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Transanal total mesorectal excision in the era of robotic surgery 机器人手术时代的经肛门全肠系膜切除术
IF 35.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-03-23 DOI: 10.1016/s2468-1253(26)00075-0
Patricia Sylla
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引用次数: 0
Long-term progression of steatotic liver disease: multiple drivers of the same disease? 脂肪变性肝病的长期进展:同一疾病的多重驱动因素?
IF 35.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-03-23 DOI: 10.1016/s2468-1253(26)00086-5
Helena Cortez-Pinto
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引用次数: 0
Transanal total mesorectal excision versus laparoscopic total mesorectal excision for mid and low rectal cancer (COLOR III): short-term outcomes of an international, multicentre, phase 3, randomised, controlled, non-inferiority trial 经肛门全肠系膜切除术与腹腔镜全肠系膜切除术治疗中低位直肠癌(COLOR III):一项国际、多中心、3期、随机、对照、非效性试验的短期结果
IF 35.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-03-23 DOI: 10.1016/s2468-1253(26)00022-1
Jurriaan B Tuynman, Hongwei Yao, Laura R Moolenaar, Colin Sietses, Roel Hompes, Felix Aigner, Antonio Caycedo–Marulanda, Chien-Chih Chen, Muneer Deeb, Pascal G Doornebosch, Bo Feng, Chi-Chung Foo, Alois Fürst, Masaaki Ito, Francisco B de Lacy, Pedro Leão, Justin A Maykel, Andrea Muratore, Stefan E van Oostendorp, Sung Chan Park, Michał Pędziwiatr, MingYang Ren, Gerald Seitinger, Hein B A C Stockmann, Aaldert K Talsma, Andreas Türler, Weidong Tong, Quan Wang, Qing Xu, Hongyu Zhang, Jan-Hein T M van Waesberghe, Mahsoem Ali, Jos W R Twisk, Zhongtao Zhang, Antonio M de Lacy, George B Hanna, Hendrik J Bonjer, Muneer Deeb, Mahsoem Ali, Jaap Bonjer, Charlotte Deijen, Roel Hompes, Thomas Koedam, Wytze Lameris, Annabel van Lieshout, Linda Mol, Laura Moolenaar, Stefan van Oostendorp, Jurriaan Tuynman, Jos Twisk, Jan-Hein van Waesberghe, Bin Huang, Feifei Huang, Zhigang Ke, Fan Li, Xiaoli Ran, Yue Tian, Weidong Tong, Li Wang, Xiangfeng Wang, Guodong Xiao, Liyang Yao, Jingwang Ye, Huichao Zheng, Yongbo An, Jiale Gao, Jianning Song, Pengyu Wei, Guocong Wu, Zhengyang Yang, Hongwei Yao, Zhongtao Zhang, Pedro Leão, Maria Sousa, Marion Brunner, Arthur Heiligensetzer, Peter Sauer, Alois Fürst, Vinzenz Völkel, Matthias Biebl, Luca Dittrich, Rosa Schmuck, Robbert Bosker, Koen Talsma, Andrea Muratore, Patrizia Marsanic, Gabie de Jong, Guusje Vughs, Colin Sietses, Antonio Caycedo-Marulanda, Sanjiv Mathur, Pamela Leduc, Raquel Bravo, Marlene Caldera, Yoelimar Guzmán, Francisco Borja de Lacy, Antonio María de Lacy, Ana Otero, Miguel Pera, Pascal Doornebosch, Maarten Vermaas, Michal Pędziwiatr, Andreas Türler, Haug-Lambert Loriz, Chien-Chih Chen, Chun-Ho Chu, Felix Aigner, Gabriele Moitzi, Richard Stadler, Gerald Seitinger, Qing Guo, MingYang Ren, Qing Teng, Dongbing Zhou, Sung Chan Park, Masaaki Ito, Hiro Hasegawa, Chi Chung Foo, Abraham Man, Lei Gu, Qing Xu, Batuer Aikemu, Bo Feng, Zhenghao Cai, Haiqin Song, Minhua Zheng, Ronald Vuylsteke, Hein Stockmann, Hou-Hsuan Cheng, Jeng-Kai Jiang, Chung-Chi Lin, Hung-Hsin Lin, Yinggang Ge, Xingye Wu, Xiang Xu, Hongyu Zhang, Liang He, Yuchen Guo, Yang Gong, Quan Wang, Karim Alavi, Justin Maykel, Paul Sturrock, Jingjing He
