论文部分内容阅读
目的:观察中药辨证颗粒剂配方联合化疗治疗老年晚期肺癌对生存质量的改善作用,并评价其安全性。方法:年龄≥65岁的老年晚期非小细胞肺癌(NSCLC)患者共82例,随机分为化疗组、中药联合组。两组均接受标准方案的化疗,中药联合组经辨证后同时口服对证的中药颗粒剂,而化疗组则口服相应的中药颗粒剂安慰剂。化疗周期为21 d,2个周期为1个疗程,共完成2个疗程;中药由化疗后第1天开始服用,化疗当天停药。观察结束,评价无进展生存期(PFS)、总生存期(OS)、客观有效率(ORR)及生活质量量表(EORTC QLQ-L43)、中医证候评分与安全性指标。结果:中药联合组的中位无疾病进展期(m PFS)和中位总生存期(m OS)分别为255 d和533 d,化疗组m PFS和m OS分别为195 d和420 d,差异均具有统计学意义(P<0.05);中医症状评分以及生存质量量表的数据显示,中药联合组的治疗积极有效,总健康状况明显优于化疗组(P<0.05)。安全性方面均无治疗相关性死亡,且中药联合组可明显减轻化疗的副作用(P<0.05)。结论:辨证使用中药颗粒剂配合化疗,对老年晚期NSCLC患者能一定程度延长疾病无进展时间和总生存时间,减轻化疗副反应,提高生存质量。
OBJECTIVE: To observe the effect of traditional Chinese medicine syndrome differentiation granule formulation combined with chemotherapy on improving the quality of life in elderly patients with advanced lung cancer and evaluate its safety. Methods: A total of 82 elderly patients with advanced non-small cell lung cancer (NSCLC) aged 65 years or older were randomly divided into chemotherapy group and traditional Chinese medicine combination group. Both groups received standard chemotherapy, Chinese medicine combined group after oral administration of traditional Chinese medicine granules on the card, while the chemotherapy group is the oral administration of traditional Chinese medicine granules placebo. Chemotherapy cycle was 21 days, 2 cycles for a course of treatment, a total of 2 courses completed; Chinese medicine from the first day after chemotherapy to take, the day of chemotherapy withdrawal. After the observation, PFS, OS, ORR and EORTC QLQ-L43, TCM syndrome score and safety index were evaluated. Results: The median progression-free disease (m PFS) and median overall survival (m OS) of the combination group were 255 d and 533 d, respectively. The m PFS and m OS in the chemotherapy group were 195 d and 420 d, respectively (P <0.05). The TCM symptom score and quality of life scale data showed that the combination therapy of TCM and Chinese medicine group was effective and the total health condition was better than that of chemotherapy group (P <0.05). Safety-related no treatment-related death, and Chinese medicine combined group can significantly reduce the side effects of chemotherapy (P <0.05). Conclusion: Syndrome Differentiation using traditional Chinese medicine granules combined with chemotherapy can prolong the disease progression-free time and total survival time to a certain extent in elderly patients with advanced stage NSCLC, reduce the side effects of chemotherapy and improve the quality of life.