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Biomedical subjects

P Pugliese

Publications and source records attributed to P Pugliese.

At least 19 recordsLinked to original sources

Thrombosis-related complications and mortality in cancer patients with central venous devices: an observational study on the effect of antithrombotic prophylaxis.

BACKGROUND: Recent guidelines do not recommend antithrombotic prophylaxis (AP) to prevent catheter-related thrombosis in cancer patients with a central line. PATIENTS AND METHODS: This study assessed the management of central lines in cancer patients, current attitude towards AP, catheter-related and systemic venous thromboses, and survival. RESULTS: Of 1410 patients enrolled, 1390 were seen at least once in the 6-month median follow-up. Continuous AP, mainly low-dose warfarin, was given to 451 (32.4%); they were older, with a more frequent history of venous thromboembolism (VTE), and more advanced cancer. There was no difference in catheter-related thrombosis in patients given AP or not (2.8% and 2.2%, odds ratio 1.29, 95% confidence interval 0.64-2.6). The median time to first catheter-related complication was 120 days. Systemic VTE including deep and superficial thromboses and pulmonary embolism, were less frequent with AP (4% versus 8.2%, P = 0.005). Mortality was also lower (25% versus 44%, P = 0.0001). Multiple logistic regression analysis found only advanced cancer and no AP significantly associated with mortality. No major bleeding was recorded with AP. CONCLUSIONS: Current AP schedules do not appear to prevent catheter-related thrombosis. Systemic VTE and mortality, however, appeared lower after prophylaxis.

Catheterization, Central Venous↗

[Medical care for HIV infection in France in 2005, the NADIS cohort study on 7416 patients].

OBJECTIVE: This study had for aim to evaluate the immuno-virological and therapeutic profile of a cohort of 7416 HIV-1 infected patients followed in six French hospital with the Nadis software. METHOD: This cross sectional and retrospective study was performed between June 1, 2004 and June 1, 2005. We analyzed the demographic (sex, age, HIV infection route), immunovirological, and therapeutic characteristics (last treatment prescribed) of the 7416 cohort patients. RESULTS: The mean age was 43 years, 29% were women and 29% HCV/HBV co infected. The viral load was 1.9 log(10)copies/ml (IQR: 1.5-3.3) and the CD4 cells count was 452/mm(3) [IQR: 306-630]. Among the 5,913 antiretroviral treated patients, VL was less than 200 copies/ml for 74.7% of patients and 50% of them had a CD4 cell count superior to 500/mm(3); the drug regimen was 2 or 3 nucleosides reverse transcriptase inhibitors (NRTI) combined with one protease inhibitor (88% Ritonavir boosted) in 42% of the patients, 26% of them were treated with 2 NRTI and 1 non-NRTI, and 14% with 3NRTI. Patients with undetectable VL were followed 5.1/year versus 7.2 for non- VL controlled patients (P<10(-3)). The heterosexual route predominated among the new 531 HIV-diagnosed patients among whom 25% had a median CD4 cell count of 242/ m(3). CONCLUSION: Close to 75% of antiretroviral treated patients had a VL<200 copies/ml but 15% kept a low CD4 cell count. The characteristics of recently diagnosed HIV positive patients stresses the need for more information on prevention and an early diagnosis.

Adult↗

Nipple sparing mastectomy with immediate breast reconstruction: a short term analysis of our experience.

Breast cancer surgery has greatly changed over the past decades; nowadays skin-sparing mastectomy (SSM) and immediate reconstruction is considered a valid oncological option to achieve good aesthetic results. The success of SSM led to several studies aimed to investigate NAC involvement whose removal increases the patient's sense of mutilation. In this study the Authors investigate the incidence of recurrences in nipple sparing mastectomy (NSM) comparing it with the other techniques to assess the actual risk of tumor involvement of the NAC; besides, they analyse the patients' satisfaction and the NSM impact on quality of life through the utilization of a questionnaire. Clinical complications, aesthetic as well as oncological and psychological results have been analysed. They conclude that in selected cases NSM can be performed without additional risks because the incidence of recurrence after NSM is similar to that of radical mastectomy. Moreover, the aesthetic and psychological outcome are considered positive by the patients.

Adult↗

Triple nucleoside reverse transcriptase inhibitor- vs. nonnucleoside reverse transcriptase inhibitor-containing regimens as first-line therapy: efficacy and durability in a prospective cohort of French HIV-infected patients.

