Biosimilar G-CSF versus filgrastim and lenograstim in healthy unrelated volunteer hematopoietic stem cell donors

The World Marrow Donor Organization recommends original granulocyte-colony stimulating factor (G-CSF) for the mobilization of stem cells in healthy unrelated hematopoietic stem cell donors. We report the comparison of a biosimilar G-CSF (Zarzio) with two original G-CSFs (filgrastim and lenograstim) in mobilization in unrelated donors. We included data of 313 consecutive donors who were mobilized during the period from October 2014 to March 2016 at the Medical University of Warsaw. The primary endpoints of this study were the efficiency of CD34+ cell mobilization to the circulation and results of the first apheresis. The mean daily dose of G-CSF was 9.1 μg/kg for lenograstim, 9.8 μg/kg for biosimilar filgrastim, and 9.3 μg/kg for filgrastim (p < 0.001). The mean CD34+ cell number per microliter in the blood before the first apheresis was 111 for lenograstim, 119 for biosimilar filgrastim, and 124 for filgrastim (p = 0.354); the mean difference was even less significant when comparing CD34+ number per dose of G-CSF per kilogram (p = 0.787). Target doses of CD34+ cells were reached with one apheresis in 87% donors mobilized with lenograstim and in 93% donors mobilized with original and biosimilar filgrastim (p = 0.005). The mobilized apheresis outcomes (mean number of CD34+ cells/kg of donor collected during the first apheresis) was similar with lenograstim, biosimilar filgrastim, and filgrastim: 6.2 × 10⁶, 7.6 × 10⁶, and 7.3 × 10⁶, respectively, p = 0.06. There was no mobilization failure in any of the donors. Biosimilar G-CSF is as effective in the mobilization of hematopoietic stem cells in unrelated donors as original G-CSFs. Small and clinically irrelevant differences seen in the study can be attributed to differences in G-CSF dose and collection-related factors. Active safety surveillance concurrent to clinical use and reporting to donor outcome registry (e.g., EBMT donor outcome registry or WMDA SEAR/SPEAR) might help to evaluate the possible short- and long-term complications of biosimilar G-CSF

Spinal cord stimulation in the treatment of chronic pain

Jednym ze sposobów leczenia bólu przewlekłego jest procedura neuromodulacyjna – stymulacja rdzenia kręgowego (spinal cord stimulation SCS). Istnieje wiele teorii wyjaśniających mechanizm jej działania, ale nie jest on ostatecznie poznany. SCS stosuje się między innymi po operacjach neurochirurgicznych w zespołach failed back surgery syndrome i post-laminectomy syndrome. Wskazaniem do stymulacji rdzenia kręgowego jest ból neuropatyczny, który powstaje w wyniku ucisku nerwów (pleksopatie, radikulopatie). Elektrodę umieszcza się w grzbietowej części przestrzeni nadtwardówkowej, na wysokości zależnej od miejsca występowania bólu. Najczęstsze miejsca implantacji generatora zlokalizowane są wzdłuż linii środkowo-pachowej, w górnej części pośladka, w linii pachowej tylnej i powłokach brzucha, tuż poniżej najniższego żebra. Elektroda dodatnia – anoda – hamuje neurony poprzez hiperpolaryzację. Wykorzystując to działanie, programuje się urządzenia stymulujące. SCS jako metoda leczenia bólu przewlekłego daje pacjentom ulgę w bólu, a niektórym stwarza możliwość powrotu do pracy.Neuromodulation is the procedure used for the spinal cord stimulation (SCS). There are many theories explaining its mechanism, however it has not been thoroughly studied. SCS is used e.g. after neurosurgical operations in failed back surgery syndrome as well as post-laminectomy syndrome. An indication for spinal cord stimulation is neuropathic pain occurring as a result of pressure on nerves. An electrode is placed within a dorsal part of the extradural space at the height dependent on the pain location. The most frequent site of generator implantation is located along the midaxillary line, in the upper part of the buttock, in the posterior axillary line and the lining of the stomach just below the lowest rib. The positive electrode – anode – suppresses neurons through hyperpolarization. SCS as a method of chronic pain treatment brings relief to patients, and in some cases it enables them to go back to work