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Biomedical subjects

S Pampallona

Publications and source records attributed to S Pampallona.

At least 55 records · Page 3Linked to original sources

Primary endocrine therapy for advanced breast cancer: to start with tamoxifen or with medroxyprogesterone acetate?

BACKGROUND: The availability of compounds effective against metastatic disease and at the same time excellently tolerated even in long-term administration has determined the choice of tamoxifen as primary treatment for palliation in metastatic breast cancer. Other drugs or other hormonal approaches were hardly tested against tamoxifen, especially as first-line treatment. PATIENTS AND METHODS: 119 patients with metastatic breast cancer and no prior endocrine therapy were randomized to receive either tamoxifen (TAM) 20 mg/day orally (64 patients), or medroxyprogesterone acetate (MAP) 1g/day i.m. 5 days/week for 4 weeks and then 500 mg twice a week (55 patients). The subsequent endocrine therapy was also prospectively defined at study entry. RESULTS: A total of 111 events, contributing to the endpoint 'time to progression' have so far been observed: a study of similar size would have a 90% power to detect a hazard ratio of 1.85. Initial MAP was associated with a significantly higher remission rate (50% versus 30% for tamoxifen; p = 0.023) and a marginally significantly longer median time to progression (8.8 versus 5.4 months; p = 0.051). Overall survival was also longer for the MAP group (28 versus 20 months; p = 0.384). The use of MAP was associated with a significantly higher toxicity, mainly hypertension, weight gain and tremor. CONCLUSIONS: The implications of these results are that initial endocrine therapy in postmenopausal patients with metastatic disease should be MAP if the patient is willing to accept the side effects of high-dose progestins. Progestins should be tested in the adjuvant setting for postmenopausal women, especially those with no tendency to hypertension or obesity.

Adult↗

Persistent tardive dyskinesia: demographic and pharmacological risk factors.

The demographic, clinical and pharmacological risk factors for persistent tardive dyskinesia (TD) were investigated in a sample of 1745 patients. When simultaneously adjusting for the effects of demographic and pharmacological factors using multivariate logistic regression, female sex and advanced age were positively and significantly associated with increased risk of TD. Interaction between these two variables, investigated by cross-stratification, was significant. Furthermore, high neuroleptic dose and concomitant use of neuroleptic and antiparkinsonian drugs were both significantly associated with increased risk of TD. The results support the view that both vulnerability factors and high neuroleptic doses contribute to the occurrence of TD and further stress the relevance of a conservative use of antipsychotic medication, particularly in older women.

Adolescent↗

Pattern of neuroleptic drug use in Italian mental health services.

The relationship between the prescribed daily dose of neuroleptic (NL) drugs and patient-, and drug-related characteristics was explored in a cross-sectional sample of 1141 patients treated in Italian mental health services. The results of a multiple linear regression showed that the prescribed daily dose was significantly lower in women, the elderly, and those with a shorter (one to six year) psychiatric history. In contrast, being an inpatient in psychiatric wards in general and public mental hospitals was significantly associated with a higher dose; marital status, education, and diagnosis were not. The number and potency (low to moderate vs. high) of the prescribed NLs were also significantly associated with the prescribed dose, and an interaction was found between the two. Implications of these findings for improvement in NL prescription patterns are discussed.

Adolescent↗

In-hospital prognosis of patients with acute myocardial infarction complicated by primary ventricular fibrillation.

The in-hospital prognosis of patients with acute myocardial infarction complicated by primary ventricular fibrillation has not been satisfactorily defined. We addressed this question by studying patients with primary ventricular fibrillation derived from a large study (11,712 patients) of intravenous streptokinase in the treatment of acute myocardial infarction. Ventricular fibrillation was considered to be primary when it complicated a first myocardial infarction not associated with heart failure or shock and occurred within 48 hours of hospital admission. The 332 patients with primary ventricular fibrillation represented an overall incidence of 2.8 percent. A significant excess of in-hospital deaths was found in the patients with primary ventricular fibrillation as compared with those in the reference group (10.8 percent vs. 5.9 percent; relative risk, 1.94; 95 percent confidence interval, 1.35 to 2.78). Thrombolytic treatment with intravenous streptokinase did not afford protection against primary ventricular fibrillation. We observed that being over 65 years old had a protective effect against primary ventricular fibrillation (relative risk, 0.6; 95 percent confidence interval, 0.45 to 0.80). Our data do not indicate whether primary ventricular fibrillation is simply a marker for patients at increased risk of death or a direct cause of the increase in mortality. Our results do show, however, that primary ventricular fibrillation occurring in a coronary care unit is a negative predictor of short-term survival in patients with acute myocardial infarction.

