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Impact of hormone replacement therapy on all-cause and cancer-specific mortality in colorectal cancer: A systematic review and dose‒response meta-analysis of observational studies. 激素替代疗法对结直肠癌全因死亡率和癌症特异性死亡率的影响:观察性研究的系统回顾和剂量反应荟萃分析。
IF 3.6 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-06-01 Epub Date: 2024-06-20 DOI: 10.1111/jebm.12622
Kefeng Liu, Yazhou He, Qiong Li, Shusen Sun, Zubing Mei, Jie Zhao

Objective: The effect of hormone replacement therapy (HRT) on colorectal cancer (CRC) mortality and all-cause mortality remains unclear. We conducted a systematic review and dose-response meta-analysis to determine the effects of HRT on CRC mortality and all-cause mortality.

Methods: We searched the electronic databases of PubMed, Embase, and The Cochrane Library for all relevant studies published until January 2024 to investigate the effects of HRT exposure on survival rates for patients with CRC. Two reviewers independently extracted individual study data and evaluated the risk of bias between the studies using the Newcastle‒Ottawa Scale. We performed a two-stage random-effects dose-response meta-analysis to examine a possible nonlinear relationship between the year of HRT use and CRC mortality.

Results: Ten cohort studies with 480,628 individuals were included. HRT was inversely associated with the risk of CRC mortality (hazard ratios (HR) = 0.77, 95% CI (0.68, 0.87), I2 = 69.5%, p < 0.05). The pooled results of seven cohort studies revealed a significant association between HRT and the risk of all-cause mortality (HR = 0.71, 95% CI (0.54, 0.92), I2 = 89.6%, p < 0.05). A linear dose-response analysis (p for nonlinearity = 0.34) showed a 3% decrease in the risk of CRC for each additional year of HRT use; this decrease was significant (HR = 0.97, 95% CI (0.94, 0.99), p < 0.05). An additional linear (p for nonlinearity = 0.88) dose-response analysis showed a nonsignificant decrease in the risk of all-cause mortality for each additional year of HRT use.

Conclusions: This study suggests that the use of HRT is inversely associated with all-cause and colorectal cancer mortality, thus causing a significant decrease in mortality rates over time. More studies are warranted to confirm this association.

目的:激素替代疗法(HRT)对结直肠癌(CRC)死亡率和全因死亡率的影响仍不清楚。我们进行了一项系统综述和剂量反应荟萃分析,以确定激素替代疗法对 CRC 死亡率和全因死亡率的影响:我们在 PubMed、Embase 和 Cochrane 图书馆的电子数据库中检索了 2024 年 1 月之前发表的所有相关研究,研究内容是探讨接触 HRT 对 CRC 患者生存率的影响。两名审稿人独立提取了单个研究数据,并使用纽卡斯尔-渥太华量表评估了研究之间的偏倚风险。我们进行了两阶段随机效应剂量反应荟萃分析,以研究使用 HRT 的年份与 CRC 死亡率之间可能存在的非线性关系:结果:共纳入了 10 项队列研究,涉及 480628 人。HRT与CRC死亡风险成反比(危险比(HR)=0.77,95% CI(0.68,0.87),I2=69.5%,P 2=89.6%,P 结论:HRT与CRC死亡风险成反比:本研究表明,使用 HRT 与全因死亡率和结直肠癌死亡率成反比,从而使死亡率随着时间的推移显著下降。需要进行更多的研究来证实这种关联。
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引用次数: 0
Rapid review: A review of methods and recommendations based on current evidence. 快速审查:基于现有证据的方法和建议回顾。
IF 3.6 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-06-01 Epub Date: 2024-03-21 DOI: 10.1111/jebm.12594
Qiong Guo, Guiyu Jiang, Qingwen Zhao, Youlin Long, Kun Feng, Xianlin Gu, Yihan Xu, Zhengchi Li, Jin Huang, Liang Du

