BNO-1016(BNO-1016) - _专利_临床

概要

基本信息

药物类型

中药

别名

sinupret extract mite

靶点-

作用机制-

治疗领域

免疫系统疾病感染耳鼻咽喉疾病+ [1]

在研适应症-

非在研适应症

慢性鼻窦炎过敏性鼻炎

原研机构

Bionorica SE

在研机构-

非在研机构

Bionorica SE

最高研发阶段无进展临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

2

项与 BNO-1016 相关的临床试验

NCT01706484 / Completed临床3期

A Multicentre, Randomised, Double-blind, Placebo-controlled, Parallel Group Trial to Assess Efficacy and Safety of Two Dosages of a Herbal Medicinal Product (Dry Extract BNO 1016) in Patients With Chronic Rhinosinusitis

The purpose of this trial is to determine whether 2 different dosages of a herbal extract (240 and 480 mg/day) are more effective than placebo in the treatment of patients with chronic rhinosinusitis (average reduction of investigator's Major Symptom Score over Visit 5 and Visit 6.

开始日期2012-09-01

申办/合作机构

Bionorica SE

NCT01146860 / Completed临床3期

A Multi-centre, Double-blind, Placebo-controlled, Randomised, Parallel Group Study to Assess the Efficacy and Safety of a Herbal Medicinal Product (Dry Extract BNO 1016) in Patients With Acute Rhinosinusitis

The purpose of this study is to determine whether the dry extract BNO 1016 is effective and safe in the treatment of acute rhinosinusitis in adults.

开始日期2010-01-01

申办/合作机构

Bionorica SE

100 项与 BNO-1016 相关的临床结果

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100 项与 BNO-1016 相关的转化医学

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100 项与 BNO-1016 相关的专利（医药）

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10

项与 BNO-1016 相关的文献（医药）

2024-10-01·Otolaryngologia Polska

Rational treatment of acute rhinosinusitis in the context of increasing antibiotic resistance

Review

作者: Arcimowicz, Magdalena

Acute rhinosinusitis is one of the most common diseases in the population, both both in primary and specialist otolaryngological care. It is also responsible for a disturbingly high percentage of prescribed antibiotic therapy, regardless of the etiology of the disease. Despite the fact that acute viral and acute postviral rhinosinusitis dominate among the phenotypes of acute rhinosinusitis, and the development of acute bacterial rhinosinusitis occurs in only 0.5–2% of all cases in adults and 5–10% in children, antibiotics still remain an important element of treatment, despite alarming data on the growing antibiotic resistance and the adverse effect of antibiotics on the human microbiome, leading to dysbiosis. The discovery of antibiotics was one of the greatest achievements of modern medicine, but their inappropriate use leads to the gradual increase in the phenomenon of antibiotic resistance, considered one of the most serious public health problems, recognized by the WHO as one of the 10 greatest threats to human health in the 21st century. The unjustified use of antibiotics in outpatient care is the key to the growth of this problem, in parallel with the lack of patient compliance. The COVID pandemic has intensified this unfavourable trend. That is why the knowledge of antibiotic stewardship is so important. According to the guidelines, in the therapy of acute rhinosinusitis, symptomatic and anti-inflammatory treatment dominates, and antibiotic therapy has very strictly defined and limited indications. The latest guidelines also recommend herbal medicines, including BNO1016, in the treatment of acute viral and postviral rhinosinusitis. Available studies indicate that it has a beneficial effect not only on shortening the duration of the disease and reducing symptoms, but also reduces the need for antibiotic treatment in acute rhinosinusitis. Complications of acute rhinosinusitis are relatively rare and are not related to taking antibiotics.

