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Biomedical subjects

M Costantini

Publications and source records attributed to M Costantini.

At least 55 records · Page 3Linked to original sources
PubMed1998

Gamma irradiation effects on poly(DL-lactictide-co-glycolide) microspheres.

Gamma radiation treatment plays an increasingly important role in the sterilization/sanitization of pharmaceutical products. However, irradiation may affect the stability of the product and thus its safety of use. We investigated the influence of ionizing radiation on modified release microparticulate drug delivery systems made of two types of polylactide-co-glycolide copolymers (PLG): RG 503 and RG 503H; these polymers have identical molecular weights but different chemical structures. The effect of gamma radiation on polymer stability of the raw polymers (P) and related microspheres (Ms) was evaluated. Samples were irradiated at different irradiation doses (5, 15 and 25 kGy) using 60Co as radiation source. The microspheres were prepared using the spray drying technique. Degradation of PLG and related microspheres was evaluated during six months in terms of average molecular weight (Mw) loss by gel permeation chromatography (GPC) and variation in glass transition temperature (Tg) using differential calorimetry (DSC). The presence of free radicals in the product was tested by electron paramagnetic resonance (EPR). Both P and Ms showed a trend in decreasing their Mw at time 0 as a function of irradiation dose. For RG503 the decay in Mw is always negligible for doses below 15 kGy while it is about 10% for 25 kGy. After 150 days Mw decay was 25% in the microspheres and 20% in the raw polymer. It was not possible to evaluate the radiation effect, at different storage times, for RG503H because this polymer resulted to be unstable even in the regular storage conditions without being irradiated. The concentration of radiation-induced free radicals was higher in RG 503H (both P and Ms) and they were more stable than the free radicals species observed in the case of polymer RG 503. Alterations and/or production of new radicals were observed on exposure of RG 503H microspheres to the light. Radiolytic degradation of RG 503 under vacuum is characterized by a prevalence of the chain scission events leading to a decrease of Mw. Some crosslinking can occur mainly in the post irradiation stage through the decay and coupling of the hydrogen abstraction radicals. A hydroperoxydative cycle, whose mechanism is suggested, is generated in the presence of oxygen.

Biocompatible Materials↗
PubMed1998

Radiological evidence of subclinical dysphagia in motor neuron disease.

Dysphagia in motor neuron disease (MND) may lead to dangerous complications such as cachexia and aspiration pneumonia. Functional evaluation of the oropharyngeal tract is crucial for identifying specific swallowing dysfunctions and planning appropriate rehabilitation. As part of a multidisciplinary study on the treatment of dysphagia in patients with neuromuscular diseases, 23 MND patients with different degrees of dysphagia underwent videofluoroscopy, videopharyngolaryngoscopy and pharyngo-oesophageal manometry. The results of the three instrumental investigations were analysed in order (1) to define the pattern of swallowing in MND patients complaining of dysphagia; (2) to evaluate whether subclinical abnormalities may be detected; and (3) to assess the role of videofluoroscopy, videopharyngolaryngoscopy and manometry in the evaluation of MND patients with deglutition problems. Correlations between the instrumental findings and clinical features (age of the patients, duration and severity of the disease, presence and degree of dysphagia) were also assessed. The results of our study showed that: (1) The oral phase of deglutition was compromised most often, followed by the pharyngeal phase. (2) In all patients without clinical evidence of dysphagia, subclinical videofluoroscopic alterations were present in a pattern similar to that found in the dysphagic group. (3) Videofluoroscopy was the most sensitive technique in identifying oropharyngeal alterations of swallowing. Impairment of the oral phase, abnormal pharyngo-oesophageal motility and incomplete relaxation of the upper oesophageal sphincter were the changes most sensitive in detecting dysphagia. Videofluoroscopy was also capable of detecting preclinical abnormalities in non-dysphagic patients who later developed dysphagia. Practical guidelines for the use of instrumental investigations in the assessment and management of dysphagia in MND patients are proposed.

Adult↗
PubMed1998

Quality-of-life evaluation: when do terminal cancer patients and health-care providers agree?

A multicenter study involving six palliative care units in Italy was carried out on 159 terminal cancer patients seen at home or in hospital. The physician or the nurse completed independently from the patient the Therapy Impact Questionnaire (TIQ), a questionnaire devised for quality-of-life evaluation in terminal cancer patients. The patient's assessment was used as the valid reference measurement to compare with the health-care workers' evaluation to assess the validity of the latter. The results showed that percentages of agreement were higher for physical than for psychological and cognitive symptoms, and that there was a greater agreement on the absence rather than on the presence of a problem. None of the characteristics of the patient nor of the proxy showed any statistically significant relationship with the two disagreement indexes. The results suggest that caution is needed in the use of health-care workers as alternative sources of information regarding patients' quality of life.

