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Biomedical subjects

L Mantovani

Publications and source records attributed to L Mantovani.

At least 19 recordsLinked to original sources

Cost-effectiveness of different diagnostic strategies to assess gastro-oesophageal reflux disease in patients with unexplained chronic persistent cough in Italy.

BACKGROUND: Chronic persistent cough is a common and disabling disorder and gastro-oesophageal reflux disease is considered to be the third leading cause, after asthma and postnasal drip. Therefore, patients with unexplained chronic persistent cough usually undergo a stepwise evaluation to establish the existence of a reflux disease. AIM: To identify the most cost-effective diagnostic approach to assess gastro-oesophageal reflux disease in patients with unexplained chronic persistent cough. METHODS: Direct and indirect costs associated with six diagnostic strategies using 24-h oesophageal pH-metry, oesophago-gastroduodenoscopy and the proton pump inhibitors test in different sequences, were evaluated using a decision tree model. If the first test was positive, the diagnostic work-up was stopped, if negative the patient proceeded to the second test, and so on. Clinical data from an observational prospective trial conducted in 51 patients with unexplained chronic persistent cough were used in the economic model. RESULTS: All six strategies had the same clinical effectiveness (78.4%). The diagnostic work-up with the lowest cost was the proton pump inhibitors test followed by pH-metry and then oesophago-gastroduodenoscopy with a total cost of euro 211.08 (direct euro 142.93, indirect euro 68.15). CONCLUSIONS: This study shows that the lowest cost is the strategy where proton pump inhibitors test is performed as first investigation. Implementation of this diagnostic work-up may lead to cost savings in the management of patients with chronic persistent cough.

Chronic Disease↗

Quality of life assessment in clinical practice in haemophilia treatment.

The modern management of haemophilia has greatly influenced not only survival of patients, their clinical symptoms and orthopaedic outcome but also their perceived quality of life (QoL). QoL measures recently became an essential part of clinical trials being one of the most important patient-rated outcomes (PROs). Moreover, QoL assessment is essential in pharmacoeconomics. In clinical trials, not only clinical outcomes but also the so-called PROs and health-economic outcomes are included. Different types of economic evaluations may be conducted in order to describe the economic burden of a disease condition, to determine the cost of care and to assess and evaluate alternative treatments in terms of both costs and effects as well as benefits and outcomes with the aim of optimizing the use of resources. For these evaluations, the following analyses are performed: descriptive cost of illness study, incremental cost-effectiveness analysis, incremental cost-utility analysis and incremental cost-benefit analysis. By contrast, PROs are derived from direct patient reports and they allow to evaluate the impact of a disease and its treatment on patients' well-being and functioning. PROs include health-related quality of life, patient preferences/utilities, treatment satisfaction and other PROs such as functional assessment, etc. Choosing a QoL measure, study- and instrument-related aspects have to be taken into account. Finally, QoL assessment will become a part of the regular clinical assessment of persons with haemophilia, in order to provide trustworthy data of perceived well-being to be compared over time and in order to assess treatment efficacy and quality of care.

Adult↗

Current European practice in immune tolerance induction therapy in patients with haemophilia and inhibitors.

The management of patients with inhibitors is an important challenge in haemophilia care. The lack of randomized controlled trials means that clinical decisions are generally based on subjective opinions, and purchasers' attention is likely to focus on the costs of treatment. In order to assess the current management of inhibitor patients and use of immune tolerance induction therapy (ITI) in Europe, we performed a survey within a European network of 21 comprehensive care centres from 14 countries (the European Haemophilia Therapy Standardisation Board). The survey identified a total of 381 patients with inhibitors attending the centres, 211 (55.4%) of whom had never been exposed to ITI. Between 1998 and 2003, the centres performed 233 procedures and 114 (48.9%) were successful. The survey demonstrated that dosing, which is the time to start and stop the ITI, the type of concentrate to use and the definition of success varied among the centres. Well-designed trials are warranted to guide decision-making, but in the absence of these studies we have developed consensus guidance for the management of inhibitor patients based on current clinical practice, as identified by the survey, and review of the literature.

Adult↗

Anesthesiological management and outcome of 100 ''beating heart'' coronary artery bypass grafting.