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引用次数: 0
Binge drinking, metabolic dysfunction, and the spectrum of steatotic liver disease in the USA: a cross-sectional and longitudinal analysis 在美国,酗酒、代谢功能障碍和脂肪变性肝病的频谱:横断面和纵向分析
IF 35.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-03-23 DOI: 10.1016/s2468-1253(25)00376-0
Zobair M Younossi, Aleksander Krag, Shira Zelber-Sagi, Markos Kalligeros, Marco Arrese, Luis Antonio Diaz, Juan Pablo Arab, Ashwani K Singal, Mario G Pessoa, Robert J Wong, Javier Crespo, Maja Thiele, Ajay Duseja, C Wendy Spearman, Mohamed El-Kassas, Yusuf Yilmaz, Jiangao Fan, Laurent Castera, Frank Tacke, Vincent Wai-Sun Wong, Michael Betel, Andrei Racila, Ariana Nader, Gabriella Y Paik, Dana Ivancovsky Wajcman, Laura Sol Grinshpan, Linda Henry, Yuchiro Eguichi, Janus P Ong, Fatema Nader, Saleh A Alqahtani, James M Paik
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引用次数: 0
Indocyanine green fluorescence angiography for anastomotic perfusion assessment in colorectal surgery: a systematic review with meta-analysis, meta-regression, and trial sequential analyses 吲哚菁绿荧光血管造影用于结直肠手术吻合口灌注评估:荟萃分析、荟萃回归和试验序列分析的系统综述
IF 35.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-03-20 DOI: 10.1016/s2468-1253(25)00373-5
Éanna J Ryan, Odhrán K Ryan, Neil Corrigan, Gemma Ainsworth, Denise E Hilling, Alexander L Vahrmeijer, Jyrki Kössi, Jun Watanabe, David Jayne, Ronan A Cahill
<h3>Background</h3>Anastomotic leak is a serious complication in colorectal surgery. Indocyanine green fluorescence angiography (ICGFA) is an adjunctive digital method of assessing bowel perfusion intraoperatively. We assessed whether ICGFA use during surgery reduces postoperative anastomotic leak exclusively using data from randomised controlled trials (RCTs).<h3>Methods</h3>In this systematic review and meta-analysis, we searched PubMed, ScienceDirect, Scopus, Web of Science, Embase, and the Cochrane Collaboration databases from inception to July 19, 2025, for English-language RCTs comparing additive intraoperative ICGFA with standard surgeon perfusion assessment alone in patients undergoing colorectal resection with primary anastomosis according to prespecified criteria and PRISMA guidelines. Summary-level data were extracted by two reviewers. The primary outcome was overall anastomotic leak rate. The Jadad scale (Oxford quality scoring system) was used to assess trial quality, the Cochrane Risk of Bias (RoB 2) tool for RCTs was used to assess risk of bias, and GRADE was used to assess strength of evidence. Meta-regression and trial sequential analyses were performed. This study is registered with PROSPERO, CRD420250652639.