ABSTRACT
AIM: To compare the efficacy and safety of recombinant streptokinase (rSK) vs hydrocortisone acetate-based suppositories in acute hemorrhoidal disease. METHODS: A multicenter (11 sites), randomized (1:1:1), open, controlled trial with parallel groups was performed. All participating patients gave their written, informed consent. After inclusion, patients with acute symptoms of hemorrhoids were centrally randomized to receive, as outpatients, by the rectal route, suppositories of rSK 200000 IU of one unit every 8 h (first 3 units) and afterwards every 12 h until 8 administrations were completed (schedule A), one unit every 8 h until 6 units were completed (schedule B), or 25 mg hydrocortisone acetate once every 8 h up to a maximum of 24 administrations. Evaluations were performed at 3, 5, and 10 d post-inclusion. The main end-point was the 5(th)-day response (disappearance of pain and bleeding, and ≥ 70% reduction of the lesion size). Time to response and need for thrombectomy were secondary efficacy variables. Adverse events were also evaluated. RESULTS: Groups were homogeneous with regards to demographic and baseline characteristics. Fifth day complete response rates were 156/170 (91.8%; 95%CI: 87.3-96.2), 155/170 (91.2%; 95%CI: 86.6%-95.7%), and 46/170 (27.1%; 95%CI: 20.1%-34.0%) with rSK (schedule A and B) and hydrocortisone acetate suppositories, respectively. These 64.6% and 63.9% differences (95%CI: 56.7%-72.2% and 55.7%-72.0%) were highly significant (P < 0.001). This advantage was detected since the early 3(rd) day evaluation (68.8% and 64.1% vs 7.1% for the rSK and active control groups, respectively; P < 0.001) and was maintained even at the late 10(th) day assessment (97.1% and 93.5% vs 67.1% for rSK and hydrocortisone acetate, respectively; P < 0.001). Time to response was 3 d (95%CI: 2.9-3.1) for both rSK groups and 10 d (95%CI: 9.3-10.7) in the hydrocortisone acetate group. This difference was highly significant (P < 0.001). All subgroup stratified analyses (with or without thrombosis and hemorrhoid classification) showed a statistically significant advantage for the rSK groups. Thrombectomy was necessary in 4/251 and 14/133 patients with baseline thrombosis in the rSK and hydrocortisone acetate groups, respectively (P < 0.001). There were no adverse events attributable to the experimental treatment. CONCLUSION: rSK suppositories showed a significant advantage over a widely-used over-the-counter hydrocortisone acetate preparation for the treatment of acute hemorrhoidal illness, as well as having an adequate safety profile.
Subject(s)
Anti-Inflammatory Agents/administration & dosage , Fibrinolytic Agents/administration & dosage , Hemorrhoids/drug therapy , Hydrocortisone/analogs & derivatives , Streptokinase/administration & dosage , Acute Disease , Administration, Rectal , Adolescent , Adult , Aged , Anti-Inflammatory Agents/adverse effects , Cuba , Drug Administration Schedule , Female , Fibrinolytic Agents/adverse effects , Hemorrhoids/diagnosis , Humans , Hydrocortisone/administration & dosage , Hydrocortisone/adverse effects , Male , Middle Aged , Recombinant Proteins/administration & dosage , Streptokinase/adverse effects , Suppositories , Thrombectomy , Time Factors , Treatment Outcome , Young AdultABSTRACT
Se realizó un estudio descriptivo, observacional, de cohorte retrospectivo, de 90 pacientes operados de cáncer colorrectal con fines curativos, que fueron asistidos en el Servicio de Coloproctología del Hospital Universitario Dr Ambrosio Grillo Portuondo de Santiago de Cuba, desde enero de 1993 hasta diciembre del 2003, con vistas a determinar la supervivencia en ellos. Para la validación de los resultados se aplicó el test de Kaplan-Meier, y entre estos se destacaron el sexo femenino y los afectados mayores de 60 años de edad. También se observó que los pacientes operados por esta causa sobreviven un promedio de 5 años, con variaciones que no distan de las estadísticas mundiales, según las variables clinicoepidemiológicas seleccionadas(AU)
A descriptive, observational study, of retrospective cohort was carried out in 90 operated patients for colorectal cancer with curative aims, who had been attended in the Coloproctology Service of Dr Ambrosio Grillo Portuondo University Hospital in Santiago de Cuba, from January, 1993 to December, 2003, with the objective of determining their survival, for which the method of Kaplan-Meier estimate was applied. Among the relevant results there were the female sex and the age older than 60 years; it was also observed that the patients operated for this cause survived an average of 5 year, with variations not far from the world statistics, according to the clinical and epidemiological variables selected(AU)
