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BACKGROUND: The aetiology of bacterial vaginosis (BV) is still unclear but it is currently considered to be a synergistic polymicrobial syndrome. BV can often arise as a chronic or recurrent disease. The reason for such recurrences is not well elucidated. Previous studies have suggested that vaginal vitamin C may be a useful treatment in reducing recurrence rate, by increasing vaginal acidification and thereby making up for the decrease in hydrogen peroxide that results from a reduction in the number of lactobacilli present. Based on the above-mentioned consideration, a study was performed that aimed to evaluate the effect of vitamin C in the prophylaxis of BV relapses. METHODS: This was a randomised, double-blind, placebo-controlled, parallel-group clinical trial. One hundred and forty-two women, after having been cured from a recent episode of BV by either metronidazole or clindamycin, were randomised to receive vitamin C (74 patients) or placebo (68 patients) as prophylaxis for six monthly cycles, starting within 24 hours of the determination of 'BV cure'. The patients applied one vaginal tablet once a day for 6 consecutive days per month after menses. RESULTS: The rate of BV recurrence during the first 3 months was considerably lower in the vitamin C group (6.8%) than in the placebo (14.7%) group. Considering a 6-month treatment period, the recurrence rate in the vitamin C group (16.2%) was significantly lower (P = 0.024) than in the placebo group (32.4%). Moreover, at the same time point, the survival analysis of Kaplan Meyer was significant in favour of the vitamin C group compared with the placebo group (P = 0.029). CONCLUSIONS: The study showed that regular use of 250 mg ascorbic acid vaginal tablets on 6 days per month for 6 months after successful treatment of bacterial vaginosis halves the risk of recurrence from 32.4% to 16.2% (P = 0.024).

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INTRODUCTION: Primary headaches are common in women and impact on their quality of life and psychosocial functioning. Few data are available on sexuality in female headache sufferers. AIM: An observational pilot study was conducted to assess sexual function and distress in women treated for primary headaches in a tertiary university center. METHODS: From a total of 194 women consecutively observed over a 3-month period, 100 patients were recruited. Migraine with and without aura, and tension-type headache, both episodic and chronic (CTTH), were diagnosed according to the International Classification of Headache Disorders. A detailed pharmacological history was collected, and anxiety and depression were assessed using validated scales. The Female Sexual Function Index (FSFI) and Female Sexual Distress Scale-Revised were administered. MAIN OUTCOME MEASURES: The main outcome measures are sexual symptoms and distress in women treated for primary headaches. RESULTS: More than 90% of the women had a median FSFI full-scale score under the validated cutoff, while 29% reported sexual distress. Hypoactive sexual desire disorder (HSDD) was diagnosed in 20% of the women and the pain domain score (median 2, score range 0-6) was highly affected by the head pain condition. However, the FSFI domain and full-scale scores did not significantly differ by headache diagnosis. The women with CTTH displayed a high rate of sexual distress (45.5%) and a strong negative correlation between desire, arousal, and full-scale FSFI score and number analgesics/month (r: -0.77, P=0.006; r: -0.76, P=0.006; and r: -0.68, P=0.02, respectively). Depression was positively correlated with sexual distress (r: 0.63, P=0.001) only in the women with CTTH. CONCLUSION: Women treated for primary headaches were found to display a high rate of sexual symptoms and distress. Both migraine and tension-type headache were associated with sexual pain and HSDD, but women with CTTH seem to be more prone to develop sexual distress.

