[Clinico-microbiological investigation in septic complications after gastrointestinal surgery. A multicenter study].
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Bacterial Infections↗
Biomedical subjects
P Bruzzi
Publications and source records attributed to P Bruzzi.
The antiemetic efficacy of methylprednisolone compared with metoclopramide in outpatients receiving adjuvant CMF chemotherapy for breast cancer: a randomized trial.
A randomized trial was performed comparing the antiemetic efficacy of methylprednisolone (MPN) and metoclopramide (MCP) in 60 breast cancer patients eligible for outpatient adjuvant chemotherapy with cyclophosphamide, methotrexate, and 5-FU (CMF). At the time of their first chemotherapy course patients were randomized to receive either MPN 375 mg or MCP 1 mg/kg both administered in 3 equal doses, IV just prior to chemotherapy and then IM 6 and 12 hours after treatment. Patients receiving MPN experienced significantly less nausea (p less than 0.0005) and vomiting (p less than 0.0005) and antiemetic protection was maintained in patients receiving multiple chemotherapy courses. Complete protection (0 emesis) was observed in 58% of patients receiving MPN as compared with 20% of patients treated with MCP (p less than 0.005). The most frequent side effects were facial flush in 38% of patients and somnolence in 15% of patients receiving MPN and MCP, respectively. Complete protection from CMF-induced gastrointestinal side effects was observed in two-thirds of our patients receiving antiemetic MPN treatment. In these patients administration of the maximum cumulative CMF dose was possible without impairing their quality of life. MPN, at the dose and schedule reported, is an affective antiemetic drug suitable for use in breast cancer outpatients receiving adjuvant CMF therapy.
Adult↗
Estimating the population attributable risk for multiple risk factors using case-control data.
A straightforward and unified approach is presented for the calculation of the population attributable risk per cent (etiologic fraction) in the general multivariate setting, with emphasis on using data from case-control studies. The summary attributable risk for multiple factors can be estimated, with or without adjustment for other (confounding) risk factors. The relation of this approach to procedures in the literature is discussed. Given values of the relative risks for various combinations of factors, all that is required is the distribution of these factors among the cases only. The required information can often be estimated solely from case-control data, and in some situations relative risk estimates from one population can be applied to calculation of attributable risk for another population. The authors emphasize the benefits to be obtained from logistic regression models, so that risks need not be estimated separately in a large number of strata, some of which may contain inadequate numbers of individuals. This approach allows incorporation of important interactions between factors, but does not require that all possible interactions be included. The approach is illustrated with data on four risk factors from a pair-matched case-control study of participants in a multicenter breast cancer screening project.
Biopsy↗
Outcome of follow-up programs in patients previously resected for colorectal cancer.
The survival of a group of 115 patients (group A) who entered a follow-up program after apparently "curative" surgery for colorectal cancer was compared with that of 62 similar patients (group B) who did not join such a program. No significant difference was found. Clinical benefits to single patients in group A, in terms of anticipated diagnosis and effective treatment of recurrences and of metachronous neoplasias, appeared to be, if any, extremely limited. In light of the high costs of intensive follow-up programs, it is concluded that their use can be justified only within controlled perspective trials aimed to evaluate their usefulness.
Actuarial Analysis↗
Low-dose metoclopramide versus methylprednisolone in controlling chemotherapy induced nausea and vomiting.
Ninety outpatients with histologically confirmed malignancy receiving chemotherapy entered a randomized crossover trial to assess the antiemetic efficacy of low-dose metoclopramide versus methylprednisolone. Treatment consisted of either metoclorpramide (MCP) 60 mg or methylprednisolone (MPN) 375 mg administered in 3 equal doses just prior to chemotherapy and 6 and 12 hours after treatment. Patients receiving MPN had significantly less nausea (p less than 0.001) and fewer episodes of vomiting (p less than 0.0003) than patients receiving MCP. MPN also proved to be the more effective agent in cross-over trials. Both MPN and MCP were well tolerated. No important side effects were observed. MPN is a safe, effective, antiemetic treatment suitable for use in the outpatient.
Adult↗
Comparison between diurnal changes and changes induced by hydrocortisone and epinephrine in circulating myeloid progenitor cells (CFU-GM) in man.
