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Biomedical subjects

M Pavesi

Publications and source records attributed to M Pavesi.

At least 19 recordsLinked to original sources

Ethanol does not significantly affect the bioavailability of almotriptan: an open, randomized, crossover, single-dose, phase I clinical trial in healthy volunteers.

OBJECTIVE: A number of clinical reports have revealed a link between the use of alcohol and the onset or exacerbation of migraine headaches. This open, randomized, crossover, single-dose, phase I clinical trial evaluated the possible pharmacokinetic interactions between a single oral dose of almotriptan 12.5 mg, a 5-HT(1B/1D receptor agonist for the acute treatment of migraine, and ethanol in 16 healthy male volunteers. Tolerability and safety of this combined treatment were also assessed. METHODS: Subjects received a crossed oral dose of almotriptan (12.5 mg) with and without concomitant alcohol intake (target plasma concentration 0.8 g/kg) in two different treatment periods. Almotriptan was administered alone, while ethanol was diluted with orange juice, which was also given to the control group. There was a washout period of 7 days between treatments. Plasma levels of almotriptan were analyzed using a sensitive and specific liquid chromatographic-tandem mass spectrometry method. RESULTS: The 90% non-parametric confidence interval for the median t(max) of almotriptan plus ethanol compared to almotriptan alone (0.61/2.72) was outside the acceptable range (0.70 - 1.30), demonstrating that concomitant ethanol administration slightly increases the variability of absorption of almotriptan 12.5 mg. In contrast, the main bioavailability criteria parameters, C(max) and AUC, which show the rate and extent of systemic absorption, were not affected by alcohol ingestion. Therefore, it is unlikely that concomitant ethanol intake would produce clinically relevant differences in the therapeutic effect of almotriptan at the dose studied here. Tolerability of treatments was good throughout the entire study period. CONCLUSIONS: Almotriptan 12.5 mg, with or without concomitant alcohol ingestion, showed similar plasma concentrations after a single dose in healthy volunteers with no clinically relevant drug-to-drug interactions.

Adult↗

[Prevention of cardiovascular accidents during locoregional anesthesia].

Cardiovascular complications can be divided into 2 big categories involving the cardiovascular system in locoregional anaesthesia: those of local anaesthetics with direct effect on sympathetic fibres, which regulate the cardiovascular activity and those who derives from alteration of the normal cardiac function due to the toxic effect of the drugs. While the first are referred to the extension of a central block, the second considers the overdose caused by accidental intravenous injection. This is more frequent in peripheral blocks then in central blocks. The use of catheters in both central and peripheral blocks introduces another factor of risk due to a prolonged administration of local anaesthetics. The prevention of those complications should foresee through an accurate anamnesis the subjective conditions of risk: so we have to choose the best individual technique and dose of anaesthetics; the use of qualitative correct material, the ENS as a support to identify nerve structures and the application of more recent and safe drugs represented by the compound of S(-) enantiomers, Ropivacaine and Levobupivacaine. Which are described to be less cardiotoxic but with the same characteristics as Bupivacaine. Finally don't forget respect the classical rules of security during locoregional anaesthesia.

Anesthesia, Conduction↗

[Risk and prognostic factors of Pseudomonas aeruginosa bacteremia in critically ill patients].

