Prospective phase II trial of extended treatment with rituximab in patients with B-cell post-transplant lymphoproliferative disease.

BACKGROUND AND OBJECTIVES The elective treatment of patients with post-transplant lymphoproliferative disorders is controversial. The purpose of this trial was to evaluate the efficacy of treatment with extended doses of rituximab adapted to the response in patients with post-transplant lymphoproliferative disorders after solid organ transplantation. DESIGN AND METHODS This was a prospective, multicenter, phase II trial. Patients were treated with reduction of immunosuppression and four weekly infusions of rituximab. Those patients who did not achieve complete remission (CR) received a second course of four rituximab infusions. The primary end-point of the study was the CR rate. RESULTS Thirty-eight patients were assesable. One episode of grade 4 neutropenia was the only severe adverse event observed. After the first course of rituximab, 13 (34.2%) patients achieved CR, 8 patients did not respond, and 17 patients achieved partial remission. Among those 17 patients, 12 could be treated with a second course of rituximab, and 10 (83.3%) achieved CR, yielding an intention-to-treat CR rate of 60.5%. Eight patients excluded from the trial because of absence of CR were treated with rituximab combined with chemotherapy, and six (75%) achieved CR. Event-free survival was 42% and overall survival was 47% at 27.5 months. Fourteen patients died, ten of progression of their post-transplant lymphoproliferative disorder. INTERPRETATION AND CONCLUSIONS These results confirm that extended treatment with rituximab can obtain a high rate of CR in patients with post-transplant lymphoproliferative disorders after solid organ transplantation without increasing toxicity, and should be recommended as initial therapy for these patients.

Allogeneic stem cell transplantation after reduced intensity conditioning in patients with relapsed or refractory Hodgkin's lymphoma. Results of the HDR-ALLO study - a prospective clinical trial by the Grupo Español de Linfomas/Trasplante de Médula Osea (GEL/TAMO) and the Lymphoma Working Party of the European Group for Blood and Marrow Transplantation.

BACKGROUND Although Hodgkin's lymphoma is a highly curable disease with modern chemotherapy protocols, some patients are primary refractory or relapse after first-line chemotherapy or even after high-dose therapy and autologous stem cell transplantation. We investigated the potential role of allogeneic stem cell transplantation in this setting. DESIGN AND METHODS In this phase II study 92 patients with relapsed Hodgkin's lymphoma and an HLA-identical sibling, a matched unrelated donor or a one antigen mismatched, unrelated donor were treated with salvage chemotherapy followed by reduced intensity allogeneic transplantation. Fourteen patients showed refractory disease and died from progressive lymphoma with a median overall survival after trial entry of 10 months (range, 6-17). Seventy-eight patients proceeded to allograft (unrelated donors, n=23). Fifty were allografted in complete or partial remission and 28 in stable disease. Fludarabine (150 mg/m(2) iv) and melphalan (140 mg/m(2) iv) were used as the conditioning regimen. Anti-thymocyte globulin was additionally used as graft-versus-host-disease prophylaxis for recipients of grafts from unrelated donors. RESULTS The non-relapse mortality rate was 8% at 100 days and 15% at 1 year. Relapse was the major cause of failure. The progression-free survival rate was 47% at 1 year and 18% at 4 years from trial entry. For the allografted population, the progression-free survival rate was 48% at 1 year and 24% at 4 years. Chronic graft-versus-host disease was associated with a lower incidence of relapse. Patients allografted in complete remission had a significantly better outcome. The overall survival rate was 71% at 1 year and 43% at 4 years. CONCLUSIONS Allogeneic stem cell transplantation can result in long-term progression-free survival in heavily pre-treated patients with Hodgkin's lymphoma. The reduced intensity conditioning approach significantly reduced non-relapse mortality; the high relapse rate represents the major remaining challenge in this setting. The HDR-Allo trial was registered in the European Clinical Trials Database (EUDRACT, https://eudract.ema.europa.eu/) with number 02-0036.

