参芪扶正注射液联合铂类化疗治疗Ⅲ/Ⅳ期非小细胞肺癌的疗效与安全性：一项随机对照试验的系统评价与Meta分析方案
Efficacy and safety of Shenqi Fuzheng injection combined with platinum-based chemotherapy for stage III/IV non-small cell lung cancer: A protocol for systematic review and meta-analysis of randomized controlled trials.
作者信息
Chen Hongwei, Yao Xiaojun, Liu Zhengtang, Li Ting, Xu Cong, Wang Jue, Sui Xinbing, Leung Elaine Lai-Han, Wu Qibiao
机构信息
State Key Laboratory of Quality Research in Chinese Medicine.
Faculty of Medicine.
出版信息
Medicine (Baltimore). 2019 Sep;98(39):e17350. doi: 10.1097/MD.0000000000017350.
BACKGROUND
Shenqi Fuzheng injection (SFI) is a commonly used anti-cancer Chinese patent medicine and has long been prescribed as adjunctive treatment to platinum-based chemotherapy (PBC) in patients with stage III/IV non-small cell lung cancer (NSCLC). However, the efficacy and safety of this combination therapy remain unclear.
METHODS
A systematic review and meta-analysis will be conducted following the Preferred Reported Items for Systematic Review and Meta-analysis (PRISMA) guidelines. Seven databases will be searched for relevant studies from their inception to the present date: PubMed, Web of Science, Cochrane Library, EMBASE, ClinicalTrials.gov, China National Knowledge Infrastructure (CNKI), and Wanfang Databases. All randomized clinical trials comparing SFI in combination with PBC versus PBC alone will be retrieved and assessed for inclusion. Two researchers will independently perform the selection of the studies, data extraction, and synthesis. The Cochrane Risk of Bias Tool will be used to evaluate the risk of bias of the RCTs. The primary endpoint is the disease control rate (DCR), the secondary outcomes are the objective response rate (ORR), survival rate, quality of life (QOL), cellular immune function, and toxicities. Review Manager 5.3 (Nordic Cochrane Centre, Cochrane Collaboration, 2014 Copenhagen, Denmark) will be used to analyze the outcomes.
RESULTS
This study will systematically evaluate the efficacy and safety of SFI combined with platinum-based chemotherapy in the treatment of stage III/IV NSCLC. The results will be published in a peer-reviewed journal.
CONCLUSION
This systematic review will evaluate the effects of SFI as adjunctive treatment to platinum-based chemotherapy in the patients with stage III/IV non-small cell lung cancer, thus providing evidence to the clinical application of this combination therapy.
PROSPERO REGISTRATION NUMBER
CRD42019137196.
背景
参芪扶正注射液（SFI）是一种常用的抗癌中成药，长期以来一直被用作III/IV期非小细胞肺癌（NSCLC）患者铂类化疗（PBC）的辅助治疗药物。然而，这种联合治疗的疗效和安全性仍不明确。
方法
将按照系统评价和Meta分析的首选报告项目（PRISMA）指南进行系统评价和Meta分析。将检索七个数据库，以查找从开始到目前的相关研究：PubMed、科学网、Cochrane图书馆、EMBASE、ClinicalTrials.gov、中国知网（CNKI）和万方数据库。检索并评估所有比较SFI联合PBC与单纯PBC的随机临床试验，以确定是否纳入。两名研究人员将独立进行研究选择、数据提取和合成。将使用Cochrane偏倚风险工具评估随机对照试验的偏倚风险。主要终点是疾病控制率（DCR），次要结局是客观缓解率（ORR）、生存率、生活质量（QOL）、细胞免疫功能和毒性。将使用Review Manager 5.3（北欧Cochrane中心，Cochrane协作网，2014年，丹麦哥本哈根）分析结局。
结果
本研究将系统评价SFI联合铂类化疗治疗III/IV期NSCLC的疗效和安全性。结果将发表在同行评审期刊上。
结论
本系统评价将评估SFI作为III/IV期非小细胞肺癌患者铂类化疗辅助治疗的效果，从而为这种联合治疗的临床应用提供证据。
PROSPERO注册号：CRD42019137196。
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