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Biomedical subjects

G Tognoni

Publications and source records attributed to G Tognoni.

At least 163 records · Page 9Linked to original sources

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↗

Incidence and prognosis of secondary ventricular fibrillation in acute myocardial infarction. Evidence for a protective effect of thrombolytic therapy. GISSI Investigators.

The multicenter randomized study of the Gruppo Italiano per lo Studio della Streptochinasi nell'Infarto Miocardico has provided the opportunity to analyze the impact of thrombolytic treatment on secondary ventricular fibrillation incidence in a large population of patients (11,712) with acute myocardial infarction. A reduction of about 20% in the frequency of secondary ventricular fibrillation was observed among patients allocated to thrombolytic treatment (streptokinase, 2.4% versus control, 2.9%; relative risk, 0.80; 95% confidence interval, 0.64-1.00). Streptokinase appeared to exert its protective effect specifically in patients treated within 3 hours of onset of symptoms (streptokinase, 2.6% versus control, 3.7%; relative risk, 0.71; 95% confidence interval, 0.53-0.95). This protection was essentially due to a reduced incidence of late ventricular fibrillation occurring after the first day of hospitalization. The 311 patients with secondary ventricular fibrillation represented an overall incidence of 2.7%. Such incidence was not related to infarct location or sex but was significantly more common in patients older than 65 years (3.3% versus 2.3% in younger patients). A significant excess of in-hospital deaths was found in patients with secondary ventricular fibrillation compared with those in the reference group (38% versus 24%; relative risk, 1.98; 95% confidence interval, 1.56-2.52). Conversely, secondary ventricular fibrillation was not a predictor of 1-year mortality for hospital survivors. Thrombolytic treatment with intravenous streptokinase affords protection against secondary ventricular fibrillation most probably by a limitation of infarct size. When the arrhythmia complicates the course of infarction, it is associated with an adverse short-term outcome, whereas the long-term prognosis is not influenced.

Aged↗

The GISSI-2 trial: premises, results, epidemiological (and other) implications. Gruppo Italiano per lo Studio delia Sopravvivenza nell'Infarto Miocardico.

Population trials on myocardial infarction have produced significant advances in therapeutic results. The first clearly stated aim of the GISSI-2 protocol was the assessment of the overall benefit to a population attributable to the application of a package of pharmacological treatments (thrombolysis, intravenous beta blockade, and oral aspirin) shown effective in reducing mortality in large-scale randomized clinical trials. At variance with the classical concept of trials, a clinical epidemiological interest came first: The comparison between drugs was considered a main target of the investigation only within that broader framework, and was explicitly formulated as the direct confrontation between two concepts or two generations of thrombolysis. A selective, highly efficient, and specific new thrombolytic agent, tissue plasminogen activator (tPA), is compared with streptokinase with the expectation that the more selective approach could enhance the benefits of specificity, drastically limiting the systemic risks aspects (hemorrhagic complications). The main results of GISSI-2 are summarized. GISSI-2 may be considered a reliable window on the epidemiology of AMI in a whole country. There are implications for the transfer of these clinical findings into public health applications and for the choice of future research priorities.

Adrenergic beta-Antagonists↗

GISSI trials in acute myocardial infarction. Rationale, design, and results.

The first Gruppo Italiano per lo Studio della Streptochinasi nell'Infarto (GISSI) study showed striking evidence of the effectiveness and safety of intravenous thrombolytic treatment in acute myocardial infarction (MI). Since publication in The Lancet, the original report has become a reference work for every paper which deals with thrombolysis. In addition to GISSI's scientific value, these studies applied formal research to routine clinical practice outside of referral centers. Nearly all Italian CCUs took part in the GISSI projects, so that the results provide a profile of the patient who seeks care for acute MI in Italy. This wide data base allowed GISSI investigators to look into some relevant clinical events, eg, primary ventricular fibrillation, stroke, and in-hospital reinfarction. The GISSI-2 trial followed the GISSI-1 philosophy. The package of treatments recommended after extensive discussion with all the investigators (beta-blocker, aspirin, nitrates) was widely adopted. Now, only five years after the start of the GISSI-1, the overall mortality of Italian patients with acute MI has decreased from 13.0 percent to about 9 percent, and the number of patients with acute MI arriving in hospital within 1 h of the onset of symptoms has increased 50 percent. It is the wish of the GISSI investigators that this approach to treating acute MI will be regarded and acknowledged as their major contribution to the problem.

Clinical Trials as Topic↗

[Epidemiology of the avoidable delay in patients with acute myocardial infarct admitted to the coronary care unit].

Despite the availability of safe and effective drugs for the treatment of acute myocardial infarction, nowadays, only a minority of patients arrive at the hospital early enough to receive the benefit of these treatments. The reason for this is still uncertain. Our intention was to review the literature on this topic, check if there were some issues that could be identified as delay-promoters, and see if any Italian data were available, in order to make a comparison with international data. We found a substantial agreement among the Authors that median total delay (i.e. the time between the onset of symptoms and the arrival at the hospital) is between three and five hours, and it seems that this has remained fairly stable over the years. The decision delay (i.e. the time between the onset of symptoms and the first medical contact) is almost unanimously indicated as the major single component in the total delay. This represents around 40% of the pre-hospital phase. Transportation time appears to play only a slight role, if indeed any, in the total delay. Nonetheless, mobile coronary units have consistently shown that they can reduce thrombolysis time (e.g. the time between the onset of symptoms and the start of thrombolytic infusion) by almost 60 minutes, and this time-gain is comparable with the reduction in total delay obtained in Sweden with a media campaign. Strongly contrasting results were obtained from the analysis of the delay-determining factors.(ABSTRACT TRUNCATED AT 250 WORDS)

Coronary Care Units↗

Prognostic significance of the extent of myocardial injury in acute myocardial infarction treated by streptokinase (the GISSI trial).

To evaluate the different contributions of infarct site and infarct extent in determining the in-hospital outcome and efficacy of thrombolytic therapy, 8,731 patients with a first Q-wave acute myocardial infarction (AMI) enrolled in the GISSI trial were studied. On the basis of the standard 12-lead electrocardiogram, the sample was classified in 2 ways: classic electrocardiographic site pattern (anterior, inferior, lateral and multiple location), and number of standard electrocardiographic leads with ischemic ST elevation (small, modest, large and extensive infarct in 2 to 9 leads). In-hospital mortality was evaluated according to infarct site, infarct extent and fibrinolytic treatment. The mortality rate was differently distributed in the various infarct sites. Streptokinase significantly reduced mortality only in anterior (13.8 vs 18.7%) and multiple site infarcts (8.1 vs 12.5%). According to the infarct extent observed, there is a progressive increase in the mortality rate--from 6.5% in small infarcts to 9.6% in modest, 14.3% in large and 21.7% in extensive. No significant benefit was obtained by streptokinase in small infarcts; in contrast, a significant decrease in mortality was achieved in modest (7.7 vs 11.4%), large (12.8 vs 16.6%) and extensive infarcts (19.5 vs 23.9%). Thus, the extent of myocardial injury seems to be more relevant than the site in determining in-hospital mortality and efficacy of thrombolytic therapy.

Electrocardiography↗