Nystatin/Neomycin Sulphate/Polymyxin B Sulphate(Nystatin/Neomycin Sulphate/Polymyxin B Sulphate) - 药物靶点：Ergosterol x PBPs_在研适应症：阴道炎_专利_临床

概要

基本信息

药物类型

多肽抗生素

别名

nystatin/neomycin sulphate/polymyxin B sulphate、Polygynax

靶点

Ergosterol x PBPs

作用方式

调节剂、抑制剂

作用机制

Ergosterol 调节剂(麦角固醇调节剂)、PBPs抑制剂(细菌青霉素结合蛋白家族抑制剂)、细胞膜功能抑制剂

治疗领域

泌尿生殖系统疾病

在研适应症

阴道炎

非在研适应症

细菌性阴道炎感染性阴道炎

原研机构-

在研机构

Laboratoire INNOTECH International SAS

非在研机构-

权益机构-

最高研发阶段批准上市

首次获批日期

卢旺达 (1997-02-11),

阴道炎

最高研发阶段(中国)-

特殊审评-

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结构/序列

分子式C23H46N6O13

InChIKeyPGBHMTALBVVCIT-VCIWKGPPSA-N

CAS号119-04-0

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关联

2

项与 Nystatin/Neomycin Sulphate/Polymyxin B Sulphate 相关的临床试验

NCT02515656

/ Completed临床3期

Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis International, Multicentre, Randomised, Double-blind, Parallel Group Study, Comparative Versus Miconazole

POLYGYNAX® is a broad spectrum combination of nystatin, neomycin and polymixin B indicated for the local treatment of vaginitis due to sensitive germs and treatment of non specific vaginitis of adults. POLYGYNAX® has been marketed in France since 1969.
Nevertheless, despite the well established use of POLYGYNAX®, there is no clinical study supporting the interest of the combination of antifungal and antibiotics agents versus antifungal agent alone.
The aim of this project is to demonstrate that POLYGYNAX® is more effective than miconazole in the treatment of women experiencing symptoms of infectious vaginitis.

开始日期2015-09-01

申办/合作机构

Laboratoire INNOTECH International SAS

[+1]

NCT02444481

/ Completed临床4期

Open Multicenter Clinical Study of the Efficacy of the Local Treatment With Polygynax of Mycotic and/or Bacterial Vaginitis

Open prospective multicenter phase IV study in patients presenting with symptoms of bacterial and/or mycotic (mushroom) vaginitis for 12 days as specified in the product information.
Investigators/centers: 20 gynacologists are previewed to do the study in ambulatory treatment.
Objectifs of the study:
Principal objectif:
Evaluation of the efficacy of the treatment on the clinical symptoms of bacterial and/or mycotic vaginitis
Secondary objectif:
Evaluation of the efficacy of the treatment on eradication of the diagnosed germs Evaluation of the correspondence of the efficacy on the symptoms and on the eradication of the germs.
Numbers of patients previewed: 100 patients for evaluation of the efficacy
Criteria of evaluation
Principal criteria:
Clinical efficacy as judged by the investigator Secondary criteria:evaluation of clinical symptoms judged by the patient reduction or emlimination of bacteria and other germs the relationship between clinical and bacterial results
Evaluation of tolerance
Used Study Drug:
Polygynax, vaginal capsule consisting of Polymyxin 35000 UI, Neomycin 35000UI and Nystatin 100000UI Application: vaginal application once daily in the evening for 12 days
Study design:
Visit 1:
All patients presenting with the clinical symptoms, presenting all inclusion criteria and none of the exclusion criteria are included in the study at visit 1 and receive Polygynax treatment (one vaginal capsule once daily in the evening).
A vaginal smear is obtained. Visit 2 (optional) If the results of the bacteriological examination confirms an infection with germs sensible to the treatment with Polygynax the treatment is continued. If other germs not sensible to Polygynax are present, the patients is contacted to stop the treatment, to come back to a second visit to her gynacologist who will change the treatment. The other patients continue the treatment.
Visit 3:
After the treatment the patients come back to the last visit. A clinical evaluation and a vaginal smear for control is obtained.

