Sacral neuromodulation for fecal incontinence in Latin America: initial results of a multicenter study.

BACKGROUND: Sacral neuromodulation (SNM) is a widely used therapeutic option for fecal incontinence (FI). Larger series are mainly from Western countries, while few reports address the results of SNM in less developed or less wealthy countries. The aim of the present study was to evaluate the efficacy of SNM in patients with FI in Latin America. METHODS: A retrospective study was conducted on patients with FI who had SNM between 2009 and 2016 at 15 specialized colorectal surgery centers in Latin America. Main outcomes measures were functional outcomes, postoperative complications, requirement of revisional surgery, and requirement of device removal. All patients had failed conservative management and had clinical assessment including recording of the validated Cleveland Clinic Florida Fecal Incontinence Score (CCF-FIS) and, when available, anal manometry and endoanal ultrasound. Patients were followed up for a median of 36.7 (1-84) months. RESULTS: One hundred and thirty-one patients [119 females, median age of 62.2 (range 19-87) years] were included. The most common etiology of FI was obstetric injury (n = 60; 45.8%). After successful test lead implantation, the stimulator was permanently placed in 129 patients (98.5%). One patient failed to respond in the test phase and one patient did not proceed to permanent implantation for insurance reasons. Nineteen patients (14.7%) had 19 complications including infection (n = 5, 3.8%), persistent implant site pain (n = 5, 3.8%), generator/lead dislodgment (n = 5, 3.8%), malfunctioning device (n = 3, 2.3%), and hematoma (n = 1, 0.7%). Reimplantation after the first and second stages was necessary in 2 (1.5%) and 3 patients (2.3%), respectively. The device removal rate was 2.2%. At a median follow-up of 36.7 (range 1-84) months, the CCF-FIS significantly improved from a preoperative baseline of 15.9 ± 2.98 to 5.2 ± 3.92 (95%CI: 15.46 vs 4.43; p < 0.0001). Overall, 90% of patients rated their improvement as "significant". CONCLUSIONS: Sacral nerve stimulation for FI is safe and efficient, even in less wealthy or less developed countries.

Registro de linfomas cutáneos primarios de la AEDV: primer año de funcionamiento / The First Year of the AEVD Primary Cutaneous Lymphoma Registry

ANTECEDENTES Y OBJETIVO: Los linfomas primarios cutáneos son enfermedades poco frecuentes. Este artículo describe el Registro de linfomas cutáneos primarios de la AEDV y sus primeros resultados. PACIENTES Y MÉTODOS: Registro de enfermedad de pacientes con linfomas cutáneos primarios. Los centros participantes recogieron datos prospectivamente de todos los pacientes, incluyendo datos del diagnóstico, de los tratamientos, de las pruebas realizadas y del estado actual del paciente. Se realizó un análisis descriptivo. RESULTADOS: En diciembre del 2017 el registro tenía datos de 639 pacientes pertenecientes a 16 hospitales universitarios. Un 60% eran hombres y los diagnósticos, por orden de frecuencia, fueron: micosis fungoide/síndrome de Sézary (MF/SS) (348 casos; 55%), linfoma cutáneo primario de células B (LCCB) (184; 29%), trastorno linfoproliferativo de células T CD30+ (LTCD30+) (70; 11%) y otro tipo de linfoma T (OLT) (37; 5%). El número de casos incidentes recogidos durante el primer año fue de 105 (16,5%). En los pacientes con MF/SS, el diagnóstico más frecuente fue MF clásica (77,3%). La mitad de estos casos se diagnosticaron en estadio IA. La mayoría de los pacientes estaban en remisión parcial (32,5%) o enfermedad estable (33,1%). Los tratamientos más usados fueron los corticoides tópicos (90,8%) seguidos de fototerapia. En los pacientes con LCCB el diagnóstico más frecuente fue el linfoma de la zona marginal (50%). Casi todos los pacientes tuvieron afectación exclusivamente cutánea y casi la mitad fue T1a. La mayoría (76,1%) estaba en remisión completa. Los tratamientos más utilizados fueron la cirugía (55,4%) y la radioterapia (41,9%). En los pacientes con LTCD30+, el diagnóstico más frecuente fue la papulosis linfomatoide (68,6%). La mayoría fueron clasificados T3b (31,4%). La mitad de los casos estaban en remisión completa. Los tratamientos más frecuentes fueron los esteroides tópicos (68,6%), seguidos de la quimioterapia sistémica (32,9%). CONCLUSIÓN: Las características del paciente con linfoma cutáneo primario en España no difieren de otras series descritas en la literatura. El registro facilitará al grupo de linfomas de la AEDV realizar investigación clínica