Rapid review (RR) could accelerate the traditional systematic review (SR) process by simplifying or omitting steps using various shortcuts. With the increasing popularity of RR, numerous shortcuts had emerged, but there was no consensus on how to choose the most appropriate ones. This study conducted a literature search in PubMed from inception to December 21, 2023, using terms such as "rapid review" "rapid assessment" "rapid systematic review" and "rapid evaluation". We also scanned the reference lists and performed citation tracking of included impact studies to obtain more included studies. We conducted a narrative synthesis of all RR approaches, shortcuts and studies assessing their effectiveness at each stage of RRs. Based on the current evidence, we provided recommendations on utilizing certain shortcuts in RRs. Ultimately, we identified 185 studies focusing on summarizing RR approaches and shortcuts, or evaluating their impact. There was relatively sufficient evidence to support the use of the following shortcuts in RRs: limiting studies to those published in English-language; conducting abbreviated database searches (e.g., only searching PubMed/MEDLINE, Embase, and CENTRAL); omitting retrieval of grey literature; restricting the search timeframe to the recent 20 years for medical intervention and the recent 15 years for reviewing diagnostic test accuracy; conducting a single screening by an experienced screener. To some extent, the above shortcuts were also applicable to SRs. This study provided a reference for future RR researchers in selecting shortcuts, and it also presented a potential research topic for methodologists.

快速综述(RR)可以利用各种捷径简化或省略步骤,从而加快传统的系统综述(SR)过程。随着 RR 的日益普及,出现了许多捷径,但如何选择最合适的捷径却没有达成共识。本研究使用 "快速综述"、"快速评估"、"快速系统综述 "和 "快速评价 "等术语在 PubMed 上进行了文献检索,检索时间从开始到 2023 年 12 月 21 日。我们还扫描了参考文献目录,并对纳入的影响研究进行了引文追踪,以获得更多的纳入研究。我们对所有 RR 方法、捷径以及评估其在 RR 各阶段有效性的研究进行了叙述性综合。根据现有证据,我们提出了在 RR 中使用某些捷径的建议。最终,我们确定了 185 项研究,重点是总结 RR 方法和捷径,或评估其影响。相对而言,有足够的证据支持在RR中使用以下捷径:仅限于以英文发表的研究;进行简略的数据库检索(如仅检索PubMed/MEDLINE、Embase和CENTRAL);省略灰色文献检索;将医疗干预的检索时间限制在最近20年,将诊断测试准确性的审查时间限制在最近15年;由经验丰富的筛选员进行单一筛选。在某种程度上,上述捷径也适用于SR。本研究为未来的 RR 研究人员选择捷径提供了参考,同时也为方法学家提出了一个潜在的研究课题。
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引用次数: 0
Reconciling conflicting evidence in the evaluation of the MitraClip system: Assessment of and response to the MITRA-FR and COAPT trials by key stakeholders. 调和 MitraClip 系统评估中相互矛盾的证据:主要利益相关者对 MITRA-FR 和 COAPT 试验的评估和回应。
IF 3.6 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-06-01 Epub Date: 2024-05-24 DOI: 10.1111/jebm.12614
Manuela Montagnon, Yenfu Chen, Amy Grove, Jieun Park, Jean-François Obadia, Xavier Armoiry
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引用次数: 0
Expert-guided evaluation of medical research may promote publishing low-quality studies and increase research waste: A comparative analysis of Journal Impact Factor and Polish expert-based journal ranking list. 专家指导下的医学研究评估可能会促进低质量研究的发表并增加研究浪费:期刊影响因子与波兰专家期刊排名榜的比较分析》。
IF 3.6 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-06-01 Epub Date: 2024-06-21 DOI: 10.1111/jebm.12615
Albert Stachura, Łukasz Banaszek, Paweł K Włodarski
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引用次数: 0
Five aspects of research waste in biomedicine: A scoping review. 生物医学研究浪费的五个方面:范围审查。
IF 3.6 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-06-01 Epub Date: 2024-05-26 DOI: 10.1111/jebm.12616
Louise Olsbro Rosengaard, Mikkel Zola Andersen, Jacob Rosenberg, Siv Fonnes

Background: The number of published journal articles has grown exponentially during the last 30 years, which may have led to some wasteful research. However, the terminology associated with research waste remains unclear. To address this, we aimed to identify, define, and categorize the aspects of research waste in published biomedical reports.