A significant increase from 8 AM to 3 PM was found in both myeloid progenitor cell (CFU-GM) and polymorphonuclear leukocyte (PMN) blood concentration in 45 normal subjects. Diurnal blood (CFU-GM and PMN changes were significantly correlated. Spontaneous diurnal changes in blood CFU-GM levels and in PMN were compared with the changes induced by i. v. administration of hydrocortisone (16 normal volunteers) and of epinephrine (10 normal volunteers). Diurnal changes in CFU-GM and PMN seem to follow a pattern similar to that induced by epinephrine administration. These findings suggest that diurnal changes in CFU-GM reflect mainly a shift of these cells between different blood compartments.
Circadian Rhythm↗
[A controlled-case study on risk factors in tumors of the oral cavity. Perspectives and indications for early diagnosis].
The literature on carcinomas of the oral cavity shows general agreement that alcohol and smoking are risk factors. Only a few authors blame poor hygiene. The retrospective survey conducted in Genoa aimed to evaluate the relative importance of these risk factors, by means of a case-controlled study linking a specific risk factor to a specific condition. 98 histologically confirmed cases were hospitalised in 1979-80. A similar survey was conducted on a control group. Smoking and alcohol, often both together, were found to be the most significant aetiopathogenetic risk factors in the oncological pathology of the oral cavity.
Adult↗
Carcinogenicity study with technical-grade dichlorodiphenyltrichloroethane and 1,1-dichloro-2,2-bis(p-chlorophenyl)ethylene in hamsters.
Studies conducted by others have revealed that 1,1-dichloro-2,2-bis(p-chlorophenyl)ethylene (DDE), a proximal metabolite of dichlorodiphenyltrichloroethane (DDT), is a strong hepatocellular carcinogen in mice. Since hamsters appear to be resistant to tumor induction by DDT, we wanted to investigate whether DDE has any neoplastic effect in this species. DDE (99% pure) was mixed into the diet at doses of 500 or 1000 ppm and given to groups of male and female Syrian golden hamsters for life. Another group of animals received a diet containing 1000 ppm technical-grade DDT, and a further group served as control. Groups contained a minimum of 40 hamsters per sex. The tested compounds had no effect on the incidence of tumors at all sites, compared to controls. A specific finding in animals exposed to DDE was the appearance of hepatocellular tumors late in life. They were classified as neoplastic nodules, and the incidence was 15% in females and 47% in males of the 500-ppm DDE dose groups and 21% in females and 33% in males of the 1000-ppm DDE dose groups. None of the untreated or DDT-treated animals had these tumors. Eight animals treated with 1000 ppm DDE and four of those treated with DDT had hyperplastic foci of the liver. In addition, adrenocortical adenomas, spontaneous to Syrian golden hamsters, were more frequent in DDE- and DDT-treated animals than in control animals. These results showing that DDE, but not its parental compound, induces liver cell tumors in hamsters emphasize the importance of this metabolite as a proximal carcinogen of DDT.
Animals↗
Left-sided colonoscopy in screening programs. What preparation?
In order to limit patients' refusal to undergoing colorectal cancer endoscopic screening procedures, traditional cleansing enemas were compared with a new simpler oral cleansing preparation by means of a randomized controlled trial. Ninety-three patients were evaluated both for compliance and effectiveness of the two modalities tested. No difference in acceptability or effectiveness was detected. The authors discuss more rigorous cleansing techniques routinely used in diagnostic schedules which cannot be considered for preparation for colonoscopy in screening programs.
Administration, Oral↗
Value of multiple forceps biopsies in assessing the malignant potential of colonic polyps.
Fifty-nine colo-rectal polyps were detected at endoscopy and repeatedly biopsied before removal by endoscopic snare polypectomy. The aim of the present paper was to evaluate the reliability of multiple forceps biopsies in assessing both the malignant potential and the presence or absence of invasive cancer (IC) in colo-rectal adenomas (CRA). In order to achieve the first objective, the histologic types and the degree of dysplasia have been defined. The data obtained by means of multiple biopsies examination, compared with those of polyp in toto study, show that fractional biopsies were of value in the histologic classification of only the smallest 41 polyps (agreement 88.09%), whilst no reliability of biopsies was demonstrated in the 18 largest polyps (agreement 27.68%). In the field of dysplasia grading, the agreement was 55% and 61% for the smallest and the largest CRA respectively. These last figures are hardly acceptable. Biopsies examination gave also under- and overestimation of the histologic severity and of dysplasia as well as a significant incidence of false negative results in IC detection. It is concluded that polypectomy is the only method which provides adequate material for precise diagnosis, no matter how large a polyp. Therefore it should be performed whenever possible. Finally the authors discuss the management of small sessile adenomas.