Age Factors↗

Trends in perinatal, neonatal and postneonatal mortality in Italy, 1955-84.

Trends in stillbirth rates, perinatal, neonatal and postneonatal mortality in Italy over the period 1955-84 were analyzed. There was a 75% reduction (from 28.4 to 7.1/1000 births) in stillbirth rates, and a nearly 70% fall (from 46.2 to 14.5/1000 births) in overall perinatal mortality (from the 180th day of pregnancy to the first week of life). Further, mortality rates from the 8th to the 28th day of life dropped from 7.4 to 1.6/1000 livebirths, and mortality from the second month to the first year of life from 25.1 to 2.2/1000 livebirths. The fall in stillbirth rates was similarly evident across various indicators of maternal education and social class, and could only marginally be accounted for by changes in maternal age distribution. The causes of this large drop in perinatal, neonatal and postneonatal mortality are likely to be numerous and complex. In the absence of any comprehensive program of rationalization of obstetrical and neonatal care, a determinant role must have been played by a general improvement in economic and cultural conditions. However, the observation that decreased perinatal mortality was not due to a decline in the proportion of low birth weight indicates that improved perinatal care may have had an important role as well. Although the decrease in various measures of perinatal and postneonatal mortality in Italy was proportionally comparable with that registered in several other developed countries, Italian perinatal mortality rates (14.5/1000 births in 1984) still appear considerably higher than in other countries, and are clearly far from the optimal theoretical value.

Birth Weight↗

Risk factors for myocardial infarction in young women.

The interim results of a case-control study of myocardial infarction in women below age 55 years conducted in northern Italy since January 1983 are presented, based on 168 cases of acute myocardial infarction and 251 hospital controls. Cigarette smoking was strongly related to myocardial infarction, with risk estimates elevated more than 10-fold for heavy (more than 25 cigarettes per day) smokers. Smoking-related relative risks were of similar magnitude in younger (less than 45 years) and in perimenopausal (45-54 years) women and were largely unaffected by allowance for several potential distorting factors. Other factors independently and strongly related to the risk of myocardial infarction were diabetes, hypertension, and history of coronary heart disease in more than one first-degree relative. Relative risks were also elevated in women who gave birth to their first child earlier (below age 20 years) and in oral contraceptive users. However, these estimates were not significant. The apparent positive associations with clinical history of hyperlipidemia, hypertension in pregnancy, and heavy coffee consumption could be explained largely in terms of confounding, but the protection conveyed by moderate alcohol consumption remained after multivariate analysis. Thus, the interim results of this investigation in a low incidence population confirm the importance of several risk factors previously described in data collected in Northern Europe and the United States. Furthermore, possibly because of the low baseline risk, the proportion of cases attributable to smoking in middle-aged women in this population may be even larger than that previously reported from higher incidence areas.

Adult↗

Pattern of therapeutic intervention and role of psychiatric settings: a survey in two regions of Italy.

A survey of therapeutic intervention was conducted on 1513 patients treated in different psychiatric settings-psychiatric hospitals (PH), private facilities (PF), community mental health centers (CMHC) and psychiatric wards in general hospitals (PWGH). Psychotropic drugs, mainly neuroleptics and benzodiazepines, were widely prescribed irrespective of diagnosis, and 39% of patients treated with neuroleptics received two or more drugs. Psychotherapeutic intervention and social measures were administered in 21% and 20% of cases respectively, and 17% of patients received no treatment. The observed distribution of treatments over settings was compared with the expected one under the hypothesis that the two factors were independent. Differences between settings in therapeutic strategies, after adjustment for possible confounders (sex, age, education, diagnosis) were: no specific treatment was more than expected in PH and largely below unity in PF and PWGH, where treatment with psychotropic drugs alone was overrepresented; CMHC showed the most balanced therapeutic approach.

Adolescent↗

[The Italian Group for the Study of Streptokinase in Myocardial Infarct: Analysis of intrahospital causes of death].

