Efficacy and safety of oral administration of a product based on hydroxytyrosol as preventive therapy for recurrent vulvo-vaginal candidosis: a prospective observational pilot study.

OBJECTIVE: The aim of the study is to evaluate the efficacy and safety of hydroxytyrosol for the prevention of the vulvar vaginal candida infections recurrence. PATIENTS AND METHODS: This study is a prospective observational pilot study. Eligible subjects were at least 18 years old, with at least 4 documented episodes of vulvovaginal candidiasis in the last 12 months. Patients were instructed to therapy (2 tabs daily for the first month and then 1 tab daily for 2 other months). Each capsule consists of hydroxytyrosol (HT) and other components: tea tree oil, tabebuia, juglans regia, and copper. Clinical and microbiological assessments took place at baseline and 12 weeks after. The impact on Quality of Life (QoL) was evaluated with the SF-36 and the Patient Global Impression of Improvement (PGI-I) after 3 months of treatment was calculated. RESULTS: Sixty patients were enrolled in the study. In the last 1 year the mean number of previous infections was 5.83 ± 2.76. Forty-nine patients (83%) did not have candida episodes during 3 months of treatment. A significant reduction in clinical symptoms, vaginal signs, such as pruritus, burning and vulvar erythema (< 0.0001). The SF-36 showed a significant change (55.67±8.43 vs. 84.56±11.56, p < 0.0001) and the total success at PGI-I was reported in 54 patients (90%). CONCLUSIONS: The HT-based product is effective and safe in preventing recurrent candida episodes and improves the quality of life and sexual function of treated women.

A medical device containing purified bovine colostrum (Monurelle Biogel) in the treatment of vulvovaginal atrophy in postmenopausal women: Retrospective analysis of urinary symptoms, sexual function, and quality of life.

OBJECTIVE: This study assessed the effectiveness and safety of a medical device containing purified bovine colostrum (Monurelle Biogel; Zambon, Bresso, Italy) in improving vulvovaginal atrophy (VVA), sexual function, urinary symptoms, and quality of life (QoL) in postmenopausal women. METHODS: In all, 172 postmenopausal women with VVA were included in the study. All women were treated with vaginal Monurelle Biogel daily for 12 weeks. Patients underwent clinical examinations, completed a 3-day voiding diary, and had VVA graded using the Vaginal Health Index (VHI) at baseline and 12 weeks. Patients also completed the Female Sexual Function Index (FSFI), overactive bladder questionnaire (OAB-Q), and the Urogenital Distress Inventory (UDI-6), among others. RESULTS: After 12 weeks, there were significant increases in mean (± SD) VHI (12.53 ± 3.67 vs. 19.31 ± 3.49; P < .0001), the number of patients engaging in regular sexual activity 102 (59.3%) vs. 144 (83.7%), and in the total FSFI score (21.64 ± 2.99 vs. 28.16 ± 1.93; P < .0001) compared with baseline. In addition, there were significant reductions in the mean number of 24-hour voids (9.57 ± 2.12 vs. 7.13 ± 1.22; P < .0001), urgent micturition episodes per 24 hours (1.75 ± 0.76 vs. 1.14 ± 0.87; P = .001), nocturia episodes (1.58 ± 0.85 vs. 0.97 ± 1.18; P = .0002), and urinary incontinence episodes per 24 hours (0.74 ± 0.59 vs. 0.28 ± 0.52; P = .003). Finally, after 12 weeks treatment, there were significant differences in UDI-6 (7.85 ± 0.81 vs. 5.56 ± 1.40), OAB-Q symptom (53.60 ± 12.57 vs. 22.08 ± 9.63), and OAB-Q health-related QoL (21.75 ± 8.51 vs. 69.34 ± 14.59) scores compared with baseline (P < .0001 for all). The Patient Impression of Global Improvement scale revealed global improvement in 143 women (83.14%). CONCLUSIONS: Monurelle Biogel is an effective treatment for VVA in postmenopausal women, improving sexual life, urinary symptoms, and QoL.

[Tubo-peritoneal factor of infertility: diagnosis and treatment]. / Diagnosi e terapia del fattore tubo-peritoneale di sterilità.