Subject(s)
Humans , Male , Female , Young Adult , Adult , Middle Aged , Aged , Survival Analysis , Colorectal Neoplasms/surgery , Colorectal Neoplasms/mortality , Epidemiology, Descriptive , Retrospective Studies , Observational Studies as TopicABSTRACT
Se realizó un estudio descriptivo, observacional, de cohorte retrospectivo, de 90 pacientes operados de cáncer colorrectal con fines curativos, que fueron asistidos en el Servicio de Coloproctología del Hospital Universitario "Dr. Ambrosio Grillo Portuondo" de Santiago de Cuba, desde enero de 1993 hasta diciembre del 2003, con vistas a determinar la supervivencia en ellos. Para la validación de los resultados se aplicó el test de Kaplan-Meier, y entre estos se destacaron el sexo femenino y los afectados mayores de 60 años de edad. También se observó que los pacientes operados por esta causa sobreviven un promedio de 5 años, con variaciones que no distan de las estadísticas mundiales, según las variables clinicoepidemiológicas seleccionadas.
A descriptive, observational study, of retrospective cohort was carried out in 90 operated patients for colorectal cancer with curative aims, who had been attended in the Coloproctology Service of "Dr. Ambrosio Grillo Portuondo" University Hospital in Santiago de Cuba, from January, 1993 to December, 2003, with the objective of determining their survival, for which the method of Kaplan-Meier estimate was applied. Among the relevant results there were the female sex and the age older than 60 years; it was also observed that the patients operated for this cause survived an average of 5 year, with variations not far from the world statistics, according to the clinical and epidemiological variables selected.
Subject(s)
Colorectal Neoplasms/surgery , Kaplan-Meier Estimate , Survivorship , Colorectal NeoplasmsABSTRACT
Se presenta el caso clínico de un hombre de 48 años de edad, quien fuera ingresado en el Hospital Clinicoquirúrgico Docente Dr Joaquín Castillo Duany de Santiago de Cuba en el 2007, por presentar dificultades para defecar. Según valoración clínico-radiológica, se diagnosticó un cordoma sacrococcígeo y fue egresado debido al estadio del tumor, con indicación de seguimiento en consulta externa. En el mes de julio de ese mismo año se le hospitalizó en el Instituto Nacional de Oncología y Radiología, donde fue intervenido quirúrgicamente. Un año más tarde fue ingresado en el Hospital General Docente Dr Juan Bruno Zayas Alfons", con signos de recidiva tumoral de gran extensión. Falleció 6 meses después(AU)
The case report of a 48 year-old man who was admitted in Dr Joaquín Castillo Duany Teaching Clinical Surgical Hospital from Santiago de Cuba in the 2007 is presented, due to difficulties for defecating. According to a clinical-radiological evaluation, a sacrococcigeal chordoma was diagnosed and he was discharged due to the tumor stage, with the indication of follow up through out patient department. In the month of July of that same year, he was hospitalized in the National Institute of Oncology and Radiology, where he was surgically treated. A year later, he was admitted in Dr Juan Bruno Zayas Alfonso Teaching General Hospital, with signs of tumor relapse of great extension. He died 6 months later(AU)
Subject(s)
Humans , Male , Adult , Chordoma , Sacrococcygeal Region/pathology , Biopsy , Sacrum/pathologyABSTRACT
Se presenta el caso clínico de un hombre de 48 años de edad, quien fuera ingresado en el Hospital Clinicoquirúrgico Docente "Dr. Joaquín Castillo Duany" de Santiago de Cuba en el 2007, por presentar dificultades para defecar. Según valoración clínico-radiológica, se diagnosticó un cordoma sacrococcígeo y fue egresado debido al estadio del tumor, con indicación de seguimiento en consulta externa. En el mes de julio de ese mismo año se le hospitalizó en el Instituto Nacional de Oncología y Radiología, donde fue intervenido quirúrgicamente. Un año más tarde fue ingresado en el Hospital General Docente "Dr. Juan Bruno Zayas Alfonso", con signos de recidiva tumoral de gran extensión. Falleció 6 meses después.
