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Biomedical subjects

G Tognoni

Publications and source records attributed to G Tognoni.

At least 19 recordsLinked to original sources

The risk of stroke in patients with acute myocardial infarction after thrombolytic and antithrombotic treatment. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico II (GISSI-2), and The International Study Group.

BACKGROUND: Many trials in patients with acute myocardial infarction have demonstrated that thrombolytic therapy is not associated with an excessive risk of stroke, as compared with conventional treatment. However, the incidence of various forms of stroke in patients treated with different thrombolytic and antithrombotic regimens and the associated effect of risk factors for stroke are largely unknown. METHODS: Strokes occurring in patients hospitalized with acute myocardial infarction who were enrolled in either of two large trials were analyzed. The patients were randomly assigned to receive streptokinase (1.5 million units) or recombinant tissue plasminogen activator (t-PA) (100 mg) and also randomly assigned to receive subcutaneous heparin or no heparin. Ninety-one percent of the patients also received aspirin. RESULTS: Complete data were available on 20,768 patients. A total of 236 (1.14 percent) had strokes in the hospital; 0.36 percent had hemorrhagic strokes, 0.48 percent ischemic strokes, and 0.30 percent strokes of undefined cause. Patients treated with t-PA had a small but significant excess of stroke as compared with those who received streptokinase (1.33 vs. 0.94 percent; adjusted odds ratio, 1.42; 95 percent confidence interval, 1.09 to 1.84). The administration of subcutaneous heparin in addition to a thrombolytic agent did not increase the risk of stroke (risk with heparin, 1.13 percent; without heparin, 1.14 percent). Older age, a higher Killip class, and the occurrence of anterior infarction significantly increased the risk of stroke, whereas a higher body-mass index or a history of hypertension, diabetes, or smoking did not. CONCLUSIONS: Patients with acute myocardial infarction who receive thrombolytic therapy have a small risk of stroke. Treatment with t-PA as compared with streptokinase resulted in a small but significant excess of stroke. Subcutaneous heparin, given together with t-PA or streptokinase and aspirin, did not result in an increased risk of stroke.

Aged

Patterns of aftercare for psychiatric patients discharged after short inpatient treatment. An Italian collaborative study.

This is the first of a series of papers presenting the results of an Italian collaborative study on psychiatric inpatient service utilisation. Patterns of care of a large sample of patients discharged after short inpatient treatment are discussed in the light of the changes introduced by the 1978 Mental Health Act in the Italian psychiatric care delivery system. Three closely related issues are considered: a) use of psychiatric hospitalisation, b) relationships between inpatient and community treatment before and after an admission episode, c) continuity of care. The main findings are: 1) great variability between services suggests that local factors play an important role in determining the contents of care in Italian post-reform psychiatry. 2) The relationship between inpatient and community services is complex, partial integration being the most common picture. 3) Psychiatric hospitalisation is the entry point into the care system for a sizeable group of patients. 4) Continuity of care is achieved for half the patients, mostly with diagnoses of severe mental disorders. 5) Subjects with a recent history of revolving door behaviour or a past history of mental hospital admission show the highest likelihood of remaining in community care following discharge.

Adult

Outcome of discharged psychiatric patients after short inpatient treatment: an Italian collaborative study.

This paper presents the results of an Italian multicentre study on the 6-month outcome of psychiatric patients discharged after short-term in-patient treatment from 21 general hospital psychiatric units. Two outcome measures were used: relapses (defined as readmissions for psychiatric treatment or suicide) and community tenure. The data showed, on average, a fairly high relapse rate (43% in 6 months) combined with a good community tenure. The findings are discussed in the light of the heterogeneity in patterns of care provision observed in Italian psychiatric services after the changes introduced by the 1978 Mental Health Act, reported in a previous paper.

Activities of Daily Living

Use of plasma levels for antiepileptic drug monitoring in clinical practice. Gruppo Collaborativo per lo Studio dell'Epilessia.

