RESUMEN
BACKGROUND: Currently, no vaccine against Pseudomonas is available. IC43 is a new, recombinant, protein (OprF/I)-based vaccine against the opportunistic pathogen, Pseudomonas aeruginosa, a major cause of serious hospital-acquired infections. IC43 has proven immunogenicity and tolerability in healthy volunteers, patients with burns, and patients with chronic lung diseases. In order to assess the immunogenicity and safety of IC43 in patients who are most at risk of acquiring Pseudomonas infections, it was evaluated in mechanically ventilated ICU patients. METHODS: We conducted a randomized, placebo-controlled, partially blinded study in mechanically ventilated ICU patients. The immunogenicity of IC43 at day 14 was determined as the primary endpoint, and safety, efficacy against P. aeruginosa infections, and all-cause mortality were evaluated as secondary endpoints. Vaccinations (100 µg or 200 µg IC43 with adjuvant, or 100 µg IC43 without adjuvant, or placebo) were given twice in a 7-day interval and patients were followed up for 90 days. RESULTS: Higher OprF/I IgG antibody titers were seen at day 14 for all IC43 groups versus placebo (P < 0.0001). Seroconversion (≥4-fold increase in OprF/I IgG titer from days 0 to 14) was highest with 100 µg IC43 without adjuvant (80.6%). There were no significant differences in P. aeruginosa infection rates, with a low rate of invasive infections (pneumonia or bacteremia) in the IC43 groups (11.2-14.0%). Serious adverse events (SAEs) considered possibly related to therapy were reported by 2 patients (1.9%) in the group of 100 µg IC43 with adjuvant. Both SAEs resolved and no deaths were related to study treatment. Local tolerability symptoms were mild and rare (<5% of patients), a low rate of treatment-related treatment-emergent adverse events (3.1-10.6%) was observed in the IC43 groups. CONCLUSION: This phase II study has shown that IC43 vaccination of ventilated ICU patients produced a significant immunogenic effect. P. aeruginosa infection rates did not differ significantly between groups. In the absence of any difference in immune response following administration of 100 µg IC43 without adjuvant compared with 200 µg IC43 with adjuvant, the 100 µg dose without adjuvant was considered for further testing of its possible benefit of improved outcomes. There were no safety or mortality concerns. TRIAL REGISTRATION: ClinicalTrials.gov, NCT00876252 . Registered on 3 April 2009.
Asunto(s)
Infecciones por Pseudomonas/prevención & control , Vacunas contra la Infección por Pseudomonas/farmacología , Adulto , Anciano , Método Doble Ciego , Femenino , Humanos , Unidades de Cuidados Intensivos/organización & administración , Masculino , Persona de Mediana Edad , Placebos , Infecciones por Pseudomonas/tratamiento farmacológico , Vacunas contra la Infección por Pseudomonas/uso terapéutico , Pseudomonas aeruginosa/patogenicidad , Respiración Artificial/métodos , Sepsis/prevención & controlRESUMEN
Recognition of the commonly encountered colorectal cancer (CRC) generally begins and takes place because of and based on symptoms and signs, due to the unsettled screening of this type of cancer. Sometimes, because of advanced stage cancer urgent surgical intervention could become necessary and, if this is the case, there is no time and possibility for searching for an eventual second tumor and perhaps the patient's status does not permit performing intraoperative investigations either. The incidence of multiple colon cancer is considered to be between 2.5 and 30% according to the literature. That is why one should exclude them even in the absence of pre- and intraoperative investigations and complaints. On the other hand, colonoscopy and perhaps irrigoscopy of seemingly healthy followed-up patients is mandatory. In the case of the presence of complaints/symptoms denoting impaired intestinal passage seen in a followed-up patient or during the adjuvant setting or metastatic/recurrent disease, treatment and even during hospice care we should evaluate the possibility of a second metachronous tumor. Moreover, if there is no urgency, the multidisciplinary team (oncoteam) should recommend the adequate treatment by balancing gain/utility and risk.
Asunto(s)
Biomarcadores de Tumor/análisis , Neoplasias del Colon/diagnóstico , Neoplasias Primarias Múltiples/diagnóstico , Vigilancia de la Población , Neoplasias del Recto/diagnóstico , Adenocarcinoma/diagnóstico , Biomarcadores de Tumor/sangre , Biopsia , Antígeno Carcinoembrionario/sangre , Neoplasias del Colon/epidemiología , Neoplasias del Colon/patología , Neoplasias del Colon/terapia , Colonoscopía , Medios de Contraste , Estudios de Seguimiento , Humanos , Hungría/epidemiología , Imagen por Resonancia Magnética , Estadificación de Neoplasias , Neoplasias Primarias Múltiples/epidemiología , Neoplasias Primarias Múltiples/patología , Neoplasias Primarias Múltiples/terapia , Vigilancia de la Población/métodos , Salud Pública , Neoplasias del Recto/epidemiología , Neoplasias del Recto/patología , Neoplasias del Recto/terapia , Sistema de Registros , Tomografía Computarizada por Rayos X , UltrasonografíaRESUMEN
The risk of venous thromboembolic events (VTE) in cancer patients is higher than in the general population. Treatment may also increase this risk in these patients. Based on the appropriate criteria (of which the most important are the current ministerial guidelines) thrombosis prophylaxis should be started (given that there is no contraindication) on these patients and be continued while they are at risk. In the event of permanent risk thrombosis prophylaxis should be given lifelong. The drug of choice is low-molecular-weight heparin (LMWH) which is safer and more effective than the oral vitamin K antagonists. Platelet aggregation inhibitors have proved unsuccessful in this patient group. The evidence so far suggests that LMWH (during VTE prophylaxis) can have a positive impact on the course of cancer and perhaps it will be registered under the indication section for cancer patients in the future.
Asunto(s)
Anticoagulantes/uso terapéutico , Heparina de Bajo-Peso-Molecular/uso terapéutico , Neoplasias/complicaciones , Tromboembolia Venosa/etiología , Tromboembolia Venosa/prevención & control , Vitamina K/antagonistas & inhibidores , Humanos , Medición de Riesgo , Factores de Riesgo , Tromboembolia/etiología , Tromboembolia/prevención & control , Resultado del Tratamiento , Tromboembolia Venosa/inducido químicamente , Trombosis de la Vena/etiología , Trombosis de la Vena/prevención & controlRESUMEN
Careful preoperative treatment of giant abdominal hernias can prevent severe postoperative complications such as abdominal compartment syndrome and uncontrollable cardiorespiratory failure. Our departments have been studying the various pathological conditions associated with enormous abdominal hernias (eventration disease) and the possibilities of preventing visceral abnormalities caused by the reconstruction of the abdominal wall. Here, we present the indication, technique and the results of using progressive preoperative pneumo-peritoneum based on two cases.