BISPHOSPHONATES

双膦酸盐
  • 文章类型: Systematic Review
    目标:提高年龄,健康状况下降,利益/风险平衡的转变保证了老年人明智地使用预防性药物,包括取消处方的考虑。缺乏关于开处方的指导是处方者在日常实践中考虑开处方的主要障碍。这篇综述的目的是评估骨质疏松症指南在多大程度上包括双膦酸盐处方建议。
    方法:我们进行了系统评价,搜索PubMed,Embase,灰色文学我们纳入了用双膦酸盐治疗骨质疏松症的指南。两名独立审稿人筛选了标题,摘要,和全文。提出了取消处方的建议,并对指南的质量进行了评估。
    结果:在9345篇参考文献中,包括42条准则。共有32项(76%)指南包括开处方建议:29项(69%)指南包括非特定的开处方建议,将其定为毒品假期,其中2(5%)还包括基于个人健康状况的具体处方建议(例如预期寿命,脆弱,函数,偏好/目标)。二十四(57%)指南包括实际的开药建议,和27(64%)指南包括建议何时不应考虑开处方.
    结论:骨质疏松症指南中的双膦酸盐处方建议主要是作为药物假期,关于如何根据个人健康状况做出个性化处方决定的指导有限。这表明需要在骨质疏松症指南中进一步关注处方。
    Advancing age, declining health status, and a shift in benefit/risk balance warrant judicious use of preventive medications in older persons, including consideration of deprescribing. Lack of guidance on deprescribing is a major barrier for prescribers to consider deprescribing in daily practice. The aim of this review was to evaluate to what extent osteoporosis guidelines include bisphosphonate deprescribing recommendations.
    We conducted a systematic review, searching PubMed, Embase, and grey literature. We included guidelines on treatment of osteoporosis with bisphosphonates. Two independent reviewers screened titles, abstracts, and full texts. Recommendations for deprescribing were extracted, and quality of guidelines were assessed.
    Among 9345 references, 42 guidelines were included. A total of 32 (76%) guidelines included deprescribing recommendations: 29 (69%) guidelines included non-specific deprescribing recommendations framed as a drug holiday, of which 2 (5%) also included specific deprescribing recommendations based on individual health context (e.g. life expectancy, frailty, function, preferences/goals). Twenty-four (57%) guidelines included practical deprescribing recommendations, and 27 (64%) guidelines included recommendations for when deprescribing should not be considered.
    Bisphosphonate deprescribing recommendations in osteoporosis guidelines were primarily framed as drug holidays, with limited guidance on how to make individualized deprescribing decisions based on individual health context. This suggests a need for additional focus on deprescribing in osteoporosis guidelines.
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  • 文章类型: Journal Article
    非通信,慢性疾病需要长期甚至终生的药物干预。在特定时期暂时或永久停止药物治疗,被称为“药物假期”,\'应由医疗保健专业人员计划。
    我们在制定《意大利指南》的背景下,评估了脆性骨折患者治疗的连续性(依从性或持久性)与多种结局之间的关系。
    系统评价。
    我们系统地搜索了PubMed,Embase,和Cochrane图书馆截至2020年11月进行随机临床试验(RCT)和观察性研究,分析脆性骨折患者的药物假期。三位作者独立提取了数据,并评估了纳入研究的偏倚风险。使用建议分级评估来评估证据质量,开发和评估方法。使用随机效应模型在荟萃分析中汇集效应大小。主要结局为再骨折和生活质量;次要结局为死亡率和治疗相关不良事件。
    6项RCT和9项观察性研究符合我们的纳入标准,从非常低到中等质量。抗骨质疏松药物的依从性与非椎骨骨折的风险[相对风险(RR)0.42,95%置信区间(CI)0.20-0.87;三项研究]与非依从性相比,而与健康相关的生活质量没有检测到差异。连续治疗与不连续治疗相比,观察到再骨折风险降低(RR0.49,95%CI0.25-0.98;三项研究)。坚持和坚持措施的死亡率较低,而在接受连续和不连续治疗的个体中,胃肠道副作用没有显着差异。
    我们的研究结果表明,除非发生严重的不良反应,否则临床医生应提高脆性骨折患者抗骨质疏松治疗的依从性和持久性。
    UNASSIGNED: Noncommunicable, chronic diseases need pharmacological interventions for long periods or even throughout life. The temporary or permanent cessation of medication for a specific period, known as a \'medication holiday,\' should be planned by healthcare professionals.