Evaluation Studies as Topic↗
PubMed1998

Is euthyroidism the goal of surgical treatment of diffuse toxic goitre?

OBJECTIVE: To find out by studying a homogeneous group of patients whether euthyroidism is achievable by surgical treatment of diffuse toxic goitre. DESIGN: Retrospective study. SETTING: Teaching hospital, Italy. SUBJECTS: 128 of the 152 patients operated on for diffuse toxic goitre during the period January 1971-December 1994 and followed up for a median of 83 months (range 6-289). INTERVENTION. Standard subtotal thyroidectomy. MAIN OUTCOME MEASURES: Operative mortality, recurrence, hypothyroidism and late complications. RESULTS: There were no operative deaths. After 10 years follow up, 11 patients (9%) had developed recurrences and 61 (48%) were euthyroid. In the univariate analysis the risk of hypothyroidism was significantly associated with the year of operation (p = 0.04), the duration of symptoms (p < 0.01), and the degree of lymphocytic infiltration (p < 0.01). The last two were confirmed by multivariate analysis. CONCLUSION: Subtotal thyroidectomy seems to be an effective treatment of diffuse toxic goitre as a stable euthyroid state can be achieved in nearly half the patients after a prolonged follow up.

Adolescent↗
PubMed1998

Normal esophageal body function: a study using ambulatory esophageal manometry.

OBJECTIVE: The objective of this study was to establish normative ambulatory manometric data for contractions and contraction propagation in three levels of the esophagus. METHODS: Twenty-five healthy volunteers underwent simultaneous ambulatory 24 h manometry. Concomitant 24 h pH studies were performed to exclude the presence of increased esophageal acid exposure. Pressures were recorded over a complete circadian cycle while patients continued with their normal lifestyles including eating and sleeping. Data were analyzed with a software program that was previously modified and validated and that enables quantitation of contractions in terms of efficacy. RESULTS: The frequency of contractions was lowest during sleep, was increased when awake, and was highest during meals. Contraction amplitude increased during meals, providing a greater propulsive force for bolus transport. Similarly, the prevalence of peristaltic waves varied according to different physiologic states, ie., while eating, upright, awake, and sleeping. An increased amplitude and prevalence of peristalsis resulted in an increase in manometric efficacy during meals. CONCLUSIONS: This study provides normative data for ambulatory manometry for comparison when studying patients with disease.

Adult↗
PubMed1998

[Not Available].

Explore the source record for details and available documents.

Europe↗
PubMed1997

Cohort study of association of risk of breast cancer with cyst type in women with gross cystic disease of the breast.

OBJECTIVE: To assess correlation between type of breast cyst and risk of breast cancer in women with gross cystic disease of the breast. DESIGN: Cohort study of women with breast cysts aspirated between 1983 and 1993 who were followed up until December 1994 for occurrence of breast cancer. SETTING: Major cancer prevention centre. SUBJECTS: 802 women with aspirated breast cysts. MAIN OUTCOME MEASURES: Type of breast cyst based on cationic content of cyst fluid: type I (potassium:sodium ratio > 1.5), type II (potassium:sodium ratio < 1.5), or mixed (both types). Subsequent occurrence and type of breast cancer. RESULTS: After median follow up of six years (range 2-12 years) 15 cases of invasive breast cancer and two ductal carcinomas in situ were diagnosed in the cohort: 12 invasive cancers (and two carcinomas in situ) among the 417 women with type I cysts, two cancers among the 325 women with type II cysts, and one among the 60 women with mixed cysts. The incidence of breast cancer in women with type I cysts was significantly higher than that in women with type II cysts (relative risk 4.62 (95% confidence interval 1.26 to 29.7)). These results were confirmed after adjustment for several risk factors for breast cancer (relative risk 4.24 (1.12 to 27.5)). CONCLUSIONS: The increased risk of breast cancer of women with breast cysts seems to be concentrated among women with type I breast cysts.

Adult↗
PubMed1997

Illness awareness in cancer patients: a conceptual framework and a preliminary classification hypothesis.