Methods: In this scoping review, we systematically searched for biomedical literature reports from 1993 to 2023 in two databases, focusing on those addressing and defining research waste. Through data charting, we analyzed and categorized the aspects of research waste.

Results: Based on 4285 initial records in the searches, a total of 832 reports were included in the analysis. The included reports were primarily narrative reviews (26%) and original reports (21%). We categorized research waste into five aspects: methodological, invisible, negligible, underreported, and structural (MINUS) research waste. More than half of the reports (56%) covered methodological research waste concerning flaws in study design, study conduct, or analysis. Invisible research waste covered nonpublication, discontinuation, and lack of data-sharing. Negligible research waste primarily concerned unnecessary repetition, for example, stemming from the absence of preceding a trial with a systematic review of the literature. Underreported research waste mainly included poor reporting, resulting in a lack of transparency. Structural research waste comprised inadequate management, collaboration, prioritization, implementation, and dissemination.

Conclusion: MINUS encapsulates the five main aspects of research waste. Recognizing these aspects of research waste is important for addressing and preventing further research waste and thereby ensuring efficient resource allocation and scientific integrity.

背景:在过去 30 年里,期刊论文的发表数量呈指数级增长,这可能导致了一些研究的浪费。然而,与研究浪费相关的术语仍不明确。为了解决这个问题,我们旨在对已发表的生物医学报告中研究浪费的各个方面进行识别、定义和分类:在此次范围界定综述中,我们在两个数据库中系统地搜索了 1993 年至 2023 年的生物医学文献报告,重点关注那些涉及和定义研究浪费的报告。通过数据图表,我们对研究浪费的各个方面进行了分析和分类:结果:根据搜索的 4285 条初始记录,共有 832 篇报告被纳入分析。纳入的报告主要是叙事性综述(26%)和原创性报告(21%)。我们将研究浪费分为五个方面:方法性研究浪费、隐形研究浪费、可忽略不计的研究浪费、报告不足的研究浪费和结构性研究浪费(MINUS)。一半以上的报告(56%)涉及方法论研究浪费,包括研究设计、研究实施或分析中的缺陷。隐形研究浪费包括未发表、中止和缺乏数据共享。可忽略不计的研究浪费主要涉及不必要的重复,例如,在试验之前没有对文献进行系统回顾。未充分报告的研究浪费主要包括报告不充分,导致缺乏透明度。结构性研究浪费包括管理不足、合作不足、优先次序安排不足、实施不足和传播不足:MINUS 囊括了研究浪费的五个主要方面。认识到研究浪费的这些方面对于解决和防止进一步的研究浪费,从而确保有效的资源分配和科学诚信非常重要。
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引用次数: 0
Diagnosis and management of inflammatory bowel disease. 炎症性肠病的诊断和治疗。
IF 3.6 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-06-01 Epub Date: 2024-06-27 DOI: 10.1111/jebm.12626
Lili Li, Rui Cheng, Yushan Wu, Hao Lin, Huatian Gan, Hu Zhang

Inflammatory bowel disease (IBD) is a chronic and relapsing immune-mediated disease of the gastrointestinal tract with a gradually increasing global incidence and prevalence. A prolonged course of IBD leads to a decline in patient quality of life and the creation of a substantial economic burden on society. Owing to the lack of specific diagnostic markers, the diagnosis of IBD still needs a gold standard based on a combination of clinical manifestations, imaging, laboratory, and endoscopic results. Accordingly, the current goals of IBD treatment are to alleviate clinical symptoms and reduce recurrence rates. Therefore, it is imperative to develop a standard set of procedures to diagnose and treat IBD. In this review, we summarize prominent and emerging studies, outline classical and contemporary approaches to diagnosing and managing IBD, and integrate multiple guidelines. Furthermore, we propose the possibility of establishing an early and comprehensive diagnostic workflow and personalized management strategy in the future. We aim to enhance the quality and standardization of diagnostic and treatment procedures for IBD.

