biologic therapy

生物治疗
  • 文章类型: Journal Article
    目的:儿童炎症性肠病(IBD)的发病率在全球成人和儿童中持续增加,超过三分之一的患者对抗肿瘤坏死因子生物制剂和免疫调节剂没有反应。这篇叙述性综述概述了儿科IBD管理中的新药理学发展,包括新的生物疗法。
    方法:进行了PubMedMedline搜索,包括随机对照试验,回顾性和前瞻性观察研究,以及2018年至2023年1月期间发布的IBD儿童相关病例报告。相关儿科和成人胃肠病学会的指南和协议,如欧洲儿科胃肠病学会,肝病学和营养学与欧洲克罗恩病和结肠炎组织,也包括在内。包括治疗性饮食和粪便微生物群移植在内的非药物治疗不在这项工作的范围之内。
    结果:早期的现实世界证据表明,较新的生物制品和小分子,如抗整合素,白介素-12和/或白介素-23抑制剂,Janus激酶和信号转导和转录蛋白抑制剂的激活因子,对成人IBD患者安全有效,儿科IBD的证据越来越多。
    结论:虽然治疗IBD的新药物治疗取得了许多进展,需要正在进行的研究以确认其在儿科年龄的有效性和安全性。将新治疗的许可扩展到儿童对于解决对常规治疗的反应日益丧失至关重要。国际指南将需要及时更新,以将新的治疗方法纳入现有方案。
    OBJECTIVE: The incidence of paediatric inflammatory bowel disease (IBD) continues to increase in both adults and children across the globe, with more than one third of the patients not responding to anti-tumour necrosis factor biologics and immune modulators. This narrative review provides an overview of novel pharmacological developments in the management of paediatric IBD, including new biological therapies.
    METHODS: A PubMed Medline search was performed to include randomised controlled trials, retrospective and prospective observational studies, and relevant case reports of children with IBD published between 2018 and January 2023. Guidelines and protocols from relevant paediatric and adult gastroenterology societies, such as the European Society for Paediatric Gastroenterology, Hepatology and Nutrition and the European Crohn\'s and Colitis Organisation, were also included. Non-pharmacological treatments including therapeutic diets and faecal microbiota transplantation were outside the scope of this work.
    RESULTS: Early real-world evidence suggests that newer biologics and small molecules, such as anti-integrins, interleukin-12 and/or interleukin-23 inhibitors, Janus kinase and signal transducer and activator of transcription proteins inhibitors, are safe and effective in adult patients with IBD, with promising growing evidence for paediatric IBD.
    CONCLUSIONS: While many developments have been achieved with novel pharmacological treatments to manage IBD, ongoing research is required to confirm their effectiveness and safety in the paediatric age. Extending the licence of novel treatments to children will be crucial to tackle the increasing loss of response to conventional treatments. International guidelines will require timely updating to incorporate novel treatments within the existing protocols.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

    求助全文

  • 文章类型: Journal Article
    目的:已知生物疗法可以减少急性发作并改善重度哮喘控制。在COVID-19大流行期间,生物制剂的家庭管理有所增加,但是,重度未控制的哮喘患者可能从家庭生物治疗中获益的特征尚未确定.
    方法:此项目基于Delphi方法,旨在通过多学科科学委员会解决以下问题达成专家共识:临床特征,治疗依从性,患者或护理人员的管理能力,病人自我护理,与医疗保健专业人员的关系,患者偏好,并进入医院。
    结果:一百三十一名医疗保健专业人员(肺科医师,变态反应学家,护士,和医院药剂师)完成了两份德尔菲共识问卷。14个项目被确定为优先特征,前五个是:1。患者遵循医疗团队的适应症/建议来控制他们的疾病,2.患者能够检测到他们疾病的任何恶化,并确定恶化的触发因素,3.患者接受生物治疗,病情稳定,无重大危险,4.病人对他们的自我保健负责,5.患者有职业/教育义务,阻止他们定期去医院。
    结论:对于接受生物治疗的重度不受控制的哮喘患者,选择在家中给药时,疾病的稳定性和控制性以及确定恶化触发因素的能力是最重要的特征。这些建议可能适用于临床实践。
    Biologic therapies are known to reduce exacerbations and improve severe uncontrolled asthma management. The at-home administration of biologics has increased during the COVID-19 pandemic, but the characteristics of severe uncontrolled asthma patients who may benefit from at-home administration of biologic therapy have yet to be identified.
    This project is based on the Delphi method, designed to reach an expert consensus through a multidisciplinary scientific committee addressing the following questions: clinical characteristics, treatment adherence, patient or caregiver administration ability, patient self-care, relationship with the healthcare professional, patient preference, and access to the hospital.
    One hundred and thirty-one healthcare professionals (pulmonologists, allergists, nurses, and hospital pharmacists) completed two Delphi consensus questionnaires. Fourteen items were identified as priority characteristics, the first five being: 1. The patient follows the healthcare team\'s indications/recommendations to control their disease, 2. The patient is capable of detecting any deterioration in their disease and of identifying exacerbation triggers, 3. The patient receives biologic therapy and has stable disease with no vital risk, 4. The patient takes responsibility for their self-care, 5. The patient has occupational/educational obligations that prevent them from going to the hospital regularly.
    Disease stability and control plus the ability to identify exacerbation triggers are the most important characteristics when opting for at-home administration for a patient with severe uncontrolled asthma on biologic therapy. These recommendations could be applicable in clinical practice.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

