RESUMEN
This study evaluates the effectiveness of immunomodulating drug isoprinosine in a comprehensive treatment of genital warts in men. Most of the patients were aged 20-30 years. The combination therapy was found to have long term effectiveness. In the group of patients undergoing only destructive methods of treatment relapse after 8 month follow-up was diagnosed in 32% and in patients of the combination therapy group (destruction plus isoprinosine) - in 7% of patients. The pharmacological action of the drug (immunostimulating, antiviral) and the effectiveness of its combination with destructive therapies justify the use of inosine pranobex (isoprinosine) both in the complex therapy of genital warts and for the prevention of the disease recurrence.
Asunto(s)
Adyuvantes Inmunológicos/uso terapéutico , Antivirales/uso terapéutico , Condiloma Acuminado/tratamiento farmacológico , Enfermedades de los Genitales Masculinos/tratamiento farmacológico , Inosina Pranobex/uso terapéutico , Infecciones por Papillomavirus/tratamiento farmacológico , Adyuvantes Inmunológicos/administración & dosificación , Adyuvantes Inmunológicos/efectos adversos , Adulto , Antivirales/administración & dosificación , Antivirales/efectos adversos , Terapia Combinada , Condiloma Acuminado/inmunología , Condiloma Acuminado/cirugía , Condiloma Acuminado/virología , Quimioterapia Combinada , Enfermedades de los Genitales Masculinos/inmunología , Enfermedades de los Genitales Masculinos/cirugía , Enfermedades de los Genitales Masculinos/virología , Humanos , Inosina Pranobex/administración & dosificación , Inosina Pranobex/efectos adversos , Masculino , Infecciones por Papillomavirus/inmunología , Infecciones por Papillomavirus/cirugía , Infecciones por Papillomavirus/virología , Resultado del Tratamiento , Adulto JovenRESUMEN
AIM: To study the development of children with selectively treated cytomegalovirus infection. PATIENTS AND METHODS: We studied prospectively a risk group of 12 children with cytomegalovirus infection. These children were diagnosed by serological screening in the first three months after birth and are defined as congenital and perinatal infections. Thirteen infants with no serological evidence of previous or present cytomegalovirus infection at 4-12 months of age were used as controls. Ganciclovir in a dose of 10-15 mg/kg/day for at least 2 weeks followed by 5-7.5 mg/kg/day administered intravenously for at least 2 weeks more was given to 4 children from the risk group with PCR confirmed cytomegalovirus infection: to one with suspected congenital infection that presented with encephalitis, to two children with abnormal auditory evoked potentials (AEPs) and other non-neurological symptoms of a suspected congenital infection, and to one child with proven congenital infection with systemic manifestations. There was no infant with cytomegalic inclusion disease in the study. All other children in the risk group that had clinically manifested infection received isoprinosine in a dose of 50 mg/kg for one month. RESULTS: Psychomotor development delay at age three was found in two children from the risk group and in one child in the control group. There was no difference between the two groups regarding the frequency of paroxysmal events, sensory deficiency or frequent illnesses. CONCLUSIONS: The prognosis in cases of cytomegalovirus infection diagnosed at three years of age and treated selectively can be similar to that in infection free 3-year-old children (if there are no cases of CMV inclusion disease).
