Bacterial vaginosis (BV) occupies one of the leading places in the structure of the of gynecologic morbidity. This syndrome affects from 26 to 29% of women of reproductive age. Bacterial vaginosis is a non-inflammatory syndrome based on the replacement of normal lactoflora by opportunistic microorganisms. The modern concept of pathogenesis of bacterial vaginosis is the formation of biofilms, mainly Gardnerella vaginalis, on the surface of the vaginal epithelium. Associated with biofilms bacterial vaginosis is characterized by increased resistance to pathogenetic therapy, ability to evade protective mechanisms and prolonged persistence in the vaginal environment, which is manifested by an increase in the rate of recurrent and chronic course.
In connection with the above described, it is relevant to study in vivo the role of drug action on biofilms in order to destroy them and, as a consequence, to increase the effectiveness of pathogenetic antibacterial therapy, reduce the frequency of BV recurrences and improve the quality of life of women. According to the local and international literature, there are various ways to affect biofilms, one of which is enzymatic destruction of the matrix. Bovgialuronidase azoximer was chosen as the study drug.

开始日期2024-06-01

申办/合作机构

I.M. Sechenov First Moscow State Medical University

NCT06458543 / Recruiting临床4期IIT

Efficacy of Bovhyaluronidase Azoximer on Biofilms Destruction in the Urogenital Tract of the Patients With Reccurent Bacterial Vaginosis.

The purpose of this clinical trial is to study the efficacy of bovgialuronidase azoximere in the treatment and duration of recurrence-free course of bacterial vaginosis in women of reproductive age. The main questions it aims to answer are:
Is bovgialuronidase azoximer able to destroy G. vaginalis associated biofilms of the vaginal epithelium
use of bovgialuronidase azoximer together with Metronidazole increases the effectiveness of treatment of bacterial vaginosis.
use of azoximers bovgialuronidase together with Metronidazole increases the duration of relapse-free course of bacterial vaginosis.
Participants in the experimental and control group will be:
Amsel criteria assessment
Colpotest-PH (vaginal acidity)
aminotest with 10% KOH solution ("fish odor")
microscopic examination of vaginal discharge
Bacteriologic culture of vaginal discharge
Polymerase chain reaction of epithelial cell scrapings from the vagina
electron microscopy of vaginal epithelial cell scrapings
Participants in the main group will be given the drug Bovgialuronidase azoximer and Metronidazole.
Participants in the control group: Metronidazole.
Researchers will compare the experimental and control groups to see if there are differences after treatment in biofilm structure, treatment efficacy, and duration of recurrence-free survival.

开始日期2024-06-01

申办/合作机构

I.M. Sechenov First Moscow State Medical University

NCT06568718 / CompletedN/A

A Multicenter, Randomized, Parallel, Controlled, Prospective, Open-label Study of the Efficacy and Safety of Longidaze Lyophilisate for Solution for Injections and Rectal Suppositories 3,000 IU in the Combined Treatment of Patients With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia

The goal of this clinical trial is to learn if Longidaze works to treat lower urinary tract symptoms in adult males with benign prostatic hyperplasia. It will also learn about the safety of Longidaze. The main question it aims to answer is:
* Does addition of Longidaze to tamsulosin lower the severity of symptoms assessed by International Prostate Symptom Score?
* What medical problems do participants have under the combined treatment by Longidaze and tamsulosin?
Researchers will compare combined therapy (Longidaze + tamsulosin) with monotherapy (tamsulosin only) to see if the combination works better.
Participants will:
* Take tamsulosin (0.4mg) every day for 130 days
* In combined therapy arm -- make intramuscular injections of Longidaze every 5 days (5 injections); then apply Longidaze rectal suppositories every 3 days (10 applications); then apply Longidaze rectal suppositories every 7 days (10 applications)
* Visit the clinic on day 1, 26±1, 60±1, 130±3 for checkups and tests

开始日期2023-03-20

申办/合作机构

NPO Petrovax Pharm Ltd.

100 项与阿佐西姆牛透明质酸酶相关的临床结果

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100 项与阿佐西姆牛透明质酸酶相关的转化医学

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100 项与阿佐西姆牛透明质酸酶相关的专利（医药）

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项与阿佐西姆牛透明质酸酶相关的文献（医药）

2023-09-19·Life (Basel, Switzerland)

Anti-Inflammatory and Antifibrotic Potential of Longidaze in Bleomycin-Induced Pulmonary Fibrosis.

Article

作者: Pakhomova, Angelina ; Bochkov, Pavel ; Pan, Edgar ; Sandrikina, Lubov ; Ermakova, Natalia ; Zhukova, Mariia ; Kogai, Lena ; Dagil, Yulia ; Grimm, Wolf-Dieter ; Avdeev, Sergey ; Pershina, Olga