<h3>Findings</h3>719 records were initially identified, with 387 remaining after screening and 184 sought for full eligibility screening, of which nine were eligible RCTs (with 4754 patients) for analysis. ICGFA significantly reduced overall anastomotic leak (risk ratio 0·66 [95% CI 0·56–0·78], p<0·0001; number needed to treat [NNT]=24), with trial sequential analysis showing that the required information size (2183) was exceeded overall. ICGFA reduced both anastomotic leak requiring intervention (risk ratio 0·73 [95% CI 0·60–0·89], p=0·0020; NNT=39) and anastomotic leak not requiring intervention (0·48 [0·31–0·72], p=0·0004, NNT=35). Significant benefit was observed for left-sided resections (risk ratio 0·62 [95% CI 0·51–0·74], p<0·0001; NNT=19), rectal resections (0·62 [0·51–0·76], p<0·0001; NNT=19), and low anterior resections (0·62 [0·48–0·79], p<0·0001; NNT=13), in which the required information size was also exceeded, but not for right-sided resections. In the meta-regression analysis, among all tested covariates, only patient BMI significantly modified the ICGFA treatment effect, with an increasing protective effect with increasing BMI (coefficient –0·0153 [95% CI –0·0251 to –0·0056], p=0·0020). Evidence was graded as high certainty for overall, left-sided, rectal, asymptomatic, and 30-day anastomotic leaks, and moderate certainty for clinically significant anastomotic leak.<h3>Interpretation</h3>Intraoperative use of ICGFA reduces anastomotic leak rates in left-sided and rectal colorectal resections. Given the evidence available now, further general efficacy trials are no longer required and research should shift to implementation and defined targeted subgroup ICGFA role definition (ie, in non-rectal left
背景:吻合口瘘是结直肠手术中一种严重的并发症。吲哚菁绿荧光血管造影(ICGFA)是一种辅助的数字方法评估肠灌注术中。我们仅使用随机对照试验(RCTs)的数据来评估手术中使用ICGFA是否能减少术后吻合口漏。方法在本系统综述和荟萃分析中,我们检索了PubMed、ScienceDirect、Scopus、Web of Science、Embase和Cochrane Collaboration数据库,检索了从成立到2025年7月19日的英文随机对照试验,比较术中添加ICGFA和标准外科医生单独灌注评估在结肠直肠癌切除术中进行初级吻合的患者中按照预先指定的标准和PRISMA指南。摘要级数据由两名审稿人提取。主要观察结果为吻合口总漏率。采用Jadad量表(牛津质量评分系统)评估试验质量,采用Cochrane rct偏倚风险(RoB 2)工具评估偏倚风险,采用GRADE评估证据强度。进行meta回归和试验序列分析。本研究已注册:PROSPERO, CRD420250652639。最初确定了719个记录,筛选后剩余387个记录,184个记录进行了完全合格筛选,其中9个是符合条件的rct(4754例患者)进行分析。ICGFA显著降低整体吻合口漏(风险比0.66 [95% CI 0.56 - 0.78], p< 0.0001;需要治疗的人数[NNT]=24),试验序贯分析显示总体超过所需信息大小(2183)。ICGFA降低了需要干预的吻合口瘘(风险比0.73 [95% CI 0.60 - 0.89], p= 0.0020; NNT=39)和不需要干预的吻合口瘘(风险比0.48 [0.31 - 0.72],p= 0.0004, NNT=35)。左侧切除术(风险比0.62 [95% CI 0.51 - 0.74], p< 0.0001; NNT=19)、直肠切除术(风险比0.62 [0.51 - 0.76],p< 0.0001; NNT=19)和前低位切除术(风险比0.62 [0.48 - 0.79],p< 0.0001; NNT=13)也有显著的获益,其中所需的信息大小也超过了,但右侧切除术没有。在meta回归分析中,在所有检验的协变量中,只有患者BMI显著改变了ICGFA的治疗效果,且保护作用随BMI的增加而增加(系数- 0.0153 [95% CI - 0.0251 ~ - 0.0056], p= 0.0020)。对于整体、左侧、直肠、无症状和30天的吻合口瘘,证据的确定性为高,对于临床显著的吻合口瘘,证据的确定性为中等。术中应用ICGFA可降低左侧和直肠结直肠切除术吻合口漏率。鉴于现有证据,不再需要进一步的一般疗效试验,研究应转向实施和确定靶向亚组ICGFA的作用定义(即在非直肠左侧切除术中)。
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引用次数: 0
Indocyanine green works: redefining research priorities in colorectal surgery 吲哚菁绿色工程:重新定义结直肠手术的研究重点
IF 35.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-03-20 DOI: 10.1016/s2468-1253(26)00009-9