Asunto(s)
Antivirales/efectos adversos , Desarrollo Infantil/efectos de los fármacos , Infecciones por Citomegalovirus/tratamiento farmacológico , Ganciclovir/efectos adversos , Trastornos Psicomotores/inducido químicamente , Desempeño Psicomotor/efectos de los fármacos , Antivirales/uso terapéutico , Preescolar , Protocolos Clínicos , Citomegalovirus/genética , Citomegalovirus/inmunología , Infecciones por Citomegalovirus/complicaciones , Infecciones por Citomegalovirus/congénito , Infecciones por Citomegalovirus/diagnóstico , Ganciclovir/uso terapéutico , Humanos , Lactante , Recién Nacido , Inyecciones Intravenosas , Inosina Pranobex/efectos adversos , Inosina Pranobex/uso terapéutico , Atención Perinatal , Pronóstico , Estudios Prospectivos , Trastornos Psicomotores/diagnóstico , Factores de TiempoRESUMEN
In vivo magnetic resonance techniques such as magnetic resonance imaging (MRI) and magnetic resonance spectroscopy have been some of the most useful tools for evaluation of neurologic diseases. In subacute sclerosing panencephalitis, magnetic resonance spectroscopy can be an additional tool for evaluation of disease progression or the efficacy of the treatment, such as interferon or inosiplex, compared with MRI. Inosiplex is one of the effective drugs for subacute sclerosing panencephalitis, but our in vivo and in vitro magnetic resonance spectroscopic study indicated that inosiplex affects the spectra, suggesting a possible failure of neurologic evaluation in a patient with subacute sclerosing panencephalitis treated with inosiplex.
Asunto(s)
Antivirales/efectos adversos , Artefactos , Inosina Pranobex/efectos adversos , Espectroscopía de Resonancia Magnética , Panencefalitis Esclerosante Subaguda/tratamiento farmacológico , Adolescente , Antivirales/química , Antivirales/farmacocinética , Antivirales/uso terapéutico , Ácido Aspártico/análogos & derivados , Ácido Aspártico/metabolismo , Colina/metabolismo , Progresión de la Enfermedad , Dominancia Cerebral/fisiología , Femenino , Lóbulo Frontal/efectos de los fármacos , Lóbulo Frontal/metabolismo , Humanos , Inosina Pranobex/química , Inosina Pranobex/farmacocinética , Inosina Pranobex/uso terapéutico , Inositol/metabolismo , Ácido Láctico/metabolismo , Imagen por Resonancia Magnética , Examen Neurológico/efectos de los fármacos , Reproducibilidad de los Resultados , Panencefalitis Esclerosante Subaguda/diagnóstico , Ácido gamma-Aminobutírico/metabolismoRESUMEN
The efficacy of oral inosiplex alone (group A) versus combined treatment of inosiplex (Isoprinosine) and intraventricular interferon-alpha2b (Intron A) (group B) in patients with subacute sclerosing panencephalitis (SSPE) was compared. One hundred and twenty-one patients who met the diagnostic criteria for subacute sclerosing panencephalitis and presented at stage 2 or less were randomized into group A or B. Data were analyzable on 67 patients who met the inclusion criteria and adhered to the protocol. The inosiplex dosage was 100 mg/kg/day to a maximum of 3 g/day, taken orally in three divided doses for 6 months. Interferon-alpha2b started with 100,000 U/m2 and escalated to 1,000,000 U/m2 over 5 inpatient days and then 1,000,000 U/m2 twice a week for 6 months. Neurologic status was rated by the Neurological Disability Index, Brief Assessment Examination, and stages. Kaplan-Meier survival rates were not statistically significant between group A and group B (log-rank test chi2 = .1374, P = .7109). In longitudinal morbidity analyses, regression results were fitted to three outcome measures: the Neurological Disability Index, the Brief Assessment Examination, and stage. Group medians of the estimated regression slopes were then compared using the Wilcoxon rank-sum test. There was no statistically significant difference between the two groups on any of these three measures. Morbidity comparisons of clinical classification of outcomes (improvement, stabilization, worsening after treatment stopped, deterioration) also showed no statistically significant difference between groups. There were no statistically significant differences between the two treatment groups on any efficacy measure. However, the observed rates of satisfactory outcome (stabilization, improvement) of 34% in group A and 35% in group B were higher than the spontaneous remission rates of 5 to 10% reported in the literature, suggesting that treatment was superior to no treatment.