Infertility, defined as the inability to conceive despite regular unprotected sexual intercourse over 12 years, affects approximately 10% of the fertile population. The commonest cause of tubal damage is pelvic inflammatory disease (PID), which in the developed world is caused mainly by Chlamydia trachomatis infection. The incidence of tubal damage after one episode of pelvic infection is approximately 12%, 23% after two episodes and 54% after three episodes. Other causes of tubal damage include postsurgical adhesions or endometriosis. Tubal patency can be diagnosed by hysterosalpingography (HSG) or laparoscopy with chromopertubation. Surgery represents the best therapeutic approach for tubal pathology, with a term pregnancy rate of 70% after surgery in selected patients, while the latest results in Italy of assisted reproductive technology (ART) report a live birth rate per cycle of 13.8%. In conclusion, tubal reconstructive surgery remains an important option for many couples and surgery should be the fi rst line approach for a correct diagnosis and treatment of tubal infertility.

[Use of bulking agents in urinary incontinece]. / L'utilizzo dei bulking agents nel trattamento dell'incontinenza urinaria.

Urinary incontinence consist in voluntary urine leakage. Female affected in the world are about 200 thousand. Urinary incontinence affect severely women quality of life. There are different kinds of urinary incontinence that can be treated in different ways. We can use pelvic floor rehabilitation, drug therapy, invasive and non-invasive surgical treatment. Different treatments are used for different incontinence types. Periurethral injection is the most common procedure between non-invasive surgery. The most recent bulking agents occasionally determine severe adverse reaction or complication. Frequently we can have just pain during injection and a temporary urine retention. During the latest years we used a lot of bulking agents: bovine collagen, autologous fat, carbon particles, macroplastique, calcium hydroxylapatite, ethylene vinyl alcohol copolymer, dextranomer. Urethral injection have success in 40-90%. We can assert that macroplastique is the most efficacy and safe on the basis of literature data and of our experience data. This surgical procedure, in fact, has good percentage of success in accurately selected patients. In our experience Macroplastique can also be used in oncological patients, in elderly women, in patients with important comorbidity and with high surgical risk with good objective and subjective results.

Bulky lymph node resection in patients with recurrent epithelial ovarian cancer: impact of surgery.

The aim of this study was to evaluate the role of systematic lymphadenectomy, feasibility, complications rate, and outcome in epithelial ovarian cancer (EOC) patients with recurrent bulky lymph node disease. A prospective observational study of EOC patients with pelvic/aortic lymph node relapse was conducted between January 1995 and June 2005. After a clinical and laparoscopic staging, secondary cytoreduction, including systematic lymphadenectomy, were performed. The eligibility criteria were as follows: disease-free interval > or =6 months, radiographic finding suggestive of bulky lymph node recurrence, and patients' consent to be treated with chemotherapy. Forty-eight EOC patients with lymph node relapse were recruited. Twenty-nine patients were amenable to cytoreductive surgery. Postoperatively, all patients received adjuvant treatment. The median numbers of resected aortic and pelvic nodes were 15 (2-32) and 17 (8-47), respectively. The median numbers of resected aortic and pelvic positive lymph nodes were 4 (1-18) and 3 (1-17), respectively. The mean size of bulky nodes was 3.3 cm. Four patients (14%) experienced one severe complication. No treatment-related deaths were observed. After a median follow-up of 26 months, among cytoreduced patients, 18 women were alive with no evidence of disease, nine were alive with disease. Among the 11 patients not amenable to surgery, five women were alive with persistent disease, six patients died of disease, at a median follow-up of 18 months. Estimated 5-year overall survival and disease-free interval for operated women were 87% and 31%, respectively. In conclusion, patients with bulky lymph node relapse can benefit from systematic lymphadenectomy in terms of survival. The procedure is feasible with an acceptable morbidity rate.

Liposome-encapsulated doxorubicin citrate in previously treated recurrent/metastatic gynecological malignancies.

