Zoledronic acid

唑来膦酸
  • 文章类型: Journal Article
    背景:2018年,根据10个临床相关问题,为骨质疏松症和骨折预防的循证指南提供了一笔赠款。
    方法:由荷兰科学和专业协会的代表组成了一个多学科工作组,包括患者组织和荷兰医学知识研究所的代表。目的是在所有参与社会之间达成广泛共识,以促进执行更新的准则。
    结果:我们指南中的新建议如下:-对于腰椎和髋部有DXA适应症的患者,也有VFA的迹象。-在骨折风险非常高的患者中直接使用合成代谢药物(特立帕肽或romosozumab);-在75岁及以上的髋部骨折患者中直接使用唑来膦酸(独立于DXA);-直接使用肠胃外药物(denosumab,特立帕肽,唑来膦酸)在糖皮质激素诱导的骨质疏松中具有很高的骨折风险;-终身骨折风险管理,包括生活方式,从第一次治疗开始指示。
    结论:在我们新的多学科指南骨质疏松和骨折预防中,我们开发了5个“相对较新的声明”,这都是优化骨折预防诊断和治疗的关键一步。我们还开发了5个流程图,我们认为这可能对个别医生及其患者在日常实践中有所帮助,并可能促进实施。
    BACKGROUND: In 2018, a grant was provided for an evidence-based guideline on osteoporosis and fracture prevention based on 10 clinically relevant questions.
    METHODS: A multidisciplinary working group was formed with delegates from Dutch scientific and professional societies, including representatives from the patient\'s organization and the Dutch Institute for Medical Knowledge. The purpose was to obtain a broad consensus among all participating societies to facilitate the implementation of the updated guideline.
    RESULTS: Novel recommendations in our guideline are as follows: - In patients with an indication for DXA of the lumbar spine and hips, there is also an indication for VFA. - Directly starting with anabolic drugs (teriparatide or romosozumab) in patients with a very high fracture risk; - Directly starting with zoledronic acid in patients 75 years and over with a hip fracture (independent of DXA); - Directly starting with parenteral drugs (denosumab, teriparatide, zoledronic acid) in glucocorticoid-induced osteoporosis with very high fracture risk; - A lifelong fracture risk management, including lifestyle, is indicated from the start of the first treatment.
    CONCLUSIONS: In our new multidisciplinary guideline osteoporosis and fracture prevention, we developed 5 \"relatively new statements\" that are all a crucial step forward in the optimization of diagnosis and treatment for fracture prevention. We also developed 5 flowcharts, and we suppose that this may be helpful for individual doctors and their patients in daily practice and may facilitate implementation.
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  • 文章类型: Editorial
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  • 文章类型: Randomized Controlled Trial
    目前在英国和爱尔兰,髋部骨折后,大多数患者不接受骨保护药物治疗,以降低再骨折的风险。然而,专门检查髋部骨折患者的随机对照试验数据表明,静脉注射唑来膦酸钠可将再骨折风险降低三分之一。尽管有这些证据,使用静脉注射唑来膦酸盐是高度可变的髋部骨折后;许多医院提供这种治疗,而大多数目前还没有。一系列临床不确定性,对证据基础的怀疑和实际关切被认为是原因。本文讨论了这些问题,并从专家共识中提供了指导,旨在帮助矫正儿科医生,药剂师和卫生服务管理人员建立本地协议,在患者出院前提供这种高度临床和成本效益的治疗,为了减少这个脆弱人群代价高昂的再骨折。
    Currently in the UK and Ireland, after a hip fracture most patients do not receive bone protection medication to reduce the risk of refracture. Yet randomised controlled trial data specifically examining patients with hip fracture have shown that intravenous zoledronate reduces refracture risk by a third. Despite this evidence, use of intravenous zoledronate is highly variable following a hip fracture; many hospitals are providing this treatment, whilst most are currently not. A range of clinical uncertainties, doubts over the evidence base and practical concerns are cited as reasons. This paper discusses these concerns and provides guidance from expert consensus, aiming to assist orthogeriatricians, pharmacists and health services managers establish local protocols to deliver this highly clinically and cost-effective treatment to patients before they leave hospital, in order to reduce costly re-fractures in this frail population.