Biopsy↗
Influence of the spleen on the blood distribution of the leukocytes producing colony-stimulating activity (CSA) in man.
The colony-stimulating activity (CSA) produced by the blood leukocytes has been studied before and after epinephrine administration in ten normal, 15 splenomegalic, and seven splenectomized subjects through a double layer agar culture system. A significant increase of mean values of the CSA per milliliter produced by blood monocytes has been observed after epinephrine administration in the groups of normal and of splenomegalic subjects. In the group of splenectomized subjects the baseline mean value of CSA per milliliter of blood was higher than those observed in the other groups, but it did not show any increase after epinephrine infusion. The CSA produced by 10(6) blood leukocytes was similar in all three groups of subjects, and it was not similarly modified by epinephrine administration. Our results seem to indicate that the leukocytes producing CSA are distributed within two rapidly exchangeable blood compartments, the spleen representing an important section of the marginal compartment of blood monocytes.
Colony-Stimulating Factors↗
Influence of the spleen on the blood distribution of the colony-forming cells (CFU-C) in man.
The incidence of the blood committed granulocyte progenitor cells (CFU-C) before and after epinephrine administration has been studied in 10 normal, 16 splenomegalic and 8 splenectomized subjects through a double-layer agar culture system. A significant increase of the mean values of CFU-C per milliliter of blood has been observed after epinephrine administration in normal and in splenomegalic subjects. In splenectomized patients the baseline mean values of CFU-C per milliliter of blood were higher than those observed in the other groups of subjects, but they did not increase after epinephrine infusion. The concentration of CFU-C per 10(6) total blood leukocytes was the same in all three groups of subjects and it was not modified by epinephrine administration. Our results seem to indicate that the CFU-C are distributed in two blood compartments, the spleen representing an important section of the marginal compartment of the blood CFU-C.
Blood Cells↗
Estrogen-like action of tamoxifen on vaginal epithelium in breast cancer patients.
The action of prolonged administration of Tamoxifen on the vaginal epithelium in postmenopausal breast cancer patients has been investigated by means of exfoliative cytology. Our study gives quite convincing evidence of a clear-cut estrogenic effect of Tamoxifen on vaginal epithelium. The relationship between estrogenic properties of Tamoxifen and breast cancer management is discussed.
Age Factors↗
Mobilization of colony-forming cells (CFU-C) into the peripheral blood of man by hydrocortisone.
The effect of hydrocortisone on blood CFU-C has been studied in six normal subjects through a double layer agar culture system. Increased numbers of CFU-C appeared in the peripheral blood reaching a maximum 366% to 631% increase 5-8 hours after the i.v. administration of the hormone. Contemporary lymphopenia caused a 4 to 10 fold enrichment in the proportion of CFU-C to lymphocytes. Hydrocortisone added in vitro somewhat inhibited the colony growth. The results suggest that the increase of blood CFU-C is due to mobilization from the bone marrow. Hydrocortisone, when compared to other agents, appears to offer some advantages in increasing the blood CFU-C for clinical purposes.
Bone Marrow Cells↗
Ceftazidime plus amikacin versus ceftazidime plus vancomycin as empiric therapy in febrile neutropenic children with cancer.
Two antibiotic regimens, ceftazidime plus amikacin and ceftazidime plus vancomycin, were compared in a prospective, randomized clinical trial as empiric therapy in febrile granulocytopenic children with cancer. The rate of response was similar in the two groups (66% vs. 77%). The prevalence of secondary gram-negative bacteremia was higher--but not significantly higher--in the group receiving vancomycin. Adverse reactions also occurred more often in the latter group (35% vs. 4%). Mortality did not differ significantly in the two groups. Adjustment for independent predictors of response to treatment by means of multivariate analysis confirmed the lack of any remarkable difference between the responses to the two regimens. We conclude that the use of vancomycin instead of amikacin in combination with ceftazidime does not significantly improve the outcome of treatment of fever and infection in granulocytopenic children with cancer and that the use of vancomycin is associated with an increased frequency of both secondary infections due to gram-negative bacteria and adverse reactions.