    求助全文

  • 文章类型: Journal Article
    暂无摘要。
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

    求助全文

  • 文章类型: Journal Article
    溃疡性结肠炎(US)是一种病因不明的慢性疾病。它是无法治愈的,它的临床过程是间歇性的,以缓解和复发为特征。该疾病的患病率和发病率在世界范围内一直在增加。本文提供的更新包括医疗保健专业人员的参与,决策者,和患者的代表,所有这些人都宣布了他们的利益冲突。制定了可回答的临床问题,并对结果进行分级。信息搜索是在Medline/PubMed上进行的,Embase,认识论,和LILACS数据库,并涵盖了灰色文献来源,也是。该搜索于2020年11月30日更新,没有日期或语言限制。建议评估的分级,实施了开发和评估(GRADE)分类系统,以建立推荐强度和证据质量。达成了正式共识,基于兰德/加州大学洛杉矶分校的方法,该文件经过同行评审。本文介绍了成人人群溃疡性结肠炎治疗临床实践指南的简短版本,以及支持证据和各自的建议。在轻度至中度UC中,当5-ASA治疗失败时,布地奈德MMX是一种选择,在使用全身性类固醇之前。在中度至重度UC中,英夫利昔单抗,阿达木单抗,维多珠单抗,ustekinumab,托法替尼可以作为一线治疗。如果抗TNF治疗失败,ustekinumab和tofacitinib提供了最好的结果。在抗生素难治性囊炎患者中,抗TNF是首选的治疗方法。
    Ulcerative colitis (US) is a chronic disease of unknown etiology. It is incurable and its clinical course is intermittent, characterized by periods of remission and relapse. The prevalence and incidence of the disease has been increasing worldwide. The update presented herein includes the participation of healthcare professionals, decision-makers, and a representative of the patients, all of whom declared their conflicts of interest. Answerable clinical questions were formulated, and the outcomes were graded. The information search was conducted on the Medline/PubMed, Embase, Epistemonikos, and LILACS databases, and covered grey literature sources, as well. The search was updated on November 30, 2020, with no restrictions regarding date or language. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) classification system was implemented to establish the strength of the recommendation and quality of evidence. A formal consensus was developed, based on the RAND/UCLA methodology and the document was peer reviewed. The short version of the Clinical Practice Guidelines for the Treatment of Ulcerative Colitis in the Adult Population is presented herein, together with the supporting evidence and respective recommendations. In mild-to-moderate UC, budesonide MMX is an option when treatment with 5-ASA fails, and before using systemic steroids. In moderate-to-severe UC, infliximab, adalimumab, vedolizumab, ustekinumab, and tofacitinib can be used as first-line therapy. If there is anti-TNF therapy failure, ustekinumab and tofacitinib provide the best results. In patients with antibiotic-refractory pouchitis, anti-TNFs are the treatment of choice.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