BACKGROUND: To determine risk and prognostic factors in patients admitted to the intensive care unit (ICU) in which an episode of bacteremia caused by Pseudomonas aeruginosa has been diagnosed. PATIENTS AND METHOD: Cohort, observational, prospective, multicenter study. Patients admitted to 30 ICUs in Spain in whom one or more pathogens were isolated from blood cultures were included. RESULTS: In a total of 16,216 patients admitted to the participating ICUs during the study period, 949 episodes of bacteremia were diagnosed In 77 cases (8.11%), P. aeruginosa was the causative pathogen, with an infection rate of 4.7 episodes per 1000 patients. Independent risk factors associated with P. aeruginosa bacteremia were as follows: respiratory infection focus (OR 3.92; 95% IC 2.33-6.59; p </= 0.0001), previous use of antibiotics (OR 2.13; 95% IC 1.18-3.81; p </= 0.0078), arterial catheter (OR 4.09; 95% IC 2.26-7.38; p </= 0.0001), and previous longer ICU stay (days) (OR 1.02; 95% IC 1.003-1.033; p = 0.0274). Crude mortality rate in patients with bacteremia caused by P. aeruginosa was 50.6% (39/77), whereas mortality rate of bacteremia caused by other pathogens was 38.6% (337/872) (p = 0.039). This difference was also found for attributed mortality (31.2% [24/77] vs. 20.4% [178/872], (p = 0.027). In the multivariate analysis adjusted by respiratory infection focus, previous ICU stay, and age, crude mortality (OR 1.55; 95% CI 0.96-2.51; p = 0.071) and attributed mortality (OR 1.63; 95% CI 0.96-2.78; p = 0.0709) of P. aeruginosa bacteremia were higher than in bacteremia caused by other pathogens. In the multivariate analysis, risk factors significantly associated with crude mortality were respiratory infection focus (OR 4.13; 95% IC 1.15-14.76; p = 0.0293) and severe sepsis or septic shock (OR 4.96; 95% IC 1.23-20.09; p = 0.0248). CONCLUSIONS: Bacteremia caused by P. aeruginosa admitted to the ICU have a higher crude and attributed mortality than bacteremias caused by other pathogens. Prognosis is associated with the presence of severe sepsis or septic shock and respiratory infection focus.

Anti-Bacterial Agents↗

Dirofilariasis due to Dirofilaria repens in Italy, an emergent zoonosis: report of 60 new cases.

AIMS: Sixty new cases of human dirofilariasis due to Dirofilaria repens, occurring in Italy between 1990 and 1999, are presented. This is the most extensive case study of this zoonosis reported worldwide by a single study group. The aim is to utilize this large experience to characterize the different histopathological findings in the parasitic lesions in man. METHODS AND RESULTS: Diagnosis was performed on histological sections of the nematode enclosed in the nodules excised at biopsy or surgery. The nematode was located in the subcutaneous tissue (49 cases), the epididymis (two cases), the spermatic cord (two cases), the lung (two cases), the breast (two cases), the omentum (two cases) and under the conjunctival tissue (one case). The majority of cases (46) were from Piedmont; the remainder were from Emilia-Romagna, Sardinia, Sicily, Tuscany, Apulia and Lombardy. The histopathological features of the lesions are described and the clinical and epidemiological aspects of the zoonosis are discussed. The prevalence in Italy in general and in the area of Piedmont in particular, comprising the provinces of Alessandria, Asti, Novara and Vercelli, which is one of the most severely affected areas of the world, is emphasized. The evident increase in the number of cases in the last few years is a clear indication that it is an emergent zoonosis. CONCLUSIONS: We recommend that each and every case observed be recorded, to enable the true extent of human dirofilariasis in Italy to be assessed, and that a reference centre be set up in the area to collate the data. The importance of the histopathologist's role in the diagnosis is stressed.

Adult↗

[Continuous brachial plexus blockade for shoulder surgery].

Continuous brachial plexus block is the technique of choice for postoperative shoulder pain treatment. The localization of the plexus is usually obtained drawing landmarks on the skin and using the electrical nerve stimulator; these and other different modalities are applied in order to reach safely and precisely nerve roots to be blocked with an anaesthetic solution. The Author presents a new anatomical perspective to guide the localization of the brachial plexus. It is shown how it is possible to detect the pathway of the brachial plexus from the cutaneous surface, linking between each other various landmarks: a) the apex of the scalene triangle, at the cross of a line leaving from the cricoid process and directed posterior to the posterior border of the sternocleidomastoid muscle, b) the midline of the clavicle c)the deltoid-pectoral sulcus d) the midpoint between the coracoid process and the chest profile e) the pulsation of the artery in the axylla. Following the guide of the so formed anesthetic line, is possible to place the needle, with a direction from distal to proximal, in a tangential route towards the interscalenic groove, thus allowing to perform a block of the plexus in a simple and efficacious way.

