Biomedical subjects
Publications and source records attributed to Fulvio Zullo.
In women with polycystic ovary syndrome, metformin administration, not laparoscopic ovarian drilling, reduces plasminogen activator inhibitor 1 (PAI-1) activity. The lack of a decrease in PAI-1 activity is related to a high risk for miscarriage.
OBJECTIVE: To compare the efficacy of clomiphene citrate (CC) administration for ovulation induction in CC-resistant oligo-ovulatory women with polycystic ovary syndrome (PCOS) after metformin treatment or laparoscopic ovarian drilling (LOD). Design Prospective controlled study. PATIENTS: Twenty-eight overweight oligo-amenorrhoeic women with PCOS who were still anovulatory after metformin administration (group A, n = 8) or LOD (group B, n = 20). METHODS: Treatment with CC 150 mg/day for 5 days from the third to the seventh day of a progesterone-induced uterine bleeding for 6 months. MEASUREMENTS: The ovulation, pregnancy, abortion and live-birth rates were evaluated in each group. RESULTS: The subjects of groups A and B were studied for a total of 36 and 74 cycles, respectively. At the end of the study, no differences in ovulation [11/36 (30.6%) vs. 23/74 (31.1%); P = 0.96], pregnancy [6/36 (16.7%) vs. 12/74 (16.2%); P = 0.95], abortion [2/6 (33.3%) vs. 5/12 (41.7%); P = 1.00] and the live-birth [4/6 (66.7%) vs. 7/12 (58.3%); P = 1.00] rates were observed between groups A and B. CONCLUSION: Metformin administration as well as LOD improves the effectiveness of CC for ovulation induction in overweight infertile CC-resistant women with PCOS.
OBJECTIVE(S): To compare the long-term effectiveness of two different laparoscopic colposuspension procedures. STUDY DESIGN: Sixty women affected by genuine stress incontinence (GSI) were enrolled in a prospective randomized controlled trial (RCT) and treated by transperitoneal laparoscopic colposuspension using nonabsorbable sutures (group A) or prolene mesh fixed with tackers or staplers (group B). In each group the subjective and objective failure rates were evaluated at 12, 24, and 36 months after surgery. For the subjective evaluation patients were asked whether they had experienced urine leakage and any urine loss they reported was recorded on a visual analogue scale (VAS). The objective evaluation was performed by means of a clinical examination and multichannel urodynamic studies. The data were analyzed by the intention-to-treat method. RESULTS: The subjective failure rate was significantly (P < 0.05) lower in group A than in group B at 12 months (3.3% versus 13.3%, respectively), 24 months (20.0% versus 36.7%, respectively), and 36 months (33.3% versus 53.3%, respectively) after surgery. The objective failure rate also differed significantly (P < 0.05) between the two groups after 12 (10.7% versus 25.0% for group A and group B, respectively), 24 (29.6% versus 57.7%, respectively), and 36 (42.3% versus 61.5%, respectively) months of follow-up. CONCLUSION(S): Laparoscopic colposuspension performed with sutures is more effective than laparoscopic colposuspension accomplished with the use of prolene meshes in the long term, and the use of prolene meshes should be avoided in treatment of GSI.
White blood cell (WBC) count is a known risk factor for atherosclerotic vascular disease in adult women. Polycystic ovary syndrome (PCOS) is potentially a risk factor for atherosclerosis and cardiovascular disease. The aim of the present study was to investigate leukocyte count in PCOS. One hundred and fifty PCOS women matched for age and body mass index with 150 healthy women were enrolled. WBC count, C-reactive protein, and a complete anthropometrical, metabolic, and hormonal evaluation were performed in both groups. Serum insulin, glucose level, and lipid profile were also measured in each subject. WBC count was significantly higher (P < 0.0001) in PCOS with (interquartile range in parentheses) 7260 (393) cells/mm(3), compared with controls with 5220 (210) cells/mm(3). C-reactive protein levels were significantly increased (P < 0.0001) in PCOS with 2 (1) mg/liter compared with healthy women with 0.7 (0.8) mg/liter. In both groups, there was a significant (P < 0.0001) linear correlation between WBC count and homeostasis model assessment score (PCOS, r = 0.94; controls, r = 0.91). Multiple linear regression analysis showed that other hormone levels are not predictors of leukocyte count both in PCOS and control women. In conclusion, our data demonstrate that PCOS women have an increased WBC count that correlates with homeostasis model assessment values.