Asunto(s)
Antivirales/administración & dosificación , Inosina Pranobex/administración & dosificación , Interferón-alfa/administración & dosificación , Panencefalitis Esclerosante Subaguda/tratamiento farmacológico , Administración Oral , Adolescente , Adulto , Antivirales/efectos adversos , Niño , Preescolar , Evaluación de la Discapacidad , Relación Dosis-Respuesta a Droga , Esquema de Medicación , Quimioterapia Combinada , Femenino , Humanos , Inyecciones Intraventriculares , Inosina Pranobex/efectos adversos , Interferón alfa-2 , Interferón-alfa/efectos adversos , Masculino , Examen Neurológico/efectos de los fármacos , Proteínas Recombinantes , Panencefalitis Esclerosante Subaguda/diagnóstico , Resultado del TratamientoAsunto(s)
Vértebras Cervicales , Mioclonía/diagnóstico , Cráneo , Panencefalitis Esclerosante Subaguda/diagnóstico , Edad de Inicio , Antivirales/efectos adversos , Antivirales/uso terapéutico , Demencia/inducido químicamente , Electroencefalografía , Electromiografía , Ensayo de Inmunoadsorción Enzimática , Humanos , Inmunoglobulina G/líquido cefalorraquídeo , Inmunoglobulina G/inmunología , Inosina Pranobex/efectos adversos , Inosina Pranobex/uso terapéutico , Imagen por Resonancia Magnética , Virus del Sarampión/inmunología , Panencefalitis Esclerosante Subaguda/tratamiento farmacológico , Grabación de Cinta de VideoRESUMEN
A randomized double-blind placebo controlled study was carried out to assess the efficacy of inosine pranobex (1 g orally 3 times a day for 6 weeks) in the treatment of symptomatic subclinical human papillomavirus infection of the vulva. In a series of 55 women, 22 patients in the inosine pranobex group and 24 patients in the placebo group were suitable for analysis. A total of 14 (63.5%) of the inosine pranobex treated patients and 4 (16.7%) of the placebo treated patients showed significant vulval epithelial morphological improvement (P = 0.005) at 2 months after initiation of treatment. Whereas 13 (59.1%) and 9 (37.5%) patients in the respective groups showed significant improvement in the severity of pruritus vulvae (P = 0.435). Twelve (66.7%) of 18 patients with morphological improvement compared to 10 (35.7%) of 28 patients with no morphological improvement experienced significant symptomatic alleviation of pruritus vulvae (P = 0.041). Similar results were seen at the second assessment 4 months after the initiation of treatment. Adverse drug reactions were reported by 2 patients in the treatment group and by 2 patients (skin rash) in the placebo group. These adverse reactions were mild and self limiting. It is concluded that inosine pranobex demonstrated a significant pharmacological activity in subclinical HPV infection of the vulva and should be considered an alternative treatment for the condition.
Asunto(s)
Antivirales/uso terapéutico , Inosina Pranobex/uso terapéutico , Papillomaviridae , Infecciones por Papillomavirus/tratamiento farmacológico , Infecciones Tumorales por Virus/tratamiento farmacológico , Administración Oral , Adulto , Antivirales/administración & dosificación , Antivirales/efectos adversos , Método Doble Ciego , Femenino , Humanos , Inosina Pranobex/administración & dosificación , Inosina Pranobex/efectos adversos , Persona de Mediana Edad , Prurito Vulvar/tratamiento farmacológico , Vulva/virologíaRESUMEN
Six cases of subacute sclerosing panencephalitis (1 stage I, 3 stage II, 2 stage III) were diagnosed at our institution in the last 10 years. Five patients were treated with isoprinosine and the antiepileptic drug valproic acid. Three patients presented with myoclonic seizures refractory to valproic acid and the usual antiepileptic therapy. They received trihexyphenidyl with good results. We suggest the use of trihexyphenidyl in combination with isoprinosine in patients with subacute sclerosing panencephalitis with myoclonic seizures refractory to valproic acid.