炎症性肠病(IBD)是一种由免疫介导的慢性、复发性胃肠道疾病,在全球的发病率和流行率逐渐上升。IBD 病程长会导致患者生活质量下降,并给社会造成巨大的经济负担。由于缺乏特异性诊断标志物,IBD 的诊断仍然需要一个基于临床表现、影像学、实验室和内镜检查结果相结合的金标准。因此,目前 IBD 治疗的目标是缓解临床症状和降低复发率。因此,制定一套诊断和治疗 IBD 的标准程序势在必行。在这篇综述中,我们总结了著名的和新出现的研究,概述了诊断和治疗 IBD 的经典和现代方法,并整合了多种指南。此外,我们还提出了未来建立早期综合诊断工作流程和个性化管理策略的可能性。我们的目标是提高 IBD 诊断和治疗程序的质量和标准化。
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引用次数: 0
The fate of rejected manuscripts in different biomedical disciplines. 不同生物医学学科的退稿命运。
IF 3.6 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-06-01 Epub Date: 2024-06-06 DOI: 10.1111/jebm.12617
Clovis M Faggion, Max C Menne
{"title":"The fate of rejected manuscripts in different biomedical disciplines.","authors":"Clovis M Faggion, Max C Menne","doi":"10.1111/jebm.12617","DOIUrl":"10.1111/jebm.12617","url":null,"abstract":"","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141260277","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Real-world experience of Fuzheng Yiqing granule as chemoprophylaxis against COVID-19 infection among close contacts: A prospective cohort study. 将扶正益青颗粒作为预防密切接触者感染 COVID-19 的化学预防药物的实际经验:前瞻性队列研究。
IF 3.6 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-06-01 Epub Date: 2024-04-09 DOI: 10.1111/jebm.12591
Qianzi Che, Ruili Huo, Chen Zhao, Wei Yang, Xinghua Xiang, Shihuan Tang, Jiaheng Shi, Cheng Lu, Hongmei Li, Luqi Huang

Background: The objective of the current study was to evaluate whether the use of traditional Chinese medicine, Fuzheng Yiqing granule (FZYQG), was associated with a reduced infection risk of COVID-19 in close contacts.

Research design and methods: This was a prospective cohort study across 203 quarantine centres for close contacts and secondary contacts of COVID-19 patients in Yangzhou city. FZYQG group was defined as quarantined individuals who voluntarily took FZYQG; control group did not take FZYQG. The primary outcome was the coronavirus test positive rate during quarantine period. Logistic regression with propensity score inverse probability weighting was used for adjusted analysis to evaluate independent association between FZYQG and test positive rate.

Results: From July 13, 2021 to September 30, 2021, 3438 quarantined individuals took FZYQG and 2248 refused to take the granule. Test positive rate was significantly lower among quarantined individuals who took FZYQG (0.29% vs. 1.73%, risk ratio 0.17, 95% confidence interval (CI): 0.08-0.34, p < 0.001). On logistic regression, odds for test positive were decreased in FZYQG group (odds ratio: 0.16, 95% CI: 0.08-0.32, p < 0.001).

Conclusions: Close and secondary contacts of COVID-19 patients who received FZYQG had a lower test positive rate than control individuals in real-world experience.

Trial registration: This study has been registered on Chinese Clinical Trial Registry (ChiCTR2100049590) on August 5, 2021.

