Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz最新文献_第5页

[Regulation of phage therapy medicinal products: developments, challenges and opportunities]. [噬菌体治疗药品监管：发展、挑战和机遇]。

IF 1.7 4区医学

Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz Pub Date : 2025-06-01 Epub Date: 2025-05-05 DOI: 10.1007/s00103-025-04060-2

Miriam Fürst-Wilmes, Vanessa Respondek, Nils Lilienthal, Katrin Buss, Anja Düchting

{"title":"[Regulation of phage therapy medicinal products: developments, challenges and opportunities].","authors":"Miriam Fürst-Wilmes, Vanessa Respondek, Nils Lilienthal, Katrin Buss, Anja Düchting","doi":"10.1007/s00103-025-04060-2","DOIUrl":"10.1007/s00103-025-04060-2","url":null,"abstract":"Due to their biological properties, bacteriophages represent a regulatory peculiarity and a challenge for drug approval. Adopted European guidelines on pharmaceutical quality, preclinical, and clinical development are only partially applicable to phage products. The increasing threat of infections with multi-resistant pathogens has not only given a major boost to the development of bacteriophages for the treatment of bacterial infections in recent years but has also led to major progress in the adaptation of regulatory requirements. This review article presents these recent developments and the current status of regulatory requirements for phage therapeutics.In 2024, harmonised quality criteria for phage products and active pharmaceutical ingredients have been implemented in the European Pharmacopoeia for the first time. Both the EU pharmaceutical reform and the national Medical Research Act should enable exemptional regulations taking into account the special features of phage therapeutics and allow novel regulatory pathways. Although increasing clinical data on the use of phage therapeutics have been published, the desired breakthrough in the form of proof of efficacy in randomised controlled clinical trials has not yet been achieved. However, the growing knowledge on phage preparations could be used to adjust the regulatory requirements. The next and decisive step on the path to approval of a defined phage product is the evidence-based proof of efficacy and safety in a randomised controlled clinical trial.","PeriodicalId":9562,"journal":{"name":"Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz","volume":" ","pages":"645-652"},"PeriodicalIF":1.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12129831/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143960839","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

[Phage therapy in Germany-Update 2025]. [噬菌体治疗在德国-更新2025]。

IF 1.7 4区医学

Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz Pub Date : 2025-06-01 Epub Date: 2025-05-08 DOI: 10.1007/s00103-025-04063-z

Christian Willy, Felix Bröcker

{"title":"[Phage therapy in Germany-Update 2025].","authors":"Christian Willy, Felix Bröcker","doi":"10.1007/s00103-025-04063-z","DOIUrl":"10.1007/s00103-025-04063-z","url":null,"abstract":"Phage therapy is a promising approach to combat the antibiotic resistance crisis worldwide and in Germany. However, after widespread use in Germany from the 1930s to the 1960s, the number of patients treated with phages each year dropped to under a hundred in the following decades. An overview of the current situation of phage therapy in Germany and the translational research supporting it is provided. Aspects taken into account here are phage production, phage banks, clinical phage application, and ongoing translational research projects in Germany.There is a lack of phages for clinical use. Phage therapy is only used in a limited number of patients in a few clinics as an individual treatment attempt. There are several phage banks that, due to different institutional backgrounds and guidelines, do not work in a comparable way and only exchange phage stocks in the context of scientific projects. Projects in basic and translational phage research have increased considerably in Germany. The most urgent change seems to be the expansion of phage production capacities.There is still no high-quality evidence on the clinical success of phage therapy in the medical field by means of randomized controlled clinical trials. In close consultation with the regulatory authorities, it seems sensible to urgently enable a few centers to treat patients according to the Belgian model.","PeriodicalId":9562,"journal":{"name":"Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz","volume":" ","pages":"617-624"},"PeriodicalIF":1.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12129867/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143977380","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

[Strategies for mitigating antibiotic resistance in human medicine from the perspective of the Ministry of Health]. [从卫生部的角度看人类医学中减轻抗生素耐药性的战略]。

IF 1.7 4区医学

Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz Pub Date : 2025-06-01 Epub Date: 2025-05-05 DOI: 10.1007/s00103-025-04049-x

