ABSTRACT
OBJECTIVES: To evaluate the efficacy of topical miconazole or amorolfine compared to placebo for mild to moderately severe onychomycosis. DESIGN: Randomised, double-blind, placebo-controlled trial, with computer-generated treatment allocation at a 1:1:1 ratio. SETTING: Primary care, recruitment from February 2020 to August 2022. PARTICIPANTS: 193 patients with suspected mild to moderately severe onychomycosis were recruited via general practices and from the general public, 111 of whom met the study criteria. The mean age of participants was 51 (SD 13.1), 51% were female and onychomycosis was moderately severe (mean OSI 12.1 (SD 8.0)). INTERVENTIONS: Once-daily miconazole 20 mg/g or once-weekly amorolfine 5% nail lacquer solution was compared with placebo (denatonium benzoate solution). MAIN OUTCOME MEASURES: Complete, clinical and mycological cure at 6 months. Secondary outcomes were clinical improvement, symptom burden, quality of life, adverse effects, compliance, patient-perceived improvement and treatment acceptability. RESULTS: Based on intention-to-treat analysis, none of the participants receiving miconazole or amorolfine reached complete cure compared with two in the placebo group (OR not estimable (n.e.), p=0.493 and OR n.e., p=0.240, respectively). There was no evidence of a significant difference between groups regarding clinical cure (OR n.e., p=0.493 and OR 0.47, 95% CI 0.04 to 5.45, p=0.615) while miconazole and amorolfine were less effective than placebo at reaching both mycological cure (OR 0.25, 95% CI 0.06 to 0.98, p=0.037 and OR 0.23, 95% CI 0.06 to 0.92, p=0.029, respectively) and clinical improvement (OR 0.26, 95% CI 0.08 to 0.91, p=0.028 and OR 0.25, 95% CI 0.07 to 0.85, p=0.021, respectively). There was no evidence of a significant difference in disease burden, quality of life, adverse reactions, compliance, patient-perceived improvement or treatment acceptability. CONCLUSIONS: Topical miconazole and amorolfine were not effective in achieving a complete, clinical or mycological cure of mild to moderately severe onychomycosis, nor did they significantly alleviate the severity or symptom burden. These treatments should, therefore, not be advised as monotherapy to treat onychomycosis. TRIAL REGISTRATION NUMBER: WHO ICTRP NL8193.
Subject(s)
Administration, Topical , Antifungal Agents , Miconazole , Morpholines , Onychomycosis , Humans , Miconazole/administration & dosage , Miconazole/therapeutic use , Onychomycosis/drug therapy , Female , Double-Blind Method , Male , Middle Aged , Antifungal Agents/administration & dosage , Antifungal Agents/therapeutic use , Treatment Outcome , Adult , Primary Health Care , Quality of Life , Aged , Severity of Illness IndexABSTRACT
BACKGROUND: Oral thrush is the most common occurring fungal infection in the oral cavity in uncontrolled diabetic patients, it is treated by various antifungal drugs according to each case. This study aimed to evaluate the therapeutic effects of topical application of miconazole and miconazole-loaded chitosan nanoparticles in treatment of diabetic patients with oral candidiasis. METHODS: In this randomized controlled clinical trial. A total of 80 diabetic patients presenting with symptomatic oral candidiasis were randomly assigned into two treatment groups: miconazole and miconazole-loaded chitosan nanoparticles. The patients were treated for 28 days, and clinical assessments were conducted at baseline, 7, 14, 21 and 28 days. Clinical parameters, including signs and symptoms of oral candidiasis were evaluated and microbiological analysis was performed to determine the Candida species and assess their susceptibility to the antifungal agents. Statistical analysis was done to the categorical and numerical data using chi-square test and Kruskal Wallis test. RESULTS: The antifungal efficacy between the miconazole and miconazole-loaded chitosan nanoparticles (CS-MCZ) groups insignificant difference (P > 0.05) was observed. Both treatment modalities exhibited comparable effectiveness in controlling oral candidiasis symptoms and reducing Candida colonization as miconazole-loaded chitosan nanoparticles group showed a significant difference in the clinical improvement in respect of both signs and symptoms from baseline (70%) until the end of study at 28 days (5%) (P < 0.05) Moreover, miconazole-loaded chitosan nanoparticles, there was a significant reduction in the number of colonies forming units of Candida albicans from baseline until the end of the study at 28-day with P value < 0.000. CONCLUSIONS: This randomized controlled clinical trial and microbiological analysis demonstrate that both miconazole and miconazole-loaded chitosan nanoparticles are effective in the treatment of oral candidiasis in diabetic patients with no adverse reactions. TRIAL REGISTRATION: NCT06072716 with first registration first registration in 10/10/2023.