BACKGROUND AND OBJECTIVE: Primary cutaneous lymphomas are uncommon. This article describes the Primary Cutaneous Lymphoma Registry of the Spanish Academy of Dermatology and Venereology (AEDV) and reports on the results from the first year. PATIENTS AND METHODS: Disease registry for patients with primary cutaneous lymphoma. The participating hospitals prospectively recorded data on diagnosis, treatment, tests, and disease stage for all patients with primary cutaneous lymphoma. A descriptive analysis was performed. RESULTS: In December 2017, the registry contained data on 639 patients (60% male) from 16 university hospitals. The most common diagnoses, in order of frequency, were mycosis fungoides/Sézary syndrome (MF/SS) (348 cases, 55%), primary cutaneous B-cell lymphoma (CBCL) (184 cases, 29%), primary cutaneous CD30+ T-cell lymphoproliferative disorder (CD30+ CLPD) (70 cases, 11%), and other types of T-cell lymphoma (37 cases, 5%). In total, 105 (16.5%) of the cases recorded were incident cases. The most common diagnosis in the MF/SS group was classic MF (77.3%). Half of the patients with MF had stage IA disease when diagnosed, and the majority were either in partial remission (32.5%) or had stable disease (33.1%). The most widely used treatments were topical coricosteroids (90.8%) and phototherapy. The most common form of primary CBCL was marginal zone lymphoma (50%). Almost all of the patients had cutaneous involvement only and nearly half had stage T1a disease. Most (76.1%) were in complete remission. The main treatments were surgery (55.4%) and radiotherapy (41.9%). The most common diagnosis in patients with CD30+ CLPD was lymphomatoid papulosis (68.8%). Most of the patients (31.4%) had stage T3b disease and half were in complete remission. The most common treatments were topical corticosteroids (68.8%) and systemic chemotherapy (32.9%). CONCLUSION: The characteristics of patients with primary cutaneous lymphoma in Spain do not differ from those described in other series in the literature. The registry will facilitate clinical research by the AEDV's lymphoma group

The First Year of the AEVD Primary Cutaneous Lymphoma Registry. / Registro de linfomas cutáneos primarios de la AEDV: primer año de funcionamiento.

BACKGROUND AND OBJECTIVE: Primary cutaneous lymphomas are uncommon. This article describes the Primary Cutaneous Lymphoma Registry of the Spanish Academy of Dermatology and Venereology (AEDV) and reports on the results from the first year. PATIENTS AND METHODS: Disease registry for patients with primary cutaneous lymphoma. The participating hospitals prospectively recorded data on diagnosis, treatment, tests, and disease stage for all patients with primary cutaneous lymphoma. A descriptive analysis was performed. RESULTS: In December 2017, the registry contained data on 639 patients (60% male) from 16 university hospitals. The most common diagnoses, in order of frequency, were mycosis fungoides/Sézary syndrome (MF/SS) (348 cases, 55%), primary cutaneous B-cell lymphoma (CBCL) (184 cases, 29%), primary cutaneous CD30+ T-cell lymphoproliferative disorder (CD30+ CLPD) (70 cases, 11%), and other types of T-cell lymphoma (37 cases, 5%). In total, 105 (16.5%) of the cases recorded were incident cases. The most common diagnosis in the MF/SS group was classic MF (77.3%). Half of the patients with MF had stage IA disease when diagnosed, and the majority were either in partial remission (32.5%) or had stable disease (33.1%). The most widely used treatments were topical corticosteroids (90.8%) and phototherapy. The most common form of primary CBCL was marginal zone lymphoma (50%). Almost all of the patients had cutaneous involvement only and nearly half had stage T1a disease. Most (76.1%) were in complete remission. The main treatments were surgery (55.4%) and radiotherapy (41.9%). The most common diagnosis in patients with CD30+ CLPD was lymphomatoid papulosis (68.8%). Most of the patients (31.4%) had stage T3b disease and half were in complete remission. The most common treatments were topical corticosteroids (68.8%) and systemic chemotherapy (32.9%). CONCLUSION: The characteristics of patients with primary cutaneous lymphoma in Spain do not differ from those described in other series in the literature. The registry will facilitate clinical research by the AEDV's lymphoma group.

