Multi⁃centered randomized controlled study of Chinese medicine integrated with chemotherapy for stage Ⅳ non⁃small cell lung cancer

LI⁃jun SONG; Xue⁃jiao MA; Jia⁃bin ZHENG; Xue⁃qian WANG; Ying ZHANG; Jie LIU; Wei HOU; Li⁃zhu LIN; YI⁃Lan Jiang; Ying XIE; Ping LI; Shen⁃yu WANG; Hong⁃liang ZHANG; Qi⁃jin SHU; Hong⁃sheng LIN

doi:10.16025/j.1674-1307.2022.01.001

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Multi⁃centered randomized controlled study of Chinese medicine integrated with chemotherapy for stage Ⅳ non⁃small cell lung cancer

更新时间：2023-02-15

- Multi⁃centered randomized controlled study of Chinese medicine integrated with chemotherapy for stage Ⅳ non⁃small cell lung cancer
- Beijing Journal of Traditional Chinese Medicine Vol. 41, Issue 1, Pages: 2-6(2022)
- 作者机构：
  
  1.中国中医科学院广安门医院肿瘤科，北京 100053
  2.中日友好医院中西医结合肿瘤内科，北京 100029
  3.广州中医药大学第一附属医院肿瘤科，广州 510405
  4.湖南省中医药研究院附属医院肿瘤科，长沙 410006
  5.山西省肿瘤医院中医科，太原 030013
  6.安徽医科大学第一附属医院中西医结合肿瘤科，合肥 230038
  7.辽宁省肿瘤医院中西医结合科，沈阳 110042
  8.新疆维吾尔自治区中医医院肿瘤科，乌鲁木齐 830000
  9.浙江省中医院肿瘤科，杭州 310053
- 作者简介：
- 基金信息：
- DOI：10.16025/j.1674-1307.2022.01.001
  CLC：
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宋丽君，马雪娇，郑佳彬，等.中医综合方案联合化疗治疗Ⅳ期非小细胞肺癌的多中心随机对照研究［J］.北京中医药，2022，41（1）：2-6.

SONG LI⁃jun,MA Xue⁃jiao,ZHENG Jia⁃bin,et al.Multi⁃centered randomized controlled study of Chinese medicine integrated with chemotherapy for stage Ⅳ non⁃small cell lung cancer[J]. Beijing Journal of Traditional Chinese Medicine,2022,41(01):2-6.
宋丽君，马雪娇，郑佳彬，等.中医综合方案联合化疗治疗Ⅳ期非小细胞肺癌的多中心随机对照研究［J］.北京中医药，2022，41（1）：2-6. DOI： 10.16025/j.1674-1307.2022.01.001.

SONG LI⁃jun,MA Xue⁃jiao,ZHENG Jia⁃bin,et al.Multi⁃centered randomized controlled study of Chinese medicine integrated with chemotherapy for stage Ⅳ non⁃small cell lung cancer[J]. Beijing Journal of Traditional Chinese Medicine,2022,41(01):2-6. DOI： 10.16025/j.1674-1307.2022.01.001.

摘要

目的,2,验证中医综合方案联合化疗治疗Ⅳ期非小细胞肺癌的疗效和安全性。,方法,2,通过多中心、前瞻性随机对照设计，纳入Ⅳ期非小细胞肺癌患者263例，随机分为观察组135例，对照组128例。观察组给予标准化疗方案联合中医综合方案，对照组接受单纯标准化疗方案。21~28 d为1个周期，连续治疗2个周期后，评估疗效和安全性。,结果,2,治疗2个周期后，观察组患者身体健康领域评分高于对照组（,P<,0.05），观察组身体健康、情绪健康和肺癌其他情况3个领域评分均显著高于治疗前（,P<,0.05）；观察组中医症状总有效率优于对照组（,P,<,0.05）；观察组食欲下降、呕吐总发生率及≥3级食欲下降发生率均低于对照组（,P,<,0.05）；实体瘤疗效2组间差异无统计学意义（,P,>,0.05）。,结论,2,Ⅳ期非小细胞肺癌患者采用中医综合方案联合化疗较单纯化疗在肿瘤控制率方面疗效相当，但能够显著改善中医症状，降低消化道不良反应的发生，提高患者生活质量。

Abstract

Objective,2,To verify the efficacy and safety of comprehensive TCM regimen combined with chemotherapy in the treatment of stage IV non-small cell lung cancer.,Methods,2,A total of 263 patients with stage Ⅳ non-small cell lung cancer were enrolled in this study in a multi-centered，prospective randomized controlled design. They were randomly divided into a observation group（,n,=135） and a control group（,n,=128）.The observation group received standard chemotherapy combined with TCM comprehensive regimen，while the control group received standard chemotherapy alone.The efficacy and safety were evaluated after 2 consecutive cycles with 21~28 days as one circle.,Results,2,After 2 cycles，the PWB（Physical Well-Being） score in test group was significantly higher than that in control group.The three Liang Yu scores of physical health， emotional health and other conditions of lung cancer in observation group were significantly higher than those before treatment （,P,<,0.05）.The total effective rate of TCM symptoms in observation group is better than that in control group（,P,<,0.05）.The total incidence of anorexia，vomiting and≥3 grade anorexia in observation group were lower than those in control group（,P,<,0.05）.There was no statistical difference in the efficacy of solid tumor between the two groups（,P,>,0.05）.,Conclusion,2,Patients with stage Ⅳ non-small cell lung cancer who adopt the comprehensive regimen of traditional Chinese medicine combined with chemotherapy have the same effect as chemotherapy alone in terms of tumor control rate，but can significantly improve the symptoms of TCM，reduce the occurrence of adverse reactions in gastrointestinal tract，and make the patients have a better quality of life.

关键词

非小细胞肺癌Ⅳ期中医综合治疗化疗不良反应中医症状生活质量

Keywords

Non-small cell lung cancer（NSCLC）stage Ⅳcomprehensive treatment of traditional Chinese medicinechemotherapyadverse reactionTCM symptomquality of life

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Department of Oncology Radiology,Zhebei Mingzhou Hospital,Huzhou City,Zhejing Province,International Branch of The First Hospital of Huzhou City

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