A multi-center survey of antiepileptic treatment was conducted in Italy on 245 previously untreated ("new") patients with epilepsy and 355 patients treated for more than three months ("old" patients). Therapeutic drug monitoring (TDM) of antiepileptic drugs was evaluated in the context of routine clinical conditions, in relation to individual therapeutic problems and mode of treatment. Plasma levels (PL) were determined in 75% of "new" patients and 78% of "old" patients, with wide intercenter variability. TDM was done at 69% of the follow-up attendences for "new" patients and at 34% for "old" patients, but was apparently unrelated to specific therapeutic problems, such as poor disease control or adverse drug reactions. Plasma drug concentration measurements were made more often among patients on polytherapy. The age of the patient and the time elapsing since diagnosis did not seem to affect request patterns significantly. From these findings it appears that TDM is largely influenced by factors unrelated to the common recommendations in the literature. In addition, the use of TDM in clinical practice reflects the limitations of the available techniques.

Adolescent

GISSI update. Which patients with myocardial infarction should receive thrombolysis?

Large-scale, randomized clinical trials have produced over the last few years a wide consensus about the role of thrombolysis in the treatment of acute myocardial infarction (AMI). It has been estimated from the trials with broader inclusion criteria that about 40% of the patients admitted to coronary care units with AMI are eligible for fibrinolytic therapy and can benefit from it. On the other hand, drug utilization data suggest that only a fraction of eligible patients actually receive thrombolysis. A reason for this dissociation between knowledge and practice lies in the widespread assumption that thrombolysis is inefficacious in particular population subsets, as well as in the setting of a number of contraindications based on controversial evidence. Age per se does not represent a contraindication to thrombolysis, which could display a lifesaving potential two or three times that estimated for the general population of patients with AMI. Although it has been shown that the sooner thrombolytic treatment is provided after the onset of symptoms the more effective it is, the available evidence seems to indicate that the effect could well extend up to 12 h from the onset of symptoms. Patients with an inferior myocardial infarction should also receive thrombolytic treatment on the basis of the results of a meta-analysis carried out on 12,000 patients. Very misleading recommendations for practice can be produced by adjusting the main results so as to conveniently allow for subgroup findings, regardless of their degree of epidemiologic, biologic, and pathophysiologic consistency. For all categories of patients included in the population trials (with the exception of those with ST depression), thrombolysis should be considered a recommended treatment. From an epidemiologic perspective, the extension of the benefits of thrombolytic therapy to all AMI patients for whom the drug is not clearly contraindicated is a goal of primary importance.

Adult

Cerebrovascular events after myocardial infarction: analysis of the GISSI trial. Gruppo Italiano per lo Studio della Streptochinasi nell'Infarto Miocardico (GISSI).

OBJECTIVES: To describe the epidemiology of cerebrovascular events in patients given or not given fibrinolytic treatment and to assess the prognostic implications and risk factors. DESIGN: Case series derived from the GISSI randomised trial. SETTING: 176 coronary care units in Italy giving various levels of care. PATIENTS: 5860 patients with acute myocardial infarction treated with 1.5 million units of intravenous streptokinase and 5852 patients not given fibrinolytic treatment. MAIN OUTCOME MEASURES: Cerebrovascular event, sex, age, blood pressure, history of previous infarct, site of infarction, and Killip class. RESULTS: 99 of 11,712 patients (0.84%) had a cerebrovascular event. Older age, worse Killip class, and anterior location of infarction seemed to be risk factors for cerebrovascular events (40/3201 aged 65-75 v 42/7295 aged less than 65, odds ratio 2.18; 9/437 class 3 v 55/8277 class 1, 1.81; and 57/4878 anterior v 24/4013 posterior, 1.96). No significant difference was found in the rate of cerebrovascular events between patients treated with streptokinase and controls (45/5852 (0.92%) streptokinase v 54/5860 (0.77) control). More patients in the streptokinase group than in the control group had cerebrovascular events (especially haemorrhagic strokes) on day 0-1 after randomisation (27 streptokinase v 7, control), although this was balanced by late events in control patients (54 streptokinase v 45 control at one year). The mortality of patients who had a cerebrovascular event was higher than that of those who did not (47% (47/99) v 11.6% (1350/11,613]. CONCLUSIONS: Although the incidence of cerebrovascular events complicating myocardial infarction was low, they increased morbidity and mortality. Treatment with streptokinase did not significantly alter the incidence, but age and poor haemodynamic state were associated with an increased risk.

