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Onur Medical Research Ltd., Istanbul, Turkey.
OBJECTIVE To evaluate the efficacy of Neo-Penotran pessaries (metronidazole 500 mg + miconazole nitrate 100 mg) in candidal, bacterial and trichomonal vaginitis and in mixed vaginal infections. METHOD Ninety-seven patients with clinical diagnosis of vaginitis entered this open, non-comparative study. Each patient inserted one pessary twice daily for 7 days. Gynecological and microbiological assessments were carried out before, and 8-10/21-23 days after the start of treatment. RESULTS Vaginitis symptoms were resolved in 91% of the 74 patients evaluated, and improved in a further 7%. Microbiological cure rates were 97.3% for trichomonal, 86.6% for bacterial and 81% for candidal vaginitis. Recurrence rates were 2.7, 3.8 and 16.1%, respectively. Overall microbiological cure rate for mixed infections was 86%, with 93% for trichomonal+bacterial, and 73% for bacterial+candidal vaginitis. In two out of three cases with trichomonal+bacterial+candidal infection, the microorganisms were eradicated completely. CONCLUSION Neo-Penotran provides immediate and effective treatment for vaginitis, irrespective of single or multiple infection, even when the diagnosis may be uncertain.

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Laboratorio de Control de Calidad de Medicamentos, Cátedra de Química Analítica I, Facultad de Bioquímica y Ciencias Biológicas Universidad Nacional del Litoral, C.C. 242, S3000ZAA Santa Fe, Argentina. mmdezan@fbcb.unl.edu.ar
A simple and stability-indicating high performance liquid chromatographic method was developed and validated for the determination of miconazole nitrate in bulk and cream preparations. The extraction step for cream samples consisted in a warming, cooling and centrifugation procedure that assures the elimination of the lipophilic matrix component, in order to avoid further precipitation in the chromatographic system. Separation was achieved on a ZORBAX Eclipse XDB - C18 (4.6 mm x 150 mm, 5 microm particle size) column, using a mobile phase consisting of water, methanol and acetonitrile, in a flow and solvent gradient elution for 15 min. The column was maintained at 25 degrees C and 10 microL of solutions were injected. UV detection was performed at 232 nm, although employment of a diode array detector allowed selectivity confirmation by peak purity evaluation. The method was validated reaching satisfactory results for selectivity, precision and accuracy. Degradation products in naturally aged samples could be simultaneously evaluated, without interferences in the quantitative analysis.
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Department of Pharmaceutics, Hamdard University, New Delhi-110062, India.
An acid buffering bioadhesive vaginal (ABBV) gel was developed for the treatment of mixed vaginal infections. Different bioadhesive polymers were evaluated on the basis of their bioadhesive strength, stability and drug release properties. Bioadhesion and release studies showed that guar gum, xanthan gum and hydroxypropyl methylcelullose K4M formed a good combination of bioadhesive polymers to develop the ABBV gel. Monosodium citrate was used as an acid buffering agent to provide acidic pH (4.4). The drugs clotrimazole (antifungal) and metronidazole (antiprotozoal as well as antibacterial) were used in the formulation along with Lactobacillus spores to treat mixed vaginal infections. The ex vivo retention study showed that the bioadhesive polymers hold the gel for 12-13 hours inside the vaginal tube. Results of the in vitro antimicrobial study indicated that the ABBV gel had better antimicrobial action than the commercial intravaginal drug delivery systems and retention was prolonged in an ex vivo retention experiment.
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Sezione di Ostetricia e Ginecologia, Dipartimento di Medicina e Scienze dell'Invecchiamento, Facoltà di Medicina e Chirurgia, Università "G. d'Annunzio", Chieti-Pescara, Italy.
