Management of infection in PNH patients treated with eculizumab or other complement inhibitors: Unmet clinical needs.

This article presents the results of group discussion among an ad hoc constituted panel of experts aimed at identifying and addressing unmet clinical needs (UCNs) in the management of infectious risk associated with eculizumab or new terminal complement inhibitors (CIs) in paroxysmal nocturnal hemoglobinuria (PNH). With the Delphi technique, the most clinically relevant UCNs in PNH patients candidate to or on terminal CI were selected. They resulted to be: optimizing the infection prevention measures; developing non pharmacological infectious risk-mitigation strategies; improving the management of disease exacerbation during infectious complications.

A population-based study of chronic myeloid leukemia patients treated with imatinib in first line.

Chronic myeloid leukemia (CML) treatment is based on company-sponsored and academic trials testing different tyrosine kinase inhibitors (TKIs) as first-line therapy. These studies included patients selected according to many inclusion-exclusion criteria, particularly age and comorbidities, with specific treatment obligations. In daily clinical practice (real-life), inclusion-exclusion criteria do not exist, and the treatment outcome does not only depend on the choice of first-line TKI but also on second- and third-line TKIs.

Long term outcome of Ph+ CML patients achieving complete cytogenetic remission with interferon based therapy moving from interferon to imatinib era.

Interferon α (IFNα) prolongs survival of CML patients achieving CCyR and potentially synergizes with TKIs. We report on the molecular status and long term outcome of 121 patients who were treated in Italy between 1986 and 2000 with IFNα based therapy and who obtained CCyR. After a median follow up of 16.

The influence of planned kinds of delivery on pregnant women's emotional state.

Objective: To evaluate if labour induction and elective caesarean section could influence anxiety and depression in pregnant women.

Methods: One hundred and sixteen consecutive pregnant women with uncomplicated singleton pregnancy at term, scheduled for these two obstetric procedures were enrolled. An anonymous questionnaire with two self-rating instruments STAI and HAM-A for anxiety and HAM-D for depression was administered.

Maternal thyroid function in different conditions of iodine nutrition in pregnant women exposed to mild-moderate iodine deficiency: an observational study.

Objective: We examined the effect of different conditions of nutritional iodine intake on maternal thyroid function throughout gestation in a cohort of healthy, anti-thyroid antibody-negative women from a mild-moderately iodine-deficient (ID) area.

Design: Observational cohort study.

Patients: The study included 168 women receiving prenatal preparations containing 150 μg of iodine from early pregnancy (150-I group); 105 women who had regularly used (>2 years) iodized salt prior to becoming pregnant (I-salt group); 160 women neither taking iodine supplements nor using iodized salt (no-I group).

Thyroid function in women found to have early pregnancy loss.

Background: Pregnancy influences thyroid function and may bring to light mild and latent disorders. Thyroid dysfunction has been related to obstetrical complications such as premature delivery, gestational hypertension, preeclampsia, and placental abruption. The aim of our study was to evaluate whether the occurrence and timing of pregnancy loss could be related to thyroid autoimmunity or subclinical hypothyroidism (SH) per se.

Wound length and corticosteroid administration as risk factors for surgical-site complications following cesarean section.

Objective: To evaluate the effect of some specific gestational factors and other known variables associated with poor wound healing in women who delivered by cesarean section.

Design: Observational, prospective study.

Setting: University Hospital of Messina.

General versus spinal anaesthesia for elective caesarean sections: effects on neonatal short-term outcome. A prospective randomised study.

Objective: To compare neonatal short-term outcome in patients who underwent spinal, general anaesthesia and conversion from spinal to general anaesthesia.

Methods: One hundred seventy-nine pregnant women undergoing elective caesarean section were allocated randomly to general (n=89) or spinal anaesthesia (n=90) and compared with 63 patients who required conversion to general anaesthesia. Umbilical cord artery pH, Apgar score as well as its individual parameter and need for assisted ventilation were evaluated.

Long-term follow-up of 386 consecutive patients with essential thrombocythemia: safety of cytoreductive therapy.

Cytotoxic agents like Hydroxyurea, Busulfan and Interferon-alpha are to date the most commonly used therapeutic approaches in Essential Thrombocythemia (ET). However, few data on the efficacy and safety of these agents in the long-term are currently available. We report a retrospective analysis of the long-term outcome of 386 consecutive ET patients, followed at single Institution for a median follow-up of 9.

Gestational thyroid function abnormalities in conditions of mild iodine deficiency: early screening versus continuous monitoring of maternal thyroid status.

Objective: To longitudinally evaluate the timing of maternal thyroid underfunction occurrence in mildly iodine-deficient (ID) pregnant women, and ultimately assess the benefit of thyroid function testing at early gestation only in identifying maternal thyroid underfunction.

Participants/methods: Serum free-thyroxine and TSH were measured in 220 consecutive women once in early pregnancy (by week 12) and twice per trimester subsequently. Anti-thyroperoxidase and anti-thyroglobulin were also determined at initial and final observation.

Emotional state and dreams in pregnant women.

