“气血生化”分阶段治疗对肺癌术后辅助化疗患者相关症状群影响的多中心随机对照双盲临床研究

Effects of‘qi-blood biochemistry’staged treatment on symptom clusters associated with postoperative adjuvant chemotherapy lung cancer patients:A multicenter randomized controlled double-blind clinical study

目的:分析“气血生化”分阶段治疗对肺癌术后辅助化疗阶段患者相关症状群的影响。方法:研究采用多中心、随机对照、双盲试验设计,观察2016年12月至2020年8月在上海5家医院收治的Ⅰb~Ⅲa期肺癌术后辅助化疗患者,按照2∶1比例随机分为治疗组与对照组,共173例完成治疗,治疗组(分阶段中药+化疗)116例和对照组(分阶段中药安慰剂+化疗)57例,21 d为1个周期,共治疗4个周期。结果:治疗结束,治疗组中医临床证候总有效率(40.20%,41/102)优于对照组(5.77%,3/52)(P<0.01);第1周期化疗第14天及以后,治疗组较对照组疲乏相关症状群(神疲乏力、食欲不振、失眠)评分显著改善(P<0.05);第3周期化疗第14天及第4周期化疗第14天,治疗组较对照组肺癌特异性症状群(咳嗽、咯痰、气短、胸闷)评分显著改善(P<0.05)。结论:“气血生化”分阶段治疗可改善肺癌术后辅助化疗患者相关症状群。

Objective:To analyze the effects of‘qi-blood biochemistry’staged treatment on the symptom clusters associated with adjuvant chemotherapy in postoperative lung cancer patients.Methods:A multicenter,randomized,controlled,double-blind trial was designed to observe postoperative adjuvant chemotherapy patients with stageⅠb~Ⅲa lung cancer.They were admitted to 5 hospitals in Shanghai from December 2016 to August 2020,randomly divided into treatment and control groups according to a 2∶1 ratio,with a total of 173 cases completing treatment,116 cases in the treatment group(staged Chinese medicine+chemotherapy)and 57 cases in the control group(staged Chinese medicine placebo+chemotherapy),every 21 days for 1 cycle,a total of 4 cycles of treatment.Results:After treatment,the total effective rate of the traditional Chinese medicine(TCM)clinical evidence in the treatment group(40.20%,41/102)was better than that in the control group(5.77%,3/52)(P<0.01).The scores of fatigue-related symptom cluster(fatigue,loss of appetite,insomnia)were significantly improved in the treatment group compared with the control group on the 14th day of 1st cycle of chemotherapy and after that(P<0.05).The scores of lung cancer-specific symptom cluster(cough,sputum,shortness of breath and chest tightness)were significantly improved in the treatment group compared with the control group on the 14th day of 3rd cycle and the 14th day of 4th cycle(P<0.05).Conclusion:‘Qi-blood biochemistry’staged treatment can improve the symptom clusters associated with adjuvant chemotherapy in postoperative lung cancer patients.