Experience from the Argentine Pegvisomant Observational Study: preliminary data.

The GH receptor antagonist pegvisomant is an efficient agent to achieve biochemical control of acromegaly in those cases refractory to surgery and medical therapy with somatostatin analogs. We conducted an observational multicenter study consisting of data collection in accordance with the standard management of patients with acromegaly in everyday practice. We reviewed the medical records of 28 patients, 23 females, who were treated with pegvisomant due to the lack of biochemical response or intolerance to the somatostatin analogs. The objective was to monitor long-term safety and efficacy of the antagonist. 82% of the patients had previous pituitary surgery, 53.6% radiotherapy and 96.4% received medical therapy for acromegaly. Only 19.2% of the patients had pituitary residual tumor size larger than 1 cm, the remainder harbored a microadenoma or no visible tumor in the pituitary images. In terms of biochemical efficacy, IGF-I levels decreased to normal ranges in 45% and 58.8% of patients after 3 and 6 months of treatment, respectively, the daily mean dose of pegvisomant being 9.6+/-1.1 mg. Adverse events, potentially related to pegvisomant were reported in 6 patients (21.4%), local injection site reaction and elevated liver enzymes being the most frequent. Tumor size did not show enlargement in the evaluated population (15 patients) during the period of the study. This paper presents preliminary data from a small observational study in Argentina which represents the first database in our country.

A new gastric impedancemeter for detecting the development of a visceral edema: a proof-of-concept study on an experimental endotoxemic shock.

Visceral congestion and edema are important features of advanced heart failure. Monitoring the evolution of fluid content in the gastric wall might provide an index of the development of this phenomenon and therefore constitute an innovative marker to early detect acute decompensated heart failure episodes. The evolution of the fluid content in the gastric wall is measured using a device implanted in the submucosa layer of the fundic region of the stomach. The device composed of two electrodes measures the bioimpedance values that reflects the water content of the tissue.An in-vivo experiment in a pig was carried out to validate the feasibility of detecting the gastric bioimpedance variations during the development of an experimental acute visceral edema caused by an endotoxemic shock. Our preliminary results confirm the possibility to monitor the bioimpedance variations due to moderate changes in tissue water content (10%) with a two-electrode configuration device implanted in the submucosa of the stomach.

Photopheresis in cutaneous T-cell lymphoma: five-year experience.

BACKGROUND: Cutaneous T-cell lymphoma (CTCL) includes several lymphoproliferative disorders involving mature T-lymphocyte proliferation initially confined to the cutis. These affections, after variable periods, may progress to the blood, limph nodes and visceral organs. Mycosis fungoides (MF) is the most frequent form of CTCL and has an indolent clinical course. The therapy of CTCL depends on the stage of the disease and the patient's general conditions. For advanced cases it includes chemotherapy, retinoids, and interferon-alpha. Since 1987 extracorporeal photochemotherapy (ECP), a novel immunomodulatory approach based on apheresis and photoirradiation of leukocytes, has been successfully introduced for the treatment of advanced CTCL. It can prolong survival of patients with erythrodermic CTCL without significant side effects. OBJECTIVE: To review our five-year experience with ECP in CTCL. METHODS: Since June 1994, 33 CTCL patients have been recruited for ECP, using two different regimens: two procedures on two consecutive days at four-week intervals for six months, or at two-week intervals for three months with progressive tapering in the second three-month period for the more severe forms. Six patients received ECP with IFN-alpha. ECP was done using the photopheresis UVAR system and UVAR XTS (Therakos, West Chester, Pa) and always with 8-MOP liquid formulation injected directly into the buffy coat bag. Lymphocytes in peripheral blood were immunophenotypically characterized for each patient and every ECP session. RESULTS: All patients tolerated ECP well, without significant side effects. Thirty patients are clinically evaluable (at least three ECP cycles). A favourable clinical response was obtained in 80.9% (16/21) of MF patients (complete response 33%, partial response 47.6%) and in 66% (6/9) of patients in the Sézary's syndrome phase (complete response 33.3%, partial response 33.3%). Five of the six patients given IFN-alpha as adjunctive therapy had a PR and one a CR. Four patients are in CR without therapy at follow-ups of 46, 20, 10 and 8 months. There have been no changes in the peripheral lymphocyte immunophenotype during the follow-up. In 19/30 patients the CD95 antigen, correlated with cellular apoptosis, was expressed and was frequently associated with a good clinical response. CONCLUSIONS: In our experience ECP achieved favourable clinical responses in 73% of patients, in monotherapy or in combination with IFN-alpha, without significant side effects.

