Biomedical subjects
Publications and source records attributed to A Messori.
SUMMARY: When Whipple disease (WD) is confined to the CNS, diagnosis may be difficult. We report a case of WD with spinal presentation in an otherwise healthy woman who had a 5-year history of relapsing-remitting cervico-thoracic myelopathy. We suggest that the diagnosis of WD should be considered in the presence of an enlarged and enhancing spinal cord even in the absence of any systemic involvement.
BACKGROUND AND OBJECTIVES: Although several studies have determined quality of life (QOL) in patients with hemophilia, generic questionnaires have rarely been used. The objectives of our study were; 1) to measure QOL and utility in patients with hemophilia using the Short Form 36 (SF-36) and the EuroQOL questionnaires; 2) to evaluate the influence of some clinical variables on QOL and utility; 3) to assess the correlation between the two questionnaires. DESIGN AND METHODS: All consecutive patients with hemophilia were asked to complete the SF-36 and the EuroQOL questionnaires. The following information was recorded from each patient: age, type of hemophilia, severity of disease, HCV and HIV infection, number of bleeding episodes and cumulative dose of coagulation factors over the previous year. These items were entered into a multivariate analysis to assess their effect on QOL. Correlation analyses were conducted to evaluate the relationship between the EuroQOL and SF-36. RESULTS: Fifty-six patients completed the SF-36 and the EuroQOL questionnaires. The mean scores of the SF-36 ranged from 55.2 (general health) to 74.7 (social functioning). The EuroQOLself-classifier and the EuroQOLvas showed a mean score of 0.67 (SD=0.26) and 0.66 (SD=0.17), respectively. Among the clinical variables, age significantly influenced both the EuroQOL and the SF-36 scores. The EuroQOL indices showed a statistically significant correlation with each dimension of the SF-36. INTERPRETATION AND CONCLUSIONS: Our study quantified the degree to which QOL is impaired in patients with hemophilia by using both a generic questionnaire and a utility-based approach.
Vertex epidural hematomas (VEDHs) are well known but uncommon. Their clinical presentation may be misleading and missed by routine CT axial scanning; thus, diagnosis may be delayed, with possibly fatal consequences. We report a case of acute posttraumatic paraplegia caused by a VEDH, which was evident at CT and for which the patient underwent successful surgery.
OBJECTIVES: To determine the effectiveness of ranitidine and sucralfate in the prevention of stress ulcer in critical patients and to assess if these treatments affect the risk of nosocomial pneumonia. DESIGN: Published studies retrieved through Medline and other databases. Five meta-analyses evaluated effectiveness in terms of bleeding rates (A: ranitidine v placebo; B: sucralfate v placebo) and infectious complications in terms of incidence of nosocomial pneumonia (C: ranitidine v placebo; D: sucralfate v placebo; E: ranitidine v sucralfate). Trial quality was determined with an empirical ad hoc procedure. MAIN OUTCOME MEASURES: Rates of clinically important gastrointestinal bleeding and nosocomial pneumonia (compared between the two study arms and expressed with odds ratios specific for individual studies and meta-analytic summary odds ratios). RESULTS: Meta-analysis A (five studies) comprised 398 patients; meta-analysis C (three studies) comprised 311 patients; meta-analysis D (two studies) comprised 226 patients: and meta-analysis E (eight studies) comprised 1825 patients. Meta-analysis B was not carried out as the literature search selected only one clinical trial. In meta-analysis A ranitidine was found to have the same effectiveness as placebo (odds ratio of bleeding 0.72, 95% confidence interval 0.30 to 1.70, P=0.46). In placebo controlled studies (meta-analyses C and D) ranitidine and sucralfate had no influence on the incidence of nosocomial pneumonia. In comparison with sucralfate, ranitidine significantly increased the incidence of nosocomial pneumonia (meta-analysis E: 1.35, 1.07 to 1.70, P=0.012). The mean quality score in the four analyses (on a 0 to 10 scale) ranged from 5.6 in meta-analysis E to 6.6 in meta-analysis A. CONCLUSIONS: Ranitidine is ineffective in the prevention of gastrointestinal bleeding in patients in intensive care and might increase the risk of pneumonia. Studies on sucralfate do not provide conclusive results. These findings are based on small numbers of patients, and firm conclusions cannot presently be proposed.