Subject(s)
Candidiasis, Oral , Chitosan , Diabetes Mellitus , Nanoparticles , Humans , Miconazole/pharmacology , Miconazole/therapeutic use , Antifungal Agents/pharmacology , Candidiasis, Oral/drug therapy , Candida , Gels/therapeutic useABSTRACT
Background: Candidiasis is one of the most common opportunistic oral infections that presents different acute and chronic clinical presentations with diverse diagnostic and therapeutic approaches. The present study carries out a bibliographic review on the therapeutic tools available against oral candidiasis and their usefulness in each clinical situation. Material and Methods: Recent studies on treatment of oral candidiasis were retrieved from PubMed and Cochrane Library. Results: Nystatin and miconazole are the most commonly used topical antifungal drugs. Both antifungal drugs are very effective but need a long time of use to eradicate the infection. The pharmacological presentations of miconazole are more comfortable for patients but this drug may interact with other drugs and this fact should be assessed before use. Other topical alternatives for oral candidiasis, such as amphotericin B or clotrimazole, are not available in many countries. Oral fluconazole is effective in treating oral candidiasis that does not respond to topical treatment. Other systemic treatment alternatives, oral or intravenous, less used are itraconazole, voriconazole or posaconazole. Available novelties include echinocandins (anidulafungin, caspofungin) and isavuconazole. Echinocandins can only be used intravenously. Isavuconazole is available for oral and intravenous use. Other hopeful alternatives are new drugs, such as ibrexafungerp, or the use of antibodies, cytokines and antimicrobial peptides. Conclusions: Nystatin, miconazole, and fluconazole are very effective for treating oral candidiasis. There are systemic alternatives for treating recalcitrant infections, such as the new triazoles, echinocandins, or lipidic presentations of amphotericin B
No disponible
Subject(s)
Humans , Candida/isolation & purification , Candidiasis, Oral/drug therapy , Antifungal Agents/therapeutic use , Miconazole/therapeutic use , Nystatin/therapeutic use , Amphotericin B/therapeutic use , Fluconazole/therapeutic use , Echinocandins/therapeutic useABSTRACT
Abstract: Dermatophytes are fungi capable of invading keratinized tissues. Isolation of the fungus with the culture is essential to guide the treatment, because there are more resistant species like Microsporum canis. The chronic use of corticosteroids leads to the deregulation of immunity, promoting atypical manifestations of infections. Topical antifungal therapy is often insufficient, requiring systemic medications. We describe the case of a patient undergoing systemic corticosteroid therapy with a large figurate lesion who presented complete response to exclusively topical treatment.
Subject(s)
Humans , Female , Adult , Immunocompromised Host , Dermatomycoses/drug therapy , Erythema/drug therapy , Miconazole/analogs & derivatives , Antifungal Agents/therapeutic use , Administration, Cutaneous , Dermatomycoses/microbiology , Erythema/microbiology , Miconazole/therapeutic use , Microsporum/isolation & purificationABSTRACT
En la presente revisión sistemática se analizaron 55 artículos estructurados sobre la eficacia terapéutica frente al dolor y a los signos clínicos del liquen plano oral (LPO). La búsqueda bibliográfica se elaboró siguiendo los criterios del sistema PRISMA, seleccionando los ensayos realizados mediante alguno de los siguientes diseños metodológicos: entre fármaco (principio activo) vs. mismo fármaco en diferente excipiente o concentración, fármaco vs. diferente principio activo, fármaco vs. fitoterapia y fármaco vs. tratamiento con fototerapia. Basándonos en los resultados se propone un algoritmo que sirva de guía para establecer el tratamiento del LPO en sus formas clínicas atrófica y erosiva. Se destaca el empleo del propionato de clobetasol al 0,025-0,05% de aplicación tópica como primera alternativa terapéutica. En segundo lugar, el tacrolimús al 0,1% y pimecrolimús al 1% también formulado para su pauta tópica. Y, finalmente, se aborda el empleo de corticosteroide sistémico y la aplicación de láser de diodo (AU)
In this systematic review, 55 structured articles on the therapeutic efficacy against pain and clinical signs of oral lichen planus (OLP) were analysed. The literature search was developed according to the criteria of the PRISMA system, selecting the tests performed using one of the following methodological designs: drug (active ingredient) vs. drug in different excipient or concentration, drug vs. different active principle, drug vs. phytotherapy and drug vs. treatment with phototherapy. Based on the results, an algorithm is proposed to guide the treatment of OLP in its atrophic and erosive clinical forms. The use of clobetasol propionate at 0.025-0.05% of topical application as the first therapeutic alternative is highlighted. Secondly, 0.1% tacrolimus and 1% pimecrolimus also formulated for its topical regimen. And finally, we address the use of systemic corticosteroids and the application of diode lasers (AU)