[Clinico-statistical study on hydropinic and balneothermal therapy of psoriatic patients using the low mineral-content waters of the Comano springs]. / Indagine clinico-statistica sulla terapia idropinica e balneotermale con acqua oligominerale delle Terme di Comano in soggetti affetti da psoriasi.

The authors report the results obtained treating 39 subjects affected from psoriasis with hydropinic therapy and thermal balneo-therapy, using the thermal water of Comano. At the end of the treatment the results were rather bad with an inclusive reduction of 8.5% of the lesions as regards the initial data, but after 3-6 months an average per cent reduction of the lesions about 50% and in some cases quite a total regression of the psoriasis has been noted. No kind of collateral effects has been noted.

[Esophago-gastro-duodenal endoscopic findings in patients with urticaria]. / Rilievi endoscopici esofagogastroduodenali in pazienti affetti da orticaria.

In a study carried out on 54 patients affected with urticaria the Authors try to demonstrate, by esophagogastroduodenoscopy, concomitant lesions of the gastroduodenal tract. The superior panendoscopic examination has shown gastroduodenal lesions in about 39% of cases.

[Effect of thermal mud baths on normal, dry and seborrheic skin]. / Effetti dell'uso di un fango termale su cute normale, secca e seborroica.

PURPOSE: To investigate the curative effects of thermal water and thermal muds in various cutaneous pathologies. PATIENTS AND METHODS: Modifications of phmetry and sebometry using sulphur thermal muds in normal, dry and seborrheic skin have been studied. The three groups of patients have been submitted to a 14 day treatment with thermal muds. RESULT: The application of thermal mud normalized the value of cutaneous pH and sebometry. CONCLUSIONS: These beneficial effects are long-lasting in individuals who have a prolonged treatment with thermal muds.

[Allergic fungal sinusitis: is this rare disease an allergy or infection?]. / Sinusite Allergica Micotica: una rara affezione allergica o infettiva?

Allergic Fungal Sinusitis (AFS) is a newly recognized form of benign, non invasive sinusitis the histopathologic features of which are similar to those of allergic bronchopulmonary aspergillosis. AFS is a rare condition. However, because treatment and prognosis vary widely, it is important that this disorder be recognized and differentiated from chronic bacterial sinusitis and other forms of fungal sinusitis. AFS does not discriminate by age although it is primarily found in young adults. AFS patients are usually atopic, often having a history of asthma and nasal polyposis. Many have suffered from the symptoms of chronic sinusitis for years while others have had multiple sinus surgery. Radiographs reveal the involvement of multiple sinuses, often with bone destruction. Laboratory findings support an allergic state with a marked increase in eosinophilia and total IgE. At times RAST testing proves positive for fungi and immediate cutaneous reactivity to fungi is also present. Histologic review of the sinus contents reveals characteristic "allergic mucin", with numerous eosinophiles, Charcot-Leyden crystals and fungal hyphae, without any fungi tissue invasion. A wide variety of fungal agents has been implicated, although the majority belong the Dematiacee family. Those patients with allergic mucin but no documented fungi are indicated as having AFS-like syndrome. The pathogenesis of AFS is uncertain. There is controversy in the literature as to what role hypersensitivity (Gell and Coombs type I and type III responses) in infection play. To date current therapeutic recommendations include complete exenteration of all allergic mucin. Adjunctive, short-term systemic steroids often prove useful and nasal steroid spray should be continued for long term. Systemic antifungal agents are not recommended in AFS. Recurrence is common and thus close clinical, endoscopic and radiographic follow-up is important. The clinicopathologic features of one patient with AFS are reported and etiopathogenetic problems are discussed. The presented case showed a positive culture with negative immunological testing (RAST-positive and immediate cutaneous reactivity to fungal antigen), thus confirming the pathogenetic hypothesis of the saprophytic fungal growth in an atopic patient.

[Multisystemic sarcoidosis. A clinical case report]. / Sarcoidosi multisistemica. A proposito di un caso clinico.

Sarcoidosis is a granulomatous disorder of unknown etiology with a multi-disciplinary interest. However, a multiple organ involvement is not always clearly presented. A case of a 62-year-old woman with cutaneous, pulmonary, ocular, cardiac, bone and articular involvement is described.

