An investigational tetravalent meningococcal serogroups A, C, W-135 and Y-tetanus toxoid conjugate vaccine co-administered with Infanrix™ hexa is immunogenic, with an acceptable safety profile in 12-23-month-old children

Tetravalent meningococcal serogroups ACWY conjugate vaccines will provide an advantage to those at most risk of invasive meningococcal disease; namely young children. Co-administration of ACWY-TT with DTaP-HBV-IPV/Hib was assessed in a randomized trial in 793 children aged 12-23 months. Pre-specified criteria for non-inferiority of immunogenicity following co-administration versus separate ACWY-TT and DTaP-HBV-IPV/Hib administration were reached. One month post-vaccination, ≥97.3% of ACWY-TT vaccinees had rSBA titres ≥1:8 (all serogroups). Seroprotection/seropositivity rates against DTaP-HBV-IPV/Hib antigens were ≥98.2%. The safety profile of co-administration was similar to that of DTaP-HBV-IPV/Hib alone. ACWY-TT and DTaP-HBV-IPV/Hib co-administration during the second year would facilitate introduction of ACWY-TT into routine toddler vaccination schedules.     

Safety Profile of Sequential Transcatheter Chemoembolization with DC Bead?: Results of 237 Hepatocellular Carcinoma (HCC) Patients

Introduction

Complications of chemoembolization performed with DC Bead^? loaded with doxorubicin (DEBDOX) of diameters 100?C300???m and 300?C500???m are presented in this paper. These diameters are currently the smallest available in drug-eluting technology.

Methods

Included are 237 patients who were treated with sequential DEBDOX with doxorubicin loaded at 37.5?mg/ml of DC Bead. The National Cancer Institute Common Terminology Criteria for Adverse Events (version 3.0) were used to categorize complications.

Results

Thirty-day mortality was 1.26% (3/237). Incidence of grade 5 complications was 1.26% (3/237). Overall, grade 4 complications resulted in 5.48% (13/237) (irreversible liver failure, cholecystitis). Grade 2 liver function deterioration developed in 10 patients (4.2%). Cholecystitis/grade 2 and 4 incidents were observed in 3.6?C5.06% across sessions (overall 13 patients; 5.48%). Postembolization Syndrome (PES) grade 1 or 2 was observed in up to 86.5%; however, grade 2 was observed in 25?C42.19% across treatments. Pleural effusion was seen in eight patients (overall 3.37%; grade 1 in 1.8?C3.7% across treatments; grade 3 in 0.42%). Grade 1 procedure-related laboratory pancreatitis was seen in 0.45%, and grade 2 gastrointestinal bleeding was seen in 0.84%. Procedure-associated skin erythema/grade 1 was seen in 0.84%. There was no correlation of liver failure or transient liver function deterioration with the diameter of the beads (p?=?0.25?C0.37 and p?=?0.14?C0.89, respectively). Stratifying with the diameter of the beads correlation values was: for cholecystitis (p?=?0.11?C0.96 across treatments), PES (p?=?0.35?C0.83), temporary/grade 1 elevation of liver enzymes (p?=?0.002?C0.0001), and bilirubin (p?=?0.04?C0.99).

Conclusions

DEBDOX chemoembolization is safe and small calibres do not result in increased complication rates compared with results of series using larger diameters of beads.     

The Role of Colchicine in Treating Postoperative and Post-catheter Ablation Atrial Fibrillation

Purpose

The goal of this review was to summarize, analyze, and compare trials studying the efficacy of colchicine in the prevention of atrial fibrillation (AF) post-operatively (POAF) and post–catheter ablation. Ongoing studies and current guidelines are also presented and reviewed.