Preoperative low-dose weekly cisplatin and continuous infusion fluorouracil plus hyperfractionated radiotherapy in stage II-III esophageal carcinoma.

BACKGROUND: The optimal regimen of preoperative chemoradiotherapy for resectable esophageal cancer has not been established. We evaluated accelerated hyperfractionated radiotherapy (RT) concurrent to low-dose weekly cisplatin and continuous infusion fluorouracil (LDCI-FU) followed by esophagectomy in patients with locally advanced squamous cell carcinoma (SCC) of the esophagus. METHODS: Patients with clinical stage II or III SCC of the esophagus received cisplatin 30 mg/m2/week (days 1, 8, 15), LDCI-FU 300 mg/m2/day (days 1-21), and concomitant RT to a dose of 45 Gy (150 cGy/fraction, 2 fractions/day) on tumor and affected lymph nodes, followed by radical esophagectomy. RESULTS: From 1997 to 2012, 64 patients were treated with this regimen. Twenty-four patients (37 %) had grade 3 esophagitis, 18 (28 %) of whom required hospitalization. The risk of hospitalization was reduced by placement of a jejunostomy tube before starting induction chemoradiotherapy. Six patients (9 %) had grade 3-4 neutropenia. Fifty-three patients (83 %) underwent esophageal resection and complete resection was achieved in 45 (70 %). The overall median survival was 28 months (95 % CI: 20.4-35.6) and 5-year survival was 38 %. In the 18 patients attaining a pathological complete response, median survival was 132 months and 5-year survival was 72 %. Positron emission tomography standardized uptake values (PET SUVmax) post-chemoradiotherapy were associated with pathological response (p = 0.03) and survival (p = 0.04). CONCLUSIONS: Intensive preoperative hyperfractionated RT concomitant to low-dose cisplatin and LDCI-FU is effective in patients with locally advanced SCC of the esophagus, with good pathological response and survival and manageable toxicities. Post-chemoradiotherapy PET SUVmax shows promise as a potential prognostic factor.

Dealing with the high cost of biological therapies: developing and implementing a biological therapy prioritization protocol for ankylosing spondylitis patients in a tertiary hospital.

OBJECTIVE: In January 2011, a biological therapies commission was created in our hospital to fully address the management of biological drugs. A biological therapy prioritization protocol was developed for ankylosing spondylitis (AS) patients. Here, we describe it and report on its economic impact to illustrate how we are optimizing the use of these expensive new drugs. METHODS: The biological therapies commission established several procedures for the rational use of biological drugs such as cost-efficiency therapeutic protocols, pharmacovigilance, and therapeutic drug monitoring programs. The AS protocol was based on clinical and economic aspects. We estimated the economic impact of the protocol by comparing the cost of treating AS patients with biological drugs in the pre-commission (2009 - 2010) vs. post-commission period (2011 - 2013). AS patients treated with adalimumab (ADA), etanercept (ETN) or infliximab (IFX) for at least 6 months in the 2009 - 2013 period were included. RESULTS: 107 patients were included. In the pre-commission period, total expenses increased by +30,944 Euro (+4%). After protocol implementation, total expenses decreased by 11,441 Euro (-1%) during 2011, and by an additional 36,781 Euro (-4%) and 53,872 Euro (-8%) in 2012 and 2013, respectively. In the 2010 - 2013 period the cost of biological therapy per patient-year decreased by 869 €, suggesting the positive effects of the biological therapy prioritization protocol instauration. CONCLUSION: We describe the establishment of a multidisciplinary biological therapy commission to optimize the use of biological therapies. We illustrate its work in developing a protocol for the management of AS patients with such therapies. We show that after 3-years of implementation, the biological therapy prioritization protocol allowed us to steadily decrease the direct cost of biological drug therapies per patient, up to 869 Euro.

Economical impact associated with a biological therapy prioritization protocol in patients with rheumatoid arthritis in the Hospital of Sagunto.

