A Prospective,Randomized, Multicenter,Controlled Study of the Safety of Seprafilm® Adhesion Barrier in Abdominopelvic Surgery of the Intestine

INTRODUCTION: Seprafilm® adhesion barrier (Seprafilm®) has been proven to prevent adhesion formation after abdominal and pelvic surgery. This article reports safety results, including the postoperative incidence of abdominal and pelvic abscess and pulmonary embolism, from a large, multicenter trial designed to evaluate the safety and effectiveness of Seprafilm® for reduction of adhesion-related postoperative bowel obstruction after abdominopelvic surgery. METHODS: A total of 1,791 patients participated in this prospective, randomized, multicenter, multinational, single-blind, controlled study in patients undergoing abdominopelvic surgery, the majority of whom had inflammatory bowel disease. Just before closure of the abdomen, patients were randomized to a Seprafilm® or no-treatment control group. Patients received an average of 4.4 and as many as 10 Seprafilm® adhesion barriers applied to organs and tissue surfaces that sustained direct surgical trauma and to suspected adhesiogenic surfaces. Complications that occurred within the first month after surgery were evaluated. RESULTS: During the safety evaluation period, the difference between the Seprafilm® and control groups for the incidence of abscess (4 vs. 3 percent, respectively) or pulmonary embolism (<1 percent in both groups) was not statistically significant (P > 0.05). Foreign body reaction was not reported in either group. Fistula (2 vs. <1 percent) and peritonitis (2 vs. <1 percent) occurred more frequently (P 0.05) in the Seprafilm® group. In a subpopulation of patients in whom Seprafilm® was wrapped around a fresh bowel anastomosis, leak-related events, which included anastomotic leak, fistula, peritonitis, abscess, and sepsis, occurred more frequently (P 0.05). There were no other differences in the incidence, severity, or causative relationship of complications between study groups. CONCLUSIONS: This study confirmed the safety of Seprafilm® adhesion barrier with respect to abdominal abscess, pelvic abscess, and pulmonary embolism when administered to patients undergoing abdominopelvic surgery. Foreign body reaction was not reported for any patient. However, wrapping the suture or staple line of a fresh bowel anastomosis with Seprafilm® should be avoided, because the data suggest that this practice may increase the risk of sequelae associated with anastomotic leak.     

IL-2 induces in vivo suppression by CD4(+)CD25(+)Foxp3(+) regulatory T cells

Interleukin-2 (IL-2) treatment is currently used to enhance T cell-mediated immune responses against tumors or in viral infections. At the same time, IL-2 is essential for the peripheral homeostasis of CD4(+)CD25(+)Foxp3(+ )regulatory T cells (Treg). In our study, we show that IL-2 is also an important activator of Treg suppressive activity in vivo. IL-2 treatment induces Treg expansion as well as IL-10 production and increases their suppressive potential in vitro. Importantly, in vivo application of IL-2 via gene-gun vaccination using IL-2 encoding DNA plasmids (pIL-2) inhibited naive antigen-specific T cell proliferation as well as a Th1-induced delayed type hypersensitivity response. The suppressive effect can be transferred onto naive animals by Treg from IL-2-treated mice and the suppression depends on the synergistic action of IL-10 and TGF-beta. These data highlight that during therapeutic treatment with IL-2 the concomitant activation of Treg may indeed counteract the intended activation of cellular immunity.     

Delayed prompting: a review of procedural variations and results

The delayed prompt procedure transfers stimulus control via the introduction of a time delay between the presentation of a stimulus and a prompt. This procedure has received increasingly greater attention in the literature during the past decade. The present paper reviews 26 studies that used the delayed prompt procedure in applied and laboratory settings. Subjects included developmentally disabled children and adults as well as children of normal intelligence who were taught a wide variety of tasks. Procedural variations across studies were noted in delay length and ceiling, criterion for increasing the delay, mastery criterion, and error correction. Results suggest that the delayed prompt procedure is an efficient teaching stategy, with subjects typically acquiring discriminations within a few training sessions or limited number of trials. However, not all subjects have benefited from the procedure. Additionally, little maintenance data have appeared in the literature, raising questions about long-term effectiveness. Alternative explanations for the reported success of the procedure as well as future areas of research are discussed.     