OBJECTIVE: Based on the short-term results of the AIDS Clinical Trials Group (ACTG) A5095 trial, zidovudine (ZDV)/lamivudine (3TC)/abacavir (ABC) is no longer recommended as a first-line antiretroviral regimen. Data on the efficacy of this triple nucleoside reverse transcriptase inhibitor (NRTI) combination compared with the gold-standard nonnucleoside reverse transcriptase inhibitor (NNRTI) regimen could provide important information. METHODS: Patients were selected from three prospective cohorts of patients who received first-line therapy with ZDV/3TC plus an NNRTI or ABC, started after January 1998. Immunovirological changes and the proportion of treatment discontinuations were compared between groups. RESULTS: Of the 380 patients, 190 started on ABC [the triple-NRTI group (3N)] and 190 on NNRTI. At baseline, there was no statistical difference between the NNRTI and 3N groups for age (mean=38 years), sex (66% male) or CD4 cell count (mean=305 cells/muL). Mean baseline plasma HIV-1 viral load (pVL) was higher in the 3N group (4.6 vs. 4.3 log10 HIV-1 RNA copies/mL: P<0.01). Lower and higher estimates of median pVL decrease at month 24 were 2.05 and 4.76 log10 copies/mL in the 3N group, and 1.73 and 4.31 log10 copies/mL in the NNRTI group (not significant). CD4 cell count evolution did not differ between groups. Treatment discontinuation occurred in 45% vs. 44% of patients in the NNRTI and 3N groups, respectively, after median durations of 9 and 4 months, respectively (P=0.02). CONCLUSIONS: In this prospective cohort, 3N and NNRTI regimens as first-line therapy produced similar immunovirological responses.

Adult↗

Gas chromatographic evaluation of pesticide residue contents in nectarines after non-toxic washing treatments.

Washing with aqueous solutions of citric acid, ethanol, glycerol, hydrogen peroxide, potassium permanganate, sodium metabisulfite, sodium laurylsulfate (SLS), sodium hypochlorite, and urea is evaluated for pesticide residue reduction in nectarines and compared with simple tap water washing. Residues of pesticides commonly utilized in nectarines (chlorpyrifos, fenarimol, iprodione, malathion, methidathion, myclobutanil, parathion and pirimicarb) are extracted with ethyl acetate and anhydrous sodium sulfate, extract is concentred and analyzed by GC with nitrogen-phosphorus detection. The formation of possible toxic by-products (chlorpyrifos oxon, malaoxon, methidaoxon and paraoxon methyl) is studied by GC-MS. No toxic by-products are identified in the extracts of the washed samples for the washing-time and concentrations studied, but high levels of sodium hypochlorite, hydrogen peroxide and potassium permanganate form oxons from the organophosphorus pesticides. Ethanol, glycerol and SLS solutions removed near the 50% of the pesticide residues. The other solutions were not more effective than tap water washing. The amount of pesticide removed by washings is related to its water solubility and octanol-water partition coefficient.

Chromatography, Gas↗

[NADIS 2000, development of an electronic medical record for patients infected by HIV, HBV and HCV].

OBJECTIVE: to develop an electronic medical record for patients living with HIV, HBV or HCV in order to improve their management, facilitate communication between all the caregivers, and to create a useful medical database for research and assessments. This project (NADIS 2000) involved 6 centres of Infectious Diseases in France in partnership with Fédialis Médica (subsidiary of the GSK group in France). METHODS: A specifications sheets was drawn-up by a piloting Committee regrouping the various correspondents in each centre and a computer expert representing Fédialis Médica. A Scientific and Development committee regrouped the heads of departments of each centre and the representatives from Fédialis Médica and GSK and was charged with defining the general concept of the project and guaranteeing the scientific and clinical aspects. RESULTS: NADIS 2000 version 1.0 was activated in the departments of infectious diseases in Nice and Toulouse in November 2000 and in others Units at the end of 2001. NADIS 2000 permitted real-time use by the physicians in the Outpatients and Day-care Units and was easily handled by all the practitioners. Its use was eased by the principles clearly defined before its application (department project, progressive but exhaustive use), an intuitive interface simulating a consultation, and functions proposing direct benefits for the physicians (graphical visualization of the biological variables, printing of prescriptions and letters). CONCLUSION: The activation and input methods of NADIS 2000 are user friendly and the physicians find it rapidly easy to use. New functional aspects are being developed as well as its use in other hospital departments.

