dose reduction

剂量减少
  • 文章类型: Journal Article
    在先前的范围审查中已经描述了用于斑块状银屑病的第一代生物制剂(TNF-α抑制剂(i)和白介素(IL)-12/23i)的剂量减少(DR)。关于最新一代生物制剂(IL-17/23i)的DR的文献很少。当前的评论提供了有关所有生物制剂DR的先前范围审查的文献更新,包括最新一代,注重DR在实践中的吸收和实施。当前有关DR的文献检索显示,除了先前的综述外,还有14篇新文章。新发现的四篇文章测试了DR策略,主要集中在第一代生物制剂;只有guselkumab(IL-23i)被纳入一项研究.其他10项研究显示了DR失败后恢复反应的数据,安全,成本效益,以及吸收和实施,以及有关IL-17/23i的信息。开始DR的资格标准包括绝对和相对银屑病面积和严重程度指数(PASI)评分(PASI≤3/≤5/PASI75-100)和/或皮肤病生活质量指数(DLQI)≤3/≤5,或BSA≤1/≤2,或医师全球评估(PGA)≤1/0-2,时间从12周到≥1年。大多数研究使用PASI≤5和/或DLQI≤5或PGA≤1≥6个月。DR策略主要通过分两步逐步延长间隔(达到标准剂量的67%,其次是50%)。IL-17/23i的一些研究将剂量降低至±25%。对TNF-αi和IL-12/23i的逐步或固定DR的测试DR策略(三项研究),以及一项关于IL-23iguselkumab的“按需”给药研究,是成功的。在TNF-αi和IL-12/23i的DR复发的情况下,标准剂量再治疗可恢复临床疗效.所有研究均显示TNF-αi和IL-12/23i的生物学DR可节省大量成本。发现的阻碍实施DR的障碍主要是缺乏关于有效性和安全性的指南和科学证据,缺乏时间和(技术)支持。确定的主持人主要是明确的指导方针,可行的协议,对患者和医生进行充分的教育,和降低成本。总之,博士似乎很有希望,但是随机研究仍然存在差距,前瞻性研究测试DR策略,尤其是IL-17/23i,妨碍完成DR.考虑到已确定的障碍和促进因素,最有可能在实践中更成功地实施生物DR。
    Dose reduction (DR) of first-generation biologics for plaque psoriasis (TNF-alpha inhibitors (i) and interleukin (IL)-12/23i) has been described in a previous scoping review. The literature on the DR of the newest generation of biologics (IL-17/23i) was scarce. The current review provides a literature update on the previous scoping review on the DR of all biologics, including the newest generation, with a focus on the uptake and implementation of DR in practice. The current literature search on DR revealed 14 new articles in addition to those in the previous review. Four of the newly found articles tested DR strategies, mostly focusing on first-generation biologics; only guselkumab (IL-23i) was included in one study. The other 10 studies showed data on regaining response after failure of DR, safety, cost-effectiveness, and uptake and implementation, as well as information about IL-17/23i. The eligibility criteria to start DR included both absolute and relative Psoriasis Area and Severity Index (PASI) scores (PASI ≤3/≤5/PASI 75-100) and/or Dermatology Life Quality Index (DLQI) ≤3/≤5, or BSA ≤1/≤2, or Physician Global Assessment (PGA) ≤1/0-2 during a period ranging from 12 weeks to ≥1 year. Most studies used PASI ≤5 and/or DLQI ≤5 or PGA ≤1 for ≥6 months. DR strategies were mostly performed by stepwise interval prolongation in two steps (to 67% of the standard dose, followed by 50%). Some studies of IL-17/23i reduced the dose to ±25%. The tested DR strategies on stepwise or fixed DR on TNF-αi and IL-12/23i (three studies), as well as one \"on-demand\" dosing study on IL-23i guselkumab, were successful. In the case of relapse of DR on TNF-αi and IL-12/23i, clinical effectiveness was regained by retreatment with the standard dose. All studies showed substantial cost savings with the biologic DR of TNF-αi and IL-12/23i. The identified barriers against the implementation of DR were mainly a lack of guidelines and scientific evidence on effectiveness and safety, and a lack of time and (technical) support. The identified facilitators were mainly clear guidelines, feasible protocols, adequate education of patients and physicians, and cost reduction. In conclusion, DR seems promising, but a research gap still exists in randomized, prospective studies testing DR strategies, especially of IL-17/23i, hampering the completion of guidelines on DR. Taking into account the identified barriers and facilitators most likely results in a more successful implementation of biologic DR in practice.