Brachial Plexus↗

[Two in one block for carotid surgery].

The choose of the best anaesthesia for carotid surgery is a very debated item: the locoregional techniques probably offer more hemodynamic stability and a direct neurologic monitoring, while general anaesthesia allows the complete control of airways and ventilation and reduces the global stress for the patient. This review analyzes the data of studies that compare general and locoregional anaesthesia. Among the latter, possibly elective techniques, the one described by Winnie combines an optimal analgesic efficacy with the lowest rate of adverse effects. A single bolus of a local anesthetic injected at a C4 level (apex of scalene muscles triangle) guarantees a complete block of the superficial and deep cervical plexuses.

Anesthesia, Local↗

[Assessment of the comprehension of new rephrasing drug package inserts].

BACKGROUND: The information included in drug package inserts is often difficult for users to understand. The impact of rephrasing inserts on comprehension was assessed. SUBJECTS AND METHOD: A community double-blind clinical trial was undertaken with random allocation of subjects to unmodified or modified inserts, in which presentation and structure had been improved and technical content expressed in plain language. A questionnaire on comprehension of the use of four common drugs was administered to all participants. The following aspects were analyzed: indications, interval of administration, administration in relation to meals, contraindications, storage and what to do in cases of missing a dose or improvement in symptoms. RESULTS: 1,560 participants were included, among whom 770 randomly received the unmodified inserts. The mean proportion of correct answers was 45.7% in the unmodified insert group and 75.5% among those who received the modified version. In all groups of age, study level and employment status, participants with modified texts achieved a higher correct response rate than the unmodified group. An improvement > 73% in the correct response rate was observed in interval of administration, administration in relation to meals and what to do in cases of missing a dose. With the modified leaflet the odds ratio of successfully answering more than 70% of questions was 13.5 (95% confidence interval, 10.5-17.5) compared with the unmodified leaflet. CONCLUSIONS: The comprehension of drug package inserts may be considerably improved by making simple changes in their content. These changes may contribute to accident prevention or inappropriate use of commonly prescribed drugs.

Adolescent↗

Cyclical etidronate versus sodium fluoride in established postmenopausal osteoporosis: a randomized 3 year trial.

To compare the effects of sodium fluoride and etidronate in severe postmenopausal osteoporosis, we conducted a 3 year, prospective, trial in 118 postmenopausal osteoporotic women with at least one vertebral fracture, who were randomly assigned to receive sodium fluoride (25 mg twice daily, as enteric-coated tablets) plus calcium (1000 mg/day) or intermittent etidronate (400 mg/day for 14 days) followed by calcium (1000 mg/day for 76 days). Lateral spine X-ray films and dual-energy X-ray absorptiometry (DXA) measurements of the lumbar spine and proximal femur were performed at enrollment and yearly. Nonvertebral fractures were recorded every 6 months. Thirty-one women in the fluoride group and 47 in the etidronate group completed the trial. At 36 months, the mean change from baseline of the lumbar bone density in the fluoride group was 8.5 +/- 2.04% (p = 0.001) and in the etidronate group was of 3.6 +/- 0. 84% (p < 0.001). The changes in the fluoride group were significantly higher than in the etidronate group (p = 0.01). Both groups showed nonsignificant changes in femoral neck bone density. There was no significant difference between groups in the cumulative proportion of women with new vertebral fractures, with an incidence in the fluoride group of 16% vs. 17% in the etidronate group. However, the number of new vertebral fractures was significantly lower in the fluoride group (6 fractures) than in the etidronate group (19 fractures) (p = 0.05). The number of patients with nonvertebral fractures was similar in both groups. A high incidence of side effects, mainly gastrointestinal symptoms and lower extremity pain syndrome, was observed in the fluoride group. Etidronate was well tolerated. We conclude that, in women with severe osteoporosis, although sodium fluoride is more favorable than cyclical etidronate for increasing lumbar bone mass, no differences were observed in the incidence of fractures.

