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Biomedical subjects

M De Simone

Publications and source records attributed to M De Simone.

At least 109 records · Page 6Linked to original sources

Safety and immunogenicity of conventional subunit and MF59-adjuvanted influenza vaccines in human immunodeficiency virus-1-seropositive patients.

In this study of influenza vaccination, 37 human immunodeficiency virus (HIV)-1-seropositive patients were randomized to receive either a vaccine with a conventional subunit or one adjuvanted with MF59. Blood samples were collected at the time of vaccination, and then 30 and 180 days later, to evaluate immunogenicity, CD4+ T-lymphocyte count and HIV-1 RNA levels. Seroconversion rates against the three viral strains included in the vaccine ranged between 44% and 72% and 53% and 68% for the adjuvanted vaccine and the subunit vaccine, respectively. Other criteria of the European Medicines Evaluation Agency were also met. Vaccination was not associated with serious adverse events. Local and systemic effects were mild and of short duration. CD4+ T-lymphocyte counts and viraemia levels were not negatively affected by vaccination. These results confirmed the safety and immunogenicity of these currently available vaccines in HIV-1-seropositive patients, thus supporting the recommendation for influenza immunization in this high-risk category.

Adjuvants, Immunologic↗

[Leiomyomas and extramucosal cysts of the esophagus in adults. The clinical picture and surgical therapy].

BACKGROUND: Leiomyoma is the most common type of benign esophageal tumor, whereas extramucosal cysts of the esophagus are congenital anomalies frequently asymptomatic in the adult and in most cases detected incidentally on chest X-ray. Conventional imaging tests do not lead to a precise diagnosis. Endoscopic ultrasonography is very accurate in visualizing these lesions and in differentiating cystic from solid submucosal esophageal masses; in addition, the test can establish the exact location of the mass in relation to the esophageal wall and mediastinum. METHODS: Fifteen patients with esophageal leiomyoma and 27 patients with extramucosal esophageal cyst were operated on in our Institution. Dysphagia was the most common symptom in patients affected by leiomyoma and esophageal duplication cyst, whereas chest pain was more frequent in patients with bronchogenic cyst. RESULTS: Complete surgical excision of the mass was performed in all patients with esophageal leiomyoma and in 26 patients with mediastinal cyst, while a right upper pulmonary lobectomy was performed in the patient with an intrapulmonary cyst. CONCLUSIONS: Endoscopic ultrasonography plays an important role in the differential diagnosis of leiomyoma and mediastinal cyst. Surgery is mandatory in all patients especially after the advent of the mini-invasive procedures. Observation alone must be reserved for patients who refuse or are not suitable for thoracic surgery.

Adult↗

Hyaline vascular Castleman's disease of the mediastinum.

Castleman's disease is rare and can be present in many sites and with a variety of symptoms. Surgery is always recommended for localized lesions to remove the mass as completely as possible, reserving other treatment modalities for unresectable cases.

Adult↗

Pulmonary capillary hemangiomatosis in an asymptomatic elderly patient.

Thoracic hemangiomatosis is an extremely rare condition of the thorax of unknown origin: thin-walled capillary blood vessels infiltrate the lung parenchyma, blood vessels, interlobular septa, bronchiolar walls and pleura. The infiltration of pulmonary veins and venules induces secondary pulmonary veno-occlusive disease and pulmonary hypertension with a slowly progressive clinical course. This condition can be associated with vascular dementia and disseminated intravascular coagulation (DIC).

Aged↗

Melphalan monitoring during hyperthermic perfusion of isolated limb for melanoma: pharmacokinetic study and 99mTc-albumin microcolloid technique.

BACKGROUND: The kinetics of melphalan leakage from extracorporeal fluid to the peripheral blood was studied in ten patients undergoing hyperthermic isolation perfusion of the lower limbs as an adjuvant treatment in high-risk melanoma. MATERIALS AND METHODS: Systemic leakage was monitored by a new technique using 99mTc-albumin microcolloid. Serial samples were drawn from a peripheral vein and from the perfusion circuit during surgical treatment and analysed by HPLC. RESULTS: The leakage measured with 99mTc-albumin microcolloid ranged from 1.5 to 18%/h (mean 8%/h). The average concentrations in the perfusate were 200-300-fold those found in the systemic circulation. A good correlation (R=0.945) was obtained between systemic AUC (0 to 1 hour) and leakage measured through the 99mTc procedure. Negligible toxicity was found and the survival rate yielded 92% of objective response. CONCLUSION: By studying the pharmacokinetic data of melphalan in the circuit and in the systemic circulation, we were able to validate the 99mTc procedure used during clinical perfusion. Moreover, considering the efficiency of the system as well as the minimum toxicity and the high survival rate, a reduction of perfusion time may be considered.