开始日期2009-04-01

申办/合作机构

Laboratoire INNOTECH International SAS

100 项与 Nystatin/Neomycin Sulphate/Polymyxin B Sulphate 相关的临床结果

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100 项与 Nystatin/Neomycin Sulphate/Polymyxin B Sulphate 相关的转化医学

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100 项与 Nystatin/Neomycin Sulphate/Polymyxin B Sulphate 相关的专利（医药）

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8

项与 Nystatin/Neomycin Sulphate/Polymyxin B Sulphate 相关的文献（医药）

2020-12-01·International journal of pediatric endocrinology

Undervirilized male infant with in utero exposure to maternal use of high dose antifungal therapy

作者: Yau, Mabel ; Costin, Gertrude ; Gujral, Jasmine ; Rapaport, Robert ; Romero, Christopher J ; Sethuram, Swathi ; Wilkes, Meredith ; Wallach, Elizabeth ; Khurana, Divya

Abstract:

Background:

Antifungals act on fungal sterols structurally similar to human cholesterol. Ketoconazole reversibly suppresses steroidogenesis by inhibiting cytochrome P450 enzymes and interferes with dihydrotestosterone (DHT) activity by binding to the androgen receptor. Hypospadias was reported in infants exposed to nystatin in utero.

Case presentation:

A male infant exposed to antepartum nystatin presented with severe under-undervirilization and transient adrenal corticosteroid abnormalities. He was born in USA at 31 weeks gestation to a mother treated with vaginal Polygynax capsules (nystatin-100,000 international units, neomycin sulphate-35,000 international units and polymyxin B-35,000 international units) for vaginal discharge in the Ivory Coast. She used approximately 60 capsules between the first trimester until delivery. The infant was born with micropenis, chordee, perineo-scrotal hypospadias and bifid scrotum with bilaterally palpable gonads. The karyotype was 46,XY. No Mullerian structures were seen on ultrasound. Serum 17-hydroxyprogesterone (17 OHP) on newborn screening was high (304 ng/ml, normal < 35). Cortisol response to cosyntropin on the 3rd day of life (DOL) was 10 mcg/ml; the subnormal cortisol response may have resulted from prematurity and the predelivery treatment with betamethasone. The elevation of several adrenal corticosteroids was not consistent with any specific enzymatic defect. Hydrocortisone and fludrocortisone were initiated at another hospital for suspected mild glucocorticoid and mineralocorticoid deficiencies. Genetic screening for adrenal and gonadal developmental defects performed when transferred to our care were normal. All medications were gradually discontinued over 5–8 months. Adrenal and testicular responses to cosyntropin and human chorionic gonadotropin (hCG) were normal at 8 months.

Conclusions:

We report severe undervirilization in a 46,XY infant born to a mother treated with prolonged and high dose nystatin during pregnancy. This presentation suggests that prolonged antepartum use of high dose nystatin could lead to severe but transient defects in androgen synthesis and/or action possibly by acting as an endocrine disruptor. Further studies are warranted to confirm this finding. Thus, endocrine disruptors should be considered in male newborns with atypical genitalia not explained by common pathologies.

2019-05-01·Medecine et maladies infectieuses4区 · 医学

PRISM study: Comparison of a nystatin-neomycin-polymyxin B combination with miconazole for the empirical treatment of infectious vaginitis

4区 · 医学

Article

作者: Mas, Y ; Bohbot, J M ; Verrière, F ; Goubard, A ; Lucas, N ; Coatantiec, E ; Aubin, F

OBJECTIVE:

An empirical treatment of infectious vaginitis is justified because of its multiple etiologies, the frequent uncertainty of clinical diagnosis and limits of microbiological analysis. Our aim was to comparatively investigate nystatin-neomycin-polymyxin B combination (NNP, Polygynax^®) and miconazole.

PATIENTS AND METHODS:

In this European multicenter, double-blind PRISM trial, participating women presenting with infectious vaginitis were randomized to receive one vaginal capsule containing either NNP for 12 days or miconazole for 3 days followed by 9 days of placebo.