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  • 文章类型: Journal Article
    现在在修订前列腺癌指南时需要考虑的证据是前所未有的。我们认为,以英语出版国家临床指南摘要,以供其他人阅读和评论是有价值的。
    这是2022年6月发布的瑞典前列腺癌指南摘要的第2部分。本部分涵盖局部治疗后的复发以及转移性和去势抗性疾病的管理。第一部分包括早期检测,诊断,分期,非转移性疾病的患者支持和管理。
    2022年瑞典指南包括一些新建议。其中建议对预期寿命约10年、在前列腺癌根治术后BCR超过2-5年的患者进行重复PSA检测的观察时间。以便在决定是否给予抢救性放疗之前估计PSA倍增时间。PEACE-1试验的最新结果导致建议使用GnRH激动剂进行三联治疗,阿比特龙联合泼尼松龙和6周期多西他赛治疗适合化疗的高容量转移性疾病患者。瑞典指南与欧洲指南的不同之处在于,对转移性前列腺癌男性的基因检测和大剂量唑来膦酸或denosumab治疗有更严格的建议。并建议对选定的低容量转移性疾病患者考虑使用比卡鲁胺单药治疗。
    2022年瑞典前列腺癌指南包括一些新的建议和一些不同于欧洲指南的建议。
    UNASSIGNED: There is now an unprecedented amount of evidence to consider when revising prostate cancer guidelines. We believe that there is a value in publishing summaries of national clinical guidelines in English for others to read and comment on.
    UNASSIGNED: This is part 2 of a summary of the Swedish prostate cancer guidelines that were published in June 2022. This part covers recurrence after local treatment and management of metastatic and castration resistant disease. Part 1 covers early detection, diagnostics, staging, patient support and management of non-metastatic disease.
    UNASSIGNED: The 2022 Swedish guidelines include several new recommendations. Among these is a recommendation of a period of observation with repeated PSA tests for patients with approximately 10 years\' life expectancy who experience a BCR more than 2-5 years after radical prostatectomy, to allow for estimating the PSA doubling time before deciding whether to give salvage radiotherapy or not. Recent results from the PEACE-1 trial led to the recommendation of triple-treatment with a GnRH agonist, abiraterone plus prednisolone and 6 cycles of docetaxel for patients with high-volume metastatic disease who are fit for chemotherapy. The Swedish guidelines differ from the European ones by having more restrictive recommendations about genetic testing of and high-dose zoledronic acid or denosumab treatment for men with metastatic prostate cancer, and by recommending considering bicalutamide monotherapy for selected patients with low-volume metastatic disease.
    UNASSIGNED: The 2022 Swedish prostate cancer guidelines include several new recommendations and some that differ from the European guidelines.
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  • 文章类型: Journal Article
    OBJECTIVE: To assess adherence to the current European Society for Medical Oncology (ESMO) clinical practice guideline on bone health in cancer patients and the German guidelines for lung, breast, and prostate cancer among German oncologists in hospitals and office-based physicians and to identify predictors of guideline compliance to assess the needs for dedicated training.
    METHODS: This was a retrospective sample analysis representing hospitals and office-based physicians in Germany in 2016. Records from lung, breast, and prostate cancer patients who had received a diagnosis of bone metastasis between April 1, 2015, and March 31, 2016, were included. Oncologists at participating centers answered a self-assessment survey on aspects related to their professional life, including guideline adherence and years of clinical experience in medical oncology. Guideline adherence rates were assessed from patient records. Treatment variables and survey data were used to identify predictors of guideline compliance in a Classification and Regression Tree (CART) analysis.
    RESULTS: Disregarding recommendations for supplementation of calcium and vitamin D, guideline adherence among physicians treating lung, breast, or prostate cancer patients was 62%, 92%, and 83%, respectively. Compliance was 15%, 42%, and 40% if recommendations for dietary supplements were taken into account. Identified predictors of guideline compliance included treatment setting, medical specialty, years of professional experience, and frequency of quality circle attendance.
    CONCLUSIONS: Compliance with the ESMO and the German guidelines in cancer patients varies between medical specialties. In particular, patients with lung cancer and bone metastases often do not receive the recommended osteoprotective treatment and required supplementation. Discrepancies between guideline recommendations and common practice should be addressed with dedicated training.