The potential interactivity of the antimicrobials miconazole and metronidazole in the induction of teratogenic effects was investigated in the present study. Drugs were injected at 60mg/kg either individually or in combination to pregnant mice on gestation day (GD) 8, 9, or 10. Teratological assessments were carried out on GD 18. A potent teratogenic interaction resulted from miconazole-metronidazole co-administration, causing an increment in axial skeletal defects incidence. While, the individual exposure to miconazole or metronidazole produced axial skeletal defects at frequencies that did not exceed 5.6% in the various treatment groups, the percentage of fetuses with malformed skeleton reached 26% after co-exposure on GD 8 or GD 9. No significant synergism was noted when drugs were co-administered on GD 10. This study shows that a teratogenic interaction can result from miconazole-metronidazole concomitant exposure.
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Department of Microbiology and Molecular Genetics, Rutgers, The State University of New Jersey, New Brunswick, NJ 08854-8097, USA.
Bacterial vaginosis (BV), a condition affecting millions of women each year, is primarily caused by the gram-variable organism Gardnerella vaginalis. A number of organisms associated with BV cases have been reported to develop multidrug resistance, leading to the need for alternative therapies. Previously, we reported the antimicrobial peptide subtilosin has proven antimicrobial activity against G. vaginalis, but not against the tested healthy vaginal microbiota of lactobacilli. After conducting tissue sensitivity assays using an ectocervical tissue model, we determined that human cells remained viable after prolonged exposures to partially-purified subtilosin, indicating the compound is safe for human use. Subtilosin was shown to eliminate the motility and forward progression of human spermatozoa in a dose-dependent manner, and can therefore be considered a general spermicidal agent. These results suggest subtilosin would be a valuable component in topical personal care products aimed at contraception and BV prophylaxis and treatment.
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Laboratory of Human Reproduction, Teaching Hospital, Federal University of Minas Gerais, Brazil. fabiocpeixoto@terra.com.br
OBJECTIVE To evaluate the efficacy and tolerability of a vaginal pessary containing 750 mg of metronidazole and 200 mg of miconazole nitrate used daily for 7 days in the treatment of vaginitis. METHODS Ninety-two women with vaginitis participated in this phase 3 study using one vaginal pessary daily for 7 days. Gynecological and microbiological evaluations were carried out prior to and following treatment. RESULTS Reductions occurred in symptoms and signs of vaginitis. Clinical cure rate was 87.7%, while the cure rates according to microscopy and Candida albicans culture were 81.8% and 73.9%, respectively. The cure rate for bacterial vaginosis was 75% and culture of Gardnerella vaginalis turned negative in 63.6% of cases following treatment. The medication was well tolerated. CONCLUSION Use of a combination of 750 mg of metronidazole and 200 mg of miconazole in a single daily application was found to be effective in the treatment of the most common causes of vaginitis.
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School of Biotechnology, The Royal Institute of Technology, 100 44 Stockholm, Sweden.
OBJECTIVE To evaluate the safety of the antimicrobial peptide, lactocin 160. METHODS Lactocin 160, a product of vaginal probiotic Lactobacillus rhamnosus 160 was evaluated for toxicity and irritation. An in vitro human organotypic vaginal-ectocervical tissue model (EpiVaginal) was employed for the safety testing by determining the exposure time to reduce tissue viability to 50%(ET-50). Hemolytic activity of lactocin160 was tested using 8% of human erythrocyte suspension. Susceptibility of lactobacilli to lactocin160 was also studied. Rabbit vaginal irritation (RVI) model was used for an in vivo safety evaluation. RESULTS The ET-50 value was 17.5 hours for lactocin 160 (4.9 hours for nonoxynol 9, N9). Hemolytic activity of lactocin 160 was 8.2%(N9 caused total hemolysis). Lactobacilli resisted to high concentrations of peptide preparation. The RVI model revealed slight vaginal irritation. An average irritation index grade was evaluated as "none." CONCLUSIONS Lactocin 160 showed minimal irritation and has a good potential for intravaginal application.