Aim of the present study was to analyse the causes of death of the patients admitted to the G.I.S.S.I. Study. Clinical records of the 1386 in-hospital deaths were centrally analysed by two independent clinicians, who were not aware of the performed treatment and based their classification criteria upon clinical and anatomic data. Death causes were classified as follows: cardiac failure, electromechanical dissociation, cardiac rupture, sudden death and extracardiac deaths. Cardiac failure was the most frequent cause of mortality, as 725 pts out of the 1386 (52%) died from this complication in the whole group. 392 pts were part of the control group (6.7%), while 333 had received SK (5.6%): the difference was significant. No difference was observed between treated patients and control group for what concerns the remaining causes of death. Mortality from cardiac failure was strikingly reduced in a few groups of patients: females (from 11.4 down to 8.7%); age less than 65 years (from 4.1 down to 3.2%); early treated pts (up to 3 hrs): from 6.3 down to 5.2%; anterior location of AMI (9.2 down to 7.4%); first AMI episode (from 5.9 down to 4.7%). Such a reduction was remarkable for patients who remained alive after the 7th day from onset of symptoms: cardiac failure was the cause of death in 65 out of 5385 treated patients, and in 100 out of 5333 control group patients.(ABSTRACT TRUNCATED AT 250 WORDS)

Arrhythmias, Cardiac↗

Parental age and risk of complete and partial hydatidiform mole.

The relation between age of parents and the risk of complete and partial hydatidiform mole was examined using data from a case-control study conducted in Northern Italy of 149 histologically confirmed complete moles, 45 partial moles and 306 controls subjects who delivered normal babies. Compared to women aged 21 to 35, the relative risk (RR) of complete mole was elevated for teenage women (RR = 1.9) and for those aged 36-40 (RR = 1.9) or over 40 (RR = 7.5). There was no association between women's age and partial mole. Likewise, older paternal age (greater than 45) was related with the risk of complete mole (RR = 4.9, though allowance for women's age reduced this point estimate to 2.9), but not of partial mole. The present findings indicate that there are important differences in the epidemiology of complete and partial hydatidiform mole.

Adolescent↗

Age at first birth, dietary practices and breast cancer mortality in various Italian regions.

Breast cancer death certification rates in Italy showed a consistent geographic variation, with approximately a 2-fold ratio between the highest rates registered in Northern (and richer) regions, and the lowest ones in the South. This variation in breast cancer mortality was positively and strongly correlated with mean age at first birth (r = + 0.73). This positive correlation could not be totally explained by several other economic or dietary variables considered, though some of them substantially reduced the strength of the association. Breast cancer mortality rates were found to be positively correlated with milk, meat and sugar consumption, and negatively with pasta, thus confirming previous studies on national or international scales. These correlation coefficients, however, were considerably reduced after controlling for mean age at first birth. Further, when allowance was made for economic variables and age at first birth, only the correlation coefficients for milk and cheese remained significantly positive. Thus, the evidence from this study suggests that the Italian geographical correlations between breast cancer mortality and dietary variables may be largely explained in terms of reproductive factors, though there may be some effect of dietary variables on breast cancer risk as well.

Adult↗

Methylxanthine, alcohol-free diet and fibrocystic breast disease: a factorial clinical trial.

A controlled clinical trial was conducted in Milan, Italy to analyze the effects of methylxanthine (MTX) and alcohol abstention on signs and symptoms of fibrocystic breast disease. A total of 192 women with a clinical and thermographic diagnosis of fibrocystic breast disease were randomly assigned to four groups on the basis of two-by-two factorial design: (1) abstention from MTX-containing beverages, (2) abstention from alcohol, (3) abstention from MTX and alcohol, and (4) no dietary advice. Of these, 162 (84.4%) were followed up at approximately 6 months. No statistically or clinically significant effect of a MTX- or alcohol-free diet was observed on signs and symptoms of fibrocystic breast disease. On the basis of the results of the present and previous randomized controlled studies, it thus appears possible to exclude that abstention from coffee and other MTX-containing beverages can substantially reduce signs and symptoms of fibrocystic breast disease within a few months.

Adult↗

Reproductive patterns and the risk of gestational trophoblastic disease.

The relation between reproductive pattern and the risk of gestational trophoblastic disease was evaluated in a case-control study conducted in Northern Italy on 310 women with histologically confirmed gestational trophoblastic disease and two control groups consisting of 290 obstetric subjects and 394 patients in hospital for acute, nonobstetric, nongynecologic conditions. Compared to that for nulliparous women, the estimated age-adjusted relative risk of trophoblastic disease for parous women was 0.6 (90% confidence limit = 0.4 to 0.9) when obstetric controls were used as a comparison group and 0.4 (95% confidence limit = 0.2 to 0.6) compared with other controls. Conversely, a history of spontaneous abortions was associated with elevated risk of gestational trophoblastic disease, and the risk increased significantly with increasing number of spontaneous abortions. When the combined effect of parity and spontaneous abortions was considered, the major factor influencing the risk of gestational trophoblastic disease was the existence of one or more previous term pregnancies.