    UNASSIGNED: We evaluated the association between continuity (adherence or persistence) of treatment and several outcomes in patients with fragility fractures in the context of the development of the Italian Guidelines.
    UNASSIGNED: Systematic review.
    UNASSIGNED: We systematically searched PubMed, Embase, and the Cochrane Library up to November 2020 for randomized clinical trials (RCTs) and observational studies that analyzed medication holidays in patients with fragility fracture. Three authors independently extracted data and appraised the risk of bias of the included studies. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation methodology. Effect sizes were pooled in a meta-analysis using random effects models. Primary outcomes were refracture and quality of life; secondary outcomes were mortality and treatment-related adverse events.
    UNASSIGNED: Six RCTs and nine observational studies met our inclusion criteria, ranging from very low to moderate quality. The adherence to antiosteoporotic drugs was associated with a lower risk of nonvertebral fracture [relative risk (RR) 0.42, 95% confidence interval (CI) 0.20-0.87; three studies] than nonadherence, whereas no difference was detected in the health-related quality of life. A reduction in refracture risk was observed when continuous treatment was compared to discontinuous therapy (RR 0.49, 95% CI 0.25-0.98; three studies). A lower mortality rate was detected for the adherence and persistence measures, while no significant differences were noted in gastrointestinal side effects in individuals undergoing continuous versus discontinuous treatment.
    UNASSIGNED: Our findings suggest that clinicians should promote adherence and persistence to antiosteoporotic treatment in patients with fragility fractures unless serious adverse effects occur.
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  • 文章类型: Journal Article
    目的:在绝经后激素受体阳性乳腺癌(ER+eBC)患者中,芳香化酶抑制剂(AIs)广泛用于有效预防复发。然而,AI降低骨密度,增加骨相关事件(BRE)。除了补充钙和维生素D3,双膦酸盐和地诺单抗是改善骨骼健康和乳腺癌预后的众所周知的选择。本研究旨在评估现实世界中EReBC患者基于骨骼健康指南的管理实践模式。
    方法:总共,这项回顾性队列研究包括2009年至2014年在巴塞尔大学医院接受ER+eBC治疗的68例患者。对图表评论进行了分析。基线,临床病理,治疗,并提取BRE数据。每位患者都接受了瑞士骨骼健康指南(瑞士骨质疏松协会2010[SVGO])的治疗依从性。
    结果:患者平均年龄为66.5岁(范围,56-74)年,所有绝经后。最常见的肿瘤特征是pT1-pT2的肿瘤大小(N=53,77.9%)和来曲唑治疗(N=35,51.5%),其次是他莫昔芬作为转换策略(N=27,40.3%)。AIs的中位治疗时间为47(范围,30-60)个月。五名患者(7.8%)在AI治疗期间或之后发生骨折。此外,51例(75%)患者根据SVGO建议进行治疗。
    结论:我们的回顾性队列中的骨折率与较大的III期随机试验中的骨折率相当。骨骼健康指南的依从性令人满意,但仍欠佳。临床医生应严格遵守当前的骨健康指南,以确保对BRE的最佳预防,并维持ER+eBC患者的骨健康和癌症预后。
    OBJECTIVE: In patients with postmenopausal hormone receptor-positive breast cancer (ER + eBC), aromatase inhibitors (AIs) are widely used for effective relapse prevention. However, AIs reduce bone density and increase bone-related events (BREs). Alongside calcium and vitamin D3 supplementation, bisphosphonates and denosumab are well-known options for improving outcomes in bone health and breast cancer prognosis. This study aimed to evaluate the practice patterns of bone health guideline-based management in real-world patients with ER + eBC.
    METHODS: In total, 68 patients with ER + eBC treated between 2009 and 2014 at the University Hospital Basel were included in this retrospective cohort study. Chart reviews were analyzed. Baseline, clinicopathological, treatment, and BRE data were extracted. Each patient was specifically reviewed for therapy adherence to the Swiss bone health guidelines (Swiss Association against Osteoporosis 2010 [SVGO]).
    RESULTS: The mean patient age was 66.5 (range, 56-74) years, all post-menopausal. The most frequent tumor characteristics were tumor size of pT1-pT2 (N = 53, 77.9%) and treatment with letrozole (N = 35, 51.5%), followed by tamoxifen as a switch strategy (N = 27, 40.3%). The median treatment time with AIs was 47 (range, 30-60) months. Five patients (7.8%) experienced a fracture during or after AI treatment. Moreover, 51 (75%) patients were treated according to the SVGO recommendations.