Computer Communication Networks↗

Association of tau gene polymorphism with Parkinson's disease.

We investigated the segregation of the dinucleotide GT repeat polymorphism in the intron between exons 9 and 10 of the tau gene in 300 patients with Parkinson's disease (PD) and in 197 normal controls. The A3 allele was more frequent in cases than in controls (30% versus 16%, p<0.001), and individuals carrying at least one A3 allele in their genotype had an increased risk of developing PD (odds ratio 2.78, 95% confidence interval 1.81-4.29). No significant differences were found between patients by considering the age at onset and the presence of family history or dementia. Our findings suggest a possible involvement of the tau gene in the pathogenesis of PD.

Age of Onset↗

Dietary and nutritional patterns in an elderly rural population in Northern and Southern Italy: (I). A cluster analysis of food consumption.

OBJECTIVE: To describe the food consumption patterns of Italian elderly subjects and the factors associated with different dietary habits. DESIGN: Cross-sectional study. SETTING: Population-based study. SUBJECTS: A total of 847 men and 1465 women aged 65 y or older, living in rural areas in the province of Pavia (Northern Italy) and near Cosenza (Southern Italy) in 1992-1993. INTERVENTIONS: The dietary information was collected by means of a quantitative food-frequency questionnaire, with cluster analysis being used to segregate the subjects on the basis of similarities in their food consumption. A generalised logistic regression model including residence, age, living status, education, physical activity and degree of disability was fitted to assess the factors associated with different food consumption habits. RESULTS: Six dietary clusters were selected for men and seven for women. The largest cluster for both genders was "small eaters" (46% of men and 51% of women); "big eaters", "light diet" and "alcohol" clusters were also identified for both genders. The men were also grouped into "balanced diet" and "cheese" clusters, and the women into "sweet", "greens" and "butter" clusters. CONCLUSIONS: In addition to the influence of the area of residence--residents in Northern Italy consume greater amounts of animal fats, sugar and alcoholic beverages, and those living in Southern Italy have a greater intake of fruit, vegetables, fish and olive oil--all of the other studied variables predicted the probabilities of falling into a specific dietary cluster. SPONSORSHIP: National Research Council (Italy)--Invecchiamento Project No. 95.01048. PF40.

Aged↗

Dietary and nutritional patterns in an elderly rural population in Northern and Southern Italy: (II). Nutritional profiles associated with food behaviours.

OBJECTIVE: To describe the nutritional profiles of the food consumption patterns identified in an elderly Italian rural population. DESIGN: Cross-sectional study. SETTING: : Population-based study. SUBJECTS: A total of 847 men and 1465 women aged 65 y or older, resident in rural areas in the province of Pavia (Northern Italy) and near Cosenza (Southern Italy) in 1992-1993. INTERVENTIONS: A cluster analysis segregated the subjects into six groups for men and seven for women on the basis of similarities in their food intake (see companion paper). The mean daily energy, macronutrient, mineral and vitamin intakes were calculated for the sample as a whole and for each cluster, and then compared with the age- and gender-specific recommended daily allowances for the Italian population. RESULTS: The largest cluster ("small eaters", which included about half of the population) had an insufficient intake of essential fatty acids, calcium, potassium, zinc (men), iron (women), thiamin, riboflavin, niacin, beta-carotene, and vitamins A, D and E. The most noticeable characteristics of some of the other clusters were a high intake of fats, a high proportion of total energy provided by sugars, a high intake of vitamin C, folic acid and beta-carotene, and a high alcohol consumption. Furthermore, sodium intake was too high in all of the clusters and vitamin D intake was generally inadequate. CONCLUSIONS: The dietary habits of elderly Italians living in rural areas combine elements of the Mediterranean and "wealthy" diets. SPONSORSHIP: National Research Council (Italy) - Invecchiamento Project no. 95.01048.PF40.

Aged↗

Heparin reversal in off-pump coronary artery bypass surgery: complete, partial, or no reversal?