Administration, Oral↗

Usefulness of hospital admission risk stratification for predicting nonfatal acute myocardial infarction or death six months later in unstable angina pectoris. RESCATE Study Group. Resources Used in Acute Coronary Syndromes and Delays in Treatment.

The aim of this study was to assess the clinical course of unstable angina and the prognostic value of clinical and electrocardiographic variables measured during admission in a prospective, multicenter cohort study with 6-month follow-up. The population corresponds to 4 general teaching hospitals in Catalonia, Spain. The clinical course was analyzed in 839 consecutive patients aged up to 80 years with primary unstable angina, without myocardial infarction or previous coronary bypass. The main outcome measures were cardiac mortality and nonfatal myocardial infarction. Patients involved in the present analysis belonged to the Resources Used in Acute Coronary Syndromes and Delays in Treatment (RESCATE) study. Six-month overall mortality, cardiac mortality, and nonfatal myocardial infarction rates were 4.6%, 4.1%, and 3.9%, respectively. Six-month cardiac mortality or myocardial infarction rate did not differ among clinical forms of presentation. Peripheral artery disease (RR 3.5, 95% confidence interval [CI] 1.88 to 6.50, p = 0.0001), ST-T-wave electrocardiographic changes on admission (RR 2.22, 95% CI 1.13 to 4.36, p = 0.0203), and age >65 years (RR 1.74, 95% CI 1.04 to 2.91, p = 0.0356) independently predicted 6-month cardiac mortality or nonfatal myocardial infarction. Their positive predictive values were 21%, 10%, and 11%, respectively, whereas their negative predictive value was > or = 93% in all cases. Prevalences were 9%, 70%, and 41%, respectively. In this prospective study, patients with unstable angina without prior myocardial infarction have a relatively low, although not negligible, 6-month severe complication rate. Stratification risk can easily be established with clinical and electrocardiographic characteristics measured during admission. Their absence almost rules out future adverse events, while their presence does not necessarily imply bad prognosis.

Adult↗

Relationship of therapeutic improvements and 28-day case fatality in patients hospitalized with acute myocardial infarction between 1978 and 1993 in the REGICOR study, Gerona, Spain. The REGICOR Investigators.

BACKGROUND: The aim of this study was to analyze 28-day case fatality trends between 1978 and 1993 among hospitalized acute myocardial infarction (AMI) patients in the REGICOR registry, Gerona, Spain, and relate them to thrombolytic and antiplatelet drug use and changes in patient characteristics. METHODS AND RESULTS: A total of 2053 consecutive patients 25 to 74 years of age with a first Q-wave AMI admitted to the reference hospital between 1978 and 1993 were registered. Clinical characteristics and patient management were recorded. Four 4-year periods were considered: 1978 to 1981, 1982 to 1985 (prethrombolytic therapy), 1986 to 1989 (thrombolytic and antiplatelet drugs introduced), and 1990 to 1993 (thrombolytic and antiplatelet drugs used routinely). The end point was death at 28 days. Case fatality at 28 days decreased 6% per year between 1978 and 1993. A logistic model adjusted for comorbidity and severity showed the last 3 periods to present a steep decrease in the OR of death at 28 days: 0.86 (95% CI, 0.52 to 1.41), 0.59 (95% CI, 0.35 to 0.99), and 0.40 (95% CI, 0.24 to 0.69), respectively, compared with the first period. After 1986, 85.7% of the 112 lives saved could be attributed to the use of antiplatelet and thrombolytic drugs. Adjusted relative risk reduction was 56.0% for antiplatelet drugs, 34.1% for thrombolytic drugs, and 77.9% for the 2 combined. CONCLUSIONS: Our results strongly suggest that new therapies introduced since 1986 have contributed to the decrease in 28-day case fatality of patients admitted with a first Q-wave AMI. This decrease could be attributable mainly to the use of antiplatelet and thrombolytic drugs. These findings should encourage the routine use of thrombolytic and antiplatelet drugs and particularly their combination in the acute phase of AMI.

