Biomedical subjects

E Cicinelli

Publications and source records attributed to E Cicinelli.

53 records · Page 3Linked to original sources

PubMed1994

Improved equipment for abdominal fetal electrocardiogram recording: description and clinical evaluation.

Reliable computer-based equipment for transabdominal or indirect recording of fetal electrocardiogram (FECG) is described. The proposed equipment allows a real-time displaying of the signals (fetal + maternal ECG) without averaging procedures and it does not require the employment of a shielded room; moreover, it is user-friendly to medical personnel. An elementary form of semi-automatic computation of the fetal heart rate (FHR) was also implemented. The equipment simultaneously acquires three signals from seven electrodes, six placed on the maternal abdomen following the three space axes, and one placed on the left leg as a indifferent electrode. The signals are magnified and analogically filtered before undergoing digital finite impulse response (FIR) filter. Then the signals are displayed on the screen of a personal computer (PC). The PC also provides the possibility of storing the acquired signals for further analysis of elaborations. The quality of the recordings allows the analysis of both the rapid and slow electrical phenomena of the fetal heart, and it is not significantly influenced by the occurrence at the same time of uterine contractions. The performance of this method was assessed in 140 pregnant women with gestation periods of 29-42 weeks. In 131 cases (93.6%) the fetal QRS complex was detected and the FHR was obtained. A reliable evaluation of P and QRS waves and of ST interval, in spite of the interference of the maternal complexes, was possible in 102 cases (72.8%).

Amplifiers, Electronic↗

PubMed1994

Sonohysterography versus hysteroscopy for diagnosing endouterine abnormalities in fertile women.

OBJECTIVES: To evaluate the usefulness of abdominal and vaginal sonohysterography (SHG) (considered both singly and in combination) for the diagnosis of intrauterine abnormalities. METHODS: At the Department of Obstetrics and Gynecology, University of Bari, Italy, the results of the abdominal and vaginal SHG were retrospectively compared with those of conventional transvaginal sonography and hysteroscopy in 35 fertile women in whom a hysteroscopy was indicated. The sensitivity and specificity for the diagnosis of intrauterine abnormalities of both kinds of SHG (considered both singly and in combination), transvaginal sonography and hysteroscopy were compared; the predictive values of abnormal and normal SHG were determined by a 2 x 2 table relating the test results to the patients' abnormalities shown at hysteroscopy. RESULTS: The combination of both abdominal and vaginal SHG had a sensitivity of 95% and a specificity of 100%; the predictive value of an abnormal test was 100% and that of a normal test 94%. CONCLUSIONS: SHG provides a reliable diagnosis of intrauterine abnormalities. However, hysteroscopy and guided biopsies remain the decisive diagnostic test for investigating intrauterine abnormalities.

Adult↗

PubMed1994

Nasal spray administration of unmodified progesterone: evaluation of progesterone serum levels with three different radioimmunoassay techniques.

A 11.20 mg dose of progesterone was administered by nasal spray (NS) to six healthy postmenopausal women. Serial blood samples were collected and plasma progesterone was assayed by radioimmunoassay (RIA) according to three different procedures. In the first, RIA was carried out directly on plasma aliquot (Method A), in the second after diethyl ether extraction (Method B) and the third, after diethyl ether extraction and Celite column chromatography (Method C). The mean serum peak level (CMax) calculated with Method A (2.87 +/- 1.14 ng/ml) was higher than that obtained with both Method B (2.24 +/- 0.76 ng/ml) and C (1.58 +/- 0.76 ng/ml; P < 0.05); similarly the area under the curve (AUC) measured with Method A (695.79 +/- 348.24 ng h/ml) was higher than that obtained with both Method B (390.12 +/- 95.16 ng h/ml) and C (243.71 +/- 82.97 ng h/ml; P < 0.02). On the other hand, progesterone serum levels measured with Method C peaked earlier than those observed with Methods B and A (21.67 +/- 19.40, 25.83 +/- 18.55 and 35 +/- 20.70 min, respectively). These data are consistent with the high specificity of Method C for progesterone whereas the other methods could overestimate the progesterone serum levels probably measuring also progesterone metabolites particularly 5 alpha- and 5 beta-dihydroprogesterone. This study confirmed the rapid absorption of progesterone across the nasal mucosa avoiding the first-pass liver metabolism; however, a 'first-pass effect' of the nasal mucosa should be taken into consideration when progesterone is delivered by the nasal route because probably a significant portion of progestational effects are due to its active metabolites.

