Tibolone in the treatment of menopause: compliance, efficacy and safety in a ten year experience.

AIM: To assess tibolone compliance, efficacy and safety in everyday clinical practice a non-randomized, prospective, cohort clinical study was carried out. METHODS: One hundred and fifty post-menopausal women aged 48 to 73 years were prescribed tibolone: 72 of them were treated for 36.4 months, 55 terminated treatment after less than 1 year, while 23 never took the tablets after seeking for menopause counseling and having agreed upon the treatment. We examined: endometrial thickness and histology, total cholesterol, triglycerides, fibrinogen, AST, ALT, gamma-gt, and the body weight. RESULTS: Side effects were the main causes of withdrawal (32%), and insufficient therapeutic effect and adverse events for a small number of cases (5.5% and 4.7% respectively), while various causes (fear of cancer, missing tablets, family doctor or other specialist's advice, remission of symptoms) were responsible for terminating treatment after extended periods. Laboratory findings showed a favorable trend; only the (GT showed slightly higher mean values, although within a normal range. On average, weight during treatment increased of 1.5 kg, and endometrial thickness grew of 1.3 mm in a mean time of 34.5 months of observation. An average of 2.3%/year increase of bone mineral density was reported, though bone mass didn't improve in some patients. CONCLUSIONS: Different causes of terminating treatment are related to the length of treatment, side effects being the main reason for early withdrawals, efficacy on symptoms or medical advice or fear of treatment for extended periods of time. Effectiveness on bone mass, safety as resulting from endometrial thickness and laboratory measures are confirmed. It is suggested to enhance follow-up accuracy and reinforce counseling as measures to improve compliance.

Determination of enrofloxacin and its metabolite ciprofloxacin in goat milk by high-performance liquid chromatography with diode-array detection. Optimization and validation.

A high-performance liquid chromatography-diode array detection method (HPLC-DAD) combined with liquid chromatography-mass spectrometry was developed for the determination of enrofloxacin and its metabolite ciprofloxacin in goat milk. The HPLC-DAD method validation was compliant with the "DG SANCO 1805/2000" European regulation. The residues were extracted from milk with phosphate buffer, purified on a C18 Speedisk cartridge SPE (Baker) and then analysed using HPLC-DAD set at 277 nm. The decision limit (CCa) calculated by spiking samples at 100 microg/kg with both analytes, taking into account the maximum residue limit (MRL) of 100 microg/kg established by the European Union for the sum of enrofloxacin and its metabolite ciprofloxacin in milk, was 105.3 microg/kg for enrofloxacin and 105.5 microg/kg for ciprofloxacin. The detection capability (CCbeta) was 110.7 and 110.9 microg/kg for enrofloxacin and ciprofloxacin, respectively. The mean recoveries of the method, calculated by spiking samples at 50, 100 and 150 microg/kg were 84% for enrofloxacin and 88% for ciprofloxacin. The limit of quantification was 20 microg/kg for both analytes. The HPLC-DAD validated method was successfully applied for the first time in goats milk, and proved to be suitable for the sensitive and accurate quantification and confirmation analysis of enrofloxacin and ciprofloxacin for regulatory purposes.

Treatment of vulvar vestibulitis with submucous infiltrations of methylprednisolone and lidocaine. An alternative approach.

OBJECTIVE: To assess the efficacy of submucous infiltrations of methylprednisolone and lidocaine into the vulvar vestibule for the treatment of vulvar vestibulitis. STUDY DESIGN: Twenty-two patients were referred for vulvar vestibulitis. Methylprednisolone and lidocaine were injected into the vulvar vestibule once a week for three weeks at decreasing doses (1, 0.5, 0.3 mL). Follow-up was performed monthly for three months, then at six and nine months. Fourteen women have had 12 months and 5 women, 24 months of follow-up. RESULTS: Fifteen women (68%) responded favorably to the treatment, seven (32%) with absence of symptoms and eight (36%) with a marked improvement. Seven patients (32%) failed to respond in spite of a fourth dose (0.3 mL) given after 30 days. No relapse was observed at nine months' follow-up, while a further 0.5 mL infiltration followed by quick remission of symptoms was needed after one year in five patients. Five patients completed the 24 months' follow-up, with no need for further treatment. CONCLUSION: Submucous infiltration allows methylprednisolone to be deposited in the submucosa, the site of the inflammatory reaction, while the depot formulation allows gradual and prolonged release of the drug. Seven patients (32%) failed to respond, suggesting either that they had a kind of vulvar vestibulitis syndrome where inflammation is less remarkable or failure of the infiltrated drug to become adequately diffused.

[Vulvo-vaginitis in pediatric age]. / Vulvo-vaginite in età pediatrica.

In pediatric gynecology, inflammatory vulvo-vaginitis are very common. Their diagnosis cannot be based either on the symptoms (itching or pain) or on the signs (leucoxanthorrhea) for these classifications are "non-specific". At the Consulting Room of pediatric gynecology of the Vittore Buzzi Hospital, 215 "non-specific" vulvo-vaginitis cases have been analyzed through bacteriological and microscopical examinations of vaginal secretions. The vaginal tampon resulted negative in 53% of the cases and positive in the remaining 47%. Comparing these results with microscopical examinations we obtain: 81.8% of sensibility, 77.4% of specificity, 87.8% of negative predictive value and 62.2% of positive predictive value. In particular, this last figure is influenced by the high number of false positives of the vaginal tampons, due to the growth "in vitro" of opportunist germs momentarily quiescent "in vivo". Thus it is useful to associated the microscopical examination (that will indicate all the cases in need of treatment) and the bacteriological examination (that will indicate the right cure).