Adult↗

Six-month outcome in unstable angina patients without previous myocardial infarction according to the use of tertiary cardiologic resources. RESCATE Investigators. Recursos Empleados en el Síndrome Coronario Agudo y Tiempos de Espera.

OBJECTIVES: The study assessed whether varying accessibility of patients with unstable angina (UA) to coronary angiography and revascularization determined differing usages and outcomes. BACKGROUND: The appropriate use rate of coronary angiography and revascularization procedures in UA remains to be established. METHODS: A total of 791 consecutive patients with UA without previous acute myocardial infarction (AMI) admitted to four reference teaching hospitals (one with tertiary facilities) were followed for six months. End points were six-month mortality and readmission for AMI, UA, heart failure, or severe ventricular arrhythmias. RESULTS: Patients admitted to the tertiary hospital were 3.27 (95% confidence interval [CI] 2.32 to 4.62) times more likely to undergo coronary angiography after adjustment for comorbidity and severity than were those admitted to nontertiary facilities (overall six-month use rates 70.1% and 48.3%, respectively). Revascularization procedures were performed in 36.2% of patients in the tertiary hospital and 24.6% in the others (p = 0.0007); adjusted relative risk (RR) 2.37 (95% CI 1.55 to 3.63). Median delay for urgent coronary angiography was shorter in the tertiary hospital (24 h vs. 4 days, p < 0.0002). Six-month mortality and readmission rates were similar in tertiary and nontertiary hospitals: 3.9% versus 5.3% and 16.9% versus 21.2%, respectively. Adjusted RR of death or readmission for the nontertiary hospitals was 1.23 (95% CI 0.57 to 2.67). CONCLUSIONS: The use of coronary angiography and revascularization procedures in UA patients with no previous AMI is higher in tertiary than in nontertiary hospitals, but the more selective use of these procedures in nontertiary centers does not imply worse outcome.

Aged↗

Relationship of lipoprotein(a) levels to physical activity and family history of coronary heart disease.

OBJECTIVES: This study evaluated the association of physical activity with serum lipoprotein(a) [La(a)] levels in individuals according to whether they had a family history of coronary heart disease (CHD). METHODS: Lp(a) levels in 332 healthy Spanish men aged 20 to 60 years were measured. Physical activity and family history of CHD were assessed. RESULTS: For men with a family history of CHD, the odds ratio for Lp(a) levels above the median value was 0.13 (95% confidence interval = 0.03, 0.50) in very active men (energy expended in physical activity > 300 kcal/day) compared with active men (energy expended in physical activity < 300 kcal/day). CONCLUSIONS: Regular daily physical activity in individuals with a family history of CHD could be useful for controlling Lp(a) levels.

Adult↗

Postoperative analgesia for early extubation after cardiac surgery. A prospective, randomized trial.

BACKGROUND: Early extubation after cardiac surgery is a procedure recently gaining interest due to its ability to shorten intensive care unit and hospital stay and to limit the operation-related costs. Its use, however, raised new problems in terms of pain control in the early postoperative course, due to the need for limiting opioid analgesia. This study deals with non-opioid pain control after cardiac surgery and early extubation. METHODS: Prospective, randomized trial aimed to investigate the effectiveness of three intravenous analgesic drugs (ketorolac, 60 mg i.v.; propacetamol, 2 g i.v.; tramadol, 200 mg i.v.) for the management of postoperative pain in early extubated cardiac surgical patients. Each treatment group comprised 20 patients. RESULTS: The pain assessment (5-item verbal scale) demonstrated a significant (p < 0.05) lower value in patients treated with ketorolac vs propacetamol, while patients treated with tramadol did not significantly differ from the other two groups. There was a significantly (p < 0.05) higher rate of patients with severe pain in propacetamol group. Patients treated with tramadol had a significantly (p < 0.01) higher PaCO2 (48 +/- 6 mmHg) versus patients treated with ketorolac (43.4 +/- 3.7 mmHg) or propacetamol (42.9 +/- 3.4 mmHg). CONCLUSIONS: Tramadol and ketorolac seem to be the best options for treating postoperative pain in the specific setting of early extubation after cardiac surgery; high doses of tramadol may result in a significant even if clinically not relevant respiratory depression.

