咪康唑/甲硝唑(Miconazole/Metronidazole) - 药物靶点：CYP51A1_在研适应症：念珠菌病，滴虫感染，阴道炎_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Neo-Penotran

+ [1]

靶点

CYP51A1

作用机制

CYP51A1抑制剂(细胞色素P450家族成员51抑制剂)、DNA合成抑制剂

治疗领域

感染泌尿生殖系统疾病

在研适应症

念珠菌病滴虫感染阴道炎

非在研适应症-

原研机构

Chemo Ibérica SA

在研机构

Bayer AG

非在研机构

Exeltis Pharmaceuticals Holding SL

最高研发阶段批准上市

首次获批日期

土耳其 (1994-09-01),

念珠菌病滴虫感染阴道炎

最高研发阶段(中国)-

特殊审评-

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结构

分子式C24H24Cl4N6O7

InChIKeyHRMGIVXOZXLNIF-UHFFFAOYSA-N

CAS号132359-89-8

关联

3

项与咪康唑/甲硝唑相关的临床试验

NCT01361048 / Completed临床2期IIT

Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis

The investigators are trying a combination vaginal product of higher dose metronidazole combined with miconazole to see if it is effective in treating vaginal trichomonas.

开始日期2011-12-01

申办/合作机构

The University of Alabama at Birmingham

[+1]

NCT01230814 / Completed临床2期IIT

A Double-Blind, Randomized Trial of Monthly Treatment With Topical Metronidazole and Miconazole Co-formulated Vaginal Suppositories Versus Placebo for Preventing Vaginal Infections in HIV-seronegative Women

This research study is about vaginal infections such as bacterial vaginosis, yeast infections, and trichomoniasis. Usually, these infections can be treated with medication, but sometimes they come back after treatment. Researchers want to know if using vaginal suppositories can decrease the risk of vaginal infections. Participants will include 234 women who are sexually active (greater than or equal to 4 episodes of sex with men during the past month), HIV-negative, 18 to 45 years old, with bacterial infection [vaginosis and/or vulvovaginal candidiasis (VVC) and/or Trichomonas vaginalis] detected by laboratory testing at a screening visit. Women will receive vaginal suppositories containing drug or inactive ingredients (placebo). Participation in the study will be about 12 months. Study procedures include: urine and blood tests, physical exams, and questionnaires.

开始日期2011-04-01

申办/合作机构

National Institute of Allergy & Infectious Diseases

NCT01335373 / CompletedN/A

Observational Program Neo-Penotran® Forte

Vaginitis is the most common gynecologic diagnosis in the primary care setting. In approximately 90 percent of affected women, this condition occurs secondary to bacterial vaginosis, vulvovaginal candidiasis, trichomoniasis or mixed infection.
Neo-Penotran Forte is registered for treatment of these most common vaginal infections. Efficacy and safety of this product is already established, and this observational study was designed to learn more about practical use of Neo-Penotran® Forte in real life setting.

开始日期2010-10-01

申办/合作机构

Bayer AG

100 项与咪康唑/甲硝唑相关的临床结果

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100 项与咪康唑/甲硝唑相关的转化医学

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100 项与咪康唑/甲硝唑相关的专利（医药）

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4

项与咪康唑/甲硝唑相关的文献（医药）

2001-07-01·International Journal of Gynecology & Obstetrics4区 · 医学

Efficacy of 7‐day treatment with metronidazole+miconazole (Neo‐Penotran®) — a triple‐active pessary for the treatment of single and mixed vaginal infections

4区 · 医学

Article

作者: O. Morton ; I.L. Danilyans ; G. Baktir ; E. Ozyurt ; M.B. Toykuliyeva

AbstractObjective: 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.

1996-01-01·International Journal of Gynecology & Obstetrics4区 · 医学

Treatment of vaginitis

4区 · 医学

Article

作者: M. Uǧur ; H. Yeşilyurt ; T. Ergin ; O. Gökmen ; S. Kükner ; N. Ciçek

AbstractObjective: 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. Sudent'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.

1966-10-01·Wiener medizinische Wochenschrift (1946)

[Directed treatment with Penotran].

Article

作者: Rainer, A

100 项与咪康唑/甲硝唑相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	P01AB51 D01AC52	-

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
念珠菌病	土耳其	-	1994-09-01
滴虫感染	土耳其	-	1994-09-01
阴道炎	土耳其	-	1994-09-01

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
念珠菌病	临床1期	土耳其	Exeltis Pharmaceuticals Holding SL	2008-06-01

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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


NCT01361048 (CTgov)	临床2期	滴虫性阴道炎	40	neo penotran forte (Neo Penotran Forte)	鬱鏇衊廠淵網鹽膚繭遞(鬱構顧簾夢網築築網遞) = 廠餘遞餘鬱簾窪膚夢鏇鹽積鹹蓋構蓋鬱獵窪艱 (製鹽簾膚構獵鹽廠窪鬱, 網範顧範齋膚襯廠醖鏇 ~ 積憲襯膚鹹糧獵廠蓋鑰) 更多	-	2014-02-20
				neo penotran forte once a day (Neo Penotran Forte Once a Day)	鬱鏇衊廠淵網鹽膚繭遞(鬱構顧簾夢網築築網遞) = 願願蓋襯齋顧網積廠積鹽積鹹蓋構蓋鬱獵窪艱 (製鹽簾膚構獵鹽廠窪鬱, 願選廠糧鏇顧糧夢壓鹽 ~ 膚製遞鑰夢窪淵範獵醖) 更多