Asunto(s)
Adyuvantes Inmunológicos/uso terapéutico , Antiparkinsonianos/uso terapéutico , Inosina Pranobex/uso terapéutico , Panencefalitis Esclerosante Subaguda/diagnóstico , Trihexifenidilo/uso terapéutico , Adyuvantes Inmunológicos/efectos adversos , Adulto , Anticonvulsivantes/efectos adversos , Anticonvulsivantes/uso terapéutico , Antiparkinsonianos/efectos adversos , Niño , Preescolar , Quimioterapia Combinada , Electroencefalografía/efectos de los fármacos , Femenino , Humanos , Inosina Pranobex/efectos adversos , Masculino , Panencefalitis Esclerosante Subaguda/tratamiento farmacológico , Tomografía Computarizada por Rayos X , Trihexifenidilo/efectos adversos , Ácido Valproico/efectos adversos , Ácido Valproico/uso terapéuticoRESUMEN
A placebo controlled clinical trial. Thirty two patients with chronic C hepatitis have been enrolled in a double blinded study to assess the therapeutic effect on an orally given antiviral-immunomodulatory drug, Isoprinosine. Seventeen patients were given Isoprinosine (3 g/day) and fifteen were on placebo. The treatment has been lasted for four months, when patients examined monthly. Clinical signs, liver function tests and side effects were evaluated. At the end of the trial, side effects and elevated serum alanine aminotransferase (ALT/GPT) levels occurred with higher frequency in Isoprinosine-treated patients. The results show that this antiviral drug has no beneficial effect in chronic C hepatitis.
Asunto(s)
Hepatitis C/tratamiento farmacológico , Inosina Pranobex/uso terapéutico , Adulto , Alanina Transaminasa/sangre , Método Doble Ciego , Evaluación de Medicamentos , Femenino , Hepatitis C/enzimología , Humanos , Inosina Pranobex/efectos adversos , Masculino , Persona de Mediana Edad , Placebos , Estudios ProspectivosRESUMEN
In 35 cases of SSPE sensibilized neuropsychological testing was done before and after 6 months of immunostimulatory and virostatic treatment. Three groups of patients were studied. All groups received isoprinosine, one group was given additionally TFX-thymus extract Polfa, and another group received additionally Propionibacterium granulosum KP-45. A tendency for improvement of verbal function and emotional status was observed only in the group receiving isoprinosine with propionibacterium. In both remaining groups, receiving only isoprinosine or isoprinosine with TFX worsening was noted, particularly in the isoprinosine-only group. This was particularly evident in the visuospatial orientation. Prolongation of survival time in SSPE owing to specific treatment increases the need for psychoreactive and therapeutic influences for stimulation of cognitive processes.
Asunto(s)
Trastornos del Conocimiento/etiología , Trastornos Mentales/etiología , Panencefalitis Esclerosante Subaguda/psicología , Adolescente , Niño , Trastornos del Conocimiento/diagnóstico , Femenino , Humanos , Inosina Pranobex/efectos adversos , Inosina Pranobex/uso terapéutico , Masculino , Trastornos Mentales/diagnóstico , Pruebas Neuropsicológicas , Propionibacterium , Percepción Espacial/efectos de los fármacos , Panencefalitis Esclerosante Subaguda/tratamiento farmacológico , Extractos del Timo/uso terapéutico , Conducta Verbal , Percepción Visual/efectos de los fármacosRESUMEN
We performed a randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of inosine pranobex (Isoprinosine) [corrected] in the treatment of patients with human immunodeficiency virus (HIV) infection but without manifest acquired immunodeficiency syndrome (AIDS). A total of 866 patients were enrolled in 21 centers in Denmark and Sweden. The patients were stratified in three groups according to their CD4+ cell count and randomly assigned to receive either inosine pranobex (1 g three times a day) (n = 429) or matching placebo (n = 437) for 24 weeks. Of the 831 patients who could be evaluated, AIDS developed in 17 in the placebo group as compared with 2 in the inosine pranobex group (P less than 0.001; odds ratio, 8.6 [95 percent confidence limits, 2.2 and 52.6]). There were no significant differences between the groups with respect to changes in CD4+ cell count or the development of other HIV-related conditions, with the exception of thrush, which developed in fewer patients in the inosine pranobex group (P = 0.05). No serious side effects were observed. We conclude that treatment with inosine pranobex delays progression to AIDS in patients with HIV infection. The duration of this beneficial effect, the optimal dose, and the mode of action of inosine pranobex remain to be clarified.
