Chinese herbal medicine as maintenance therapy for improving the quality of life for advanced non-small cell lung cancer patients
Chinese herbal medicine as maintenance therapy for improving the quality of life for advanced non-small cell lung cancer patients
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中草药维持治疗改善晚期非小细胞肺癌患者的生活质量
DOI：
10.1016/j.ctim.2015.12.008
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发表时间：
2016-02-01
影响因子：
3.6
通讯作者：
Yang, Guowang
中科院分区：
文献类型：
--
作者：
Han, Yan;Wang, Huan;Yang, Guowang
目的：本研究的目的是评估使用中药作为维持治疗的有效性和安全性，考虑一线常规铂类化疗后晚期非小细胞肺癌（NSCLC）患者的生存率。设计：一项开放标签、随机、对照试验。设置：中国四家医院。干预措施和主要结局指标：共有106例患者符合条件，并随机分为两组，来自中国的四家医院。两组均给予最佳支持护理（BSC）。另外，试验组患者每天服用中药，直至病情加重或患者辞职。本研究以无进展生存期（PFS）和生活质量（QOL）为主要结局，综合评价治疗效果。通过癌症治疗功能评估-肺（FACT-L）4.0问卷测量QOL。结果：106例患者中，99例完成研究。治疗和随访后的PFS无显著差异。两组间的中位PFS时间和6个月PFS概率。但试验组3个月无进展生存概率明显高于对照组（FAS、PPS：P< 0.01）。生活质量方面，两组在躯体健康、情感健康、功能健康、肺癌症状领域及FACT-L4.0总分方面差异有统计学意义（FAS，PPS：P<0. 05）。在社会幸福感方面没有显著差异。结论：中药治疗晚期非小细胞肺癌患者耐受性好，可改善患者生活质量。CHM值得在今后的研究中进一步研究。(C)2015作者由Elsevier Ltd.发布。这是一篇CC-BY-NC-ND许可证下的开放获取文章（http：//creativecommons.orgilicensesiby-nc-nd/4.0/）。
Objective: The purpose of the study was to assess the efficacy and safety of using Chinese herbal medicine (CHM) as maintenance therapy considering the survival of advanced non-small-cell lung cancer (NSCLC) patients after first-line conventional platinum-based chemotherapy.Design: An open-label, randomized, controlled trial.Setting: Four hospitals in China.Interventions and main outcome measures: A total of 106 patients were eligible and randomly divided into two groups from four hospitals in China. Both groups received the best supporting care (BSC). Additionally, patients in the trial group were given CHM every day until the disease became aggravated or the patients resigned. The study took both progression-free survival (PFS) and quality of life (QOL) as the primary outcomes to comprehensively evaluate the effect of the treatment. QOL was measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L) 4.0 questionnaire. Side effects and safety were evaluated at the same time.Results: Of the 106 patients, 99 completed the study. After treatment and follow-up for PFS, there were no significant differences. in the median PFS time and the 6-month PFS probability between the two groups. However, the 3-month PFS probability in the trial group was significantly higher than that in the control group (FAS, PPS: P< 0.01). For QOL, there were significant differences between the two groups in the following: physical well-being, emotional well-being, functional well-being, lung cancer symptom domain and total score of the FACT-L4.0 (FAS, PPS: P< 0.05). There was no significant difference in the social well-being domain. No serious adverse side effects to the treatment were observed.Conclusions: CHM is well tolerated and may improve the QOL of advanced NSCLC patients. CHM is worth studying in future investigations. (C) 2015 The Authors. Published by Elsevier Ltd. This is an open access article under the CC-BY-NC-ND license (http://creativecommons.orgilicensesiby-nc-nd/4.0/).