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  • 文章类型: Meta-Analysis
    目的:TDM引导的TNFi治疗风湿性疾病患者的益处仍存在争议。进行了系统评价和荟萃分析,以探讨TDM指导的TNFi治疗是否优于经验指导的治疗。
    方法:我们系统地搜索了PubMed,WebofScience,科克伦图书馆,和EMBASE数据库,用于在数据库开始到2023年10月5日之间发表的文章。包括报告TDM指导的TNFi治疗和经验性治疗终点的研究。结果将以风险比(RR)和平均差表示,报告95%置信区间(CI)。本研究在PROSPERO(CRD42022353956)注册。
    结果:共有14项研究(8项随机对照试验和6项队列研究)纳入本荟萃分析,涉及2427例患者。在响应预测的场景中,与经验指导疗法相比,TDM引导的TNFi治疗与更高的治疗至目标率相关(RR1.30,95%CI1.02-1.65,P=0.03,I2=79%),更具体地说,较高的低疾病活动率(RR2.11,95%CI1.22-3.66,P=0.007,I2=61%),但临床缓解率无差异(RR0.98,95%CI0.87-1.11,P=0.75,I2=0%)。在剂量减少预测的情况下,与经验指导剂量减少策略相比,观察到较低的复发率(RR0.73,95%CI0.65-0.82,P<0.00001,I2=0%),但TDM引导剂量减少和标准剂量治疗之间没有差异(RR1.24,95%CI0.85-1.80,P=0.27,I2=57%).疾病活动性评分变化无显著差异,平均疾病活动评分,放射学进展,和安全。TDM指导的治疗与每位患者每年的成本降低相关,计算为治疗成本的总累积总和。
    结论:TDM引导的TNFi治疗与低疾病活动度和复发风险降低相关,与风湿性疾病患者的经验指导治疗相比,可以节省成本。但这并不意味着可以提倡使用TDM引导的TNFi治疗,因为临床缓解率和许多其他结局没有差异。更多研究,特别是随机临床试验需要验证这一结论。
    The benefits of TDM-guided TNFi therapy in patients with rheumatic disease was still controversial. This systematic review and meta-analysis was conducted to explore if the TDM-guided TNFi therapy is superior to empirical-guided therapy.
    We systematically searched PubMed, Web of Science, Cochrane Library, and EMBASE databases for articles published between database inception and October 05, 2023. Studies reporting endpoints in TDM-guided TNFi therapy and empirical therapy were included. Results would be presented in risk ratio (RR) and mean difference, with 95 % confidence interval (CI) reported. This study is registered with PROSPERO (CRD42022353956).
    A total of 14 studies (eight RCTs and six cohort studies) involving 2427 patients were included in this meta-analysis. In the scenario of response prediction, compared with empirical-guided therapy, TDM-guided TNFi therapy had association with higher treat-to-target rates (RR 1.30, 95 % CI 1.02-1.65, P=0.03, I2=79 %), more specifically, higher low disease activity rates (RR 2.11, 95 % CI 1.22-3.66, P=0.007, I2=61 %), but no difference in clinical remission rates (RR 0.98,95 % CI 0.87-1.11, P=0.75, I2=0 %). In the scenario of dose reduction prediction, lower relapse rates (RR 0.73, 95 % CI 0.65-0.82, P <0.00001, I2=0 %) were observed compared with empirical-guided dose reduction strategy, but no difference (RR 1.24, 95 % CI 0.85-1.80, P=0.27, I2=57 %) between TDM-guided dose reduction and standard-dosing therapy. No significant difference was observed in change of disease activity score, mean disease activity score, radiographic progression, and safety. And TDM-guided therapy was associated with reduced cost per patient per year calculated as the total accumulated sum of therapy cost.
    TDM-guided TNFi therapy was associated with increased rates of low disease activity and decreased risks of relapse, and may save cost compared with empirical-guided therapy in patients with rheumatic disease. But this does not mean that the use of TDM-guided TNFi therapy can be advocated, because there is no difference in clinical remission rates and many other outcomes. More researches, especially randomized clinical trials are needed to verify this conclusion in the future.
