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鸦胆子油乳注射液作为晚期结直肠癌患者的辅助治疗:一项系统评价与荟萃分析方案

Brucea javanica oil emulsion injection (BJOEI) as an adjunctive therapy for patients with advanced colorectal carcinoma: A protocol for a systematic review and meta-analysis.

作者信息

Xu Chunhong, Guo Xinxin, Zhou Changhui, Zhang Hualing

机构信息

Department of Gastroenterology.

Department of Central Laboratory, Liaocheng People's Hospital, Liaocheng, Shandong Province, China.

出版信息

Medicine (Baltimore). 2020 Jul 2;99(27):e21155. doi: 10.1097/MD.0000000000021155.

Abstract

BACKGROUND

Brucea javanica oil emulsion injection (BJOEI) has been widely applied as a promising adjunctive drug for colorectal carcinoma (CRC). However, the exact effects and safety of BJOEI remains controversial. In this study, we aimed to summarize the efficacy and safety of BJOEI for the treatment of advanced CRC through the meta-analysis, in order to provide scientific reference for the design of future clinical trials.

METHODS

Eligible prospective controlled clinical trials were searched from PubMed, Cochrane Library, Google Scholar, Medline, Web of Science (WOS), Excerpt Medica Database (Embase), Chinese BioMedical Database (CBM), China Scientific Journal Database (VIP), China National Knowledge Infrastructure (CNKI) and Wanfang Database. Papers in English or Chinese published from January 2000 to May 2020 will be included without any restrictions. The clinical outcomes including therapeutic effects, quality of life (QoL), immune function and adverse events, were systematically evaluated.Study selection and data extraction will be performed independently by 2 reviewers. Review Manager 5.3 and Stata 14.0 were used for data analysis, and a fixed or random-effect model will be used depending upon the heterogeneity observed between trials. Subgroup and meta-regression analysis will be carried out depending on the availability of sufficient data.

RESULTS

The results of this systematic review will be published in a peer-reviewed journal.

CONCLUSION

Our study will draw an objective conclusion of the effects and safety of BJOEI for advanced CRC, and provide a helpful evidence for clinicians to formulate the best postoperative adjuvant treatment strategy for CRC patients.INPLASY registration number: INPLASY202060014.

摘要

背景

鸦胆子油乳注射液(BJOEI)已被广泛用作治疗结直肠癌(CRC)的一种有前景的辅助药物。然而,BJOEI的确切疗效和安全性仍存在争议。在本研究中,我们旨在通过荟萃分析总结BJOEI治疗晚期CRC的疗效和安全性,以便为未来临床试验的设计提供科学参考。

方法

从PubMed、Cochrane图书馆、谷歌学术、Medline、科学引文索引(WOS)、医学文摘数据库(Embase)、中国生物医学文献数据库(CBM)、中文科技期刊数据库(VIP)、中国知网(CNKI)和万方数据库中检索符合条件的前瞻性对照临床试验。纳入2000年1月至2020年5月发表的英文或中文论文,无任何限制。系统评价临床结局,包括治疗效果、生活质量(QoL)、免疫功能和不良事件。研究选择和数据提取将由2名评审员独立进行。使用Review Manager 5.3和Stata 14.0进行数据分析,并根据试验间观察到的异质性使用固定或随机效应模型。根据是否有足够的数据进行亚组分析和Meta回归分析。

结果

本系统评价的结果将发表在同行评审期刊上。

结论

我们的研究将对BJOEI治疗晚期CRC的效果和安全性得出客观结论,并为临床医生为CRC患者制定最佳术后辅助治疗策略提供有益证据。INPLASY注册号:INPLASY202060014。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dc02/7337478/77eca2ba5ac0/medi-99-e21155-g002.jpg

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