Nephrology
-
The imminent expiry of patents on biological medicinal products, such as epoetin alfa in 2006, has significant implications for nephrology in Australia. The purpose of this review is to examine the differences between biosimilars (similar biological medicinal products) and generic low molecular weight (chemical) drugs. The approach that regulatory agencies, including the European Medicines Agency (EMEA) and the Therapeutic Goods Administration (TGA), are taking towards biosimilars is also discussed. ⋯ Therefore, it has been acknowledged by the EMEA that established legal and regulatory principles of 'essential similarity' that are applied to standard chemical generics cannot be readily applied to biosimilars. One of the key areas of concern with the introduction of biosimilars into the field of nephrology will be guaranteeing the safety and efficacy of biosimilars. New manufacturers will need to ensure that their biopharmaceutical has a similar efficacy and safety profile to the innovator product through more extensive clinical trials than the limited testing done for generic versions of low molecular weight chemical medicines.
-
Randomized Controlled Trial
Enhancing the survival of tunneled haemodialysis catheters using an antibiotic lock in the elderly: a randomised, double-blind clinical trial.
Tunneled-cuffed catheters (TCC) are often used among the elderly to commence and carry out haemodialysis (HD). Complications like infection and thrombosis frequently reduce the lifespan of TCC. The role of an antibiotic heparin 'lock' in the prevention of thrombotic and infectious complications and enhancement of TCC survival in the elderly has not been investigated previously. ⋯ Cefotaxime and heparin locks safely and effectively enhance the lifespan of TCC by lowering the incidence of thrombotic and infectious complications among elderly end-stage renal failure (ESRD) patients.
-
Post-transplant lymphoproliferative disorder (PTLD) following solid organ transplantation is an important form of post-transplant malignancy. PTLD is typically associated with Epstein-Barr virus (EBV) and occurs in the setting of profound immunosuppression resulting in a deficiency of EBV-specific cytotoxic T lymphocytes (CTL). Predisposing factors include EBV mismatch between donor and recipient, use of immunosuppression especially T-cell depletive therapies and genetic predisposition of recipients. ⋯ Recent work has highlighted a potential role for dendritic cells in both the pathogenesis and treatment of PTLD. Current treatment modalities include adoptive immunotherapy using ex vivo generated autologous EBV-specific CTL or allogeneic CTL, cytokine therapies, antiviral agents, and more recently, rituximab and dendritic-cell based therapies. This review focuses on the developments and progress in the pathogenesis, diagnosis and treatment of PTLD.
-
Case Reports
Rhabdomyolysis following laparoscopic radical nephrectomy: a case to heighten awareness.
Rhabdomyolysis, myoglobinuria and acute renal failure are rare complication of surgery. Long operative time, increased body mass, lateral decubitus positioning and extracellular volume depletion may predispose to this condition. ⋯ His postoperative course was complicated by acute renal failure due to rhabdomyolysis. Heightened awareness, early recognition and treatment of this condition are important, particularly as laparoscopic nephrectomy is becoming a common procedure for living donor transplantation.