RESUMEN
BACKGROUND: Etanercept (ETN) 50 mg once weekly (QW) or 50 mg twice weekly (BIW) for 12 weeks, followed by 50 mg QW in all subjects to Week 24 improved psoriasis in patients with concomitant psoriatic arthritis in the PRESTA trial. OBJECTIVES: To use data from PRESTA to evaluate the effect of ETN in the treatment of psoriasis by Psoriasis Area Severity Index (PASI) body-region and component, and determine if PASI responses correlate with the Dermatology Life Quality Index (DLQI). METHODS: Median time to 75% improvement in PASI (PASI75), body- and component-specific subscales over 24 weeks were estimated. Pearson correlation coefficients determined the association between DLQI score and PASI total score, body- and component-specific subscales with ETN treatment at baseline and up to Week 24. RESULTS: In total, 748 patients from PRESTA were included (ETN 50 mg QW/QW, n = 371; BIW/QW, n = 377). Patients achieved PASI75 total score and 75% improvements in all body regions and components faster on ETN 50 mg BIW/QW than QW/QW (all P < 0·05). Median time to 75% improvement was faster for the head and trunk followed by upper and lower extremities, and for induration and desquamation followed by erythema and total area. Weak to moderately positive correlations between improvements in DLQI and PASI total score (r = 0·223-0·463), all PASI body-specific (r = 0·114-0·432) and component-specific (r = 0·178-0·478) subscales were observed over 24 weeks. CONCLUSIONS: Etanercept treatment-response appears to occur in a body- and component-specific manner. Changes in quality of life are not captured by PASI or its subscales.
Asunto(s)
Antiinflamatorios no Esteroideos/administración & dosificación , Antirreumáticos/administración & dosificación , Inmunoglobulina G/administración & dosificación , Psoriasis/tratamiento farmacológico , Receptores del Factor de Necrosis Tumoral/administración & dosificación , Artritis Psoriásica/tratamiento farmacológico , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Esquema de Medicación , Etanercept , Femenino , Humanos , Masculino , Persona de Mediana Edad , Resultado del TratamientoRESUMEN
BACKGROUND: Pruritus is a clinically important symptom of psoriasis that has a major impact on quality of life (QoL). OBJECTIVE: The objective of this study was to examine pruritus and QoL in patients with moderate-to-severe psoriasis treated with etanercept (ETN) in the PRISTINE clinical trial. METHODS: Patients were randomized (1 : 1, double-blind) to ETN 50 mg QW or 50 mg BIW for 12 weeks, followed by 50 mg QW for 12 weeks. Pruritus was reported as 0 (no itching) to 5 (severe itching). Associations were examined between pruritus and Psoriasis Area and Severity Index, Dermatology Life Quality Index (DLQI), Hospital Anxiety and Depression Screening (HADS), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), Euro-Qol 5D (EQ-5D) and Medical Outcomes Study (MOS) Sleep Index II. RESULTS: At baseline, patients (n = 270) had a mean pruritus level of 3.6. Itching (level ≥1) was reported by 96% of patients, 62% of whom had severe itching (level ≥4) and 26% had the highest level of itching. DLQI, HADS-Anxiety, HADS-Depression, FACIT-Fatigue, EQ-5D visual analog scale, and MOS Sleep Index II were significantly associated with itch. At week 12, mean pruritus improvement in the ETN BIW/QW group was greater than in the QW/QW group (2.4 vs. 1.6, P < 0.001), but not at week 24 (2.2 vs. 2.0, P = 0.180). Patients with the most severe itching at baseline (score of 5) had a mean score of 1.7 at week 24. Overall, patients with clinically meaningful pruritus improvement at week 24 reported greater improvement in QoL measures than other patients. CONCLUSION: Most patients with moderate-to-severe psoriasis in this study (96%) reported pruritus. Pruritus improved significantly with ETN therapy and was strongly associated with improvements in QoL. These data support the clinical relevance of pruritus as an important symptom of patients with moderate/severe psoriasis.