Proceso adeno-amigdalectomía : guía de información para pacientes

En la cub.: Respuestas sencillas a las preguntas más frecuentes sobre la intervención. Publicado en la página web de la Consejería de Salud: www.juntadeandalucia.es/salud (Consejería de Salud / Ciudadanía / Nuestro Compromiso por la Calidad / Guías de información para pacientes / Guías de información para pacientes)

Intrapericardial pacemaker in a 2-kilogram newborn.

A 2-kilogram child had a pacemaker implanted by a subxyphoid approach with the generator located under the rectus sheath. Days later, the battery eroded the abdominal wall and the peritoneum. The whole system was removed and a new one was implanted inside the pericardium on an emergent basis.

Transaortic Fallot repair in a grown-up patient: advantages in a situs inversus setting.

We present the case studies of two adult patients with tetralogy of Fallot who were scheduled for surgery. After addressing the right ventricular outflow tract obstruction, the aorta was opened and the ventricular septal defect was approached in a straightforward manner as it was located just under the overriding aortic valve. The second patient presented with was a situs inversus, dextroapex Fallot. In this setting, the aortic approach simplified the repair expeditiously. After 2 years, both patients are in New York Heart Association class I, with no residual ventricular septal defect, no aortic regurgitation, and complete relief of right ventricular outflow tract obstruction.

Trans-scleral local resection of toxic choroidal melanoma after proton beam radiotherapy.

AIM: To report on trans-scleral local resection of choroidal melanoma for exudative retinal detachment and neovascular glaucoma (toxic tumour syndrome) after proton beam radiotherapy (PBR). METHODS: A non-randomised, prospective study of secondary trans-scleral local resection of choroidal melanoma for exudative retinal detachment with or without neovascular glaucoma after PBR. The patients were treated at the Liverpool Ocular Oncology Centre between February 2000 and April 2008. The trans-scleral local resection was performed with a lamellar-scleral flap, using systemic hypotension to reduce haemorrhage. RESULTS: 12 patients (six women, six men) with a mean age of 51 years (range 20-75) were included in this study. The tumour margins extended anterior to ora serrata in six patients. On ultrasonography, the largest basal tumour dimension averaged 12.4 mm (range 6.8-18.1) and the tumour height averaged 7.1 mm (range 4.2-10.7). The retinal detachment was total in seven patients. Neovascular glaucoma was present in four patients. The time between PBR and local resection had a mean of 17.4 months (range 1-84). The ophthalmic follow-up time after the local resection had a mean of 46.2 months (range 14-99). At the latest known status, the eye was conserved in 10 patients, with a flat retina in all these patients and visual acuity equal or better than 6/30 in four patients. The reasons for enucleation were: patient request for enucleation when rhegmatogenous retinal detachment complicated the resection (one patient) and phthisis (one patient). CONCLUSIONS: Exudative retinal detachment, rubeosis and neovascular glaucoma after PBR of a choroidal melanoma can resolve after trans-scleral local resection of the tumour. Our findings suggest that these complications are caused by the persistence of the irradiated tumour within the eye ('toxic tumour syndrome').

Angiographic demonstration of neoangiogenesis after intra-arterial infusion of autologous bone marrow mononuclear cells in diabetic patients with critical limb ischemia.

Critical limb ischemia in diabetic patients is associated with high rates of morbidity and mortality. Suboptimal responses to the available medical and surgical treatments are common in these patients, who also demonstrate limited vascular homeostasis. Neovasculogenesis induced by stem cell therapy could be a useful approach for these patients. Neovasculogenesis and clinical improvement were compared at baseline and at 3 and 12 months after autologous bone marrow-derived mononuclear cell (BMMNC) transplantation in diabetic patients with peripheral artery disease. We conducted a prospective study to evaluate the safety and efficacy of intra-arterial administration of autologous BMMNCs (100-400 × 10(6) cells) in 20 diabetic patients with severe below-the-knee arterial ischemia. Although the time course of clinical effects differed among patients, after 12 months of follow-up all patients presented a notable improvement in the Rutherford-Becker classification, the University of Texas diabetic wound scales, and the Ankle-Brachial Index in the target limb. The clinical outcome was consistent with neovasculogenesis, which was assessed at 3 months by digital subtraction angiography and quantified by MetaMorph software. Unfortunately, local cell therapy in the target limb had no beneficial effect on the high mortality rate in these patients. In diabetic patients with critical limb ischemia, intra-arterial perfusion of BMMNCs is a safe procedure that generates a significant increase in the vascular network in ischemic areas and promotes remarkable clinical improvement.