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As bacterial vaginosis (BV) is a potential cause of obstetric complications and gynecological disorders, there is substantial interest in establishing the most effective treatment. Standard treatment - metronidazole or clindamycin, by either vaginal or oral route � is followed by relapses in about 30% of cases, within a month from treatment completion. This inability to prevent recurrences reflects our lack of knowledge on the origins of BV. Atopobium vaginae has been recently reported to be associated with BV in around 80% of the cases and might be involved in the therapeutic failures. This review looks at the potential benefits of nifuratel against A. vaginae compared to the standard treatments with metronidazole and clindamycin. In vitro, nifuratel is able to inhibit the growth of A. vaginae, with a MIC range of 0.125-1 µg/mL; it is active against G. vaginalis and does not affect lactobacilli. Metronidazole is active against A. vaginae only at very high concentrations (8-256 µg/mL); it is partially active against G. vaginalis and also has no effect on lactobacilli. Clindamycin acts against A. vaginae with an MIC lower than 0.125 µg/mL and is active on G. vaginalis but it also affects lactobacilli, altering the vaginal environment. These observations suggest that nifuratel is probably the most valid therapeutic agent for BV treatment.

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UNLABELLED: Implantation failure is common in assisted reproduction techniques (ART). The role of low-molecular-weight heparin (LMWH) is a matter of debate as a potential factor to improve implantation. AIM: To evaluate the pregnancy rate in patients with or without heparin administration. MATERIALS & METHODS: We performed a retrospective observational analysis of patients with at least two IVF/intracytoplasmic sperm injection cycles with implantation failure, screened for inherited thrombophilia and submitted to further ART cycles with or without administration of LMWH. A total of 265 patients fulfilled the enrollment criteria. Of these 149 (56%) were primary infertile and 116 (44%) were secondary infertile. Their mean age was 36.3 ± 3.6 years. We analyzed basal FSH, smoking habit, gene variants for inherited thrombophilia (i.e., MTHFR C677T, prothrombin G202A10G and Factor V Leiden). The patients underwent 569 new ART cycles: 512 (90%) without and 57 (10%) with LMWH. RESULTS: In total 105 clinical pregnancies were observed in 569 cycles (18.8%). The pregnancy rate was 17.19% (88/512) in patients not treated with LMWH and 29.52% (17/57) in the LMWH-treated group (p = 0.006). In women over 36 years of age the pregnancy rate was 15.53% (50/322) in nontreated versus 35.71% (10/28) in treated cycles (p = 0.007), while no difference was found in younger women. No statistical difference was found between the presence of inherited thrombophilia and pregnancy rate in treated and untreated cycles. DISCUSSION: significantly higher pregnancy rate in patients with previous ART implantation failures was observed with LMWH. Our results confirm no relation among inherited thrombophilia and pregnancy rate in patients with previous IVF implantation failures. These findings should be confirmed by randomized controlled trials before use of LMWH for ART cycles is recommended.

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Among primary headaches, migraine is the form more sensitive to the ovarian hormonal milieu. Migraine without aura (MO) benefits from the hyperestrogenic state of pregnancy and the lack of hormonal fluctuations, while migraine with aura (MA) presents distinctive features. Indeed, a very strong improvement of MO has been documented across gestation, and only a minority of pregnant women still suffers during the third trimester. On the other hand, fewer women with MA report improvement or remission, and new onset of aura may be observed during pregnancy. After delivery, breastfeeding exerts a protective action on migraine recurrence. The persistence of migraine during gestation seems to affect neonatal outcomes, and several studies indicate a link between migraine and an increased risk of developing gestational hypertension/preeclampsia and other vascular complications.

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BACKGROUND: Migraine with aura (MA) is a contraindication to the use of combined oral contraceptives (COCs) because of the increased risk of ischemic stroke. Progestogen-only contraceptive pill (POP) is a safe alternative to COCs and it is preferable in women with cerebrovascular diseases or risk factors for stroke. STUDY DESIGN: Prospective diary-based pilot study. Thirty women with MA (n = 15 who have never used COCs and n = 15 who had previously used COCs were diagnosed according to the International Headache Society criteria. The observational period lasted 9 months during which women filled in a diary with the clinical characteristics of headache attacks. After a 3-month run-in period, each subject received an estrogen-free desogestrel (DSG) (75 mcg/day)-containing OC (Cerazette(®); Schering-Plough, formerly NV Organon, Oss, The Netherlands). Follow-up evaluations were planned at the end of the third and sixth month of treatment. RESULTS: The number (mean±S.D.) of migraine attacks was significantly reduced both in previous COCs users (from 3.9±1.0 to 2.9±0.8; p<.001) and nonusers (from 3.2±0.9 to 2.6±1.3; p<.02) following 6 months of POP use in comparison with the run-in period. Duration of headache pain did not differ significantly in both groups throughout the study. Interestingly enough, a beneficial POP effect on the duration (mean±S.D.) of visual aura (from 16.3±9.5 to 11.4±5.6 min) and on the total duration (mean±S.D.) of neurological symptoms (from 33.6±23.3 to 18.6±18.0 min) was only significantly reported by previous COCs users (p<.001, for both) by the end of the study period. The POP was well tolerated by each woman and the bleeding pattern was variable with a tendency towards infrequent bleeding. CONCLUSIONS: The present study supports the use of the POP containing desogestrel in a population of women with MA and underlines a positive effect on symptoms of aura, especially in MA sensitive to previous use of COCs.