AIM: The aim of this paper is to describe the anesthesiological management and the outcome of beating heart revascularization. METHODS: A prospective study has been performed in a tertiary teaching hospital on 100 consecutive patients undergoing off-pump coronary artery revascularization. The main features of anesthetic technique are the maintenance hemodynamic stability and atrial kick. RESULTS: Mechanical stabilisers shunts have improved the management of these patients. In hospital mortality was 1%, acute myocardial infarction 3%, low output syndrome 2%, atrial fibrillation 16%. Only 2% of patients had acute renal failure, but no patient needed renal replacement treatment. No neurologic event was noted. Only 19% of patients received blood transfusion. Ninety-seven % of patients were extubated within 12 h. CONCLUSIONS: The application of this anesthetic strategy combined with surgical skillful and new devices makes off-pump surgery safe also in high risk patients.

Aged↗

Multicentre randomised phase III study comparing the same dose and schedule of cisplatin plus the same schedule of vinorelbine or gemcitabine in advanced non-small cell lung cancer.

This study compares two cytotoxic regimens comprising the same dose and schedule of cisplatin (CP) plus vinorelbine (VNR) or gemcitabine (GEM) administered under the same schedule to patients with advanced non-small cell lung cancers (NSCLC). From April 1998 to February 2003, 285 patients were randomised to receive either VNR 25 mg/m(2) on days 1 and 8 as an intravenous (i.v.) bolus plus CP 75 mg/m(2) on day 1 (regimen A) or GEM 1200 mg/m(2) on days 1 and 8 as an i.v. 30-min infusion plus CP 75 mg/m(2) on day 1 (regimen B). Both treatments were recycled every 21 days. If no progression had occurred after six cycles, the patients continued to receive VNR or GEM monochemotherapy weekly. Cross-over of the two single agents was considered if disease progression occurred. Objective response (OR), time to progression (TTP) and overall survival (OS) were analysed according to the intention-to-treat principle. 272 patients were ultimately eligible (137 on A and 135 on B). Their main characteristics were: male/female ratio 214/58; median age 63 (range 32-77) years; median Karnofsky Performance Status (PS) 80 (range 70-100); stage IIIB 34%, stage IV 61%, recurrent disease 5%; histology - epidermoid 29%, adenocarcinoma 53%, other NSCLC 18%. The characteristics of the patients in the two arms were well matched. The following response rates were observed in regimens A and B, respectively: complete response (CR) 0.7% and 3.7%, partial response (PR) 31.9% and 22.2% (P = 0.321). Median CR+PR duration was 8 months in both arms. Clinical benefit represented by an improvement in symptoms was evident in 25.7% and 28.1%, respectively. Median TTP was 5 months in both arms and median OS 11 months in both arms. Grade III-IV neutropenia occurred in 30.7% and 17.7% of the patients in arms A and B, respectively (P = 0.017); thrombocytopenia occurred in 0% and 9.3% (P = 0.004), respectively. No difference in the incidence of anaemia was observed. Non-haematological toxicity was generally mild: a higher incidence of grade 1-2 peripheral neurotoxicity and grade 1-2 local toxicity with regimen A and grade 1-2 liver toxicity with regimen B was reported. A pharmaco-economic comparison showed a difference between the two doublets, principally due to the different costs of VNR and GEM. Under the study conditions the combination of VNR or GEM with the same dose and schedule of CP produced similar OR, clinical benefits, TTP and OS in advanced NSCLC, and only mild toxicological differences were observed. Pharmaco-economic evaluation favoured the CP + VNR doublet.

Adult↗

A comparative study of Endoflare-Hero Shaper and Mtwo NiTi instruments in the preparation of curved root canals.

AIM: To analyse the shaping ability of two new NiTi rotary systems in molar curved canals. METHODOLOGY: Thirty molar root canals with curvatures from 24 degrees to 69 degrees were divided into two groups that were balanced in terms of curvature. The canals in one group were shaped using the Mtwo (Sweden & Martina, Padova, Italy) and the canals in the other group using the Endoflare-Hero Shaper (Micro-Mega, Besançon, France) in a modified sequence. Pre- and post-instrumentation X-rays were taken using a radiographic platform, with a contrast medium being used to enhance canal opacity. The dentine removed at five positions along the canals, the symmetry of canal shaping and the presence of aberrations were analysed through computer-aided measurements. The instrument failures, the working time and the changes in working length were also recorded. The Mann-Whitney U-test was used for statistical analyses. RESULTS: Both systems produced uniform dentine removal and symmetrical canal shapes; there was no significant difference between the systems (P > 0.05). In the apical region, preparations were centred in the canal. A mean loss of working length of 0.55 mm for Mtwo and 0.58 mm for Endoflare-Hero Shaper was detected, with no significant differences between the instruments (P > 0.05). No aberrations were seen and no instruments separated. The mean working time was 124.4 s for the Mtwo system and 141.3 s for the Endoflare-Hero Shaper but this difference was not statistically significant (P > 0.05). CONCLUSION: The systems tested in this study were effective in shaping curved canals in extracted teeth.