Subject(s)
Humans , Lichen Planus, Oral/therapy , Clobetasol/therapeutic use , Triamcinolone Acetonide/therapeutic use , Calcineurin/therapeutic use , Laser Therapy , Clinical Protocols , Pain Management/methods , Practice Patterns, Dentists'/trends , Treatment Outcome , Miconazole/therapeutic use , Dexamethasone/therapeutic useABSTRACT
Aim: The current investigation was aimed to develop and optimize the microsponges of miconazole nitrate for treatment of diaper dermatitis for enhanced therapeutic effect. Material and Methods: Microsponges were developed by emulsion solvent diffusion technique using 23 factorial design. Fabricated microsponges were optimized in order to analyze the effects of independent variables on the encapsulation efficiency, particle size, surface topography and in vitro drug release. The optimized formulation was then incorporated into the gel and evaluated. Results: Particle size of all formulations was found to be uniform and scanning electron microscopy (SEM) indicates spherical shape and porous nature of microsponges. In vitro drug release studies of all formulations revealed the release rate within the range of 67%±0.09 to 80.6%± 0.68 at the end of 12 hours. On its basis, formulation F8 was selected and incorporated into the gel (CF8) which was evaluated for pH, viscosity, spreadability, in vitro drug diffusion studies, in vitro anti fungal studies and stability studies. Conclusion: The formulated microsponge-based gel of miconazole nitrate would be a capable substitute to traditional treatment for reliable and economical cure of diaper dermatitis
Objetivo: La presente investigación tuvo como objetivo desarrollar y optimizar las microesponjas de nitrato de miconazol para el tratamiento de la dermatitis del pañal para un efecto terapéutico mejorado. Material y métodos: Las microesponjas fueron desarrollados por emulsión técnica de difusión del disolvente usando un diseño factorial 23. Las microesponjas fabricadas han sido optimizadas con el fin de analizar los efectos de las variables independientes sobre la eficacia de encapsulación, tamaño de partícula, la topografía de la superficie y en la liberación de fármaco in vitro. A continuación, la formulación optimizada se incorporo en un gel y se evaluó. Resultados: Se encontró que el tamaño de partículas de todas las formulaciones fue uniforme y la microscopía electrónica de barrido (SEM) indicó forma esférica y de naturaleza porosa de las microesponjas. En la liberación del fármaco, estudios in vitro de todas las formulaciones, revelaron la velocidad de liberación dentro de un intervalo de 67±0,09% a 80,6±0,68% al cabo de 12 horas. Con esta base, La formulación F8 se seleccionó y se incorporó en el gel (CF8) en el que se evaluó el pH, viscosidad, capacidad de extensión, estudios de difusión in vitro del fármaco, estudios in vitro anti hongos y estudios de estabilidad. Conclusión: El gel a base de microesponja formulado de nitrato de miconazol sería un sustituto adecuado al tratamiento tradicional para la curación fiable y económica de la dermatitis del pañal
Subject(s)
Humans , Male , Female , Miconazole/pharmacology , Miconazole/therapeutic use , Dermatitis/diagnosis , Dermatitis/drug therapy , Diaper Rash/drug therapy , Microscopy, Electron, Scanning/methods , Microscopy, Electron, Scanning , Rheology/instrumentation , Rheology/methods , In Vitro Techniques/methods , In Vitro TechniquesABSTRACT
Introducción: la Empresa Productora Roberto Escudero Díaz, llevó a cabo la reformulación de la crema de nitrato de miconazol al 2 por ciento, por incumplimiento de algunas especificaciones de calidad y contaminaciones microbiológicas de varios lotes industriales, por lo que hubo que realizar cambios mayores a la composición de la formulación registrada. Objetivo: determinar la estabilidad de la nueva formulación de nitrato de miconazol crema al 2 por ciento, para determinar su período de validez. Métodos: se realizaron los estudios según las regulaciones vigentes. Se emplearon tres lotes elaborados a escala piloto, envasados en tubos comprimibles de aluminio por 25 g. Se emplearon como métodos analíticos una técnica por cromatografía líquida de alta resolución y una por cromatografía en capa delgada previamente validadas para estos propósitos. Se consideraron dos temperaturas de almacenamiento: 30 ± 2 ºC (vida de estante) y 40 ± 2 ºC (estabilidad acelerada). Se determinaron los parámetros: propiedades organolépticas, pH, área de extensibilidad, valoración, contenido de sustancias relacionadas y/o productos de degradación, y además se evaluó la calidad de la formulación desde el punto de vista microbiológico. Resultados: desde el punto de vista químico, los lotes evaluados mostraron contenidos superiores al 98 por ciento de analito y niveles muy bajos de sustancias relacionadas, independientemente del lote y la temperatura de almacenamiento. No se detectaron manchas adicionales por cromatografía en capa delgada atribuibles a posibles productos de degradación. La...