    求助全文

  • 文章类型: Practice Guideline
    目标:自成立以来,西班牙皮肤病和性病学会(AEDV)的银屑病小组(GPs)一直致力于根据现有的最佳证据,并纳入来自临床实践并针对临床实践的建议,不断更新银屑病治疗建议.由于治疗模式的变化以及近年来大量新的生物制剂的批准,需要更新的关于中重度银屑病治疗的全科医生共识文件。
    方法:使用名义分组技术并辅以范围审查,制定了共识文件。首先,指定的协调员根据他们对银屑病的经验和知识为小组选择了一组全科医生成员.协调员确定了文件的目标和要点,在纪录片家的帮助下,在Medline上对文章进行了范围审查,Embase,和Cochrane图书馆至2021年1月。该综述包括系统评价和荟萃分析以及未包括在这些研究和高质量现实世界研究中的临床试验。还审查了有关中重度银屑病管理的国家和国际临床实践指南和共识文件。然后,协调员起草了一套拟议的建议,在名义上的小组会议上进行了讨论和修改。经过几次审查,包括其他全科医生成员的外部审查,最后文件已经起草。
    结果:本指南包括评估银屑病严重程度的最新建议和全身治疗适应症的标准。它们还包括治疗中度至重度银屑病患者的一般原则,并定义这些患者的治疗目标以及初始和后续治疗的适应症和选择标准实际问题,如治疗失败和维持反应,也解决了。
    OBJECTIVE: Since its inception, the Psoriasis Group (GPs) of the Spanish Academy of Dermatology and Venereology (AEDV) has worked to continuously update recommendations for the treatment of psoriasis based on the best available evidence and incorporating proposals arising from and aimed at clinical practice. An updated GPs consensus document on the treatment of moderate to severe psoriasis was needed because of changes in the treatment paradigm and the approval in recent years of a large number of new biologic agents.
    METHODS: The consensus document was developed using the nominal group technique complemented by a scoping review. First, a designated coordinator selected a group of GPs members for the panel based on their experience and knowledge of psoriasis. The coordinator defined the objectives and key points for the document and, with the help of a documentalist, conducted a scoping review of articles in Medline, Embase, and the Cochrane Library up to January 2021. The review included systematic reviews and meta-analyses as well as clinical trials not included in those studies and high-quality real-world studies. National and international clinical practice guidelines and consensus documents on the management of moderate to severe psoriasis were also reviewed. The coordinator then drew up a set of proposed recommendations, which were discussed and modified in a nominal group meeting. After several review processes, including external review by other GPs members, the final document was drafted.
    RESULTS: The present guidelines include updated recommendations on assessing the severity of psoriasis and criteria for the indication of systemic treatment. They also include general principles for the treatment of patients with moderate to severe psoriasis and define treatment goals for these patients as well as criteria for the indication and selection of initial and subsequent therapies Practical issues, such as treatment failure and maintenance of response, are also addressed.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

    求助全文

  • 文章类型: Practice Guideline
    目标:自成立以来,西班牙皮肤病和性病学会(AEDV)的银屑病小组(GPs)一直致力于根据现有的最佳证据,并纳入来自临床实践并针对临床实践的建议,不断更新银屑病治疗建议.由于治疗模式的变化以及近年来大量新的生物制剂的批准,需要更新的关于中重度银屑病治疗的全科医生共识文件。
    方法:使用名义分组技术并辅以范围审查,制定了共识文件。首先,指定的协调员根据他们对银屑病的经验和知识为小组选择了一组全科医生成员.协调员确定了文件的目标和要点,在纪录片家的帮助下,在Medline上对文章进行了范围审查,Embase,和Cochrane图书馆至2021年1月。该综述包括系统评价和荟萃分析以及未包括在这些研究和高质量现实世界研究中的临床试验。还审查了有关中重度银屑病管理的国家和国际临床实践指南和共识文件。然后,协调员起草了一套拟议的建议,在名义上的小组会议上进行了讨论和修改。经过几次审查,包括其他全科医生成员的外部审查,最后文件已经起草。
    结果:本指南包括评估银屑病严重程度的最新建议和全身治疗适应症的标准。它们还包括治疗中度至重度银屑病患者的一般原则,并定义这些患者的治疗目标以及初始和后续治疗的适应症和选择标准实际问题,如治疗失败和维持反应,也解决了。
    OBJECTIVE: Since its inception, the Psoriasis Group (GPs) of the Spanish Academy of Dermatology and Venereology (AEDV) has worked to continuously update recommendations for the treatment of psoriasis based on the best available evidence and incorporating proposals arising from and aimed at clinical practice. An updated GPs consensus document on the treatment of moderate to severe psoriasis was needed because of changes in the treatment paradigm and the approval in recent years of a large number of new biologic agents.
    METHODS: The consensus document was developed using the nominal group technique complemented by a scoping review. First, a designated coordinator selected a group of GPs members for the panel based on their experience and knowledge of psoriasis. The coordinator defined the objectives and key points for the document and, with the help of a documentalist, conducted a scoping review of articles in Medline, Embase, and the Cochrane Library up to January 2021. The review included systematic reviews and meta-analyses as well as clinical trials not included in those studies and high-quality real-world studies. National and international clinical practice guidelines and consensus documents on the management of moderate to severe psoriasis were also reviewed. The coordinator then drew up a set of proposed recommendations, which were discussed and modified in a nominal group meeting. After several review processes, including external review by other GPs members, the final document was drafted.
    RESULTS: The present guidelines include updated recommendations on assessing the severity of psoriasis and criteria for the indication of systemic treatment. They also include general principles for the treatment of patients with moderate to severe psoriasis and define treatment goals for these patients as well as criteria for the indication and selection of initial and subsequent therapies Practical issues, such as treatment failure and maintenance of response, are also addressed.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

