Graf W.,Akademiska Sjukhuset |
Mellgren A.,University of Minnesota |
Matzel K.E.,Friedrich - Alexander - University, Erlangen - Nuremberg |
Hull T.,Cleveland Clinic |
And 2 more authors.
The Lancet | Year: 2011
Injection of a bulking agent in the anal canal is an increasingly used treatment for faecal incontinence, but efficacy has not been shown in a controlled trial. We aimed to assess the efficacy of injection of dextranomer in stabilised hyaluronic acid (NASHA Dx) for treatment of faecal incontinence. In this randomised, double-blind, sham-controlled trial, patients aged 18-75 years from centres in USA and Europe were randomly assigned (2:1) to receive either transanal submucosal injections of NASHA Dx or sham injections. Randomisation was stratified by sex and region in blocks of six, and managed with a computer generated, real-time, web-based system. Patients and investigators were masked to assignment for 6 months when the effect on severity of faecal incontinence and quality of life was assessed with a 2-week diary and clinical assessments. The primary endpoint was response to treatment based on the number of incontinence episodes. A response to treatment was defined as a reduction in number of episodes by 50 or more. Patients in the active treatment group are still being followed up. This trial was registered with ClinicalTrials.gov, number NCT00605826. 278 patients were screened for inclusion, of whom 206 were randomised assigned to receive NASHA Dx (n=136) or sham treatment (n=70). 71 patients who received NASHA Dx (52) had a 50 or more reduction in the number of incontinence episode, compared with 22 patients who received sham treatment (31; odds ratio 2·36, 95 CI 1·24-4·47, p=0·0089). We recorded 128 treatment-related adverse events, of which two were serious (1 rectal abscess and 1 prostatic abscess). Anal injection of NASHA Dx is an effective treatment for faecal incontinence. A refinement of selection criteria for patients, optimum injected dose, ideal site of injection, and long-term results might further increase the acceptance of this minimally invasive treatment. Q-Med AB. © 2011 Elsevier Ltd.
Trabectedin plus pegylated liposomal doxorubicin in relapsed ovarian cancer: Outcomes in the partially platinum-sensitive (platinum-free interval 6-12 months) subpopulation of OVA-301 phase III randomized trial
Poveda A.,Valencian Institute of Oncology |
Vergote I.,University Hospital |
Tjulandin S.,Russian Cancer Research Center |
Kong B.,Shandong University |
And 9 more authors.
Annals of Oncology | Year: 2011
Background: OVA-301 is a large randomized trial that showed superiority of trabectedin plus pegylated liposomal doxorubicin (PLD) over PLD alone in relapsed ovarian cancer. The optimal management of patients with partially platinum-sensitive relapse [6-12 months platinum-free interval (PFI)] is unclear. Patients and methods: Within OVA-301, we therefore now report on the outcomes for the 214 cases in this subgroup. Results: Trabectedin/PLD resulted in a 35% risk reduction of disease progression (DP) or death [hazard ratio (HR) = 0.65, 95% confidence interval (CI), 0.45-0.92; P = 0.0152; median progression-free survival (PFS) 7.4 versus 5.5 months], and a significant 41% decrease in the risk of death (HR = 0.59; 95% CI, 0.43-0.82; P = 0.0015; median survival 23.0 versus 17.1 months). The safety of trabectedin/PLD in this subset mimicked that of the overall population. Similar proportions of patients received subsequent therapy in each arm (76% versus 77%), although patients in the trabectedin/PLD arm had a slightly lower proportion of further platinum (49% versus 55%). Importantly, patients in the trabectedin/PLD arm survived significantly longer after subsequent platinum (HR = 0.63; P = 0.0357; median 13.3 versus 9.8 months). Conclusion: This hypothesis-generating analysis demonstrates that superior benefits with trabectedin/PLD in terms of PFS and survival in the overall population appear particularly enhanced in patients with partially sensitive disease (PFI 6-12 months). © The Author 2010. Published by Oxford University Press on behalf of the European Society for Medical Oncology.