Several clinical studies have reported that avoiding cardiopulmonary bypass reduces postoperative bleeding. The purpose of this study is to verify that protamine during off-pump coronary artery bypass surgery produces significant reduction of postoperative bleeding. Sixty consecutive patients undergoing off-pump coronary artery bypass surgery were prospectively randomized in three groups: Group A received 1 mg of protamine every 100 IU of heparin, Group B 0.5 mg of protamine every 100 IU of heparin, and Group C none. The three groups were analyzed for differences in preoperative cardiac function, pre-, intra-, and postoperative coagulation profile, intraoperative variables, and postoperative bleeding. In the three study groups, no statistically significant difference was found in preoperative cardiac function, pre- and intraoperative coagulation profile, and prothrombin time, activated partial thromboplastin time, platelet count in the first postoperative day. In Group A, total postoperative bleeding, use of packed red blood cells, and mild pericardial effusion prevalence at discharge were significantly lower only when compared to Group C, but they were not significantly different when compared to Group B. In off-pump coronary artery bypass surgery, heparin should be reverted with protamine, otherwise the postoperative bleeding risk might increase. Partial heparin reversal might not increase postoperative bleeding risk, but it may reduce dose-dependent protamine adverse effects.

Aged↗

Left atrial epicardial ablation associated to a Bentall procedure.

Aortic coarctation is quite a common congenital disease and very often associated with other cardiac malformations. A 21-year-old patient presented to our observation with aortic coarctation, aortic valve regurgitation on a dilated aortic root and chronic atrial fibrillation. We performed a two-step operation: the aortic coarctation was treated first and 1 month later a Bentall procedure associated to an epicardial ablation was performed. Since most of the ablation was performed before aortic cross clamping, the ischemic time was only slightly increased. At 3 months follow-up the patient is still on normal sinus rhythm.

Adult↗

Quality of life and chronotherapy.

The importance of evaluating patient's quality of life (QoL) in clinical practice and research is recognized clearly in oncology. In the advanced phase of disease such an evaluation represents an endpoint as important as survival. Quality of life is both a subjective and multidimensional concept evaluated mainly by validated questionnaires. In colorectal trials involving advanced stage disease the effects of different chemotherapy treatments on QoL were evaluated. Almost all the studies found no deterioration in QoL during chemotherapy. The European Organization for the Research and Treatment of Cancer (EORTC) Chronotherapy Study Group utilized three different approaches to assess QoL. The first centered on the stability of QoL during a 6mon treatment period in patients undergoing chronotherapy. The second centered on research of the biological and clinical determinants of QoL involving features of the circadian activity rhythm and patient survival and the relationship between QoL and patient performance status, response to therapy, and psychosocial variables as well as drug-induced toxicity. The third centered on the clinical effectiveness of psychological intervention on patients undergoing chronotherapy to improve psychosocial status during treatment. This papers reviews the results of EORTC Chronotherapy Group studies on QoL.

Antineoplastic Agents↗

A phase II study of sequential 5-fluorouracil, epirubicin and cyclophosphamide (FEC) and paclitaxel in advanced breast cancer (Protocol PV BC 97/01).

Sequential administration of the association of 5-fluorouracil, epirubicin and cyclophosphamide (FEC) and paclitaxel could be better tolerated than the association of an anthracycline and paclitaxel while having a similar antitumour effect. 69 patients with advanced breast cancer previously untreated with anthracyclines or paclitaxel entered a phase II multicentre study in which FEC was followed by paclitaxel. Both regimens were administered 4 times every 21 days. The median follow-up is 20 months and 38/69 patients have died. Grade III-IV toxicity was acceptable. Leukopenia occurred in 26% of patients, thrombocytopenia in 2% and anaemia in 4%. One patient had reversible heart failure during FEC therapy. Peripheral neuropathy and arthralgia-myalgia occurred in 9% and 4% of patients, respectively and one patient had respiratory hypersensitivity during paclitaxel treatment. 9 patients did not complete therapy because of: treatment refusal (n = 1), cardiac toxicity (n = 1), early death during FEC chemotherapy (n = 1), major protocol violations (n = 4), hypersensitivity reaction (n = 1) and early death during paclitaxel chemotherapy (n = 1). The overall response rate was 65% (95% CI = 53-76), and 7% of patients had stable disease. Therapy was defined as having failed in 28% of patients because they were not evaluable (13%) or had progressive disease (15%). The median time to progression and survival are 13.2 and 23.5 months, respectively. Sequential FEC-paclitaxel is a suitable strategy for patients with metastatic breast cancer who have not been previously treated with anthracyclines and/or taxanes. In fact, it avoids major haematologic toxicity and has a good antitumour effect.

Adult↗

Irinotecan and chronomodulated infusion of 5-fluorouracil and folinic acid in the treatment of patients with advanced colorectal carcinoma: a phase I study.