Acute myeloid leukaemia of donor cell origin developing 17 years after allogenic hematopoietic cell transplantation for acute promyelocytic leukaemia.

Donor cell leukaemia (DCL) is a rare complication of allogenic hematopoietic cell transplantation (HCT). We report the case of a female patient with acute promyelocytic leukaemia (APL), FAB type M3, who developed acute myeloid leukaemia (AML) type M5 of donor origin 17 years after allogenic bone marrow transplantation (BMT) from her HLA-matched sister. Morphology and immunophenotyping showed differences with the initial leukaemia, and short tandem repeat (STR) analysis confirmed donor-type haematopoiesis. Interphase fluorescence in situ hybridisation (FISH) showed an 11q23 deletion. Given that the latency period between transplant and development of leukaemia was the longest reported to date, we discuss the mechanisms underlying delayed leukaemia onset.

Estudio piloto sobre el manejo de la fluidoterapia intravenosa en pacientes adultos de un hospital de tercer nivel.

The purpose of intravenous fluid therapy (IFT) is to maintain or restore internal equilibrium by administering fluids and/or different electrolyte components. Its correct use and the prevention of complications arising from their misuse depend on the knowledge of the medical team on this subject. We analyzed this issue in different clinical areas of a tertiary hospital. MATERIAL AND METHODS We performed a descriptive cross-sectional pilot study via a questionnaire given to physicians specializing in internal medicine (IM) and digestive system surgery (SDS) who perform clinical practice in hospital units with unit dose drug dispensing system. We designed an anonymous questionnaire with 25 questions relative to knowledge of theory and practices, as well as the opinion of physicians regarding IFT. We evaluated the association between nominal qualitative variables with the Chi-square or Fisher's exact test. The behavior of the quantitative variables was assessed using the t-student test. The analysis of the data was generated using SAS/STAT, Version 9. RESULTS 28 questionnaires were collected from 13 surgeons and 15 digestive interns. Over 40% of specialists considered further education in IFT a necessity , especially regarding its prescription (SDS: 61.54%, IM: 71.43%). No statistically significant differences were found between the specialties in terms of perceived frequency of complications associated with IFT or in the frequency indication with the exception of hypovolemic shock, which is considered to be more prevalent in gastrointestinal surgery (p = 0.046). 90% of professionals prefer an individualized prescription. Statistically significant differences in terms of scores in the area of knowledge, with IM physicians achieving the highest scores (p = 0.014). There were also differences in attitude but they are not significant (p = 0.162). Knowledge of intravenous fluid increases with years of clinical experience (Spearman correlation coefficient = 0.386, p = 0.047). CONCLUSIONS The professionals who prescribe IFT perceive the need to design IFT training programs, together with the production of guides and consensus protocols.

Valoración del nivel de satisfacción en un grupo de mujeres de Granada sobre atención al parto, acompañamiento y duración de la lactancia.

INTRODUCTION: The satisfaction's analysis is being used as an instrument to create different sanitary reforms to improve the quality and numerous studies aim to the increase the mother's satisfaction directly related to the maternity care. OBJECTIVES: [corrected] Identify the woman satisfaction's degree about birth attention, accompaniment during nativity and the breastfeeding's term. MATERIAL AND METHOD: [corrected] Descriptive transversal study in the university hospital San Cecilio in Granada (España), during the time of August 2011 to 2012, it performed with a second prospective tracing phase to a N = 60 mothers. It used a protocol (Annex 1) after 24 hours in hospital and at 14 days by telephone. After 3 months, it performed a tracing pertaining to the baby food. RESULTS: The global satisfaction's level about birth is high in study population. It has been shown that breastfeeding (P = 0,514) and vaginal birth without epidural (P = 0,320) creates higher satisfaction for mother. On the other hand, birth satisfaction related with duration of breastfeeding. CONCLUSION: Satisfactory mothers' opinion related with birth care and accompaniment during nativity increases in women whose birth happened in a uncomplicated way without epidural and they started early breastfeeding.