Alexandra Clarici

{"title":"[Strategies for mitigating antibiotic resistance in human medicine from the perspective of the Ministry of Health].","authors":"Alexandra Clarici","doi":"10.1007/s00103-025-04049-x","DOIUrl":"10.1007/s00103-025-04049-x","url":null,"abstract":"Antibiotic resistance (AMR) is increasing worldwide. The complex interrelationships in their development and spread require a bundle of measures and a cross-sectoral approach that considers the One Health approach. The German Antibiotic Resistance Strategy \"DART\" summarizes the measures for Germany. Building on two predecessor strategies, \"DART 2030,\" which was adopted in 2023, describes the strategic goals to be achieved during its term. It is supplemented by an action plan published in May 2024, which contains specific activities in the six fields of action: prevention, surveillance and monitoring, appropriate use of antibiotics including laboratory diagnostics, communication and cooperation, European and international cooperation, and research and development. Important actions in human medicine include ensuring the availability of recommendations/guidelines on infection prevention and on the diagnosis and treatment of infections, particularly those in which resistance plays a role. The development of expertise in infectiology will be supported and the surveillance of resistance and antibiotic consumption strengthened across all sectors. Proven exchange formats will be continued in order to improve communication within and between sectors. The population's knowledge about infections, their treatment, and the appropriate use of antibiotics will be strengthened.The action plan will be regularly reviewed and updated. This will be linked to reporting, which will also address progress in achieving specific targets for human medicine.","PeriodicalId":9562,"journal":{"name":"Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz","volume":" ","pages":"593-599"},"PeriodicalIF":1.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12129872/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143970639","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Empfehlungen zum Schutz vor Cyanobakterientoxinen im Trinkwasser : Empfehlung des Umweltbundesamtes nach Anhörung der Trinkwasserkommission. 关于饮用水中蓝藻毒素的建议：联邦环境署咨询饮用水委员会后的建议。

IF 1.7 4区医学

Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz Pub Date : 2025-06-01 DOI: 10.1007/s00103-025-04046-0

引用次数: 0

[Mental health of children and adolescents in times of global crises: findings from the longitudinal COPSY study from 2020 to 2024]. [全球危机时期儿童和青少年的心理健康：来自2020年至2024年COPSY纵向研究的结果]。

IF 1.7 4区医学

Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz Pub Date : 2025-06-01 Epub Date: 2025-04-28 DOI: 10.1007/s00103-025-04045-1

Anne Kaman, Michael Erhart, Janine Devine, Ann-Kathrin Napp, Franziska Reiß, Steven Behn, Ulrike Ravens-Sieberer

{"title":"[Mental health of children and adolescents in times of global crises: findings from the longitudinal COPSY study from 2020 to 2024].","authors":"Anne Kaman, Michael Erhart, Janine Devine, Ann-Kathrin Napp, Franziska Reiß, Steven Behn, Ulrike Ravens-Sieberer","doi":"10.1007/s00103-025-04045-1","DOIUrl":"10.1007/s00103-025-04045-1","url":null,"abstract":"Background: The mental health of children and adolescents is increasingly affected by global crises, but so far there are only limited longitudinal studies on this topic. This longitudinal, population-based study aimed to explore changes in mental health during global crises.Methods: The study analyzed data from 2865 families with children and adolescents aged 7 to 22 years who participated in at least one wave of the COPSY (COvid-19 and PSYchological health) study from May 2020 (T1) to October 2024 (T7). On average, the families took part in 56.7% of the survey waves. Descriptive statistics and multivariate regression analyses were used to examine changes in mental health as well as the effects of crisis-related worries and digital media use.Results: The mental health of children and adolescents was significantly impaired at the beginning of the pandemic, improved again in the following years, but remained at an impaired level in fall 2024 compared to pre-pandemic levels. At the same time, concerns about wars, economic crises, and the climate crisis have increased significantly. Risk factors such as low parental education and parental mental health problems were associated with poorer mental health, while personal, familial, and social resources had a protective effect. A high level of media consumption was documented, which was associated with stressful experiences.Conclusion: Global crises pose significant challenges to the mental health of children and adolescents. Resource-oriented prevention and intervention efforts are urgently needed to support young people in coping with these challenges.","PeriodicalId":9562,"journal":{"name":"Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz","volume":" ","pages":"670-680"},"PeriodicalIF":1.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12129870/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143972762","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