BACKGROUND: Until 2010 the cost of biological treatments in Rheumatoid Arthritis (RA) was increasing annually by 15% in our hospital. In 1st January 2011, a Hospital Commission of Biological Therapies involving rheumatology and pharmacy services was created to improve the management of biological drugs and a biological therapy prioritization protocol in RA patients was also established to improve the efficient usage of biological drugs in RA. OBJECTIVE: To evaluate the economic impact associated with a biological therapy prioritization protocol for RA patients in the Hospital of Sagunto. METHODS: Observational, ambispective study comparing the associated cost of RA patients treated with biological drugs in the pre-protocol (2009 - 2010) versus post-protocol periods (2011 - 2012). RA patients treated with Abatacept (ABA), Adalimumab (ADA), Etanercept (ETN) or Infliximab (IFX) for at least 6 months during the study period (2009 - 2012) were included. In 2012, Tocilizumab (TCZ) was also included in the prioritization protocol. Prioritization protocol was established based on both clinical and economical aspects and supervised case by case by our Commission. Cost savings and economic impact were calculated using Spanish official prices. RESULTS: In the pre-protocol period (2009 - 2010), total expenses were increasing by €110,000, up to €1,761,000 in 2010 (€11,362 pat/year). After protocol implementation, total expenses decreased by 53,676€ on the 2010 - 2011 period, and 149,200€ on the 2011 - 2012 period. On the 2010 - 2011 period the cost of biological therapy per patient-year decreased 355€ (11,007€ pat/year) and additional 653€ (up to 10,354€ pat/year) by 2012, with a cumulative effect of the protocol implementation of 1,008€ per patient-year. In the pre-protocol period (2009), the annual cost/patient was 10.812€ with ETN, 10.942€ with IFX, 12.961€ with ADA and 12.739€ with ABA. By 1st January 2013, the annual cost per patient was 9,469€ with ETN, 10,579€ with IFX, 11,117€ with ADA, 13,540€ with ABA and 14,932€ with TCZ. CONCLUSIONS: The creation of our Commission of Biological Therapies is key to rational management of RA patients and optimization of resources, allowing us to save 200,000€ after 2-year efficiency protocol implementation.

Hernioplastia inguinal ambulatoria con anestesia local y sedación: análisis de 1.840 pacientes tras 6 años de seguimiento / Inguinal hernia repair in day surgery setting: a 6 years review in 1840 patients

Introducción: Estudio para evaluar a largo plazo la aplicación y los beneficios del tratamiento de la hernia inguinal con la prótesis de prolene hernia system (PHS), con anestesia local y sedación y en programa de cirugía mayor ambulatoria. Pacientes y métodos: En el periodo 1997-2005 fueron tratados 2.138 pacientes con hernia inguinal en la unidad de cirugía mayor ambulatoria. Todos fueron anestesiados con anestesia local, una mezcla en 20 ml de suero fisiológico de 10 ml de lidocaína al 5 % y 10 ml de bupivacaína con adrenalina. Asimismo, todos fueron sedados con midazolan (0,5-2 mg) y propofol (0,5 ml/kg). Las hernioplastias se realizaron según la técnica de Gilbert y no se empleó quimiprofilaxis de forma rutinaria. El dolor postoperatorio fue valorado según una escala analógica visual. El dolor leve y moderado fue tratado con analgésicos antiinflamatorios no esteroideos o paracetamol. El tiempo medio de los pacientes para el alta en la unidad fue de 6 horas. Se realizaron controles postoperatorios a los 30 días, 3 meses y 6 años por teléfono y siempre que fuese necesario. Resultados: Del total de pacientes intervenidos, en 1.840 casos (86,1 %) se realizó un seguimiento y fueron controlados a los 6 años. Todos habían sido intervenidos en circuito sin ingreso, 147 (7,98 %) mujeres y 1.693 (92,02 %) hombres, y no presentaron eventos adversos en el periodo postoperatorio. La edad media fue de 56 (18-82 años). La clasificación de Gilbert fue I: 15 (0,81 %), II: 49 (2,66 %), III: 736 (40 %), IV: 939 (51,03 %) y V: 101 (5,48 %). En el 91,95 % eran hernias primarias y recidivadas el 8,04 %. La revisión a los 6 años mostró curación en 1.824 pacientes (99,13 %), curación con alguna secuela en 6 pacientes (0,32 %) y recidivas herniarias en 10 pacientes (0,54 %). Conclusiones: El estudio presentado demuestra a largo plazo que la técnica de PHS realizada bajo anestesia local y sedación consciente en un programa de cirugía sin ingreso es un procedimiento efectivo con muy escaso número de recidivas (AU)