Introduction: Roberto Escudero Diaz drug producing company is carrying out the reformulation of 2 percent miconazole nitrate cream due to non-compliance with some quality specifications and the microbiological contamination of several industrial batches, so it was required to make major changes in the registered formulation composition. Objective: to determine the stability of the new 2 percent miconazol nitrate cream formulation to verify its validity period. Methods: the studies followed the regulations in force. Three pilot-scaled batches, packed in 25 g aluminum tubes, were used. The analytical methods were high resolution liquid chromatography technique and thin layer chromatography, being both methods previously validated for these purposes. The selected storage temperatures were 30 ± 2 °C (shelf life) and 40 ± 2 ºC (accelerated stability). The estimated parameters included organoleptic properties, pH, extensibility area, titration, content of related substances and/or degradation products in addition to evaluating the quality of formulation from the microbiological viewpoint. Results: from the chemical viewpoint, the evaluated batches showed contents over 98 percent of analyte and very low levels of related substances, regardless of batch and the storage temperature. The thin layer chromatography did not detect any additional stain attributed to possible degradation products. The extensibility showed normal decrease resulting from progressive structuring of the system and the pH also lowered within the set limits. The microbiological stability of the drug was proved to be high after 12 months. Conclusions: the cream was chemically, physically and microbiologically stable at room temperature for 12 months, so this is the term suggested as the temporary validity period(AU)
Subject(s)
Humans , Miconazole/therapeutic use , Skin Cream/therapeutic use , Chromatography, Thin LayerABSTRACT
Se presenta el caso de un paciente, sin antecedentes ni evidencias de alteraciones de inmunidad, con un cuadro de meningoencefalitis crónica. Este fue ingresado en tres ocasiones con diferentes diagnósticos en un período de 10 meses. Se le realizó el diagnóstico de neurocriptococosis, y corroboró con los estudios de tinta china y cultivo micológico del líquido cefalorraquídeo; no se detectó otra localización del hongo en el paciente. El egresado curado, después del tratamiento con anfotericin B y miconazol y el seguimiento inmunológico hasta el año 2014; se le dio recientemente de alta después de 10 años, excluyéndose definitivamente la inmunosupresión adquirida(AU)
A patient having no history or evidences of immune disorders, presented chronic meningoencephalitis. This patient was admitted three times with different diagnosis in a 10-month period. The diagnosis of neurocryptococcosis was confirmed by means of studies with India ink stain and mycological culture of cerebrospinal fluid, no other localization of fungus was found. The patient was discharged after the treatment with Amphotericin B and miconazole along with immunological follow-up to 2014; he was recently discharged after 10 years, definitely excluding an acquired immunocompetence.
Subject(s)
Humans , Male , Adult , Meningitis, Cryptococcal/diagnosis , Meningitis, Cryptococcal/drug therapy , Meningitis, Cryptococcal/microbiology , Cryptococcus neoformans/isolation & purification , Immunocompetence/immunology , Miconazole/therapeutic useABSTRACT
INTRODUCCIÓN: la Empresa Productora Roberto Escudero Díaz, llevó a cabo la reformulación de la crema de nitrato de miconazol al 2 por ciento, por incumplimiento de algunas especificaciones de calidad y contaminaciones microbiológicas de varios lotes industriales, por lo que hubo que realizar cambios mayores a la composición de la formulación registrada. OBJETIVO: determinar la estabilidad de la nueva formulación de nitrato de miconazol crema al 2 por ciento, para determinar su período de validez. MÉTODOS: se realizaron los estudios según las regulaciones vigentes. Se emplearon tres lotes elaborados a escala piloto, envasados en tubos comprimibles de aluminio por 25 g. Se emplearon como métodos analíticos una técnica por cromatografía líquida de alta resolución y una por cromatografía en capa delgada previamente validadas para estos propósitos. Se consideraron dos temperaturas de almacenamiento: 30 ± 2 ºC (vida de estante) y 40 ± 2 ºC (estabilidad acelerada). Se determinaron los parámetros: propiedades organolépticas, pH, área de extensibilidad, valoración, contenido de sustancias relacionadas y/o productos de degradación, y además se evaluó la calidad de la formulación desde el punto de vista microbiológico. RESULTADOS: desde el punto de vista químico, los lotes evaluados mostraron contenidos superiores al 98 por ciento de analito y niveles muy bajos de sustancias relacionadas, independientemente del lote y la temperatura de almacenamiento. No se detectaron manchas adicionales por cromatografía en capa delgada atribuibles a posibles productos de degradación. La extensibilidad mostró un decrecimiento normal debido a la estructuración progresiva del sistema, y el pH también disminuyó discretamente pero dentro de los límites propuestos. Además se comprobó la elevada estabilidad microbiológica del medicamento a los 12 meses. CONCLUSIONES: la crema es estable química, física y microbiológicamente a temperatura ambiente durante 12 meses, por lo que se propone este tiempo como período de validez provisional(AU)
INTRODUCTION: Roberto Escudero Diaz drug producing company is carrying out the reformulation of 2 percent miconazole nitrate cream due to non-compliance with some quality specifications and the microbiological contamination of several industrial batches, so it was required to make major changes in the registered formulation composition. OBJECTIVE: to determine the stability of the new 2 percent miconazol nitrate cream formulation to verify its validity period. METHODS: the studies followed the regulations in force. Three pilot-scaled batches, packed in 25 g aluminum tubes, were used. The analytical methods were high resolution liquid chromatography technique and thin layer chromatography, being both methods previously validated for these purposes. The selected storage temperatures were 30 ± 2 °C (shelf life) and 40 ± 2 ºC (accelerated stability). The estimated parameters included organoleptic properties, pH, extensibility area, titration, content of related substances and/or degradation products in addition to evaluating the quality of formulation from the microbiological viewpoint. RESULTS: from the chemical viewpoint, the evaluated batches showed contents over 98 percent of analyte and very low levels of related substances, regardless of batch and the storage temperature. The thin layer chromatography did not detect any additional stain attributed to possible degradation products. The extensibility showed normal decrease resulting from progressive structuring of the system and the pH also lowered within the set limits. The microbiological stability of the drug was proved to be high after 12 months. CONCLUSIONS: the cream was chemically, physically and microbiologically stable at room temperature for 12 months, so this is the term suggested as the temporary validity period(AU