    CONCLUSIONS: The fracture rate in our retrospective cohort was comparable to that in the larger phase III randomized trials. The adherence to bone health guidelines was satisfactory but still suboptimal. Clinicians should strictly adhere to the current bone health guidelines to ensure the best possible prevention of BREs and maintain bone health and cancer prognosis in patients with ER + eBC.
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  • 文章类型: Journal Article
    The objective of this consensus statement is to inform the clinical practice communities, research centres and policymakers across Africa of the results of the recommendations for osteoporosis prevention, diagnosis and management. The developed guideline provides state-of-the-art information and presents the conclusions and recommendations of the consensus panel regarding these issues.
    To reach an African expert consensus on a treat-to-target strategy, based on current evidence for best practice, for the management of osteoporosis and prevention of fractures.
    A 3-round Delphi process was conducted with 17 osteoporosis experts from different African countries. All rounds were conducted online. In round 1, experts reviewed a list of 21 key clinical questions. In rounds 2 and 3, they rated the statements stratified under each domain for its fit (on a scale of 1-9). After each round, statements were retired, modified or added in view of the experts\' suggestions and the percent agreement was calculated. Statements receiving rates of 7-9 by more than 75% of experts\' votes were considered as achieving consensus.
    The developed guidelines adopted a fracture risk-centric approach. Results of round 1 revealed that of the 21 proposed domains, 10 were accepted whereas 11 were amended. In round 2, 32 statements were presented: 2 statements were retired for similarity, 9 statements reached consensus, whereas modifications were suggested for 21 statements. After the 3rd round of rating, the experts came to consensus on the 32 statements. Frequency of high-rate recommendation ranged from 83.33 to 100%. The response rate of the experts was 100%. An algorithm for the osteoporosis management osteoporosis was suggested.
    This study is an important step in setting up a standardised osteoporosis service across the continent. Building a single model that can be applied in standard practice across Africa will enable the clinicians to face the key challenges of managing osteoporosis; furthermore, it highlights the unmet needs for the policymakers responsible for providing bone health care together with and positive outcomes of patients\' care.
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  • 文章类型: Journal Article
    背景:骨质疏松症是一种代谢性骨病,通常影响老年人。可能需要手术干预的退行性脊柱疾病在这种易感人群中也很普遍。如果脊柱手术前未确诊或未治疗,骨质疏松可能导致术后不良事件的风险增加.术前不治疗骨质疏松症可能与对骨骼生理学的了解不足有关。缺乏标准化的治疗算法,有限的成本效益干预措施,脊柱外科医生不愿成为骨质疏松症管理的主要提供者。
    目的:本循证综述的目的是制定脊柱手术患者骨质疏松的术前评估和治疗指南。
    方法:使用美国国家医学图书馆/PubMed数据库和Embase对相关的术前诊断研究进行了文献系统综述,这些研究预测骨质疏松症相关术后不良事件的风险增加,以及骨质疏松症患者术前治疗低骨密度(BMD)是否能改善预后。
    结果:在281项研究中,17人符合纳入标准,被纳入系统评价。工作组确认了B级建议,即术前使用双能X线骨密度仪扫描进行骨质疏松症测试(T评分<-2.5),计算机断层扫描(Hounsfield单位<97.9),血清维生素D3水平(<20ng/mL)可预测脊柱手术后骨质疏松相关不良事件的风险增加。专责小组确定了B级建议,即术前使用特立帕肽治疗骨质疏松症可增加BMD,诱导更早和更强大的融合,并可能改善选定患者的预后。关于术前单独使用双膦酸盐治疗和术后结果的证据不足。
    结论:本循证临床指南建议怀疑有骨质疏松的患者接受术前评估,如果骨质疏松被证实,应就术后不良事件的风险给予适当建议。此外,术前优化BMD并选择治疗可改善某些患者的预后.可以在https://www上访问完整的指南。cns.org/guidelines/browse-guidelines-detail/3-术前-骨质疏松-评估。
    BACKGROUND: Osteoporosis is a metabolic bone disease that commonly affects the elderly. Degenerative spinal disease that may require surgical intervention is also prevalent in this susceptible population. If undiagnosed or untreated before spine surgery, osteoporosis may result in an increased risk of postoperative adverse events. Nontreatment of osteoporosis preoperatively may be related to a poor understanding of bone physiology, a lack of standardized treatment algorithms, limited cost-effective interventions, and reluctance by spine surgeons to be the primary provider of osteoporosis management.