    求助全文

  • 文章类型: Practice Guideline
    目标:自成立以来,西班牙皮肤病和性病学会(AEDV)的银屑病小组(GPs)一直致力于根据现有的最佳证据,并纳入来自临床实践并针对临床实践的建议,不断更新银屑病治疗建议.由于治疗模式的变化以及近年来大量新的生物制剂的批准,需要更新的关于中重度银屑病治疗的全科医生共识文件。
    方法:使用名义分组技术并辅以范围审查,制定了共识文件。首先,指定的协调员根据他们对银屑病的经验和知识为小组选择了一组全科医生成员.协调员确定了文件的目标和要点,在纪录片家的帮助下,在Medline上对文章进行了范围审查,Embase,和Cochrane图书馆至2021年1月。该综述包括系统评价和荟萃分析以及未包括在这些研究和高质量现实世界研究中的临床试验。还审查了有关中重度银屑病管理的国家和国际临床实践指南和共识文件。然后,协调员起草了一套拟议的建议,在名义上的小组会议上进行了讨论和修改。经过几次审查,包括其他全科医生成员的外部审查,最后文件已经起草。
    结果:本指南包括评估银屑病严重程度的最新建议和全身治疗适应症的标准。它们还包括治疗中度至重度银屑病患者的一般原则,并定义这些患者的治疗目标以及初始和后续治疗的适应症和选择标准实际问题,如治疗失败和维持反应,也解决了。
    OBJECTIVE: Since its inception, the Psoriasis Group (GPs) of the Spanish Academy of Dermatology and Venereology (AEDV) has worked to continuously update recommendations for the treatment of psoriasis based on the best available evidence and incorporating proposals arising from and aimed at clinical practice. An updated GPs consensus document on the treatment of moderate to severe psoriasis was needed because of changes in the treatment paradigm and the approval in recent years of a large number of new biologic agents.
    METHODS: The consensus document was developed using the nominal group technique complemented by a scoping review. First, a designated coordinator selected a group of GPs members for the panel based on their experience and knowledge of psoriasis. The coordinator defined the objectives and key points for the document and, with the help of a documentalist, conducted a scoping review of articles in Medline, Embase, and the Cochrane Library up to January 2021. The review included systematic reviews and meta-analyses as well as clinical trials not included in those studies and high-quality real-world studies. National and international clinical practice guidelines and consensus documents on the management of moderate to severe psoriasis were also reviewed. The coordinator then drew up a set of proposed recommendations, which were discussed and modified in a nominal group meeting. After several review processes, including external review by other GPs members, the final document was drafted.
    RESULTS: The present guidelines include updated recommendations on assessing the severity of psoriasis and criteria for the indication of systemic treatment. They also include general principles for the treatment of patients with moderate to severe psoriasis and define treatment goals for these patients as well as criteria for the indication and selection of initial and subsequent therapies Practical issues, such as treatment failure and maintenance of response, are also addressed.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

