我国高血压合理用药文献研究计量学分析

目的 了解我国医院高血压合理用药文献的研究趋势和热点，为提出促进高血压合理用药的相关措施提供参考。方法 检索2010—2017年中国知网数据库、万方数据库、维普数据库收录的高血压合理用药的相关文献，运用书目信息共现分析系统（BICOMB）2.0提取关键词、年份及相应文献量、期刊、作者及机构等参量进行文献计量学分析，并构建高频关键词词篇矩阵；将该词篇矩阵导入SPSS21.0软件进行系统聚类分析；利用图形聚类工具包（gCLUTO）1.0版对词篇矩阵进行词篇共现分析和双聚类可视化分析。结果 从知网、万方、维普三大数据库共检索到高血压合理用药相关文献1 010篇；从年发文量来看，高血压合理用药问题一直是研究热点；从期刊分布来看，高血压合理用药相关文献分布于262种期刊，高血压合理用药问题受到期刊界的广泛关注；从发文作者来看，我国还未形成高血压合理用药研究的核心力量；从单位分布来看，发文机构分散，多数为医院；高频关键词聚焦于“抗高血压药物/降压药、合理用药、高血压、用药分析”等。结论 我国目前对于高血压合理用药的研究多为对单个医院高血压患者用药合理性评价或是对抗高血压药物临床应用的分析，该领域的研究仍需从简单定性分析转向多地区、多层次、大样本的定量分析，以更好地促进高血压合理用药。     

互联网药学服务研究现状和热点的可视化分析

目的 分析国内外互联网药学服务的研究现状和热点,为进一步开展互联网药学服务提供参考。方法 检索中国知网、万方数据库、PubMed和Web of Science核心合集数据库自建库至2021年发表的有关互联网药学服务研究的文献,采用BICOMB 2.02软件对纳入的中英文文献分别进行提取和统计,并生成高频关键词的词篇矩阵和共现矩阵;利用NetDraw 2.089软件对共现矩阵进行社会网络分析,绘制社会网络图,并利用Ucinet 6.212软件对网络进行中心度分析;利用gCLUTO 1.0软件对词篇矩阵进行聚类分析。结果 最终纳入关于互联网药学服务研究的中文文献159篇,互联网药学概念最早出现于2000年;英文文献纳入62篇,相关研究最早发表于1999年;发文量最多的中英文期刊分别是《中国药房》和Journal of Medical Internet Research;确定了当前关于互联网药学服务研究的6个主题:互联网药学服务在社区慢病患者中工作模式的研究、移动互联网平台在药学咨询服务中的研究、云药房(网上药店)互联网药学服务研究、新型冠状病毒肺炎疫情期间互联网药学服务模式研究、互联网药学实践在药师或临床药师继续教育培训体系中的应用研究、互联网药学服务的发展对药师的影响研究。结论 该研究全面深入分析了互联网药学服务的发展现状和研究热点,新型冠状病毒肺炎疫情催化加速了互联网药学服务的发展,在疫情防控新形势和国家各项政策支持下,伴随着"互联网+医疗健康"的发展,互联网药学服务也将蓬勃发展。     

利拉鲁肽的文献计量学分析

摘 要 目的：深入了解利拉鲁肽的研究概况,客观反映相关国家、机构和科学家在研究利拉鲁肽的领域中具备的科学能力和影响力。方法：以科学引文索引（SCI）数据库Web of Science为检索平台,以liraglutide or victoza or saxenda”为主题词进行检索,采用文献计量学的方法,分析以利拉鲁肽为主题的相关文献在国家/地区、机构、作者来源、出版物、年发文量、年引文量和引用排名前10名的情况。同时,以中国知网（CNKI）中的中国期刊全文数据库为检索平台,检索以“利拉鲁肽或诺和力”为主题词的所有中文文献并进行文献计量学的分析。时间跨度为1986年1月1日～2015年10月5日。结果：在Web of Science数据库中检索到文献1 596篇,发文量与引文数呈递增趋势,h index 为63;美国和丹麦的研究超过总数的一半以上总被引前10 位的SCI 文章有7篇为LEAD项目的试验结果,我国发表的SCI 文献为110篇;CNKI中收录的中文文章有348篇,10家机构中的9家为综合性的三级甲等医院,发文量最多的为解放军总医院。结论：关于利拉鲁肽的研究,是逐渐上升的趋势,仍是目前研究的热点。中国与国际前沿研究间存在着一定差距。     