Asunto(s)
Etanercept/uso terapéutico , Inmunosupresores/uso terapéutico , Prurito/psicología , Psoriasis/tratamiento farmacológico , Psoriasis/psicología , Calidad de Vida , Adulto , Ansiedad/etiología , Depresión/etiología , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Prurito/complicaciones , Prurito/tratamiento farmacológico , Psoriasis/complicaciones , Índice de Severidad de la EnfermedadRESUMEN
BACKGROUND: Revisional bariatric procedures are on the rise. The higher complexity of these procedures has been reported to lead to increased risk of complications. The objective of our study was to compare the perioperative risk profile of revisional bariatric surgery with primary bariatric surgery in our experience. METHODS: A prospectively maintained database of all patients undergoing bariatric surgery by three fellowship-trained bariatric surgeons from June 2005 to January 2013 at a center of excellence was reviewed. Patient demographics, type of initial and revisional operation, number of prior gastric surgeries, indications for revision, postoperative morbidity and mortality, length of stay, 30-day readmissions, and reoperations were recorded. These outcomes were compared between revisional and primary procedures by the Mann-Whitney or Chi square tests. RESULTS: Of 1,556 patients undergoing bariatric surgery, 102 patients (6.5%) underwent revisional procedures during the study period. Indications for revisions included inadequate weight loss in 67, failed fundoplications with recurrent gastroesophageal reflux disease in 29, and other in 6 cases. Revisional bariatric procedures belonged into four categories: band to sleeve gastrectomy (n = 23), band to Roux-en-Y gastric bypass (n = 25), fundoplication to bypass (n = 29), and other (n = 25). Revisional procedures were associated with higher rates of readmissions and overall morbidity but no differences in leak rates and mortality compared with primary procedures. Band revisions had similar length of stay with primary procedures and had fewer complications compared with other revisions. Patients undergoing fundoplication to bypass revisions were older, had a higher number of prior gastric procedures, and the highest morbidity (40%) and reoperation (20%) rates. CONCLUSIONS: In experienced hands, many revisional bariatric procedures can be accomplished safely, with excellent perioperative outcomes that are similar to primary procedures. As the complexity of the revisional procedure and number of prior surgeries increases, however, so does the perioperative morbidity, with fundoplication revisions to gastric bypass representing the highest risk group.
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Cirugía Bariátrica/métodos , Laparoscopía , Obesidad/cirugía , Complicaciones Posoperatorias/epidemiología , Pérdida de Peso , Adulto , Anciano , Femenino , Estudios de Seguimiento , Derivación Gástrica/métodos , Gastroplastia/métodos , Humanos , Masculino , Persona de Mediana Edad , Morbilidad/tendencias , Readmisión del Paciente/estadística & datos numéricos , Reoperación , Estudios Retrospectivos , Tasa de Supervivencia/tendencias , Resultado del TratamientoRESUMEN
BACKGROUND: Diagnostic laparoscopy is minimally invasive surgery for the diagnosis of intraabdominal diseases. The aim of this review is a critical examination of the available literature on the role of laparoscopy for chronic intraabdominal conditions. METHODS: A systematic literature search of English-language articles on MEDLINE, the Cochrane database of evidence-based reviews, and the Database of Abstracts of Reviews of Effects was performed for the period 1995-2006. The level of evidence in the identified articles was graded. The search identified and reviewed six main categories that have received attention in the literature: pelvic pain and endometriosis, primary and secondary infertility, nonpalpable testis, and liver disease. RESULTS: The indications, contraindications, risks, benefits, diagnostic accuracy of the procedure, and its associated morbidity are discussed. CONCLUSIONS: The limitations of the available literature are highlighted, and evidence-based recommendations for the use of laparoscopy to stage intraabdominal cancers are provided.