Subject(s)
Humans , Male , Female , Chromatography, High Pressure Liquid/methods , Chromatography, Thin Layer/methods , Skin Cream/therapeutic use , Miconazole/therapeutic useABSTRACT
Objetivo: validar el método para control de la calidad del nitrato de miconazol en una nueva crema al 2 por ciento. Métodos: se realizó la validación según los parámetros exigidos para la categoría I y considerando la metodología y los criterios de aceptación vigentes en Cuba. Una vez validado, se aplicó al análisis de los tres lotes elaborados a escala piloto. Resultados: los resultados fueron satisfactorios, cumpliendo en todos los parámetros los límites establecidos. El método fue lineal, exacto y preciso en el rango de 10 a 30 mg/g y no hubo interferencias de ninguno de los componentes de la nueva formulación. Los lotes presentaron correcta dosificación, sin diferencias estadísticamente significativas entre las réplicas y los lotes analizados. Conclusiones: El método evaluado resulta válido para el objetivo con el cual se propuso(AU)
Objective: to validate a quality control method for a 2 percent new miconazole nitrate cream. Methods: the validation was made following the category I parameters and taking into account the methodology and acceptance criteria in force in Cuba. Once validated, the analysis of the three batches was applied on pilot scale. Results: the results were satisfactory since they fulfilled all the set parameters. The method was linear, accurate and precise in the 10-30 mg/g range. there was no interference from any of the components of the new formulation. The batches presented correct dosing, without any statistically significant differences between replicas and analyzed batches. Conclusions: the evaluated method proved to be valid for the stated purpose(AU)
Subject(s)
Humans , Titrimetry/methods , Validation Studies as Topic , Miconazole/therapeutic use , CubaABSTRACT
Introducción: La vaginosis bacteriana (VB) es un síndrome polimicrobiano, en la cual la flora dominante de lactobacilos normales es sustituida por una flora polimicrobiana. La prevalencia de VB en Perú varía entre 27 y 43,7%. El Centro de Control y Prevención de Enfermedades (DCD) sugiere el tratamiento de VB en mujeres sintomáticas con metronidazol oral/gel o clindamicina crema. Se planteó en el presente estudio evaluar la eficacia, tolerancia y seguridad de la combinación de metronidazol, miconazol, centella asiática, polimixina y neomicina en cápsula blanda para el tratamiento de VB. Material y Métodos: El presente estudio de tipo abierto, observacional, prospectivo, permitió evaluar la eficacia, tolerancia y seguridad en la aplicación de la combinación de metronidazol, miconazol, centella asiática, polimixina y neomicina en cápsula blanda. Resultados: Se incluyó a 61 pacientes con edad promedio de 29.28 años (rango 18-48) de las cuales 93,4% tenía historia previa de flujo vaginal anormal. Se realizaron dos visitas durante el estudio, la primera para diagnóstico e inicio de tratamiento y la segunda de control post tratamiento. Tres pacientes no tuvieron segunda visita y 8 no tenían registrada toda la información para definir la respuesta terapéutica. La segunda visita se realizó a los 21 días en promedio. Los principales signos y síntomas en la primera visita de diagnóstico fueron flujo vaginal (100,0%), disconfort vaginal (85,2%), dispareunia (70,5%) y dolor abdominal bajo (57,4%), las cuales disminuyeron en forma significativa (p<0,05) a la segunda visita post tratamiento. La prueba de aminas resultó positiva en el 93,4% de los casos en la primera visita y en el 15,5% de los casos en la segunda visita (p<0,05). De la población inicial de estudio, solo 53 mujeres son evaluables para eficacia terapéutica...
Introduction: Bacterial vaginosis (BV) is a polymicrobial syndrome, in which the normal dominant flora consisting in Lactobacillus is replaced by polymicrobial flora. The prevalence of BV in Peru varies between 27 and 43.7%. The Centers for Disease Control and Prevention suggest therapy for BV in symptomatic women should include oral/gel metronidazole or clindamycin cream. We proposed in this study to evaluate the efficacy, tolerability and safety of the combination of metronidazole, miconazole, Gotu kola (Centella asiatica), polymixin, and neomycin in soft capsules, for the treatment of BV. Material and Methods: This investigation was an open, observational, and prospective study, which allowed us to evaluate the efficacy, tolerability and safety of the aforementioned combined therapy administered in soft capsules. Results: The study included 61 patients with a mean age of 29.28 years (range, 18-48) and 93.4% had a history of abnormal vaginal discharge. Two visits took place during the study, the first for making the diagnosis and initiating therapy, and the second was the post-treatment control. Three patients did not have a second visit and 8 did not record all the information required to define the therapeutic response. The second visit took place after 21 days on average. The main signs and symptoms at the first visit were vaginal discharge at diagnosis (100.0%), vaginal discomfort (85.2%), dyspareunia (70.5%) and lower abdominal pain (57.4%), which were significantly reduced (p <0.05) in the second visit after treatment. The amine test was positive in 93.4% of cases in the first visit and in 15.5% of cases in the second visit (p <0.05). From the initial population in the study, only 53 women are evaluable for efficacy. An overall response rate in 44 women (83.02%) was achieved with the soft capsule combination treatment. Adverse events were reported in only one case...
