生脉注射液联合常规疗法治疗阿霉素相关性心脏毒性：一项随机对照试验的系统评价与Meta分析方案
Shengmai injection combined with conventional therapy in treating Adriamycin-related cardiotoxicity: A protocol for systematic review and meta-analysis of randomized controlled trials.
作者信息
Liu Lanchun, Liu Chao, Duan Lian, Bai Jing, Mao Qiyuan, Jie Wang
机构信息
Guang'anmen Hospital, China Academy of Chinese Medical Sciences.
Beijing University of Chinese Medicine, Beijing, China.
出版信息
Medicine (Baltimore). 2020 Nov 6;99(45):e23084. doi: 10.1097/MD.0000000000023084.
BACKGROUND
Tumor is a common and frequently-occurring disease that seriously threatens human health, and is one of the main causes of death. Adriamycin (ADM) is the most commonly used and effective anti-tumor chemotherapeutics in clinical practice, but they can cause severe cardiotoxicity, which obviously limits their clinical application. Shengmai injection is a modern injection form of traditional Chinese medicine widely used for heart failure, myocardial infarction, cardiogenic shock, and cardiotoxicity patients in China. Therefore, we design this systematic review and meta-analysis to assess the effectiveness and safety of Shengmai injection for treating ADM-related cardiotoxicity.
METHODS
We will methodically search PubMed, EMBASE, Cochrane Library, Science Network, China National Knowledge Infrastructure, Wanfang Database, Chinese Journal Database, and China Biomedical Literature Database, in order to include randomized controlled trials which used Shengmai injection in treating ADM-related cardiotoxicity up to September 2020. The search strategies will use the following phrase: "Shengmai injection," "Adriamycin," "doxorubicin," "cardiotoxicity," "cardiomyopathy," "randomized controlled trial." The outcomes included cardiotoxicity rate, echocardiography, electrocardiogram, myocardial enzymes. Two researchers will independently select the study, extract the data and assess the quality by using Stata 14.0 and RevMan 5.3 software. The plan follows the preferred reporting items declared by the systematic review and meta-analysis plan, and the complete systematic review will follow the preferred reporting items for systematic reviews and meta-analysis (PRISMA) statement.
CONCLUSION
The effectiveness and safety of Shengmai injection will be assessed in treating ADM-related cardiotoxicity which can give some evidence for clinical decision making.
TRIAL REGISTRATION NUMBER
INPLASY202090040.
背景
肿瘤是一种严重威胁人类健康的常见多发病，是主要死因之一。阿霉素（ADM）是临床实践中最常用且有效的抗肿瘤化疗药物，但它们会引起严重的心脏毒性，这明显限制了其临床应用。生脉注射液是一种现代中药注射剂，在中国广泛用于心力衰竭、心肌梗死、心源性休克和心脏毒性患者。因此，我们设计了这项系统评价和荟萃分析，以评估生脉注射液治疗阿霉素相关心脏毒性的有效性和安全性。
方法
我们将系统检索PubMed、EMBASE、Cochrane图书馆、中国知网、万方数据库、维普数据库和中国生物医学文献数据库，以纳入截至2020年9月使用生脉注射液治疗阿霉素相关心脏毒性的随机对照试验。检索策略将使用以下短语：“生脉注射液”、“阿霉素”、“多柔比星”、“心脏毒性”、“心肌病”、“随机对照试验”。结局指标包括心脏毒性发生率、超声心动图、心电图、心肌酶。两名研究人员将独立选择研究、提取数据并使用Stata 14.0和RevMan 5.3软件评估质量。本方案遵循系统评价和荟萃分析方案声明的首选报告项目，完整的系统评价将遵循系统评价和荟萃分析的首选报告项目（PRISMA）声明。
结论
将评估生脉注射液治疗阿霉素相关心脏毒性的有效性和安全性，可为临床决策提供一些依据。
试验注册号
INPLASY202090040。
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