研究背景本研究旨在评估使用中药扶正益青颗粒(FZYQG)是否与降低密切接触者感染COVID-19的风险有关:这是一项前瞻性队列研究,涉及扬州市203个COVID-19患者密切接触者和二次接触者检疫中心。FZYQG组定义为自愿服用FZYQG的被隔离者;对照组不服用FZYQG。主要结果是检疫期间冠状病毒检测阳性率。采用倾向得分反概率加权的逻辑回归进行调整分析,以评估 FZYQG 与检测阳性率之间的独立关联:从 2021 年 7 月 13 日至 2021 年 9 月 30 日,3438 名被检疫者服用了 FZYQG,2248 名被检疫者拒绝服用颗粒剂。服用 FZYQG 的被检疫者检测阳性率明显降低(0.29% vs. 1.73%,风险比 0.17,95% 置信区间 (CI):0.08-0.34,P 结论:COVID 密切接触者和二次接触者的检测阳性率明显降低:在真实世界中,接受FZYQG治疗的COVID-19患者的密切接触者和二次接触者的检测阳性率低于对照组:本研究已于2021年8月5日在中国临床试验注册中心注册(ChiCTR2100049590)。
{"title":"Real-world experience of Fuzheng Yiqing granule as chemoprophylaxis against COVID-19 infection among close contacts: A prospective cohort study.","authors":"Qianzi Che, Ruili Huo, Chen Zhao, Wei Yang, Xinghua Xiang, Shihuan Tang, Jiaheng Shi, Cheng Lu, Hongmei Li, Luqi Huang","doi":"10.1111/jebm.12591","DOIUrl":"10.1111/jebm.12591","url":null,"abstract":"<p><strong>Background: </strong>The objective of the current study was to evaluate whether the use of traditional Chinese medicine, Fuzheng Yiqing granule (FZYQG), was associated with a reduced infection risk of COVID-19 in close contacts.</p><p><strong>Research design and methods: </strong>This was a prospective cohort study across 203 quarantine centres for close contacts and secondary contacts of COVID-19 patients in Yangzhou city. FZYQG group was defined as quarantined individuals who voluntarily took FZYQG; control group did not take FZYQG. The primary outcome was the coronavirus test positive rate during quarantine period. Logistic regression with propensity score inverse probability weighting was used for adjusted analysis to evaluate independent association between FZYQG and test positive rate.</p><p><strong>Results: </strong>From July 13, 2021 to September 30, 2021, 3438 quarantined individuals took FZYQG and 2248 refused to take the granule. Test positive rate was significantly lower among quarantined individuals who took FZYQG (0.29% vs. 1.73%, risk ratio 0.17, 95% confidence interval (CI): 0.08-0.34, p < 0.001). On logistic regression, odds for test positive were decreased in FZYQG group (odds ratio: 0.16, 95% CI: 0.08-0.32, p < 0.001).</p><p><strong>Conclusions: </strong>Close and secondary contacts of COVID-19 patients who received FZYQG had a lower test positive rate than control individuals in real-world experience.</p><p><strong>Trial registration: </strong>This study has been registered on Chinese Clinical Trial Registry (ChiCTR2100049590) on August 5, 2021.</p>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140870419","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Comparation of fixed-ratio (IDegLira and iGlarLixi) versus free combination of basal insulin and glucagon-like peptide-1 receptor agonist for uncontrolled type 2 diabetes: A systematic review and network meta-analysis. 固定比例(IDegLira 和 iGlarLixi)与基础胰岛素和胰高血糖素样肽-1 受体激动剂自由组合治疗不受控制的 2 型糖尿病的比较:系统综述和网络荟萃分析。
IF 3.6 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-06-01 Epub Date: 2024-06-10 DOI: 10.1111/jebm.12620
Junling Weng, Ying Tao, Zian Xu, Shanyan Zhou, Dunming Xiao, Zhixu Zhu, Ruizhi Zheng, Yi Yang, Yingyao Chen

Objective: This study aimed to evaluate the safety and efficacy of the fixed-ratio combination (FRC) and free combination of basal insulin and glucagon-like peptide-1 receptor agonist (GLP-1RA) in patients with type 2 diabetes mellitus (T2DM).

Methods: PubMed, Web of Science, Embase, The Cochrane Library, and four Chinese databases were searched for relevant studies from inception to April 13, 2023. Phase III clinical trials involving FRC or free combination in patients with uncontrolled T2DM were included. A network meta-analysis (NMA) was used to evaluate the effects of FRC and free combination. The Cochrane Collaboration's tool was used to evaluate the risk-of-bias. The primary outcomes were changes in hemoglobin A1c (HbA1c), body weight, and incident hypoglycemia. Secondary outcomes included changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP). This study was registered with PROSPERO (CRD42023409585).