Analgesics↗

Mortality differences between men and women following first myocardial infarction. RESCATE Investigators. Recursos Empleados en el Síndrome Coronario Agudo y Tiempo de Espera.

CONTEXT: Mortality after acute myocardial infarction is worse in women than in men, even after adjustment for comorbidity and age dissimilarities between sexes. OBJECTIVE: To assess the influence of sex on survival after acute myocardial infarction. DESIGN: Inception cohort obtained in a prospective registry of patients with acute myocardial infarction from 1992 through 1994. SETTING: Four teaching hospitals in northeastern Spain. PATIENTS: All consecutive patients aged 80 years or younger with first acute myocardial infarction. A total of 331 women and 1129 men were included. MAIN OUTCOME MEASURE: Survival at 28 days and mortality or readmission at 6 months. RESULTS: Women were older (mean, 68.6 vs 60.1 years), presented more often with diabetes (52.9% vs 23.3%), hypertension (63.9% vs 42.3%), or previous angina (44.6% vs 37.4%), and developed more severe myocardial infarctions than men (acute pulmonary edema or cardiogenic shock occurred in 24.8% of women and 10.5% of men) (all P<.02). Men were more likely than women to receive thrombolytic therapy (41.3% vs 23.9%; P<.001), but rates of percutaneous transluminal angioplasty and coronary artery bypass graft surgery at 28 days were similar among men and women. The 28-day mortality rate was significantly higher among women (18.5% for women, 8.3% for men; P<.001). Revascularization procedures at 6 months were performed in a similar proportion of women and men. However, women had higher 6-month mortality rates (25.8% in women, 10.8% in men; P<.001) and readmission rates (23.3% for women, 12.2% for men; P<.001). After adjustment, women had greater risk of death than men at 28 days (odds ratio [OR], 1.72; 95% confidence interval [CI], 1.12-2.65) and at 6 months (OR, 1.73; 95% CI, 1.18-2.52). CONCLUSIONS: In this study population, women experienced more lethal and severe first acute myocardial infarction than men, regardless of comorbidity, age, or previous angina.

Aged↗

Platelet glycoprotein IIb/IIIa genetic polymorphism is associated with plasma fibrinogen levels in myocardial infarction patients. The REGICOR Investigators.

Fibrinogen is the major ligand of platelet glycoprotein IIb/IIIa platelet receptor. Genes coding for platelet fibrinogen receptor glycoprotein IIb/IIIa are polymorphic. The PLA alloantigen has two antigenic determinants, PLA1 and PLA2, located in a 17-23 kD fragment of glycoprotein IIIa. We analyzed whether PLA genotype has any effect on plasma fibrinogen concentration and investigated if the effect has different magnitude in myocardial infarction patients compared with subjects free of angina or myocardial infarction. One hundred sixteen consecutive patients who suffered a myocardial infarction and 136 subjects recruited by random sampling from the local census were included in the study. PLA genotype distribution and allele frequencies in patients did not significantly differ from those in the control group. Mean fibrinogen concentration tended to be higher in controls with genotype PLA1PLA1 than in those with genotype PLA1PLA2 or PLA2PLA2, and in patients this difference reached statistical significance (p < 0.001). We conclude that the PLA polymorphism may be in linkage disequilibrium with another functional mutation in or near the promoter area of the fibrinogen gene or even in another gene, which controls the production or the clearance of fibrinogen.

Chi-Square Distribution↗