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  • 文章类型: Journal Article
    使用GRADE方法开发了诊断和管理Paget骨病(PDB)的循证临床指南,由佩吉特协会(英国)领导的指导方针发展小组(GDG)领导。对诊断测试以及药理学和非药理学治疗方案进行了系统评价,旨在解决临床相关的几个关键问题。提出了12项建议和5项有条件建议,但是没有足够的证据来解决提出的八个问题。以下建议被认为是最重要的:1)放射性核素骨扫描,除了有针对性的射线照片,建议作为一种方法,充分和准确地定义代谢活跃疾病的PDB患者的程度。2)推荐血清总碱性磷酸酶(ALP)作为一线生化筛查试验,结合肝功能检查,筛查代谢活性PDB的存在。3)双膦酸盐被推荐用于治疗与PDB相关的骨痛。唑来膦酸被推荐作为双膦酸盐最有可能给出有利的疼痛反应。4)建议采用旨在改善症状的治疗,而不是旨在使PDB中的总ALP正常化的治疗目标策略。5)对于患有骨关节炎的PDB患者,建议进行全髋关节或膝关节置换,其中药物治疗不足。没有足够的信息来推荐一种类型的手术方法。该准则得到了欧洲钙化组织协会的认可,国际骨质疏松基金会,美国骨与矿物研究学会,骨研究协会(英国),和英国老年病学会。GDG指出,PDB中缺乏以患者为中心的临床结果的研究,并确定了需要进一步研究的几个领域。©2019作者Wiley期刊公司出版的骨与矿物研究杂志。
    An evidence-based clinical guideline for the diagnosis and management of Paget\'s disease of bone (PDB) was developed using GRADE methodology, by a Guideline Development Group (GDG) led by the Paget\'s Association (UK). A systematic review of diagnostic tests and pharmacological and nonpharmacological treatment options was conducted that sought to address several key questions of clinical relevance. Twelve recommendations and five conditional recommendations were made, but there was insufficient evidence to address eight of the questions posed. The following recommendations were identified as the most important: 1) Radionuclide bone scans, in addition to targeted radiographs, are recommended as a means of fully and accurately defining the extent of metabolically active disease in patients with PDB. 2) Serum total alkaline phosphatase (ALP) is recommended as a first-line biochemical screening test in combination with liver function tests in screening for the presence of metabolically active PDB. 3) Bisphosphonates are recommended for the treatment of bone pain associated with PDB. Zoledronic acid is recommended as the bisphosphonate most likely to give a favorable pain response. 4) Treatment aimed at improving symptoms is recommended over a treat-to-target strategy aimed at normalizing total ALP in PDB. 5) Total hip or knee replacements are recommended for patients with PDB who develop osteoarthritis in whom medical treatment is inadequate. There is insufficient information to recommend one type of surgical approach over another. The guideline was endorsed by the European Calcified Tissues Society, the International Osteoporosis Foundation, the American Society of Bone and Mineral Research, the Bone Research Society (UK), and the British Geriatric Society. The GDG noted that there had been a lack of research on patient-focused clinical outcomes in PDB and identified several areas where further research was needed. © 2019 The Authors. Journal of Bone and Mineral Research Published by Wiley Periodicals Inc.
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  • 文章类型: Journal Article
    目的更新,与安大略省癌症护理(CCO)合作,美国临床肿瘤学会(ASCO)关于骨修饰药物(BMAs)在转移性乳腺癌中的作用的指南的主要建议。这一重点更新解决了给药间隔和BMA在控制骨痛中的作用的新数据。方法ASCO-CCO联合更新委员会进行了有针对性的系统文献综述,以确定相关研究。结果更新委员会审查了三个给药间隔的III期非劣效性试验,对BMAs降级研究的系统评价和荟萃分析,和两项BMAs控制骨转移继发疼痛的随机试验。建议有骨转移证据的乳腺癌患者应接受BMA治疗。选项包括denosumab,120毫克皮下,每4周;帕米膦酸盐,90毫克静脉注射,每3至4周;或唑来膦酸,4毫克静脉内每12周或每3至4周。BMAs的镇痛作用是适度的,它们不应该单独用于骨痛。更新委员会建议,目前的支持性护理和疼痛管理标准-镇痛,辅助疗法,放射治疗,手术,全身抗癌治疗,并转诊支持治疗和疼痛管理-应应用。证据不足以支持使用一种BMA而不是另一种BMA。其他信息可在www上获得。asco.org/bast-cancer-guidelinesandwww.asco.org/guidelineswiki。
    Purpose To update, in collaboration with Cancer Care Ontario (CCO), key recommendations of the American Society of Clinical Oncology (ASCO) guideline on the role of bone-modifying agents (BMAs) in metastatic breast cancer. This focused update addressed the new data on intervals between dosing and the role of BMAs in control of bone pain. Methods A joint ASCO-CCO Update Committee conducted targeted systematic literature reviews to identify relevant studies. Results The Update Committee reviewed three phase III noninferiority trials of dosing intervals, one systematic review and meta-analysis of studies of de-escalation of BMAs, and two randomized trials of BMAs in control of pain secondary to bone metastases. Recommendations Patients with breast cancer who have evidence of bone metastases should be treated with BMAs. Options include denosumab, 120 mg subcutaneously, every 4 weeks; pamidronate, 90 mg intravenously, every 3 to 4 weeks; or zoledronic acid, 4 mg intravenously every 12 weeks or every 3 to 4 weeks. The analgesic effects of BMAs are modest, and they should not be used alone for bone pain. The Update Committee recommends that the current standard of care for supportive care and pain management-analgesia, adjunct therapies, radiotherapy, surgery, systemic anticancer therapy, and referral to supportive care and pain management-be applied. Evidence is insufficient to support the use of one BMA over another. Additional information is available at www.asco.org/breast-cancer-guidelines and www.asco.org/guidelineswiki .