Aged↗

[Indications for integrated surgical treatment of peritoneal carcinomatosis of colorectal origin: experience of the Italian Society of Locoregional Integrated Therapy in Oncology].

A multicentric prospective study has been carried on 69 patients affected by peritoneal carcinomatosis from colorectal cancer. Patients have been treated by cytoreductive surgery and intraoperative hyperthermic chemoperfusion. CC 0-1 has been achieved in 82%. Major morbidity and mortality was respectively 21.7% and 2.9%. Three years overall survival was 26.7% for all series. Difference in survival evaluating CC 0-1 vs CC 2 patients and PCI < or = 10 vs > 10 was statistically significant. Evaluating only patients CC 0-1 and PCI < or = 10 overall survival rised up to 44.7% at 4 years. A smaller subgroup of patients with a disease-free interval to peritoneal carcinomatosis > or = 2-year showed a 50% disease-free survival at 5 years. In conclusion PCI < or = 10, complete or optimal cytoreduction feasibility and disease-free interval have to be considered for the patients selection to the integrate treatment.

Antineoplastic Combined Chemotherapy Protocols↗

[Treatment of peritoneal mesothelioma using cytoreduction and intraperitoneal hyperthermic chemotherapy].

UNLABELLED: Malignant mesothelioma of the peritoneum is a rare tumor for which the therapeutic approach has not yet been standardized. Cytoreductive surgery and hyperthermic antiblastic peritoneal perfusion (HAPP) may be effective in the treatment of this neoplasm. From 1995 to March 2003, we operated 24 patients with malignant peritoneal mesothelioma. Nineteen times we were able to perform radical surgery and HAPP: 6 CC-0, 10 CC-1 and 3 CC-2 (nodules smaller than 1 cm). HAPP was performed by the original "semi-closed" technique, using MMC+ CDDP in 3 patients, CDDP + doxorubicin in 15 patients, only doxorubicin in 1 patient). RESULTS: Operating mortality was 11% and postoperative morbidity was 26%. 4 patients are DOD (40, 20, and 2 at 2 months); 5 patients are AWD (72, 34, 25, and 2 at 15 months); 8 patients are NED (81, 47, 2 at 20 months, 16, 13, 12 months, 1 patient recently operated). The median survival is 40 months. The high rate of morbidity and mortality is due to the presence of postoperative paraneoplastic syndromes, with alterations of coagulation and onset of ARDS. Therefore the good survival results make the methodic one of the best options in the treatment of the disease.

Antineoplastic Combined Chemotherapy Protocols↗

[Treatment of pseudomyxoma peritonei using cytoreduction and intraperitoneal hyperthermic chemotherapy].

Pseudomixoma peritonei (PMP) is a rare neoplasia with a low grade of clinical malignity. Generally, the main treatment of this tumor is the surgical debulking. Best results are obtained combining surgery and hyperthermic antiblastic peritoneal perfusion (HAPP) with CDDP and MMC. From April '97 to March 2003, we operated on 132 patients, 8 times with a palliative intent. In 27 times we achieved a complete cytoreduction (17 CC0 and 10 CC1) followed by HAPP. As regards results, no post-operative mortality was reported and 19% of major morbidity was observed. 26 patients are NED at maximum follow-up of 6 years and 1 patient had recurrence 6 months after primary resection. We believe that cytoreduction and HAPP is the golden standard of PMP therapy when it is possible to achieve a complete cytoreduction. Most of the times, the disease is not radically treated and therefore, after diagnosis, patients should be only referred to specialized centers.

Antineoplastic Combined Chemotherapy Protocols↗

[Use of pentaglobin in the treatment of sepsis in the patient undergoing intraperitoneal hyperthermic chemotherapy].