[Report of a case of allergic granulomatous vasculitis (Churg-Strauss syndrome)]. / Osservazioni su di un caso di vasculite granulomatosa allergica (sindrome di Churg-Strauss).

A 35 year female with a previous history of asthma came to our observation about 10 months ago. She was dyspneic, showed small nodules (2 to 5 mm) in arms, hands and legs and had radiological evidence of pulmonary granulomatosis and pleural effusion. Diagnosis was made by means of cutaneous biopsy showing a necrotic granulomatous vasculitic lesions with eosinophilic infiltration and giant cells, consistent with allergic granulomatosis of Churg-Strauss syndrome. Steroid therapy alone (prednisone 1 mg/kg/die) led to a rapid and complete clinical and humoral remission. The patient is still doing an alternate day prednisone therapy (15 mg) and is well after a 10 months follow-up.

[Acro-osteolysis with hereditary sensory ulcero-mutilating neuropathy. Apropos of an atypical case]. / Acroosteolisi con neuropatia ulcero-mutilante ereditaria sensitiva. A proposito di un caso atipico.

The authors report an acroosteolysis case with sensory radicular ulcero-mutilating neuropathy. The differential diagnosis are discussed and the case is presented as an intermediate form between the congenital sensory neuropathy, type II, according to Otha classification, and the non-progressive, sporadical sensory neuropathy.

[Eosinophilic cellulitis (Wells' syndrome)]. / Cellulite eosinofila (sindrome di Wells).

The Authors report a case of eosinophilic cellulitis (Wells' syndrome). The patient was a 61 year old woman, diabetic, with a cardio-respiratory insufficiency and a maniaco-depressive psycosis. She presented, on the upper arms and trunk, a cutaneous eruption of erythematous-urticarial plaques, that histopathologically were characterized by a dermic leukocyte population, with a prevalence of eosinophils, distributed in the perivascular site. Laboratory tests revealed eosinophilia and circulating immune complexes. The etiopathogenesis of the disease is discussed as is the possible role of immune complexes in eosinophilic cellulitis.

Redox options in two-dimensional electrophoresis.

Two-dimensional electrophoresis is usually run on fully reduced samples. Under these conditions even covalently bound oligomers are dissociated and individual polypeptide chains may be fully unfolded by both, urea and SDS, which maximizes the number of resolved components and allows their pI and M(r) to be most accurately evaluated. However, various electrophoretic protocols for protein structure investigation require a combination of steps under varying redox conditions. We review here some of the applications of these procedures. We also present some original data about a few related samples -- serum from four species: Homo sapiens, Mus musculus, Rattus norvegicus, Bos taurus -- which we run under fully unreduced and fully reduced conditions as well as with reduction between first and second dimension. We demonstrate that in many cases the unreduced proteins migrate with a better resolution than reduced proteins, mostly in the crowded 'alpha-globulin' area of pI 4.5-6 and M(r) 50-70 kDa.

Pharmacokinetic studies in healthy volunteers on a new gastroprotective pharmaceutic form of diclofenac.

The pharmacokinetic properties of a new gastroprotective pharmaceutical formulation of diclofenac (CAS 15307-79-6) were investigated in twelve healthy volunteers. In this new form the diclofenac is the nucleus of sequential sucralfate-covered tablets. The experimental design was an open, random, two period balanced cross-over study. All the subjects received a single oral dose of 50 mg diclofenac contained in the new formulation or in the reference enteric-coated tablets. Plasma concentrations of diclofenac were determined at 0.5, 1, 2, 4, 6, and 8 h after drug administration using HPLC method. After administration of a diclofenac-sucralfate association diclofenac was quickly absorbed and the peak plasma concentration (0.773 +/- 0.08 microgram/ml) was achieved in about 1 h. AUC(0-infinity) value was about 1.8 micrograms/ml/h and the mean elimination half-life was 1.20 +/- 0.12 h. The pharmacokinetic profile of diclofenac-sucralfate association is similar to the values reported in previous papers for enteric-coated forms; anyway an early occurrence of the peak plasma concentration was observed for the new formulation. The new diclofenac-sucralfate association shows a different rate of absorption (namely an early and greater peak plasma concentration of diclofenac) and a similar extent of absorption (AUC(0-infinity) being not statistically different) as compared to the reference enteric-coated tablets of 50 mg diclofenac. These results could be related to the delaying and protective effect of sucralfate whose action is different from the one carried by the coat of the enteric-coated tablets.