Amikacin↗
Hematologic parameters during treatment with high-dose medroxyprogesterone acetate.
Blood clotting, platelet aggregation, complete blood count and lipid profile were evaluated in 12 postmenopausal patients with advanced breast cancer. Patients under treatment with high-dose MPA were considered not at risk for thomboembolic disease and were given MPA orally, 800 mg/day, for at least 3 months. Laboratory investigations were performed prior to treatment with MPA then once weekly during the first month and every 2 weeks during the following months. PTT, TEG, antithrombin III and platelet adhesiveness underwent statistically significant changes, tending towards hypercoagulability, although, on the average, they did not exceed the upper normal range. The authors conclude that a clinically relevant thrombotic activity cannot be attributed to MPA at the administered oral doses in the absence of additional risk factors.
Blood Cell Count↗
Combined epirubicin and interleukin-2 regimen in the treatment of malignant mesothelioma: a multicenter phase II study of the Italian Group on Rare Tumors.
The Italian Group on Rare Tumors undertook a phase II study of a combination of epirubicin and interleukin-2 in 21 chemotherapy-naive patients with malignant mesothelioma. All patients had bidimensionally measurable disease at CT scan. Treatment included Intravenous administration of epirubicin at a dose of 110 mg/m2 i.v. on day 1, and interleukin-2 at a dose of 9 MU subcutaneously from day 8 to day 12 and from day 15 to day 19. Cycles were repeated every three weeks, up to six times in the absence of progressive disease. Treatment response was evaluated after two cycles of therapy. Only one patient achieved a partial response, resulting in an overall response rate of 5% (1/21) with a median progression-free and overall survival of 5 and 10 months, respectively. Toxicity was relevant and caused treatment discontinuation in many patients. These results do not support the use of such a combination in the management of malignant mesothelioma.
Adult↗
The role of vindesine and lonidamine in the treatment of elderly patients with advanced non-small cell lung cancer: a phase III randomized FONICAP trial. Italian Lung Cancer Task Force.
AIMS: To evaluate the efficacy and treatment compliance in elderly patients with advanced non-small cell lung cancer (NSCLC) of two chemotherapeutic agents with mild toxicity, 153 previously untreated patients aged over 70 years were randomized to receive lonidamine (450 mg daily p.o. until progression), vindesine (3 mg/m2/daily i.v. weekly for 4 weeks and then every 2 weeks until progression), the combination of the two drugs at the same dose and schedule, or supportive therapy only in a four-arm factorial randomized trial. METHODS: 126 patients were included in the final analysis. Their median age was 75 years. Forty percent had stage IV disease and 60% stage III. Most patients were males (85%) and the majority had squamous histology (68%). RESULTS: Among 104 patients evaluable for response there were only 3 PRs (1/30 in the lonidamine arm and 2/33 in the lonidamine + vindesine arm). Overall, 8.7% and 9.5% of the patients, respectively, progressed or died early, before response evaluation; another 9.4% refused treatment continuation because of poor compliance with the study protocol. Eighty-five patients were fully evaluable for toxicity, which was generally mild. Leukopenia grade 1-3 was found in less than 30% of patients treated with vindesine or vindesine + lonidamine. The most common complaints associated with lonidamine treatment were myalgia (70% of patients), fatigue (55% and 83% of patients treated with lonidamine or lonidamine + vindesine, respectively) and testicular pain in nearly 40% of cases. The overall median survival was 170 days, with no significant impact on survival of either lonidamine or vindesine. CONCLUSIONS: The low response rate and survival together with the poor treatment compliance, even in the presence of mild toxicity, do not support the usefulness of these "gentle" chemotherapies in elderly NSCLC patients. The standard management of advanced NSCLC in elderly patients remains to be defined. Specifically designed studies to address this issue are warranted.
Aged↗