The effect of FASN inhibition on the growth and metabolism of a cisplatin‐resistant ovarian carcinoma model

Overexpression of fatty acid synthase (FASN), a key regulator of the de novo synthesis of fatty acids, has been demonstrated in a variety of cancers and is associated with poor prognosis and increased multidrug resistance. Inhibition of FASN with the anti‐obesity drug orlistat has been shown to have significant anti‐tumourigenic effects in many cancers, notably breast and prostate. In our study, we investigated whether FASN inhibition using orlistat is an effective adjunctive treatment for ovarian cancers that have become platinum resistant using a cisplatin‐resistant ovarian tumour xenograft model in mice. Mice were treated with orlistat or cisplatin or a combination and metabolite analysis and histopathology were performed on the tumours ex vivo. Orlistat decreased tumour fatty acid metabolism by inhibiting FASN, cisplatin reduced fatty acid β‐oxidation, and combination treatment delayed tumour growth and induced apoptotic and necrotic cell death in cisplatin‐resistant ovarian cancer cells over and above that with either treatment alone. Combination treatment also decreased glutamine metabolism, nucleotide and glutathione biosynthesis and fatty acid β‐oxidation. Our data suggest that orlistat chemosensitised platinum‐resistant ovarian cancer to treatment with platinum and resulted in enhanced efficacy.     

Seroepidemiology of Hepatitis B in Greek Children 6 Years After the Implementation of Universal Vaccination

Abstract The seroepidemiology of hepatitis B in children living in Greece 6 years post-implementation of universal infant immunization (1998) was studied. We collected 90–100 sera/year of age, stratified by geographic region. The prevalence of HbsAg(+) was 0.6% (95% CI 0.3–1.3) whereas 4.5% (95% CI 3.4–5.9%) of children over 12 months of age had evidence of past HBV infection. A significant decline in the prevalence of past infection between children born before and after 1998 (5.5% vs 2.9%; RR = 1.9, 95% CI 1.03–3.5) was noted. Conversely, the prevalence of past HBV infection did not change significantly among immigrant children. Reinforcement of early vaccination of immigrant population is necessary.     

Too far away to work with each other: Does location impact on pharmacists’ perceptions of interprofessional interactions?

In recent years, the delivery of health services has seen a shift towards interprofessional teamwork in order to effectively utilise the skills of each member of the healthcare team to deliver optimal patient care. Nevertheless, a variety of barriers, including lack of communication between healthcare professionals (HCPs), have been identified. The expanding clinical services provided by community pharmacies have increased the potential for pharmacist-HCP interaction; however, primary care pharmacy environments vary from individual distinct premises to part of interprofessional ‘health centres’. As such, one potential factor affecting interprofessional communication could be the geographical location (‘space’) of HCPs. This study sought to determine whether these different primary healthcare ‘spaces’ impact on the frequency of interprofessional interactions. An anonymous, self-complete questionnaire was sent to all community pharmacies in Wales (n = 716) to quantify the frequency of interprofessional interactions between community pharmacists and other HCPs. A response rate of 62% was achieved. Results showed that pharmacists working in pharmacies physically linked to general practitioner (GP) surgeries had significantly more frequent interaction with HCPs based within the surgeries. This suggests that housing HCPs in the same physical space will enable more interprofessional interaction, supporting the drive to improve the quality of patient care.     

Immunologic effects of emdogain in humans: one-year results

Tissue regeneration after therapeutic manipulations is essential in periodontology, oral surgery, and trauma of the periodontal tissues. Local inflammation because of poor oral hygiene also plays a crucial role in the above situations. Local inflammatory reaction, accompanied by the local production of cytokines, profoundly influences bone turnover and regeneration. Several products of low immunogenicity for augmenting tissue regeneration have been recently proposed as boosters of soft and mineralized tissue regeneration. Among them, Emdogain, an amelogenin derivative of porcine origin, has recently been introduced. Clinical results indicate that this product might be a good additive, producing fast tissue regeneration with no apparent clinical side effects. In contrast, very little is known about its in vivo immunologic effects. A previous study showed that Emdogain does not modify the cellular or humoral immune response in vitro. In the present work, performed in 10 patients, only a slight, nonsignificant activation of the immune system occurred during the first year following Emdogain application. Neither cellular immunity nor humoral immune response was significantly modified. In addition, the in vitro response of the patients' lymphocytes to Emdogain was assayed 2 and 12 months postoperative. We did not find any significant specific lymphocyte transformation in the presence of Emdogain, although lymphocytes could be stimulated by nonselective mitogens. These results indicate the immunologic safety of the agent in vivo, at least after 1 year.