The aim of this study was to evaluate the safety and efficacy of liposome-encapsulated doxorubicin citrate (LEDC) in patients affected by recurrent/metastatic gynecological malignancies scheduled for palliative chemotherapy. Inclusion criteria were proven recurrent/advanced gynecological neoplasms, measurable/assessable disease, adequate organ function, left ventricular ejection fraction >50% as determined by echocardiography, informed consent. LEDC was administered intravenously over 1 h at the dose of either 75 mg/m(2) or 60 mg/m(2) (every 3 weeks until disease progression or toxicity prohibiting further therapy). From May 2003 to September 2005, 36 patients were enrolled. Primary disease was ovarian, endometrial, and cervical cancers in 15 (42%), 11 (30%), and 10 (28%) patients, respectively. LEDC was employed as third- or fourth-line chemotherapy in 25 (70%) and 11 (30%) patients, respectively. The median number of courses of LEDC received was 3 (range 2-9). Six patients (17%) achieved a partial response to treatment lasting 27 weeks and 10 patients (28%) experienced stable disease lasting 18 weeks. The predominant toxicity was hematological, especially neutropenia. Among patients receiving a dose of 75 mg/m(2), two (11%) suspended therapy for febrile neutropenia, and nine (50%) required a dose reduction of 25%. As a result, the next 18 patients were treated at a reduced dose (60 mg/m(2)) of LEDC. Severe neutropenia (G3-G4) was significantly less common in this group (61% versus 22%; P= 0.04). LEDC has shown antineoplastic activity in previously treated recurrent/metastatic gynecological cancer patients and the toxicity profile could be considered acceptable at a 60 mg/m(2) dosage.

Hemoglobin variation and blood transfusion rates in patients affected by locally advanced cervical cancer undergoing neo-adjuvant chemotherapy followed by radical surgery: the role of erythropoietic growth factors.

BACKGROUND: The objectives of the present study were to evaluate hemoglobin levels and consequent clinical behaviors related to anemia developed in patients affected by locally advanced cervical cancer treated with neo-adjuvant chemotherapy in the last decade and to evaluate the impact that the introduction of erythropoietic growth factors had in the clinical practice. PATIENTS AND METHODS: Blood chemistries, prospectively recorded from 98 cervical cancer patients, treated with neo-adjuvant chemotherapy and, if necessary, erythropoietic growth factors, were compared with matched historical controls before the introduction of growth factors in clinical practice. RESULTS: Hemoglobin level in the study group did not differ significantly during chemotherapy. At the third cycle of chemotherapy and at the end of chemotherapy, hemoglobin level was significantly higher in the study group compared with the control group. Transfusion rates in the study group were significantly lower. The analysis within the study group revealed that hemoglobin level in patients who suffer at diagnosis from anemia tends to increase whereas hemoglobin level in nonanemic patients tends to decrease. CONCLUSIONS: Erythropoietic growth factors increase hemoglobin level and reduce blood transfusions in cervical cancer patients undergoing neo-adjuvant chemotherapy followed by radical surgery. An appropriate autologous blood donation program can noticeably reduce homologous blood transfusions.

The role of neoadjuvant chemotherapy followed by radical surgery in the treatment of locally advanced cervical cancer.

In 1984 the first pilot study on neoadjuvant chemotherapy in cervical cancer was reported. Since then, many investigators have studied the possible role that this therapeutic strategy could achieve in patients. Different chemotherapic combinations are constantly being attempted in order to obtain the maximum tumour response. At the same time few randomised studies have demonstrated the superiority of this treatment when adopted before radical surgery, in terms of overall survival compared to radiotherapy alone. Recently a detailed meta-analysis has been performed and the results confirmed what previously was achieved by the randomised trials. Since the beginning of all the phase III trials, the standard treatment of locally advanced disease has been modified from radiotherapy alone to concomitant radio-chemotherapy. For this reason the EORTC group has launched a trial with the objective of comparing neoadjuvant chemotherapy followed by radical surgery versus concomitant chemo-radiotherapy.

[Efficacy of estrogen therapy in urinary incontinence. A meta-analytic study]. / Efficacia della terapia estrogenica sull'incontinenza urinaria. Studio metanalitico.