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[My paper] P G Larsson, U Forsum
Department of Molecular and Clinical Medicine, Linköping University, and Department of Obstetrics and Gynaecology, Kärnsjukhuset, Skövde, Sweden. p-g.larsson@vgregion.se
The syndrome bacterial vaginosis (BV) is characterized by a disturbed vaginal microflora in which the normally occurring lactobacilli yield quantitatively to an overgrowth of mainly anaerobic bacteria. As BV is a possible cause of obstetrics complications and gynaecological disease--as well as a nuisance to the affected women--there is a strong impetus to find a cure. In BV treatment studies, the diagnosis criteria for diagnosis of BV vary considerably and different methods are used for cure evaluation. The design of study protocols varies and there is no consensus respecting a suitable time for follow-up visits. For the purpose of this review, available data were recalculated for 4-week post treatment cure rates. For oral metronidazole the 4-week cure rate was found not to exceed 60-70%. Treatment regimens with topical clindamycin or topical metronidazole have the same cure rates. It can thus be said that no sound scientific basis exists for recommending any particular treatment. There is no evidence of beneficial effects on BV engendered by partner treatment, or by addition of probiotics or buffered gel. Long-term follow-up (longer than 4 weeks) shows a relapse rate of 70%. With a primary cure rate of 60-70%, and a similar relapse rate documented in the reviewed literature, clinicians simply do not have adequate data for determining treatment or designing clinical studies. This is unfortunate since--apart from the obvious patient benefits--clinical studies can often serve as a guide for more basic studies in the quest for underlying disease mechanisms. In the case of BV there is still a need for continued basic studies on the vaginal flora, local immunity to the flora and host-parasite interactions as an aid when designing informative clinical studies.
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Instituto de Patologia Tropical e Saúde Pública da Universidade Federal de Goiás, Brasil.
Between April 2001 and April 2002 were studied 106 women with a clinical diagnosis of vaginal candidiasis seen at the Gynecology and Obstetrics Ambulatory of the Hospital das Clínicas da Universidade Federal de Goiás. The patients were assessed on two occasions, before starting treatment with itraconazole or fluconazole (initial visit) and 14 days after treatment (return). At two visits the signs and symptoms were recorded and vaginal secretion was collected. According to the clinical evaluation, itraconazole was effective in 64.3%, while fluconazole was effective in 71.0% of the patients. The mycological cure rates (negative culture) in the return were 64.3% for the patients treated with itraconazole and 78.9% for the patients treated with fluconazole. The MICs of itraconazole and fluconazole for 80 Candida isolates were determined by Etest method. We investigated the correlation between in vitro susceptibility (Susceptible, Susceptibility Depending Dose and Resistant) to itraconazole and fluconazole with clinical outcome of the patients. The success rates were 63.9% for itraconazole and 90.6% for fluconazole in the susceptible category, 100.0% for both drugs in the susceptible dose dependent category, and 0.0% for both drugs in the resistant category. Our results showed there were a positive correlation between in vitro susceptibility test results with clinical outcome in vaginal Candida infections and that both drugs might be one choice in the treatment of vaginal candidiasis.

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[My paper] O Morton
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[My paper] O Morton
After 11 years of banging electrons and positrons together at higher energies than any other machine in the world, CERN, the European laboratory for particle physics, had decided to shut down the Large Electron-Positron collider (LEP) and install a new machine, the Large Hadron Collider (LHC), in its 27-kilometer tunnel. In 2005, the LHC will start bashing protons together at even higher energies. But tantalizing hints of a long-sought fundamental particle have forced CERN managers to grant LEP a month's reprieve.
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[My paper] O Morton
Physicists at CERN, the European particle physics laboratory near Geneva, are making a last-ditch appeal to postpone demolition of the lab's Large Electron-Positron (LEP) collider. Scheduled to be scrapped in September to make room for a new device, the Large Hadron Collider, LEP was granted a 1-month stay of execution so physicists could continue experiments hinting at evidence for the Higgs boson--a theoretical particle that physicists have coveted for decades. On 8 November, CERN's director-general turned down a further extension, but the executive committee of the lab's staff association blasted the decision, saying that the case against LEP had not been made clearly enough.