BACKGROUND: Our aim was to evaluate the long-term effectiveness and safety of GnRH agonist plus raloxifene administration in women with symptomatic uterine leiomyomas. METHODS: Fifty pre-menopausal women with uterine leiomyomas were treated with leuprolide acetate depot at dose of 3.75 mg/28 days and raloxifene hydrochloride at 60 mg/day for 18 cycles. At admission and after each six cycles of treatment, bone mineral density (BMD), uterine, leiomyoma and non-leiomyoma dimensions, serum bone metabolism markers, lipid, glucose and insulin levels were evaluated. Leiomyoma-related and climacteric-like symptoms were assessed using a daily diary. RESULTS: Throughout the study, no significant change in BMD or in any bone metabolism markers was observed. A significant decrease in uterine, leiomyoma and non-leiomyoma sizes was detected in comparison with baseline already after 6 months. No other significant change was observed at the successive follow-up visits. No significant change in lipid and glucose profile was detected throughout the study. The treatments were well tolerated. All treatment withdrawals (16%, eight out of 50) were due to lack of compliance, and none to drug-related adverse experiences. CONCLUSION: GnRH agonist plus raloxifene administration is an effective and safe treatment for pre-menopausal women with uterine leiomyomas.
Low-dose alendronate is as effective as standard-dose alendronate, and its effects continue after drug withdrawal in postmenopausal osteoporotic women who are being treated with estrogen.
OBJECTIVE: To apply preimplantation genetic diagnosis (PGD) for the treatment of patients with a history of failed IVF-ET or habitual aborters. DESIGN: Prospective clinical study. SETTING: Tertiary center for assisted reproduction. PATIENT(S): Ninety-four couples with failed IVF-ET after >2 IVF cycles and 64 couples with >2 spontaneous abortions. INTERVENTION(S): Patients were prepared for oocyte retrieval using standard controlled ovarian hyperstimulation protocols after standard laboratory techniques. Blastomeres from 6- to 8-cell embryos were analysed using fluorescence in situ hybridization with commercial chromosomal probes, and normoploid embryos were transferred on day 3 after fertilization. MAIN OUTCOME MEASURE(S): Pregnancy and implantation rates and live births. RESULT(S): Both 3- and 5-probe PGD resulted in a significantly higher outcome than controls for failed IVF-ET. Five-probe PGD appeared to be more suitable for habitual aborters. CONCLUSION(S): This pilot study suggests that 3-probe PGD is a valid option for failed IVF-ET patients. The use of five or more probes is indicated for habitual aborters.
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OBJECTIVE: To determine the efficacy of GnRH analogue plus add-back therapy compared with GnRH analogue alone and estroprogestin in patients with relapse of endometriosis-associated pain. DESIGN: Randomized, controlled study. SETTING: University hospital. PATIENT(S): One hundred thirty-three women with relapse of endometriosis-related pain after previous endometriosis surgery. INTERVENTION(S): Forty-six women were treated with GnRH analogue plus add-back therapy, 44 women were given GnRH analogue alone, and 43 women received estroprogestin, for 12 months. MAIN OUTCOME MEASURE(S): Pain evaluation by a visual analogue scale, quality of life in treated patients according to the SF-36 questionnaire, and occurrence of adverse effects, including bone mass density loss, at pretreatment, after 6 months of treatment, at the end of treatment (12 months), and 6 months after discontinuation of treatment. RESULT(S): Patients treated either with GnRH analogue alone or GnRH analogue plus add-back therapy showed a higher reduction of pelvic pain, dysmenorrhea, and dyspareunia than patients treated with oral contraceptive, whereas patients treated with add-back therapy showed a better quality of life, as assessed with the SF-36 questionnaire, and adverse effects rate than the other two groups. CONCLUSION(S): Add-back therapy allows the treatment of women with relapse of endometriosis-associated pain for a longer period, with reduced bone mineral density loss, good control of pain symptoms, and better patient quality of life compared with GnRH analogue alone or oral contraceptive.