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  • 文章类型: Journal Article
    背景:生物疗法是炎症性肠病(IBD)的有效治疗方法。然而,出于成本和安全考虑,在达到缓解后,已经提出了剂量递减策略。
    目的:严格审查关于IBD中生物制剂(或其他先进疗法)剂量递减的现有数据。我们将专注于评估最初优化的患者降低至标准剂量的研究,以及评估标准剂量降级的研究。
    方法:进行了系统的书目检索。
    结果:先前剂量增强后的平均降频率(12项研究,1,474例患者)为34%。从标准剂量降低的相应频率(5项研究,3,842例患者)为4.2%。在最初剂量递增的患者中,抗TNF降低至标准剂量后IBD的复发率(10项研究,301例患者)为30%。抗TNF从标准剂量降低后的相应复发率(9项研究,494例患者)为38%。临床上患者的复发风险较低,生物学,和内镜/放射学缓解时的降级。已经证明了抗TNF治疗药物监测在剂量递减决定中的作用。在降级后复发的患者中,重新升级通常是有效的。降级并不总是与更好的安全性相关联。降级战略的成本效益仍然不确定。最后,没有足够的证据推荐不同于抗-TNFs或小分子的生物制剂的剂量递减.
    结论:必须针对IBD中生物治疗降级的任何考虑,考虑到耀斑的风险和后果以及患者的偏好。
    BACKGROUND: Biologic therapy is an effective treatment for inflammatory bowel disease [IBD]. However due to cost and safety concerns, dose de-escalation strategies after achieving remission have been suggested.
    OBJECTIVE: To critically review available data on dose de-escalation of biologics [or other advanced therapies] in IBD. We will focus on studies evaluating de-escalation to standard dosing in patients initially optimised, and also on studies assessing de-escalation from standard dosing.
    METHODS: A systematic bibliographic search was performed.
    RESULTS: The mean frequency of de-escalation after previous dose intensification [12 studies, 1,474 patients] was 34%. The corresponding frequency of de-escalation from standard dosing [five studies, 3,842 patients] was 4.2%. The relapse rate of IBD following anti-tumour necrosis factor [TNF] de-escalation to standard dosing in patients initially dose-escalated [10 studies, 301 patients] was 30%. The corresponding relapse rate following anti-TNF de-escalation from standard dosing [nine studies, 494 patients] was 38%. The risk of relapse was lower for patients in clinical, biologic, and endoscopic/radiological remission at the time of de-escalation. A role of anti-TNF therapeutic drug monitoring in the decision to dose de-escalate has been demonstrated. In patients relapsing after de-escalation, re-escalation is generally effective. De-escalation is not consistently associated with a better safety profile. The cost-effectiveness of the de-escalation strategy remains uncertain. Finally, there is not enough evidence to recommend dose de-escalation of biologics different from anti-TNFs or small molecules.
    CONCLUSIONS: Any consideration for de-escalation of biologic therapy in IBD must be tailored, taking into account the risks and consequences of a flare and patients\' preferences.
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  • 文章类型: Journal Article
    生成人工智能,特别是关于生成对抗网络(GAN),是放射学的重要研究领域,最近几年发表的有关GAN在放射学中的作用的许多文献综述证明了这一点。然而,尚未发表关于GAN在儿科放射学中的评论文章.本文的目的是系统地回顾GAN在儿科放射学中的应用。他们的表演,以及他们的业绩评价方法。电子数据库于2023年4月6日用于文献检索。37篇论文符合选择标准并被纳入。这篇综述揭示了GAN可以应用于磁共振成像,X光片,计算机断层扫描,用于图像平移的超声和正电子发射断层扫描,分割,重建,质量评估,综合和数据增强,和疾病诊断。大约80%的纳入研究将他们的GAN模型性能与其他方法的性能进行了比较,并表明他们的GAN模型优于其他方法0.1-158.6%。然而,这些研究结果应谨慎使用,因为一些方法学上的弱点。对于未来的GAN研究,更强大的方法对于解决这些问题至关重要。否则,这将影响基于GAN的儿科放射学应用的临床采用,GAN的潜在优势无法得到广泛认识.