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The present short review underlines the role of testosterone (T) in the motivational and satisfaction components of women's sexuality and critically discusses the strategies to treat hypoactive sexual desire disorder (HSDD), a condition of low desire associated with personal and/or interpersonal difficulties, which is more common in surgical menopausal women. There are multiple ways androgens target the brain regions (hypothalamic, limbic and cortical) involved in sexual function and behaviour. Even though circulating available androgens have been implicated in several domains of sexual response, they seem to be related weakly to symptoms, such as low sexual desire, poor sexual arousal, orgasm and diminished well-being in postmenopausal women. The possibilities of treating low sexual desire/HSDD are multifaceted and should include the combination of pharmacological treatments able to maximize biological signals driving the sexual response, and individualized psychosocial therapies in order to overcome personal and relational difficulties. Transdermal T has been shown to be effective at a dose of 300 µg/day both in surgically and naturally menopausal women replaced with estrogen or not, without any relevant side-effects. However, the decision to treat postmenopausal women with HSDD with T is mainly based on clinical judgement, after informed consent regarding the unknown long-term risks.

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Hypoactive sexual desire disorder (HSDD) is a common multifactorial condition which is characterized by a decrease in sexual desire that causes marked personal distress and/or interpersonal difficulty. The general idea that HSDD is a sexual dysfunction difficult to treat is due to the large number of potential causes and contributing factors. Indeed, a balanced approach comprising both biological and psycho-relational factors is mandatory for accurate diagnosis and tailored management in clinical practice. There are currently no approved pharmacological treatments for premenopausal women with HSDD, while transdermal testosterone is approved in Europe for postmenopausal women who experience HSDD as a result of a bilateral oophorectomy. Even though the role of sex hormones in modulating the sexual response during the entire reproductive life span of women is crucial, a better understanding of the neurobiological basis of sexual desire supports the idea that selective psychoactive agents may be proposed as nonhormonal treatments to restore the balance between excitatory and inhibitory stimuli leading to a normal sexual response cycle. We conclude that the ideal clinical approach to HSDD remains to be established in term of efficacy and safety, and further research is needed to develop specific hormonal and nonhormonal pharmacotherapies for individualized care in women.

