摘要
Objective： To assess the role of chemotherapy combined with the compound Chinese herbal medicine,Fuzhenggubenfang （FZGBF）, for treating advanced non-small-cell lung cancer. Methods： A total of 84 eligible patientswere enrolled from October 2013 to July 2016. Patients were randomized to receive either chemotherapy alone as thecontrol group or chemotherapy combined with FZGBF as the experimental group. The primary endpoint of the study wasquality of life （QOL） and progression-free survival （PFS）. Secondary endpoints were tumor response rate, toxicity,dropout rate, and univariate and multivariate analyses of clinicopathologic factors for QOL and PFS. Results： There wasa significant improvement in QOL, including better overall health （P 〈 0.001）, physical function （P 〈 0.001）, rolefunction （P 〈 0.001）, emotional function （P 〈 0.001）, cognitive function （P 〈 0.001）, and social function （P = 0.031）.Less fatigue, nausea or vomiting, insomnia, appetite loss, constipation, and alopecia were noted （All P 〈 0.001） whenFZGBF was combined with chemotherapy in comparison to chemotherapy alone. The experimental group had a betterPFS compared with the control group （P = 0.032）. There was no significant difference in tumor response rate. FZGBFsignificantly reduced chemotherapy-induced anemia （P 〈 0.001）, neutropenia （P = 0.023）, nausea and vomiting （P 〈0.001）. The use of Chinese herbal compounds had only mild side effects. In this study, factors influencing QOL were theuse of the Chinese herbal compounds （P 〈 0.001）, performance status score （P = 0.027）, clinical staging of cancer （P =0.009）, and sex （P = 0.044）. Use of traditional Chinese medicine （P = 0.043） and the number of previous chemotherapysessions （P = 0.003） were the factors influencing PFS in this study. Conclusion： FZGBF could improve QOL,compliance to treatment, relieved chemotherapy-related toxicities of patients, and consequently improved PFS, which isa promising drug combination in complementary medicine for the treatment of advanced NSCLC.
目的：评估化疗联合扶正固本方治疗晚期非小细胞肺癌的作用.方法：2013年10月至2016年7月共收治符合条件的患者84例.随机分配到接受化疗的对照组和化疗联合扶正固本方的实验组.研究的主要终点指标是生活质量（QOL）和无进展生存期（PFS）.次要终点指标是肿瘤反应率,化疗相关毒性,出组率,QOL和PFS临床病理因素的单因素和多因素分析.结果：实验组较对照组总体生活质量包括躯体功能、角色功能、情绪功能、认知功能、社会功能均有显著改善（均P〈0.001）,疲乏、恶心或呕吐、失眠、食欲减退、便秘亦显著改善（均P〈0.001）.实验组较对照组获得更好的PFS且有显著性差异（P=0.032）.两组肿瘤反应率无显著性差异.扶正固本方明显减少化疗引起的贫血,中性粒细胞减少、恶心、呕吐（均P〈0.001）,且只有轻微的副作用.本研究中影响QOL的临床病理因素包括：中药（P〈0.001）、体力状态评分（P=0.027）、临床分期（P=0.009）、性别（P=0.044）.影响PFS的临床病理因素包括中药（P=0.043）和既往化疗次数（P=0.003）.结论：扶正固本方可通过改善晚期非小细胞肺癌患者QOL,改善患者对治疗的治疗依从性,减轻化疗相关毒副反应,从而改善PFS,提高生存率,是晚期非小细胞肺癌治疗期间可选择的辅助用药.