Gonzalez-Pizarro P.,Akademiska Sjukhuset |
Garcia-Fernandez J.,Puerta Of Hierro University Hospital |
Canfran S.,Complutense University of Madrid |
Gilsanz F.,Hospital Universitario La Paz
Respiratory Care | Year: 2016
Background: Causing pneumothorax is one of the main concerns of lung recruitment maneuvers in pediatric patients, especially newborns. Therefore, these maneuvers are not performed routinely during anesthesia. Our objective was to determine the pressures that cause pneumothorax in healthy newborns by a prospective experimental study of 10 newborn piglets (<48 h old) with healthy lungs under general anesthesia. Methods: The primary outcome was peak inspiratory pressure (PIP) causing pneumothorax. Animals under anesthesia and bilateral chest tube catheterization were randomly allocated to 2 groups: one with PEEP and fixed inspiratory driving pressure of 15 cm H2O (PEEP group) and the second one with PEEP = 0 cm H2O and non-fixed inspiratory driving pressure (zero PEEP group). In both groups, the ventilation mode was pressure-controlled, and PIP was raised at 2-min intervals, with steps of 5 cm H2O until air leak was observed through the chest tubes. The PEEP group raised PIP through 5-cm H2O PEEP increments, and the zero PEEP group raised PIP through 5-cm H2O inspiratory driving pressure increments. RESULTS: Pneumothorax was observed with a PIP of 90.5 ± 15.7 cm H2O with no statistically significant differences between the PEEP group (92 ± 14.8 cm H2O) and the zero PEEP group (89 ± 18.2 cm H2O). The zero PEEP group had hypotension, with a PIP of 35 cm H2O; the PEEP group had hypotension, with a PIP of 60 cm H2O (P = .01). The zero PEEP group presented bradycardia, with PIP of 40 cm H2O; the PEEP group presented bradycardia, with PIP of 70 cm H2O (P = .002). Conclusions: Performing recruitment maneuvers in newborns without lung disease is a safe procedure in terms of pneumothorax. Pneumothorax does not seem to occur in the clinically relevant PIPs of <50 cm H2O. Hemodynamic impairment may occur with high driving pressures. More studies are needed to determine the exact hemodynamic impact of these procedures and pneumothorax PIP in poorly compliant lungs. © 2016 Daedalus Enterprises.
Hasford J.,Ludwig Maximilians University of Munich |
Baccarani M.,University of Bologna |
Hoffmann V.,Ludwig Maximilians University of Munich |
Guilhot J.,University of Poitiers |
And 9 more authors.
Blood | Year: 2011
The outcome of chronic myeloid leukemia (CML) has been profoundly changed by the introduction of tyrosine kinase inhibitors into therapy, but the prognosis of patients with CML is still evaluated using prognostic scores developed in the chemotherapy and interferon era. The present work describes a new prognostic score that is superior to the Sokal and Euro scores both in its prognostic ability and in its simplicity. The predictive power of the score was developed and tested on a group of patients selected from a registry of 2060 patients enrolled in studies of first-line treatment with imatinib-based regimes. The EUTOS score using the percentage of basophils and spleen size best discriminated between high-risk and lowrisk groups of patients, with a positive predictive value of not reaching a CCgR of 34%. Five-year progression-free survival was significantly better in the lowthan in the high-risk group (90% vs 82%, P = .006). These results were confirmed in the validation sample. The score can be used to identify CML patients with significantly lower probabilities of responding to therapy and survival, thus alerting physicians to those patients who require closer observation and early intervention. © 2011 by The American Society of Hematology.
PubMed | Akademiska sjukhuset, European directorate for the quality of medicines, Rigshospitalet, NHS blood and transplant and 2 more.
Type: | Journal: Transfusion clinique et biologique : journal de la Societe francaise de transfusion sanguine | Year: 2017
Allergy accounts to near 0.5% of all reported transfusion adverse events. The responsibility of blood components themselves and -therefore- of blood donors is still questioned. The European Community undertook a large international survey to address the consistency and homogeneity of medical selection of blood donors with regard to the risk of allergy, and especially of transferring allergy to recipients. This short report presents the salient points of the survey, stressing that there is inconsistency in addressing the allergy question within countries or systems, with paths of improvement.
Van Der Speeten K.,Ziekenhuis Oost Limburg |
Stuart O.A.,Washington Hospital Center |
Chang D.,Westat |
Mahteme H.,Akademiska Sjukhuset |
Sugarbaker P.H.,Washington Hospital Center
Cancer Chemotherapy and Pharmacology | Year: 2011
Background: Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy are a combined treatment modality considered for selected patients with peritoneal carcinomatosis from colorectal and appendiceal cancer. Mitomycin C is a drug often used in this clinical setting. The surgical and clinical factors that may influence the pharmacokinetics of hyperthermic intraperitoneal chemotherapy should be further elucidated. Materials and methods: The patients included were 145 who had colorectal or appendiceal carcinomatosis resected using cytoreductive surgery prior to treatment with hyperthermic intraperitoneal chemotherapy with mitomycin C as part of a multidrug regimen. The effect of clinical and surgical factors on drug distribution after single intraperitoneal bolus administration with mitomycin C was determined. Results: The pharmacokinetics of 145 patients treated with intraperitoneal mitomycin C showed a 27 times greater exposure to peritoneal surfaces when compared to plasma. At 90 min, 29% of the drug remained in the chemotherapy solution, 62% was retained in the body, and 9% was excreted in the urine. The extent of peritonectomy increased the clearance of mitomycin C from the peritoneal space (p = 0.051). A major resection of visceral peritoneal surface and a contracted peritoneal space reduced drug clearance. A contracted peritoneal space significantly reduced (p = 0.0001) drug concentrations in the plasma. Conclusions: Surgical and clinical factors may require modifications of drug dose or timing of chemotherapy administration. A large visceral resection and a contracted peritoneal space caused a reduced mitomycin C clearance. Total diffusion surface is an important determinant of mitomycin C pharmacokinetics. © 2010 Springer-Verlag.