In patients subjected to cytoreduction and hyperthermic antiblastic peritoneal perfusion (HAPP), their immunocompromized conditions claim a very aggressive therapeutic approach in case of periotonitis and sepsis. Therefore, we use an adjuvant therapy of severe bacterial infections additional to antibiotic therapy by using Pentaglobin. It contains human plasma proteins, of which immunoglobulin at least 95%, with high rate of IgG, IgM and IgA, infused intravenously at 12 mL/h for 3 days continuously. From November 2000 to March 2003, we combined this approach for the treatment of peritonitis/sepsis in 11 patients. In 10 patients we obtained a complete control of the infective status in 8 days, while 1 patient died for MOFF. So, even with the exiguity of our casuistry, we obtained a better and more rapid clinical control of the patients respect to the previous period when the Pentaglobin was not used.

Anti-Bacterial Agents↗

Subclinical coeliac disease.

The prevalence of coeliac disease (CD) was investigated in an epidemiological study of school children from a district of Rome. Mass screening of IgA-AGA levels (anti-gliadin antibody) were determined in blood samples from the study group and the results were positive in 19 children. Eighteen of these agreed to undergo endoscopic biopsy. Histological study of the duodenal specimens revealed villous atrophy in twelve children none of whom had the characteristic symptoms of CD. The most frequent complaints were abdominal pain, aphtous stomatitis, and atopic dermatitis. The high prevalence of CD in this study suggests the necessity for the widest range of epidemiological research.

Adolescent↗

[Aspects of the on-line hemodiafiltration with regeneration and reinfusion of the ultrafiltrate (HFR): multicenter study].

Despite technological advances in dialysis treatment, survival, morbidity and the quality of life in hemodialysis (HD) patients are affected by long-term complications, often related to the treatment itself. Among these complications, moderate protein and caloric malnutrition are present in approximately 30% of dialysis patients and are viewed as major contributors to increased mortality. In malnutrition pathogenesis, great importance is given to protein catabolism and to the loss of somatic protein and amino acids during dialysis. On the contrary, toxin clearance is believed to influence, positively, both protein anabolism and dietary protein intake. In hemodiafiltration (HDF), the clearance process is potentiated by three mechanisms (diffusion, convection and adsorption) and this could have a favorable effect on malnutrition. In addition, the reinfusion of regenerated ultrafiltrate (UF) would avoid the loss of large amounts of useful solutes as occurs with standard HD. In fact, all amino acids are present in the UF, which is not important in standard HD, but could be a problem in hemodiafiltration reinfusion (HFR). We treated 16 patients with HFR during the previous 3 months (the study will last for 12 months). Patients had been previously treated with bicarbonate dialysis for at least 6 months. The clinical tolerance of HFR was excellent and the technique appeared to be quite simple. The preliminary biochemical results demonstrated the stabilization of some parameters (such as urea and uric acid) with an adequate clearance of small molecules, while variables related to nutritional status (body weight, serum albumin and serum transferrin) did not change substantially. Surprisingly, the loss of both branched chain amino acids (BCAA) and essential amino acids (EAA) seemed slightly lower in HFR compared with standard HD. However, the reduced loss of amino acids (AA) observed with HFR should take into account other factors, such as absorption on adsorbent material and the basal plasma AA concentrations. Therefore, although each patient is in control of himself, it is difficult to draw any definite conclusions after only 3 months. However, it is evident that the loss of AA in HFR is quite modest and is not increased by the fact that it is a hemofiltration technique with all the consequent positive effects.

Amino Acids↗

[Complications of cytoreductive surgery associated with intraperitoneal chemohyperthermia: prevention and treatment].

New approach to peritoneal carcinomatosis combining cytoreductive surgery and hypertermic intraperitoneal chemotherapy suggest improved survival when it is possible to achieve a complete cytoreduction. In this study we consider the major complications related to this procedure and purpose our approach for their prevention and treatment.

Chemotherapy, Cancer, Regional Perfusion↗

[Cytoreduction and intraoperative peritoneal chemohyperthermia in carcinomatosis from colonic carcinoma and in peritoneal pseudomyxoma].