The study describes the initial phases of research aimed at developing a methodology for assessing awareness in cancer patients. A first sample of cancer patients (n = 36) was interviewed about their knowledge of the diagnosis and their perception of treatment goals and outcomes. Thirteen domains which refer both to cognitive and emotional areas were identified, and considered as content valid by a panel of six experts. A second sample of patients (n = 54) participated in a semi-structured interview developed to explore awareness by means of the domains identified. Seven patterns of awareness were identified, ranging from 'completely aware patient' to 'completely unaware patient'. Twenty of the 54 patients (37.0%) were completely aware, 19 (35.2%) were partially aware with defence mechanisms and 15 (27.8%) were not aware of their diagnosis. Patients from the National Cancer Institute were more frequently aware (54.3%) compared with the patients interviewed in the community hospitals (5.3%) (p < 0.001). A computerized content analysis allowed the identification of two main groups of patients on the basis of the content of the recorded interviews. This independent classification agreed with the classification of the patients performed by the psychologists, suggesting the validity of the procedure of awareness evaluation proposed in this study.

Adaptation, Psychological↗
PubMed1997

One-year follow-up after laparoscopic Heller-Dor operation for esophageal achalasia.

BACKGROUND: The Heller-Dor operation has recently been proposed for the treatment of esophageal achalasia even via a laparoscopic approach. METHODS: To measure the medium-term effectiveness of this new minimally invasive technique, an evaluation of pre- and postoperative symptoms, esophagogram, endoscopic findings, esophageal manometry, and pH monitoring was prospectively designed in 43 patients with primary esophageal achalasia. The mean clinical follow-up for all the patients is 12 months (range 3-43), while the mean radiological follow-up is 11 months (range 1-23). Endoscopic data 1 year after surgery are currently available for 27 patients (63%), whereas a 12-month (range 1-26) functional follow-up (including manometric and pH-monitoring studies of the esophagus) is currently available for 35 patients (81.4%). RESULTS: No dysphagia was reported in 38 cases (88.4%); two (4.6%) complained of occasional swallowing discomfort which regressed spontaneously; two (4.6%) had persistent dysphagia which regressed with pneumatic dilatation. One patient (2.8%) reported mild occasional dysphagia after a 1-year asymptomatic period. Preoperatively, esophagograms showed an average maximum diameter of 40.6 +/- 9.1 mm which decreased to 24.1 +/- 6.0 mm after operation. Mean lower esophageal sphincter (LES) resting and residual pressures decreased significantly from 28.6 +/- 10.7 mmHg to 8.8 +/- 4.1 mmHg and from 17.0 +/- 9.7 mmHg to 4.7 +/- 4.0 mmHg, respectively (p < 0.0001). These effects on esophageal diameter and LES function seem to persist over time. The complete absence of any peristaltic contractions recorded preoperatively in all cases remained unchanged after surgery in all but four patients. However, this rare recovery of peristalsis proved to be transient, and patients revealed a manometric impairment of their esophageal body function, but without complaining of dysphagia. Twenty-four-hour pH monitoring showed abnormal gastroesophageal reflux episodes in two (5.7%) of the 35 patients who were monitored: one was asymptomatic; the other had heartburn and endoscopically demonstrated grade II esophagitis. CONCLUSIONS: Laparoscopic Heller-Dor operation achieves excellent medium-term results which, together with the already-demonstrated advantages of a minimal surgical trauma and rapid convalescence, validate the use of such a minimally invasive approach to treat patients with primary achalasia of the esophagus.

Adolescent↗
PubMed1997

Distal hyperplastic polyps do not predict proximal adenomas: results from a multicentric study of colorectal adenomas.

BACKGROUND: The association between distal hyperplastic polyps and proximal adenomas is still a matter of debate. We investigated this association while taking into account patient characteristics. METHODS: After exclusion of patients with inflammatory bowel diseases, familial adenomatous polyposis, or any cancer, 3088 eligible consecutive subjects aged 18 to 69 years underwent total colonoscopy in four gastroenterology units. The odds ratios (OR) of having proximal adenomas according to patient characteristics (age, sex, medical center, year of endoscopy, reasons for referral, and distal findings) were estimated in univariate and multivariate analyses. RESULTS: Patients with distal polyps of any type showed an adjusted OR of 2.5 (95% CI [1.9, 3.1] p < .001) of having proximal adenomas as compared with those without distal polyps. When distal adenomas and distal hyperplastic polyps were included in the multivariate model as independent factors, the presence of adenomas significantly increased the risk of proximal adenomas (OR = 2.8: 95% CI [2.2, 3.6] p < .001), whereas the presence of hyperplastic polyps did not (OR = 1.1: 95% CI [0.8, 1.5] p = .64). No association with number, size, or location of distal hyperplastic polyps was seen. CONCLUSIONS: Our data show that the presence of hyperplastic polyps should not be the sole indication for total colonoscopy because they are not associated with proximal adenomas when adjusting for patient characteristics and presence of distal adenomas.

