Kiwi Omnicup versus Malmstrom metal cup in vacuum assisted delivery: a randomized comparative trial

AIM: To compare the success, clinical outcomes, and maternal and neonatal complications between the Kiwi Omnicup and the Malmstrom metal cup in vacuum assisted delivery. METHODS: This was a prospective randomized comparative trial. Women who required vacuum assisted vaginal delivery were randomized into the Kiwi Omnicup (KO) group and the Malmstrom metal cup (MM) group. The vacuum assisted deliveries were conducted according to hospital protocol. Details of the procedure and delivery outcomes including success and complications were analyzed. RESULTS: One hundred and sixty-four women were recruited - 85 were assigned to vacuum assisted delivery using the KO and 79 the MM. One hundred percent delivery success was achieved with no significant differences between the two instruments in terms of maternal morbidity (P = 0.66). Six women in the MM group sustained post delivery complications in comparison to five in the KO group. Three babies were diagnosed with birth asphyxia in each group. More babies in the MM group were admitted to the Neonatal Intensive Care Unit (NICU) (10 babies versus 5 babies) and suffered complications (14 versus 12 babies), compared to the KO group, although the difference was not statistically significant. There were no intrapartum or neonatal deaths and of those admitted to the NICU, all were discharged within a week without any serious consequences. CONCLUSION: Kiwi Omnicup is an effective alternative to the currently available Malmstrom metal cup for vacuum assisted delivery with no increase in maternal or neonatal morbidity or mortality.     

Aromatase cytochrome P450 enzyme expression in prolactinomas and its relationship to tumor behavior

The aim of the study was to evaluate the presence of aromatase cytochrome P450 enzyme (P450AROM) expression in normal pituitary tissues and tumor tissues of patients with prolactinoma and to examine the impact of the P450AROM expression on clinical outcome. Twenty-six consecutive human pituitary tissue samples were obtained from autopsies performed at the Institute of Forensic Medicine. Sixty-four patients who had an adenomectomy between 2000 and 2009 after prolactinoma diagnosis with histologically confirmed pituitary tumor tissues were retrospectively included in this study. The slices from the pituitary tissues were subjected to immunohistochemical staining for evaluation of P450AROM and estrogen receptor beta (ER beta) subunit. Immunohistochemistry results were compared according to age, gender, remission rate, resistance and invasion status of the patients. Higher than normal P450AROM expression was found in the pituitary tissues of the patients with prolactinoma (p < 0.001). P450AROM intensity had no relation to resistance or remission in patients with prolactinoma (p = 0.44, p = 0.45, respectively). The subgroup analysis showed that compared to males without invasive adenoma, males with invasive adenoma had higher P450AROM expression (p = 0.048). ER beta was found to have an impact on resistance (p = 0.049). This study shows that P450AROM expression is present in the pituitary tissues of patients with prolactinoma and that this presence could be important in development and tumor behavior of prolactinomas.     

Psychiatric disorders in adolescents and adults with autism and intellectual disability: A representative study in one county in Norway

Few studies assess psychiatric disorders in representative samples of individuals with autism and ID. Symptoms of autism and psychiatric disorders have been confounded. PAC, a conceptually analysed and validated screening instrument, was used.AimsAssess prevalence of psychiatric disorders in individuals with intellectual disability only (ID-only) and with combination of autism and ID (autism). Sixty-two (autism) and 132 (ID-only) participants were screened for psychiatric disorders with the Psychopathology in Autism Checklist (PAC); included general adjustment problems (GAP), and severe adjustment problems (SGAP) in one county in Norway. Psychosis, depression, anxiety, and OCD were addressed. Both SGAP and a high psychiatric disorder score were required to screen a psychiatric disorder. “Diagnostic overlap” was defined as more than one psychiatric disorder concurrent with autism.Psychiatric disorders and SGAP were found to be high both in the autism (53.2%) and ID-only group (17.4%). More than 50% of the autism and approximately 20% of ID-only group had SGAP. The differences were significant. The autism–psychiatric disorder interaction was significant. The largest differences between the prevalence in the autism and the ID-only group were shown in individuals with anxiety. The majority of the individuals in both study groups were afflicted with more than one psychiatric disorder. About 60% were found to have more than one disorder. The individuals with more severe psychiatric symptoms had higher degrees of diagnostic overlap. Having an intellectual disability seem to imply high risk for developing adjustment problems, and it seems especially difficult for individuals with autism to master every-day challenges.     