药品不良反应信号挖掘文献计量学分析

摘 要 目的：深入了解药品不良反应信号的研究概况,客观反映相关国家、机构和科学家在研究药品不良反应的领域中具备的科学能力和影响力。方法：以科学引文索引(SCI) 数据库Web of Science为检索平台,以“adverse reaction signal mining”“adverse reaction data mining”为主题词进行高级检索,采用文献计量学的方法,分析以不良反应信号挖掘为主题的相关文献在国家/地区、机构、作者来源、出版物、年发文量、年引文量和引用排名前10名的情况。同时,以中国知网(CNKI) 中的中国期刊全文数据库为检索平台,高级检索“不良反应信号挖掘”“不良反应数据挖掘”为主题词的所有中文文献并进行文献计量学的分析。检索时间截止到2018年6月30日。 结果：在Web of Science 数据库中检索到英文文献191篇,年发文量与年引文数以2013为最多,h index为36,美国和法国的发文量为103篇,占总数的53.93%。在CNKI中检索到的中文文献为41篇,研究最多的机构为第二军医大学,发文量为11篇,占总数的26.83%。结论：关于药品不良反应信号挖掘的研究发展迅速,且一直保持着一定的研究热度,但挖掘技术和数据利用的方法还需要进一步探索。     

基于CiteSpace对红花研究进展及未来趋势的可视化分析

目的 通过分析红花研究领域的英文文献，归纳红花研究热点，总结红花的药理活性，挖掘红花未来研究方向。方法 基于Web of Science数据库，运用CiteSpace 5.8.R3软件通过检索平台收录2000—2021年红花相关研究的英文文献进行文献计量学分析，从机构发文量、国家发文量、作者发文量、Top20被引文献、Top15期刊发文量、关键词的共现以及未来热点等方面进行分析和可视化展现。结果 研究共纳入1230篇文献，2007—2021年发文量占比89.5%，主要集中在亚洲国家，例如中国、伊朗以及印度等。发文机构主要集中在亚洲国家的高校，其中伊朗伊斯兰阿扎德大学为发文量最多的机构，多达53篇；在中国范围内形成了以中国科学院大学、北京大学等大学为核心的科研合作网络，是红花研究领域的密切合作机构。发文量最多的作者是以Meili Guo为代表的团队，该团队研究内容涉及红花以及其近缘种的遗传机制，发文量共计13篇。关键词分析显示研究方向集中在红花的种植、有效成分、药理机制、活化反应等方面，红花有效成分的抗氧化能力以及对阿尔茨海默病的治疗将成为未来的研究热点。结论 红花的年发文量呈逐年递增趋势，其未来的研究热点方向主要集中在发掘其有效成分新的药理作用以及疾病治疗效果的验证方面。对于红花的相关研究仍处于发展阶段，相关研究团队应加强跨区域合作，为后续红花的相关研究提供重要参考。     

2010—2022年地龙的研究热点及趋势的可视化分析

目的 分析2010—2022年地龙的研究现状、热点及发展趋势。方法 检索2010—2022年Web of Science核心合集数据库、中国知网（CNKI）收录的有关地龙的文献，应用CiteSpace软件，对文献的数据进行可视化分析。结果 共纳入2071篇文献，2010—2022年地龙的研究发文量整体呈下降趋势。其中，发文量最高的国家为中国，并与多国建立了良好的合作关系；发文量最高的机构为山东中医药大学、中国科学院；发文量最高的作者为胡建山、JAMES S；研究热点主要围绕数据挖掘、用药规律、抗菌活性、活性部位、新物种等方面；前沿与趋势主要集中在数据挖掘、用药规律、聚类分析、临床经验以及新物种等。结论 该研究利用现代信息技术，对地龙的研究现状、热点、前沿趋势进行了更深层次的整合与分析，可为该领域的进一步研究提供新思路。     