Aim: The study is conducted to evaluate long time the feasibility and benefits of inguinal hernia repair with prolene hernia system (PHS) mesh using local anaesthesia with sedation as a day surgery procedure. Patients and methods: 2138 patients with inguinal hernia were attended in the day surgery setting from 1997 to 2005. Patients were sedated with midazolam (0.5-2 mg) and propofol (0.5 ml/kg). Local anaesthesia (20 ml saline solution, 10 ml lidocaine (5 %) and 10 ml bupivacaine with adrenaline. Hernioplasties were performed according to Gilbert technique. No routine chemoprophylaxis. Postoperative pain was assessed using analogical visual scale pain. Mild and moderate postoperative pain was managed with simple analgesics or NSAID or paracetamol. Patients were discharged at 6 hours. Postoperative controls: 30 days, 3 months and 6 years by phone, and always was necessary. Results: 1840 (86,1 %) were controlled 6 years. They were operated as day cases, 147 women (7,98 %) and 1693 men (92,02 %). Mean age was 56 (18-82 years). Gilbert’s classification: I-15 (0.81 %), II-49 (2.66 %), III-736 (40 %), IV-939 (51.03 %) and V-101 (5.48 %). Primary hernias were 1692 (91.95 %) and recurrent 148 (8.04 %). The review at 6 years showed healing in 1824 patients (99.13 %), cure with a sequel in 6 patients (0.32 %) and hernia recurrences in 10 patients (0.54 %). Conclusion: The study presented demonstrates the long term PHS technique performed under local anesthesia and conscious sedation in a program of outpatient surgery is an effective procedure with very low number of relapses (AU)

Study on the efficiency of nanosized magnetite and mixed ferrites in magnetic hyperthermia.

Magnetic materials, which have the potential for application in heating therapy by hyperthermia, were prepared. This alternative treatment is used to eliminate cancer cells. Magnetite, magnesium-calcium ferrites and manganese-calcium ferrites were synthesized by sol-gel method followed by heat treatment at different temperatures for 30 min in air. Materials with superparamagnetic behavior and nanometric sizes were obtained in all the cases. Thus, these nanopowders may be suitable for their use in human tissue. The average sizes were 14 nm for magnetite, 10 nm for both Mg(0.4)Ca(0.6)Fe(2)O(4) and Mg(0.6)Ca(0.4)Fe(2)O(4) and 11 nm for Mn(0.2)Ca(0.8)Fe(2)O(4). Taking into account that the Mg(0.4)Ca(0.6)Fe(2)O(4) and Mg(0.6)Ca(0.4)Fe(2)O(4) treated at 350 °C showed the lower coercivity values, these nanoparticles were selected for heating tests and cell viability. Heating curves of Mg(0.4)Ca(0.6)Fe(2)O(4) subjected to a magnetic field of 195 kHz and 10 kA/m exhibited a temperature increase up to 45 °C in 15 min. A high human osteosarcoma cell viability of 90-99.5% was displayed. The human osteosarcoma cell with magnesium-calcium ferrites exposed to a magnetic field revealed a death cell higher than 80% in all the cases.

Generalised erythematous skin eruptions induced by sorafenib: cutaneous toxicity and treatment outcome.

A woman diagnosed of a renal cell carcinoma in 1989 had a metastatic kidney cancer localised in subcutaneous nodules, gut and lung in 2007. Sorafenib treatment was initiated a 400 mg orally twice a day. The patient developed generalised erythematous skin eruptions and two weeks later a widespread erythematous maculopapular eruption located exclusively on the legs and arms, along with an objective response. The most likely cause of the generalised erythematous skin eruptions was considered to be sorafenib because of the close temporal relationship between exposure to the drug and onset of symptoms. Furthermore, a relationship between sorafenib skin toxicity and treatment efficacy was observed. This therapeutic efficacy of EGFR inhibitors and cutaneous side effects should be better assessed in large cohorts or trials to determine whether the skin toxicity of patients can be linked to an objective antitumour response.