Efectividad de la terapia cognitivo-conductual en la pérdida de peso tras dos años de cirugía bariátrica en pacientes con obesidad mórbida.

To evaluate the effectiveness of Cognitive Behavioral Therapy (CBT) in the success of postoperative weight loss after 2 years of CB. METHODS: A prospective observational study was conducted in consecutive patients with morbid obesity aged between 18 and 59 yrs and enrolled in the bariatric surgery program of the Obesity Surgery Unit of our hospital from June 2007 through June 2010, with two years postoperative follow-up. Participants were divided into two groups according to their participation in Cognitive Behavioral Therapy or not. Over a 3-month period, CBT was applied in 12 2-h sessions. The main dependent variables studied were body weight and height, from which we calculated BMI and percentage of excess weight lost (weight lost x 100)/(initial weight-ideal weight), classifying patients as successful (E ) those with EPP > 50%, and unsuccessful (NE) those with EPP <50%. Participants were also, assessed for general (stress, anxiety, depression and self-esteem) and specific (binge eating and food craving) psychopathology. RESULTS: Of the 35 patients with bariatric surgery, 30 responded postoperative evaluations, 16 underwent CBT before CB and 14 underwent surgery without receiving psycho-nutritional therapy, (76% female) with a mean age of 41 ± 9.5 years. The mean baseline BMI was 42 ± 10 and 45% of patients were classified as super obese (BMI: 56 ± 6). Mean excess weight loss (EPP) was 77%. According to the EPP were classified as "successful" (S) (59%) and "unsuccessful" (U) (41%). Of the patients assigned to S, 94% received CBT (15 individuals of 17 total), compared with only 12% who did not receive (2 individuals of the 17 total) with statistically significant differences (p < 0.05). Also, the S patients appeared to be significantly less anxious and stressed and have higher self-esteem (P < 0.05). Regarding specific psychopathology, the food craving guided by hunger, loss of control over food intake and guilt was lower in patients who achieved > 50% of EPP (p < 0.04, p < 0.001, p < 0.001, respectively). It was also noted that these patients were plans to eat less and ate less for positive reinforcement (p < 0.03 and p < 0.000, respectively) than the patient group NE

Reproducibility of straylight measurement by C-Quant for assessment of retinal straylight using the compensation comparison method.

BACKGROUND: Straylight gives the appearance of a veil of light thrown over a person's retinal image when there is a strong light source present. We examined the reproducibility of the measurements by C-Quant, and assessed its correlation to characteristics of the eye and subjects' age. PARTICIPANTS AND METHODS: Five repeated straylight measurements were taken using the dominant eye of 45 healthy subjects (age 21-59) with a BCVA of 20/20: 14 emmetropic, 16 myopic, eight hyperopic and seven with astigmatism. We assessed the extent of reproducibility of straylight measures using the intraclass correlation coefficient. RESULTS: The mean straylight value of all measurements was 1.01 (SD 0.23, median 0.97, interquartile range 0.85-1.1). Per 10 years of age, straylight increased in average by 0.10 (95%CI 0.04 to 0.16, p < 0.01]. We found no independent association of refraction (range -5.25 dpt to +2 dpt) on straylight values (0.001; 95%CI -0.022 to 0.024, p = 0.92). Compared to emmetropic subjects, myopia reduced straylight (-.011; -0.024 to 0.02, p = 0.11), whereas higher straylight values (0.09; -0.01 to 0.20, p = 0.09) were observed in subjects with blue irises as compared to dark-colored irises when correcting for age. The intraclass correlation coefficient (ICC) of repeated measurements was 0.83 (95%CI 0.76 to 0.90). CONCLUSIONS: Our study showed that straylight measurements with the C-Quant had a high reproducibility, i.e. a lack of large intra-observer variability, making it appropriate to be applied in long-term follow-up studies assessing the long-term effect of surgical procedures on the quality of vision.