The case report of a 48 year-old man who was admitted in "Dr. Joaquín Castillo Duany" Teaching Clinical Surgical Hospital from Santiago de Cuba in the 2007 is presented, due to difficulties for defecating. According to a clinical-radiological evaluation, a sacrococcigeal chordoma was diagnosed and he was discharged due to the tumor stage, with the indication of follow up through out patient department. In the month of July of that same year, he was hospitalized in the National Institute of Oncology and Radiology, where he was surgically treated. A year later, he was admitted in "Dr. Juan Bruno Zayas Alfonso" Teaching General Hospital, with signs of tumor relapse of great extension. He died 6 months later.
Subject(s)
Recurrence , Sacrococcygeal Region , Chordoma , Neoplasm Recurrence, Local , NeoplasmsABSTRACT
AIM: To compare the efficacy and safety of recombinant streptokinase (rSK) and phenylephrine-based suppositories in acute hemorrhoidal disease. METHODS: A multicenter (14 sites), randomized (1:1), open, parallel groups, active controlled trial was done. After inclusion, subjects with acute symptoms of hemorrhoids, who gave their written, informed consent to participate, were centrally randomized to receive, as outpatients, rSK (200000 IU) or 0.25% phenylephrine suppositories, which had different organoleptic characteristics. Treatment was administered by the rectal route, one unit every 6 h during 48 h for rSK, and up to a maximum of 5 d (20 suppositories) for phenylephrine. Evaluations were performed at 3, 5 and 10 d post-inclusion. The main end-point was the 5(th)-day complete clinical response (disappearance of pain and edema, and ≥ 70% reduction of the lesion size). Time to response and need for thrombectomy were secondary efficacy variables. Adverse events were evaluated too. RESULTS: 5(th) day complete response rates were 83/110 (75.5%) and 36/110 (32.7%) with rSK and phenylephrine suppositories, respectively. This 42.7% difference (95%CI: 30.5-54.2) was highly significant (P < 0.001). The advantage was detected since the early 3(rd) day evaluation (37.3% vs 6.4% for the rSK and active control groups, respectively; P < 0.001) and was kept even at the late 10(th) day assessment (83.6% vs 58.2% for rSK and phenylephrine, respectively; P < 0.001). Time for complete response was significantly shorter (P = 0.031; log-rank test) in the rSK group (median: 4.9 d; 95%CI: 4.8-5.0) with respect to the active control (median: 9.8 d; 95%CI: 9.8-10.0). Thrombectomy was necessary in 1/59 and 8/57 patients with baseline thrombosis in the rSK and phenylephrine groups, respectively (P = 0.016). There were no adverse events attributable to the experimental treatment. CONCLUSION: rSK suppositories showed a significant advantage over a widely used over-the-counter phenylephrine preparation for the treatment of acute hemorrhoidal illness, with an adequate safety profile.
