BACKGROUND.The safety profiles of standard therapy versus everolimus with reduced-exposure calcineurin inhibitor (CNI) therapy using contemporary protocols in de novo kidney transplant recipients ...have not been compared in detail.
METHODS.TRANSFORM was a randomized, international trial in which de novo kidney transplant patients were randomized to everolimus with reduced-exposure CNI (N = 1014) or mycophenolic acid (MPA) with standard-exposure CNI (N = 1012), both with induction and corticosteroids.
RESULTS.Within the safety population (everolimus 1014, MPA 1012), adverse events with a suspected relation to study drug occurred in 62.9% versus 59.2% of patients given everolimus or MPA, respectively (P = 0.085). Hyperlipidemia, interstitial lung disease, peripheral edema, proteinuria, stomatitis/mouth ulceration, thrombocytopenia, and wound healing complications were more frequent with everolimus, whereas diarrhea, nausea, vomiting, leukopenia, tremor, and insomnia were more frequent in the MPA group. The incidence of viral infections (17.2% versus 29.2%; P < 0.001), cytomegalovirus (CMV) infections (8.1% versus 20.1%; P < 0.001), CMV syndrome (13.6% versus 23.0%, P = 0.044), and BK virus (BKV) infections (4.3% versus 8.0%, P < 0.001) were less frequent with everolimus. CMV infection was less common with everolimus versus MPA after adjusting for prophylaxis therapy in the D+/R− subgroup (P < 0.001). Study drug was discontinued more frequently due to rejection or impaired healing with everolimus, and more often due to BKV infection or BKV nephropathy with MPA.
CONCLUSIONS.De novo everolimus with reduced-exposure CNI yielded a comparable incidence, though a distinctly different pattern, of adverse events versus current standard of care. Both regimens are safe and effective, yet their distinct profiles may enable tailoring for individual kidney transplant recipients.
Intimkirurgi i Norge Rosenberg, Bjørn E; Morken, Nils-Halvdan
Tidsskrift for den Norske Lægeforening,
2017, 2017-00-00, Letnik:
137, Številka:
14
Journal Article
Kirurgisk behandling ved urininkontinens hos barn Skari, Hans; Urdal, Andreas; Hagen, Trine Sæther ...
Tidsskrift for den Norske Lægeforening,
2020, 2020-00-00, Letnik:
140, Številka:
4
Journal Article
Background In 2005, the International Study Group of Pancreatic Fistula developed a definition and grading of postoperative pancreatic fistula that has been accepted universally. Eleven years later, ...because postoperative pancreatic fistula remains one of the most relevant and harmful complications of pancreatic operation, the International Study Group of Pancreatic Fistula classification has become the gold standard in defining postoperative pancreatic fistula in clinical practice. The aim of the present report is to verify the value of the International Study Group of Pancreatic Fistula definition and grading of postoperative pancreatic fistula and to update the International Study Group of Pancreatic Fistula classification in light of recent evidence that has emerged, as well as to address the lingering controversies about the original definition and grading of postoperative pancreatic fistula. Methods The International Study Group of Pancreatic Fistula reconvened as the International Study Group in Pancreatic Surgery in order to perform a review of the recent literature and consequently to update and revise the grading system of postoperative pancreatic fistula. Results Based on the literature since 2005 investigating the validity and clinical use of the original International Study Group of Pancreatic Fistula classification, a clinically relevant postoperative pancreatic fistula is now redefined as a drain output of any measurable volume of fluid with an amylase level >3 times the upper limit of institutional normal serum amylase activity, associated with a clinically relevant development/condition related directly to the postoperative pancreatic fistula. Consequently, the former “grade A postoperative pancreatic fistula” is now redefined and called a “biochemical leak,” because it has no clinical importance and is no longer referred to a true pancreatic fistula. Postoperative pancreatic fistula grades B and C are confirmed but defined more strictly. In particular, grade B requires a change in the postoperative management; drains are either left in place >3 weeks or repositioned through endoscopic or percutaneous procedures. Grade C postoperative pancreatic fistula refers to those postoperative pancreatic fistula that require reoperation or lead to single or multiple organ failure and/or mortality attributable to the pancreatic fistula. Conclusion This new definition and grading system of postoperative pancreatic fistula should lead to a more universally consistent evaluation of operative outcomes after pancreatic operation and will allow for a better comparison of techniques used to mitigate the rate and clinical impact of a pancreatic fistula. Use of this updated classification will also allow for more precise comparisons of surgical quality between surgeons and units who perform pancreatic surgery.
We sought to examine prevalence of headache in patients with histopathologically verified intracranial tumors scheduled for surgery, and assess change in headache 1 and 6 months after surgical ...resection. Possible tumor and patient related predictors for preoperative headache and early postoperative symptom relief were also explored.
The European Organization for Research and Treatment of Cancer (EORTC) has developed a quality of life questionnaire (EORTC QLQ-C30) with a brain cancer specific module, QLQ-BN20, containing 20 questions rating symptoms the past week on an ordinal scale ranging from 1-4. Analyses are based on question 4 in this questionnaire.
In this prospective population based cohort study of 507 patients we found that headache is a frequent symptom in patients with intracranial neoplasms. 52% reported some degree of preoperative headache, and the prevalence dropped to 43% and 30% 1 and 6 months postoperatively. 19% and 9% reported postoperative worsening or new headache 1 and 6 months after surgery. Younger age, female gender and occipital tumor location were significant predictors for both preoperative headache and early postoperative relief. Additionally, Karnofsky Performance Status (KPS) below 70 was a predictor for headache relief 1 month after surgery. No independent risk factors for worsening or new headache after surgery were identified.
Headache is a common symptom in patients with intracranial tumors, especially in younger and female patients. Many patients experience improvement after surgery, and younger age, female gender, occipital tumor location and functional dependence were identified as factors associated with early postoperative headache relief.
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