Idiopathic pulmonary fibrosis (IPF) is one of the most common forms of interstitial lung disease, characterized by progressive parenchymal fibrosis and respiratory failure. In a model of bleomycin-induced pulmonary fibrosis, the antifibrotic and anti-inflammatory activity of Longidaze (Bovhyaluronidase Azoxymer), which contains a conjugate of the hyaluronidase enzyme with a high molecular weight synthetic carrier azoxymer bromide, was investigated. Experiments were conducted in male C57BL/6 mice. Longidaze was administered at different doses by intranasal and intramuscular routes. Histology, hematology, and enzyme-linked immunosorbent assay were used in the study. The use of Longidaze reduced pulmonary fibrosis, as evidenced by an improvement in histopathologic damage to the lungs, a decrease in the area of connective tissue, and the levels of profibrotic factors (TGF-β1, hydroxyproline, collagen I) in lung tissue. In addition, Longidaze inhibited the inflammatory response in pulmonary fibrosis, and decreased the levels of IL-6, TNF-α, and hyaluronic acid in lung tissue and the recruitment of inflammatory cells into lung tissue. The highest therapeutic efficacy was observed with the use of Longidaze at doses of 120 and 1200 U/kg intramuscularly, which was superior to that of the reference drug pirfenidone axunio. The data presented in this study suggest that Longidaze is a new and promising drug for the treatment of IPF that warrants further investigation in patients with fibrotic interstitial lung disease.

2021-06-28·Urologiia (Moscow, Russia : 1999)

Multicenter randomized study of bovhyalu-ronidase azoximer (Longidaza®) in men after transuretral resection of the prostate

Article

作者: Bolotov, A D ; Vorobyova, A V ; D, Surenkov N ; Kotov, S V ; Belomyttsev, S V

INTRODUCTION:

Transurethral resection of the prostate (TURP) is the gold standard of BPH surgical treatment. It is of current interest to search for medications that can reduce the incidence of complications after TURP.

AIM:

To evaluate the efficiency of Longidaza (rectal suppositories of 3000 IU) as part of combined therapy in order to prevent complications after TURP.

MATERIALS AND METHODS:

The study included 202 patients who underwent TURP in 3 hospitals. The patients were divided into 2 groups: main group - 96 men taking standard postoperative therapy with Longidaza rectal suppositories N 20; control group - 106 men - taking standard postoperative therapy (tamsulosin 30 days; fluoroquinolone 5 days). Follow-up included IPSS, urinalysis, urine culture, ultrasound examination of the prostate volume (PV), post void residual urine, uroflowmetry at 1,2,3,6 months after surgery. Average preoperative indices: IPSS 27 [23; 30], Qol 5 [4; 6], prostate volume (PV) 71+/-19cc (30-272 c), Qmax 7.5+/-2.5ml/s (1,3-18,7 ml/s).

RESULTS:

There was a significant improvement in IPSS, QoL, Qmax, PV, post void residual urine (PVR) compared to preoperative values during the entire observation period. There was no statistical difference between the main and control groups for these indexes in 6 months. In the main group had statistically lower incidence of bacteriuria at 3 (11% vs 17%) and 6 months (7% vs 17%), and leukocyturia at 3 (31% vs 46%) and 6 months of follow-up (20% vs 44%). Overall incidence of infectious complications and additional antibacterial drugs prescription was lower in the Longidaza group compared to the control group (17,7% vs 20,7%). Urethral strictures developed in 7 men in the main group, and 8 in the control group.

CONCLUSION:

Our results show that prescription of Longidaza significantly reduces the incidence of leukocyturia and bacteriuria postoperatively, decreasing the rate of infectious complications in men after TURP.

2020-01-30·Urologiia (Moscow, Russia : 1999)

Improvement of performance of semen culture in infertile men undergone to diagnostic evaluation

Article

作者: S P Semikina ; A Yu Tsukanov ; D O Satybaldin

INTRODUCTION:

Barren marriage is an important medical and social problem. Up to 20-60% of cases of male infertility are associated with inflammatory diseases of the reproductive system. Chronic prostatitis constitutes up to 50% cases. In this regard, a search of methods aimed at improvement of detection rate of pathogens in inflammatory prostatic diseases of the prostate is still relevant.

AIM:

To study the influence of bovhyaluronidaze azoximer (Longidaza) on the diagnostic sensitivity of semen culture in infertile men.

MATERIALS AND METHODS:

a total of 87 infertile men were included in the study. The main group consisted of 41 patients who received Longidaza 3000 IU, one suppository every two days, for a total of 5 suppositories, prior to semen culture. In the control group, 46 patients had semen culture without any interventions. When evaluating the result of semen culture, clinically significant bacterial count was more or equal 103 CFU/ml.

RESULTS:

In the main group, bacterial growth was seen in 19 (46.3%) patients, which is 2.7 times higher than in the control group (n=8; 17.4%; 2=4.47, p=0.0346). A total of 36 patients in the control group with negative semen culture at baseline undergone to repeat analysis, according to the protocol in the main group. As a result, in 12 more patients in the control group (33% men with initially negative semen analysis) a bacterial growth was shown. The detection rate of bacteria in the ejaculate in the control group after repeat analysis was similar to those in the main group (43.5 46.3%, respectively, =0.87).

CONCLUSION:

The preliminary use of bovhyaluronidaze azoximer rectal suppositories (Longidaza) in infertile men, when they undergone diagnostic evaluation, contributes to increase in diagnostic sensitivity of semen culture and allows to improve the quality of diagnosis of the inflammatory diseases of reproductive system.

100 项与阿佐西姆牛透明质酸酶相关的药物交易

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纤维化	临床3期	俄罗斯	NPO Petrovax Pharm Ltd.	2022-04-08
间质性肺疾病	临床3期	俄罗斯	NPO Petrovax Pharm Ltd.	2022-04-08
新冠肺炎后遗症	临床3期	俄罗斯	NPO Petrovax Pharm Ltd.	2022-04-08