Zoe Garoufalia
No Abstract
没有抽象的
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引用次数: 0
How to test for hepatitis D virus infection: evidence and rationale to inform policy recommendations and future directions 如何检测丁型肝炎病毒感染:为政策建议和未来方向提供依据和依据
IF 35.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-03-18 DOI: 10.1016/s2468-1253(25)00265-1
Emi E Okamoto, Robia Islam, Sahar Bajis, Niklas Luhmann, Ashley Kallarakal, Frédéric Le Gal, Philippa Easterbrook
Chronic hepatitis D virus (HDV) coinfection in people with chronic hepatitis B is associated with rapid progression to liver cirrhosis and high mortality. In 2020, the estimated global HDV burden among people with chronic hepatitis B was 12 million people, with a seroprevalence of 4·5%. Treatment options are now evolving with the introduction of bulevirtide; however, testing for HDV remains very low. In 2024, WHO published comprehensive guidelines on the management of people with chronic hepatitis B, including recommendations for the first time on who to test and how to test for HDV infection. WHO recommends an anti-HDV serological assay for those with chronic hepatitis B, and if reactive, an HDV RNA test to confirm active infection and, where available, reflex laboratory-based testing for anti-HDV in those who are HBsAg positive and an HDV RNA test in those who are anti-HDV positive. WHO also recommended universal anti-HDV testing among all individuals who are HBsAg positive, or a risk-based approach among populations at high risk when this is not feasible. We present two complementary Reviews—one on who to test and one on how to test for HDV infection. This Review on how to test provides a comprehensive landscape and performance review of available serological and molecular diagnostic assays, as well as the evidence and rationale for the adoption of reflex testing both for anti-HDV in individuals who are HBsAg positive, and HDV RNA testing in those who are anti-HDV positive. Key implementation considerations and research priorities include the need for countries to incorporate HDV testing into their national policies and guidelines for chronic hepatitis B, expand laboratory capacity and training that leverages existing networks and infrastructure, promote access to quality diagnostics, including anti-HDV rapid diagnostic tests, and conduct evaluations of quality-assured assays using all HDV genotypes.
慢性乙型肝炎患者合并慢性丁型肝炎病毒(HDV)感染与迅速发展为肝硬化和高死亡率相关。2020年,慢性乙型肝炎患者的全球HDV负担估计为1200万人,血清患病率为4.5%。随着布利韦肽的引入,治疗方案正在不断发展;然而,对HDV的检测仍然很低。2024年,世卫组织发布了关于慢性乙型肝炎患者管理的综合指南,包括首次就检测谁以及如何检测HDV感染提出建议。世卫组织建议对慢性乙型肝炎患者进行抗HDV血清学检测,如果有反应性,则进行HDV RNA检测以确认活动性感染,并在有条件的情况下,对HBsAg阳性患者进行基于实验室的抗HDV检测,对抗HDV阳性患者进行HDV RNA检测。世卫组织还建议在所有HBsAg阳性个体中普遍进行抗人肝病毒检测,或者在不可行的情况下在高危人群中采用基于风险的方法。我们提出了两份互补的综述——一份是关于检测谁,一份是关于如何检测HDV感染。这篇关于如何检测的综述对现有的血清学和分子诊断方法进行了全面的概述和性能综述,以及对HBsAg阳性的人采用反射检测抗HDV和对抗HDV阳性的人采用HDV RNA检测的证据和理由。关键的实施考虑因素和研究重点包括,各国需要将HDV检测纳入其国家慢性乙型肝炎政策和指南,扩大利用现有网络和基础设施的实验室能力和培训,促进获得高质量诊断,包括抗HDV快速诊断检测,并对使用所有HDV基因型的有质量保证的检测方法进行评估。