RESULTS:

The clinical success rate was higher in the NNP group (n=302) than the miconazole group (n=309), with a difference between groups close to statistical significance (91.1% vs. 86.7%, P=0.0906). The risk of treatment failure was 36% lower in the NNP group (odds ratio, 0.64; 95% confidence interval, 0.38-1.07). Vaginal burning on Day 2 and vaginal discharge on Day 4 were significantly less intense in the NNP group than in the miconazole group (39.1 vs. 42.3, P=0.031 and 34.6 vs. 37.6, P=0.031, respectively). Adverse drug reactions were reported by 1.2% and 2.1% of patients in the NNP and miconazole group respectively, with the ratio of adverse drug reactions relative to total adverse events significantly higher in the miconazole group (20.3% vs. 6.9%, P=0.022).

CONCLUSION:

The widespread use of NNP for several decades and its good efficacy and safety profile, as well as the frequent diagnostic uncertainties due to the various pathogens sustain the initiation of this broad-spectrum empirical treatment in infectious vaginitis.

2016-01-01·Akusherstvo i ginekologiia

[POLYGYNAX IN THE TREATMENT OF VAGINAL INFECTIONS IN PREGNANT AND NON-PREGNANT WOMEN--CLINICAL EXPERIENCE].

Article

作者: Popovski, K ; Popovski, N ; Nedelkovski, V

Vaginal infections /VI/ represent some of the most common diseases by infection of FGS. The aim of this study is to analyze clinical and bacteriological efficacy of Polygynax in the treatment of vaginal infections and to take into account the correlation between the results of microbiological controls and reduction of clinical symptoms. The study included 100 patients, including 50 pregnant and non-pregnant 50 for a period of 3 months. All of them was diagnosed with vaginitis clinical examination, taken material from vagina for microbiological testing. The studied women was conducted targeted therapy Polygynax 12 capsules, in the form of vaginal capsules for 12 days, after which the sample control microbiology. Behind the subjective complaints of the patient and to reduce them as a result of treatment. The effective implementation of Polygynax 12 capsules is equally good as in non-pregnant and pregnant women. In a summary of the survey data to make relevant analyzes and conclusions from the results.

100 项与 Nystatin/Neomycin Sulphate/Polymyxin B Sulphate 相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
阴道炎	卢旺达	Laboratoire INNOTECH International SAS	1997-02-11

未上市

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适应症	最高研发状态	国家/地区	公司	日期
细菌性阴道炎	临床3期	捷克	Laboratoire INNOTECH International SAS	2015-09-01
细菌性阴道炎	临床3期	法国	Laboratoire INNOTECH International SAS	2015-09-01
细菌性阴道炎	临床3期	塞尔维亚	Laboratoire INNOTECH International SAS	2015-09-01
细菌性阴道炎	临床3期	斯洛伐克	Laboratoire INNOTECH International SAS	2015-09-01
感染性阴道炎	临床3期	捷克	Laboratoire INNOTECH International SAS	2015-09-01
感染性阴道炎	临床3期	法国	Laboratoire INNOTECH International SAS	2015-09-01
感染性阴道炎	临床3期	塞尔维亚	Laboratoire INNOTECH International SAS	2015-09-01
感染性阴道炎	临床3期	斯洛伐克	Laboratoire INNOTECH International SAS	2015-09-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02515656 (PRISM, CTgov)	临床3期	感染性阴道炎 \| 阴道炎 \| 细菌性阴道炎	661	POLYGYNAX® (POLYGYNAX®)	鹽獵觸鏇觸齋顧網願襯(鹹艱憲築積憲壓觸網夢) = 簾淵獵鹽蓋淵憲範齋衊壓選淵窪鏇觸鏇選襯構 (製積鏇積網簾獵蓋製積, 範膚窪憲糧簾構積構齋 ~ 醖餘範範襯遞選鹹鏇鹽) 更多	-	2019-01-22
				Placebo+GYNODAKTARIN® (Miconazole + Placebo)	鹽獵觸鏇觸齋顧網願襯(鹹艱憲築積憲壓觸網夢) = 遞鏇積醖築鬱選夢構選壓選淵窪鏇觸鏇選襯構 (製積鏇積網簾獵蓋製積, 壓膚餘鹽觸簾構鑰鏇觸 ~ 壓憲製醖願獵顧餘鹹積) 更多