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  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    Purpose To make recommendations regarding the use of bisphosphonates and other bone-modifying agents as adjuvant therapy for patients with breast cancer. Methods Cancer Care Ontario and ASCO convened a Working Group and Expert Panel to develop evidence-based recommendations informed by a systematic review of the literature. Results Adjuvant bisphosphonates were found to reduce bone recurrence and improve survival in postmenopausal patients with nonmetastatic breast cancer. In this guideline, postmenopausal includes patients with natural menopause or that induced by ovarian suppression or ablation. Absolute benefit is greater in patients who are at higher risk of recurrence, and almost all trials were conducted in patients who also received systemic therapy. Most studies evaluated zoledronic acid or clodronate, and data are extremely limited for other bisphosphonates. While denosumab was found to reduce fractures, long-term survival data are still required. Recommendations It is recommended that, if available, zoledronic acid (4 mg intravenously every 6 months) or clodronate (1,600 mg/d orally) be considered as adjuvant therapy for postmenopausal patients with breast cancer who are deemed candidates for adjuvant systemic therapy. Further research comparing different bone-modifying agents, doses, dosing intervals, and durations is required. Risk factors for osteonecrosis of the jaw and renal impairment should be assessed, and any pending dental or oral health problems should be dealt with prior to starting treatment. Data for adjuvant denosumab look promising but are currently insufficient to make any recommendation. Use of these agents to reduce fragility fractures in patients with low bone mineral density is beyond the scope of the guideline. Recommendations are not meant to restrict such use of bone-modifying agents in these situations. Additional information at www.asco.org/breast-cancer-adjuvant-bisphosphonates-guideline , www.asco.org/guidelineswiki , https://www.cancercareontario.ca/guidelines-advice/types-of-cancer/breast .
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  • 文章类型: Journal Article
    目的:对男性前列腺癌患者的骨健康和骨靶向治疗提出建议。
    方法:通过搜索MEDLINE,EMBASE和Cochrane图书馆从成立到2016年1月。如果系统评价和随机对照试验涉及旨在改善骨骼健康或诸如骨骼相关事件等结局的治疗,则考虑纳入。有或没有骨转移的前列腺癌患者的疼痛和生活质量。治疗包括药物,单独或联合补充或改变生活方式,并与安慰剂进行比较,没有治疗或其他药物。排除了疾病靶向药物,例如雄激素受体靶向药物和化学治疗剂。内部和外部审查小组审查了建议。
    结果:在接受雄激素剥夺治疗的前列腺癌患者中,鼓励基线骨密度测试。Denosumab应被考虑用于降低接受雄激素剥夺治疗的男性骨折风险,并增加骨折风险。双膦酸盐可有效改善骨密度,但对骨折的影响尚无定论。不建议使用药物来预防首次骨转移的发展。Denosumab和唑来膦酸被推荐用于预防或延迟男性转移性去势抵抗性前列腺癌的骨骼相关事件。镭-223被推荐用于减少有症状的转移性去势抵抗性前列腺癌男性的症状性骨骼事件和延长生存期。
    结论:这些建议代表了目前可行的护理标准,结果受到临床医生和患者的重视。
    OBJECTIVE: To make recommendations with respect to bone health and bone-targeted therapies in men with prostate cancer.
    METHODS: A systematic review was carried out by searching MEDLINE, EMBASE and the Cochrane Library from inception to January 2016. Systematic reviews and randomised-controlled trials were considered for inclusion if they involved therapies directed at improving bone health or outcomes such as skeletal-related events, pain and quality of life in patients with prostate cancer either with or without metastases to bone. Therapies included medications, supplements or lifestyle modifications alone or in combination and were compared with placebo, no treatment or other agents. Disease-targeted agents such as androgen receptor-targeted and chemotherapeutic agents were excluded. Recommendations were reviewed by internal and external review groups.
    RESULTS: In men with prostate cancer receiving androgen deprivation therapy, baseline bone mineral density testing is encouraged. Denosumab should be considered for reducing the risk of fracture in men on androgen deprivation therapy with an increased fracture risk. Bisphosphonates were effective in improving bone mineral density, but the effect on fracture was inconclusive. No medication is recommended to prevent the development of first bone metastasis. Denosumab and zoledronic acid are recommended for preventing or delaying skeletal-related events in men with metastatic castration-resistant prostate cancer. Radium-223 is recommended for reducing symptomatic skeletal events and prolonging survival in men with symptomatic metastatic castration-resistant prostate cancer.
    CONCLUSIONS: The recommendations represent a current standard of care that is feasible to implement, with outcomes valued by clinicians and patients.
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