Subject(s)
Humans , Adolescent , Adult , Female , Young Adult , Middle Aged , /therapeutic use , Metronidazole/therapeutic use , Miconazole/therapeutic use , Neomycin/therapeutic use , Polymyxins/therapeutic use , Vaginosis, Bacterial/therapy , Observational Studies as Topic , Prospective StudiesABSTRACT
Información sobre el caso: La consulta de indicación farmacéutica la hizo el padre para su hija de 3 años. Él hizo el siguiente comentario: «tiene unos puntitos blancos en la boca y le molestan bastante desde hace varios días». Anteriormente había tomado amoxicilina/ ácido clavulánico 100 mg/12,5 mg durante 3-4 días. Después utilizó nistatina en suspensión oral durante 2 días, y posteriormente miconazol gel oral durante 1 día. Al día siguiente acudió a una farmacia comunitaria. No presentaba alergias ni otros problemas de salud. Evaluación: Según el informe médico de urgencias, presentaba una candidiasis oral asociada al tratamiento con antibióticos de amplio espectro. La paciente fue tratada con nistatina y miconazol. La duración del tratamiento fue inferior a 1 semana. La candidiasis oral es un resultado negativo de la medicación de inseguridad no cuantitativa del antibiótico amoxicilina/ácido clavulánico. Actuación: Le recomendé que continuara con el tratamiento de miconazol, recordándole que debía extenderlo bien por la boca, y tomara una cucharada dosifi cadora grande cada 6 horas. Le aconsejé que realizara una correcta higiene oral y un tratamiento no farmacológico con probióticos (Symbioram®), con la posología de un sobre al día con el estómago vacío hasta que desapareciesen los síntomas. Registro de la actuación: La niña mejoró muy rápidamente. La coadministración de probióticos junto con el tratamiento para la candidiasis oral pareció acortar el tiempo de recuperación de la paciente. El farmacéutico comunitario debe trabajar en colaboración con el resto de profesionales sanitarios para mejorar la salud del paciente, nuestra razón de ser(AU)
Information about the case: The consultation of pharmaceutical indication came from the father to his 3-year-old daughter. He commented: she has a few white spots in her mouth and bother her enough from several days ago. She had previously taken amoxicillin/ clavulanic acid 100 mg/12.5 mg during 3-4 days. After, she used nystatin oral suspension for two days and then, miconazole oral gel during a day. The following day they went to a community pharmacy. She did not have allergies, or other health problems. Evaluation: According to the medical emergency report, she presented oral candidiasis associated with treatment with broad-spectrum antibiotics. The patient was treated with nystatin and miconazole. The duration of the treatment was less than 1 week. Oral candidiasis is a negative result of the medication of not quantitative insecurity of the amoxicillin/clavulanic acid antibiotic. Action: I recommended that she continue with the treatment of miconazole, reminding him that he must extend well through the mouth, a measuring tablespoonful every 6 hours. I advised him a correct oral hygiene and a non-pharmacological treatment with probiotics (Symbioram®). Dosage: one on a day with the empty stomach until symptoms disappears. Record of the action: The girl improved very quickly. Coadministration of probiotics with the treatment for oral candidiasis, seemed to shorten the patients recovery. The community pharmacist must work in collaboration with other health professionals to improve the patients health, our reason for being(AU)
Subject(s)
Humans , Female , Child, Preschool , Pharmacies/standards , Pharmacies , Nystatin/therapeutic use , Miconazole/therapeutic use , Anti-Bacterial Agents/therapeutic use , Probiotics/therapeutic use , Candidiasis, Oral/drug therapy , Adrenal Cortex Hormones/therapeutic useABSTRACT
Introducción. La candidiasis cutánea es una enfermedad que afecta tanto a población infantil como adulta. Las forma de presentación puede ser localizada o sistémica y el agente etiológico múltiple, siendo las especies infecciosas de Candida albicans más prevalentes en niños. Objetivo. Presentar un caso de candidiasis cutánea congénita cuya causa aparente fue la transmisión vertical durante el parto. Material y metodología. Se describe el caso de un recién nacido a término expuesto a una candidiasis vaginal subclínica, que desarrolló una candidiasis cutánea congénita por C. albicans asociada a sepsis y dificultad respiratoria en las primeras 24 horas de vida. Se practicaron hemocultivos, biopsia cutánea de las lesiones pápulopústulo-vesiculosas, análisis de sangre y punción lumbar. Resultados. En la bioquímica y el hemograma se encontró una proteína C reactiva de 5,7 mg/dl, leucocitosis con desviación a la izquierda y anemia leve. A las 24 horas, en el control se encontró una proteína C reactiva (7,82 mg/dl) que fue en aumento progresivo durante tres días, por lo que se practicó punción lumbar. El hemocultivo fue positivo para Staphylococcus aureus. La biopsia cutánea dio como resultado histológico la candidiasis cutánea. Conclusiones. El diagnóstico precoz es fundamental para prevenir complicaciones derivadas del cuadro producido por C. albicans en neonatos.
