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

Multi-centered randomized controlled study of Chinese medicine integrated with chemotherapy for stageⅣnon-small cell lung cancer

目的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。

Objective To verify the efficacy and safety of comprehensive TCM regimen combined with chemotherapy in the treatment of stageⅣnon-small cell lung cancer.Methods A total of 263 patients with stageⅣnon-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 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 Patients with stageⅣnon-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.