a patient with intestinal colonization by Entamoeba histolytica, Entamoeba coli e Iodamoeba butschilli. Two treatments with metronidazole did not eradicate the protozoans, however, a treatment with secnidazole showed to be effective.

Apresenta-se uma mulher com colonização intestinal por Entamoeba histolytica, Entamoeba coli e lodamoeba butschilli. Dois tratamentos com metronidazol oral não erradicaram os protozoários, porém, um tratamento com secnidazol mostrou-se eficaz.