Dental Alloys↗

Non-HDL cholesterol predicts coronary heart disease in primary prevention: findings from an Italian 40-69 year-old cohort in general practice.

OBJECTS: Non-HDL cholesterol is now recommended as an index of risk associated with combined dyslipidemia, and it has also been found useful in predicting coronary heart disease (CHD) risk in patients with diabetes. We studied the association between known CHD risk factors, enclosed non-HDL cholesterol, and a "high CHD risk condition", i.e. a "5-years CHD risk >15%" in general practice. METHODS: We studied 4,085 40-69 year-old diabetic (no. 489) and non-diabetic (no. 3,596) individuals from an opportunistic cohort. Cross-sectional descriptive statistics, and age- and gender-adjusted multiple logistic exponential betas have been calculated. RESULTS: About 12% of the participants had diabetes. Age- and gender-adjusted comparison showed that all the study variables were significantly worse in diabetic vs. non-diabetic individuals (except cigarette smoking, total blood cholesterol and the ratio of total to HDL cholesterol). They had a mean "5-year CHD-risk" significantly higher than non-diabetic individuals (18.8+/-11.9% vs 7.5+/-6.9%, P<0.01), and a four-fold prevalence of "5-years CHD risk >15%" (55.4% vs 11.1%, P<0.01). As to diabetic individuals, the study variables associated to a "high CHD risk condition" were cigarette smoking, systolic blood pressure, and non-HDL blood cholesterol levels. As to non-diabetic individuals cigarette smoking, systolic blood pressure, and HDL (inversely) and non-HDL blood cholesterol levels were associated to a "high CHD risk condition". CONCLUSIONS: Non-HDL cholesterol--and cigarette smoking and systolic blood pressure--strongly predicted a "high CHD risk condition" both in diabetic and non-diabetic individuals.

Adult↗

Combined skin prick and patch testing enhances identification of peanut-allergic patients with atopic dermatitis.

BACKGROUND: Food atopy patch tests (APTs) are considered a useful tool for the diagnosis of food allergy. Hypersensitivity to peanuts has not been investigated by means of APTs so far. METHODS: APTs and skin prick tests (SPTs) with peanuts were performed in 136 atopic dermatitis (AD) patients. Relevance of positive and negative responses to these tests was assessed by repeated open challenges with peanuts. RESULTS: Nine percent of our AD patients reacted to the challenge. Positive responses to APTs were recorded in 19% of the patients, whereas in 12% positive SPTs were observed. APTs were more frequently positive in subjects with eczematous responses after challenge with respect to those with urticarial reactions. SPT reactivity proved to be higher in patients above 12 years of age, whereas APT positivity was more frequent in children under 6 years. APT sensitivity proved significantly higher than SPT sensitivity, in particular in children under 12 years of age. On the contrary, SPT specificity and positive predictive value were significantly higher with respect to those of APT in the age group of subjects under 6 years of age. CONCLUSIONS: Our data suggest that APTs with peanuts may represent a useful integration to standard testing modalities employed for the diagnosis of peanut allergy in AD patients.

Adolescent↗

Sensitization to disperse dyes in a patch test population over a five-year period.

BACKGROUND: In spite of sporadic data pointing at the role of textile dyes as important contact allergens, only few studies have addressed the issue of the frequency of sensitization to textile dyes in populations of consecutive patients. OBJECTIVE: The purpose of this study was to evaluate the prevalence of sensitization to disperse dyes, to investigate cross reactivity between azo dyes and para-amino compounds, to describe azo-dye-positive patients, and to study the correlation between clinical aspects and sensitization to different disperse dyes. METHODS: From January 1996 to December 2000, 6,478 consecutive patients were tested with 7 textile dyes: Disperse Blue 124, Disperse Blue 106, Disperse Red 1, Disperse Yellow 3, Disperse Orange 3 (DO3), para-aminoazobenzene (PAAB), and para-dimethylaminoazobenzene (PDAAB). RESULTS: Of the above, 437 patients were allergic. The most common sensitizers were Disperse Blue (DB) dyes and Disperse Orange 3. Both the clinical aspect and the localization of the lesions were unusual in a fair percentage of cases, especially in DB-positive subjects. Involvement of skin folds was observed in 27% of disperse dye-positive patients, mainly comprising DB-sensitive women. Cross-reactivity between azo-dyes and paraphenylenediamine (PPD) was frequent in DO3-, PAAB-, and PDAAB-positive subjects, but not in DB-allergic ones. Moreover, cross reactions between DB106 and DB124 were observed in 59% of DB106- and/or DB124-positive patients. CONCLUSIONS: The frequency of disperse dye allergy is higher than generally estimated. Further studies, using routine diagnostic testing with disperse dyes, are needed to investigate whether this increasing trend is present outside of Europe.

