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雷莫西尤单抗治疗晚期结直肠癌患者的疗效与安全性:一项系统评价和荟萃分析方案

Efficacy and safety of ramucirumab treatment in patients with advanced colorectal cancer: A protocol for systematic review and meta analysis.

作者信息

Ju Man, Cheng Honggang, Qu Kai, Lu Xiangqian

机构信息

Department of Anus & Intestine Surgery.

Department of Gastrointestinal Surgery, Liaocheng People's Hospital, Liaocheng, Shandong Province.

出版信息

Medicine (Baltimore). 2020 Jun 12;99(24):e20618. doi: 10.1097/MD.0000000000020618.

Abstract

BACKGROUND

vascular endothelial growth factor receptor 2 (VEGFR-2) has an important role in colorectal cancer pathogenesis and progression. The aim of our study is to provide a protocol for assessing the efficacy and safety of ramucirumab (a monoclonal antibody VEGFR-2 antagonist) for the treatment of advanced colorectal cancer.

METHODS

The systematic review will be reported according to the preferred reporting items for systematic reviews and meta-analyses protocols. Relevant randomized controlled trials were searched from PubMed, Cochrane Library, Web of Science, Excerpt Medica Database, China National Knowledge Infrastructure, and Wanfang Database. Papers in English or Chinese published from their inception to February 2020 will be included without any restrictions.Study selection and data extraction will be performed independently by 2 investigators. The clinical outcomes including overall response rate, complete response rate (disease control rate), overall survival, progression-free survival, quality of life, immune function, and adverse events, were systematically evaluated. Review Manager 5.3 and Stata 14.0 were used for data analysis, and a fixed or random-effect model of meta-analysis will be used depending upon the heterogeneity observed between studies. Subgroup analysis will be carried out depending on the availability of sufficient clinical data.

RESULTS AND CONCLUSION

The findings of this systematic review and meta-analysis will be published in a peer-reviewed journal, and provide more evidence-based guidance in clinical practice.

PROSPERO REGISTRATION NUMBER

CRD42020165683.

摘要

背景

血管内皮生长因子受体2(VEGFR - 2)在结直肠癌的发病机制和进展中起重要作用。我们研究的目的是提供一个方案,用于评估雷莫西尤单抗(一种VEGFR - 2拮抗剂单克隆抗体)治疗晚期结直肠癌的疗效和安全性。

方法

本系统评价将按照系统评价和Meta分析方案的首选报告项目进行报告。从PubMed、Cochrane图书馆、科学网、医学文摘数据库、中国知网和万方数据库中检索相关随机对照试验。纳入自数据库建立至2020年2月发表的英文或中文论文,无任何限制。研究选择和数据提取将由2名研究者独立进行。系统评价包括总缓解率、完全缓解率(疾病控制率)、总生存期、无进展生存期、生活质量、免疫功能和不良事件等临床结局。采用Review Manager 5.3和Stata 14.0进行数据分析,并根据研究间观察到的异质性采用固定效应或随机效应Meta分析模型。将根据是否有足够的临床数据进行亚组分析。

结果与结论

本系统评价和Meta分析的结果将发表在同行评审期刊上,并为临床实践提供更多循证指导。

PROSPERO注册号:CRD42020165683。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3c3f/7302601/8a6afc97b325/medi-99-e20618-g002.jpg

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