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      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

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          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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          Most cited references31

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          Trends in stage distribution for patients with non-small cell lung cancer: a National Cancer Database survey.

          We examined the recent changes in stage distribution in newly diagnosed patients with non-small cell lung cancer (NSCLC) using a national database to assess the impact of recent advances in imaging modalities. We searched the National Cancer Database for patients with NSCLC diagnosed between the calendar years 1998 and 2006 for which staging information was available. Among the 877,518 patients diagnosed with NSCLC during the study period, staging information was available for 813,302 patients (92.6%). We observed a change in stage distribution between the years 2000 and 2001, with a decrease in stage I, from 27.5 to 24.8%, and a corresponding increase in stage IV, from 35.4 to 38.8%. No significant changes in stage distribution were noted after 2002. Our study showed a recent and significant stage migration in patients with NSCLC. It is likely that increased acceptance and widespread use of (18)fluorodeoxyglucose-positron emission tomography scan and routine brain imaging could account for these changes.
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            Preoperative evaluation of patients undergoing lung resection surgery.

            Lung cancer continues to be the leading case of cancer deaths in the United States. In patients with resectable non-small cell lung cancer, surgical resection is the treatment of choice. An accurate preoperative general and pulmonary-specific evaluation is essential as postoperative complications and morbidity of lung resection surgery are significant. After confirming anatomic resectability, patients must undergo a thorough evaluation to determine their ability to withstand the surgery and the loss of the resected lung. The measurement of spirometric indexes (ie, FEV(1)) and diffusing capacity of the lung for carbon monoxide (DLCO) should be performed first. If FEV(1) and DLCO are > 60% of predicted, patients are at low risk for complications and can undergo pulmonary resection, including pneumonectomy, without further testing. However, if FEV(1) and DLCO are 40%, the patient can undergo lung resection. If the ppo FEV(1) and ppo DLCO are 15 mL/kg, surgery can be undertaken. If the O(2)max is < 15 mL/kg, surgery is not an option. This review discusses the existing modalities for preoperative evaluation prior to lung resection surgery.
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              Elemene injection as adjunctive treatment to platinum-based chemotherapy in patients with stage III/IV non-small cell lung cancer: a meta-analysis following the PRISMA guidelines

              Elemene injection is an anticancer Chinese patent medicine that is widely used for the treatment of advanced lung cancer. Its active ingredients are β-, γ- and δ-elemene, which are extracted from Curcumaaromatica Salisb. (Curcumawenyujin Y.H. Chen & C. Ling).
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                Author and article information

                Journal
                Medicine (Baltimore)
                Medicine (Baltimore)
                MEDI
                Medicine
                Wolters Kluwer Health
                0025-7974
                1536-5964
                September 2019
                27 September 2019
                : 98
                : 39
                : e17350
                Affiliations
                [a ]State Key Laboratory of Quality Research in Chinese Medicine
                [b ]Faculty of Medicine
                [c ]Faculty of Chinese Medicine, Macau University of Science and Technology, Macau
                [d ]Department of Geriatrics, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing
                [e ]Department of Medical Oncology, Holistic Integrative Oncology Institutes and Holistic Integrative Cancer Center of Traditional Chinese and Western Medicine, the Affiliated Hospital of Hangzhou Normal University
                [f ]Department of Cancer Pharmacology, Holistic Integrative Pharmacy Institutes, College of Medicine, Hangzhou Normal University, Hangzhou, Zhejiang, P. R. China.
                Author notes
                []Correspondence: Qibiao Wu, State Key Laboratory of Quality Research in Chinese Medicines, Macau University of Science and Technology, Avenida Wai Long, Taipa, Macau 999078, P. R. China (e-mail: qbwu@ 123456must.edu.mo ), Elaine Lai Han Leung, State Key Laboratory of Quality Research in Chinese Medicines, Macau University of Science and Technology, Avenida Wai Long, Taipa, Macau 999078, P. R. China (e-mail: lhleung@ 123456must.edu.mo ), Xinbing Sui, Department of Medical Oncology, Holistic Integrative Oncology Institutes and Holistic Integrative Cancer Center of Traditional Chinese and Western Medicine, the Affiliated Hospital of Hangzhou Normal University, College of Medicine, Hangzhou Normal University, Hangzhou, Zhejiang, P. R. China (e-mail: hzzju@ 123456zju.edu.cn ).
                Article
                MD-D-19-06889 17350
                10.1097/MD.0000000000017350
                6775431
                31574877
                9abb65ce-7754-4385-8113-3cc6e0dc4e59
                Copyright © 2019 the Author(s). Published by Wolters Kluwer Health, Inc.

                This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0

                History
                : 3 September 2019
                : 3 September 2019
                Categories
                5700
                Research Article
                Study Protocol Systematic Review
                Custom metadata
                TRUE

                efficacy,meta-analysis,non-small cell lung cancer,platinum-based chemotherapy,randomized controlled trial,safety,shenqi fuzheng injection,systematic review

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