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ININ, Ap. Post. 18-1027, C.P. 11801, México D.F., Mexico.
(137)Cs and (40)K activity concentrations and stable elements have been measured in Clavariadelphus truncatus collected in Mexico. Iron-chelating compounds of siderophore-type was also studied in the species.(137)Cs and (40)K were determined in soil and mushroom samples with HpGe gamma-ray spectrometry. Macro- and micro-elemental concentrations were determined by XRF and ICP-MS. Siderophore detection was obtained with a colorimetric assay and X-ray diffraction analysis was performed using a Siemens D5000 diffractometer.(137)Cs geometric mean concentration in C. truncatus was 26 times higher as compared with other Mexican edible mushroom species, while (40)K showed stability. Soil-C. truncatus concentration ratio for (137)Cs and other micro-elements such as Cs, Rb and Pb were also higher than other Mexican edible species. The (137)Cs committed effective dose due to the ingestion of C. truncatus was 8x10(-6)Svyear(-1). The main crystalline structure found in C. truncatus was d-Mannitol.
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Department of Neurology, Cerrahpaşa Medical School, Istanbul University, Cerrahpaşa, Istanbul, Turkey 34303. snaz@atlas.net.tr
To evaluate the hypothetical link between apolipoprotein E (APOE) polymorphisms and mesial temporal lobe epilepsy with hippocampal sclerosis (MTLE-HS) and whether presence of APOE epsilon4 allele shortens the latent period between febrile seizures and epilepsy. A further interest is whether presence of APOE epsilon4 allele has an impact on severity of the disease. Forty-seven patients with MTLE-HS were compared with 62 controls. APOE polymorphisms were determined from lymphocytes by standard methods. Eight patients (17%) and 10 controls (16.1%) were demonstrated to have one APOE epsilon4 allele. There was not any statistically significant difference in APOE epsilon4 frequency between patients and controls (P > 0.05). There was not any difference statistically according to onset age of epilepsy and the presence of APOE epsilon4 allele within patient group. APOE epsilon4 polymorphisms did not influence the severity of epilepsy. APOE epsilon4 polymorphisms had no impact on outcome after surgery. Patients with bilateral memory deficits, bilateral hippocampal atrophy and with bilateral epileptiform interictal EEG transients, were independently compared with patients having unilateral features and there were not any statistically significant differences. This study has found no association between APOE epsilon4 polymorphisms and presentation of MTLE-HS in a group of Turkish patients.
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Geophysics Institute, National Autonomous University of Mexico, Circuito Exterior, C.U., México 04510 D.F., Mexico.
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[My paper] O Morton
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Department of Pharmacology and Clinical Pharmacology, Marmara University, The School of Medicine, Istanbul, Turkey.
The interaction of neurotransmitters has been a major interest in pathophysiological conditions like epilepsy. In vivo microdialysis has recently gained much validity in measuring neurotransmitter release in experimental animals. However, there is a paucity of data concerning its use in humans on the grounds of safety considerations. Microdialysis experiments were performed using the hippocampal head region removed from patients with medically intractable seizures, who underwent surgery for mesial temporal lobe epilepsy with hippocampal sclerosis (MTLE-HS). Following en bloc resection, the tissues were immediately transferred to the essential in vitro milieu. Slices were incubated in lactated Ringer's solution and microdialysis probes inserted into the slices were perfused with artificial cerebrospinal fluid (aCSF). When the K+ concentration of aCSF was elevated to 100 mM, GABA and L-glutamic acid levels increased by 293% and 177%, respectively. This method may serve as an experimental model for human brain, to throw more light on the interactions between GABA and L-glutamic acid in hippocampal tissues obtained from patients with MTLE-HS.
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Department of Pharmacology, Faculty of Pharmacy, University of Istanbul, 34452 Universite, Istanbul, Turkey.