Adenoma↗
PubMed1997

A retrospective comparison of detection and treatment of breast cancer in young and elderly patients.

The medical records of all women (297 cases) with breast cancer > or = 70 years of age, presenting at our Institute from January 1980 to December 1989, were reviewed. Data from 226 elderly women was compared to that from 100 stage-matched patients < 50 years of age, presenting during the same 10-year study interval. Conservative surgery was significantly more frequent in young patients (71.1%) compared to elderly women (26.1%) and radical mastectomy according to Halsted was undertaken in 34.3% of the elderly group compared to 8.9% of young patients (p < 0.001). Since 'incidental' diagnosis was significantly more frequent in the elderly group (59.9% versus 6.0%) (p < 0.001), primary care physicians may play an important role in the early diagnosis of breast cancer in the majority of elderly women.

Adult↗
PubMed1997

Quality of life assessment and clinical decision-making.

Survival and quality of life are the two end-points of cancer treatment. Recommendations are available as to how quality of life should be assessed in clinical studies in order for quantitative scores to be provided for it, along with survival data. The two measurements can be combined, and their total should yield a definition of the state of the art in cancer treatment with respect to both the quantity and the quality of life. However, at the individual level, quality of life can be traded off against survival only by taking into account the patient's attitude toward risk. More importantly, the quality of health status may be valued in a completely different way from patient to patient. Thus, when a clinical choice is to be made from among different treatment options, the ethical principle of respect for the patient's autonomy would require that the patient be informed of their possible respective outcomes, and allowed to provide his/her own assessment of the quality of life associated with these outcomes. This might have consequences for quality of life assessment in clinical studies, which should not only quantify average scores for treatment comparisons, but also provide a 'health state description' with respect to the aftermath of each of the treatment options. These data could be formalized in the already proposed decision instruments incorporating clinical scenarios for patient information. In any case, this should allow individualized clinical decisions incorporating each patient's preferences for the quality of his/her expected life span. Providing average quality of life scores may be useful, indeed, for population-based health decisions, as are those on resource allocation and those on registration of new drugs.

Clinical Medicine↗
PubMed1997

Esophageal motor function in primary Sjögren's syndrome: correlation with dysphagia and xerostomia.

The incidence of dysphagia in patients with primary Sjogren's syndrome (pSS) has been underestimated and all too often ascribed to xerostomia, without considering the possible presence of esophageal motor abnormalities affecting other nonscleroderma connective tissue diseases. Esophageal and salivary functions were prospectively evaluated in 27 females who met the four criteria proposed by Fox for the diagnosis of pSS, using esophageal manometry after wet swallows and Saxon's test, respectively. Dysphagia was graded using a standard symptoms questionnaire and results were compared with those obtained in a group of 21 healthy controls. Seven patients with pSS (26%) had no swallowing discomfort, 2 (7.4%) had mild dysphagia, 7 (26%) had moderate dysphagia, and 11 (40.6%) had severe dysphagia. Saxon's test revealed an overall decrease in the salivary flow rate compared to controls, with no difference between patients with or without dysphagia. Esophageal manometry demonstrated the absence of any lower or upper esophageal sphincter function abnormalities in all patients. In the patients with pSS as a whole, manometric study of the esophageal body showed a motor pattern comparable with that of controls, with no difference between patients with and without dysphagia. Defective peristalsis, ie, the presence of simultaneous contractions in more than 30% of wet swallows was detected, however, in the distal tract of the esophagus of six patients (22.2%) and in the proximal tract of three (11.1%). All these patients had severe dysphagia and the modified Saxon's test revealed a salivary secretion comparable with that of patients with a normal peristalsis. Dysphagia is a very common complaint in patients with pSS and does not seem to correlate with xerostomia, which is a constant and typical finding of the disease. About one third of patients with pSS have an abnormal esophageal peristalsis that is responsible for severe dysphagia, whereas decreased salivary outflow exacerbates the swallowing discomfort. This has to be taken into account and justifies the routine use of esophageal manometry in patients with pSS. The cause of dysphagia in pSS patients without peristaltic disorders of the esophagus has to be investigated.

Adult↗
PubMed1997

Cost-effectiveness of autologous bone marrow transplantation in patients with relapsed non-Hodgkin's lymphoma.