Administration, Intranasal↗

PubMed1994

Bone metabolism changes after transdermal estradiol dose reduction during estrogen replacement therapy: a 1-year prospective study.

Twenty-four surgically menopausal women were randomly allocated to one of two transdermally-administered estrogen replacement therapies (ERT): Group A was administered Estradiol (E2) TTS 0.05 mg/day for 6 months and 0.025 mg/day for the following six months and group B, E2 TTS 0.10 mg/day for the first 6 months and 0.05 mg/day for the following 6 months. For both groups, the treatment regimen was based upon the twice-weekly application of transdermal patches to the lower abdomen for three weeks a month. Serum E2, alkaline phosphatase (AP), osteocalcin (BGP) and urinary hydroxyproline (OHP) excretion levels were measured before the operation, at the beginning of ERT and after 6 and 12 months of treatment. Bone mineral density (BMD) in the distal regions of the forearms was measured by single photon absorptiometry at the start of the study and after 6 and 12 months. In Group A, both mean cortical and trabecular BMD had increased by, respectively, 1.53% and 2.17% after 6 months of therapy; after the second 6 months a significant decrease was observed in both parameters (2.40% and 3.62%, respectively). In Group B, mean cortical and trabecular BMD increased by 1.50% and 2.10%, respectively (significant increase in trabecular bone) after the first 6 months of treatment; after the following 6 months, these values persisted (+0.15 and -0.03%, respectively). Mean AP, OHP and BGP serum levels rose after the operation. In Group A, AP and OHP showed a significant decrease after the first 6 months (-34.90% and -30.90%), followed by an increase at the last evaluation of 22.50% and 35.50%, that reached statistical significance only for OHP.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Cutaneous↗

PubMed1994

Sonohysterography versus hysteroscopy in the diagnosis of endouterine polyps.

The objective of this retrospective study was to evaluate the usefulness of abdominal and vaginal sonohysterography (SHG; considered both singly and in combination) for the diagnosis of uterine polyps. Fifty fertile women hospitalized for hysterectomy for benign gynecologic indications were enrolled. Main outcome measures were preoperative conventional vaginosonography, transabdominal and vaginal SHG, hysteroscopy and histologic evaluation of the surgical specimen. Conventional vaginosonography had a sensitivity of 33.3% and a specificity of 100%; the predictive values of abnormal and normal scans were 100 and 79.5%, respectively. Transabdominal SHG had a sensitivity of 75% and a specificity of 100%. The predictive value of an abnormal scan was 100%; that of a normal scan 91.2%. Vaginal SHG had a sensitivity of 58.3% and a specificity of 100%; the predictive value of an abnormal scan was 100%, that of a normal scan 86.1%. The combination of the two kinds of SHG had a sensitivity of 91.7% and specificity of 100%; the predictive value of an abnormal test was 100% and that of a normal test 96.9%. The sensitivity, specificity and predictive values of abnormal and normal hysteroscopic examination were all 100%. In conclusion, the presence of endouterine polyps can be effectively investigated by SHG; nevertheless, hysteroscopy is more sensitive, being capable of detecting even very small endouterine neoformations.

Adult↗

PubMed1993

Effects of progesterone administered by nasal spray on the human postmenopausal endometrium.

The aim of the study was to assess the effectiveness of progesterone (P) administered by nasal spray (NS) in inducing secretory changes within estrogen and non-estrogen primed postmenopausal endometrium. Ten healthy post-menopausal women before vaginal hysterectomy for prolapse were randomly treated by either oral estrogens for 3-4 weeks combined for the last 5-7 days with nasally administered P at the daily dose of 34 mg, or by only P for 6 days. Endometrial samples were taken before P administration and 8 h after the last dose. In the group not treated with estrogens, P did not induce significant secretory changes in any case except one which showed a proliferative endometrial pattern at the first evaluation. In the group treated with estrogens, in all the cases after P administration clear secretory changes (abundant vacuoles, endoluminal secretion) occurred. It is possible to conclude that P administered by NS exerts an end-organ effect within the endometrium of postmenopausal women pretreated with estrogens.

