西药黄丸治疗胃癌的疗效和安全性：系统评价和荟萃分析方案。
Efficacy and safety of Xihuang pill for gastric cancer: A protocol for systematic review and meta-analysis.
机构信息
Department of Traditional Chinese Medicine Oncology, Guang'anmen Hospital South District, Beijing.
Department of Traditional Chinese Medicine Oncology, The First People's Hospital of Xiangtan City, Xiangtan, Hunan Province.
出版信息
Medicine (Baltimore). 2021 May 14;100(19):e25726. doi: 10.1097/MD.0000000000025726.
BACKGROUND
Xihuang pill has been widely applied as a promising adjunctive drug for gastric cance. However, the exact effects and safety of Xihuang pill have yet to be systematically investigated. We aimed to summarize the effificacy and safety of Xihuang pill for the treatment of advanced GC through the meta-analysis, in order to provide scientific reference for the design of future clinical trials.
METHODS
The protocol followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols. Relevant randomized controlled trials were searched from PubMed, the Cochrane Library, Embase, the China National Knowledge Infrastructure, Wanfang Database, Chinese Science and echnology Periodical Database, and Chinese Biomedical Literature Database. Papers in English or Chinese published from their inception to October 2020 will be included without any restrictions. Cochrane Risk of Bias tool will be used to assess the risk of bias of included studies. The RevMan 5.4 and Stata 16.0 software will be applied for statistical analyses. Statistical heterogeneity will be computed by I2 tests. Sensitivity analysis will be conducted to evaluate the stability of the results. The publication bias will be evaluated by funnel plots and Egger test. The quality of evidence will be assessed by the Grading of Recommendations Assessment, Development and Evaluate system.
RESULTS
The results of our research will be published in a peer-reviewed journal.
CONCLUSION
The conclusion of this study will provide helpful evidence of the effect and safety of Xihuang pill for the treatment of GC in clinical practice.
OSF REGISTRATION NUMBER
10.17605/OSF.IO/VFJAK.
背景
西黄丸已广泛应用于胃癌的辅助治疗，具有广阔的应用前景。但西黄丸治疗胃癌的疗效和安全性尚未得到系统评价。本研究旨在通过 Meta 分析系统评价西黄丸治疗晚期胃癌的疗效和安全性，为未来临床试验的设计提供科学参考。
方法
本研究方案遵循《系统评价和荟萃分析优先报告的条目》。通过检索 PubMed、Cochrane Library、Embase、中国知网、万方数据库、中国科技期刊数据库、中国生物医学文献数据库，搜集西黄丸联合化疗对比单纯化疗治疗晚期胃癌的随机对照试验，检索时限均从建库至 2020 年 10 月。语言限定为中文或英文。不设纳入和排除标准。采用 Cochrane 偏倚风险评估工具评价纳入研究的偏倚风险。采用 RevMan 5.4 和 Stata 16.0 软件进行统计分析。采用 I 2 检验评价异质性，若 I 2 < 50%，采用固定效应模型进行 Meta 分析；若 I 2 > 50%，采用随机效应模型进行 Meta 分析。敏感性分析用于评价结果的稳定性。漏斗图和 Egger 检验用于评估发表偏倚。采用 GRADE 系统评价证据质量。
结果
研究结果将发表在同行评议期刊上。
结论
本研究将为西黄丸治疗胃癌的临床应用提供疗效和安全性方面的有益证据。
OSF 注册号：10.17605/OSF.IO/VFJAK。
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