Aloe vera (L.) Burm. fil.(= A. barbadensis Miller)(Liliaceae) is native to North Africa and also cultivated in Turkey. Aloes have long been used all over the world for their various medicinal properties. In the past 15 years, there have been controversial reports on the hypoglycaemic activity of Aloe species, probably due to differences in the parts of the plant used or to the model of diabetes chosen. In this study, separate experiments on three main groups of rats, namely, non-diabetic (ND), type I (IDDM) and type II (NIDDM) diabetic rats were carried out. A. vera leaf pulp and gel extracts were ineffective on lowering the blood sugar level of ND rats. A. vera leaf pulp extract showed hypoglycaemic activity on IDDM and NIDDM rats, the effectiveness being enhanced for type II diabetes in comparison with glibenclamide. On the contrary, A. vera leaf gel extract showed hyperglycaemic activity on NIDDM rats. It may therefore be concluded that the pulps of Aloe vera leaves devoid of the gel could be useful in the treatment of non-insulin dependent diabetes mellitus

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Medarex, Princeton, NJ, USA.
BACKGROUND: New therapies are needed to manage the increasing incidence, severity, and high rate of recurrence of Clostridium difficile infection. METHODS: We performed a randomized, double-blind, placebo-controlled study of two neutralizing, fully human monoclonal antibodies against C. difficile toxins A (CDA1) and B (CDB1). The antibodies were administered together as a single infusion, each at a dose of 10 mg per kilogram of body weight, in patients with symptomatic C. difficile infection who were receiving either metronidazole or vancomycin. The primary outcome was laboratory-documented recurrence of infection during the 84 days after the administration of monoclonal antibodies or placebo. RESULTS: Among the 200 patients who were enrolled (101 in the antibody group and 99 in the placebo group), the rate of recurrence of C. difficile infection was lower among patients treated with monoclonal antibodies (7% vs. 25%; 95% confidence interval, 7 to 29; P<0.001). The recurrence rates among patients with the epidemic BI/NAP1/027 strain were 8% for the antibody group and 32% for the placebo group (P=0.06); among patients with more than one previous episode of C. difficile infection, recurrence rates were 7% and 38%, respectively (P=0.006). The mean duration of the initial hospitalization for inpatients did not differ significantly between the antibody and placebo groups (9.5 and 9.4 days, respectively). At least one serious adverse event was reported by 18 patients in the antibody group and by 28 patients in the placebo group (P=0.09). CONCLUSIONS: The addition of monoclonal antibodies against C. difficile toxins to antibiotic agents significantly reduced the recurrence of C. difficile infection.(ClinicalTrials.gov number, NCT00350298.)
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Department of Obstetrics and Gynaecology, Clinical Centre of Vojvodina, Branimira Cosica 37, Novi Sad, Serbia. aleksandranovakov@yahoo.com
OBJECTIVE Bacterial vaginosis (BV) is characterized by a mixed flora of pathogenic anaerobic bacteria and associated with risks of pathologic conditions. In the present study, therapy with a local antiseptic spray (octenidine hydrochloride/phenoxyethanol, OHP) for 7 or 14 days is compared against the standard local therapy of BV (metronidazole) in a Serbian patient population. METHODS As much as 450 women were treated in groups with either 7 days metronidazole vaginal tablets, 7 days OHP, or 14 days OHP. Control smears were taken after each treatment period. RESULTS In total, 63.2% of the women were without indications of BV after therapy (metronidazole: 61.0%, OHP 7 days: 57.6%, and OHP 14 days: 71.0%). Significantly fewer women were affected from infections after treatment with 14 days OHP compared to OHP for 7 days. CONCLUSIONS Octenidine hydrochloride/phenoxyethanol spray was as effective as the standard therapy with metronidazole. Patients stated that OHP was more comfortable, easier to apply, and side effects were lesser.