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OBJECTIVE: The aim of the present observational, cross-sectional study was to examine the effects of hormonal and psycho-relational variables on sexual function during menopausal transition and at early postmenopause in women with hot flushes. STUDY DESIGN: The sample comprised 138 women referred to a clinic for the treatment of hot flushes. They were categorised according to their stage of menopausal transition using the STRAW criteria: early menopausal transition (EMT) if their menstrual cycle was 7 or more days different from normal; late perimenopause (LMT) if they had experienced 60 days or more of amenorrhoea; and early postmenopause (EPM) if their amenorrhoea had lasted for at least 12 months but less than 4 years. MAIN OUTCOME MEASURES: Sexual function was measured by using the Female Sexual Function Index (FSFI), while anxiety (state and trait), depression, eating disorder and marital adjustment were evaluated by validated self-report questionnaires. Levels of free testosterone (FT), dehydroepiandrosterone sulfate (DHEAS) and estradiol (E2) were also measured. RESULTS: Overall sexual function varied significantly with stage of menopause, with total FSFI score less in EPM than in EMT (p=.009). A similar pattern was evident on FSFI sub-scales for sexual desire (p=.02), arousal (p=.01) orgasm (p=.01) and also pain (p=.02), but not for lubrication and satisfaction. Ratings for anxiety, depression and eating disorder did not differ across the menopausal sub-groups, and neither did ratings of marital adjustment. Both FT (p=.01) and DHEAS (p=.03) levels were slightly reduced at EPM in comparison with EMT, as were E2 levels (p=.001 EMT versus LMT; p=.0001 LMT versus EPM). In multiple regression analyses, plasma FT level was the only factor to predict FSFI full score (beta=.48; p=0.004) in women at EMT, while in women at LMT the depression score was the only factor to do so (beta=-.62; p=0.0001). The best model predicting FSFI full score at EPM included levels of DHEAS and E2 levels and state anxiety score. CONCLUSIONS: Hormonal and some psychological variables are relevant to sexual function in symptomatic women during menopausal transition and at early menopause but their role differs with the specific stage of reproductive ageing.

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Considerable advances have been made in hormonal contraception in recent years, geared at maximizing compliance and minimizing discontinuation. In oral contraceptive (OC) formulations, the estrogenic component, generally ethinyl estradiol (EE), has been reduced significantly and newer progestins like dienogest and drospirenone (DRSP), compounds with different molecular structures, have been introduced; in addition, new regimens (extended, flexible, 24/4 formats instead of the standard 21/7 format) and innovative delivery systems (vaginal rings, transdermal patches, subcutaneous implants and intrauterine devices) are available. The multitude of choices allows hormonal contraception to be tailored to the individual woman in order to obtain non-contraceptive benefits, without significant side effects, and also a favorable risk/benefit profile for her general and reproductive health. Over the past few years, new OC formulations combining DRSP (3 mg), a unique progestin with both antimineralocorticoid and antiandrogenic activities, with estrogen (30 mcg or 20 mcg EE), in two regimens (24/4 and 21/7) of active pills in a 28-day cycle, have shown positive effects on water retention-related weight gain and physical, emotional and psychosexual well-being. It seems likely that the use of a low-dose, well-balanced OC and the shorter 4-day hormone-free interval may minimize the side effects that can impair quality of life and thus increase women's compliance with hormonal contraception therapy.

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In this review, we underline the importance of linking migraine to reproductive stages for optimal management of such a common disease across the lifespan of women. Menopause has a variable effect on migraine depending on individual vulnerability to neuroendocrine changes induced by estrogen fluctuations and on the length of menopausal transition. Indeed, an association between estrogen 'milieu' and attacks of migraine is strongly supported by several lines of evidence. During the perimenopause, it is likely to observe a worsening of migraine, and a tailored hormonal replacement therapy (HRT) to minimize estrogen/progesterone imbalance may be effective. In the natural menopause, women experience a more favourable course of migraine in comparison with those who have surgical menopause. When severe climacteric symptoms are present, postmenopausal women may be treated with continuous HRT. Even tibolone may be useful when analgesic overuse is documented. However, the transdermal route of oestradiol administration in the lowest effective dose should be preferred to avoid potential vascular risk.

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INTRODUCTION: Estrogen is relevant to women's well-being including sexual functioning. Aim. The goal of this Continuing Medical Education article was to provide a comprehensive review of the effect of exogenous estrogen use on women's sexual function. Main Outcome Measures. We present a literature review. METHODS: The medical literature was accurately searched (1990-2008) with regard to estrogen therapy in menopausal women by using several terms related to and including the terms "estrogen" and "sexual function." RESULTS: A review of the studies most useful to guide menopausal practice. CONCLUSIONS: Estrogen decline is one of the key factors contributing to sexual functioning during menopausal transition and beyond. Systemic estrogen treatments are associated with significant benefits in some domains of menopausal sexual function, especially when estradiol is delivered transdermally, whereas local estrogens are effective in preventing urogenital aging. Even tibolone, a selective tissue estrogenic activity regulator, displays positive effects in postmenopausal women with sexual complaints. However, a tailored approach to the individual woman is always needed.