    OBJECTIVE: The objective of this evidence-based review is to develop guidelines for the preoperative assessment and treatment of osteoporosis in patients undergoing spine surgery.
    METHODS: A systematic review of the literature was performed using the National Library of Medicine/PubMed database and Embase for studies relevant to preoperative diagnostic studies that predict increased risk of osteoporosis-related postoperative adverse events and whether the preoperative treatment of low bone mineral density (BMD) in patients with osteoporosis improves outcome.
    RESULTS: Out of 281 studies, 17 met the inclusion criteria and were included for systematic review. The task force affirmed a Grade B recommendation that preoperative osteoporosis testing with a dual-energy X-ray absorptiometry scan (T-score < -2.5), a computed tomography scan (Hounsfield units <97.9), and serum vitamin D3 level (<20 ng/mL) predict an increased risk of osteoporosis-related adverse events after spine surgery. The task force determined a Grade B recommendation that preoperative osteoporosis treatment with teriparatide increases BMD, induces earlier and more robust fusion, and may improve select patient outcomes. There is insufficient evidence regarding preoperative treatment with bisphosphonates alone and postoperative outcome.
    CONCLUSIONS: This evidence-based clinical guideline provides a recommendation that patients with suspected osteoporosis undergo preoperative assessment and be appropriately counseled about the risk of postoperative adverse events if osteoporosis is confirmed. In addition, preoperative optimization of BMD with select treatments improves certain patient outcomes.The full guidelines can be accessed at https://www.cns.org/guidelines/browse-guidelines-detail/3-preoperative-osteoporosis-assessment.
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  • 文章类型: Congress
    药物相关性颌骨坏死(MRONJ)的诊断过程及其预防发挥着越来越重要的作用,不仅取决于患者的生活质量(QoL),而且还涉及大多数参与MRONJ预防(一级和二级)的牙医和口腔外科医生的决策过程。本文报告了在意大利口腔病理学与医学学会(SIPMO)研讨会上举行的共识会议(2018年10月20日,安科纳,意大利)-在两个科学学会(意大利颌面外科学会和口腔病理学与医学学会发表关于MRONJ的最新建议(2020年)之后,SICMF和SIPMO),根据意大利ONJ联盟委员会(IAC-ONJ)专家的意见编写。会议的重点是MRONJ,特别是关于MRONJ诊断和治疗中存在不适当风险的常见做法,以及MRONJ的预防和对MRONJ风险患者的牙科管理。这是一个癌症和骨代谢患者的问题,因为他们暴露于几种具有抗吸收性的药物(即,双膦酸盐和狄诺单抗)或,最近,抗血管生成活性。同时,会议为牙医和口腔外科医生追踪了一些简单适用的适应症和程序,以降低MRONJ发病风险并及早诊断。不断更新这些问题,对病人社区来说非常重要,是推荐的。
    The Medication-Related Osteonecrosis of Jaws (MRONJ) diagnosis process and its prevention play a role of great and rising importance, not only on the Quality of Life (QoL) of patients, but also on the decision-making process by the majority of dentists and oral surgeons involved in MRONJ prevention (primary and secondary). The present paper reports the update of the conclusions from the Consensus Conference-held at the Symposium of the Italian Society of Oral Pathology and Medicine (SIPMO) (20 October 2018, Ancona, Italy)-after the newest recommendations (2020) on MRONJ were published by two scientific societies (Italian Societies of Maxillofacial Surgery and Oral Pathology and Medicine, SICMF and SIPMO), written on the inputs of the experts of the Italian Allied Committee on ONJ (IAC-ONJ). The conference focused on the topic of MRONJ, and in particular on the common practices at risk of inappropriateness in MRONJ diagnosis and therapy, as well as on MRONJ prevention and the dental management of patients at risk of MRONJ. It is a matter of cancer and osteometabolic patients that are at risk since being exposed to several drugs with antiresorptive (i.e., bisphosphonates and denosumab) or, more recently, antiangiogenic activities. At the same time, the Conference traced for dentists and oral surgeons some easy applicable indications and procedures to reduce MRONJ onset risk and to diagnose it early. Continuous updating on these issues, so important for the patient community, is recommended.