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Laparoscopía , Criptorquidismo/diagnóstico , Criptorquidismo/cirugía , Endometriosis/complicaciones , Endometriosis/diagnóstico , Endometriosis/cirugía , Medicina Basada en la Evidencia , Femenino , Humanos , Infertilidad Femenina/diagnóstico , Infertilidad Femenina/cirugía , Laparoscopía/métodos , Hepatopatías/diagnóstico , Hepatopatías/cirugía , Masculino , Dolor Pélvico/diagnóstico , Dolor Pélvico/etiología , Dolor Pélvico/cirugía , Adherencias Tisulares/complicaciones , Adherencias Tisulares/diagnóstico , Adherencias Tisulares/cirugíaRESUMEN
Diagnostic laparoscopy is minimally invasive surgery for the diagnosis of intraabdominal diseases. The aim of this review is a critical examination of the available literature on the role of laparoscopy for the staging of intraabdominal cancers. A systematic literature search of English-language articles on MEDLINE, the Cochrane database of evidence-based reviews, and the Database of Abstracts of Reviews of Effects was performed for the period 1995-2006. The level of evidence in the identified articles was graded. The search identified and reviewed seven main categories that have received attention in the literature: esophageal cancer, gastric cancer, pancreatic cancer, hepatocellular carcinoma, biliary tract cancer, colorectal cancer, and lymphoma. The indications, contraindications, risks, benefits, diagnostic accuracy of the procedure, and its associated morbidity are discussed. The limitations of the available literature are highlighted, and evidence-based recommendations for the use of laparoscopy to stage intraabdominal cancers are provided.
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Neoplasias Abdominales/patología , Laparoscopía , Estadificación de Neoplasias , Neoplasias Abdominales/cirugía , Humanos , Valor Predictivo de las PruebasRESUMEN
BACKGROUND: Stress can negatively impact surgical performance, but mental skills may help. We hypothesized that a comprehensive mental skills curriculum (MSC) would minimize resident performance deterioration under stress. METHODS: Twenty-four residents were stratified then randomized to receive mental skills and FLS training (MSC group), or only FLS training (control group). Laparoscopic suturing skill was assessed on a live porcine model with and without external stressors. Outcomes were compared with t-tests. RESULTS: Twenty-three residents completed the study. The groups were similar at baseline. There were no differences in suturing at posttest or transfer test under normal conditions. Both groups experienced significantly decreased performance when stress was applied, but the MSC group significantly outperformed controls under stress. CONCLUSIONS: This MSC enabled residents to perform significantly better than controls in the simulated OR under unexpected stressful conditions. These findings support the use of psychological skills as an integral part of a surgical resident training.
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Competencia Clínica , Cognición , Laparoscopía/psicología , Estrés Laboral/psicología , Técnicas de Sutura/psicología , Adulto , Animales , Femenino , Cirugía General/educación , Ginecología/educación , Humanos , Internado y Residencia , Laparoscopía/educación , Masculino , Técnicas de Sutura/educación , Porcinos , Estados UnidosRESUMEN
BACKGROUND: The role of simulation-based education continues to expand exponentially. To excel in this environment as a surgical simulation leader requires unique knowledge, skills, and abilities that are different from those used in traditional clinically-based education. METHODS: Leaders in surgical simulation were invited to participate as discussants in a pre-conference course offered by the Association for Surgical Education. Highlights from their discussions were recorded. RESULTS: Recommendations were provided on topics such as building a simulation team, preparing for accreditation requirements, what to ask for during early stages of development, identifying tools and resources needed to meet educational goals, expanding surgical simulation programming, and building educational curricula. CONCLUSION: These recommendations provide new leaders in simulation with a unique combination of up-to-date best practices in simulation-based education, as well as valuable advice gained from lessons learned from the personal experiences of national leaders in the field of surgical simulation and education.