The aim of this study was to investigate the frequency of recall and the content of dreams during pregnancy, as well as their correlation with socio-demographic, obstetric and physician-patients relationship variables, emotional state and duration of labour. A questionnaire, designed to analyse background characteristics, was given to 290 women in the third trimester of gestation. The psychiatric analysis of anxiety and depression was performed using the Hamilton Rating Scale for Anxiety and the Montgomery-Asberg Depression Rating Scale, while dreams were divided into masochistic and pleasant according to Beck's criteria.

Prenatal identification of isolated bilateral radial dysplasia.

Radial aplasia or hypoplasia is characterized by complete or partial absence of the radius and/or radial ray structure occurring in 1:30,000 live births. It may be unilateral or bilateral of varying severity, and may be isolated or associated with other anomalies. We report an unusual case of isolated radial aplasia at 20 weeks' gestation with complete absence of the right radius and thumb associated with marked hypoplasia of the left radius.

Endoglin, PlGF and sFlt-1 as markers for predicting pre-eclampsia.

Objective: To evaluate the ability of endoglin, placental growth factor (PlGF) and the soluble form of vascular endothelial growth factor receptor (sFlt-1) measurements in gestational weeks 24-28 were used to predict pre-eclampsia.

Design: Observational, prospective study. Setting.

Effects of antepartum electronic fetal monitoring on maternal emotional state.

Background: To evaluate the emotional state of pregnant women undergoing computerised cardiotocography (cCTG).

Methods: A questionnaire including questions about socio-demographic background, personal obstetric history and physician-patient relationship was given to 204 pregnant women about to undergo cCTG. The Edinburgh Post-natal Depression Scale (EPDS) was used to assess patients' mood state before CTG, while the Spielberger State-Trait Anxiety Inventory (STAI) was used to evaluate anxiety levels before and after this examination.

Long-term outcome of complete cytogenetic responders after imatinib 400 mg in late chronic phase, philadelphia-positive chronic myeloid leukemia: the GIMEMA Working Party on CML.

Purpose: Imatinib mesylate (IM) has rapidly become the front-line treatment of Philadelphia-positive (Ph-pos) chronic myeloid leukemia, but the number of patients who were treated and are being treated with IM second-line is still substantial.

Patients And Methods: We have monitored and analyzed the cytogenetic and molecular response to IM 400 mg/d in a cohort of 277 late chronic phase (LCP) patients who were resistant or intolerant to interferon-alpha and were observed for 48 to 79 months (median, 72 months).

Results: One hundred fifty-three patients (55%) achieved a complete cytogenetic response (CCgR).

Phase II trial of proteasome inhibitor bortezomib in patients with relapsed or refractory cutaneous T-cell lymphoma.

Purpose: To determine the antitumor activity of the proteasome inhibitor bortezomib in patients with cutaneous T-cell lymphoma (CTCL) or peripheral T-cell lymphoma unspecified (PTCLU) with isolated skin involvement.

Patients And Methods: From May 2005 to June 2006 at our institute, we treated patients with previously pretreated CTCL or PTCLU using bortezomib as a single agent, at a dose of 1.3 mg/m2 intravenously on days 1, 4, 8, and 11, every 21 days for a total of six cycles.

The efficacy of imatinib mesylate in patients with FIP1L1-PDGFRalpha-positive hypereosinophilic syndrome. Results of a multicenter prospective study.

Background And Objectives: The hypereosinophilic syndrome (HES) may be associated with the fusion of the platelet derived growth factor receptor a (PDGFRalpha) gene with the FIP1L1 gene in chromosome 4 coding for a constitutively activated PDGFRalpha tyrosine kinase. These cases with FIP1L1-PDGFRalpha rearrangement have been reported to be very sensitive to the tyrosine kinase inhibitor imatinib mesylate.

Design And Methods: A prospective multicenter study of idiopathic or primary HES was established in 2001 (Study Protocol Registration no.

Prospective, randomized study of single compared with double autologous stem-cell transplantation for multiple myeloma: Bologna 96 clinical study.

Purpose: We performed a prospective, randomized study of single (arm A) versus double (arm B) autologous stem-cell transplantation (ASCT) for younger patients with newly diagnosed multiple myeloma (MM).

Patients And Methods: A total of 321 patients were enrolled onto the study and were randomly assigned to receive either a single course of high-dose melphalan at 200 mg/m2 (arm A) or melphalan at 200 mg/m2 followed, after 3 to 6 months, by melphalan at 120 mg/m2 and busulfan at 12 mg/kilogram (arm B).

Results: As compared with assignment to the single-transplantation group (n = 163 patients), random assignment to receive double ASCT (n = 158 patients) significantly increased the probability to attain at least a near complete response (nCR; 33% v 47%, respectively; P = .

Midtrimester amniotic fluid leptin and insulin levels and subsequent gestational diabetes.

Aims: To evaluate midtrimester amniotic fluid leptin levels in pregnancies subsequently complicated by gestational diabetes.

Methods: We studied 32 pregnant women with gestational diabetes and a control group of 43 normal pregnancies with an adequate gestational age fetus. All underwent a midtrimester amniocentesis: leptin and insulin were measured in the amniotic fluid.