Pelvic floor rehabilitation for defecation disorders.

Pelvic floor rehabilitation is frequently recommended for defecation disorders, in both constipation and fecal incontinence. However, the lack of patient selection, together with the variety of rehabilitation methods and protocols, often jeopardize the results of this approach, causing difficulty in evaluating outcomes and addressing proper management, and above all, in obtaining scientific evidence for the efficacy of these methods for specific indications. The authors represent different gastroenterological and surgical scientific societies in Italy, and their aim was to identify the indications and agree on treatment protocols for pelvic floor rehabilitation of patients with defecation disorders. This was achieved by means of a modified Delphi method, utilizing a working team (10 members) which developed the statements and a consensus group (15 members, different from the previous ones) which voted twice also suggesting modifications of the statements.

[The advent of biosimilars: new rules to guarantee patient safety]. / L'avvento dei biosimili: nuove regole per garantire la sicurezza del paziente.

Biosimilars are medicinal products proposed as copies of biotech drugs whose patents have expired. Their entry into the therapeutic armamentarium entails knowledge of the rules established in Europe relevant to their use in clinical practice. In September 2007, an Italian panel of experts comprising two nephrologists, a clinical immunologist, an oncohematologist, a pharmacologist, and a hospital pharmacist examined the main features of biotech drugs and the issues faced by the regulatory authorities in the definition of a specific approval pathway for biosimilars in Europe. The panel of experts agreed that it is important to inform the medical and scientific community that biosimilars are not exact copies of their reference products; therefore the rules governing their clinical use are not the same as those established for biotech drugs in general. Patient safety should be the fundamental principle guiding therapeutic choices, and making these choices should be the prerogative of physicians.

Gastrointestinal tubercular arteritis during HIV infection.

Although digestive tract is often involved in HIV disease, severe gastrointestinal bleeding rarely occurs. We describe a case of severe gastrointestinal bleeding associated with a mycobacterium tuberculosis arteritis of colonic tract. It is reported a morphology change of mesenteric arteries by mycobacterium tuberculosis revealed by angiography. The superselective embolization of branches mesenteric inferior artery resolved the important bleeding without surgical intervention. In AIDS patients, during intestinal tuberculosis, massive enteric-hemorrhage suggests for involvement of mesenteric arteries by mycobacterium tuberculosis. An angiography is basic to discover bleeding and if necessary for the therapeutic treatment.

Intestinal microsporidiosis in Italian individuals with AIDS.

A survey on microsporidiosis in individuals with AIDS presenting chronic diarrhoea was carried out in Italy, over a four-year period (1992-1995). Three out of 72 (4.2%) individuals were found positive, on intestinal biopsies, for Enterocytozoon bieneusi by light microscopy and transmission electron microscopy (TEM). Sixteen individuals with AIDS, from a second group of subjects, were confirmed positive, by TEM, for intestinal microsporidiosis due to Enterocytozoon bieneusi. Of these 19 cases, 10 (52.6%) were homosexual men. Two of these individuals, under albendazole treatment, showed also spores with unusual features. The prevalence of intestinal microsporidiosis (12-50%) reported in European countries, Australia and North America, where homosexuality is the major HIV risk factor (63-77%), is higher than in Italy, where homosexual men represent only 16% of the total number of AIDS cases.

[A case of Kaposi sarcoma of the pharynx as a primary manifestation of the acquired immunodeficiency syndrome]. / Su di un caso di kaposi faringeo come prima manifestazione della sindrome da immunodeficienza acquisita.

Unusual infectious and neoplastic complications regularly represent the first manifestation of the acquired immunodeficiency syndrome. Otorhinolaryngologists have to be aware of AIDS manifestations in as much as head and neck findings are frequent and are sometimes the initial presentation of HIV infection. The Authors report the case of a patient with a pharyngeal Kaposi in sarcoma, then point out the importance of otorhinolaryngological evaluation complete diagnosis of the syndrome.

Stability of ifosfamide in solutions for multiday infusion by external pump.

The stability of ifosfamide in Ringer lactate buffer solution either alone or mixed with mesna at 37 degrees C for a 7-day period was analyzed by HPLC. This study was performed to investigate the feasibility of continuous infusion of ifosfamide by a multiday pump in order to reduce the toxicity and to increase the production of active alkylating metabolites of the parent drug. The total decay of ifosfamide activity did not exceed 3.2% at day 7. We conclude that ifosfamide can be safely delivered in a 7-day infusion with no significant loss of activity.

Effect of a medium dose of ursodeoxycholic acid with or without taurine supplementation on the nutritional status of patients with cystic fibrosis: a randomized, placebo-controlled, crossover trial.

Ursodeoxycholic acid administration has been reported to improve cholestasis and inflammatory activity in primary biliary cirrhosis and, in an uncontrolled study, also in young adults with cystic fibrosis (CF) and chronic cholestasis. As an improvement in nutritional status was also observed in these young adult patients, we investigated whether the administration of a medium dose of ursodeoxycholic acid ameliorates the nutritional status of malnourished young adult CF patients with chronic liver disease. The study included 51 patients (27 male patients and 24 female patients; age range, 8-32 years; median, 14) with body mass percentiles < 90%. Patients were randomly assigned to receive either ursodeoxycholic acid (10-12 mg/kg/day) alone or with taurine (18-22 mg/kg/day). Patients were followed in a crossover fashion within each group; 6 months of treatment was randomly alternated with 6 months of placebo. Nine patients dropped out before concluding the study. Liver function tests, nutritional status, and coefficients of fat absorption were determined at entry and after each 6 months of placebo or treatment. Nutritional status and fat absorption were not significantly modified by either treatment. Liver function tests improved after ursodeoxycholic acid administration only in patients with concomitant chronic liver disease. Our findings indicate that 6 months of therapy with a medium dose of ursodeoxycholic acid, either alone or with taurine, does not improve the nutritional status of young malnourished CF patients. Higher doses given for longer periods might be worth investigating.

Prevalence of hepatitis C virus antibodies and hepatitis C virus-RNA in an urban population.

Several studies had been carried out on anti-hepatitis C virus (HCV) prevalence in populations with blood exposure risks and in blood donors. New tests are now available which allow the investigation to extend to other parameters such as antibody type and HCV-RNA. In this study the prevalence of anti-HCV c100-3 and the associated epidemiological, clinical, and virological markers were evaluated in subjects from an urban population located in central Italy. In positive cases the time persistence of HCV-RNA and anti-HCV antibody pattern was studied. For this purpose, sera from 1,484 randomly sampled individuals, aged 30-69 years, collected in 1985 and stored at -80 degrees C were retrospectively tested. The prevalence was 0.87% (i.e., 13 anti-HCV c100-3 positive cases). A significant association was observed with raised alanine transaminase (ALT) levels (P less than 0.001). Paired serum samples from 11 out of the 13 subjects collected in 1985 and 1991 were tested by nested polymerase chain reaction (PCR) using primers from the 5' non-coding region and by 4-RIBA. Concordant RIBA patterns between 1985 and 1991 were observed in the majority of positive paired sera (7/9) as well as for HCV-RNA (6/9). HCV-RNA was present in sera simultaneously positive to both types of antibody or to anti-c100-3 or anti-c22 alone. A wide spectrum of viral and antibody patterns in anti-HCV c100-3 positive sera was observed in this urban population and persisted for at least 6 years.