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Laboratory of Human Reproduction, Teaching Hospital, Federal University of Minas Gerais, Brazil. fabiocpeixoto@terra.com.br
OBJECTIVE To evaluate the efficacy and tolerability of a vaginal pessary containing 750 mg of metronidazole and 200 mg of miconazole nitrate used daily for 7 days in the treatment of vaginitis. METHODS Ninety-two women with vaginitis participated in this phase 3 study using one vaginal pessary daily for 7 days. Gynecological and microbiological evaluations were carried out prior to and following treatment. RESULTS Reductions occurred in symptoms and signs of vaginitis. Clinical cure rate was 87.7%, while the cure rates according to microscopy and Candida albicans culture were 81.8% and 73.9%, respectively. The cure rate for bacterial vaginosis was 75% and culture of Gardnerella vaginalis turned negative in 63.6% of cases following treatment. The medication was well tolerated. CONCLUSION Use of a combination of 750 mg of metronidazole and 200 mg of miconazole in a single daily application was found to be effective in the treatment of the most common causes of vaginitis.
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Department of Obstetrics and Gynecology, Western Galilee Hospital, Nahariya, Israel. mdjacob@gmail.com
BACKGROUND We compared a novel vaginal tablet consisting of 100 mg of clotrimazole and 100 mg of metronidazole ('Clo-Met') to a 100-mg clotrimazole tablet in the treatment of vaginitis. METHODS A multicenter, double-blind, randomized controlled study. Women with vaginal discharge and diagnosed as suffering from vaginitis caused by Trichomonas vaginalis, bacterial vaginosis or Candida albicans, or any combination of the three, and who had not received treatment for vaginitis during the previous month, were studied. RESULTS 165 patients were enrolled into the study--84 into the combined therapy group, and 81 into the clotrimazole group. In women with Candida vaginitis, Clo-Met was more effective than clotrimazole treatment (p < 0.012 and p < 0.05, respectively). CONCLUSION A combination vaginal tablet consisting of clotrimazole and metronidazole is therapeutically effective in candidal vaginitis. The effectiveness of Clo-Met on bacterial vaginosis, T. vaginalis infection as well as on vaginal infections due to a combination of these microorganisms should be studied further.
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Obstetric and Gynecology Department 'Ospedale Civile', Giussano, Italy.
OBJECTIVE: We evaluated the efficacy and tolerability of a new chlorhexidine-based bioadhesive vaginal gel (Clomirex) in women with vaginal infections. Study design and subjects: A total of 90 nonpregnant women with vaginal infections of both bacterial (bacterial vaginosis: BV) or fungal (vaginal candidiasis VC) origin, were enrolled in the study: a randomised, controlled, 4-week, multicentre trial. Patients were randomly treated with either chlorhexidine 0.5% vaginal gel (CHX-VG), 2.5 g or with metronidazole vaginal tablets 500 mg (M) or clotrimazole (CL) vaginal cream, depending on aetiology of the infection, daily for 7 days (treatment phase) in a 2:1 ratio. A total of 45 women had a diagnosis of BV and 45 a diagnosis of VC. Sixty women were treated with CHX-VG, 15 with M and 15 with CL. All patients were followed for an additional 3 weeks without treatments (follow-up phase). For women with BV,clinical cure rate was defined as the disappearance of the following signs and symptoms: homogenous vaginal discharge; presence of >or= 2 or more clue cells at the wet mount microscopy; a vaginal pH > 4.7 and a positive whiff test. For women with VC, clinical cure rate was defined as a resolution of signs and symptoms plus absence of hyphae, pseudohyphae and blastospores on 10% KOH wet mount microscopy. Clinical cure rate was assessed at the end of the study (week 4) by an investigator unaware of the patient's treatment allocation. RESULTS: At week 4, in women with BV, 28 out of 30 (93%) women in the CHX-VG group were clinically cured in comparison with 11 out of 15 (74%) in the M group (p = 0.3). In women with VC, 26 out of 30 (86.6%) women in the CHX-VG group were clinically cured in comparison with 13 out of 15 (86%) in the CL group (p = 0.5). Tolerability was good and very good in 90% of the CHX-VG patients. Six women (10%) complained of a mild transient burning sensation after CHX-VG vaginal application. No serious adverse events were observed during the trial in all treated groups. No women presented with vaginal discharge after treatment.