Administration, Intranasal↗

PubMed1993

Effects of the repetitive administration of progesterone by nasal spray in postmenopausal women.

OBJECTIVE: To study the effects of 10 days of nasal spray P treatment on P serum levels and the endometrium. DESIGN: Prospective. SETTING: University Medical School. PATIENTS: Eight postmenopausal women received oral conjugated estrogens at a daily dose of 0.625 mg for 4 weeks immediately before vaginal surgery for prolapse. For the first 9 of the last 10 days the patients also received a nasal spray dosage of 11.2 mg P three times a day; on the 10th day they received only one dose. MAIN OUTCOME MEASURES: Blood samples were taken at 8:00 A.M. on treatment days 1, 3, 5, 7, 10, and 11 to follow P serum concentration levels. Endometrial samples for histologic examination were collected before P administration and immediately after surgery to evaluate the end-organ effect. RESULTS: Mean P serum levels increased sixfold after 9 days of nasal spray P administration [from 0.612 +/- 0.280 ng/mL (1.958 +/- 0.896 nmol/L) to 3.925 +/- 1.553 ng/mL (12.560 +/- 4.970 nmol/L)] and declined thereafter, returning to the before treatment levels 24 hours after the last administration. In all subjects, the first histologic evaluation showed proliferative endometrium; the second showed clear secretive changes. CONCLUSIONS: Repetitive nasal spray P administration for 10 days in postmenopausal women led to increasing P serum levels and, when the estrogen stimulation was adequate, to secretory changes in the endometrium (end-organ effect).

Administration, Intranasal↗

PubMed1993

Comparative study of progesterone plasma levels after nasal spray and intramuscular administration of natural progesterone in menopausal women.

11 mg natural progesterone (P) was administered to 20 healthy menopausal women by means of a nasal spray or intramuscular injection. Circulating P levels were calculated at various times after administration. The spray formulation yielded a CMax of 3.75 ng/ml at TMax = 60 min, the area under the curve (AUC)0-720 being 1,481.6 +/- 343. Intramuscular administration yielded a mean CMax of 4.137 ng/ml at TMax = 240 min, the AUC0-720 being 2,491.2 +/- 540. P absorption was faster through the nasal than through the intramuscular route, but intramuscular administration led to high serum levels for a much longer period.

Absorption↗

PubMed1993

Hysteroscopy for diagnosis and treatment of endometrial adenocarcinoma precursors. A review of literature.

The guidelines for early detection of adenocarcinoma and its precursors are controversial. Ultrasound, due to its non invasive nature, could represent a useful technique for screening patients at risk but its specificity is low. Endometrial cytology, especially by using new device, is an effective, easy, and inexpensive method for screening asymptomatic women; however, cytologic investigation shows some limits due to the scarce desquamation of endometrial cells and to the difficulty in diagnosing hyperplasia. Blind biopsy can miss the pathology in cases of focal lesions. Dilatation and curettage gives, in most cases, a certain histologic diagnosis but, requiring anesthesia and hospitalization, is not suitable for mass screening; moreover, in cases of focal lesions its sensitivity is low. Microhysteroscopy allows an atraumatic and direct investigation of the uterine cavity and could be used as a routine basis in patients with risk factors for endometrial pathology and signs of hyperestrogenism. In symptomatic patients its employment must be considered necessary for a correct and modern management of these patients. Operative hysteroscopy represents a promising way for treating hyperplastic endometrial lesions without signs of atypia, but its value in comparison with hysterectomy must be confirmed; when atypia is found, hysterectomy is the treatment of choice.

Adenocarcinoma↗

PubMed1992

Progesterone administration by nasal spray in menopausal women: comparison between two different spray formulations.