基于CiteSpace和VOSviewer的吸入性三联药物治疗慢性阻塞性肺疾病的文献计量学分析

目的 通过对慢性阻塞性肺疾病(chronic obstructive pulmonary disease，COPD)吸入性三联药物进行文献计量学分析，探索2000年以来三联药物领域的研究热点和研究趋势。方法 基于CiteSpace和VOSviewer软件，对Web of Science核心合集数据库进行检索，将筛选所得文献的年度发文量、作者、机构、期刊和关键词等进行可视化分析，并对机构的聚类情况、关键词的时间线和突显年份进行探讨。结果 2000—2022年COPD吸入性三联药物相关文献发表量为403篇，总体呈增长趋势，主要集中在美国、英国、意大利、德国和加拿大等国；发文量前5名的作者为SINGH D、LIPSON D、MARTINEZ F、DORINSKY P和ISMAILA A，与发文量前5位的研究机构GlaxoSmithKline、AstraZeneca、The University of Manchester、University of Pennsylvania和McMaster University相互吻合，机构间合作密切；COPD病理生理学、三联药物与相关临床试验、药物吸入器技术与种类等是COPD吸入性三联药物领域研究的热点与重点方向；单吸入器三联疗法、多吸入器三联疗法、患者生存率、治疗有效性是三联药物的前沿研究内容。结论 2014年以来COPD的吸入性三联药物越来越受到重视，疾病的病理生理学、三联药物临床试验与主要结局指标、吸入器技术是该领域研究热点，单吸入器三联疗法是该领域前沿研究方向。中国相关研究层次深度与国际影响力有待进一步提升。     

基于CiteSpace探讨马钱子碱的研究现状及趋势分析

目的 对马钱子碱相关的中英文文献进行文献计量分析,探讨马钱子碱的研究现状、研究热点及发展趋势。方法 系统检索中国知网、Web of Science数据库关于马钱子碱的相关文献,基于CiteSpace 5.8.R3软件运用文献计量学方法对发表年份、核心作者、国家、关键词等进行可视化分析。结果 本研究共纳入中文文献439篇、英文文献602篇。近40年马钱子碱相关发文量总体呈稳步增长趋势。中文文献高产作者主要为蔡宝昌研究团队,该团队研究内容涉及马钱子主要生物碱及相应氮氧化物的含量测定、抗肿瘤作用、药动学、炮制转化、新剂型开发等。基于国别分析,中国发文量最高,有待与其他国家进一步发展合作研究。关键词分析表明,中英文文献共同的研究热点主要为2个方面:抗肿瘤等药理活性和机制研究和马钱子碱新型给药系统研究。中文文献研究热点已从质量控制向药理活性及新剂型转变;英文文献多集中于药理活性、新剂型研发领域。结论 马钱子碱研究仍处于发展阶段,研究团队间的合作交流有待加强。减毒增效仍将是未来的研究重点及趋势。     

药学质性研究文献数据的信息可视化分析

目的:分析近十年国际上药学质性研究的现状和热点,为国内开展相关研究提供参考。方法:检索PubMed数据库2009-2018年发表的有关药学质性研究的文献,运用BICOMB-2软件对文献资料进行提取和统计,得到高频主题词的词篇矩阵和共现矩阵,利用gCLUTO 1.0进行聚类分析,利用NetDraw 2.089绘制社会网络图,并利用UCINET 6.212进行中心度和多维尺度分析。结果:共纳入157篇文献,刊载在65种期刊上,其中英格兰、美国发文最多;确定了当前研究的五大主题:药学教育课程、医联体教学及体验式教育模式、医院药学服务质量、社区药师沟通能力和社区药师药学服务能力的质性研究。结论:药学质性研究在国际上发文量呈逐年增长趋势,我国可以借鉴国际上的现状和热点,从药学教育课程、教育模式、医院药学服务等方面,开展我国的药学质性研究。     

我国儿童用药不良反应报告分析模式的文献计量分析

摘 要 目的：对我国儿童用药不良反应（ADR）报告分析模式进行初步探析。方法：从中国知网（CNKI）数据库检索并筛选出符合标准的文献183 篇,分别提取关键字段建立数据库,分别从刊出情况（年刊出量、文献量比重、主要刊物分布）、来源情况（发文作者及合作情况、发文机构及合作情况、发文地区及行政等级分布）、内容分析（高频关键词分析、文献数据来源分析、文献主题分布）三个方面对我国儿童用药ADR报告分析类文献进行文献计量和题录信息分析。结果：我国儿童用药ADR报告分析的相关文献发文量逐年增长,且主要分布于药学类刊物,发文机构集中于医院,以机构内合作发文居多,发文主题以常规分析、抗菌药类药物分析和中药及类中药注射剂分析见长。结论：我国儿童ADR报告分析类研究有较大的提升空间,应加快推进我国儿童用药ADR基层监测及规范化建设,重视多中心合作,有效利用我国儿童ADR数据,以期今后在一定程度上减少儿童ADR的发生。     