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Department of Obstetrics and Gynecology, Kärnsjukhuset, S-541 85 Skövde, Sweden. p-g.larsson@vgregion.se
OBJECTIVE: Bacterial vaginosis (BV) is a known risk factor for postoperative infection following abdominal hysterectomy. Vaginal bacterial flora scored as intermediate has been shown to have the same risk of postoperative infection as BV. METHODS: Women undergoing total abdominal hysterectomy for benign diseases were open-randomized according to Zelen to either treatment with metronidazole rectally for at least 4 days or no treatment. At the preoperative gynecological examination a vaginal smear was collected and Gram stained. Women with BV or intermediate flora were merged to one group called abnormal vaginal flora. RESULTS: In total 213 women were randomized to treatment or no treatment. After exclusion of 71 women, 142 women were eligible for analysis. Among the 59 women diagnosed with abnormal vaginal flora there were no vaginal cuff infections in the treated arm, compared with 27% in the 'no treatment' arm (p < 0.01). Treatment also reduced the vaginal cuff infection rate from 9.5 to 2% among the 83 women with lactobacilli flora. However, this difference was not statistically significant. Treatment had no effect on the rate of wound infections. Intention-to-treat analysis showed a significant reduction in vaginal cuff infections among women randomized to treatment. CONCLUSION: Pre- and postoperative treatment for at least 4 days with metronidazole rectally reduces significantly vaginal cuff infection among women with abnormal vaginal flora.
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Department of Obstetrics and Gynecology, Baylor College of Medicine, Houston, Texas, USA.
OBJECTIVE: To compare the safety and efficacy of a single vaginal dose of a butoconazole nitrate 2% bioadhesive, sustained-release cream*(butoconazole 1-BSR) with a seven-day schedule of miconazole nitrate vaginal cream 2%(miconazole 7). STUDY DESIGN: The clinical trial was conducted according to a randomized, parallel, investigator-blind, multicenter study design. The patients self-administered the respective creams to the posterior vaginal fornix. Two hundred twenty-three patients started the trial and were analyzed for safety. A total of 205 patients qualified for efficacy analysis, 101 receiving butoconazole 1-BSR and 104 using miconazole 7. Patients receiving butoconazole 1-BSR inserted one applicator full of medication once. Those assigned to receive miconazole 7 inserted one applicator full daily for seven days. Patients were evaluated 7-10 and 30 days after completion of therapy. RESULTS: Butoconazole 1-BSR rapidly relieved the signs and symptoms of vulvovaginal candidiasis. The proportion of patients with severe symptoms declined from the pretreatment 20% to 6% on the 1st day, to 3% on the 4th day, and to 2-1% on the 5th-7th day after single-dose application. Eight to ten days after treatment completion, clinical symptoms regressed in 92%, and fungal cultures were negative in 87% of patients. At the 30-day posttreatment visit, 88% of patients remained clinically cured, and 74% had negative fungal cultures. In the miconazole 7 group, the proportion of patients with severe symptoms declined from 23% to 19% after the first dose; thereafter, symptom relief proceeded more rapidly. Eight to ten days after treatment completion, clinical symptoms regressed in 92% and fungal cultures were negative in 87% of patients. At the 30-day follow-up examination, 86% patients were clinically cured, and 77% were culture negative. After single-dose butoconazole 1-BSR, severe symptoms receded faster than after the first dose of miconazole 7, and the difference was statistically significant (P =.01). In all other efficacy parameters, the differences between the two groups were not statistically significant. Neither treatment regimen caused significant adverse events. CONCLUSIONS: This clinical trial demonstrated that butoconazole 1-BSR is an effective and safe alternative to longer-term therapy with miconazole nitrate (seven days) for vulvovaginal candidiasis.