The aim of the study was to compare the bioavailability of progesterone dissolved in almond oil or dimethicone, and administered by nasal spray. Twenty healthy menopausal women were randomly allocated to treatment by four doses of intranasal spray either of a progesterone solution in almond oil, 2 mg/0.1 ml, corresponding to a total dose of approximately 11 mg of progesterone, or a progesterone solution in dimethicone 5 mg/0.1 ml corresponding to a total dose of approximately 28 mg of progesterone. Circulating progesterone levels were calculated at various time intervals following administration. The formulation with almond oil yielded a maximum progesterone concentration (Cmax of 3.75 ng/ml at Tmax = 60 min, and the area under the curve (AUC0-720) value was 1481.6 +/- 343. The formulation with dimethicone yielded a mean Cmax of 1.049 ng/ml at Tmax = 30 min; the AUC0-720 value was 302.06 +/- 37.5. Therefore, bioavailability of progesterone dissolved in almond oil proved to be largely superior compared to the solution in dimethicone. The crucial role of the carrier in the spray formulations is discussed; in addition to ensuring clinical safety, it must have good solubility for progesterone, be fluid enough to enable efficient 'spraying' and also must allow progesterone to be absorbed through the nasal mucosa.

Absorption↗

PubMed1991

Nasally-administered progesterone: comparison of ointment and spray formulations.

The aim of the study was to compare the bioavailability and clinical usefulness of progesterone (P) administered nasally in spray or ointment form. Twenty healthy post-menopausal women were randomly allocated to treatment by either intranasal spray (4 doses of an oil-based P solution at a concentration of 2 mg/0.1 ml, corresponding to a total dose of approximately 11 mg of P) or an ointment (quantity 0.1 ml, P concentration 20 mg/0.1 ml). Circulating P levels were calculated at various time intervals following administration. The spray formulation yielded a mean maximum concentration (CMax) of 3.75 ng/ml after 60 min (TMax) and the area under the curve (AUC) 0-720 min was 1481.6 +/- 343 ng.h/ml. The ointment yielded a mean CMax of 1.19 ng/ml at TMax = 30 min, the AUC 0-720 value being 404.35 +/- 148 ng.h/ml. The study findings confirmed that the intranasal route is a potentially useful alternative for the administration of natural sex steroid hormones, making it possible to avoid first-pass liver metabolism. P administered by spray showed greater bioavailability than it did when administered in ointment form, while both formulations seemed to be acceptable to patients and were probably clinically safe.

Administration, Intranasal↗

PubMed1991

Progesterone administration by nasal spray.

The bioavailability and the clinical usefulness of the P administered by nasal spray were investigated. Ten healthy menopausal women received an IN spray administration (4 doses of an oleic P solution 20 mg/mL, corresponding to nearly 11.2 mg of P) and the circulating P levels were calculated. Sixty minutes after administration, the maximum concentration (CMax, 3.75 +/- 0.214 ng/mL) was reached. High P levels (greater than 2 ng/mL) lasted until 360 minutes, and the AUC 0 to 720 was 1,481.6 +/- 343 ng.h/mL. Progesterone administration by spray formulation has proven to be effective in reaching therapeutic levels and to be acceptable to patients and, probably, clinically safe.

Absorption↗

PubMed1989

Biophysical and endocrine-metabolic changes during menopausal hot flashes: increase in plasma free fatty acid and norepinephrine levels.

Thermocutaneous, vascular, metabolic and hormonal changes were investigated during 11 hot flashes from 6 postmenopausal women. The first detectable change was an increase in finger blood flow with a concomitant enhancement of skin conductance. The increase in skin conductance was followed rapidly by a sharp rise in finger temperature. The main endocrine-metabolic changes associated with the above phenomena were a sharp increase in plasma free fatty acids (approximately 65%), norepinephrine (approximately 100%) and LH (approximately 20%) levels. Plasma glucose and cortisol tended to be increased but did not reach statistical significance; on the other hand, plasma insulin, glucagon, growth hormone, epinephrine and dopamine remained unchanged.

Adult↗

PubMed1986

Effectiveness of defibrotide for prophylaxis of deep venous thrombosis in gynecological surgery: a double-blind, placebo-controlled clinical trial.