Introduction. Cutaneous candidiasis is a disease that affects children as well as adults. The presentation may be localized or systemic, and with multiple etiological agents. The most prevalent infecting species in children differs from that of the adult. Objective. A case is presented where a congenital cutaneous candidiasis was transmitted to the child during birth. Materials and methods. A full term newborn was exposed to a subclinical vaginal candidiasis infection, and 24 hr after birth, developed congenital cutaneous candidiasis. The etiological agent was Candida albicans, and was associated with sepsis and respiratory distress. Blood cultures, cutaneous biopsy of vesicular lesions, blood tests and lumbar puncture were performed. Results. Biochemistry and blood count showed a CRP of 5.7 mg/dl, leukocytosis with left shift and mild anemia. After 24 hr, the blood analyses showed an increase in a CRP (7.8 mg/dl) and increased progressively for three days; consequently, a lumbar puncture was performed. Blood culture was positive for Staphylococcus aureus. Cutaneous biopsy confirmed the cutaneous candidiasis. Conclusions. The early diagnosis is essential to prevent complications derived by the Candida albicans in newborns.
Subject(s)
Female , Humans , Infant, Newborn , Male , Pregnancy , Candidiasis, Cutaneous/congenital , Infectious Disease Transmission, Vertical , Administration, Cutaneous , Administration, Oral , Anti-Infective Agents/administration & dosage , Anti-Infective Agents/therapeutic use , Bacteremia/complications , Bacteremia/drug therapy , Bacteremia/microbiology , Bicarbonates/administration & dosage , Bicarbonates/therapeutic use , Coinfection , Candidiasis, Cutaneous/complications , Candidiasis, Cutaneous/diagnosis , Candidiasis, Cutaneous/drug therapy , Candidiasis, Cutaneous/pathology , Candidiasis, Cutaneous/transmission , Candidiasis, Vulvovaginal/transmission , Cefotaxime/administration & dosage , Cefotaxime/therapeutic use , Cerebrospinal Fluid/microbiology , Chlorhexidine/therapeutic use , Early Diagnosis , Emollients/administration & dosage , Emollients/therapeutic use , Miconazole/administration & dosage , Miconazole/therapeutic use , Pregnancy Complications, Infectious , Potassium Permanganate/administration & dosage , Potassium Permanganate/therapeutic use , Respiration Disorders/etiology , Sepsis/etiology , Staphylococcal Infections/complications , Staphylococcal Infections/drug therapy , Staphylococcal Infections/microbiology , Staphylococcus aureus/isolation & purification , Therapeutic IrrigationABSTRACT
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Subject(s)
Humans , Female , Child , Pruritus Vulvae/complications , Pruritus Vulvae/diagnosis , Pruritus Vulvae/therapy , Enterobacter cloacae/isolation & purification , Enterobacter cloacae/pathogenicity , Azithromycin/therapeutic use , Ketoconazole/therapeutic use , Miconazole/therapeutic use , Lichen Sclerosus et Atrophicus/diagnosis , Lichen Sclerosus et Atrophicus/drug therapy , Dermatitis/complications , Dermatitis/diagnosis , Lichen Sclerosus et Atrophicus/prevention & controlABSTRACT
El término «tiña incógnita» se utiliza para dermatofitosis con características clínicas no habituales, por utilización tópica de corticoides o inmunomoduladores. Pacientes y métodos: Se exponen 10 casos diagnosticados durante 20 años, con una media de edad de 6,5 años y un tiempo de evolución medio de 2,7 meses. Resultados: En 3 pacientes existía más de un caso familiar, lesiones micropapulosas, pustulosas y descamativas localizadas en la cara, el cuello o las extremidades, T. mentagrophytes en 7 casos y M. canis en uno. Conclusiones: Las lesiones inusuales o difíciles de reconocer, tratadas previamente con corticoides o inmunomoduladores tópicos, requieren siempre un estudio micológico
The term tinea incognito is used to refer to dermatophytosis with uncommon clinical characteristics, usually due to topical utilization of corticosteroides or immunomodulators. The purpose of this report was to demonstrate the importance of the clinical history and additional diagnostic procedures in determining the etiology of tinea. Patients and methods: A total of 10 cases were diagnosed over a 20-year period. The mean age was 6.5 years and the mean duration of disease at inclusion in the study was 2.7 months. Results: In 3 cases, more than one family member was affected, and micropapular, pustular and desquamated lesions located on face, neck or extremities were identified. The etiological agents were T. mentagrophytes in 7 cases and M. canis in one. Conclusions: Unusual or difficult to recognize lesions that had been previously treated with corticosteroids or topical immunosuppressive therapy always require a mycological study
Subject(s)
Male , Female , Infant , Child, Preschool , Child , Humans , Tinea/diagnosis , Tinea/drug therapy , Dermatomycoses/complications , Dermatomycoses/diagnosis , Dermatomycoses/drug therapy , Adrenal Cortex Hormones/therapeutic use , Mupirocin/therapeutic use , Ketoconazole/therapeutic use , Dermatitis, Contact/diagnosis , Dermatitis, Contact/drug therapy , Tinea/complications , Cycloheximide , Miconazole/therapeutic use , Tinea/genetics , Tinea/transmission , Retrospective Studies , Adjuvants, Immunologic/therapeutic use , ChloramphenicolABSTRACT