Abortion, Habitual↗

ABO blood-groups and the risk of gestational trophoblastic disease.

The relation between ABO blood group, mating patterns of patient/husband blood group, and the risk of gestational trophoblastic disease was investigated in a case-control study conducted in Milan on 286 women with histologically confirmed trophoblastic disease (245 benign hydatidiform moles and 41 persistent trophoblastic disease) and 433 control subjects admitted for normal delivery to the same hospitals where cases had been identified. ABO blood groups were associated with the risk of gestational trophoblastic disease (chi 2(6) for heterogeneity = 14.46, p = 0.02). Compared to women of group O or B, women of group A and AB had an elevated relative risk (RR) of benign mole (RR = 1.4 and 2.3, respectively). The risk estimates were higher for persistent trophoblastic disease, i.e., 2.2 for women of group A and 4.8 of group AB. The tests for linear trend in risk from benign to persistent disease were statistically significant in both A and AB groups. There was a significant interaction between blood group and age, since the ABO-related risk was elevated only for women over the age of 35. When mating combinations of maternal/paternal blood groups were considered, women of group A married to males of group O had a risk estimate not substantially different than those married to group A males.

ABO Blood-Group System↗

A pilot study of high-dose domperidone as an antiemetic in patients treated with cisplatin.

A dose-finding multicenter study was undertaken to evaluate the antiemetic efficacy of domperidone, an antidopaminergic drug, which has been proposed as a suitable alternative to high-dose metoclopramide in the control of cisplatin-induced nausea and vomiting. Forty-five patients were treated with different increasing high doses of domperidone (30, 60, 120 or 150 mg) administered by i.v. infusion over 20 min every 2 hr for a total of four doses for each patient, starting 30 min before chemotherapy. The number of episodes of emesis, the duration of nausea and vomiting and side-effects were recorded. Results do not suggest any specific difference in protective effect between the regimens tested. Moreover, occurrence of serious side-effects indicated that the safety of high-dose domperidone is doubtful.

Adolescent↗

Characteristics of women undergoing induced abortion: results of a case-control study from Northern Italy.

In order to identify subgroups of women at elevated risk of induced abortion, personal characteristics and habits, selected medical histories and contraceptive practices of 873 women undergoing legal abortion in various areas of Northern Italy were compared with those of 504 control subjects identified in family planning clinics of the same hospitals or area health authorities. When age was allowed for, the risk of induced abortion was not strongly influenced by marital status, education or other indicators of social class. However, women who were employed, independently from the type of occupation, showed markedly lower abortion risks than housewives. Among various indicators of sexual habits investigated, the strongest determinant of legal abortion was the frequency of sexual intercourses over the previous six months, women with less frequent intercourses showing a markedly elevated risk estimate (RR = 2.82). Induced abortion was less frequent among ex-smokers and more frequent in heavy smokers, but was not appreciably influenced by several other indicators of lifestyle habits and history of gynaecological or psychiatric complaints. The risk of abortion was not influenced by the number of livebirths, but was lower for women with later age at first birth. Less than 5% of case and control subjects reported more than two previous induced abortions, thus indicating that abortion is more of an "accidental" event rather than a widespread contraceptive practice. However, over three-quarters of abortions occurred in women reporting no contraception at all or coitus interruptus, thus underlining the scope for family planning education in this population.

Abortion, Legal↗

Alcohol consumption and the risk of breast cancer in women.

The relationship between breast cancer and alcoholic beverage consumption was investigated in a case-control study of 437 women with breast cancer and 437 age-matched controls admitted to the hospital for acute conditions apparently unrelated to alcohol consumption. Compared to the relative risks (RR) for women who had never drunk alcohol, the RR for those reporting 1-3 and more than 3 alcoholic drinks per day were 1.24 and 1.93, respectively. A similar positive trend in risk with increasing daily consumption was evident for wine alone, and the point estimates were above unity for beer and spirits. Allowance for all identified potential confounding factors (including the major risk factors for breast cancer and a few selected dietary items) did not appreciably change any of the alcohol-related estimates. The RR, however, were higher at younger ages and did not rise with increasing duration of use. Nonetheless, the findings of the present study and their similarity with those of another case-control study conducted in northeastern Italy indicate that the association between alcoholic beverage consumption and breast cancer in this population is probably real, though not necessarily causal.

Adult↗