    Generative artificial intelligence, especially with regard to the generative adversarial network (GAN), is an important research area in radiology as evidenced by a number of literature reviews on the role of GAN in radiology published in the last few years. However, no review article about GAN in pediatric radiology has been published yet. The purpose of this paper is to systematically review applications of GAN in pediatric radiology, their performances, and methods for their performance evaluation. Electronic databases were used for a literature search on 6 April 2023. Thirty-seven papers met the selection criteria and were included. This review reveals that the GAN can be applied to magnetic resonance imaging, X-ray, computed tomography, ultrasound and positron emission tomography for image translation, segmentation, reconstruction, quality assessment, synthesis and data augmentation, and disease diagnosis. About 80% of the included studies compared their GAN model performances with those of other approaches and indicated that their GAN models outperformed the others by 0.1-158.6%. However, these study findings should be used with caution because of a number of methodological weaknesses. For future GAN studies, more robust methods will be essential for addressing these issues. Otherwise, this would affect the clinical adoption of the GAN-based applications in pediatric radiology and the potential advantages of GAN could not be realized widely.
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  • 文章类型: Meta-Analysis
    目的:对两种最常见的商用CT深度学习算法进行系统的文献综述和荟萃分析。
    方法:我们使用PubMed,Scopus,Embase,和WebofScience进行系统搜索,以评估最常见的商用深度学习CT重建算法:在人类参与者的腹部中的TrueFidelity(TF)和Advanced智能Clear-IQEngine(AiCE),因为目前只有这两种算法有足够的已发布数据进行可靠的系统分析。
    结果:44篇文章符合纳入标准。32项研究评估了TF,12项研究评估了AiCE。DLR算法产生的图像噪声明显较少(比IR低22-57.3%),但保留了理想的噪声纹理,对比度噪声比增加,并改善了常规CT上的病变可检测性。DLR的这些改进类似地在双能量CT中注意到,其仅针对单个供应商进行评估。报告的辐射还原电位为35.1-78.5%。九项研究评估了观察者的表现,其中两项专门的肝脏病变研究在同一供应商重建(TF)上进行。这两项研究表明,在CTDIvol6.8mGy(BMI23.5kg/m2)至12.2mGy(BMI29kg/m2)时,保留了低对比肝病变检测(>5mm)。如果需要更小的病变检测和改进的病变表征,正常体重的肥胖人群需要13.6-34.9mGy的CTDIvol.已经报道了在高DLR重建强度下的轻度信号损失和模糊。
    结论:深度学习重建可显著改善腹部CT图像质量。需要评估其他剂量水平和临床适应症。仔细选择辐射剂量水平是必要的,特别是对于小的肝脏病变评估。
    To perform a systematic literature review and meta-analysis of the two most common commercially available deep-learning algorithms for CT.
    We used PubMed, Scopus, Embase, and Web of Science to conduct systematic searches for studies assessing the most common commercially available deep-learning CT reconstruction algorithms: True Fidelity (TF) and Advanced intelligent Clear-IQ Engine (AiCE) in the abdomen of human participants since only these two algorithms currently have adequate published data for robust systematic analysis.
    Forty-four articles fulfilled inclusion criteria. 32 studies evaluated TF and 12 studies assessed AiCE. DLR algorithms produced images with significantly less noise (22-57.3% less than IR) but preserved a desirable noise texture with increased contrast-to-noise ratios and improved lesion detectability on conventional CT. These improvements with DLR were similarly noted in dual-energy CT which was only assessed for a single vendor. Reported radiation reduction potential was 35.1-78.5%. Nine studies assessed observer performance with the two dedicated liver lesion studies being performed on the same vendor reconstruction (TF). These two studies indicate preserved low contrast liver lesion detection (> 5 mm) at CTDIvol 6.8 mGy (BMI 23.5 kg/m2) to 12.2 mGy (BMI 29 kg/m2). If smaller lesion detection and improved lesion characterization is needed, a CTDIvol of 13.6-34.9 mGy is needed in a normal weight to obese population. Mild signal loss and blurring have been reported at high DLR reconstruction strengths.
    Deep learning reconstructions significantly improve image quality in CT of the abdomen. Assessment of other dose levels and clinical indications is needed. Careful choice of radiation dose levels is necessary, particularly for small liver lesion assessment.