    求助全文

  • 文章类型: Journal Article
    背景:炎症性肠病(IBD)是慢性的,复发缓解性炎症性疾病对健康相关生活质量和工作效率有重大负面影响。生物疗法的出现彻底改变了IBD的治疗方法,最初使用抗TNF药物,最近使用多种替代靶标,还有更多正在开发中。
    目的:大约三分之一的患者对生物治疗没有反应,更重要的是,在治疗期间有相当一部分患者出现部分反应或反应丧失。后者是常见的临床情况,矛盾的是,在商业药物标签和可用指南中没有解决。因此,临床上需要医生了解何时以及如何最终优化生物治疗。
    方法:阿联酋胃肠病学和肝病学会促进和支持了使用德尔菲方法的共识,以缩小这一差距。
    方法:在对超过60,000项研究进行了广泛的系统回顾之后,选择了81项剂量递增研究和5项解决药物监测的研究,此外还有5项系统评价和3项指南。
    结论:经过三轮投票,选择了18个声明,同意范围从80%到100%。
    BACKGROUND: Inflammatory bowel diseases (IBD) are chronic, relapsing-remitting inflammatory conditions with a substantial negative impact on health-related quality of life and work productivity. Treatment of IBD has been revolutionized by the advent of biologic therapies, initially with anti-TNF agents and more recently with multiple alternatives targets, and yet more under development.
    OBJECTIVE: Approximatively one third of patients do not respond to biologic therapy and more importantly a significant proportion experiences partial response or loss of response during treatment. The latter are common clinical situations and paradoxically are not addressed in the commercial drug labels and available guidelines. There is therefore a clinical need for physicians to understand when and how eventually to optimize the biologic therapy.
    METHODS: This consensus using a Delphi methodology was promoted and supported by the Emirates Society of Gastroenterology and Hepatology to close this gap.
    METHODS: Following an extensive systematic review of over 60,000 studies, 81 studies with dose escalation and five addressing drug monitoring were selected and in addition five systematic reviews and three guidelines.
    CONCLUSIONS: after three rounds of voting 18 statements were selected with agreement ranging from of 80% to 100.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    新型冠状病毒(COVID-19)几乎对每个器官系统都有亲和力,包括皮肤。这篇综述文章将汇编和比较与COVID-19大流行期间患者皮肤病护理相关的皮肤病学指南。
    回顾和比较在皮肤病患者中使用生物制剂和其他全身疗法的现有指南和建议。
    我们为皮肤病学提供者搜索了指南和建议,特别注意COVID-19期间生物制剂和非生物全身性药物的管理。基于国际和美国的特定于皮肤病学领域的指南和对医疗保健提供者的指导被用作纳入标准。可用的登记册也包括在内。
    该指南强调了共同的决策方法,并针对每个独特的患者病例进行了风险收益分析和治疗策略修改。这些指南在强调患者不应该在不首先与提供者交谈的情况下停止用药的重要性方面都是一致的。
    UNASSIGNED: The novel coronavirus (COVID-19) has an affinity for almost every organ system, including the skin. This review article will compile and compare dermatology guidelines related to the dermatologic care of patients during the COVID-19 pandemic.
    UNASSIGNED: To review and compare the available guidelines and recommendations on use of biologics and other systemic therapies in dermatology patients.
    UNASSIGNED: We conducted a search for guidelines and recommendations for dermatology providers, with specific attention to the management of biologics and non-biologic systemic agents during COVID-19. International and United States-based guidelines specific to the field of dermatology and guidance for healthcare providers were used as inclusion criteria. Available registries were included as well.
    UNASSIGNED: The guidelines stress a shared decision-making approach with risk-benefit analysis and treatment strategy modifications tailored to each unique patient case. The guidelines were all concordant with one another in highlighting the importance that patients should not discontinue their medications without first speaking with their providers.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Sci-hub)

  • 文章类型: Journal Article
    OBJECTIVE: There have been major advances in biologic treatment options for psoriatic arthritis (PsA) since the publication of the 2015 consensus recommendations by the Chapter of Rheumatologists, College of Physicians, Academy of Medicine, Singapore, for government-assisted funding, thus warranting a revision of this guideline.
    METHODS: Recent trials and nine published guidelines on the use of biologic therapy for PsA were reviewed. Based on the synthesized evidence, a task force panel (TFP), consisting of 10 practicing rheumatologists in Singapore, rated the statements pertaining to the use of biologic therapy, using a modified Delphi approach. Consensus was obtained if >70% agreed on a statement.
    RESULTS: The TFP agreed on 10 recommendations pertaining to the initiation, choice and continuation of biologic therapy. A biologic is indicated in patients with PsA: (a) with at least three swollen and tender joints, digits or entheses; and (b) who have failed at least two conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) strategies for a minimum of 3 months each. Any approved drug class including tumor necrosis factor inhibitors, interleukin-17 inhibitors (IL-17i), IL-12/23i or targeted synthetic DMARDs may be considered as first-line treatment, and continued only if a response is achieved by 6 months.
    CONCLUSIONS: These recommendations developed through a formal consensus method may be useful to guide funding considerations for appropriate and equitable use of biologic therapy for eligible patients with PsA.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Sci-hub)

公众号