[Phage endolysins-a novel class of antibacterial agents with a wide range of applications]. [噬菌体内溶素——一类具有广泛应用的新型抗菌剂]。

IF 1.7 4区医学

Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz Pub Date : 2025-06-01 Epub Date: 2025-05-06 DOI: 10.1007/s00103-025-04059-9

Evgeny A Idelevich, Karsten Becker

{"title":"[Phage endolysins-a novel class of antibacterial agents with a wide range of applications].","authors":"Evgeny A Idelevich, Karsten Becker","doi":"10.1007/s00103-025-04059-9","DOIUrl":"10.1007/s00103-025-04059-9","url":null,"abstract":"As \"enzybiotics,\" endolysins represent a new class of antibacterial agents that are naturally produced at the end of the lytic cycle in bacteriophage-infected bacterial cells to enable the phage particles formed to be released from the inside of the host cell. Their enzymatic effect on the cell wall peptidoglycan, which leads to lysis of the infected bacteria, can also be exerted externally as an applied agent. While the endolysin activity can be directly effective in Gram-positive bacteria, the endolysin must be modified for activity against Gram-negative bacteria so that it can overcome the outer cell membrane. For this reason, and to optimize endolysin specificity and stability, endolysins are increasingly being genetically modified and produced recombinantly, which is relatively easy to achieve due to their modular structure consisting of lytic and binding domains. Endolysins have already found increasing actual or extensively postulated use for preventive, therapeutic, and diagnostic purposes in human and veterinary medicine as well as in food safety, biotechnology, and the One Health sector; however, this still needs to be better substantiated by valid studies. Although, in contrast to phage therapy, the regulatory aspects can follow the approval procedures also required for other pharmaceuticals, only less than a dozen randomized controlled studies of phases 1 to 3 have been initiated or completed in the field of human medicine. Only very few endolysin formulations approved as medical products are currently available on the market and approval as medicinal drugs is being sought for some endolysins.","PeriodicalId":9562,"journal":{"name":"Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz","volume":" ","pages":"660-669"},"PeriodicalIF":1.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12130063/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143959654","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

[Application of phages in farm animals, food and the environment as part of a One Health approach-potentials and challenges]. [噬菌体作为同一个健康方针的一部分在农场动物、食品和环境中的应用——潜力和挑战]。

IF 1.7 4区医学

Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz Pub Date : 2025-06-01 Epub Date: 2025-05-20 DOI: 10.1007/s00103-025-04055-z

Sophie Kittler, Jens A Hammerl

{"title":"[Application of phages in farm animals, food and the environment as part of a One Health approach-potentials and challenges].","authors":"Sophie Kittler, Jens A Hammerl","doi":"10.1007/s00103-025-04055-z","DOIUrl":"10.1007/s00103-025-04055-z","url":null,"abstract":"In order to ensure the holistic protection of human, animal and environmental health (commonly referred to as One Health), alternatives to the available antimicrobial approaches are required. Although antibiotic drugs have an outstanding broad spectrum of activity, their use is under discussion due to increasingly occurring resistances. Furthermore, the utilisation of antibiotics can result in significant consequences for the affected microbiome, often irreversibly altering its natural composition. The necessity for the implementation of alternative and targeted control measures for bacterial pathogens (e.g. zoonoses) represents a significant challenge for all sectors within the One Health framework. With growing interest, control strategies, some of which have been neglected for centuries, are under discussion for use as valuable tool for safeguarding health across all sectors.Bacteriophages (phages) represent a naturally occurring biological resource with promising potential for use in targeted biocontrol of specific bacteria. As bacterial viruses, they interact specifically with their bacterial hosts, invading them to utilize the bacterial metabolism for their replication, finally destroying the infected bacterial cell. The benefits of this natural predator-prey relationship for the control of bacterial pathogens have long been recognized and extensively studied. This review summarises selected studies on the use of phages, illustrating the potential and application possibilities, but also the challenges of phage use. Due to their cross-sectoral relevance, the use of phages in farm animals, food and the environment is presented as an example.","PeriodicalId":9562,"journal":{"name":"Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz","volume":" ","pages":"625-630"},"PeriodicalIF":1.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12130145/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144109961","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Richtlinie der Gendiagnostik-Kommission (GEKO) für die Anforderungen an die Durchführung genetischer Analysen zur Klärung der Abstammung und an die Qualifikation von ärztlichen und nichtärztlichen Sachverständigen gemäß § 23 Abs. 2 Nr. 4 und Nr. 2b GenDG : revidierte Fassung vom 11.04.2025, veröffentlicht und in Kraft getreten am 28.04.2025, ersetzt die Fassung vom 17.07.2012. 偷盗和Gendiagnostik-Kommission (GEKO)要求需要进行基因分析背景和技能的医生和专家nichtärztlichen根据§23 . Abs号2 .号4 . 2b GenDG: 11.04.2025日修订本出版,并生效28.04.2025码头换上了修订17.07.2012 .