2023-09-13·Otolaryngologia Polska

Microbiota and antibiotic therapy in rhinosinusitis

Article

作者: Zawadzka - Głos, Lidia

Rhinosinusitis is one of the most frequently diagnosed diseases in patients seeking medical consultation. Sinusitis is a heterogeneous group of diseases and can be acute or chronic.The current state of knowledge on rhinosinusitis is presented in the recommendations of the European Position Paper on Rhinosynusitis and Nasal Polyps 2020 (EPOS 2020). More and more attention is paid to the condition of the microbiota in the context of inflammatory changes in the sinuses.There is also a negative effect of excessively prescribed antibiotics on the increase in bacterial resistance to drugs and significant changes in the disturbance in the composition of the microbiota during antibiotic therapy. Since the most common etiology of acute sinusitis is viral, the use of antibiotics in uncomplicated sinusitis is unjustified. New therapeutic solutions are sought, including the use of herbal medicines. The EPOS 2020 document recommends the use of BNO1016 in uncomplicated acute rhinosinusitis. New models of treatment also take into account the use of biological drugs, especially in the treatment of chronic rhinosinusitis.

2023-08-01·Postgraduate medicine

Efficacy and effectiveness of the herbal medicinal product BNO 1016 in the management of acute rhinosinusitis in the context of antibiotic stewardship.

Article

作者: Abels, Christoph ; Plach, Michael ; Abramov-Sommariva, Dimitri ; Bittner, Claudia B ; Bachert, Claus ; Steindl, Hubert

OBJECTIVESTo substantiate the clinical efficacy and investigate the real-world effectiveness of the herbal medicinal product BNO 1016 in acute rhinosinusitis (ARS) in the context of antibiotic stewardship.METHODSWe performed a meta-analysis of the clinical trials ARhiSi-1 (EudraCT No. 2008-002794-13) and ARhiSi-2 (EudraCT No. 2009-016682-28) comprising 676 patients, analyzing the reduction of the Major Symptom Score (MSS) and improvement of the Sino-Nasal Outcome Test 20 (SNOT-20) by the herbal medicinal product BNO 1016. In addition, we performed a retrospective cohort study including 203,382 patients, comparing the real-life effectiveness of BNO 1016 in reducing ARS-related adverse outcomes in comparison to antibiotics and several other established therapies.RESULTSTreatment with BNO 1016 ameliorated symptoms of ARS by reducing MSS by 1.9 points (p < 0.0001) and improved quality of life (QoL) for patients by improving SNOT-20 by 3.5 points (p = 0.001) in comparison to placebo. In patients with moderate/severe symptoms, the positive effects of BNO 1016 were even more pronounced (MSS: -2.3 points (p < 0.0001); SNOT-20: -4.9 points (p = 0.0158)). In addition, treatment with BNO 1016 was as effective or significantly more effective in reducing the risk for adverse ARS-related outcomes such as follow-up antibiotic prescriptions, sick leave ≥7 days or medical appointments due to ARS, especially when compared to antibiotics.CONCLUSIONBNO 1016 is a safe and effective treatment for ARS that can help reduce the overuse of antibiotics.

100 项与 BNO-1016 相关的药物交易

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研发状态

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
慢性鼻窦炎	临床3期	比利时	Bionorica SE	2012-09-01
过敏性鼻炎	临床3期	德国	Bionorica SE	2010-01-01

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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


NCT01146860 (CTgov)	临床3期	过敏性鼻炎	386	BNO 1016 (BNO 1016)	餘顧積選衊衊壓觸範獵(廠顧製衊淵衊齋簾築餘) = 襯餘憲鬱網簾夢鹹蓋鹹鏇鹽顧選餘鑰廠願憲醖 (簾餘構蓋蓋鬱築齋鬱窪, 築觸膚簾願積糧襯築選 ~ 齋鑰積獵鏇簾鹹築餘齋) 更多	-	2013-08-02
				Placebo (Placebo)	餘顧積選衊衊壓觸範獵(廠顧製衊淵衊齋簾築餘) = 築製糧夢糧壓鹽鹽築築鏇鹽顧選餘鑰廠願憲醖 (簾餘構蓋蓋鬱築齋鬱窪, 網衊鑰範範膚壓鹹鹹鬱 ~ 廠製顧壓鹹餘醖願窪艱) 更多