Aged

Randomized clinical trial of transabdominal versus transcervical chorionic villus sampling methods.

The relative advantages and disadvantages of transabdominal (TA) and transcervical (TC) chorionic villus sampling (CVS) in terms of fetal risks and efficacy were evaluated in a clinical trial conducted on 1194 women randomized at 7-12 weeks' gestation. The results of the study indicate that, if any, the relative risk of fetal loss following either procedure is less than double that of the alternative technique when performed by a skilled operator. Overall, the fetal loss rate (spontaneous abortions following randomization, terminations of pregnancy, and perinatal deaths) is 16.5 and 15.5 per cent, respectively, among women allocated to TA- and TC-CVS. The two procedures are equally effective, although TA-CVS is associated with a significantly lower rate of repeat device insertions; on the other hand, a higher weight of chorionic tissue is obtained, on average, with TC-CVS. Bleeding is more common following TC-CVS, while peritoneal reaction developed only after TA-CVS. No diagnostic problems specifically related to one sampling technique were identified.

Birth Weight

Warning signs in subarachnoid hemorrhage: a cooperative study.

The present study is part of a survey of subarachnoid hemorrhage cases observed in 16 neurosurgical and 8 neurological departments in Italy between June 1985 and June 1986. Warning signs preceding major hemorrhage were analyzed in 364 patients with intracranial aneurysms confirmed by angiography and reliable clinical history. Seventy-four (20.3%) had warning signs. Clinical features of premonitory warning signs were compared with symptoms of 78 patients without a history of minor leak and clinical grade 1 (according to the criteria of Hunt & Hess) at admission. Symptoms of warning signs are generally clear enough to be considered a misdiagnosis of intracranial aneurysm. Thunderclap headache described as severe, unusual and sudden was the main symptom in every case though the higher frequency of focal of diffuse signs in groups with a correct diagnosis attracted more careful attention in referral and diagnostic-therapeutic management. Improving the identification of minor leak and defining diagnostic strategy are discussed.

Adult

Thrombolysis in acute myocardial infarction.

The 1980s has been a critical decade for the management of acute myocardial infarction (MI) because of the concentration in a very short time span of innovative results produced by a new generation of trials, in which thrombolysis has been the preeminent topic. The message coming from the results in the more than 50,000 patients included in the five key trials is simple and clear: thrombolysis, of any type, is the cornerstone of acute treatment of MI, and it works well to produce a very favorable epidemiologic picture. In the GISSI-2 trial, the nationwide adoption of a package of recommended treatments centered on thrombolysis for the overall population of patients with an acute MI has produced a relevant modification of the natural history of the disease, reducing the in-hospital mortality by about 40% in few years (from 13% to 8.8%). In particular, in the great majority of cases (patients aged less than 70 years in Killip class I with a first acute MI), the mortality has gone down to 3%, making a further reduction very hard to obtain with new drugs or strategies. In this context, we will discuss the concept of the relevance for clinical practice of obtaining even greater patency rates with new thrombolytic agents (hopefully more efficient and safe) or with new combinations of traditional agents.

Fibrinolytic Agents

The teaching and organisation of clinical pharmacology in European medical schools (W.H.O. Working Group on Clinical Pharmacology).

A World Health Organisation (European Regional Office) working party has been established to review the progress of clinical pharmacology in European countries. As part of this review a questionnaire on the teaching of clinical pharmacology was sent to the Deans of all 350 medical schools in the region. Very few replies were received from U.S.S.R., Greece and Portugal and these countries' returns were not analysed further. The overall compliance rate (excluding these countries) was 82% with a figure of 84% from Western Europe and 74% from Eastern Europe. An average time of 96 h (range 0-320) was devoted to pharmacology teaching in the medical curriculum in Western Europe with 124 (0-240) h in Eastern Europe. In contrast 28 h (0-210) was devoted to clinical pharmacology teaching in Western Europe and 27 h (0-90) in Eastern Europe. On average in Western Europe each medical school had 2 individuals trained in clinical pharmacology with 1.3 posts in the subject and the figures for Eastern Europe were 2.3 and 1.1 respectively. However these figures hide a wide variance in the teaching of clinical pharmacology. Particularly in Western Europe there are a number of medical schools in Italy, Spain and the Federal Republic of Germany (FRG) where clinical pharmacology is not taught and there is a dearth of individuals trained in the subject. Every effort to encourage clinical pharmacology and its teaching should be made, particularly in these countries.

