天佛参口服液治疗非小细胞肺癌气阴两虚证的临床研究

Tianfoshen oral liquid for NSCLC with both qi and yin deficiency syndrome

目的探讨天佛参口服液对非小细胞肺癌(NSCLC)气阴两虚证化疗患者的疗效及安全性。方法选取2012年4月至2014年7月间全国46个临床研究中心收治的接受化疗的852例NSCLC患者,均接受化疗联合天佛参口服液治疗至少9周。在3周、6周和9周时记录患者中医症候评分、生活质量评分和不良反应等,9周时评估患者治疗近期疗效。结果患者中医症候评分在3周、6周和9周时均较基线值发生明显改善,差异均有统计学意义(均P<0.01)。生活质量评价指标包括体重增加、体能状况评分、生活质量测定量表和疼痛程度等,9周时与基线水平比较均有明显改善,差异均有统计学意义(均P<0.05)。入组病例中化疗完成率为89.1%。治疗9周后,有可评价病灶的患者疾病控制率(DCR)为95.1%,不良反应发生率为0.6%。结论天佛参口服液治疗气阴两虚证的NSCLC化疗患者,具有改善中医症候群,提高患者生活质量的作用,同时能够减轻化疗引起的不良反应,提高化疗依从性。

Objective To study the efficacy and safety of Tianfoshen oral liquid for non-small cell lung cancer（NSCLC） with both qi and yin deficiency syndrome. Methods From April 2012 to July 2014,852 patients with NSCLC were enrolled from 46 clinical research centers in China. The patients received combined treatment of chemotherapy and Tianfoshen oral liquid at least for 9 weeks. The symptom score,quality of life score and adverse effect were recorded at 3,6 and 9 weeks. The short-term efficacy was evaluated at 9 weeks. Results The symptom score was significantly improved at 3,6 and 9 weeks compared with baseline（P〈0. 01）. Quality of life score including weight gain,ECOG scores,functional assessment of cancer therapy（FACT-L） and pain intensity were improved significantly at 9 weeks compared with baseline（all P〈0. 05）. The completion rate for chemotherapy was 89. 1%. The disease control rate（DCR）for assessable lesions was 95. 1% at 9 weeks after the treatment. In terms of safety index,the incidence of study associated adverse effects was 0. 6%. Conclusion Tianfoshen oral liquid can improve the symptom and quality of life in NCSLC patients with qi and yin deficiency. Meanwhile,it can reduce side effects of chemotherapy and improve chemotherapy compliance.