Asunto(s)
Síndrome de Inmunodeficiencia Adquirida/prevención & control , Infecciones por VIH/tratamiento farmacológico , Inosina Pranobex/uso terapéutico , Inosina/análogos & derivados , Adolescente , Adulto , Anciano , Linfocitos T CD4-Positivos , Método Doble Ciego , Humanos , Inosina Pranobex/administración & dosificación , Inosina Pranobex/efectos adversos , Recuento de Leucocitos , Persona de Mediana Edad , Ensayos Clínicos Controlados Aleatorios como Asunto , Linfocitos T ReguladoresRESUMEN
In a randomised, placebo controlled, double blind study inosine pranobex was assessed as a possible second line drug in rheumatoid arthritis. Twenty four patients received inosine pranobex (3 g/day) and 26 patients received placebo for up to 24 weeks. Morning stiffness, articular index, grip strength, pain score, erythrocyte sedimentation rate, C reactive protein, IgG, IgM, and serum urate were assessed at weeks 0, 12, and 24. Baseline characteristics were similar except for a significantly higher C reactive protein in the placebo group. No significant improvement occurred in any variable: (a) when comparing week 0 with week 12 or week 24 for either group, (b) comparing active drug with placebo at week 12 or 24, or (c) taking all 50 patients as one group. Withdrawal from the study for lack of response or side effects was similar in both groups. Serum urate increased transiently but significantly with inosine pranobex (a recognised side effect). It is concluded that inosine pranobex has no second line activity in rheumatoid arthritis. Further, 50 patients effectively given placebo showed no spontaneous improvement in their disease activity.
Asunto(s)
Artritis Reumatoide/tratamiento farmacológico , Inosina Pranobex/uso terapéutico , Inosina/análogos & derivados , Adulto , Anciano , Método Doble Ciego , Humanos , Inosina Pranobex/administración & dosificación , Inosina Pranobex/efectos adversos , Persona de Mediana Edad , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
Twenty-five of 34 patients with alopecia totalis of at least 1 year's duration and associated defects in cell-mediated immunity completed a randomized, double-blind, placebo-controlled crossover trial of the therapeutic effect of inosiplex, a synthetic immunomodulator. Each patient received 20 weeks of treatment with inosiplex and 20 weeks with placebo in randomized order. Eleven patients were identified clinically as responders to inosiplex in terms of hair regrowth. Scalp biopsy results correlated well with drug therapy. Enhanced immune function was found in the majority of responding patients; however, statistical analysis of the results of the entire patient population revealed limited significant differences. No patient experienced adverse side effects attributable to therapy. These results show that inosiplex is a safe and effective therapy for certain patients with alopecia totalis.
