斑蝥酸钠维生素B6注射液对肝细胞癌患者生存、肝功能、免疫功能及生活质量的影响：一项Meta分析方案
Effect of sodium cantharidinate/vitamin B6 injection on survival, liver function, immune function, and quality of life in patients with hepatocellular carcinoma: Protocol for a meta-analysis.
作者信息
Zhu Min, Liu Xiujing, Zhou Changhui, Li Juan
机构信息
Department of Clinical Laboratory.
Department of Central Laboratory, Liaocheng People's Hospital, Liaocheng, Shandong Province, P.R. China.
出版信息
Medicine (Baltimore). 2020 Aug 21;99(34):e21952. doi: 10.1097/MD.0000000000021952.
BACKGROUND
Sodium cantharidinate/vitamin B6 (SC/VB6) injection, a famous insect-derived traditional Chinese medicine preparation, has been widely applied as a promising adjunctive drug for hepatocellular carcinoma (HCC). However, its exact clinical efficacy and safety is still not well investigated. In this study, we aimed to summarize the efficacy of SC/VB6 injection on survival, liver function, immune function, and quality of life (QoL) in patients with HCC through the meta-analysis.
METHODS
All available randomized controlled trials (RCTs) and high-quality prospective cohort studies that investigated the efficacy and safety of SC/VB6 for patients with HCC were searched from ten electronic databases including PubMed, Google Scholar, Cochrane Library, Excerpt Medica Database (Embase), Medline, Web of Science (WOS), Chinese Biomedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI), China Scientific Journal Database (CSJ), and Wanfang Database. Papers in Chinese or English published from January 2000 to July 2020 will be included without any restrictions.Study selection and data extraction will be performed independently by 2 researchers. The clinical outcomes including overall survival (OS), QoL, liver function, 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 clinical trials was also evaluated.
RESULTS
The results of this study will be published in a peer-reviewed journal, and provide a helpful evidence for clinicians to formulate the best postoperative adjuvant treatment strategy for HCC patients.
CONCLUSION
Our study will draw an objective conclusion of the efficacy of SC/VB6 on survival, liver function, immune function, and QoL in patients with HCC.
INPLASY REGISTRATION NUMBER
INPLASY202070121.
背景
斑蝥酸钠维生素B6注射液是一种著名的昆虫源中药制剂，作为一种有前景的肝细胞癌（HCC）辅助药物已被广泛应用。然而，其确切的临床疗效和安全性仍未得到充分研究。在本研究中，我们旨在通过荟萃分析总结斑蝥酸钠维生素B6注射液对HCC患者生存、肝功能、免疫功能和生活质量（QoL）的疗效。
方法
从包括PubMed、谷歌学术、Cochrane图书馆、医学文摘数据库（Embase）、Medline、科学引文索引（WOS）、中国生物医学文献数据库（CBM）、中国知网（CNKI）、中国科学期刊数据库（CSJ）和万方数据库在内的10个电子数据库中检索所有研究斑蝥酸钠维生素B6对HCC患者疗效和安全性的随机对照试验（RCT）和高质量前瞻性队列研究。纳入2000年1月至2020年7月发表的中文或英文论文，无任何限制。研究筛选和数据提取将由2名研究人员独立进行。系统评价总生存（OS）、QoL、肝功能、免疫功能和不良事件等临床结局。使用Review Manager 5.3和Stata 14.0进行数据分析，并评估临床试验的质量。
结果
本研究结果将发表在同行评审期刊上，为临床医生为HCC患者制定最佳术后辅助治疗策略提供有益证据。
结论
我们的研究将对斑蝥酸钠维生素B6对HCC患者生存、肝功能、免疫功能和QoL的疗效得出客观结论。
INPLASY注册号：INPLASY202070121。
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