New approach in treatment of peritoneal carcinomatosis combining cytoreductive surgery and intraperitoneal chemotherapy suggests improved survival when it is possible to achieve a complete cytoreduction. In this study we consider the carcinomatosis from colorectal and appendiceal adenocarcinoma. In all cases, patients in whom cytoreductive surgery was complete had a median survival much longer compared with patients in whom was not possible and, as perfusion works on minimal residual disease, peritonectomy is the only surgical technique that aim at total removal of parietal and visceral peritoneal lesions.

Carcinoma↗

Ten years experience in the treatment of pseudomyxoma peritonei by cytoreduction, peritonectomy and semi-closed hyperthermic antiblastic peritoneal perfusion.

BACKGROUND: In the literature good results have been reported for the treatment of Pseudomyxoma peritonei (PMP) by cytoreduction, peritonectomy and hyperthermic antiblastic peritoneal perfusion (H.A.P.P.). Forty-eight patients affected by PMP have been treated with this technique over the past ten years. PATIENTS AND METHODS: Peritoneal perfusion has been performed with the original semiclosed tecnique after complete surgical cytoreduction in 188 patients affected by peritoneal carcinomatosis. In 48 of the cases the patients were affected from PMP. Aggressive surgical cytoreduction was performed with multiple visceral resections and peritonectomies. RESULTS: Seventeen patients (38%) presented major perioperative complications, and in five cases the reoperation of the patient was required. In spite of this high complication rate, there was no perioperative mortality. The results of the Kaplan-Meier 5- and 10-year survival analysis, were 94% and 82%, respectively, with a disease-free survival of 80% at 5 years and 70% at 10 years. Thirty-nine patients (81.2%) had no evidence of disease at follow-up (range 1-120 months). DISCUSSION: Up to date, the most effective treatment for PMP has been aggressive cytoreduction plus H.A.P.P.

Adult↗

120 peritoneal carcinomatoses from colorectal cancer treated with peritonectomy and intra-abdominal chemohyperthermia: a S.I.T.I.L.O. multicentric study.

A multicentric study has been carried out on 120 patients affected by peritoneal carcinomatosis from colorectal cancer. Patients have been treated by cytoreductive surgery and intra-operative hyperthermic chemoperfusion (HIPEC) with cisplatin (CDDP) and mitomycin-c (MMC). A small group of patients were treated with oxaliplatin (LOHP) following the Elias et al. scheme [intravenous 5-fluorouracil (400 mg/m2) and leucovorin (20 mg/m2) followed by intraperitoneal perfusion with LOHP (460 mg/m2) in 2 l/m2, during 30 min at 43 degrees C]. CC-0 cytoreduction was achieved in 85.2% of the patients. Major morbidity and mortality was 22.5% and 3.3%, respectively. No G4 toxicity was registered. The three-year survival was 25.8%. The difference in survival evaluating complete cytoreduction (CC-0) vs. incomplete (CC1-2; residual tumor nodules greater than 2.5 mm) was statistically significant (p < 0.0001). Evaluating only the patients that could be cytoreduced to CC-0, the 3-year survival was raised to 33.5%. In our experience the peritoneal cancer index (PCI) has been demonstrated to be a weak prognostic factor reaching a statistical significance only after the exclusion of patients with resected hepatic metastases. The patients treated with oxaliplatin were alive and free-of-disease after a 16-month median follow-up.

Adenocarcinoma↗

[The postoperative survival in pulmonary carcinomas depending on the histological type and stage].

The prognostic significance of age, sex, location of the tumor in the various lobes, size, histological type, node metastases, local extent and stage has been studied in a series of 742 surgically resected lung carcinomas. The histological type was a very important prognostic factor: the highest survival was observed in epidermoid carcinomas, followed by adenocarcinomas, anaplastic large cell carcinomas, and anaplastic small cell carcinomas. The stage, as well, except for the adenocarcinoma, bore heavily on the prognosis; however, in small stage I tumours, the postoperative survival was independent from the histological type. The presence of lymph node metastases resulted in an extremely poor survival, except for the epidermoid carcinoma. The size of the tumours, excluding adenocarcinomas, was an important prognostic factor provided lymph node metastases were absent. No significant differences in survival according to the location in different lobes could be ascertained.

Adenocarcinoma↗