Asunto(s)
Alopecia/tratamiento farmacológico , Inosina Pranobex/uso terapéutico , Inosina/análogos & derivados , Adulto , Alopecia/inmunología , Biopsia con Aguja , Ensayos Clínicos como Asunto , Método Doble Ciego , Femenino , Cabello/crecimiento & desarrollo , Humanos , Pruebas Inmunológicas , Inosina Pranobex/efectos adversos , Masculino , Placebos , Distribución Aleatoria , Cuero Cabelludo/efectos de los fármacos , Cuero Cabelludo/patología , Factores de TiempoRESUMEN
A total of 151 cases of subacute sclerosing panencephalitis (SSPE), comprising 89 cases treated with MND-19 (Inosiplex) and 62 untreated cases, were retrospectively investigated as to background characteristics, survival rate and clinical course in order to compare the findings in the 2 groups of cases. The survival rate for the cases treated with MND-19 (MND-19-treated group) was significantly higher than that for the untreated cases (control group), which was also true on stratified analysis or on smoothing of the background factors by means of Cox's multiple regression model. Investigation of the clinical course revealed that progression through the disease stages was significantly slow in the MND-19-treated group, compared with in the control group. Global rating of the clinical course showed that a prolonged remission was obtained in more MND-19-treated cases than control cases. The measles virus antibody titer was in no way affected in the former group. Side effects of MND-19 were observed in 17 of the 89 treated cases (19.1%).
Asunto(s)
Inosina Pranobex/uso terapéutico , Inosina/análogos & derivados , Panencefalitis Esclerosante Subaguda/tratamiento farmacológico , Adolescente , Niño , Preescolar , Ensayos Clínicos como Asunto , Quimioterapia Combinada , Femenino , Humanos , Inosina Pranobex/efectos adversos , Masculino , Estudios RetrospectivosRESUMEN
Twenty patients with classical or proved rheumatoid arthritis were treated with Isoprinosine. 13 patients received a dose of 25 mg/kg/day and 7 received a dose of 50 mg/kg/day, continuously for 2 months and then discontinuously, 5 days every fortnight. The series being treated with 25 mg/kg/day (7 patients) have received treatment for 12 months. No side effects have been observed; the only reason for ceasing treatment was its ineffectiveness (after at least 3 months of administration). The dosage of the associated anti-inflammatory drugs did not need to be increased, but neither was it decreased. The authors conclude that Isoprinosine is largely ineffective clinically, on laboratory tests and in terms of immunology, at least with the therapeutic protocols tested here.
Asunto(s)
Artritis Reumatoide/tratamiento farmacológico , Inosina Pranobex/uso terapéutico , Inosina/análogos & derivados , Adulto , Anciano , Antiinflamatorios/administración & dosificación , Artritis Reumatoide/sangre , Artritis Reumatoide/inmunología , Ensayos Clínicos como Asunto , Quimioterapia Combinada , Femenino , Humanos , Inosina Pranobex/administración & dosificación , Inosina Pranobex/efectos adversos , Masculino , Persona de Mediana Edad , Linfocitos T Reguladores/efectos de los fármacosRESUMEN
The incidence of chromatid and chromosome abnormalities and that of SCE induced by isoprinosine was studied in human lymphocyte cultures. No effect was detected in vivo. In vitro the only effect detected was an increased SCE incidence when isoprinosine at 1000 microgram/ml in culture medium was used.
Asunto(s)
Aberraciones Cromosómicas , Intercambio Genético/efectos de los fármacos , Inosina Pranobex/efectos adversos , Inosina/análogos & derivados , Intercambio de Cromátides Hermanas/efectos de los fármacos , Adolescente , Adulto , Niño , Cromátides/efectos de los fármacos , Humanos , Técnicas In Vitro , Masculino , Persona de Mediana EdadRESUMEN
The prophylactic efficacy of isoprinosine was evaluated in a double-blind fashion in volunteers challenged with two types of rhinovirus. In the rhinovirus 44 and 32 trials, each of 9 men received a placebo, and eight and 11 men received the drug, respectively. Oral isoprinosine, 6 g a day, was given for 2 days prior to intranasal challenge with 100 mean tissue culture infective doses of the virus and for 7 postchallenge days. In both trials the occurrence and severity of colds were greater in the placebo group, but the difference between the two groups was not significant. Higher antibody titers for both viruses and a greater number of rhinovirus 32 isolations were demonstrated in the drug group but without statistically significant differences. The prophylactic isoprinosine treatment may suppress the cold syndrome, but its effect was not convincingly apparent.