Clinical efficacy and safety of Aidi injection plus paclitaxel-based chemotherapy for advanced non-small cell lung cancer: A meta-analysis of 31 randomized controlled trials following the PRISMA guidelines. (10th January 2019)

• Record Type: Journal Article
• Authors: Xiao, Zheng; Wang, Chengqiong; Zhou, Minghua; Hu, Shanshan; Jiang, Yuan; Huang, Xiaorong; Li, Nana; Feng, Jihong; Tang, Fushan; Chen, Xiaofan; Ding, Jie; Chen, Ling; Wang, Yuhe; Li, Xiaofei
• Is Part Of: Journal of ethnopharmacology. Volume 228(2018)
• Page Start: 110
• Page End: 122
• Publication Date: 2019-01-10
• Subjects: ADRs adverse drug reactions -- AMI astragalus membranaceus injection -- CNKI China national knowledge infrastructure database -- CBM China biological medicine database -- CR complete response -- CI confidence interval -- CTCAE 3.0 Common Terminology Criteria for Adverse Events, Version 3.0 -- DCR disease control rate -- DP docetaxel and cisplatin -- EP etoposide and platinol -- FEM fixed-effects model -- GP gemcitabine and cisplatin -- GRADE Grading of Recommendations Assessment, Development and Evaluation -- ISI Web of Science -- KPS Karnofsky Performance Scale -- NSCLC non-small cell lung cancer -- NC no change -- NP navelbine and cisplatin -- ORR objective response rate -- OS overall survival -- PB publication bias -- PR partial response -- PD progressive disease -- PFS progression free survival -- PRISMA guidelines Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines -- QOL quality of life -- RECIST Response Evaluation Criteria in Solid Tumors -- RCT randomized controlled trial -- RevMan5.3 Review Manager 5.3 -- REM random-effects model -- RR risk ratios -- SM statistical method -- SR systematic review -- Taxol paclitaxel -- TP paclitaxel and cisplatin -- TO paclitaxel and oxaliplatin -- TC paclitaxel and carboplatin -- WHO World Health Organization -- VIP Chinese Scientific Journals Full-Text Database; Astragaloside II (PubChem CID: 71306915) -- Astragaloside IV (PubChem CID: 13943297) -- Cantharidin (PubChem CID: 5944) -- Ginsenoside Rb1 (PubChem CID: 118987129) -- Ginsenoside Rg1 (PubChem CID: 441923) -- Ginsenoside Rg3 (PubChem CID: 9918693) -- Ginsenoside Rh2 (PubChem CID: 119307) -- Ginsenoside Rc (PubChem CID: 12855889) -- Ginsenoside Rd (PubChem CID: 24721561) -- Ginsenoside Re (PubChem CID: 441921) -- Isofraxidin (PubChem CID: 5318565) -- Syringin (PubChem CID: 5316860); Aidi injection -- Non-small cell lung cancer (NSCLC) -- Paclitaxel-based chemotherapy -- Randomized controlled trial (RCT) -- Meta-analysis; Ethnopharmacology -- Periodicals; Pharmacognosy -- Periodicals; Herbs -- Periodicals; Herbs -- Periodicals; Pharmacognosy -- Periodicals; Pharmacognosie -- Périodiques; Herbes -- Périodiques; 615.1
• DOI: 10.1016/j.jep.2018.09.024
• Languages: English
• ISSNs: 0378-8741

Abstract

Abstract: Ethnopharmacological relevance: As an important Chinese herb injection, Aidi injection is composed of the extracts from Astragalus, Eleutherococcus senticosus, Ginseng, and Cantharis. Aidi injection plus paclitaxel-based chemotherapy is often used to in the treatment of non-small cell lung cancer (NSCLC) in China. Aim of the study: The objective of this study is to further confirm whether Aidi injection can improve the tumor responses and survivals, and reveal its safety, optimal usage and combination with paclitaxel. Materials and methods: A meta-analysis was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. All randomized controlled trials (RCTs) concerning the Aidi injection plus paclitaxel-based chemotherapy for NSCLC were selected. Main outcomes were objective response rate (ORR), disease control rate (DCR), survivals, quality of life (QOL) and adverse drug reactions (ADRs). All data were extracted by using a standard data extraction form and synthesized through meta-analysis. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used for rating the quality of evidence. Results: Thirty-one RCTs involving 2058 patients were included, and most trials had an unclear methodological bias risk. The risk ratio (RR) and 95% confidence intervals (CI) of ORR, DCR, QOL, neutropenia, thrombocytopenia, gastrointestinal toxicity and liver injury were as following: 1.32 (1.20–1.46), 1.14 (1.09–1.20), 1.89 (1.66–2.16), 0.61 (0.51–0.74), 0.62 (0.45–0.87), 0.59 (0.49–0.72) and 0.52 (0.36–0.75). Compared to chemotherapy alone, all differences were statistically significant. Subgroup analysis showed that only with the TP, Aidi injection could increase the ORR and DCR. Treatment with 100 ml, 80 ml or 50 ml/time, and 14 days/2 cycles or 21 days/2–4 cycles, Aidi injection could increase the ORR and DCR, respectively. Sensitivity analysis showed that the results had good robustness. None of the trials reported the overall survivals (OS), progression free survival (PFS). The quality of evidences was moderate. Conclusions: Current moderate evidence revealed that Aidi injection plus paclitaxel-based chemotherapy, especially TP can significantly improve the clinical efficacy and QOL for patients with stage III/IV NSCLC. Aidi injection can relieve the risk of hematotoxicity, gastrointestinal toxicity and liver injury in patient with NSCLC receiving paclitaxel-based chemotherapy. The optimal usage may be 50 ml/time and 14 days/2 cycles. Graphical abstract: Main findings: Aidi injection plus paclitaxel-based chemotherapy, especially TP can significantly improve the clinical efficacy and QOL in patients with advanced NSCLC. Aidi injection can relieve the risk of hematotoxicity, gastrointestinal toxicity and liver injury in patient with NSCLC receiving paclitaxel-based chemotherapy. Based on the optimization of efficacy and safety, the optimal usage may be 50 ml/time and 14 days/2 cycles. Aidi injection may have attenuation and synergistic efficacy to paclitaxel-based chemotherapy.