Plerixafor and granulocyte colony-stimulating factor for first-line steady-state autologous peripheral blood stem cell mobilization in lymphoma and multiple myeloma: results of the prospective PREDICT trial.

In Europe, the combination of plerixafor + granulocyte colony-stimulating factor is approved for the mobilization of hematopoietic stem cells for autologous transplantation in patients with lymphoma and myeloma whose cells mobilize poorly. The purpose of this study was to further assess the safety and efficacy of plerixafor + granulocyte colony-stimulating factor for front-line mobilization in European patients with lymphoma or myeloma. In this multicenter, open label, single-arm study, patients received granulocyte colony-stimulating factor (10 μg/kg/day) subcutaneously for 4 days; on the evening of day 4 they were given plerixafor (0.24 mg/kg) subcutaneously. Patients underwent apheresis on day 5 after a morning dose of granulocyte colony-stimulating factor. The primary study objective was to confirm the safety of mobilization with plerixafor. Secondary objectives included assessment of efficacy (apheresis yield, time to engraftment). The combination of plerixafor + granulocyte colony-stimulating factor was used to mobilize hematopoietic stem cells in 118 patients (90 with myeloma, 25 with non-Hodgkin's lymphoma, 3 with Hodgkin's disease). Treatment-emergent plerixafor-related adverse events were reported in 24 patients. Most adverse events occurred within 1 hour after injection, were grade 1 or 2 in severity and included gastrointestinal disorders or injection-site reactions. The minimum cell yield (≥ 2 × 10(6) CD34(+) cells/kg) was harvested in 98% of patients with myeloma and in 80% of those with non-Hodgkin's lymphoma in a median of one apheresis. The optimum cell dose (≥ 5 × 10(6) CD34(+) cells/kg for non-Hodgkin's lymphoma or ≥ 6 × 10(6) CD34(+) cells/kg for myeloma) was harvested in 89% of myeloma patients and 48% of non-Hodgkin's lymphoma patients. In this prospective, multicenter European study, mobilization with plerixafor + granulocyte colony-stimulating factor allowed the majority of patients with myeloma or non-Hodgkin's lymphoma to undergo transplantation with minimal toxicity, providing further data supporting the safety and efficacy of plerixafor + granulocyte colony-stimulating factor for front-line mobilization of hematopoietic stem cells in patients with non-Hodgkin's lymphoma or myeloma.

Diabetic nephropathy: changes after diabetes surgery?

Introduction: Obesity, as a central piece inside metabolic syndrome, is associated with early chronic kidney disease (CKD). In addition, several observational, cross sectional, and longitudinal studies have demonstrated that obesity is as an independent risk factor for the onset, aggravated course, and poor outcomes of CKD including diabetic nephropathy. This implies that when obesity is reversed, many CKD risk factors and CKD itself could be favorably influenced. So all measures aimed at weight loss are recommended to minimize risks from obesityrelated conditions and generate improvements in the metabolic profile. Recent evidence shows that bariatric surgery (BS) can revert or improve proteinuria and CKD in morbidly obese patients. Objectives and methods: The present review is aimed to provide the evidence regarding the beneficial effects of weight loss after BS in different stages of CKD including kidney transplant recipients, with an special focus on the beneficial effect in reducing or improving proteinuria and renal failure. Furthermore, this updated systematic review of the literature analyzes potential adverse effects that BS could induce not only on renal function but also on morbidity and mortality risk in perioperative and postoperative period. Conclusions: Results from the different case reports, meta analysis as well as systematic review of clinical trials show that obesity treatment by way of lifestyle changes, pharmacotherapies and BS can reduce proteinuria and help to prevent loss of renal function. Also BS may reduce complications, and allow obese patients with end-stage renal disease to undergo kidney transplantation with good results.

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