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UNLABELLED: The prevalence of venous thromboembolism (VTE) in ovarian cancer during first-line chemotherapy (CHT) ranges between 6.4% and 10.6%. Identification of the susceptible population is crucial for effective thromboprophylaxis. METHODS: We performed a retrospective study of all our patients with epithelial ovarian cancer who underwent ambulatory first-line CHT between 1990 and 2004. Data were collected regarding age, body mass index (BMI), previous deep vein thrombosis, pulmonary embolism (PE), menopause status, FIGO stage, grade, histology, type of surgery, residual disease, and CHT. Univariable and multivariable regression analyses were performed to assess independent prognostic factors for VTE/PE to calculate a prognostic index (PI). RESULTS: Of 203 patients, 16 (7.8%) had symptomatic VTE: 15 deep vein thrombosis and 1 PE. Multivariable regression analysis found that age (P = 0.01), BMI (P = 0.01), and stage (P = 0.05) were independent prognostic factors for VTE. Age, BMI, and stage were used to calculate the PI: 0.285 x age + 0.555 x BMI + 1.110 x stage. The PI was dichotomized according to its median cutoff (5.8) to define a low (3.8% at 6 months) and a high (11.3%) VTE incidence group. CONCLUSIONS: Age, BMI, and stage permit to identify ovarian cancer patients with a high risk in developing symptomatic VTE during CHT.

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AIMS: To investigate domains of sexual function in healthy women attending a gynecological office for routine annual check-up using the Italian translation of the Female Sexual Function Index (FSFI) according to age, reproductive status and hormonal treatments; and to confirm the usefulness of the FSFI in detecting relevant clinical entities. METHODS: Of 720 women (age range 18-65 years), 564 (78%) filled in a short anamnestic questionnaire and the FSFI assessing desire, arousal, lubrication, orgasm, satisfaction and pain. A semi-structured DSM-IV-TR clinical interview was administered to a convenience sample of women selected according to the quartile distribution of the median full scale FSFI score. Analysis of data was performed by frequency tables and non-parametric statistics. RESULTS: The median full scale score of FSFI in our study population was 27.6 (lower quartile: 18.7, upper quartile: 30.9) and the percentage of women under the lower quartile of the distribution was 24.4%. Sexual function decreased progressively with age, being significantly lower after 30 years and after 60 years (chi(2) = 52.6; p = 0.0001). Menopausal women had significantly lower median FSFI full scale score compared with fertile women and women who used oral contraception (OC) (p < 0.0001 for both), while users of hormone replacement therapy (HRT) displayed better overall sexual function than untreated postmenopausal women (p < 0.005). A positive diagnosis of female sexual dysfunction (FSD) was evident only in young women scoring under the lower quartile of the distribution (cut-off score: 23.4 for women not taking OC and 20.8 for OC users), while older women were dysfunctional also above the lower quartile of the distribution (cut-off score: 14.1 for menopause, 18.5 for HRT) of the FSFI full scale score. CONCLUSIONS: The FSFI is a powerful screening tool for FSD, especially in young fertile women, and may be used effectively in routine gynecological practice.

