Unethical placebo assignment in clinical trials of thrombolysis.
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Biomedical subjects
Publications and source records attributed to E Geraci.
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255 patients with acute non-lymphoid leukaemia (ANLL), observed between October 1984 and June 1987, entered a chemotherapy regimen consisting of induction therapy with cytarabine in combination with idarubicin (IDA/ARA) or daunorubicin (DNR/ARA), followed by consolidation with four courses of IDA + ARA plus 6-thioguanine (6-TG) or DNR + ARA + 6-TG and a 6 month maintenance therapy with 6-TG and ARA. The median age was 62 years (range 55-78 years) and 33 were aged more than 70 years. The treatment groups were comparable for median age, FAB type, performance status and initial blood counts. 249 patients were randomised, 124 to the IDA/ARA arm and 125 to the DNR/ARA arm. Complete remission was achieved in 50 patients (40%) on the IDA/ARA treatment program and 49 patients (39%) on DNR/ARA. No definite differences were found between patients receiving IDA/ARA and those treated with DNR/ARA as far as complete response (CR), overall survival, failure free and relapse free survival are concerned. 74% of the complete responders in the IDA/ARA arm and 51% in the DNR/ARA arm achieved CR after a single course of treatment. Resistant leukaemia was observed in 13.7% of the patients in the IDA/ARA arm and in 31.2% in the DNR/ARA one, whereas hypoplastic death occurred in 29% and 14.4%, respectively. In conclusion, our data failed to show any advantage of idarubicin over daunorubicin even though there is some evidence that IDA, despite the higher toxicity, is more rapid in eradicating leukaemia as proved by the higher CR rate obtained after one course of induction.
The occurrence of secondary bladder neoplasms is very uncommon, especially when the bladder is the only site of metastasis. The Authors report on one case of bladder metastasis from primary small cell carcinoma of the lung.
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Cystic nephroma is an uncommon lesion, whose etiology and pathogenesis is still debated: some Authors designate it as being of neoplastic origin, other ones of dysplastic or hamartomous origin. Also epidemiology makes difficult its pathogenetic interpretation, as being especially affected children under age of fourth year and adults within the 5th and 6th decade. The Authors report two cases of cystic nephroma examined in two female patients 30 and 74 aged. The most interesting matters are: 1) Possibility of a pre-operative diagnosis of founded suspicion, based on pathologic criteria, codified in literature (unilateral and multilocular cyst which doesn't communicate with the renal collecting system, separated by delicate septae without mature renal tissue) and on respective ultrasonographic, CT and angiographic patterns; 2) Possibility of programming a surgical-conservative strategy; 3) Knowledge about possibility of foci association of adeno-carcinoma or nephroblastoma in the lesion, that, nevertheless, if not widespread, it should not modified neither therapeutical proceeding nor prognosis, generally favourable.
Inverted papilloma of the pelvis and the ureter is a rather uncommon (only 40 cases in the relevant literature) benign epithelial tumor, occasionally harboring foci of malignancy. Since it does not metastasize, a conservative treatment is advisable, but a strict follow up is always required. The Authors report a case of inverted papilloma of the ureter near which an area of transitional carcinoma was discovered.
After a brief review about pathogenetic hypothesis of the endometriosis of the ureter, the Authors describe a case occurred to their observation. Diagnostic problems and choice in treatment (especially partial ureterectomy, end-to-end ureteral anastomosis and omentoplasty) are discussed.
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