Vedung T.,Akademiska Sjukhuset
Journal of Plastic Surgery and Hand Surgery | Year: 2012
Two patients presented with intense pain in the shoulder followed by weakness and paralysis of muscles in the shoulder and arm, together with a peculiar swelling on the hand. The swelling seems to predispose to rupture of the extensor tendon. If this tumour is a regular finding in Parsonage-Turner syndrome, it may also help in making a definitive diagnosis. © 2012 Informa Healthcare.
Eggers K.,Akademiska sjukhuset
Lakartidningen | Year: 2015
Due to technical and medical advances, the complication rate associated with elective percutaneous coronary intervention (PCI) has decreased considerably during the past decades. Accordingly, patients might be scheduled for same-day discharge without exposing them to an increased risk. We conducted a retrospective single-center study to test such an approach. Overall, we noted no difference in the 30-day complication rate in a total of 128 angina patients undergoing elective PCI before and after implementation of a same-day discharge policy. The only variable associated with an increased complication rate was PCI of >2 coronary segments. These patients as well as those with PCI of left main or bifurcational stenoses, femoral access and reduced well-being are recommended to stay at the hospital according to routines at our institution. In summary, our data indicate that same-day discharge after elective PCI is safe provided that suitable patients are identified by appropriate criteria. © 2015, Swedish Medical Association. All rights reserved.
Rhodin A.,Akademiska Sjukhuset
Journal of Pain and Palliative Care Pharmacotherapy | Year: 2013
Chronic pelvic pain is a common, multifactorial complaint that affects both women and men, causing disability and frustration for patients. The exact aetiology remains unknown, although several theories have been proposed. Assessment should be undertaken with care and compassion, while considering the sensitive nature of the area. Management involves ruling out treatable pathology concomitant with strategies to control pain. Novel treatment approaches have been investigated for specific clinical scenarios. The more severe CPP cases are best managed using a multidisciplinary approach. Management requires good integration and knowledge of all pelvic organ systems and including musculoskeletal, neurologic and psychological mechanisms. © 2013 Informa Healthcare USA, Inc.
Barenius B.,Karolinska Institutet |
Ponzer S.,Karolinska Institutet |
Shalabi A.,Akademiska Sjukhuset |
Bujak R.,Sodersjukhuset |
And 2 more authors.
American Journal of Sports Medicine | Year: 2014
Background: The reported prevalence of radiological osteoarthritis (OA) after anterior cruciate ligament (ACL) reconstruction varies from 10% to 90%. Purpose/Hypothesis: To report the prevalence of OA after ACL reconstruction and to compare the OA prevalence between quadrupled semitendinosus tendon (ST) and bone-patellar tendon-bone (BPTB) grafts. The hypothesis was that there would be no difference in OA prevalence between the graft types. The secondary aim was to study whether patient characteristics and additional injuries were associated with long-term outcomes. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Radiological examination results, Tegner activity levels, and Knee injury and Osteoarthritis Outcome Score (KOOS) values were determined in 135 (82%) of 164 patients at a mean of 14 years after ACL reconstruction randomized to an ST or a BPTB graft. Osteoarthritis was defined according to a consensus by at least 2 of 3 radiologists of Kellgren-Lawrence grade >2. Using regression analysis, graft type, sex, age, overweight, time between injury and reconstruction, additional meniscus injury, and a number of other variables were assessed as risk factors for OA 14 years after ACL reconstruction. Results: Osteoarthritis of the medial compartment was most frequent, with 57% of OA cases in the ACL-reconstructed knee and 18% of OA cases in the contralateral knee (P < .001). There was no difference between the graft types: 49% of OA of the medial compartment for BPTB grafts and 65% for ST grafts (P = .073). The KOOS results were lower for patients with OA in all subscales, indicating that OA was symptomatic. No difference in the KOOS between the graft types was found. Meniscus resection was a strong risk factor for OA of the medial compartment (odds ratio, 3.6; 95% CI, 1.4-9.3) in the muttivariable logistic regression analysis. Conclusion: A 3-fold increased prevalence of OA was found after an ACL injury treated with reconstruction compared with the contralateral healthy knee. No differences in the prevalence of OA between the BPTB and quadrupled ST reconstructions were found. An initial meniscus resection was a strong risk factor for OA; the time between injury and reconstruction was not. © 2014 The Author(s).