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OBJECTIVE: The present randomized prospective study aimed to compare the effect of tibolone (T) with conventional low-dose estrogen-progestogen therapy (EPT) administered in a combined continuous regimen on the course of primary headaches in postmenopausal women requesting hormone therapy (HT) for climacteric complaints. DESIGN: Forty women presenting for clinical evaluation of headache (migraine without aura and episodic tension-type headache) were enrolled. The observational period lasted 7 months during which women kept a diary of the clinical characteristics of headache attacks and analgesic use. Climacteric symptoms and both anxiety and depression were also measured. After a 1-month run-in period, women received two different HT regimens: 1 mg 17beta-estradiol + 0.5 mg norethisterone acetate (EPT) or 2.5 mg T. Follow-up evaluations were planned after 3 and 6 months of treatment. RESULTS: Although T did not affect the number of days with migraine without aura, it significantly reduced the number of hours during which pain intensity prohibited daily activities (P < 0.001) and the number of analgesics (P < 0.001) after 3 months. Conventional low-dose EPT administered in a combined continuous regimen was confirmed to have a mild, but negative, effect on the course of migraine without aura by increasing the number of days with head pain (P < 0.001) and the number of analgesics (P < 0.001). Interestingly, both treatments were effective in the management of episodic tension-type headache, significantly reducing the number of days with head pain, severity, and analgesic consumption. CONCLUSIONS: In postmenopausal headache sufferers, analgesics are more effective in alleviating severe head pain when women are treated with T in comparison with low-dose EPT for climacteric complaints.

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OBJECTIVE: The aim of the present pilot, randomized, study was to assess hemodynamic status of clitoral erectile tissues in postmenopausal women reporting female sexual dysfunction (FSD), namely libido and arousal disorders, under hormone therapy (HT). Vaginal health and sexual function were also investigated. STUDY DESIGN: Fifty patients presenting for clinical evaluation of menopausal status and suffering from FSD were randomly assigned to receive tibolone (2.5 mg) or 1 mg 17beta-estradiol .5 mg NETA (EPT) for 6 months. The observational period lasted 7 months during which women underwent to duplex Doppler ultrasonography to obtain clitoral hemodynamic data, were evaluated by using the vaginal health score index (VHIS) and filled in the two-factor Italian McCoy female sexuality questionnaire (MFSQ). RESULTS: Tibolone significantly increased clitoral peak systolic and end diastolic velocity (p<.001 for both), while no significant difference was evident in clitoral circulation of women under EPT at the end of the study. Both tibolone and EPT significantly increased VHIS (p<.001), an effect already evident following 3 months of HT. The atrophic state was significantly improved at 6 months (p<.001) with no significant differences between the two HT regimens. After 3 months, both tibolone and EPT significantly increased the sexuality score (p<.001, for both), but such an effect was significantly more pronounced in FSD women treated with tibolone in comparison with those assuming EPT (p<.002). Between the 3rd and the 6th month, tibolone caused a further significant improvement of sexuality score (p<.001), while women under EPT did not show any significant further change displaying a lower score (p<.001) at the end of the study in comparison with women assuming tibolone. CONCLUSIONS: Clitoral circulation in postmenopausal women reporting FSD is significantly increased under tibolone in comparison with EPT with a better improvement of sexual function, as measured by MFSQ, following 6 months of treatment.

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The primary objective of this randomized, double-blind, controlled study was the assessment of the pH-lowering effect of three different formulations of a vaginal device each containing 250 mg vitamin C. Overall, 39 women with vaginal pH >or=5, without evidence of vaginal infections, were randomly assigned to receive one of the three formulations for 6 days. The primary parameter assessed was vaginal pH, performed by the physician at the baseline and final visits and by the subjects each day during the application period; secondary parameters included the acceptability and safety profile of the tested devices. A decrease in pH to the normal range in all groups was observed following the first application, with stable low values during the whole study period. No statistically significant differences were seen among the three groups, while statistically significant within-group differences were observed. Acceptability and tolerability were rated as very good/good in most cases. The study results confirm that the vaginal application of vitamin C has an effective and long-lasting vaginal pH-lowering effect.