Adult↗

Velocity magnitude estimation with linear arrays using Doppler bandwidth.

The dependence of pulsed wave Doppler bandwidth on parameters typical of linear transducer arrays used in commercial Duplex and color flow mapping systems is investigated experimentally. For a single flow line it is observed that this bandwidth generally depends not only on the scatterer velocity and the beam-to-flow angle, but also on the flow line range and orientation. This is due to the fact that in Duplex and color flow systems the transducer is differently focused in the scan and elevation planes and its aperture and focal lengths are often made to vary, depending on the distance of the flow line from the transducer. It is however experimentally demonstrated that, at points where the ultrasound beamwidths in the scan and elevation planes are both comparable to the sample volume length, the Doppler bandwidth is independent of the beam-to-flow angle. It is also shown that this invariance can be extended to other ranges by appropriately modifying the array aperture. Finally, as an application of this independence, the flow-line velocity magnitude in these beam regions is estimated with better than 5% uncertainty through a simple bandwidth measurement.

Ultrasonics↗

Treatment of anaemia in myelodysplastic syndromes with prolonged administration of recombinant human granulocyte colony-stimulating factor and erythropoietin.

Treatment with recombinant human erythropoietin (rhEPO) improves anaemia in approximately 20% of the patients with myelodysplastic syndromes (MDS). Recent reports suggest that a combination treatment with rhEPO plus recombinant human granulocyte colony-stimulating factor (rhG-CSF) given for up to 18 weeks may result in a higher erythroid response rate than with rhEPO alone. We investigated the potential advantage of an even more prolonged schedule of combined rhG-CSF and rhEPO treatment to obtain and maintain stable responses. In a phase II study, 33 patients with MDS [17 with refractory anaemia (RA), eight with RA with ringed sideroblasts (RARS), eight with RA with excess blasts (RAEB) with bone marrow blast counts less than 20%] were scheduled to receive at least 36 weeks of combined therapy with rhG-CSF and rhEPO. Seventeen of 28 evaluable patients demonstrated an erythroid response [61%; 95% confidence interval (CI) 41-78] after 12 weeks of treatment. The erythroid response rate was 80% (20 of 25 evaluable patients; 95% CI 59-93) after 36 weeks. Seven of these responses developed between week 12 and week 36, whereas two initially responding patients became refractory. The cytokine therapy was generally well tolerated. Nineteen of the 20 patients responding after 36 weeks continued to be treated with both cytokines. After 1 year and 2 years of continuous combined treatment, 50% of the initially included patients showed a continuing response. Our results suggest that a prolonged combination treatment with rhG-CSF and rhEPO is highly effective in achieving a stable and long-lasting erythroid response in many patients with MDS and low blast count.

Adult↗

Baseline biophysical parameters in subjects with sensitive skin.

Sensitive skin has been described as a skin type showing higher reactivity than normal skin and developing exaggerated reactions when exposed to external factors. The stinging test, performed by applying lactic acid to the nasolabial fold and evaluating the intensity of subjective symptoms, is widely accepted as a marker of sensitivity and employed for the selection of subjects experiencing invisible cutaneous irritation. However, this test is based on self-perceived assessment and lacks objectivity. In order to contribute to the finding of objective descriptors, we assessed baseline biophysical parameters in subjects with sensitive skin by means of transepidermal water loss (TEWL), capacitance, pH, sebum and skin colour measurements, and compared the data with those obtained in normal subjects, also correlating the results with those of clinical assessments and functional tests. Subjects with sensitive skin showed a trend towards higher scores at all assessment times both for the stinging and the washing test. The skin of sensitive subjects was described as less supple, less hydrated and more erythematous and telangiectatic with respect to the skin of normal subjects. A trend towards an increase in TEWL, pH and colorimetric a* values, and a decrease in capacitance, sebum and colorimetric L* values on the face of subjects with sensitive skin was observable. However, significances were only present for capacitance and a* values. Thus, alterations of baseline capacitance values indicate the tendency to barrier impairment and support the view that skin hyperreactivity to water-soluble irritants is induced by a greater amount of irritants absorbed, whereas the increase in the erythema parameter shows that cutaneous vascular hyperreactivity in subjects with sensitive skin also corresponds to baseline vasodilation.