Subject(s)
Hemorrhoids/drug therapy , Phenylephrine/therapeutic use , Streptokinase/therapeutic use , Adolescent , Adult , Aged , Female , Humans , Male , Middle Aged , Suppositories , Thrombolytic Therapy , Treatment Outcome , Young AdultABSTRACT
Se hizo un estudio descriptivo y transversal de 15 pacientes con eritroplasia bucal, tratados en la consulta de estomatología del Policlínico de Especialidades perteneciente al Hospital Provincial Docente Saturnino Lora de Santiago de Cuba, desde junio del 2003 hasta igual mes del 2007, para evaluar los resultados del diagnóstico clínico e histopatológico de esta enfermedad y vincularlos con el tabaquismo y los síntomas subjetivos. Se extrajeron muestras de las zonas dañadas para biopsias, se depositaron en un frasco de cristal que contenía formol a 10 por ciento, se fijaron en formalina a 5 por ciento, se procesaron con la técnica clásica de inclusión en parafina y luego se colorearon con hematoxilina y eosina, con lo cual se confirmó la existencia de cambios celulares. Esta afección prevaleció en el sexo masculino y la ausencia de síntomas subjetivos fue lo más relevante en los fumadores con más años de serlo. El sitio anatómico más susceptible correspondió al paladar duro, con predominio de la displasia epitelial moderada en los adictos al hábito de fumar desde hacía mayor tiempo(AU)
A descriptive and cross-sectional study of 15 patients with oral erythroplasia, treated at the stomatological service of the Specialities Polyclinic belonging to Saturnino Lora Teaching Provincial Hospital from Santiago de Cuba was carried out, from June, 2003 to the same month of 2007, to evaluate the results of the clinical and histopathological diagnosis of this disease and to link them with the smoking habit and the subjective symptoms. Samples of the damaged areas were taken for biopsies, they were deposited in a glass flask with 10 per cent formalin, they were fixed in 5 per cent formalin, and processed with the classical technique of inclusion in paraffin and then they were stained with hematoxylin and eosin, which confirmed the existence of cellular changes. This disorder prevailed in the male sex and the absence of subjective symptoms was the most important observation in the smokers with longer period of this habit. The most sensitive anatomical site corresponded to the hard palate, with prevalence of the epithelial dysplasia which was moderate in the nicotine addiction cases with longer periods of it(AU)
Subject(s)
Humans , Erythroplasia/diagnosis , Tobacco Use Disorder , Mouth Diseases/diagnosis , Epidemiology, Descriptive , Cross-Sectional StudiesABSTRACT
Se hizo un estudio descriptivo y transversal de 15 pacientes con eritroplasia bucal, tratados en la consulta de estomatología del Policlínico de Especialidades perteneciente al Hospital Provincial Docente Saturnino Lora de Santiago de Cuba, desde junio del 2003 hasta igual mes del 2007, para evaluar los resultados del diagnóstico clínico e histopatológico de esta enfermedad y vincularlos con el tabaquismo y los síntomas subjetivos. Se extrajeron muestras de las zonas dañadas para biopsias, se depositaron en un frasco de cristal que contenía formol a 10 por ciento, se fijaron en formalina a 5 por ciento, se procesaron con la técnica clásica de inclusión en parafina y luego se colorearon con hematoxilina y eosina, con lo cual se confirmó la existencia de cambios celulares. Esta afección prevaleció en el sexo masculino y la ausencia de síntomas subjetivos fue lo más relevante en los fumadores con más años de serlo. El sitio anatómico más susceptible correspondió al paladar duro, con predominio de la displasia epitelial moderada en los adictos al hábito de fumar desde hacía mayor tiempo.
A descriptive and cross-sectional study of 15 patients with oral erythroplasia, treated at the stomatological service of the Specialities Polyclinic belonging to Saturnino Lora Teaching Provincial Hospital from Santiago de Cuba was carried out, from June, 2003 to the same month of 2007, to evaluate the results of the clinical and histopathological diagnosis of this disease and to link them with the smoking habit and the subjective symptoms. Samples of the damaged areas were taken for biopsies, they were deposited in a glass flask with 10 per cent formalin, they were fixed in 5 per cent formalin, and processed with the classical technique of inclusion in paraffin and then they were stained with hematoxylin and eosin, which confirmed the existence of cellular changes. This disorder prevailed in the male sex and the absence of subjective symptoms was the most important observation in the smokers with longer period of this habit. The most sensitive anatomical site corresponded to the hard palate, with prevalence of the epithelial dysplasia which was moderate in the nicotine addiction cases with longer periods of it.
Subject(s)
Humans , Mouth Diseases/diagnosis , Erythroplasia/diagnosis , Tobacco Use Disorder , Cross-Sectional Studies , Epidemiology, DescriptiveABSTRACT
Se presenta el caso clínico de una anciana con fístula colovaginal consecutiva a enfermedad diverticular complicada, intervenida quirúrgicamente por los autores para realizarle una fistulotomía seguida de sigmoidectomía del segmento dañado, con anastomosis terminoterminal y cierre del orificio de la cúpula vaginal, que garantizó una favorable evolución posoperatoria(AU)
The clinical case of an elderly woman with colovaginal fistula after a complicated diverticular disease is reported, who was operated by the authors with the purpose of performing fistulotomy followed by sigmoidectomy of the damaged segment with termino-terminal anastomosis and closing of vaginal vault hole, warranting a favorable postoperative course(AU)
Subject(s)
Humans , Female , Aged , Vaginal Fistula , Hysterectomy , Hysterectomy, Vaginal , Colectomy , Anastomosis, Surgical , Hysterectomy/methods , Colon/pathology , Colon, Sigmoid/surgeryABSTRACT
Se presenta el caso clínico de una anciana con fístula colovaginal consecutiva a enfermedad diverticular complicada, intervenida quirúrgicamente por los autores para realizarle una fistulotomía seguida de sigmoidectomía del segmento dañado, con anastomosis terminoterminal y cierre del orificio de la cúpula vaginal, que garantizó una favorable evolución posoperatoria.