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In patients with metastatic breast cancer, second-line therapy with aromatase inhibitors can improve survival in comparison with megestrol. We conducted a meta-analysis to assess the effectiveness of aromatase inhibitors versus megestrol. After a Medline search, three trials (evaluating letrozole, anastrozole or exemestane versus megestrol) were included in the survival meta-analysis. Our methodology retrieved patient-level information on survival. In comparison with megestrol, aromatase inhibitors prolonged survival at levels of statistical significance (relative death risk for oral aromatase inhibitors=0.79, 95% confidence interval 0.69-0.91; p=0.0011). A lifetime analysis of the pooled survival curves of aromatase inhibitors versus megestrol found a mean survival gain of 4.1 months per patient. Aromatase inhibitors confer a significant survival benefit to patients with metastatic breast cancer as compared with megestrol. A preliminary calculation of the cost per life year gained shows that the pharmacoeconomic profile of these drugs is favorable.
The therapeutic options for patients with acute leukemia who relapse after the initial transplant include second bone marrow transplantation (2BMT) and conventional chemotherapy (CC). In this work, we conducted an analysis of published survival data and we evaluated the cost-effectiveness of 2BMT in comparison with CC. We retrieved survival information on 167 patients treated with 2BMT and 299 patients treated with CC. Survival figures were derived from individual patient data and were compared between 2BMT and CC. The mean lifetime survival (MLS) was estimated for each of the two patient cohorts using standard techniques of survival-curve extrapolation. The cost data of patients given 2BMT or CC were estimated from published data. Our analysis of individual survival data showed that 2BMT improved survival at levels of statistical significance (survival gain = 19.6 months per patient). Using an incremental cost of $90000 per patient, the cost-effectiveness ratio of 2BMT in comparison with CC was calculated as $52215 discounted dollars per discounted life year gained. Our results indicate that, in patients with acute leukemia who relapse after their first transplant, 2BMT significantly prolongs survival in comparison with CC and seems to have an acceptable cost-effectiveness profile.
OBJECTIVE: In patients with amyotrophic lateral sclerosis, long term treatment with riluzole has been reported to improve survival or tracheostomy-free survival in comparison with placebo. We conducted a pharmacoeconomic analysis for estimating the cost per life-year gained using this drug. DESIGN: This study was an incremental cost-effectiveness lifetime analysis. SETTING: The clinical material was derived from 2 placebo-controlled randomised controlled trials comparing riluzole versus usual care without riluzole, which were identified through a literature search based on the IOWA and the Medline systems. PATIENTS AND INTERVENTIONS: The study included 633 patients with amyotrophic lateral sclerosis. Patient-level information was retrieved from 313 patients treated with riluzole and 320 patients assigned to placebo. Survival after randomisation was compared between the 2 groups using standard statistics (log-rank test and Cox analysis), whereas the lifetime survival gain was estimated using Gompertz extrapolation. Cost data relative to the expenditure for healthcare resources were obtained from published information (using the US average wholesale price for the acquisition cost of riluzole). Sensitivity testing assessed the impact of different cost-of-illness assumptions for treated and untreated patients. MAIN OUTCOME MEASURES AND RESULTS: Our primary analysis showed that treatment with riluzole significantly prolonged survival [death risk = 0.77; 95% confidence interval (CI): 0.62 to 0.96; p = 0.022]. The lifetime survival gain (including 3% annual discounting) was, on average, 2.3 months per patient, while the incremental cost was around $US12,000 per patient. Hence, the cost-effectiveness ratio of riluzole versus usual care without riluzole was $US62,609 per life-year gained (discounted dollars per discounted years; 95% CI: $US13,458 to $US205,714). The sensitivity analysis, considering different values of national cost for riluzole, suggested an interval for this parameter ranging from $US45,048 to $US62,609. CONCLUSIONS: Our study indicates that in patients with amyotrophic lateral sclerosis, riluzole has an unfavourable cost-effectiveness ratio or, at best, a borderline pharmacoeconomic profile.
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OBJECTIVE: Lamotrigine as add-on treatment (500 mg per day) is effective in patients with refractory epilepsy, but its high cost requires a pharmacoeconomic analysis. We conducted a retrospective lifetime cost utility study in which clinical data were derived from a recent placebo-controlled clinical trial, cost-of-illness data were drawn from a previous ad-hoc study, and quality-of-life values were obtained by prospectively interviewing a separate group of 81 patients referred to our institution with epilepsy. RESULTS: Our analysis showed that chronic lamotrigine treatment implies an incremental lifetime cost of about $1,600,000 for every 100 patients. Incremental lifetime utility was around 40 quality-adjusted life-years (QALYs) for every 100 patients. On the basis of these data, adjunctive lamotrigine was estimated to cost approximately $41,000 per QALY gained. Sensitivity testing suggested a range of $25,000-$85,000 per QALY gained. CONCLUSION: Adjunctive lamotrigine (500 mg per day) in refractory epilepsy seems to have a worse pharmacoeconomic profile than many pharmacological treatments commonly used in areas other than epilepsy. Further data are needed to determine if lamotrigine can be equally effective at lower (and less costly) daily doses which could markedly improve its pharmacoeconomic characteristics.