Dimensions of Nurse Caring

Dimensions of nurse caring were elicited through nurse and patient responses on the revised Caring Behaviors Inventory (CBI), a 43-item instrument. Subjects included 278 nurses and 263 patients and former patients. An exploratory factor analysis using the principal components method with varimax rotation was used to identify CBI dimensions; a five factor solution resulted. The five dimensions of nurse caring were respectful deference to others, assurance of human presence, positive connectedness, professional knowledge and skill, and attentiveness to the other's experience     

Botulinum toxin

Botulinum toxin is regarded as the most lethal substance known. It is estimated that the human LD50 for inhalation botulism is 1 to 3 nanograms of toxin/kilogram body mass. Although only three cases of inhalational botulism have been described, an understanding of the pathophysiology of food-borne outbreaks, wound botulism, and infant botulism, and their therapies, enables the medical community to plan treatment in the event of an aerosol release of botulinum toxin. Antitoxin, vaccine, and F(ab')2 immune fragment therapies are discussed as adjuncts to supportive therapy.     

Differential internalization of hu14.18-IL2 immunocytokine by NK and tumor cell: impact on conjugation, cytotoxicity, and targeting

The hu14.18-IL2 (EMD 273063) IC, consisting of a GD(2)-specific mAb genetically engineered to two molecules of IL-2, is in clinical trials for treatment of GD(2)-expressing tumors. Anti-tumor activity of IC in vivo and in vitro involves NK cells. We studied the kinetics of retention of IC on the surface of human CD25(+)CD16(-) NK cell lines (NKL and RL12) and GD(2)(+) M21 melanoma after IC binding to the cells via IL-2R and GD(2), respectively. For NK cells, ～ 50% of IC was internalized by 3 h and ～ 90% by 24 h of cell culture. The decrease of surface IC levels on NK cells correlated with the loss of their ability to bind to tumor cells and mediate antibody-dependent cellular cytotoxicity in vitro. Unlike NK cells, M21 cells retained ～ 70% of IC on the surface following 24 h of culture and maintained the ability to become conjugated and lysed by NK cells. When NKL cells were injected into M21-bearing SCID mice, IT delivery of IC augmented NK cell migration into the tumor. These studies demonstrate that once IC binds to the tumor, it is present on the tumor surface for a prolonged time, inducing the recruitment of NK cells to the tumor site, followed by tumor cell killing.     

Culturally-Competent Treatments for Asian Americans: The Relevance of Mindfulness and Acceptance-Based Psychotherapies

The development of effective treatments for Asian Americans is important because treatment disparities continue to exist for this population. Because of their theoretical grounding in East Asian philosophies, mindfulness and acceptance-based psychotherapies appear to constitute promising ways to provide culturally responsive mental health care to Asian Americans. However, in practice these approaches often reflect conceptions of mental health that are more consistent with Western world views. We review points of intersection and divergence between Western-based mindfulness and acceptance psychotherapies and Asian American cultural values. We then propose a culturally syntonic approach that accentuates certain components of mindfulness and acceptance psychotherapies and adapts other components of these approaches to be more consistent with Asian American cultural values.     

Spatio-temporal population structuring and genetic diversity retention in depleted Atlantic Bluefin tuna of the Mediterranean Sea

Fishery genetics have greatly changed our understanding of population dynamics and structuring in marine fish. In this study, we show that the Atlantic Bluefin tuna (ABFT, Thunnus thynnus), an oceanic predatory species exhibiting highly migratory behavior, large population size, and high potential for dispersal during early life stages, displays significant genetic differences over space and time, both at the fine and large scales of variation. We compared microsatellite variation of contemporary (n = 256) and historical (n = 99) biological samples of ABFTs of the central-western Mediterranean Sea, the latter dating back to the early 20th century. Measures of genetic differentiation and a general heterozygote deficit suggest that differences exist among population samples, both now and 96–80 years ago. Thus, ABFTs do not represent a single panmictic population in the Mediterranean Sea. Statistics designed to infer changes in population size, both from current and past genetic variation, suggest that some Mediterranean ABFT populations, although still not severely reduced in their genetic potential, might have suffered from demographic declines. The short-term estimates of effective population size are straddled on the minimum threshold (effective population size = 500) indicated to maintain genetic diversity and evolutionary potential across several generations in natural populations.