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  • 文章类型: Systematic Review
    1971年,对患者的大脑进行了首次计算机断层扫描(CT)扫描。临床CT系统于1974年推出,仅用于头部成像。新技术发展,更广泛的可用性,CT的临床成功导致检查数量稳步增长。头部非对比CT(NCCT)最常见的适应症包括评估缺血和中风,颅内出血和外伤,虽然CT血管造影(CTA)已成为一线脑血管评估的标准;然而,患者管理和临床结果的改善是以辐射暴露为代价的,增加继发发病率的风险。因此,辐射剂量优化应该始终是CT成像技术进步的一部分,但是如何优化剂量?在不影响诊断价值的情况下可以实现什么剂量减少,以及即将到来的人工智能和光子计数CT技术的潜力是什么?在这篇文章中,我们通过回顾有关NCCT和头部CTA的主要临床适应症的剂量减少技术来寻找这些问题的答案,包括简要介绍CT技术在辐射剂量优化方面的当前和未来发展。
    In 1971, the first computed tomography (CT) scan was performed on a patient\'s brain. Clinical CT systems were introduced in 1974 and dedicated to head imaging only. New technological developments, broader availability, and the clinical success of CT led to a steady growth in examination numbers. Most frequent indications for non-contrast CT (NCCT) of the head include the assessment of ischemia and stroke, intracranial hemorrhage and trauma, while CT angiography (CTA) has become the standard for first-line cerebrovascular evaluation; however, resulting improvements in patient management and clinical outcomes come at the cost of radiation exposure, increasing the risk for secondary morbidity. Therefore, radiation dose optimization should always be part of technical advancements in CT imaging but how can the dose be optimized? What dose reduction can be achieved without compromising diagnostic value, and what is the potential of the upcoming technologies artificial intelligence and photon counting CT? In this article, we look for answers to these questions by reviewing dose reduction techniques with respect to the major clinical indications of NCCT and CTA of the head, including a brief perspective on what to expect from current and future developments in CT technology with respect to radiation dose optimization.
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  • 文章类型: Systematic Review
    1974年第一台全身CT扫描仪的推出标志着脊柱横断面成像的开始。在过去的几十年里,技术进步,CT的可用性和临床成功率的提高导致CT检查的数量迅速增加,也是脊柱。在最初主要用于创伤评估之后,新的适应症不断涌现,如椎骨骨折或脊柱退行性疾病的评估,术前和术后评估,或CT引导的脊柱介入治疗;然而,患者管理和临床结果的改善伴随着更高的辐射暴露,这增加了继发性恶性肿瘤的风险。因此,CT采集和重建的技术发展必须始终包括减少辐射剂量的努力。但是究竟如何减少剂量呢?在不损害脊柱CT检查的临床价值的情况下,可以实现多少剂量减少,以及CT技术中的后起之秀可以期待什么:人工智能和光子计数CT?在本文中,我们试图通过系统地回顾脊柱CT的主要临床适应症的剂量减少技术来回答这些问题。此外,我们将简要介绍CT硬件和软件未来发展的剂量减少潜力。
    The introduction of the first whole-body CT scanner in 1974 marked the beginning of cross-sectional spine imaging. In the last decades, the technological advancement, increasing availability and clinical success of CT led to a rapidly growing number of CT examinations, also of the spine. After initially being primarily used for trauma evaluation, new indications continued to emerge, such as assessment of vertebral fractures or degenerative spine disease, preoperative and postoperative evaluation, or CT-guided interventions at the spine; however, improvements in patient management and clinical outcomes come along with higher radiation exposure, which increases the risk for secondary malignancies. Therefore, technical developments in CT acquisition and reconstruction must always include efforts to reduce the radiation dose. But how exactly can the dose be reduced? What amount of dose reduction can be achieved without compromising the clinical value of spinal CT examinations and what can be expected from the rising stars in CT technology: artificial intelligence and photon counting CT? In this article, we try to answer these questions by systematically reviewing dose reduction techniques with respect to the major clinical indications of spinal CT. Furthermore, we take a concise look on the dose reduction potential of future developments in CT hardware and software.
