六君子汤加减联合吉非替尼片治疗晚期脾虚痰湿型非小细胞肺癌的临床研究  

Clinical Study on Treatment of Advanced Non-small Cell Lung Cancer with Spleen Deficiency and Phlegm-damp Syndrome by Modified Liujunzi Decoction Combined with Gefitinib Tablets

作　　者：赵良辰 李陆振[1] 袁锦辉 庄娟娜 陈婷[1] 方灿途[1] ZHAO Liang-Chen;LI Lu-Zhen;YUAN Jin-Hui;ZHUANG Juan-Na;CHEN Ting;FANG Can-Tu(Zhongshan Traditional Chinese Medicine Hospital Affiliated to Guangzhou University of Chinese Medicine,Zhongshan 528400 Guangdong,China)

机构地区：[1]广州中医药大学附属中山市中医院,广东中山528400

出　　处：《广州中医药大学学报》2021年第2期250-256,共7页Journal of Guangzhou University of Traditional Chinese Medicine

摘　　要：【目的】评价六君子汤加减联合吉非替尼片中西医结合治疗表皮生长因子受体(EGFR)阳性的非小细胞肺癌脾虚痰湿型患者的临床疗效。【方法】将120例非小细胞肺癌ⅢB-Ⅳ期脾虚痰湿型患者随机分为治疗组和对照组,每组各60例。对照组单纯采用分子靶向药物治疗(口服吉非替尼片),治疗组在服用分子靶向药物的同时给予加用中药汤剂(六君子汤加减)治疗,1个月为1个疗程,持续用药8~10个月左右,直至肿瘤进展或出现严重不良反应无法耐受时停药。观察2组患者的瘤体控制疗效、卡氏(KPS)评分改善疗效、无进展生存期(PFS)和毒副反应等。【结果】(1)至研究结束时,治疗组因病例失访脱落2例,对照组因未完成治疗脱落3例,最终完成试验115例,其中治疗组58例,对照组57例。(2)KPS评分改善疗效:疗程结束后,治疗组的总有效率为87.9%(51/58),明显优于对照组的68.4%(39/57),差异有统计学意义(P<0.05)。(3)瘤体控制疗效:疗程结束后,治疗组的缓解率和疾病控制率分别为41.8%(24/58)和75.9%(44/58),明显优于对照组的22.8%(13/57)和40.4%(23/57),差异均有统计学意义(P<0.05)。(4)治疗组患者的PFS为(9.33±3.15)个月,中位PFS为12个月;对照组患者的PFS为(8.07±2.95)个月,中位PFS为9个月;组间比较,治疗组的PFS明显高于对照组,差异有统计学意义(P<0.05)。(5)不良反应:治疗组的皮疹及腹泻发生率分别为17.2%(10/58)和15.5%(9/58),明显低于对照组的38.6%(22/57)和43.9%(25/57),差异均有统计学意义(P<0.05或P<0.01)。【结论】六君子汤加减配合靶向药物治疗非小细胞肺癌,可明显改善患者临床症状,降低靶向治疗毒副作用,提高患者生活质量。Objective To evaluate the clinical effect of modified Liujunzi Decoction combined with Gefitinib Tablets for treatment of non-small cell lung cancer(NSCLC)with epidermal growth factor receptor(EGFR)positive and differentiated as the syndrome of spleen deficiency and phlegm-damp.Methods One hundred and twenty NSCLC patients at stageⅢB-Ⅳwith the syndrome of spleen deficiency and phlegm-damp were randomized into treatment group and control group,and each group had 60 cases.The control group received conventional molecular targeted anti-tumor therapy by the medication of Gefitinib Tablets orally,and the treatment group was given Gefitinib Tablets orally combined with modified Liujunzi Decoction orally.One month constituted a course of treatment,and the medication lasted for about 8-10 months till tumor progress or the occurrence of severe adverse reaction.The outcomes included efficacy for controlling tumor mass,efficacy for improving Karnofsky Performance Status(KPS)scores,progression-free survival(PFS),and toxic and side effects in the two groups.Results(1)At the end of the trial,2 cases of the treatment group lost to follow-up,and 3 cases of the control group dropped out for failure of the completion of the trial.A total of 115 cases finished the trial,of which 58 cases were from the treatment group and 57 cases were from the control group.(2)At the end of the trial,the total effective rate for improving KPS scores of the treatment group was 87.9%(51/58),and that of the control group was68.4%(39/57),the difference being statistically significant(P<0.05).(3)At the end of the trial,the response rate(RR)and disease control rate(DCR)in the treatment group were 41.8%(24/58)and 75.9%(44/58)respectively,and those in the control group were 22.8%(13/57)and 40.4%(23/57)respectively.The intergroup comparison showed that the treatment group had stronger effect on controlling tumor mass than the control group,the difference being statistically significant(P<0.05).(4)PFS in the treatment group was 9.33±3.15 months,and the

关 键 词：非小细胞肺癌 脾虚痰湿型 中西医结合 六君子汤加减 吉非替尼片 

分 类 号：R273.342[医药卫生—中西医结合]