The analysis of published survival curves can be used as the basis for conducting cost-effectiveness analyses in which two treatments are compared in terms of cost per life year saved. In patients with relapsed chemosensitive non-Hodgkin's lymphoma, autologous bone marrow transplantation (ABMT) has been reported to improve survival in comparison with control patients who receive standard chemotherapy. An incremental cost-effectiveness analysis was undertaken in which the Gompertz model was used to determine a lifetime estimate of patient-years gained by subjects given ABMT in comparison with controls. Our study utilised the cost data calculated by Uyl-de Groot et al and the clinical data reported by Philip et al. This latter randomised clinical trial involved 55 patients subjected to ABMT and 54 controls given chemotherapy. Lifetime survival advantage for patients of the ABMT group was estimated as 3606 discounted patient-months every 100 patients. The use of ABMT as opposed to standard chemotherapy was found to imply an incremental cost of $9,229 per discounted life year gained (95% CI of $5,390 to $24,012). The cost-effectiveness ratio of ABMT in patients with relapsed chemosensitive non-Hodgkin's lymphoma is noticeably favourable.

Bone Marrow Transplantation↗
PubMed1997

Randomized phase III trial evaluating the role of erythropoietin in the prevention of chemotherapy-induced anemia.

PURPOSE: Although erythropoietin (EPO) is known to be useful in treating chemotherapy-induced anemia, few data are available on its potential preventive role. The aim of this study was to evaluate the ability of EPO in preventing the development of clinically significant anemia in patients treated with chemotherapy. PATIENTS AND METHODS: Sixty-two early-stage breast cancer patients undergoing accelerated adjuvant chemotherapy were randomized to receive EPO 150 U/kg three times a week or no additional treatment. Chemotherapy consisted of six cycles of cyclophosphamide 600 mg/m2, epirubicin 60 mg/m2, and fluorouracil 600 mg/m2 (CEF) intravenously on day 1, every 2 weeks with the support of granulocyte colony-stimulating factor (G-CSF), 5 microg/kg subcutaneously from day 4 to day 11. RESULTS: Throughout the six cycles of chemotherapy, EPO-treated patients maintained stable values of hemoglobin, whereas control patients developed a progressive anemia. At the end of chemotherapy, the mean (+/- SD) hemoglobin decrease in the control group was 3.05 g/dL (+/- 1.0; 95% confidence interval [CI], 2.6 to 3.5), whereas in the EPO group it was 0.8 (+/- 1.4; 95% CI, 0.3 to 1.4). Clinically significant anemia (hemoglobin < or = 10 g/dL) occurred in 16 patients (52%; 95% CI, 33 to 69) in the control arm and in no patient (0%; 95% CI, 0 to 14) in the EPO arm (P = .00001). CONCLUSION: EPO prevents anemia in patients undergoing chemotherapy. Further trials are required to identify subsets of patients in which the preventive use of this drug could be cost-effective.

Adult↗
PubMed1997

[Evaluation of quality of life in oncology. Rationale and objectives of the first phase of the Quality of Life in Oncology project].

Although the subjective nature of quality of life perception is generally accepted, less attention has been paid to the procedure of selecting domains to be explored with questionnaires. In most cases domains are selected by panel of experts. It is not known whether these domains are relevant for the patients. Moreover, questionnaires developed in 'foreign' countries may not be culturally sound or relevant for patients living in different cultural background. In order to explore what really contributes to quality of life of Italian patients, a survey was conducted with the aim of identifying any dimension of quality of life, positively or negatively impacted on from the illness and therapies. A sample of two hundred and eighty eight cancer patients with previously specified characteristics (primary tumor, stage of disease and place of residence) were identified. After consenting to partecipate to the study, a staff member (a physician, a nurse or a psychologist) asked the patient to complete an open-ended questionnaire in the out-patient clinic or at home. This questionnaire, partially derived from a study by Padilla et al. made up of 5 questions: 'What does the term quality of life mean to you?', 'What contributes to a good quality of life?', 'What contributes to a poor or bad quality of life?', 'Which either physical or psychological symptom interferes with your quality of life?', 'State any positive or negative change in your quality of life, due to illness or treatments'. The first question was asked to explore the meaning of quality of life for the patient; the second and third question were asked to determine the contents of quality of life not health related; the fourth question and the diary provided information about quality of life contents related to his own experience of disease. Two hundred and forty eight questionnaires (86.1%) were obtained from 7 Cancer Centres participating to the study (Genova, Milano, Roma, Perugia, Napoli, Cagliari, Palermo). All the questionnaires were transcribed and subsequently broken down in phrases on a form that allowed coding. Three raters (a research nurse, an oncologist and a clinical psychologist) made the content analysis using as conceptual framework the list of domains identified by the Italian Society of Psycho-Oncology. The present study shows the possibility to define the content domain of quality of life attributes for cancer patients, using patients as experts.

Adolescent↗