The clinical case of an elderly woman with colovaginal fistula after a complicated diverticular disease is reported, who was operated by the authors with the purpose of performing fistulotomy followed by sigmoidectomy of the damaged segment with termino-terminal anastomosis and closing of vaginal vault hole, warranting a favorable postoperative course.
Subject(s)
Humans , Female , Aged , Anastomosis, Surgical , Colectomy , Colon, Sigmoid/surgery , Colon/pathology , Hysterectomy , Hysterectomy, Vaginal , Hysterectomy/methods , Vaginal FistulaABSTRACT
Se hizo un estudio descriptivo y transversal para evaluar los resultados terapéuticos de la criocirugía como procedimiento crioquirúrgico en 82 pacientes con verrugas vulgares de la cara, de donde se derivó que las congelaciones entre 20 - 30 segundos y las descongelaciones entre 91-120 segundos fueron las mejores respuestas a la crioterapia, en tanto la costra sobresalió como signo en la evolución posoperatoria. La reparación y reepitelización de la zona tratada se produjeron generalmente entre los 7 - 14 días, luego de los cuales cicatrizó satisfactoriamente la piel en los integrantes de la casuística. Esta técnica crioquirúrgica mostró ser sencilla, atraumática y fácil de aplicar en el tejido cutáneo, por lo cual se considera un tratamiento eficaz, alternativo y aconsejable, tanto por su bajo costo como por la nulidad de riesgos y complicaciones(AU)
A descriptive and cross-sectional study was carried out to evaluate the therapeutic results of the cryosurgery as cryosurgical procedure in 82 patients with warts vulgaris of the face, from which it was concluded that freezings of 20-30 seconds and the unfreezings of 91-120 seconds were the best responses to cryotherapy, and the scab was considered the sign in the postoperative course. The repair and new epithelization of the treated area generally took place between 7-14 days, after which it healed the skin satisfactorily in the case material. This cryosurgical technique showed to be simple, non traumatic and easy to be applied in the cutaneous tissue, that is why it is considered an effective, alternative and advisable treatment, either for its low cost as for the absence of risks and complications
Subject(s)
Humans , Male , Female , Cryosurgery/methods , Warts , Face , Epidemiology, Descriptive , Cross-Sectional StudiesABSTRACT
Se hizo un estudio descriptivo y transversal para evaluar los resultados terapéuticos de la criocirugía como procedimiento crioquirúrgico en 82 pacientes con verrugas vulgares de la cara, de donde se derivó que las congelaciones entre 20 - 30 segundos y las descongelaciones entre 91-120 segundos fueron las mejores respuestas a la crioterapia, en tanto la costra sobresalió como signo en la evolución posoperatoria. La reparación y reepitelización de la zona tratada se produjeron generalmente entre los 7 - 14 días, luego de los cuales cicatrizó satisfactoriamente la piel en los integrantes de la casuística. Esta técnica crioquirúrgica mostró ser sencilla, atraumática y fácil de aplicar en el tejido cutáneo, por lo cual se considera un tratamiento eficaz, alternativo y aconsejable, tanto por su bajo costo como por la nulidad de riesgos y complicaciones.
A descriptive and cross-sectional study was carried out to evaluate the therapeutic results of the cryosurgery as cryosurgical procedure in 82 patients with warts vulgaris of the face, from which it was concluded that freezings of 20-30 seconds and the unfreezings of 91-120 seconds were the best responses to cryotherapy, and the scab was considered the sign in the postoperative course. The repair and new epithelization of the treated area generally took place between 7-14 days, after which it healed the skin satisfactorily in the case material. This cryosurgical technique showed to be simple, non traumatic and easy to be applied in the cutaneous tissue, that is why it is considered an effective, alternative and advisable treatment, either for its low cost as for the absence of risks and complications.