免疫检查点抑制剂对癌症患者甲状腺功能的影响

目的 探讨免疫检查点抑制剂（ICI）对癌症患者甲状腺功能的影响。方法 回顾性分析39例接受ICIs治疗的癌症患者，治疗期间监测患者甲状腺功能指标。结果 39例采用ICIs治疗的患者中，5例（12.8%）发生甲状腺功能减退，需要甲状腺激素替代治疗。甲状腺功能减退发生在治疗早期，平均发生时间为治疗第2周期。经左甲状腺素钠片治疗后，随访期间患者甲状腺功能未恢复。结论 ICIs可引起甲状腺功能减退，可能发生在治疗早期，建议使用ICIs期间密切监测患者的甲状腺功能。     

The safety and efficacy of pembrolizumab for the treatment of non-small cell lung cancer

ABSTRACT

Introduction: Lung cancer is the leading cancer-related cause of death worldwide. The introduction of immune checkpoint inhibitors (ICIs) for the treatment of lung cancer has significantly improved the outcome of these patients. Pembrolizumab, a monoclonal IgG4-kappa antibody against programmed-death-1 (PD-1) protein, nowadays represents a standard of care for NSCLC patients. Although it has a favorable toxicity profile, some immune-related adverse events (irAEs) can be life-threatening, therefore its knowledge may help to optimize the care of these patients.

Areas covered: The authors review data regarding the efficacy and safety of pembrolizumab from the most relevant clinical trials as well as toxicities reported in the clinical use. Special considerations of use in special populations will be noted. Finally, its toxicity profile will be compared with other ICIs used in NSCLC.

Expert opinion: In the scenario of NSCLC, pembrolizumab shows a favorable safety profile with less than 10% serious immune-related adverse events (irAEs) when used in monotherapy and without adding relevant extra-toxicity to chemotherapy when used in combination. Monotherapy with pembrolizumab is associated with better health-related quality of life than chemotherapy. Early recognition and appropriate treatment of irAEs is of prime importance as most are reversible if correctly managed. Rechallenge with pembrolizumab is frequently feasible.     

Colitis following the use of immune checkpoint inhibitors: A real-world analysis of spontaneous reports submitted to the FDA adverse event reporting system

BackgroundAlthough colitis has been reported in patients treated with immune checkpoint inhibitors (ICIs), associations between colitis and ICIs had not been thoroughly assessed in real-world studies. Here, we identified and characterized significant colitis-associated with ICIs.MethodsBased on the Food and Drug Administration Adverse Event Reporting System (FAERS) from January 2004 to December 2019, the disproportionality analysis and Bayesian analysis, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN) and the multi-item gamma Poisson shrinker (MGPS) algorithms were adopted to data mining of the suspected adverse events of colitis after ICIs administrating. Clinical characteristics of patients with ICIs-associated colitis and the time to onset of colitis following different ICI regimens were collected.ResultsA total of 3786 reports of colitis adverse events were identified with ICIs. Seven ICI monotherapies were associated with the reporting of colitis. Statistically significant ROR, PRR, information component (IC), and empirical Bayesian geometric mean (EBGM) emerged for all ICI monotherapies and combination therapies. ICIs-associated colitis affected mostly male (53.51%), with a wide mean age range (60.65 to 72 years). Colitis adverse events were commonly reported in patients with melanoma and lung cancer. Adverse outcomes of colitis concerning ICI were mainly outcomes of hospitalization-initiated or prolonged and other serious. Among colitis cases, 17.43% cases of colitis concerning ICI lead to death. The adverse event of colitis occurred earliest in ipilimumab monotherapy with a median time to onset of 64.21 days (IQR: 27–69 days) among all monotherapies.ConclusionsICI may lead to severe and disabling ICIs-associated colitis during therapy. Analysis of FAERS data identified signals for adverse events of colitis with ICI regimens. Practitioners should consider the factors that may increase the likelihood of colitis. The findings support a continued surveillance and risk factor identification studies.     

