Safety and effectiveness of oral propranolol for infantile hemangiomas started before 5Â weeks and after 5Â months of age: an Italian multicenter experience.

Background: Despite not being licensed for the treatment of infantile hemangiomas (IH) in infants younger than 5 weeks or older than 5 months, propranolol is often used in these age groups to prevent or to treat potentially severe complications. The objective of the present study was to review the experience of 8 Italian pediatric and dermatologic centers regarding propranolol treatment for IH started before 5 weeks or after 5 months of age.

Methods: We retrospectively reviewed the records of patients followed up for IH, on propranolol treatment started before 5 weeks or after 5 months of age, and collected information on sociodemographic data, treatment indications, IH involution, IH relapse, and treatment side effects.

Complications After Treatment of Head and Neck Venous Malformations With Sodium Tetradecyl Sulfate Foam.

Purpose: The aim of this study was to evaluate complications in patients with head and neck venous malformations (VMs) treated with foam sclerotherapy using sodium tetradecyl sulfate (STS).

Methods: The authors retrospectively evaluated the complications, pain. and degree of satisfaction in 69 consecutive patients affected by cervicofacial VM managed with STS using the Tessari method in a single institution.

Sixteen years of experience with persistent chylothorax in children.

Background: Persistent chylothorax in children is rare. Conservative management represents the gold standard but, in case of failure (persistent effusion or relapse), surgery must be considered. This paper aimed at presenting our series of patients who underwent surgical treatment of persistent idiopathic chylothorax and at discussing the role of thoracic duct ligation in its management.

Adjuvant role of anti-angiogenic drugs in the management of head and neck arteriovenous malformations.

Arteriovenous malformations (AVMs) are high-flow vascular malformations characterised by a complex vessel network directly connecting feeding arteries and draining veins, typically featured by a natural history of progression, while spontaneous regressions are purely anecdotal. AVMs are very aggressive entities that possess a locally infiltrative behaviour like neoplasms. Complete "radical" surgical excision presents the highest chance of cure, but nowadays there is still considerable controversy on how to treat large AVMs that are not amenable of "radical" excision.

The use of propranolol for complicated infantile hemangiomas.

Objective: To assess propranolol efficacy and safety in complicated infantile hemangiomas in two different age groups.

Patients And Methods: We report on 68 infants with infantile hemangiomas treated with oral propranolol at the lowest effective dose at different ages for a period of six months. Inclusion criteria were life-threatening hemangiomas, function-threatening hemangiomas, facial hemangiomas with risk for disfigurement, and extensive and ulcerated hemangiomas.

Congenital fetal and neonatal visceral chylous effusions: neonatal chylothorax and chylous ascites revisited. A multicenter retrospective study.

This retrospective study was carried out at eight Neonatal Intensive Care Units (NICU) Centers worldwide on 33 newborns presenting at birth with pleural, pericardial, or abdominal chylous effusions. Diagnosis of chylous effusion is based on findings of fluid with a milk-like appearance, a concentration of triglycerides in pleural effusion >1.1 mmol/l, and a total cell count >1,000 cells/ml with a predominance of >80% lymphocytes.

A case of congenital hypothyroidism in PHACE syndrome.

Although hemangiomas, benign tumors of vascular origin, are very common among children and represent the most frequent benign tumor at that age, their association with other malformations constitutes a rare neurocutaneous disorder called PHACE syndrome. This condition is characterized by posterior fossa anomalies, hemangioma of the face, arterial alterations, cardiac defects, and eye anomalies (as represented by the acronym PHACE); sternum defects, endocrinopathies, and thyreopathies may be present as well. In this report, we describe a case of congenital hypothyroidism due to an empty thyroid site, as demonstrated by ultrasound, in an Italian child.

Intra-articular venous malformations of the knee.

Background: Intra-articular venous malformations (IAVM) of the knee represent a rare group of low-flow vascular malformations, mainly reported in the literature as synovial hemangiomas, usually with an onset in early childhood. The main symptoms and signs are knee pain, swelling, and hemarthrosis. These lesions are slowly progressive and can lead to chronic synovitis and joint damage.

Application of a high-throughput screening procedure with PEG-induced precipitation to compare relative protein solubility during formulation development with IgG1 monoclonal antibodies.

Protein solubility is a critical attribute in monoclonal antibody (mAb) formulation development as insolubility issues can negatively impact drug stability, activity, bioavailability, and immunogenicity. A high-throughput adaptation of an experimental method previously established in the literature to determine apparent protein solubility is described, where polyethylene glycol (PEG) is used to reduce protein solubility in a quantitatively definable manner. Utilizing an automated, high-throughput system, an immunoglobulin G (IgG)1 mAb in a variety of buffer conditions was exposed to increasing concentrations of PEG and the amount of protein remaining in solution was determined.

Comparability assessments of process and product changes made during development of two different monoclonal antibodies.

To assess the impact of manufacturing changes on antibody structure and function during the course of product development, three comparability studies were performed for each of two different IgG1 monoclonal antibody product candidates. Comparability study #1 evaluated the effect of changing the cell line and bulk drug substance manufacturing process for cell culture and purification. Results indicated that these process changes led to differences in sialylation of N-glycans and/or C-terminal lysine levels.

Characterization of golimumab, a human monoclonal antibody specific for human tumor necrosis factor α.

We prepared and characterized golimumab (CNTO148), a human IgG1 tumor necrosis factor alpha (TNFα) antagonist monoclonal antibody chosen for clinical development based on its molecular properties. Golimumab was compared with infliximab, adalimumab and etanercept for affinity and in vitro TNFα neutralization. The affinity of golimumab for soluble human TNFα, as determined by surface plasmon resonance, was similar to that of etanercept (18 pM versus 11 pM), greater than that of infliximab (44 pM) and significantly greater than that of adalimumab (127 pM, p=0.