Digestive utilization of goat and cow milk fat in malabsorption syndrome.

We studied the effects of goat and cow milk fat on the digestive utilization of this nutrient and on some of the biochemical parameters that are related to the metabolisim of lipids, using rats with a resection of 50% of the distal small intestine and control animals (transected). The fat content in all the diets was 10% but the lipid quality was varied: the standard diet was based on olive oil, while the other two diets included fat obtained from lyophilized goat milk and cow milk, respectively. The digestive utilization of the fat was lower in the resected animals than in the transected ones for all three diets studied. In both resected and transected animals. the apparent digestibility coefficient (ADC) of the fat was greater with the standard diet (olive oil) than with diets whose fat content was provided by goat or cow milk. The digestive utilization of the fat was greater in the transected and resected rats receiving a diet of goat's milk (rich in medium-chain triglycerides) than those given a cow-milk-based diet and more closely approached the values obtained for olive oil. The consumption of goat milk reduced levels of cholesterol while levels of triglycerides, HDL, GOT and GPT remained with in the normal ranges, for both transected and resected animals. The advantageous effect of goat milk on the metabolisim of lipids with respect to cow milk suggests that the former should be included in the diet in eases of malabsorption snydrome.

[The excretion pattern and protective capacity in rabbits orally immunized with attenuated strains of Vibrio cholerae O1 biotype El Tor]. / Estudio del patrón de excreción y la capacidad protectora en conejos inmunizados de forma oral con cepas atenuadas de Vibrio cholerae O1 biotipo El Tor.

In order to study the excretion patterns, colonization and protective capacity of live attenuated strains of Vibrio cholerae O1. El Tor, rabbits were immunized in New Zealand with these strains and their corresponding parental strains. 2 doses were administered by the model of oral inoculation in adult rabbits. Rabbits were rotated 2 weeks after the second dose by the model of ligated intestine with highly virulent strains of V. cholerae O1 Ogawa and Inaba serotypes and O139 serogroup. It was proved that the genetically manipulated strains do not effect the excretion patterns when they are compared with their parental strains. It was observed in the challenge a decrease in the levels of colonization of virulent strains of both serotypes, not only among the rabbits immunized with the attenuated strains, but also among those immunized with the parental strains in comparison with control animals immunized with the strain of Escherichia coli K-12, which means that there was certain degree of protection. In the case of the animals challenged with the O139 strain it was demonstrated that the protection is specific for each serogroup, since in this case there was no reduction of the colonization.

[A comparative clinical study of calcium blockers, gallopamil and nifedipine, in the treatment of stable chest angina]. / Estudio clínico comparativo de los bloqueadores del calcio, galopamil y nifedipina, en el tratamiento de la angina de pecho estable.

Twenty seven patients, 43 to 69 years of age, all with disabling stable angina and positive Bruce stress test, no amendable for revascularization procedures mainly because of poor distal coronary run-off by angiography, were studied with two calcium-channel blockers, the recently developed gallopamil hydrochloride and nifedipine hydrochloride. According to a double blind, cross-over protocol of 12 week duration and after a 2-week washout period, the patients randomly received during 4 weeks 50 mg gallopamil capsules t i d, or 10 mg nifedipine capsules t i d. After a second 2-week wash-out, the alternative drug was administered for another 4 weeks. The number of anginal episodes decreased significantly (p less than 0.01) with both treatments (from 6.4 to 1.8 crisis with gallopamil and from 6.2 to 2.1 with nifedipine). Heart rate (HR) was progressively reduced with gallopamil (-7.9%, p less than 0.05) but increased with nifedipine (+5.7%) in relation to basal figures. Both medications reduced the level of ST depression during the stress test (52.4% with gallopamil and 41.8% with nifedipine, N.S.). The time for angina at the stress test increased 92.5% with gallopamil and 40.7% with nifedipine (p less than 0.05). HR systolic product at peak exercise was 23,101 with gallopamil and 24,906 with nifedipine (p less than 0.001). Both calcium-channel blockers are drugs with significant anti-anginal effects in patients with stable, disabling angina.(ABSTRACT TRUNCATED AT 250 WORDS)