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引用次数: 0
Who to test and reflex testing for hepatitis D virus infection: evidence and rationale to inform policy recommendations and future directions 谁来检测丁型肝炎病毒感染和反射性检测:为政策建议和未来方向提供依据和依据
IF 35.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-03-18 DOI: 10.1016/s2468-1253(25)00266-3
Sahar Bajis, Niklas Luhmann, Emi Okamoto, Robia Islam, Olufunmilayo Lesi, Philippa Easterbrook
Chronic hepatitis D coinfection affects an estimated 12 million people globally, with higher prevalence in low-income and middle-income countries, especially the African and Western Pacific regions. It leads to accelerated progression to liver cirrhosis, hepatocellular carcinoma, and increased mortality. The treatment landscape is evolving with the introduction of bulevirtide, but hepatitis D virus (HDV) testing uptake and case-finding remain low. The 2024 WHO guidelines on the management of chronic hepatitis B provide recommendations for the first time on who to test and how to test for HDV infection. WHO recommends universal anti-HDV testing among all HBsAg-positive individuals, and where this is not feasible, a complementary focused (risk-based) testing approach among higher-risk populations. We present two complementary Reviews—one on who to test and one on how to test for HDV infection. This Review on who to test summarises the evidence base and rationale for the two recommendations regarding the universal and risk-based testing approaches, as well as the recommendation for the laboratory-based reflex HDV testing both for anti-HDV and HDR RNA. Key implementation considerations include the need for countries to incorporate HDV testing into their national policies and guidelines, education and training of health-care providers in counselling and linkage to care, community awareness raising and demand creation, and the establishment of clinical care pathways for HDV infection. Research priorities include the development of HDV rapid diagnostic tests to facilitate decentralisation of HDV testing, the generation of improved epidemiological data across different populations and settings to inform testing approaches, and evaluating the cost-effectiveness and feasibility of both universal and risk-based HDV testing approaches, alongside reflex HDV serology and HDV RNA testing.
慢性丁型肝炎合并感染影响到全球约1200万人,在低收入和中等收入国家,特别是非洲和西太平洋地区,患病率较高。它会加速发展为肝硬化、肝细胞癌,并增加死亡率。随着布来韦肽的引入,治疗前景正在发生变化,但丁型肝炎病毒(HDV)检测的吸收和病例发现仍然很低。2024年世卫组织慢性乙型肝炎管理指南首次就检测谁以及如何检测HDV感染提出了建议。世卫组织建议在所有hbsag阳性个体中普遍进行抗hdv检测,如果这不可行,则在高危人群中采取补充性的重点(基于风险的)检测方法。我们提出了两份互补的综述——一份是关于检测谁,一份是关于如何检测HDV感染。这篇关于检测谁的综述总结了关于通用和基于风险的检测方法的两项建议的证据基础和理由,以及针对抗HDV和HDR RNA的基于实验室的反射式HDV检测的建议。关键的实施考虑因素包括各国需要将HDV检测纳入其国家政策和指南,对卫生保健提供者进行咨询和与护理联系方面的教育和培训,提高社区认识和创造需求,以及建立HDV感染的临床护理途径。研究重点包括开发HDV快速诊断测试,以促进HDV检测的分散,在不同人群和环境中生成改进的流行病学数据,为检测方法提供信息,以及评估通用和基于风险的HDV检测方法的成本效益和可行性,以及反射式HDV血清学和HDV RNA检测。
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引用次数: 0