El eberconazol es un derivado imidazólico tópico de amplio espectro que en estudios preclínicos demostró ser eficaz y tener una potente actividad antimicótica sobre levaduras y hongos, así como una seguridad óptima en estudios de fase I. No presenta hipersensibilidad retardada, no produce fotosensibilidad ni efecto fototóxico, con escasa absorción sistémica. Con objeto de demostrar la eficacia de eberconazol en el tratamiento de las micosis cutáneas, se diseñaron 2 ensayos clínicos comparativos frente a clotrimazol crema al 1% y miconazol crema al 2% de idéntico diseño: multicéntrico, doble ciego y aleatorizado, con una pauta de administración cada 12 h y una duración del tratamiento de 4 semanas. El eberconazol demostró eficacia superior en el tratamiento de las dermatofitosis y eficacia similar en el tratamiento de la candidiasis y la pitiriasis versicolor respecto al clotrimazol, y equivalencia terapéutica respecto al miconazol; no se encontraron diferencias entre los tratamientos en el perfil de seguridad (AU)
Eberconazole is a topical, broad-spectrum imidazole derivative that has been shown to be effective and to have potent antimycotic activity against yeasts and fungi in preclinical studies, with optimal safety in phase I trials. Eberconazole causes no delayed hypersensitivity, photosensititvity or phototoxic effects and has little systemic absorption. To demonstrate the efficacy of eberconazole in the treatment of cutaneous mycoses, two comparative clinical trials of clotrimazole 1% cream versus miconazole 2% cream were carried out with identical design: both were multicenter, double-blind, randomized trials, with doses administered every 12 hours and a treatment duration of 4 weeks. Eberconazole demonstrated greater efficacy in the treatment of dermatophytoses and similar efficacy in the treatment of candidosis and pityriasis versicolor versus clotrimazole, and therapeutic equivalence versus miconazole. No differences in safety profile were found between the treatments (AU)
Subject(s)
Female , Humans , Male , Imidazoles/therapeutic use , Mycoses/diagnosis , Mycoses/drug therapy , Clotrimazole/therapeutic use , Miconazole/therapeutic use , Administration, Topical , Tinea/drug therapy , Treatment Outcome , Dermatomycoses/diagnosisABSTRACT
Las infecciones osteoarticulares causadas por hongos son entidades poco frecuentes. Scedosporium apiospermum es un hongo filamentoso saprofito que puede causar infecciones en la piel, sistema respiratorio, sistema nervioso central o huesos, siendo grave su asociación con estados de inmunosupresión. Presentamos dos casos de artritis causada por este patógeno en rodilla y tobillo de dos hombres sanos después de cirugía e infiltración articular respectivamente. Tras desbridamiento radical y tratamiento antifúngico específico se consiguió la resolución del cuadro (AU)
Subject(s)
Aged , Male , Middle Aged , Humans , Arthritis, Infectious/microbiology , Pseudallescheria/pathogenicity , Surgical Wound Dehiscence/complications , Itraconazole/therapeutic use , Mycoses/drug therapy , Amphotericin B/therapeutic use , Ketoconazole/therapeutic use , Fluconazole/therapeutic use , Miconazole/therapeutic useABSTRACT
La mucositis, gingivitis, estomatitis herpética y candidiasis, constituyen una fuente potencial de infección sistémica en pacientes que reciben quimioterapia; su severidad e incidencia pueden disminuirse mediante procedimientos fundamentados en la prevención y eliminación de las fuentes de irritación e infección oral.Objetivo: Esta investigación tuvo como propósito evaluar la efectividad de un Protocolo de Prevención Oral en niños con cáncer, sometidos a procedimientos de quimioterapia y previo al control de la infección dentobacteriana.Material y Métodos: Se realizó un ensayo clínico, controlado, con asignación aleatoria, en doce pacientes de 5 a 12 años de edad, con diagnóstico de Leucemia Linfoblástica Aguda (LLA) o Linfoma, evaluados durante doce meses, con un total de 154 evaluaciones. Cinco pacientes recibieron refuerzo de fisioterapia oral, enjuagues bucales con flúor al 0,05 sin alcohol y aplicación tópica de jalea de miconazol y siete pacientes recibieron instrucciones sobre fisioterapia oral.Resultados: Los resultados no evidenciaron diferencias significativas entre los grupos evaluados (p>0,05). De las complicaciones orales evaluadas, la gingivitis registró un mayor porcentaje (60 por ciento), seguida de la mucositis (18 por ciento) y la infección por Candida albicans (7 por ciento). Los ganglios submandibulares (59 por ciento) y cervicales (41 por ciento) fueron los más afectados.Conclusiones: El control previo de las fuentes de infección e irritación bucal, efectivamente previenen las complicaciones orales durante la terapia no quirúrgica del cáncer (AU)