Defibrotide, a new antithrombotic compound without anticoagulant activity, has been tested for prevention of deep venous thrombosis (DVT) in patients undergoing gynecological surgery (mainly hysterectomy). Eighty-nine women (mean age 48.5) were randomly allocated to defibrotide (44 patients) or placebo (45 patients). 800 mg defibrotide was given daily (200 mg intravenously 4 times a day), starting on the day before operation and then for the next 7 days. DVT were detected by the conventional 125I-fibrinogen test. The two groups were homogeneous for known risk factors (age, varicosities, obesity, neoplasia and previous thromboembolic episodes). The results showed a statistically significant reduction of DVT incidence in patients on defibrotide, as compared with those on placebo: 4/44 = 9% vs. 13/45 = 28.8% (p less than 0.05). There were no side effects, including hemorrhagic complications. The numbers of units transfused were comparable for the 2 groups. In conclusion, the trial shows that defibrotide is an effective and safe drug for the prevention of DVT in gynecological surgery.

Double-Blind Method↗

PubMed1983

Ontogenesis of autonomic receptors in detrusor muscle and bladder sphincter of human fetus.

An investigation was made of the distribution and the ontogenesis of various types of receptors in the bladder detrusor muscles and sphincter isolated from human fetuses at different stages of pregnancy. Cholinergic receptors appear very early in the fetal urinary bladder since contractile responses to bethanechol, competitively blocked by atropine, are observed in detrusor muscle preparations at three months and in the sphincter at four months. Later on, the density of cholinergic receptors increases in the detrusor muscle whereas there is a progressive reduction in the sphincter.

Female↗

PubMedDate not supplied

Nasal spray vs oral administration of bromocriptine: pharmacology and effect on serum prolactin in puerperal women.

The oral administration of bromocriptine induces a variety of side-effects in about 50-70% of patients, the most common being nausea and vomiting, probably related to the local gastrointestinal effect of the drug. Nasal administration makes it possible to avoid intestinal and liver metabolism. This study compared the serum concentrations of bromocriptine and prolactin (PRL) in twenty puerperal women who had asked to discontinue breast feeding and were randomized to receive a single oral (2.5 mg) or nasal spray dose (0.8 mg) of bromocriptine. Serum bromocriptine and PRL concentrations were measured at various times before and after drug administration. At 15 min, the circulating concentrations of bromocriptine were about eight times higher after nasal than after oral administration; peak serum concentration (CMax) was reached respectively 45 min and 60 min after administration, and was about three times higher after nasal administration (314 +/- 102 pg/ml vs 112.30 +/- 34.47 pg/ml). The reduction in serum PRL concentrations was also more rapid in the nasally-treated group reaching the normal assay range of < 20 micrograms/l within two as against five hours post-administration. Four orally-treated patients complained of nausea; in the nasally-treated group, six patients reported only a mild endonasal burning that disappeared within a few minutes of administration. Our results suggest that the nasal administration of bromocriptine may lead to a reduction in the required overall dose and fewer gastrointestinal side-effects, and may therefore improve therapy compliance.

Administration, Intranasal↗

PubMedDate not supplied

Transvaginal progesterone: evidence for a new functional 'portal system' flowing from the vagina to the uterus.

The results of many recent experimental and clinical studies support the hypothesis that progesterone administered vaginally is distributed selectively to the uterus where tissue concentrations and effects exceed expectations. This phenomenon has multiple clinical implications in several fields of gynaecological endocrinology, notably in assisted reproductive treatments and new forms of hormone replacement therapy. Yet, the actual mechanisms by which vaginal administration of progesterone can induce higher concentrations in the uterus, despite low concentrations in the systemic circulation, remain obscure and most puzzling to many gynaecologists. This review aims to muster ideas and propose different mechanisms to explain the observed phenomenon. In particular, we will summarize data that support the various putative modes of transport including, direct diffusion through tissue, intracervical aspiration, absorption into the venous or lymphatic circulatory systems and countercurrent vascular exchange with diffusion from utero-vaginal veins/lymph vessels to arteries. All these mechanisms may concur to various extents to the uterine specificity of vaginal progesterone.

Administration, Intravaginal↗