Li Jianwei, Han Bin, Sun Guangzong, Zheng Zhong, Mu Ying, Chi Jingxia
Department of Gastroenterology.
Infection Control Office.
Medicine (Baltimore). 2020 Jun 5;99(23):e20532. doi: 10.1097/MD.0000000000020532.
JLC has been widely applied as a promising adjunctive drug for GC. However, the exact effects and safety of JLC have yet to be systematically investigated. We aimed to summarize the efficacy and safety of JLC for the treatment of advanced GC through the meta-analysis, in order to provide scientific reference for the design of future clinical trials.
The protocol followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols. Relevant randomized controlled trials were searched from Cochrane Library, PubMed, Web of Science (WOS), Excerpt Medica Database (Embase), Chinese Biomedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI), China Scientific Journal Database (VIP), and Wanfang Database. Papers in English or Chinese published from their inception to January 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, overall survival, Disease-free survival, quality of life (QoL), immune function, and adverse events, were systematically evaluated. Review Manager 5.3 and Stata 14.0 were used for data analysis, and the quality of the studies was also evaluated.
The findings of this research will be published in a peer-reviewed journal, and provide more evidence-based guidance in clinical practice. INTERNATIONAL PLATFORM OF REGISTERED SYSTEMATIC REVIEW AND META-ANALYSIS PROTOCOLS (INPLASY) REGISTRATION NUMBER:: INPLASY202040105. URL: https://inplasy.com/inplasy-2020-4-0105/.
金莲花胶囊（JLC）已被广泛用作治疗胃癌（GC）的一种有前景的辅助药物。然而，JLC的确切疗效和安全性尚未得到系统研究。我们旨在通过荟萃分析总结JLC治疗晚期GC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。
本方案遵循系统评价和荟萃分析方案的首选报告项目。从Cochrane图书馆、PubMed、科学网（WOS）、医学文摘数据库（Embase）、中国生物医学文献数据库（CBM）、中国知网（CNKI）、维普中文科技期刊数据库（VIP）和万方数据库中检索相关随机对照试验。纳入自数据库建库至2020年1月发表的英文或中文论文，无任何限制。由2名研究人员独立进行研究选择和数据提取。系统评价临床结局，包括总缓解率、完全缓解率、总生存期、无病生存期、生活质量（QoL）、免疫功能和不良事件。使用Review Manager 5.3和Stata 14.0进行数据分析，并对研究质量进行评价。
本研究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。国际注册系统评价和荟萃分析方案平台（INPLASY）注册号：INPLASY202040105。网址：https://inplasy.com/inplasy-2020-4-0105/ 。
