[Drug surveillance and adverse reactions to drugs. The literature and importance of historical data]. / Farmacovigilanza e reazioni avverse ai farmaci. Lettura e significato dei dati storici.

The authors highlight the essential role of pharmacovigilance and the need for a simple, efficient and low-cost system of adverse reaction (AR) reporting which could cover the whole population and all marketed drugs, and suggest that the only one presently viable is based on spontaneous reporting. To support their proposal the authors provide a definition of AR and of the different monitoring system, and list as many drugs as possible to find in the literature that have been associated with a specific AR, together with the active molecule, the therapeutic indication, the features of the AR and the regulatory actions (withdrawal from the market, restriction of use). Moreover, by describing the "history" behind some of these drugs the authors highlight the contribution that pharmacovigilance and spontaneous reporting have had to the development of regulations for approval and marketing of new drugs. It is also highlighted how some of these unexpected events (thalidomide, DES) have had a significant and important contribution to pharmacological and toxicological knowledge.

[Toxicology of reproduction and development. Changes in the male reproductive function caused by drugs and pollutants: potential effects on offspring]. / Tossicologia della riproduzione e dello sviluppo. Alterazioni della funzione riproduttiva maschile da farmaci e inquinanti: possibili effetti sulla progenie.

Published clinical observations underline the difficulty of defining with epidemiological studies the effects that chemicals such as drugs, illicit substances environmental and workplace pollutants might have on the offspring through the male parent. The Authors highlight how defining this issue might help both guide preclinical research and evaluate correctly clinical observations which are often difficult to interpret based only on observations in the female parent. Clinical research already available shows that some chemicals are able to modify fertility by acting either at the neuroendocrine level or on the testis. However, it is more difficult to identify and quantify the potential damage to the offsprings during the different phases of pregnancy and postnatal life. Finally, the Authors discuss the parameters that should be considered to obtain an algorithm for evaluating the reproductive risk in males, along the lines of the risk for the embryo and fetus due to the use of drugs during pregnancy. Moreover, it is suggested that among the unwanted effects of drugs and pollutants, those related to the different components and phases of the male reproductive function be reported also in relation to the patient's age.

[Acute renal damage caused by ampicillin. Description of a case]. / Danno renale acuto da ampicillina. Descrizione di un caso.

Approximately one week after a cycle of antibiotic therapy using ampicillin for pulmonary inflammation, an 82-year-old woman developed symptoms of acute renal insufficiency reminiscent of nephrotic syndrome. Symptoms were completely reversible and normal renal function was recovered (even after 14 months of follow-up). The Authors conclude by attributing this to acute tubulo-interstitial nephropathy due to hypersensitivity to ampicillin.

[Cerebral circulation and therapy of hypertensive crises]. / Circolo cerebrale e terapia delle crisi ipertensive.

The availability of new and more active drugs as well as the progress in emergency medicine have made it possible to deal in new ways with the therapy and management of hypertensive crises. The more aggressive character of this treatment leads us to reconsider the risk/benefit ratio also on the basis of changes brought about by the drugs used in the compensatory cardio-vascular equilibria that have become established in the course of the disease, as well as the possibility, that rapid and intensive pressure reductions bring about phenomena of brain hypoxia to the extent of drug syncope and brain damage. After analyzing phenomena of adaptation of brain circulation to the hypertensive disease, the authors discuss risk factors of therapeutic choices in relation to the mechanism of action of the drugs available and used, to different clinical situations and to the patient's age.

[Problems of pharmacokinetics in pregnancy. A bibliographic review]. / Problemi di farmacocinetica in gravidanza. Rassegna bibliografica.

Drug prescription in pregnancy for the treatment of maternal diseases and the first attempts to obtain therapeutic effects even on the product of conception make necessary to know the pharmacokinetics of drugs in pregnancy. The Authors discuss how changes of physiological maternal parameters and the presence of the placenta and of the foetus can affect drug pharmacokinetics in a clinically important way. The possibility that the unique multicompartmental structure of the maternal-placental-foetal unit can "trap" drugs in the foetus is highlighted. Methodological, ethical and legal problems make the acquisition of data on these changes difficult, but their knowledge is needed in order to prevent adverse and toxic effects both in the pregnant woman and in the foetus and to attempt a therapy of foetus diseases in intrauterine life.

[Changes in several immunological parameters and the presence of anti-HTLV III antibodies in drug addicts]. / Modificazioni di alcuni parametri immunologici e presenza di anticorpi anti-HTLV III in tossicodipendenti.

The immunological picture in a group of heroin addicts and in a methadone treated group was evaluated. Ninety-six per cent shows modifications of the lymphocyte pattern, independently of the type of opium derivative administered. The OKT4/OKT8 ratio considered one of the hallmarks of acquired immunodeficiency, turns out to be reduced in 64.6% of the cases. In these latter the most outstanding defect is made up by the T-helper drop (83.8% of cases), limited to 23.5% in the group with normal OKT4/OKT8 ratio. The most significant variant between the two groups is represented by the positivity of anti-HTLV III test, which switches from 47 to 74.1% in the patients with reduced ratio. Immunoglobulins turn out to be increased in 81.2% of the cases, independently of the opium derivative administered and without significant differences in relation to the OKT4/OKT8 ratio. Therefore two immunological patterns seem to coexist in the population studied, which very likely represents two evolutive moments of the same disorder with an earlier phase of hyperimmune condition from a persistent antigenic stimulation which characterizes the situation at risk. In a later phase, the impact of HTLV III infection causes the deletion of the lymphocyte helper subpopulation which elicits the immunodepressive situation.