An angiomatoid fibrous histiocytoma over the left pre auricular region in a 13-year-old boy.

A 13-year-old boy presented to us for the evaluation of a slowly growing mass over the left preauricular region. Physical examination showed a nodular swelling, firm on palpation. The patient had no lymphadenopathy.

Development of a microflow digital imaging assay to characterize protein particulates during storage of a high concentration IgG1 monoclonal antibody formulation.

The development of a Microflow digital imaging (MDI) method to detect and monitor protein particulates in a high concentration IgG1 monoclonal antibody formulation is presented. The MDI assay was optimized and qualified as a characterization assay in terms of accuracy and precision of particle size and number using polystyrene standards (5-300 microm) and protein particles (2 to >100 microm). The stability profile of a 90 mg/mL IgG1 formulation stored at 2-8 degrees C and -70 degrees C for up to 18 months was then investigated.

Nasal tip haemangiomas: guidelines for an early surgical approach.

The treatment of Cyrano nose haemangioma (CNH) is difficult because of its location and possible complications: psychological impact, severe skin infiltration and consequences on nasal growth. We suggest that the best treatment for nasal tip haemangiomas is an early surgery to remove the affected tissues and preserve the anatomy. A total of 39 children (32 females and seven males) underwent early surgery for the treatment of CNH.

Characterization of the photodegradation of a human IgG1 monoclonal antibody formulated as a high-concentration liquid dosage form.

The photodegradation of a human IgG1 monoclonal antibody has been examined in a high concentration (100 mg/mL) liquid formulation. It was observed that a yellowish color is generated when the formulation is exposed to intense and prolonged light exposure, and this discoloration occurs along with a loss in bioactivity. Extensive analytical characterization was performed to determine light induced degradation pathways that occur during exposure to intense light of ICH photodegradation conditions.

Life-threatening hemorrhage from a vulvar hemangioma.

Capillary hemangioma, the most common tumor of infancy, usually does not require any treatment, but in a minority of cases it may cause morphologic, functional, or life-threatening complications. The authors report a case of a vulvar emangioma complicated by life-threatening hemorrhage not responsive to corticosteroids therapy, which showed no signs of spontaneous involution. The therapeutic approach consisted of 3 steps of selective arterial embolizations followed 5 months later by surgical excision and reconstruction of the vulva.

TT virus-related acute recurrent hepatitis. Histological features of a case and review of the literature.

TT virus is a recently discovered virus, of which the pathogenetic potential is still uncertain. The present paper describes the histopathological features of a case of TT virus-related acute recurrent hepatitis. The patient is a 28-year-old woman with no history of drug or alcohol abuse, presenting with repeated episodes of hypertransaminasemia evidenced during the last 4 years.

Bidirectional cavo-pulmonary anastomosis with an additional flow source to the lungs: clinical experience in 21 cases.

The Fontan operation is considered a palliative procedure for the treatment of complex congenital heart diseases with a morbidity and mortality that are not negligible, especially in high-risk patients. In these cases, a bidirectional cavopulmonary anastomosis with additional source of blood flow to the lungs can represent a valuable surgical option. Between November 1992 and December 1995, 21 patients with univentricular heart physiology were submitted to bidirectional cavopulmonary anastomosis with additional blood flow the additional flow consisted of an aortopulmonary shunt in 13 cases, pulmonary artery banding in seven cases, and pulmonary artery stenosis in one case.

[Closure of patent ductus arteriosus in thoracoscopy: analysis of the experience in the Gaslini Institute of Genoa].

In 1993, Laborde et al described a new surgical approach for closure of the patent ductus arteriosus (PDA), using a videoassisted technique. For the first time, videosurgery was utilized in pediatric cardiovascular surgery. The advantages of this new method are that it is minimally invasive (thoracotomy is replaced by three small holes), it reduces postoperative pain, recovery is more rapid with a shorter hospital stay and convalescence, and last but not least, it offers better aesthetic results.

[Differential types of pulmonary flow in bidirectional cavo-pulmonary anastomosis with an additional flow source].

While Fontan operation is considered a palliative procedure for the treatment of complex congenital heart disease, its morbidity and mortality are certainly not negligible, especially in high-risk patients. In our opinion, a bidirectional cavo-pulmonary anastomosis with an additional source of blood flow to the lungs (Blalock-Taussig shunt, pulmonary artery banding, native pulmonary stenosis) represents a valuable surgical option in this subset of patients. From November 1992 to September 1994, sixteen patients with complex congenital heart disease underwent bidirectional cavo-pulmonary anastomosis, leaving an additional source of blood flow in place (modified Blalock-Taussig shunt in 9 cases, pulmonary artery banding in 6 cases, native pulmonary stenosis in 1 case).

Surgical management of complete atrioventricular canal associated with tetralogy of Fallot.

Between 1984 and 1993, 12 children with an atrioventricular canal and tetralogy of Fallot underwent surgical repair. The mean(s.d.

Effects of SKF 108922, an HIV-1 protease inhibitor, on retrovirus replication in mice.

Rationally designed synthetic inhibitors of retroviral proteases inhibit the processing of viral polypeptides in cultures of human T lymphocytes infected with human immunodeficiency virus type 1 (HIV-1) and therefore suppress the infectivity of HIV-1 in vitro. We have previously reported the antiviral activity in vitro of HIV-1 protease inhibitors against the C-type retrovirus Rauscher murine leukemia virus (RMuLV) and the lentivirus simian immunodeficiency virus (SIV). The same compounds which blocked the infectivity of HIV-1 also inhibited the infectivity of RMuLV and SIV in vitro.