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Shenlingcao oral liquid for patients with non-small cell lung cancer receiving adjuvant chemotherapy after radical resection: A multicenter randomized controlled trial

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收录情况： ◇ SCIE

作者：
Liu Yanmei[1,2,3] * ; Luo Xiaochao[1,2,3] ; Liu Jiali[1,2,3] ; Ma Yu[1,2,3] ; Tan Jing[1,2,3] ; Wang Wen[1,2,3] ; Hu Jian[4] ; Fu Xiangning[5] ; Xu Lin[6] ; Yu Fenglei[7] ; Xu Shidong[8] ; Ma Haitao[9] ; Yu Xiuyi[10] ; You Qingjun[11] ; Wang Zhiqiang[11] ; Li Ling[1,2,3,*2] ; Zhang Xun[12,*1] ; Sun Xin[1,2,3,*2] ;
机构： [1]Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, China [2]NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Chengdu, China [3]Sichuan Center of Technology Innovation for Real World Data, Chengdu, China [4]Department of Thoracic Surgery, The First Affiliated Hospital, Zhejiang University, School of Medicine, Hangzhou 310003, China [5]Department of Thoracic Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China [6]Department of Thoracic Surgery, Jiangsu Key Laboratory of Molecular and Translational Cancer Research, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, Nanjing Medical University Affiliated Cancer Hospital, Nanjing 210029, China [7]Department of Thoracic Surgery, The Second Xiangya Hospital, Central South University, Changsha 410011, China [8]Department of Thoracic Surgery, Harbin Medical University Cancer Hospital, Harbin 150081, China [9]Department of Thoracic Surgery, Dushu Lake Hospital Affiliated to Soochow University, Suzhou, Jiangsu 215006, China [10]Department of Thoracic Surgery, The First Affiliated Hospital of Xiamen University, Xiamen 361003, China [11]Department of Thoracic Surgery, The Affiliated Hospital of Jiangnan University, Wuxi 214062, China [12]Department of Thoracic Surgery, Tianjin Chest Hospital, Tianjin 300051, China
出处：
DOI： 10.1016/j.phymed.2023.154723
ISSN：

关键词： Adjuvant therapy Traditional Chinese medicine Quality of life Non-small cell lung cancer Randomized controlled trial

摘要：
Low quality of life (QoL) in patients with non-small cell lung cancer (NSCLC) receiving adjuvant chemotherapy after radical resection is a major global health issue. High-quality evidence for the effectiveness of Shenlingcao oral liquid (SOL) as a complementary treatment in this patients is lacking at present.To determine whether complementary SOL treatment in NSCLC patients receiving adjuvant chemotherapy would yield greater improvements in QoL than chemotherapy alone.We conducted a multicenter, randomized controlled trial of stages IIA-IIIA NSCLC patients undergoing adjuvant chemotherapy in seven hospitals.Using stratified blocks, participants were randomized in a 1:1 ratio to receive SOL combined with conventional chemotherapy or conventional chemotherapy alone. The primary outcome was the change in global QoL from baseline to the fourth chemotherapy cycle, and intention-to-treat analysis was applied with a mixed-effect model. Secondary outcomes were functional QoL, symptoms, and performance status scores at the 6-month follow-up. Missing data were handled with multiple imputation and a pattern-mixture model.Among 516 randomized patients, 446 (86.43%) completed the study. After the fourth chemotherapy cycle, in comparison with the control group, patients receiving SOL showed a lower reduction in mean global QoL (-2.76 vs. -14.11; mean difference [MD], 11.34; 95% confidence interval [CI], 8.28 to 14.41), greater improvement in physical function (MD, 11.61; 95% CI, 8.57 to 14.65), role function (MD, 10.15; 95% CI, 5.75 to 14.54), and emotional function (MD, 4.71; 95% CI, 1.85 to 7.57), and greater improvements in lung cancer-related symptoms (e.g., fatigue, nausea/vomiting, and appetite loss) and performance status during the 6-month follow-up period (treatment main effect, p < 0.05).SOL treatment for NSCLC patients receiving adjuvant chemotherapy can significantly improve QoL and performance status within 6 months after radical resection.ClinicalTrials.gov identifier: NCT03712969.Copyright © 2023. Published by Elsevier GmbH.

基金：
National Key R&D Program of China (Grant No. 2017YFC1700406), The National Science Fund for Distinguished Young Scholars (Grant No. 82225049), Sichuan Provincial Central Government Guides Local Science and Technology Development Special Project (Grant No. 2022ZYD0127), and the Fundamental Research Funds for the Central public welfare research institutes (Grant No. 2020YJSZX-3).
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外文
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出版当年[2023]版：
大类 | 1 区 医学
小类 | 1 区 药物化学 1 区 全科医学与补充医学 1 区 药学 1 区 植物科学
最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 药物化学 1 区 全科医学与补充医学 1 区 药学 1 区 植物科学
JCR分区：
出版当年[2023]版：
Q1 CHEMISTRY, MEDICINAL Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE Q1 PHARMACOLOGY & PHARMACY Q1 PLANT SCIENCES
最新[2023]版：
Q1 CHEMISTRY, MEDICINAL Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE Q1 PHARMACOLOGY & PHARMACY Q1 PLANT SCIENCES

影响因子： 最新[2023版] 最新五年平均 出版当年[2023版] 出版当年五年平均 出版前一年[2022版]

第一作者：
第一作者机构： [1]Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, China [2]NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Chengdu, China [3]Sichuan Center of Technology Innovation for Real World Data, Chengdu, China
通讯作者：
通讯机构： [1]Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, China [2]NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Chengdu, China [3]Sichuan Center of Technology Innovation for Real World Data, Chengdu, China [12]Department of Thoracic Surgery, Tianjin Chest Hospital, Tianjin 300051, China [*1]Department of Thoracic Surgery, Tianjin Chest Hospital, Tianjin, 300051, China [*2]Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, 37 Guo Xue Xiang, Chengdu, Sichuan 610041, China.
推荐引用方式(GB/T 7714)：
Liu Yanmei,Luo Xiaochao,Liu Jiali,et al.Shenlingcao oral liquid for patients with non-small cell lung cancer receiving adjuvant chemotherapy after radical resection: A multicenter randomized controlled trial[J].PHYTOMEDICINE.2023,113:doi:10.1016/j.phymed.2023.154723.
APA：
Liu Yanmei,Luo Xiaochao,Liu Jiali,Ma Yu,Tan Jing...&Sun Xin.(2023).Shenlingcao oral liquid for patients with non-small cell lung cancer receiving adjuvant chemotherapy after radical resection: A multicenter randomized controlled trial.PHYTOMEDICINE,113,
MLA：
Liu Yanmei,et al."Shenlingcao oral liquid for patients with non-small cell lung cancer receiving adjuvant chemotherapy after radical resection: A multicenter randomized controlled trial".PHYTOMEDICINE 113.(2023)

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