Curriculum

Assessment of nausea.

In a standardized way three different methods of measuring nausea have been assessed in 849 patients enrolled in 4 double blind, randomized, clinical trials, and 2 observational studies. Nausea was measured before and 2, 4, 6, 8 and 24 hours after cancer chemotherapy by using a discrete scale (DS), a visual analogue scale (VAS) and a continuous chromatic analogue scale (ACCS), and it was evaluated according to 4 different dimensions: maximal intensity (MI) entity (E) duration (D) and quantity (Q). The distributions of nausea measurements in the population, agreement between the scales and their sensitivity, and agreement between dimensions and their sensitivity were analyzed. A uniform distribution of nausea measurements was found only in patients receiving chemotherapy without any antiemetic treatment. There was substantial equivalence of the different scales, and no advantage was shown an using an analogue (VAS) than a discrete (DS) scale. A trend toward increasing sensitivity in detecting differences as the dimensions of nausea considered became more inclusive of the various aspects of this symptom (Q more sensible than E more sensible than MI) was observed.

Antiemetics

Clinical pharmacology and primary health care in Europe--a gap to bridge. The WHO Working Group on Clinical Pharmacology in Europe.

A group of senior European clinical pharmacologists presents a position paper on the possible role of clinical pharmacology (CP) in bridging the gap between academic drug evaluation and drug prescribing in primary health care (PHC). As a teaching, research and service discipline CP has developed in academic or other major hospitals while 80% of all drugs are prescribed in PHC. CP therefore has to extend its functions to PHC. Examples are given of how joint ventures between clinical pharmacologists and PHC physicians may improve the quality of drug research and increase the clinical relevance of drug information in PHC, thereby contributing towards rational drug utilization in PHC. Colleagues in PHC are invited to respond to this call for collaboration.

Drug Prescriptions

Drug use in pregnancy: an overview of epidemiological (drug utilization) studies.

The need for further information on drug utilization patterns during pregnancy in different countries was assessed by reviewing literature obtained by hand and computer searches for the years 1960-1988. The 13 identified studies showed that pregnant women used an average of 4.7 drugs. The most commonly ingested medications were vitamins and iron preparations (almost all women), analgesics, antiemetics and antacids. However, the important variables taken into account differently in each study, such as date of surveillance, country, size of population, personal habits, and physiopathological and demographic characteristics, may it impossible to construct a comprehensive, detailed, up-to-date picture of drug utilization during pregnancy. The evaluation confirmed the need for systematic permanent surveillance of drug utilization in pregnancy, so as to avoid the use of data based on widely differing contexts, times and methods, in a field where knowledge is often derived from scanty information.

Drug Utilization

Clinical and electrophysiological findings in two cases of Miller Fisher syndrome.

Clinical, radiological and electrophysiological data in two patients with 'Miller Fisher syndrome' (MFS), characterized by ataxia, ophthalmoplegia and areflexia are reported. Of the many tests performed only the electrophysiological findings provided any clue to the site of the lesions and the structure involved, showing a significant pattern of brainstem dysfunction. The authors discuss the role of central and peripheral lesion theory in the light of these data and stress that electrophysiological findings lend considerable weight to the former and support the hypothesis that MFS should be recognize as a distinct clinical entity.

Ataxia

Cooperation in mental health: an Italian project in Nicaragua.

The experience acquired over the last four years in developing a program of cooperation in mental health in Nicaragua is reported. The concept of 'transfer' underlying the intervention and the general framework of Nicaragua's mental health system is discussed together with the results of the cooperative work. This included organizing training for mental health workers in six teaching and supervision modules, drawing up a mental health manual for primary health care workers, and survey of patterns of care in the 15 existing psychiatric services. Besides the key aspects of general reform of the psychiatric system after the revolution, the paper focuses on differences between organization and patterns of care in urban and rural areas.

Adult