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Educación de Postgrado en Medicina/organización & administración , Cirugía General/educación , Entrenamiento Simulado/organización & administración , Acreditación , Curriculum , Educación de Postgrado en Medicina/métodos , Humanos , Liderazgo , Entrenamiento Simulado/métodos , Estados UnidosRESUMEN
BACKGROUND: Early conversion from laparoscopic to open cholecystectomy for patients with gangrenous cholecystitis has been advocated. This study investigated the impact of early conversion on patient outcome. METHODS: Data from all patients with gangrenous cholecystitis undergoing laparoscopic cholecystectomy between 1992 and 2002 whose procedure had been converted to open surgery were prospectively collected and analyzed. Morbidity, length of stay, intensive care unit admission, and operative time served as outcome measures. RESULTS: Of the 97 patients in the study, 33 underwent conversion to open cholecystectomy. The conversion was early for 24% of the patients, after the initial dissection, for 33% and after an extended attempt at completion of the laparoscopic cholecystectomy for 37%. There was no difference in the overall morbidity among the groups, whereas the length of hospital stay appeared to be longer in the early conversion group. The operative time was significantly shorter after early conversion (p < 0.01, chi-square test). CONCLUSION: Laparoscopic cholecystectomy is not feasible for all patients with gangrenous cholecystitis. However, a concerted effort to perform the cholecystectomy with the minimally invasive approach does not have an adverse impact on patient outcome and is likely to benefit patients although it poses a moderate risk of conversion.
Asunto(s)
Colecistectomía Laparoscópica , Colecistitis/cirugía , Adulto , Anciano , Colecistitis/patología , Gangrena , Humanos , Persona de Mediana Edad , Estudios Prospectivos , Factores de Tiempo , Resultado del TratamientoRESUMEN
In the absence of metastatic disease patients with localized or locally advanced pancreatic cancer can benefit from surgical resection or chemoradiation. Despite the advances of imaging technology, however, noninvasive staging modalities are still inaccurate in identifying small volume metastatic disease leading potentially to inappropriate treatment and avoidable morbidity in a subgroup of patients. Staging laparoscopy may identify those patients with unsuspected metastatic disease on preoperative imaging and prevent unnecessary laparotomy or chemoradiation. A controversy exists, however, as to whether the procedure should be used routinely or selectively in pancreatic cancer patients with no evidence of metastasis on noninvasive staging. This review aims to assess the current role of staging laparoscopy by examining its diagnostic accuracy and ability to prevent unnecessary treatment as well as its morbidity, oncologic effect and cost-effectiveness. The available literature will be evaluated critically, its limitations identified and exisiting controversies addressed.
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Adenocarcinoma/patología , Laparoscopía , Neoplasias Pancreáticas/patología , Adenocarcinoma/economía , Análisis Costo-Beneficio , Citodiagnóstico , Humanos , Metástasis de la Neoplasia , Estadificación de Neoplasias , Neoplasias Pancreáticas/economía , Selección de Paciente , Lavado PeritonealRESUMEN
It was found that 26 of 127 infants with chlamydial conjunctivitis had previously received chloramphenicol eye drops. This treatment had delayed the onset and reduced the degree of oedema, congestion and discharge compared with infected infants with no 'first-line' chemotherapy, but eye swabs remained positive in 22 (85%) of the chloramphenicol treated infants. The problems of designing laboratory tests which might accurately forecast the clinical value, or lack of value of antibiotics in chlamydial infections were investigated. The minimum inhibitory concentration (MIC) of chloramphenicol, against Chlamydia trachomatis in McCoy cell cultures varied widely according to the antibiotic preparation used, the timing and duration of its exhibition in relation to the single step growth cycle of C. trachomatis, and, in particular, the method of examination of infected tissue cultures for residual chlamydial growth after incubation with chloramphenicol.
Asunto(s)
Infecciones por Chlamydia/tratamiento farmacológico , Cloranfenicol/uso terapéutico , Conjuntivitis/tratamiento farmacológico , Enfermedades del Recién Nacido/tratamiento farmacológico , Relación Dosis-Respuesta a Droga , Humanos , Recién NacidoRESUMEN
In the present study 143 males, aged 14-70 years and being treated for gonococcal urethritis, were examined for concomitant chlamydial infection. C. trachomatis was isolated from cell cultures of the excretion of 24 (16.8%) of these patients. Chlamydia-positive men were treated with oxytetracycline 250 mg 4 times daily for two weeks and following treatment all cultures for C. trachomatis were negative.