OBJECTIVE: To analyze by meta-analysis the results of randomized controlled clinical trials on the efficacy of estrogen treatment in menopausal patients with urinary incontinence. STUDY DESIGN: Meta-analysis. MATERIALS AND METHODS: Randomized controlled clinical trials, published from January 1965 to December 1996, on estrogen therapy in patients with urinary incontinence, were selected. They included: trials with placebo vs estrogen therapy, studies on menopausal patients with confirmed diagnosis of urinary incontinence based on clinical and/or urodynamic tests, studies with sufficient statistical informations on the results obtained and with information about subjective and objective outcome. RESULTS: Out of 72 articles reviewed, 7 were selected and only 4 were considered on the basis of the requested criteria. Subjective outcome was statistically different in patients treated with estrogen therapy compared with patients treated with placebo. Objective clinical and urodynamic outcome was not statistically different in the two types of treatment (estrogen vs placebo treatment). CONCLUSIONS: There were few published randomized controlled studies on estrogen therapy in patients with urinary incontinence in medical literature. Different results between subjective and objective outcome showed by meta-analysis, could be explained either by an estrogen induced unperceivable improvement not registered by clinical and instrumental parameters or by insufficient systems used to collect subjective data. Therefore, it is suggested that, for future research, randomized controlled clinical trials on topical or transcutaneous systemic estrogen treatment with a more than 6 months follow-up will be carry out.

[Treatment in the event of antibiotic prophylaxis failure in gynecologic surgery. A retrospective study of 20 cases]. / Sul trattamento in caso di fallimento dell'antibiotico-profilassi in chirurgia ginecologica. Esame retrospettivo di 20 casi.

A retrospective study was performed of the type of treatment used in 20 patients undergoing gynecological surgery in whom antibiotic prophylaxis with Mezlocillin (2 g i.v.) had failed. Patients were subdivided into three groups: A) Initial therapy with Mezlocillin (8 patients, 2 g/die i.m.) or Cefotetan (2 patients, 2 g/die i.m.) and subsequent addition of Gentamicin (8 patients, 240 mg/die i.m.) or Tobramycin (2 patients, 200 mg/die i.m.) and subsequently Metronidazole (7 patients, 1.5 g/die per os). B) Therapy with Imipenem/Cilastatin (6 patients, 1.5 g/die i.m.). C) Therapy with Imipenem/Cilastatin (4 patients, 1.5 g/die i.m.) after a variety of antibiotics: Cotrimoxazole (Trimethoprim 160 mg/die and sulphamethoxazole 800 mg/die per os), Pefloxacin (800 mg/die per os), Cefotetan (2 g/die i.m.) and Mezlocillin (2 g/die i.m.). Time taken to lower temperature was shorter in Group B (3.5 days) compared to Group A (6.8 days) and Group C (10 days). Postoperative hospital stay was also shorter in Group B (9 days) compared to Group C (16.5 days) and Group A (11.1 days). The immediate administration of an antibiotic active against Gram+ and Gram- germs, aerobes and anaerobes is therefore useful in the event of failure of antibiotic prophylaxis, rather than the use in succession of associations of antibiotics with a limited spectrum.

Formation and spontaneous closure of an arteriovenous fistula after transvenous pacemaker placement.

We report the findings in a patient with the unusual complication of arteriovenous fistula formation of the subclavian vessels seven weeks following placement of a dual-chamber pacemaker. The fistula's subsequent course was equally unusual, closing spontaneously three weeks later. It is postulated that the thrombotic and fibrotic reaction elicited by the leads contributed to the fistula's closure. Two surgical procedures, correction of the fistula and reimplantation of the pacemaker, were thus avoided by careful monitoring of the patient.

Atrial regulation of intravascular volume: observations on the tachycardia-polyuria syndrome.

The atria, strategically located at the junction of the venous and arterial circulation, contain a network of neural and humoral structures by which they sense and regulate intravascular volume. Atrial receptors, most commonly consisting of complex unencapsulated nerve endings discharging into myelinated vagal fibers, are located in the intrapericardial portions of the caval and pulmonary veins and the adjacent atrial walls. Receptor activation by atrial distension results in increased afferent vagal fiber discharge, which in turn leads to tachycardia (Bainbridge's reflex) and decreased renal sympathetic nerve activity, renal vasomotor tone, and antidiuretic hormone activity. In addition, atrial distension also releases ANF, a peptide with potent diuretic, natriuretic, and vasorelaxant actions. The combined effect of these neurohumoral changes is the production of a large hypotonic diuresis. In the clinical setting the volume-regulating role of the atria is demonstrated by the tachycardia-polyuria syndrome. Laboratory and clinical evidence points to the activation of atrial neurohumoral mechanisms in response to atrial distension as the mediators of the polyuria that often accompanies paroxysmal tachycardias. The involvement of these mechanisms in other forms of cardiac congestion and the capability to easily measure in the blood an index of atrial distension, namely ANF, provide the opportunity to elucidate the pathophysiology and hence to open new therapeutic avenues in many cardiac disorders.