Africa must not be left out of the hepatitis B cure era 非洲绝不能被排除在乙肝治愈的时代之外
IF 35.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-03-18 DOI: 10.1016/s2468-1253(26)00024-5
Mohamed El-Kassas, Hend Shousha, Asgeir Johannessen
No Abstract
没有抽象的
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引用次数: 0
Efficacy of antiviral therapy in adults with chronic hepatitis B according to baseline hepatitis B virus DNA and alanine aminotransferase concentrations: a systematic review and meta-analysis 根据基线乙型肝炎病毒DNA和丙氨酸转氨酶浓度对成人慢性乙型肝炎患者抗病毒治疗的疗效:一项系统评价和荟萃分析
IF 35.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-03-14 DOI: 10.1016/s2468-1253(25)00301-2
Yu Ri Im, Si Emma Chen, Rukmini Jagdish, Daniela Yucuma, Arthur Rakover, Zakary Ismail Warsop, Roger Chou, Philippa Easterbrook, Yusuke Shimakawa
<h3>Background</h3>In the 2015 WHO guidelines for chronic hepatitis B (CHB), antiviral therapy was recommended for individuals with cirrhosis and individuals without cirrhosis with persistently elevated alanine aminotransferase (ALT) concentrations and hepatitis B virus (HBV) DNA >20 000 IU/mL, whereas treatment was deferred for individuals with persistently normal ALT concentrations and HBV DNA <2000 IU/mL. To inform 2024 WHO guidelines on CHB and the potential expansion of treatment threshold recommendations, we conducted two linked systematic reviews and meta-analyses; this analysis examines the efficacy of antiviral therapy in adults with non-cirrhotic CHB according to baseline HBV DNA and ALT concentrations.<h3>Methods</h3>In this systematic review and meta-analysis, we searched PubMed, Embase, Web of Science, and the Cochrane Library for randomised controlled trials (RCTs) and non-randomised (prospective or retrospective) confounder-controlled cohort studies of antiviral therapy versus placebo or no treatment in people with CHB, published in any language between Jan 1, 2000, and Feb 6, 2023. We also reviewed the reference lists of included studies and systematic reviews to identify RCTs published before 2000. Eligible studies reported baseline HBV DNA and ALT concentrations of adults with CHB, had less than 30% of participants with cirrhosis at baseline, and reported on at least one of our predefined outcomes. We excluded studies focused exclusively on pregnant women, individuals co-infected with HIV, hepatitis C virus, or hepatitis D virus, or individuals with primary conditions other than CHB, and studies that included participants who had received anti-HBV therapy in the 6 months before study enrolment. We extracted aggregate data to examine clinical outcomes (ie, hepatocellular carcinoma, cirrhosis, all-cause mortality, and liver-related mortality) and intermediate outcomes (ie, liver fibrosis, liver necroinflammation, ALT normalisation, HBsAg and HBeAg seroclearance and seroconversion, and HBV DNA suppression) stratified by baseline HBV DNA concentration (<2000 IU/mL, 2000–19 999 IU/mL, 20 000–199 999 IU/mL, 200 000–1 999 999 IU/mL, 2 000 000–19 999 