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  • 文章类型: Journal Article
    This year, the St. Gallen Consensus Conference on early breast cancer treatment standards took place for the third time in Vienna, Austria, which is where the next conference will also take place (next date: March 17-20, 2021!). Once again, more than 3,000 participants from over 100 countries came together, and, overall, the 2019 St. Gallen/Vienna conference was a great success. After 3 days of reviews conducted by a global faculty concerning the most important evidence published in the last 2 years, the Consensus votes\' challenge was to define the impact on routine everyday practice. This year, the conference\'s main theme was the optimization of early breast cancer therapies by assessment of the magnitude of benefit, aiming at further refinement when compared to de-escalation and escalation, which were mainly the topic of the 2017 conference. Patient empowerment and the importance of shared decision-making were particularly emphasized. The traditional panel votes were moderated by Eric Winer from Harvard, and for the most part, they managed to clarify most of the critical questions. This brief report by Editors of Breast Care summarizes the results of the 2019 international panel votes with respect to locoregional and systemic treatment as a quick news update for our readers, but it expressly does not intend to replace the official St. Gallen Consensus publication that will follow shortly in Annals of Oncology.
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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
    Introduction. Given the lack of independent analyses comparing numerous pharmacotherapies for osteoporosis, the study objective was to identify the optimal osteoporosis treatment based on a woman\'s age, fracture history, and ability to tolerate oral bisphosphonates adopting practices recommended in the recently revised Canadian guidelines. Methods. A cost utility analysis from the health care system perspective compared alendronate, etidronate, risedronate, zoledronate, denosumab, and no pharmacotherapy using a Markov model incorporating data on fracture risk and their associated costs, mortality, and disutility and treatment effect. Stratified analysis was conducted based on age, fracture history, and ability to tolerate oral bisphosphonates. Expected lifetime outcomes were obtained through probabilistic analysis with scenario analyses addressing methodological and structural uncertainty. Results. For women able to tolerate oral bisphosphonates, risedronate and etidronate were dominated. Compared to no therapy, alendronate was either dominant or was associated with a low incremental cost per QALY (quality-adjusted life years) gained (ICER)-less than CAN$3,751 based on age and fracture history. In comparison with alendronate, both zoledronate and denosumab were either dominated or associated with a high ICER-greater than CAN$660,000 per QALY. For women unable to tolerate bisphosphonates, dependent on age and fracture history, the ICER for zoledronate versus no therapy ranged from CAN$17,770 to CAN$94,365 per QALY. For all strata, denosumab was dominated by zoledronate or had an ICER greater than CAN$3.0 million. Scenario analyses found consistent findings. Conclusions. Based on a threshold of CAN$50,000 per QALY, alendronate is optimal for osteoporotic women who can tolerate oral bisphosphonates regardless of age or fracture history. For women unable to tolerate oral bisphosphonates, zoledronate is optimal for women with previous fracture or aged 80 to 84 or over 90 with no previous fracture.
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  • 文章类型: Consensus Development Conference
    OBJECTIVE: The task of this working group was to update the knowledge about the use of drugs and biologicals affecting healing of soft tissue and bone during implant treatment or procedures associated with it. Moreover, the impact of titanium particles and biocorrosion on complications and implant survival has been analysed.
    METHODS: The literature in the areas of interest (platelet concentrates, antiresorptive drugs as well as implant-host interaction) was screened using systematic reviews for the former two areas, whereas a narrative critical review was performed for the latter topic. Two manuscripts on platelet concentrates, one manuscript on antiresorptive drugs and one manuscript on the effects of biocorrosion, were presented for group analysis with subsequent discussion in the plenum and final consensus approval.
    RESULTS: Results and conclusions of the individual reviews of the three topics are presented in the respective papers. Conclusions of the group on strengths and weaknesses of available evidence as well as consensus statements and directions for further research are provided in this study. The following papers were subject to group discussions and formed the basis for the consensus statements: Stähli A, Strauss FJ, Gruber R. () The use of platelet-rich-plasma to enhance the outcomes of implant-related therapies: a systematic review Strauss FJ, Stähli A, Gruber R. (2018) The use of platelet-rich-fibrin to enhance the outcomes of implant-related therapies: a systematic review Mombelli A, Hashim D, Cionca N. () What is the impact of titanium particles and bio-corrosion on implant survival and complications? A critical review Stavropoulos A, Bertl K, Pietschmann P, Pandis N, Morten Schiødt, Klinge B. () The effect of antiresorptive drugs on implant therapy: a systematic review.
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