BACKGROUND: Irinotecan (CPT-11) is an active drug in the treatment of patients with advanced colorectal carcinoma. The infusion of 5-fluorouracil (5-FU) according to circadian rhythms was used previously to decrease toxicity and to increase its therapeutic efficacy. The objective of this study was to establish the maximum tolerated dose (MTD) of CPT-11 together with a chronomodulated infusion of 5-FU and the l-form of folinic acid (FA). Secondary end points were the assessment of activity and quality of life (QoL). METHODS: Twenty-six patients with advanced colorectal carcinoma who had received previous treatment with 5-FU were entered on this Phase I study. At least three patients were recruited at each dose level. The CPT-11 starting dose was 175 mg/m(2) on Day 1 with an increase of 50 mg/m2 per dose level. A daily administration of chronomodulated 5-FU (900 mg/m2; peak delivery rate at 04:00) and FA (175 mg/m2; peak delivery rate at 04:00) for 5 days every 3 weeks was given with CPT-11. After the first three patients, the 5-FU dose was reduced to 700 mg/m2 per day due to toxicity. No intrapatient dose escalation was allowed. RESULTS: One hundred sixty-one courses were delivered. Dose-limiting toxicity was observed during the first course in seven patients (27%). Four patients developed neutropenia, with one patient reporting febrile neutropenia, two patients reporting severe stomatitis, and six patients reporting severe diarrhea. CPT-11 MTD was reached at 350 mg/m2 when a toxic death was observed with a recommended dose of 325 mg/m2. Six partial responses were observed (23%). The median duration of response and the progression free and overall survival rates were 199 days, 175 days, and 359 days, respectively. QoL was not affected by the treatment. CONCLUSIONS: The recommended dose for Phase II trials is 325 mg/m2 CPT-11 on Day 1, which is similar to the dose given as a single agent, together with a 5-day chronomodulated infusion of 700 mg/m2 5-FU and 175 mg/m2 FA. Intensification of this schedule every 2 weeks should be achievable.

Adult↗

Tricuspid valve repair with the Cosgrove-Edwards annuloplasty system: early clinical and echocardiographic results.

BACKGROUND: The use of flexible rings for tricuspid valve repair is becoming popular. The purpose of this study was to evaluate the Cosgrove-Edwards annuloplasty system for tricuspid regurgitation. METHODS: From June 1998 to December 2000, 22 patients with significant secondary tricuspid regurgitation underwent tricuspid valve repair with the Cosgrove-Edwards annuloplasty system. All patients had disease of left-sided heart valves in addition to tricuspid disease; 34 concomitant procedures were performed. Twenty-one patients (95.5%) were in preoperative New York Heart Association functional class 3 or 4. The mean follow-up was 19.9 +/- 9.7 months. RESULTS: There were two in-hospital nonvalve-related cardiac deaths (9.1%) and one noncardiac death after discharge (4.5%). All survivors were in New York Heart Association functional class 1 or 2; their tricuspid regurgitation was well controlled within grade 1+ and there was a significant reduction of systolic pulmonary artery pressure. Five (83.3%) of the 6 survivors with preoperative pulmonary hypertension had no or trivial residual tricuspid regurgitation. CONCLUSIONS: The Cosgrove-Edwards annuloplasty system is very effective in the treatment of secondary tricuspid regurgitation, also in the presence of pulmonary hypertension.

Adult↗

Role of fibrates and HMG-CoA reductase inhibitors in gallstone formation: epidemiological study in an unselected population.

Fibrate derivatives and HMG-CoA reductase inhibitors modify homeostasis of cholesterol. The aim of this study was to assess in an unselected population whether these hypolipidemic drugs are risk factors for cholelithiasis or, conversely, are protective agents. Both sexes, all socioeconomic categories, pregnant women, and cholecystectomized subjects were included. Clinical data collection and gallbladder ultrasonography were both carried out in a double-blind fashion. Fibrate derivatives were predominantly fenofibrate, HMG-CoA reductase inhibitors were simvastatin and pravastatin. On univariate analysis, age (>50 years), sex, and use of fibrates were found to be significantly related to the presence of cholelithiasis. Age, sex, and fibrate treatment remained independently correlated with the presence of gallstones on multivariate analysis. With fibrates, the relative risk for lithiasis was 1.7 (P = 0.04). The HMG-CoA reductase inhibitors were not associated with a protective effect on univariate analysis. Of the lipid-lowering drugs, only fibrate derivatives were found to increase the risk of gallstone formation.

Anticholesteremic Agents↗