Function of ventricular pacemakers during resuscitation.

The reciprocal effects of resuscitation and permanent, ventricular-inhibited pacemakers were examined in four, well-documented cases of witnessed out-of-hospital arrest. The resulting observations provide useful insight in the treatment of cardiac arrest in the large number of patients with permanent pacemakers. Transient sensing malfunctions occurred in the two patients in whom direct current countershocks were not required and were probably related to the severely deranged state of the myocardium. In spite of periods of asynchronous pacing in this critically unstable setting, no arrhythmias were precipitated. In the two patients who required defibrillation, transient malfunctions of pacing, capture and sensing occurred in spite of protective electronics in the pacing system, the left-sided location of the generator and, in one patient, the bipolar configuration. The pacemaker appeared to intermittently sense coarse ventricular fibrillatory waves. The malfunctions in the two latter cases were probably the result of the combined effects of the countershock and the abnormal state of the myocardium. All four patients succumbed, three in the emergency room and one on the eighth hospital day. Outcome was predominantly determined by the patient's response to therapeutic interventions. The observed pacemaker malfunctions, although potentially life-threatening, had no obvious, adverse effect on outcome in these four cases, mainly because of the transient nature of the abnormalities. Indeed, in one case, the presence of pacemaker activity was pivotal in identifying the native rhythm, illustrating the diagnostic potential of this analytical approach.

Mitral valve prolapse and hyperthyroidism: effect of patient selection.

Patients with mitral valve prolapse and hyperthyroidism have common symptoms; the most outstanding symptom is palpitation. To determine whether or not common symptoms contributed to the reported association of these conditions, we evaluated 220 patients with symptomatic mitral valve prolapse and 216 first-degree relatives in 72 families; 65 relatives with mitral valve prolapse and 151 relatives without mitral valve prolapse, all greater than or equal to 16 years of age. Thirty subjects, aged 49 +/- 13 years (p less than 0.025 vs entire study group), had thyroid disease (23 subjects had definite thyroid disease, seven subjects had probable); 27 of 30 subjects with thyroid disease (90%) were female (p less than 0.005). The age- and sex-adjusted prevalence of hyperthyroidism was significantly higher in probands with mitral valve prolapse than in family members without mitral valve prolapse (3.5% vs 0%, p = 0.03), while an intermediate prevalence of hyperthyroidism (2.2%) was observed in family members with mitral valve prolapse. Thus, the prevalence of hyperthyroidism is increased among symptomatic patients with mitral valve prolapse as compared to family members without mitral valve prolapse, but the prevalence of thyroid conditions is similar among family members with or without this condition. These findings are explained by the effect of common symptoms on clinical detection of both mitral valve prolapse and hyperthyroidism.

Predictive value and limitations of the ST/HR slope.

To assess the value and predictive limitations of the exercise ST/HR slope, exercise test results were compared in 50 patients with stable angina and in 17 normal subjects with those in two groups known to have a high prevalence of inaccurate electrocardiographic responses to exercise. The last two groups included 51 patients tested within three weeks of acute myocardial infarction and 17 with important aortic regurgitation but no coronary disease. Of the normal subjects, 16 (94%) had ST/HR values less than or equal to 1 X 1 microV/beat/min. Of those with stable angina pectoris, 42 of 46 (91%) patients with coronary artery disease had ST/HR slopes ranging from 1 X 2 to 20 X 0 microV/beat/min, with false negative findings (slopes less than or equal to 1 X 1 microV/beat/min) in only four (9%). In contrast, of those with recent myocardial infarction, 15 of 42 (36%) with coronary disease had false negative slopes, including 12 of 20 (60%) with anterior wall injury. Of those with aortic regurgitation, conversely, 14 of 16 (88%) patients with calculable ST/HR slopes had values greater than 1 X 1 microV/beat/min despite the absence of coronary disease. Despite the accuracy of the test in patients with stable angina, false negative results are common in those after recent myocardial infarction, and false positive results occur often in those with abnormal volume loading due to aortic regurgitation.