免疫检查点抑制剂治疗期间并发肺孢子菌感染：两例病例报道并文献复习

近年来,免疫检查点抑制剂（ICI）在临床中广泛应用,给肿瘤患者带来了比放疗、化疗更进一步的生存获益。然而,在免疫抑制剂增强细胞免疫抗肿瘤的同时,也有可能增强机体正常的免疫反应,导致机体免疫耐受紊乱,引起相应器官出现不适症状,称之为免疫相关不良反应。其中,免疫相关性肺炎往往较难诊断,严重者可致命。肺孢子菌肺炎（PCP）作为一种机会性真菌感染性疾病,常发生于免疫力低下人群。鉴于ICIs对免疫功能的促进作用,目前的主要观点认为,肿瘤免疫治疗并不会增加肺孢子菌感染的机会。本文报道了两例免疫治疗期间发生肺孢子菌感染的病例,以期进一步加深人们对免疫相关性肺炎及PCP的认识。     

Immune Checkpoint Inhibitors and Cardiotoxicity: An Analysis of Spontaneous Reports in Eudravigilance

Introduction

Immune checkpoint inhibitors (ICIs) are widely used in the treatment of many cancers as they improve clinical outcomes. However, ICIs have also been associated with the development of immune-related adverse drug reactions (ADRs). Among immune-related ADRs, cardiac immune-related ADRs are rare, but also associated with high mortality rates.

Objective

The objective of this study was to evaluate the occurrence of cardiac ADRs reported with ICIs in the European spontaneous reporting system.

Methods

We retrieved individual case safety reports on ICI-induced cardiac ADRs from the website of suspected ADR (www.adrreports.eu) of the European pharmacovigilance database (Eudravigilance). Data were retrieved from the date of marketing authorization of each ICI (ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, and cemiplimab) to 14 March, 2020. The reporting odds ratio and its 95% confidence interval were computed to assess the reporting frequency of cardiac ADRs for each ICI compared to all other ICIs.

Results

A total of 2478 individual case safety reports with at least one ICI as the suspected drug were retrieved from Eudravigilance, of which 249 (10%) reported more than one ICI. The three most reported ICIs were nivolumab (43.2%), pembrolizumab (32.5%), and the association of nivolumab/ipilimumab (9.4%). A total of 3388 cardiac ADRs were identified. Cardiac ADRs were serious (99.4%) and had a fatal outcome (30.1%). The most reported cardiac events were myocarditis, cardiac failure, atrial fibrillation, pericardial effusion, and myocardial infarction. Nivolumab was reported with a small increased reporting frequency of individual case safety reports with cardiac ADRs compared to all other ICIs (reporting odds ratio 1.09, 95% confidence interval 1.01–1.18).

Conclusions

Immune checkpoint inhibitor-induced cardiac ADRs were serious and had unfavorable outcomes. In our study, nivolumab was the only ICI with a small increased reporting frequency of individual case safety reports with cardiac ADRs compared to all other ICIs. In this regard, further head-to-head studies are needed.

     

Oncolytic virotherapy,alone or in combination with immune checkpoint inhibitors,for advanced melanoma: A systematic review and meta-analysis

BackgroundAdvanced melanoma, one of the most lethal forms of skin cancer, remains a difficult condition to treat, despite the substantial scientific progression in cancer treatment. Oncolytic virotherapy (OV), either alone or combined with immune checkpoint inhibitors (ICIs), has often been administrated in an attempt to cure this malignancy. However, the clinical outcomes dramatically vary among different reports.MethodsIn this study, we performed a meta-analysis to evaluate the clinical efficacy and safety profile of OV, combined with ICIs in some cases, in advanced melanoma patients. The original clinical studies were identified based on the online query in PubMed, Cochrane, and Web of Science before December 30, 2018.ResultsA total of 18 publications involving 1472 patients were included for the final meta-analysis. The data concerning objective response rate (ORR) and incidence rate of severe immune-related adverse events (irAEs) were extracted accordingly from the text or supplementary materials. The results illustrated that a single treatment of OV could generate a 25% ORR for advanced melanoma, and the ORR could be improved to 45% if combined with ICIs. Further analysis demonstrated that the introduction of ICIs in OV could increase the incidence rate of severe irAEs (AE ≥ 3) from 12% to 39%. However, the rate attributed to OV remains at 12% in the combination group.ConclusionThe clinical efficacy of OV can be significantly improved by ICIs even though more onerous burden will be exerted simultaneously on the safety profile.     

