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三氧化二砷联合铂类药物治疗宫颈癌的效果:一项随机对照试验的系统评价和荟萃分析方案

Effects of arsenic trioxide combined with platinum drugs in treatment of cervical cancer: A protocol for systematic review and meta-analysis of randomized controlled trials.

作者信息

Zhang Yawen, Pan Di, Yang Haishi, Huang Jiaxin, He Zeyang, Li Haiying, Li Daocheng

机构信息

The First Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Province, P.R. China.

出版信息

Medicine (Baltimore). 2020 Nov 6;99(45):e22950. doi: 10.1097/MD.0000000000022950.

Abstract

INTRODUCTION

Cervical cancer is the second largest tumor disease threatening female reproductive tract health. AS2O3 is a multi-directional and multi-target anti-cervical cancer drug. It can be combined with platinum drugs to treat cervical cancer. The literatures of AS2O3 combined with platinum drugs related to cervical cancer have shown inconsistent results, and there is currently no high quality of systematic review to evaluate the effects of AS2O3 combined with platinum drugs in cervical cancer patients.

METHODS AND ANALYSIS

English and Chinese literature about AS2O3 combined with platinum drugs treatment for cervical cancer published before August 31, 2020 will be systematic searched in PubMed, Embase, Web of Science, Cochrane Library, Open Grey, Clinicaltrials.gov, Chinese Clinical Trial Registry, WANFANG, VIP Chinese Science and Technology Journal Database, CNKI, Chinese biomedical document service system (SinoMed). Only randomized controlled trials (RCTs) of patients with cervical cancer will be included. Literature screening, data extraction, and the assessment of risk of bias will be independently conducted by 2 reviewers, and the 3rd reviewer will be consulted if any different opinions existed. Clinical total effective rate, adverse events, SCCAg, CYFRA21-1, quality of life, and immune function will be evaluated. Systematic review and meta-analysis will be produced by RevMan 5.3 and Stata 14.0. This protocol reported in accordance with the Preferred Reporting Items for Systematic Review and Meta-analysis Protocols (PRISMA-P) statement, and we will report the systematic review by following the PRISMA statement.

RESULTS

The current study is a protocol for systematic review and meta-analysis without results, and data analysis will be carried out after the protocol. We will share our findings in the fourth quarter of 2021.

CONCLUSION

Efficacy and safety of AS2O3 combined with platinum drugs in the treatment of cervical cancer will be assessed. The results will be published in a public issue journal to provide evidence-based medical evidence for Obstetrician and Gynecologists to make clinical decisions.

ETHICS AND DISSEMINATION

Ethical approval is not required as the review is a secondary study based on published literature. The results of the study will be published in peer-reviewed publications and disseminated electronically or in print.

PROTOCOL REGISTRATION NUMBER

INPLASY202080130.

摘要

引言

宫颈癌是威胁女性生殖道健康的第二大肿瘤疾病。三氧化二砷是一种多向、多靶点的抗宫颈癌药物。它可与铂类药物联合用于治疗宫颈癌。关于三氧化二砷联合铂类药物治疗宫颈癌的文献结果不一致,目前尚无高质量的系统评价来评估三氧化二砷联合铂类药物对宫颈癌患者的疗效。

方法与分析

将在PubMed、Embase、Web of Science、Cochrane图书馆、Open Grey、Clinicaltrials.gov、中国临床试验注册中心、万方、维普中文科技期刊数据库、知网、中国生物医学文献服务系统(SinoMed)中系统检索2020年8月31日前发表的关于三氧化二砷联合铂类药物治疗宫颈癌的中英文文献。仅纳入宫颈癌患者的随机对照试验(RCT)。文献筛选、数据提取和偏倚风险评估将由2名研究者独立进行,如有不同意见将咨询第3名研究者。将评估临床总有效率、不良事件、鳞状细胞癌抗原(SCCAg)、细胞角蛋白19片段(CYFRA21-1)、生活质量和免疫功能。将采用RevMan 5.3和Stata 14.0进行系统评价和Meta分析。本方案按照系统评价和Meta分析方案的首选报告项目(PRISMA-P)声明进行报告,我们将按照PRISMA声明报告系统评价结果。

结果

本研究是一项系统评价和Meta分析方案,目前尚无结果,将在方案制定后进行数据分析。我们将在2021年第四季度分享研究结果。

结论

将评估三氧化二砷联合铂类药物治疗宫颈癌的疗效和安全性。结果将发表在公开期刊上,为妇产科医生的临床决策提供循证医学依据。

伦理与传播

由于本综述是基于已发表文献的二次研究,无需伦理批准。研究结果将发表在同行评议的出版物上,并以电子或印刷形式传播。

方案注册号

INPLASY202080130

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/06e9/7647570/c9f92bd869df/medi-99-e22950-g001.jpg

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