Results: Forty-two trials with 23,619 patients were included in the NMA, and treatments were categorized as FRC, free combination and NOINSGLP (neither FRC nor free combination). The forest plots revealed comparable HbA1c control (mean difference (MD) = 0.07%, 95% confidence interval (CI): -0.17 to -0.30) between free combination and FRC. However, there were significant differences in the body weight (MD = -2.06 kg; 95% CI: -3.34 to -0.77), SBP (MD = -1.22 mmHg; 95% CI: -2.41 to -0.04), and DBP (MD = -1.09 mmHg; 95% CI: -1.94 to -0.24) between the two groups.

Conclusions: In patients with uncontrolled T2DM, the safety and efficacy of FRC and free combination therapy were comparable. The use of FRC is justifiable in patients requiring free combination.

研究目的本研究旨在评估基础胰岛素和胰高血糖素样肽-1 受体激动剂(GLP-1RA)固定比例组合(FRC)和自由组合在 2 型糖尿病(T2DM)患者中的安全性和有效性:检索了 PubMed、Web of Science、Embase、The Cochrane Library 和四个中文数据库中从开始到 2023 年 4 月 13 日的相关研究。研究纳入了针对未受控制的 T2DM 患者的 FRC 或自由组合的 III 期临床试验。采用网络荟萃分析(NMA)评估 FRC 和自由联合用药的效果。Cochrane 协作组织的工具用于评估偏倚风险。主要结果是血红蛋白 A1c (HbA1c)、体重和低血糖事件的变化。次要结果包括收缩压(SBP)和舒张压(DBP)的变化。本研究已在 PROSPERO(CRD42023409585)注册:42项试验共23619名患者被纳入NMA,治疗方法分为FRC、自由组合和NOINSGLP(既非FRC也非自由组合)。森林图显示,自由联合疗法与自由联合疗法的 HbA1c 控制率相当(平均差 (MD) = 0.07%,95% 置信区间 (CI):-0.17 至 -0.30)。然而,两组患者的体重(MD = -2.06 kg;95% CI:-3.34 至 -0.77)、SBP(MD = -1.22 mmHg;95% CI:-2.41 至 -0.04)和 DBP(MD = -1.09 mmHg;95% CI:-1.94 至 -0.24)存在显著差异:结论:在未得到控制的 T2DM 患者中,FRC 和自由联合疗法的安全性和有效性相当。对于需要自由联合疗法的患者,使用 FRC 是合理的。
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引用次数: 0
Effectiveness of narrowband ultraviolet B monotherapy versus combination therapy with systemic agents in patients with early-stage mycosis fungoides and the association with plaque lesions. 窄带紫外线 B 单药治疗与全身用药联合治疗对早期真菌病患者的疗效以及与斑块病变的关系。
IF 3.6 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-06-01 Epub Date: 2024-06-19 DOI: 10.1111/jebm.12623
Yao Qin, Yuwei Lin, Zhuojing Chen, Qiuli Zhang, Yingyi Li, Yujie Wen, Ping Tu, Pei Gao, Yang Wang

Objective: Narrowband ultraviolet B (NB-UVB) has been recommended as first-line therapy for early-stage mycosis fungoides (MF) in international guidelines. NB-UVB can be used as monotherapy or part of a multimodality treatment regimen. There is limited evidence on the effectiveness and optimal patients of NB-UVB in combination with systemic therapies in MF. We aimed to assess the effectiveness of the combination versus NB-UVB monotherapy in early-stage MF and if plaque lesion status was related to these effects.

Methods: This observational cohort study included 247 early-stage MF patients who had received NB-UVB combined with systemic therapies vs. NB-UVB monotherapy from 2009 to 2021. The primary outcome was partial or complete response. Overall response rate and median time to response were calculated. Hazard ratios (HRs) were estimated using the Cox model.

Results: In 139 plaque-stage patients, the response rate for combination therapy group was higher than that of monotherapy group (79.0% vs. 54.3%, p = 0.006). The adjusted HR for combination therapy compared with NB-UVB monotherapy was 3.11 (95% CI 1.72-5.63). The combination therapy group also showed shorter time to response (4 vs. 6 months, p = 0.002). In 108 patch-stage patients, the response rate and time to response in two treatment groups showed no significant difference. There was therefore an observed interaction with patients' plaque lesion status for the effect size of NB-UVB combination therapy. No serious adverse events were observed.