儿童恶性肿瘤免疫检查点抑制剂的临床试验及应用进展

近年来免疫检查点抑制剂(immune checkpoint inhibitors，ICIs)单药治疗和联合治疗在一些成人恶性肿瘤中取得了明显的疗效，但在儿童肿瘤中的疗效及安全性尚不确切，单药治疗及联合治疗在儿童肿瘤中的早期临床试验已陆续报道。本文通过回顾已有文献，对近年来ICIs在儿童中的临床试验及应用进展进行综述，阐明儿童恶性肿瘤应用ICIs的有效性及安全性，以期为临床用药提供参考。     

Mechanisms of immune checkpoint inhibitor-mediated liver injury

The immune checkpoints, cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) and programmed cell death protein-1/ligand-1 (PD-1/PD-L1) are vital contributors to immune regulation and tolerance. Recently immune checkpoint inhibitors (ICIs) have revolutionized cancer therapy; however, they come with the cost of immune related adverse events involving multiple organs such as the liver. Due to its constant exposure to foreign antigens, the liver has evolved a high capacity for immune tolerance, therefore, blockade of the immune checkpoints can result in aberrant immune activation affecting the liver in up to 20% of patients depending on the agent(s) used and underlying factors. This type of hepatotoxicity is termed immune mediated liver injury from checkpoint inhibitors (ILICI) and is more common when CTLA4 and PD-1/PD-L1 are used in combination. The underlying mechanisms of this unique type of hepatotoxicity are not fully understood; however, the contribution of CD8⁺ cytotoxic T lymphocytes, various CD4⁺ T cells populations, cytokines, and the secondary activation of the innate immune system leading to liver injury have all been suggested. This review summarizes our current understanding of the underlying mechanisms of liver injury in immunotherapy using animal models of ILICI and available patient data from clinical studies.     

小柴胡汤联合泼尼松对肺癌患者免疫性肺炎及T淋巴细胞的影响

目的 探讨小柴胡汤联合泼尼松对肺癌患者免疫性肺炎及T淋巴细胞的影响。方法 将80例免疫检查点抑制剂（ICI）所致免疫性肺炎的肺癌患者随机分为两组,对照组（n=40）采用泼尼松治疗,联合组（n=40）在此基础上加用小柴胡汤。连续治疗7天后,比较两组患者的临床-影像-生理（CRP）评分、T淋巴细胞水平、Karnofsky评分的变化。结果 治疗后,两组CRP评分均显著下降,且联合组显著低于对照组（P<0.05）;治疗后,对照组CD4⁺、CD4⁺/CD8⁺ T细胞亚群水平较治疗前显著下降,且显著低于联合组（P<0.05）;两组治疗后Karnofsky评分均显著升高,且联合组明显高于对照组（P<0.05）。结论 小柴胡汤联合泼尼松治疗肺癌患者免疫性肺炎的疗效优于单用泼尼松,有助于调节免疫抑制状态,增强免疫功能,改善生活质量。     

A systematic review and meta-analysis of immune-mediated liver dysfunction in non-small cell lung cancer

BackgroundImmune checkpoint inhibitors (ICIs) have been identified as validated medications in non-small cell lung cancer (NSCLC). However, they are often associated with immune-related adverse events (irAEs) including liver dysfunction. Therefore, we conducted a systematic review of the literature and performed a meta-analysis to ascertain overall incidence and risk of immune mediated liver dysfunction in NSCLC patients.MethodsPubMed, the Cochrane Library, Embase and ClinicalTrials.gov (http://clinicaltrials.gov/) were searched from inception to December 2019. Studies regarding all grade (1–5), high grade (3–5) hepatitis and ALT or AST elevation were included.ResultsA total of 11 clinical trials including 7086 patients were selected for further assessment. The overall incidence of ALT elevation, AST elevation and hepatitis for the application of ICIs was 6.18%, 4.99% and 1.09%, respectively. Compared with chemotherapy group, treatment with ICIs had a significantly higher risk of all grade (RR: 7.27, p = 0.001) and high grade (RR: 6.70, p = 0.003) hepatitis. When ICIs combined with chemotherapy, the relative risk of all grade hepatitis was higher than monotherapy group (RR: 7.89, p = 0.044 vs RR: 6.94, p = 0.008).ConclusionThe application of ICIs could result in a higher incidence and relative risk of all grade immune-induced liver dysfunction. Moreover, immunotherapy combined with chemotherapy may also increase relative risk of all grade hepatic AEs when compared with monotherapy. Prompt recognition and proper administration is required for clinicians to prevent potentially hepatic deterioration.