{"title":"全面评估玻璃体内法瑞西单抗对视网膜疾病的影响:系统综述、元分析和试验序列分析》。","authors":"","doi":"10.1016/j.phrs.2024.107335","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>Faricimab stands as the inaugural and sole bispecific antibody approved by the US Food and Drug Administration (FDA) for intravitreal injection. Nonetheless, the efficacy and safety of intravitreal faricimab remained uncertain.</p></div><div><h3>Objectives</h3><p>The purpose of this study was to evaluate faricimab.</p></div><div><h3>Methods</h3><p>This systematic review and meta-analysis followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines (CRD42023398320). Five databases (Pubmed, Embase, Web of science, Cochrane Library, ClinicalTrials gov) were searched. We calculated pooled standard mean difference or odds ratio with 95 % confident interval under a random-effect model or fixed-effect model. Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) was employed to ascertain the reliability of the analyses. Trial sequential analysis was performed to gauge the statistical reliability of the data in the cumulative meta-analysis.</p></div><div><h3>Results</h3><p>8 studies (3975 participants) were included. The use of faricimab was associated with central subfield thickness (CST) change, but no difference was found in other primary efficacy outcomes. Apart from that, a correlation was observed between the use of faricimab and the risk of vitreous floaters. Based on TSA, strong evidence indicates that compared to the control group, faricimab aided in reducing CST but increasing the risk of vitreous floaters.</p></div><div><h3>Conclusions</h3><p>In this study, a correlation existed between the use of faricimab and a reduction in CST, indicating a superior therapeutic effect. Moreover, participants treated with faricimab demonstrated a higher risk of vitreous floaters. More randomized controlled trials are essential to further explore the efficacy and safety of faricimab.</p></div>","PeriodicalId":19918,"journal":{"name":"Pharmacological research","volume":null,"pages":null},"PeriodicalIF":9.1000,"publicationDate":"2024-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1043661824002809/pdfft?md5=ecef5838b7c7545ad606b7f9196dc6d7&pid=1-s2.0-S1043661824002809-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Comprehensive assessment of the impact of intravitreal faricimab on retinal diseases: A systematic review, meta-analysis, and trial sequential analysis\",\"authors\":\"\",\"doi\":\"10.1016/j.phrs.2024.107335\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>Faricimab stands as the inaugural and sole bispecific antibody approved by the US Food and Drug Administration (FDA) for intravitreal injection. Nonetheless, the efficacy and safety of intravitreal faricimab remained uncertain.</p></div><div><h3>Objectives</h3><p>The purpose of this study was to evaluate faricimab.</p></div><div><h3>Methods</h3><p>This systematic review and meta-analysis followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines (CRD42023398320). Five databases (Pubmed, Embase, Web of science, Cochrane Library, ClinicalTrials gov) were searched. We calculated pooled standard mean difference or odds ratio with 95 % confident interval under a random-effect model or fixed-effect model. Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) was employed to ascertain the reliability of the analyses. Trial sequential analysis was performed to gauge the statistical reliability of the data in the cumulative meta-analysis.</p></div><div><h3>Results</h3><p>8 studies (3975 participants) were included. The use of faricimab was associated with central subfield thickness (CST) change, but no difference was found in other primary efficacy outcomes. Apart from that, a correlation was observed between the use of faricimab and the risk of vitreous floaters. Based on TSA, strong evidence indicates that compared to the control group, faricimab aided in reducing CST but increasing the risk of vitreous floaters.</p></div><div><h3>Conclusions</h3><p>In this study, a correlation existed between the use of faricimab and a reduction in CST, indicating a superior therapeutic effect. Moreover, participants treated with faricimab demonstrated a higher risk of vitreous floaters. More randomized controlled trials are essential to further explore the efficacy and safety of faricimab.</p></div>\",\"PeriodicalId\":19918,\"journal\":{\"name\":\"Pharmacological research\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":9.1000,\"publicationDate\":\"2024-08-13\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S1043661824002809/pdfft?md5=ecef5838b7c7545ad606b7f9196dc6d7&pid=1-s2.0-S1043661824002809-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pharmacological research\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1043661824002809\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pharmacological research","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1043661824002809","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
摘要
背景:法利单抗是美国食品和药物管理局(FDA)批准用于玻璃体内注射的首个也是唯一一个双特异性抗体。然而,玻璃体内注射法利西单抗的疗效和安全性仍不确定:本研究旨在评估法尼单抗:本系统综述和荟萃分析遵循了系统综述和荟萃分析首选报告项目(Preferred Reporting Items for Systematic Reviews and Meta-Analyses,PRISMA)指南(CRD42023398320)。我们检索了五个数据库(Pubmed、Embase、Web of science、Cochrane Library、ClinicalTrials gov)。在随机效应模型或固定效应模型下,我们计算了汇集的标准平均差或几率比率及 95% 的置信区间。我们采用了推荐、评估、发展和评价分级法(GRADE)来确定分析的可靠性。进行了试验序列分析,以衡量累积荟萃分析中数据的统计可靠性:共纳入 8 项研究(3975 名参与者)。使用法尼单抗与中心视野下厚度(CST)的变化有关,但在其他主要疗效结果中未发现差异。除此之外,还观察到使用法尼单抗与玻璃体漂浮物风险之间存在相关性。基于TSA,有力的证据表明,与对照组相比,法尼单抗有助于降低CST,但会增加玻璃体漂浮物的风险:在这项研究中,法尼单抗的使用与 CST 的减少之间存在相关性,这表明法尼单抗具有卓越的治疗效果。此外,接受法尼单抗治疗的患者出现玻璃体漂浮物的风险较高。要进一步探讨法尼单抗的疗效和安全性,必须进行更多的随机对照试验。
Comprehensive assessment of the impact of intravitreal faricimab on retinal diseases: A systematic review, meta-analysis, and trial sequential analysis
Background
Faricimab stands as the inaugural and sole bispecific antibody approved by the US Food and Drug Administration (FDA) for intravitreal injection. Nonetheless, the efficacy and safety of intravitreal faricimab remained uncertain.
Objectives
The purpose of this study was to evaluate faricimab.
Methods
This systematic review and meta-analysis followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines (CRD42023398320). Five databases (Pubmed, Embase, Web of science, Cochrane Library, ClinicalTrials gov) were searched. We calculated pooled standard mean difference or odds ratio with 95 % confident interval under a random-effect model or fixed-effect model. Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) was employed to ascertain the reliability of the analyses. Trial sequential analysis was performed to gauge the statistical reliability of the data in the cumulative meta-analysis.
Results
8 studies (3975 participants) were included. The use of faricimab was associated with central subfield thickness (CST) change, but no difference was found in other primary efficacy outcomes. Apart from that, a correlation was observed between the use of faricimab and the risk of vitreous floaters. Based on TSA, strong evidence indicates that compared to the control group, faricimab aided in reducing CST but increasing the risk of vitreous floaters.
Conclusions
In this study, a correlation existed between the use of faricimab and a reduction in CST, indicating a superior therapeutic effect. Moreover, participants treated with faricimab demonstrated a higher risk of vitreous floaters. More randomized controlled trials are essential to further explore the efficacy and safety of faricimab.
期刊介绍:
Pharmacological Research publishes cutting-edge articles in biomedical sciences to cover a broad range of topics that move the pharmacological field forward. Pharmacological research publishes articles on molecular, biochemical, translational, and clinical research (including clinical trials); it is proud of its rapid publication of accepted papers that comprises a dedicated, fast acceptance and publication track for high profile articles.