A dose-escalation study of recombinant human interleukin-18 using two different schedules of administration in patients with cancer.

PURPOSE: Interleukin-18 (IL-18) is an immunostimulatory cytokine with antitumor activity in preclinical models. A phase I study of recombinant human IL-18 (rhIL-18) was done to determine the toxicity, pharmacokinetics, and biological activities of rhIL-18 administered at different doses in two different schedules to patients with advanced cancer. EXPERIMENTAL DESIGN: Cohorts of three to four patients were given escalating doses of rhIL-18 as a 2-h i.v. infusion either on 5 consecutive days repeated every 28 days (group A) or once a week (group B) for up to 6 months. Toxicities were graded using standard criteria. Blood samples were obtained for safety, pharmacokinetic, and pharmacodynamic measurements. RESULTS: Nineteen patients (10 melanoma and 9 renal cell cancer) were given rhIL-18 in doses of 100, 500, or 1,000 microg/kg (group A) or 100, 1,000, or 2,000 microg/kg (group B). Common side effects included chills, fever, headache, fatigue, and nausea. Common laboratory abnormalities included transient, asymptomatic grade 1 to 3 lymphopenia, grade 1 to 4 hyperglycemia, grade 1 to 2 anemia, neutropenia, hypoalbuminemia, liver enzyme elevations, and serum creatinine elevations. No dose-limiting toxicities were observed. Biological effects of rhIL-18 included transient lymphopenia and increased expression of activation antigens on lymphocytes. Increases in serum concentrations of IFN-gamma, granulocyte macrophage colony-stimulating factor, and IL-18-binding protein were observed following dosing. CONCLUSIONS: rhIL-18 can be given in biologically active doses by either weekly infusions or daily infusions for 5 days repeated every 28 days to patients with advanced cancer. Toxicity was generally mild to moderate, and a maximum tolerated dose of rhIL-18 by either schedule was not determined.     

Prognostic value of Bcl‐2 in breast cancer patients treated with neoadjuvant anthracycline based chemotherapy

We have analyzed the predictive/prognostic value of Bcl‐2 protein in breast cancer patients treated with neoadjuvant chemotherapy. One hundred and ten patients were submitted to two different chemotherapeutic regimens: a) 5‐fluorouracil, adriamycin or epirubicin, and cyclophosphamide (FAC/FEC) during 2–6 cycles before surgery and 3 or 4 additional cycles of FAC/FEC after surgery (n=40) and b) doxorubicin (D) 75mg/m2 or epirubicin (E) 120mg/m2 during 4 cycles before surgery, and 6 cycles of cyclophosphamide, methotrexate, and 5‐fluorouracil (CMF) after surgery (n=70). Bcl‐2 expression, evaluated by immunohistochemistry, did not change significantly after chemotherapy and was not related to clinical/pathological response. In FAC/FEC group, Bcl‐2 positive expression after chemotherapy correlated with better disease free survival (DFS) and overall survival (OS) (P=0.008 and P=0.001). In D/E group, Bcl‐2 also correlated with better DFS and OS (P=0.03 and P=0.054) in the post‐chemotherapy biopsies. An unusual nuclear localization of Bax was observed in some biopsies, but this localization did not correlate with the tumor response or outcome of the patients. We found that a high Bcl‐2 expression had no predictive value but had prognostic value in breast cancer patients treated with neoadjuvant anthracycline based chemotherapy.