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. 2019 Sep;98(39):e17350.
doi: 10.1097/MD.0000000000017350.

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

Hongwei Chen  1   2 , Xiaojun Yao  1   3 , Zhengtang Liu  4 , Ting Li  1   3 , Cong Xu  1   3 , Jue Wang  1   3 , Xinbing Sui  5   6 , Elaine Lai-Han Leung  1   3 , Qibiao Wu  1   3
Affiliations

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

Hongwei Chen et al. Medicine (Baltimore). 2019 Sep.

Abstract

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.

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Conflict of interest statement

The authors have no conflicts of interest to disclose.

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