STUDY OBJECTIVE: To assess the long-term effectiveness of presacral neurectomy (PSN) in women with severe dysmenorrhea due to endometriosis treated with conservative laparoscopic surgical intervention. DESIGN: Randomized, controlled trial (Canadian Task Force classification I). SETTING: University-affiliated department of obstetrics and gynecology. PATIENTS: One hundred forty-one sexually active women of reproductive age. INTERVENTION: Conservative laparoscopic surgery without (group A) or with (group B) PSN. MEASUREMENTS AND MAIN RESULTS: At entry and 24-months after surgical procedures, cure rates; frequency and severity of dysmenorrhea, dyspareunia, and chronic pelvic pain; and quality of life were evaluated. At follow-up visit, the cure rate was significantly (P<0.05) higher in group B (83.3%) than in group A (53.3%). The frequency and severity of dysmenorrhea, dyspareunia, and chronic pelvic pain were significantly (P<0.05) lower in both groups compared with baseline values, and only severity was significantly (P<0.05) lower in group B. A significant (P<0.05) improvement in quality of life was observed after surgery in both groups and was significantly (P<0.05) increased in group B compared with group A. CONCLUSION: PSN improves long-term cure rates and quality of life in women treated with conservative laparoscopic surgery for severe dysmenorrhea due to endometriosis.
This study aimed to evaluate plasminogen activator inhibitor-1 (PAI-1) activity in PCOS. Thirty women with PCOS - 15 normal-weight and 15 obese - and 30 healthy women matched as a group for age and body mass index (BMI) were recruited. The homeostasis model assessment (HOMA) score was significantly elevated in obese compared with normal-weight women, in both PCOS women and controls. HOMA score was significantly higher in both PCOS groups relative to controls. After further adjustment for BMI, PAI-1 activity (IU/ml +/- SD) was significantly higher in the PCOS groups compared with controls. A significant positive correlation was found between HOMA score and BMI in PCOS and control groups. Serum PAI-1 activity was significantly related to BMI and HOMA score. When considering two BMI subgroups, there was no significant difference in the relationship between serum PAI-1 activity and HOMA score in both the control and PCOS groups. No other significant relationship was found between serum PAI-1 activity and any other hormonal or metabolic parameter. In conclusion, women with PCOS have significantly elevated PAI-1 activity independent of obesity, and it is speculated that elevated PAI-1 activity may be a factor in the increased cardiovascular morbidity seen in PCOS.
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BACKGROUND: Although GnRH analogues are widely used to treat a variety of sex hormone-related diseases, little is known about their effect on metabolism. Therefore, we have evaluated the effect of a GnRH analogue, administered with or without raloxifene, on serum levels of lipoproteins, glucose, insulin and homocysteine (Hcy). METHODS: One hundred premenopausal women with symptomatic uterine leiomyomas were initially enrolled and randomized to receive 3.75 mg/28 days leuprolide acetate depot associated with 60 mg/day raloxifene hydrochloride (group A) or 1 placebo tablet/day (group B) for six cycles of 28 days. At entry and at cycle 6, subjects underwent anthropometric measurements, including body mass index and waist-to-hip ratio measurements, and blood chemistry assays for serum total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG), glucose, insulin, Hcy, vitamin B(12) and folate concentrations. Insulin resistance was evaluated with the homeostasis model assessment (HOMA) score. RESULTS: Baseline parameters were similar in the two groups. At cycle 6, TC, HDL-C, LDL-C and TG levels were significantly increased (P < 0.05) in group B. In group A, LDL-C levels were unchanged, and TC, HDL-C and TG levels were increased (P < 0.05). Serum TC and LDL-C levels differed (P < 0.05) between the groups. Glucose levels were unchanged between and within groups, whereas insulin levels and HOMA scores increased (P < 0.05) versus baseline in group B. Post-treatment Hcy levels were higher (P < 0.05) versus baseline in group B; they were unchanged in group A. Serum vitamin B(12) and folate concentrations were unchanged in both groups. CONCLUSIONS: GnRH analogues alter serum lipoprotein and Hcy levels and increase insulin resistance. These acute metabolic changes may be prevented or reduced by raloxifene.