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  • 文章类型: Journal Article
    辐射剂量优化在儿科放射学中尤为重要。因为儿童更容易受到电离辐射的潜在有害影响。然而,目前仅发表了一篇关于儿科计算机断层扫描(CT)剂量优化人工智能(AI)的叙述性综述.这项系统评价的目的是回答以下问题:“在儿科放射学中引入的用于剂量优化的AI技术和架构是什么?它们的特定应用领域,和表演?“使用电子数据库的文献检索于2022年6月3日进行。包括16篇符合选择标准的文章。包括的研究表明,深度卷积神经网络(CNN)是用于儿科放射学剂量优化的最常见的AI技术和架构。除三项研究外,所有研究均评估了AI在腹部剂量优化中的表现,胸部,头部,脖子,和骨盆CT;CT血管造影;和通过深度学习图像重建的双能CT。大多数研究表明,人工智能可以将辐射剂量减少36-70%,而不会丢失诊断信息。尽管基于深度CNN的商用AI模型占据主导地位,并取得了有希望的结果,本土模型可以提供可比的性能。由于样本量小,范围窄,未来探索AI在儿科放射学中的剂量优化价值是必要的(只有三种模式,CT,正电子发射断层扫描/磁共振成像和移动射线照相术,并非涵盖所有检查类型)现有研究。
    Radiation dose optimization is particularly important in pediatric radiology, as children are more susceptible to potential harmful effects of ionizing radiation. However, only one narrative review about artificial intelligence (AI) for dose optimization in pediatric computed tomography (CT) has been published yet. The purpose of this systematic review is to answer the question \"What are the AI techniques and architectures introduced in pediatric radiology for dose optimization, their specific application areas, and performances?\" Literature search with use of electronic databases was conducted on 3 June 2022. Sixteen articles that met selection criteria were included. The included studies showed deep convolutional neural network (CNN) was the most common AI technique and architecture used for dose optimization in pediatric radiology. All but three included studies evaluated AI performance in dose optimization of abdomen, chest, head, neck, and pelvis CT; CT angiography; and dual-energy CT through deep learning image reconstruction. Most studies demonstrated that AI could reduce radiation dose by 36-70% without losing diagnostic information. Despite the dominance of commercially available AI models based on deep CNN with promising outcomes, homegrown models could provide comparable performances. Future exploration of AI value for dose optimization in pediatric radiology is necessary due to small sample sizes and narrow scopes (only three modalities, CT, positron emission tomography/magnetic resonance imaging and mobile radiography, and not all examination types covered) of existing studies.
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  • 文章类型: Journal Article
    背景:长期使用抗TNF-α药物会导致不良反应,如感染和免疫介导的皮肤反应。通过剂量减少或间隔时间延长来降低这些不良反应是不确定的。本系统评价旨在比较抗TNF-α剂量降低与标准剂量后感染的发生率和皮肤表现。
    方法:MEDLINE,EMBASE,从开始到2022年1月14日,搜索了Cochrane中央控制试验登记册。随机对照试验(RCTs)和观察性研究,比较抗TNF-α降低策略与标准剂量在炎症患者中,报告感染,皮肤表现,或者两者兼而有之,包括在内。使用修订后的Cochrane偏差风险工具(RCT)或纽卡斯尔-渥太华量表(非RCT)评估偏差风险。
    结果:纳入了14项随机对照试验和6项观察性研究(或2706名患者)。八个随机对照试验的偏倚或一些担忧风险较低。四个非随机对照试验具有良好的方法学质量。研究描述了轴性脊柱关节炎患者(8项研究,780名患者),类风湿性关节炎(7项研究,1458名患者),牛皮癣(3项研究,332名患者),或炎症性肠病(2项研究,136名患者)。降级策略包括间隔时间延长(12项研究,1317名患者),剂量减少(6项研究,1130名患者),或两者(2项研究,259名患者)。总的来说,在标准治疗和降阶梯治疗之间,感染的发生和皮肤表现没有差异.仅在两项研究中报告了降级后感染或皮肤表现的消失。大多数研究集中在依那西普和阿达木单抗上。报告感染和皮肤表现的异质性排除了荟萃分析。
    结论:我们发现,抗TNF-α降阶梯并不能减少感染或皮肤反应。不应仅出于减少药物相关不良反应的目的而建议采取降级策略。建议对不良反应进行细致的记录,以进一步解决这一问题。
    背景:PROSPEROCRD42021252977.
    BACKGROUND: The long-term use of anti-TNF-α agents can lead to adverse effects, such as infections and immune-mediated cutaneous reactions. Whether de-escalation by dose reduction or interval lengthening reduces these adverse effects is uncertain. This systematic review aims to compare the incidence of infections and skin manifestations after anti-TNF-α dose de-escalation with standard dosing.