999 IU/mL, and ≥20 000 000 IU/mL) and ALT (less than the upper limit of normal [ULN], 1·0–1·9 × ULN, and ≥2·0 × ULN). We used random-effects meta-analysis to pool unadjusted risk ratios (RRs) from RCTs and adjusted or unadjusted hazard ratios (aHRs or HRs) or unadjusted RRs for non-randomised studies. We estimated the number needed to treat (NNT) to prevent one case of hepatocellular carcinoma with nucleoside or nucleotide (nucleos[t]ide) analogue treatment. The study was registered with PROSPERO (CRD42023437560).<h3>Findings</h3>Of 13 224 articles screened, 24 met the inclusion criteria, including 16 studies on nucleos(t)ide analogues (12 RCTs and four non-randomised studies) and eight studies on interferon alfa-2-based therapy (four RCTs and four non-randomised studies). In adult
在2015年WHO慢性乙型肝炎(CHB)指南中,建议对丙氨酸转氨酶(ALT)浓度和乙型肝炎病毒(HBV) DNA浓度持续升高的肝硬化和非肝硬化患者进行抗病毒治疗,而对ALT浓度和HBV DNA浓度持续正常的患者推迟治疗。为了为2024年世卫组织CHB指南和治疗阈值建议的潜在扩展提供信息,我们进行了两次相关的系统评价和荟萃分析;该分析根据基线HBV DNA和ALT浓度检测了成人非肝硬化CHB患者抗病毒治疗的疗效。方法在本系统评价和荟萃分析中,我们检索了PubMed、Embase、Web of Science和Cochrane图书馆,检索了2000年1月1日至2023年2月6日期间发表的随机对照试验(rct)和非随机(前瞻性或回顾性)混杂对照队列研究,这些研究涉及抗病毒治疗与安慰剂治疗或不治疗CHB患者。我们还查阅了纳入研究的参考文献和系统综述,以确定2000年以前发表的随机对照试验。符合条件的研究报告了慢性乙型肝炎成人患者的基线HBV DNA和ALT浓度,基线时肝硬化患者少于30%,并报告了至少一个我们预先确定的结局。我们排除了专门针对孕妇、合并感染HIV、丙型肝炎病毒或丁型肝炎病毒的个体,或患有慢性乙型肝炎以外的原发性疾病的个体的研究,以及在研究入组前6个月内接受过抗hbv治疗的研究。我们提取了汇总数据,以基线HBV DNA浓度(&lt;2000 IU/mL、2000 - 19 999 IU/mL、20 000 - 199 999 IU/mL、20 000 - 1 999 999 IU/mL、2000 000 - 19 999 999 IU/mL)分层来检查临床结果(即肝细胞癌、肝硬化、全因死亡率和肝脏相关死亡率)和中间结果(即肝纤维化、肝坏死炎症、ALT正常化、HBsAg和HBeAg血清清除率和血清转化以及HBV DNA抑制)。≥20 000 000 IU/mL)和ALT(低于正常[ULN]上限、1.0 ~ 1.9 × ULN、≥2.0 × ULN)。我们使用随机效应荟萃分析汇集来自随机对照试验的未调整风险比(RRs)和非随机研究的调整或未调整风险比(aHRs或HRs)或未调整风险比。我们估计了用核苷或核苷酸(核苷[t]ide)类似物治疗预防一例肝细胞癌所需治疗(NNT)的数量。该研究已在PROSPERO注册(CRD42023437560)。在筛选的13224篇文章中,24篇符合纳入标准,包括16项核苷类似物研究(12项随机对照试验和4项非随机对照试验)和8项基于干扰素α -2治疗的研究(4项随机对照试验和4项非随机对照试验)。在基线时HBV DNA浓度≥20,000 IU/mL或ALT升高(即≥1.0 × ULN)的成人中,核苷(t)类似物治疗与肝细胞癌风险降低(在非随机研究中)和多个中间结局(即肝纤维化,坏死性炎症,ALT正常化,HBV DNA抑制和HBeAg血清清除率和血清转化)的改善相关,证据的确定性范围从非常低到高。在基线HBV DNA浓度为20,000 IU/mL的成人中,核苷类似物治疗对肝细胞癌的风险无统计学意义的影响,也没有评估其他结局。在非随机研究中,接受核苷(t)类似物治疗的肝细胞癌风险ahr为:HBV DNA和lt为2000 IU/mL时为0.72 (95% CI 0.43 - 1·20),2000 - 199999 IU/mL时为0.45 (95% CI 0.14 - 1·47),≥20000 IU/mL时为0.39 (0.29 - 0.54;I2= 0.0%)。对于基线ALT正常的成人,核苷(t)类似物治疗对HBV DNA抑制有一定疗效(RR 31.50, 95% CI 2.02 - 492·36),但对其他结果无疗效。总体而言,基线HBV DNA或ALT浓度越高,证据的确定性越高。汇总估计的研究间异质性因结果而异(I2范围0 - 82.7%),但大多数分析的异质性较低(I2中位数= 0.0%,IQR为0 - 25.5)。在16项随机对照试验中,6项被评为低偏倚风险,4项被评为中等偏倚风险,6项被评为高偏倚风险。在8项非随机研究中,分别有4项被评为质量一般和质量较差。核苷(t)类似物治疗预防1例肝细胞癌的估计NNT为:基线HBV DNA≤2000 IU/mL,治疗中位时间为12.0年(IQR为4.1 - 26.2)为149;基线HBV DNA≤2000 - 199999 IU/mL,治疗中位时间为10.6年(IQR为3.7 - 24.0)为45;基线HBV DNA≥20000 IU/mL,治疗中位时间为13.6年(IQR为6.7 - 22.1)为15。 证据支持核苷类似物治疗HBV DNA≥20,000 IU/mL或ALT升高的成人的疗效。然而,核苷类似物治疗HBV DNA≥20,000 IU/mL或ALT正常的成人的疗效仍不确定。未来的研究应优先确定这些群体的治疗益处,特别是在撒哈拉以南非洲的高负担环境中。
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Lancet Gastroenterology & Hepatology
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