Mifepristone in Italy: the case of a drug trapped between ethics and clinical practice

In Italy mifepristone is not yet marketed. Gynaecologists in our hospital asked to use this medication as a less traumatic method for voluntary abortions. We followed the standard procedure defined by the Italian Health Ministry (IMH) for purchasing drugs from abroad but encountered several unexpected barriers. Starting from this case, this paper is aimed at identifying these barriers which we found to be not only professional, but also ethical, religious and moral.     

Nephrotic syndrome in a mother and her infant: relationship with cytomegalovirus infection

This case report describes infantile nephrotic syndrome (NS) in a baby girl with a clinically severe cytomegalovirus (CMV) infection. Culture of the baby's urine was positive for CMV and IgM anti-CMV antibodies were detected. After an unsuccessful course of corticosteroids, gancyclovir treatment was started and a remission of cutaneous, pulmonary, and renal symptoms was achieved. As the mother also developed NS at the end of pregnancy, a common etiology could be postulated, although there were no signs of recent CMV infection in the mother, only anti-CMV IgG. The relationship between CMV infection and glomerular disease is still unclear: NS may represent another manifestation of CMV disease.     

Detection of cryoglobulins by Coulter Counter model S-Plus IV/D

Cryoglobulins may produce interference in results from electronic particle counters. Depending on their size, cold-precipitable globulin crystals can be counted as leucocytes and/or platelets. The Coulter Counter model S-Plus IV/D permits detection of this interference and its associated spurious counts by producing a characteristic WBC histogram accompanied by a leucocyte 'flag'. Using this instrument over a 1-year period, 10 cases of cryoglobulinaemia were detected, four from patients with lymphoproliferative disease and one from a patient with autoimmune disease. The remaining five were classified as essential mixed cryoglobulinaemia. The reproducibility of this instrument anomaly permits identification of the presence of cryoglobulins.     

Prognostic value of the equivalents of transitory myocardial ischemia evaluated by exercise thallium-201 myocardial scintigraphy in an ambulatory population of 367 patients with a maximum 5-year follow-up

From 1-1-1981 to 3-31-1985, 367 subjects (227 males and 140 females) were examined by means of TL-201 myocardial scintigraphy for diagnostic purpose. A follow-up period, 5 years maximum, was run in order to assess the prognostic value of the three equivalents of transient myocardial ischemia which can be demonstrated by the test (angina, reversible hypoperfusion, and ST-T segment changes). The end points were myocardial infarction and/or sudden death. Three-hundred fifty-four patients complied (96%). During the observation period 9 severe ischemic events (SIE) occurred: 5 myocardial infarctions and 4 sudden deaths. As far as the predictivity of SIE is concerned, the "t" test for independent samples showed a statistically significant difference between the group of patients with no signs of ischemia and the group with positive scintiscan (p less than 0.05) and with the three equivalents of ischemia all together (p less than 0.05). Moreover, in the sub-group of patients with pathological scintigraphic results the probability for SIE to occur was statistically different in the patients with no hypoperfusion in the region supplied by the anterior descending coronary artery and in those with pathological scintigraphic findings in that region (p less than 0.05). In our opinion, the above data demonstrate the pathological signs noticeable with stress myocardial TL-201 scintiscan to have prognostic value.     

Difference in learning and retention by Albino-Swiss mice. Part 5. Effect of some antidepressants

According to the methods described earlier (1), the effect of some antidepressants on memory retention in "good" and "poor" learning mice was studied. The present study indicates that several antidepressants have different activity on memory retrieval of the two subtypes of animals, which is directly responsible for the results here reported. In general terms, the data obtained show that, in addition to the classical antidepressant activity, some derivatives may exert a behavioral disinhibition.     

Short-term and long-term stimulation of Na+−H+ exchange in cortical brush-border membranes during compensatory growth of the rat kidney

The effect of unilateral nephrectomy on Na⁺–H⁺ exchange in rat renal cortical brush-border membrane vesicles (BBMV) was studied by the method of acridine orange fluorescence quenching. The exchanger activity in BBMV from remnant kidney increased rapidly by 70–75% within first 30 min following uninephrectomy. Only a slight further increase was found in later stages of renal growth, i.e. 30 min to 7 days following uninephrectomy. The changes in antiporter activity were restricted toV _max, whereas theK _m for Na⁺ was similar in control and compensatory growing kidney. The increase of Na⁺–H⁺ exchange at 15 min was not affected by actinomycin D in vivo, whereas the increase at 48 h was completely abolished indicating that protein synthesis could be involved in the late, but not in the initial stimulation of renal Na⁺–H⁺ exchange. The late, but not the initial stimulations of Na⁺–H⁺ exchange were associated with elevated activities of cortical (Na⁺+K⁺)-ATPase indicating that changes in antiporter activity precede those in the (Na⁺+K⁺)-pump. The early stimulation of Na⁺–H⁺ exchange in BBMV in one kidney was induced also by the occlusion of blood flow through the contralateral kidney for 15 min, without removing it. Thirty min after the occlusion was removed and the reflow established, the Na⁺–H⁺ exchange in BBMV from the intact kidney decreased to the control values. The observed modulations in renal Na⁺–H⁺ exchanger may be regulated by phosphorylation-dephosphorylation events. In support, the concentration of a well known protein kinase C activator, 1,2-diacylglycerol, in the cortical tissue of the remnant kidney increased up to 100% within 5 min following unilateral nephrectomy and preceded the increase in Na⁺–H⁺ exchange. The early stimulation of Na⁺–H⁺ exchange may be a trigger in initiating the kidney growth.     

Antigenic characterisation of influenza B virus with a new microneutralisation assay: comparison to haemagglutination and sequence analysis

Although the haemagglutination inhibition assay is considered the "gold standard" for antigenic characterisation of influenza viruses, some limitations of this technique are well known. A new microneutralisation assay, as a tool for antigenic characterisation of influenza B viruses, has been standardised and its performance evaluated in comparison with the haemagglutination inhibition test in the light of molecular characterisation of the haemagglutinin. Twelve B viruses belonging to the two lineages and the four sub-lineages discriminated by phylogenetic analysis of HA were tested. The microneutralisation assay clearly distinguishes viruses belonging to different lineages and, in addition, discriminates strains belonging to different sub-lineages that are poorly or not discriminated using the haemagglutination inhibition test. This new microneutralisation assay could provide a useful tool for antigenic characterisation of circulating influenza viruses and contribute, together with the haemagglutination inhibition test and sequence analysis of the haemagglutinin and neuraminidase, in the choice of the strain for use in vaccine composition.