IF 1.7 4区医学

Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz Pub Date : 2025-05-28 DOI: 10.1007/s00103-025-04071-z

引用次数: 0

Richtlinie der Gendiagnostik-Kommission (GEKO) für die Anforderungen an die Inhalte der Aufklärung gemäß § 23 Abs. 2 Nr. 3 GenDG bei genetischen Untersuchungen zur Klärung der Abstammung : revidierte Fassung vom 11.04.2025, veröffentlicht und in Kraft getreten am 28.04.2025, ersetzt die Fassung vom 01.07.2011. 基因诊断委员会（GEKO）关于根据§23第2段第3款GenDG进行基因检测以澄清血统的信息内容要求的指令：2025年4月11日发布并于2025年4月28日生效的修订版本，取代了2011年7月1日的版本。

IF 1.7 4区医学

Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz Pub Date : 2025-05-28 DOI: 10.1007/s00103-025-04070-0

引用次数: 0

[Infections with the human pathogenic Mycoplasma species M. genitalium and M. pneumoniae : Current epidemiological aspects]. [人类致病性支原体种生殖支原体和肺炎支原体的感染：当前流行病学方面]。

IF 1.7 4区医学

Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz Pub Date : 2025-05-12 DOI: 10.1007/s00103-025-04052-2

Roger Dumke

{"title":"[Infections with the human pathogenic Mycoplasma species M. genitalium and M. pneumoniae : Current epidemiological aspects].","authors":"Roger Dumke","doi":"10.1007/s00103-025-04052-2","DOIUrl":"https://doi.org/10.1007/s00103-025-04052-2","url":null,"abstract":"Two human pathogenic mycoplasma species, Mycoplasma pneumoniae and M. genitalium currently pose challenges for the clinical practice.M. pneumoniae is a common cause of community-acquired respiratory infections, which can lead to asymptomatic courses as well as severe atypical pneumonia. Extrapulmonary manifestations also occur. Since December 2023, a strong increase of reported cases has been registered in the federal state of Saxony, where reporting is mandatory. These numbers far exceed those from the previous ten years and are assumed to generally translate to the other federal states. The reason for this development is likely the reduced contact with the pathogen during the COVID-19 pandemic combined with a waning immunity in the population. Although there are no reliable data on an increase in the rate of severe cases, diagnostics and treatment must be adapted. The resistance rate to macrolides (which are primarily used in Germany) remains favorable at approximately 3%.M. genitalium is a sexually transmitted bacterium and is only causally relevant in a portion of male urethritis cases. While its epidemiological significance is limited, resistance to the guideline-recommended antibiotics azithromycin and moxifloxacin is increasing, reaching 69% and 25%, respectively, in samples tested in the German consulting laboratory in recent years. Even higher rates are to be expected in high-risk groups (e.g., men who have sex with men), where M. genitalium is relatively frequent. Under these conditions, therapy can only be successful with a resistance-guided treatment concept.This review summarizes the current state of knowledge on both pathogens.","PeriodicalId":9562,"journal":{"name":"Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz","volume":" ","pages":""},"PeriodicalIF":1.7,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143973916","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0