Adult↗

Cross-sensitizations between azo dyes and para-amino compound. A study of 236 azo-dye-sensitive subjects.

Combined sensitizations to different azo dyes, probably based both on true cross-sensitization and on simultaneous positive reactions, have frequently been described. However, since azo dyes are included in the standard series in a minority of countries, the case studies considered comprise, with few exceptions, a small number of subjects. The aim of our study was to investigate cross-reactions between different azo dyes and para-amino compounds in azo-dye-sensitive subjects, to study the clinical aspects of azo dye dermatitis, to assess the relevance of sensitization to azo dyes, and to relate the pattern of cross-sensitizations to the chemical structure of the different dyes. Out of 6203 consecutively tested patients, 236 were sensitized to at least 1 of 6 azo compounds employed as textile dyes, included in our standard series. 107 subjects reacted to Disperse Orange 3 (DO3), 104 to Disperse Blue 124 (DB124), 76 to p-aminoazobenzene (PAB), 67 to Disperse Red 1 (DR1), 42 to Disperse Yellow 3 (DY3), and 31 to p-dimethylaminoazobenzene (PDAAB). Co-sensitizations to para-phenylenediamine were present in most subjects sensitized to DO3 (66%) and PAAB (75%), in 27% and 36% of DR1 and DY3-sensitive subjects, and only in 16% of subjects sensitized to DB124. Apart from the hands and the face, the neck and the axillae were the most frequently involved skin sites. Whereas the involvement of flexural areas was mainly connected with sensitization to DB124, in patients with hand dermatitis and in those working as hairdressers, sensitization to DO3 and PAAB was more frequent. Moreover, in the former patient group, a history of textile dye allergy was most frequently obtained. Out of 33 patients tested with an additional textile dye series, only 5 subjects reacted to anthraquinone dyes. Cross-sensitizations between azo dyes and para-amino compounds can partially be explained on the basis of structural affinities.

Azo Compounds↗

Parallel intraindividual evaluation of the vasoconstrictory action and the anti-allergic activity of topical corticosteroids.

The human skin blanching assay is a well established method for ranking the efficacy of corticosteroids after epicutaneous application. Vasoconstriction is a pharmacological activity, which correlates well with the clinical efficacy, the intensity of skin blanching after a single application under occlusion corresponding, generally, to the clinical efficacy after repeated application without occlusion. However, in studies dealing with the comparison between the vasoconstriction assay and the evaluation of the clinical effects on inflammatory skin diseases, some exceptions to this correlation have been reported. Therefore, in a pre-clinical phase, it would be useful to combine the blanching assay with at least one anti-inflammatory assay. In the present study the blanching assay and the allergic contact dermatitis inhibition test were performed in parallel, in order to compare the two testing procedures in the same group of subjects, utilizing standardized study designs supported by objective means of evaluation. Three commercial preparations of corticosteroids containing clobetasol propionate (CP), clobetasone butyrate (CB) and hydrocortisone acetate (HA), respectively, were employed both to treat nickel-induced positive patch test responses on the volar forearms, and to perform a vasoconstrictor assay on normal forearm skin in 16 nickel-sensitized healthy volunteers. For evaluating skin blanching, we employed colorimetric measurements, whereas for the quantitative determination of the inhibition of the intensity of allergic patch test reactions, 20 MHz B-scanning supported by image analysis was used. Both colorimetric and echogenicity values enabled us to distinguish between the three corticosteroids (at the 17 h evaluation and the 64 h assessment, respectively). A fair correlation was noted between colorimetric and echogenicity values. Both testing procedures ranked the three corticosteroids in the expected order. Corticosteroid preparations should be compared using methods which allow different effects to be simultaneously monitored, without involving a high number of patients. We are proposing this double procedure for the parallel intraindividual evaluation of the vasoconstrictory action and the anti-allergic activity of topical steroids.

Administration, Topical↗