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Department of Obstetrics and Gynecology, Numune Hospital, Ankara, Turkey.
OBJECTIVE: To evaluate the clinical efficacy and tolerance of oral or vaginal ornidazole, secnidazole and metronidazole or their combinations for treatment of bacterial vaginosis. METHOD: In an open, randomized, prospective study, 152 patients with bacterial vaginosis according to Amsel's criteria were included into the study. The patients were divided into eight groups:(1) oral ornidazole 2 x 500 mg/day for 5 days;(2) vaginal ornidazole 500 mg/day for 5 days;(3) oral and vaginal ornidazole for 5 days;(4) oral secnidazole 2 g in a single dose;(5) oral secnidazole 2 g in a single dose and vaginal ornidazole 500 mg/day for 5 days;(6) oral secnidazole 2 g in a single dose and vaginal metronidazole 2 x 500 mg/day for 7 days;(7) oral ornidazole 2 x 500 mg/day for 5 days and vaginal metronidazole 2 x 500 mg/day for 7 days; and (8) vaginal metronidazole 2 x 500 mg/day for 7 days. None of the partners received any treatment. RESULT: We found a 100% cure rate in both oral and vaginal ornidazole and oral secnidazole-vaginal metronidazole groups. CONCLUSION: Vaginal treatments including ornidazole and metronidazole are not as effective as both oral and vaginal drug combinations.
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Dr Zekai Tahir Burak Women's Hospital, Ankara, Turkey.
OBJECTIVE: The purpose of this study was to evaluate the efficacy of metronidazole 500 mg and miconazole nitrate 100 mg (Neo-Penotran, Embil Pharmacy Company, Istanbul, Turkey) in the treatment of vaginitis. METHOD: One hundred patients (mean age 26.5 years, range 18-50) with a clinical diagnosis of vaginitis entered this open, noncomparative study. Each patient inserted a Neo-Penotran pessary twice daily for 14 days. Assessments were carried out at the beginning of the study and 15 and 22 days after the start of therapy. Student's t-test was used for the statistical analysis. RESULTS: Out of 100 patients who were initially recruited to the study, 20 were subsequently excluded, leaving a total of 80 patients (80%) who completed the full course of treatment. Vaginitis was resolved in 75% of cases, it improved in 18% and was unchanged in 7%. The success rate for the treatment of trichomoniasis was 80%, 93.4% for bacterial vaginosis and 84.4% for candidal vaginitis. CONCLUSION: Neo-Penotran pessaries represent a novel and effective formulation for the treatment of common types of vaginitis and this pessary may also be of particular value in the treatment of resistant or recurrent vaginitis.
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Division of Gastroenterology, Kure Kyosai Hospital, Japan.
AIM: To investigate the effect of eradication of Helicobacter pylori using combination therapy with low-dose omeprazole and clarithromycin on the healing and recurrence of peptide ulcers. PATIENTS AND METHODS: We studied 60 patients with active duodenal ulcers and 60 with gastric ulcers who were H. pylori-positive by the rapid urease test and a histological examination of antral biopsy specimens. The eradication method used was a combination of omeprazole (20 mg a day) and clarithromycin (400 mg twice a day). The patients were followed up for 24 months after the end of the treatment. H. pylori infection and the ulcer stage were investigated by endoscopy every 6 months. We assessed the relationship between H. pylori infection, ulcer healing to a white scar and ulcer recurrence after combination therapy. RESULTS: H. pylori was eradicated in 23 out of 120 patients (22%), with suppression in 101 out of 120 patients (84%). The rate of ulcer healing to a white scar 6 months after treatment was significantly higher and the ulcer recurrence rate within 2 years after treatment was significantly lower in patients with H. pylori suppression or eradication than in those continuously positive for the organism. CONCLUSIONS: These results suggest that not only the eradication but also the suppression of H. pylori may improve ulcer healing and reduce the rate of relapse.


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