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OBJECTIVE: To evaluate the effectiveness of the injection of bupivacaine plus epinephrine before laparoscopic myomectomy. METHODS: Sixty premenopausal women with uterine leiomyomata were enrolled in a randomized controlled design and intraoperatively treated with injection of bupivacaine plus epinephrine (group A) or saline solution (group B) during laparoscopic myomectomy. Uterine size and volume, number of leiomyomata, hematological parameters, total operative time, enucleation time of each myoma, suturing time of the myomectomy, blood loss, degree of surgical difficulty, and postoperative pain were evaluated. Just before and after the injection of vasoconstrictive or saline solution, systolic and diastolic blood pressure and heart rate were recorded in each subject. RESULTS: Blood loss, total operative and enucleation time, and degree of surgical difficulty was significantly (P <.05) lower in group A than in group B. No difference was observed between groups in suturing time of the myomectomy. The number of vials of pain medication used postoperatively was significantly (P <.05) lower in group A than in group B. No differences in systolic and diastolic blood pressure or heart rate was recorded between the 2 groups. CONCLUSION: The injection of bupivacaine plus epinephrine during laparoscopic myomectomy is effective in reducing blood loss, total operative and enucleation time, degree of surgical difficulty, and postoperative pain.
The aim of this study was to evaluate the presence of early vascular damage in young normal-weight women with polycystic ovary syndrome (PCOS). Thirty young normal-weight women with PCOS, who had no additional metabolic or cardiovascular diseases, and 30 healthy women (controls) matched for age and body mass index were studied. A complete hormonal assay was performed in each subject. Serum insulin and glucose levels were measured at baseline and after the oral glucose tolerance test. Plasma endothelin-1 levels and serum lipid profile were also assessed. The endothelial function was studied by flow-mediated dilation on the brachial artery, and arterial structure was evaluated by intima-media thickness measurement using Doppler ultrasound of both common carotid arteries.A significant (P < 0.05) difference in flow-mediated dilation (14.3 +/- 1.9% vs. 18.1 +/- 2.0% for PCOS patients and controls, respectively) and in intima-media thickness (0.53 +/- 0.09 mm vs. 0.39 +/- 0.08 mm for PCOS patients and controls, respectively) was found between PCOS and control subjects. Serum endothelin-1 levels were also significantly (P < 0.05) higher in PCOS patients compared with controls (1.1 +/- 0.4 pmol/liter vs. 0.5 +/- 0.2 pmol/liter for PCOS patients and controls, respectively).In conclusion, our data show that young, normal-weight, nondyslipidemic, nonhypertensive women with PCOS have an early impairment of endothelial structure and function.
To evaluate the cardiovascular risk of polycystic ovary syndrome (PCOS), we investigated lipid profile, metabolic pattern, and echocardiography in 30 young women with PCOS and 30 healthy age- and body mass index (BMI)-matched women. PCOS women had higher fasting glucose and insulin levels, homeostasis model assessment score of insulin sensitivity, total cholesterol (TC) and low density lipoprotein cholesterol (LDL-C) levels, and TC/high density lipoprotein cholesterol (HDL-C) ratio and lower HDL-C levels than controls. Additionally, PCOS women had higher left atrium size (32.0 +/- 4.9 vs. 27.4 +/- 2.1 mm; P < 0.0001) and left ventricular mass index (80.5 +/- 18.1 vs. 56.1 +/- 5.4 g/m(2); P < 0.0001) and lower left ventricular ejection fraction (64.4 +/- 4.1 vs. 67.1 +/- 2.6%; P = 0.003) and early to late mitral flow velocity ratio (1.6 +/- 0.4 vs. 2.1 +/- 0.2; P < 0.0001) than controls. When patients and controls were grouped according to BMI [normal weight (BMI, >18 and <25 kg/m(2)), overweight (BMI, 25.1-30 kg/m(2)), and obese (BMI, >30 kg/m(2))], the differences between PCOS women and controls were maintained in overweight and obese women. In normal weight PCOS women, a significant increase in left ventricular mass index and a decrease in diastolic filling were observed, notwithstanding no change in TC, LDL-C, HDL-C, TC/HDL-C ratio, and TG compared with controls. In conclusion, our data show the detrimental effect of PCOS on the cardiovascular system even in young women asymptomatic for cardiac disease.