Mobilization of autologous and allogeneic peripheral blood stem cells for transplantation in haematological malignancies using biosimilar G-CSF.

BACKGROUND AND OBJECTIVES: Biosimilars of the granulocyte colony stimulating factor (G-CSF) filgrastim were approved by the European Medicines Agency (EMA) for registered indications of the originator G-CSF, including prevention and treatment of neutropenia, as well as mobilization of peripheral blood stem cells in 2008. Nevertheless, there is still an ongoing debate regarding the quality, efficacy and safety of biosimilar G-CSF. MATERIALS AND METHODS: This article is a meta-analysis of clinical studies on the use of biosimilar G-CSF for mobilization and transplantation of haematopoietic stem cells as available in public databases. All data sets were weighted for the number of patients and parameters and then subjected to statistical meta-analysis employing the Mann-Whitney U-test followed by the Hodges-Lehmann estimator to assess differences between biosimilar and originator G-SCF. RESULTS: A total of 1892 individuals, mostly with haematological malignancies but also including 351 healthy donors have been successfully mobilized for autologous or allogeneic stem cell transplantation using biosimilar G-CSF (Zarzio(TM) : 1239 individuals; Ratiograstim(TM) /Tevagrastim(TM) : 653 individuals). A total of 740 patients with multiple myeloma, 491 with non-Hodgkin's lymphoma (NHL), 150 with Hodgkin's lymphoma (HL) and other diseases are included in this meta-analysis, as well as 161 siblings and 190 volunteer unrelated donors. For biosimilar and originator G-CSF, bioequivalence was observed for the yield of CD34+ stem cells as well as for the engraftment of the transplants. CONCLUSION: Biosimilar G-CSF has equivalent effects and safety as originator G-CSF.

Nutritional screening for risk prediction in patients scheduled for abdominal operations.

BACKGROUND: Increased risks related to surgery might reflect the nutritional status of some patients. Such a group might benefit from perioperative nutritional support. The purpose of this study was to identify the relative importance of nutritional risk screening along with established medical, anaesthetic and surgical predictors of postoperative morbidity and mortality. METHODS: This prospective observational study enrolled consecutive eligible patients scheduled for elective abdominal operations. Data were collected on nutritional variables (body mass index, weight loss, food intake), age, sex, type and extent of operation, underlying disease, American Society of Anesthesiologists grade and co-morbidities. A modified composite nutritional screening tool (Nutritional Risk Screening, NRS 2002) currently recommended by European guidelines was used. Relative complication rates were calculated with multiple logistic regression and cumulative proportional odds models. RESULTS: Some 653 patients were enrolled of whom 132 (20.2 per cent) sustained one or more postoperative complications. The frequency of this event increased significantly with a lower food intake before hospital admission. No other individual or composite nutritional variable provided comparable or better risk prediction (including NRS 2002). Other factors significantly associated with severe postoperative complications were ASA grade, male sex, underlying disease, extent of surgical procedure and volume of transfused red cell concentrates. CONCLUSION: In abdominal surgery, preoperative investigation of feeding habits may be sufficient to identify patients at increased risk of complications. Nutritional risk alone, however, is not sufficient to predict individual risk of complications reliably.

Agency-university collaboration: home care early in the student curriculum.

Changes in the healthcare system mandate community-focused experiences for nursing students. This article describes the collaboration of San Jose State University School of Nursing faculty and the education coordinators of two home health agencies in developing successful home health clinical experiences for students early in the curriculum. Questions and concerns of agency staff strategies for developing home health experiences between home health agencies and nursing faculty are presented.

[The role of initiative in early emotional development. Organization of the second semester]. / Le rôle de l'initiative dans le développement émotionnel précoce. Organisation du deuxième semestre.

This article describes the most significant events in the second semester of emotional life. Based on empirical data and on various techniques devised by the author, points of convergence with other theories and other observations are described. Spontaneous gestures and essential expressions of the true (nuclear) self suggest that initiative, as an organizer of motricity, and self experience play a central role in the construction of the psyche. These elements would represent a first level of organization. The role of environment is considered as facilitating or inhibiting this development. The reasons of these attitudes are to be found in the fantasy world of the mother and in her preconscious attitudes. Among maternal functions, the author emphasizes mirror function in the enlarged sense he suggests. Simultaneously initiative, development of active will can be observed in the fights and confronting behaviors which aim at supporting initiative. Environmental efforts to suppress these behaviors lead to submission. The latter develops into two types of pathology: 1) reaction pathology with formation of a "false self" and 2) over-adaptation pathology with predominant psychosomatic disturbances. The possibility of negotiating, presently explored by he author, suggests some interesting further research that could have important bearings on theory and clinical practice, both in prevention and early intervention.