    METHODS: MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were searched from inception to 14 January 2022. Randomized controlled trials (RCTs) and observational studies comparing anti-TNF-α de-escalation strategies with standard dosing among patients with inflammatory conditions, that report on infections, skin manifestations, or both, were included. The risk of bias was assessed with the revised Cochrane risk-of bias tool (RCTs) or the Newcastle-Ottawa scale (non-RCTs).
    RESULTS: Fourteen RCTs and six observational studies (or 2706 patients) were included. Eight RCTs had low risk of bias or some concerns. Four non-RCTs were of good methodological quality. The studies described patients with axial spondyloarthritis (8 studies, 780 patients), rheumatoid arthritis (7 studies, 1458 patients), psoriasis (3 studies, 332 patients), or inflammatory bowel disease (2 studies, 136 patients). De-escalation strategies included interval lengthening (12 studies, 1317 patients), dose reduction (6 studies, 1130 patients), or both (2 studies, 259 patients). Overall, the occurrence of infections and skin manifestations did not differ between standard treatment and de-escalation. The disappearance of infections or skin manifestations after de-escalation was only reported in two studies. The majority of studies focused on etanercept and adalimumab. Heterogeneity in reporting of infections and skin manifestations precluded meta-analysis.
    CONCLUSIONS: We found that anti-TNF-α de-escalation does not reduce infections or skin reactions. A de-escalation strategy should not be recommended for the sole purpose of reducing drug-related adverse effects. The meticulous documentation of adverse effects is recommended to further address this question.
    BACKGROUND: PROSPERO CRD42021252977.
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  • 文章类型: Journal Article
    背景与目的:作为第二代表皮生长因子受体(EGFR)-酪氨酸激酶抑制剂,阿法替尼为常见和罕见EGFR突变患者带来生存益处.本研究采用定性和定量分析方法,比较30和40mg阿法替尼治疗非小细胞肺癌(NSCLC)的有效性和安全性,为临床用药提供参考。方法:PubMed,Embase,ClinicalTrials.gov,科克伦图书馆,中国国家知识基础设施,和万方数据库从成立到2021年2月26日进行了彻底搜索。两名研究人员独立筛选了文献,提取的数据,并评估了质量。采用RevMan和Stata15.0进行Meta分析。结果:选择了12项队列研究,包括1290例患者进行最终分析;其中,对1129名患者进行了分析以衡量有效性结果,并对470名患者进行了安全性结果分析。在非脑转移患者中,减量阿法替尼一线或二线治疗的无进展生存期与常规剂量相当.在安全方面,减少剂量可以显着降低严重腹泻和严重皮疹的发生率,但不是腹泻的总发病率,皮疹,和所有级别的甲沟炎。结论:30mg阿法替尼治疗非小细胞肺癌患者的严重不良反应发生率明显低于40mg阿法替尼。效果似乎与非脑转移患者相似。本研究为临床降低阿法替尼剂量提供参考。系统审查注册:[PROSPERO],标识符[CRD42021238043]。
    Background and Aim: As one of the second-generation epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors, afatinib brings survival benefits to patients with common and rare EGFR mutations. This study aimed to compare the effectiveness and safety of 30 and 40 mg of afatinib in patients with non-small cell lung cancer (NSCLC) using qualitative and quantitative analysis methods so as to provide reference for clinical medication. Methods: The PubMed, Embase, ClinicalTrials.gov, Cochrane Library, China National Knowledge Infrastructure, and WanFang databases were thoroughly searched from inception to February 26, 2021. Two researchers independently screened the literature, extracted data, and evaluated the quality. RevMan and Stata 15.0 were used for meta-analysis. Results: Twelve cohort studies including 1290 patients for final analysis were selected; of which, 1129 patients were analyzed to measure the effectiveness outcomes and 470 patients were analyzed for safety outcomes. In patients with non-brain metastasis, the progression-free survival of the first- or second-line treatment with reduced-dose afatinib was equivalent to the conventional dose. In terms of safety, the reduced dose could significantly lower the incidence of severe diarrhea and severe rash, but not the total incidence of diarrhea, rash, and all levels of paronychia. Conclusions: The incidence of common serious adverse reactions was significantly lower with 30 mg of afatinib than with 40 mg of afatinib in patients with NSCLC. The effectiveness appeared to be similar to that in patients with non-brain metastasis. This study provides a reference for clinical dose reduction of afatinib. Systematic Review Registration: [PROSPERO], identifier [CRD42021238043].
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