Liu Zhen, Dong Yanling, Zhu Meili, Mu Ying, Chen Lemei
Department of Neurology.
Department of Infectious Diseases, People's Hospital of Weifang Binhai Economic and Technological Development Zone, Weifang.
Medicine (Baltimore). 2020 Jun 26;99(26):e20984. doi: 10.1097/MD.0000000000020984.
Esophageal carcinoma (EC) is one of the worst malignant digestive neoplasms with a strong tendency of invasion and metastasis. Despite the improvement of diagnostic and therapeutic methods in the past decades, the prognosis of EC remains unsatisfactory. Xiaoaiping injection (XAPI), a famous traditional Chinese herbal medicine, has been widely applied as a promising adjunctive drug for EC. However, the exact effects and safety of XAPI have yet to be systematically investigated. We aimed to summarize the efficacy and safety of XAPI for the treatment of advanced EC through the meta-analysis, in order to provide scientific reference for the design of future clinical trials.
Relevant randomized controlled trials (RCTs) were searched from Cochrane Library, PubMed, Google Scholar, Web of Science, Excerpt Medica Database, Medline, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, China Scientific Journal Database and Wanfang Database. Papers in English or Chinese published from January 2000 to May 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, 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 results of this study will be published in a peer-reviewed journal, and provide more evidence-based guidance in clinical practice.
Our study will draw an objective conclusion of the effects of XAPI combined with conventional treatment for advanced EC and provide a helpful evidence for clinicians to formulate the best postoperative adjuvant treatment strategy for EC patients.
INPLASY202050094.
食管癌（EC）是最严重的恶性消化系统肿瘤之一，具有很强的侵袭和转移倾向。尽管在过去几十年中诊断和治疗方法有所改进，但EC的预后仍然不尽人意。消癌平注射液（XAPI）是一种著名的传统中药，已被广泛用作治疗EC的一种有前景的辅助药物。然而，XAPI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XAPI治疗晚期EC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。
从Cochrane图书馆、PubMed、谷歌学术、科学网、医学文摘数据库、Medline、中国知网、中国生物医学文献数据库、中国科学期刊数据库和万方数据库中检索相关随机对照试验（RCT）。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。研究选择和数据提取将由2名研究者独立进行。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、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估。
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。
我们 的研究将对XAPI联合传统治疗晚期EC的效果得出客观结论，并为临床医生为EC患者制定最佳术后辅助治疗策略提供有益证据。
INPLASY注册号：INPLASY202050094。
