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康莱特注射液治疗胃癌的疗效与安全性:一项系统评价与Meta分析方案

Efficacy and safety of Kanglaite injection for gastric cancer: A protocol for systematic review and meta-analysis.

作者信息

Hou Daorui, Yang Liangjun, Xiong Jian, Xiong Lu

机构信息

Department of Traditional Chinese Medicine Oncology, The First People's Hospital of Xiangtan City, Xiangtan 411101, Hunan Province.

Department of Gastroenterology, Tongde Hospital of Zhejiang Province, Hangzhou 310012, Zhejiang Province.

出版信息

Medicine (Baltimore). 2020 Aug 7;99(32):e21619. doi: 10.1097/MD.0000000000021619.

Abstract

BACKGROUND

Kanglaite injection is a broad-spectrum anti-tumor drug, which is extracted from the seeds of the Chinese medicinal herb Coix lacryma-jobi, and has been widely used for the treatment of gastric cancer (GC). This study aimed to systematically investigate the efficacy and safety of Kanglaite injection for the treatment of GC.

METHODS

We will perform the comprehensive literature search in English and Chinese electronic database from its inception to June 2020. Two trained researchers will independently select the qualified studies for data extraction and assess the quality and risk of bias. Cochrane Risk of Bias tool will be used to assess the risk of bias of included studies. The outcomes included overall response rate, complete response rate, 3-year progression-free survival rate, 3-year overall survival rate, and different types of treatment-related adverse events. Funnel plot analysis and Egger test will be used to assess the publication bias. Finally, the quality of evidence will be assessed by the grading of recommendations assessment, development, and evaluate system . We will calculate the risk ratio as well as their 95% confidence intervals of these outcomes and pool the results using RevMan 5.4 software and STATA 16.0 software.

RESULTS

The results of our research will be published in a peer-reviewed journal.

CONCLUSION

The conclusion of our systematic review will provide evidence to judge whether Kanglaite injection is an effective intervention for patient with GC.

OSF REGISTRATION NUMBER

10.17605/OSF.IO/HF679.

摘要

背景

康莱特注射液是一种广谱抗肿瘤药物,从中药材薏苡仁的种子中提取,已广泛用于治疗胃癌(GC)。本研究旨在系统评价康莱特注射液治疗GC的疗效和安全性。

方法

我们将在英文和中文电子数据库中进行全面的文献检索,检索时间从建库至2020年6月。两名经过培训的研究人员将独立选择合格的研究进行数据提取,并评估质量和偏倚风险。采用Cochrane偏倚风险工具评估纳入研究的偏倚风险。结局指标包括总缓解率、完全缓解率、3年无进展生存率、3年总生存率以及不同类型的治疗相关不良事件。采用漏斗图分析和Egger检验评估发表偏倚。最后,采用推荐意见评估、制定与评价系统对证据质量进行评估。我们将计算这些结局指标的风险比及其95%置信区间,并使用RevMan 5.4软件和STATA 16.0软件汇总结果。

结果

我们的研究结果将发表在同行评审期刊上。

结论

我们系统评价的结论将为判断康莱特注射液是否为GC患者的有效干预措施提供证据。

开放科学框架注册号

10.17605/OSF.IO/HF679。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/491b/7593039/4282bfe9d57c/medi-99-e21619-g001.jpg

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