Conclusions: Adding systemic treatments to NB-UVB did not improve the treatment outcome of patch-stage patients, but it surpassed NB-UVB monotherapy for early-stage patients with plaques.

目的:窄带紫外线 B(NB-UVB)已被国际指南推荐为早期真菌病(MF)的一线疗法。窄带紫外线 B 可作为单一疗法使用,也可作为多模式治疗方案的一部分。关于 NB-UVB 与系统疗法联合治疗霉菌性真菌病的有效性和最佳患者的证据有限。我们旨在评估联合治疗与 NB-UVB 单药治疗对早期 MF 的疗效,以及斑块病变状态是否与这些疗效相关:这项观察性队列研究纳入了2009年至2021年期间接受NB-UVB联合系统疗法与NB-UVB单药治疗的247名早期MF患者。主要结果为部分或完全应答。计算总反应率和中位反应时间。使用 Cox 模型估算了危险比(HRs):在139例斑块期患者中,联合疗法组的应答率高于单一疗法组(79.0% vs. 54.3%,P = 0.006)。与 NB-UVB 单一疗法相比,联合疗法的调整 HR 为 3.11(95% CI 1.72-5.63)。联合疗法组的反应时间也更短(4 个月对 6 个月,P = 0.002)。在 108 例斑贴期患者中,两个治疗组的反应率和反应时间没有明显差异。因此,NB-UVB联合疗法的效果大小与患者的斑块病变状态存在相互作用。未观察到严重不良事件:结论:在NB-UVB基础上增加全身治疗并不能改善斑块期患者的治疗效果,但对于早期斑块期患者来说,其效果优于NB-UVB单药治疗。
{"title":"Effectiveness of narrowband ultraviolet B monotherapy versus combination therapy with systemic agents in patients with early-stage mycosis fungoides and the association with plaque lesions.","authors":"Yao Qin, Yuwei Lin, Zhuojing Chen, Qiuli Zhang, Yingyi Li, Yujie Wen, Ping Tu, Pei Gao, Yang Wang","doi":"10.1111/jebm.12623","DOIUrl":"10.1111/jebm.12623","url":null,"abstract":"<p><strong>Objective: </strong>Narrowband ultraviolet B (NB-UVB) has been recommended as first-line therapy for early-stage mycosis fungoides (MF) in international guidelines. NB-UVB can be used as monotherapy or part of a multimodality treatment regimen. There is limited evidence on the effectiveness and optimal patients of NB-UVB in combination with systemic therapies in MF. We aimed to assess the effectiveness of the combination versus NB-UVB monotherapy in early-stage MF and if plaque lesion status was related to these effects.</p><p><strong>Methods: </strong>This observational cohort study included 247 early-stage MF patients who had received NB-UVB combined with systemic therapies vs. NB-UVB monotherapy from 2009 to 2021. The primary outcome was partial or complete response. Overall response rate and median time to response were calculated. Hazard ratios (HRs) were estimated using the Cox model.</p><p><strong>Results: </strong>In 139 plaque-stage patients, the response rate for combination therapy group was higher than that of monotherapy group (79.0% vs. 54.3%, p = 0.006). The adjusted HR for combination therapy compared with NB-UVB monotherapy was 3.11 (95% CI 1.72-5.63). The combination therapy group also showed shorter time to response (4 vs. 6 months, p = 0.002). In 108 patch-stage patients, the response rate and time to response in two treatment groups showed no significant difference. There was therefore an observed interaction with patients' plaque lesion status for the effect size of NB-UVB combination therapy. No serious adverse events were observed.</p><p><strong>Conclusions: </strong>Adding systemic treatments to NB-UVB did not improve the treatment outcome of patch-stage patients, but it surpassed NB-UVB monotherapy for early-stage patients with plaques.</p>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141427034","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
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