中医药用作晚期非小细胞肺癌巩固性治疗的对照性临床观察

A clinical comparative study on Traditional Chinese Medicine serving as consolidation treatment in patients with advanced non-small cell lung cancer

背景与目的中医药治疗非小细胞肺癌是否有效在中医肿瘤界已基本达到共识。本研究拟评价以中医药作为局部晚期和转移性晚期非小细胞肺癌的巩固性治疗之可行性。方法162例晚期非小细胞肺癌被分成两组(开放性非随机性对照研究),观察组81例,在完成常规治疗后应用中医药作为巩固性治疗;对照组81例,不用中医药作为巩固性治疗。中医药治疗主要根据辨证论治,观察组病例分为肺脾气虚型、肺热痰阻型、肺胃阴虚型和气滞血瘀型4种类型。结果观察组的1、2、3及5年生存率分别为70.3%、37.0%、20.9%及8.6%,中位生存期为18个月;对照组的1、2、3及5年生存率分别为61.7%、20.9%、8.6%及3.7%,中位生存期为12个月。经统计学处理,观察组的2及3年生存率明显地优于对照组(P<0.05),观察组的中位生存期比对照组延长了6个月。结论以中医药作为晚期非小细胞肺癌的巩固性治疗可能与患者2及3年生存率和中位生存期的改善密切相关,但未能明显提高5年生存率。

Background and objective The role of Traditional Chinese Medicine(TCM) is recognized in treatment of non-small cell lung cancer.The aim of this study is to evaluate the efficacy of TCM serving as consolidation treatment in patients with advanced non-small cell lung cancer.Methods One hundred and sixty-two patients with advanced non-small cell lung cancer were divided into two arms.Arm A(observation arm):81 cases,TCM serving as consolidation treatment after conventional treatment;Arm B(control arm):81 cases,only conventional treatment,no TCM serving as consolidation treatment.The TCM was given according mainly to the syndrome differentiation.Four types were found in the arm A:lung and spleen-qi deficiency type,the lung heat and phlegm-dampness type,the lung-yin and stomach-yin deficiency type,and the qi stagnation with blood stasis type.Results 1-,2-,3-and 5-year survival rate accounted for 70.3%,37.0%,20.9% and 8.6% in arm A,and 61.7%,20.9%,8.6% and 3.7% in arm B,respectively.Median survival time was 18 months in arm A and 12 months in arm B,respectively.Statistically,2-and 3-year survival rate of arm A and arm B had significant difference(P<0.05).Conclusion TCM serving as consolidation treatment in patients with advanced non-small cell lung cancer might be closely related to 2-and 3-year survival rate and median survival time improvement,but not to 5-year survival rate.