BACKGROUND: Analysis of published survival curves can be used as the basis for incremental cost-effectiveness analyses in which two treatments are compared with one another in terms of cost per life-year saved. In patients with chronic myeloid leukaemia in chronic phase, long-term treatment with alpha-interferon has been reported to improve survival in comparison with standard treatments with cytotoxic drugs. To assess the pharmacoeconomic profile of interferon treatment in terms of cost per life-year gained, we conducted an incremental cost-effectiveness analysis. PATIENTS AND METHODS: The clinical material utilised in our analysis derived from four published randomised trials comparing interferon vs. busulphan or hydroxyurea. The Gompertz model was used to estimate the total lifetime values of patient-years of subjects receiving interferon in comparison with subjects given a standard cytotoxic treatment. RESULTS: Our primary analysis showed that maintenance treatment with interferon improved survival expectancy by 37 to 93 discounted years for every 100 patients. The incremental cost-effectiveness ratio of interferon vs. cytotoxic therapy ranged from $93,000 to $226,000 per life-year gained (discounted costs per discounted years). A secondary analysis showed that the dose of interferon had significant influence on the cost-effectiveness ratio. Because our literature search identified a fifth study that showed an extremely favourable outcome using interferon but that was not included in our primary analysis due to its design, we conducted another secondary analysis based on these five studies that, however, confirmed the results of the primary analysis. CONCLUSIONS: Our study indicates that an unselected long-term treatment with interferon implies an unfavourable cost effectiveness ranking in comparison with data of cost per life-year gained which had previously been obtained from other types of medical intervention.
This article reviews the information currently available on the pharmacoeconomic profile of taxanes in ovarian cancer. Because paclitaxel is the only taxene approved for this clinical indication, our overview is almost entirely focused on the cost-effectiveness profile of this drug. In advanced ovarian cancer, first-line regimens based on paclitaxel have been reported to be more effective than standard therapy based on cyclophosphamide + cisplatin. The improved survival with paclitaxel and the increased cost induced by this drug have prompted a series of pharmacoeconomic analyses, the results of which are summarized and discussed. Three studies, published between 1996 and 1997, calculated the cost per life-year gained using paclitaxel + cisplatin as opposed to cyclophosphamide + cisplatin. The estimates of survival gain and increased expenditure using paclitaxel were very similar; consequently, the results produced by these three analyses were homogeneous with values of cost per life-year gained around $20000. Because this value is below the conventional limit of $50000, the pharmacoeconomic results on paclitaxel suggest a favorable cost-effectiveness profile. Docetaxel is another taxane proposed for the treatment of advanced ovarian cancer; however, the drug has not yet been approved for this clinical indication and so a pharmacoeconomic assessment on this agent is still premature.
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BACKGROUND: The incidence of tuberculous spondylitis, which had declined steadily for over 40 years in our countries, started increasing again in the eighties, paralleling the resurgence of pulmonary tuberculosis. Therefore it has become a matter of discussion in contemporary literature, because it can be a diagnostic challenge and, in spite of its severe neurological complications, it is a potentially curable illness. METHODS: In this retrospective study the authors report their experience concerning 12 patients operated on in a 25-year period because of serious cord compression from thoracic (9 cases) and cervical (1 case) tuberculous spondylitis or from thoracic tubercular epidural lesion (2 cases). Surgical techniques were selected on the basis of the cause of cord compression. Fusion with autologous bone and metallic osteosynthesis was performed in the cervical case (1986); no other patient received spinal instrumentation, and this can be explained with the consideration that all but one cases of Pott's paraplegia were treated in the years 1968-1977. In all of these cases fusion was achieved by means of plaster jackets and prolonged bed rest. Prolonged chemotherapy was systematically administered. RESULTS: Follow-up data collected in 1995 show good and long-lasting results. CONCLUSIONS: They conclude that surgical treatment is required in case of cord compression and results can be excellent even in presence of severe neurological impairment; spinal instrumentation available in our era should be now considered in order to make rehabilitation earlier and morphologic results more satisfactory.