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Menopause is often associated with vaginal atrophy and related symptoms, such as vaginal dryness, burning, itching, and dyspareunia, decrease in libido and in general a decrease in the quality of life. The common treatment up to the 1990's has been the oral hormone replacement therapy (HRT), but this treatment has been consequently re-considered due to its adverse effects. Topical estrogenic products have been subsequently developed to minimize the systemic adverse effects of the oral HRT, but they are still considered at risk in case of prolonged use. As an alternative, two clinical trials were performed to investigate the effects of a medical device in the form of a gel, containing hyaluronic acid, liposomes, phytoestrogens from Humulus lupulus extract, and Vitamin E, with the aim of testing its safety and efficacy in post-menopausal women with urogenital atrophy. The first pilot study confirmed in 10 women the good safety profile, both locally and systemically, of the device applied on the external genitals at the dose of 1-2 g/day for 30 days. The second study was carried out, according to a multicenter, open, non-controlled design, in 100 post-menopausal women assigned to the vaginal application of 2.5 g of gel/day for 1 week followed by two applications/week for 11 weeks. The primary end-point was the evaluation of vaginal dryness assessed by a Visual Analogue Scale both by the investigator and the subject. Secondary endpoints were the evaluation of all other symptoms and signs associated with atrophic vaginitis (itching, burning, dyspareunia, vaginal inflammation/oedema and rash assessed by a 4-point scale and presence of vaginal abrasions and disepithelialisation), and the recording of adverse events during the study. At the end of the treatment, an overall judgment on the efficacy and safety of the device was made by the investigator and a judgment on the acceptability of the treatment was made by the subjects. The results showed a marked effect of the tested product on the vaginal dryness and on all other symptoms and signs with statistically significant reductions since the first week of treatment. No treatment-related adverse events were complained by the subjects and the treatment course showed a high level of acceptability by the subjects. This device could be considered an effective and safe alternative treatment of genital atrophy in post-menopausal women, especially when HRT is not recommended.

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PROBLEM: In order to investigate the role of amniotic fluid cells (AFC) in the establishment of feto-maternal immune relationship, we evaluated their phenotype and capacity to produce cytokines. METHODS OF STUDY: CK 7-8, human leukocyte antigen (HLA)-I, HLA-DR, HLA-G, CD1d, CD34, CD45, CD14 surface antigens expression and the intracellular production of IL-4, IL-6, IL-8, IL-10, IL-12, interferon-gamma and tumor necrosis factor-1 were studied in cultured AFC and in eight samples immediately after amniocentesis using flow cytometry. IL-6 and IL-8 were detected by ELISA in all amniotic fluids and in all culture supernatants. Moreover, IL-6 and IL-8 mRNA were tested in nine samples. RESULTS: Cultured AFC express HLA-I, HLA-G and CK 7-8 and are able to produce IL-6 and IL-8, confirmed by presence of their mRNA. We quantified IL-6 and IL-8 levels in all amniotic fluids and in all supernatants. CONCLUSION: Surface antigen expression of AFC are not specific of immune cells, but AFC are able to produce cytokines and we can postulate that they may participate in mechanisms involved in normal as well as pathological pregnancy.

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OBJECTIVE: The dose-effect relationship of nifuratel (CAS 4936-47-4) + nystatin (CAS 1400-61-9, CAS 34786-70-4) (Macmiror Complex) in topical treatment of vulvo-vaginitis was studied. METHOD: Sixty patients with Trichomoniasis and/or Candidiasis were randomized to: 1) nifuratel 125 mg/nystatin 50000 IU, 2) nifuratel 250 mg/nystatin 100000 IU, 3) nifuratel 500 mg/nystatin 200000 IU. Undistinguishable ovules were intravaginally applied qd for 10 days. The dose-effect relationship was assessed by ANCOVA. RESULT: After 5 days the microbiological cure rate occurred in 10% of patients in the least dose, in 40% in the middle dose and in 85% in the highest dose group (P = 0.000). After 10 days of treatment, the microbiological cure rate increased to 45%, 84%, and 95%, respectively (P = 0.007). Clinical signs and symptoms gradually disappeared in a dose- and time-dependent manner. No relapse has been observed after 10 day-follow up on 46 patients. CONCLUSION: The results confirmed a linear relationship between nifuratel + nystatin dose and effect. The least effective dose was nifuratel 250 mg + nystatin 100,000 IU once daily for 5 days and the best dose in terms of risk/benefit ratio was nifuratel 500 mg + nystatin 200,000 IU once daily for 5 days.

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