Traditional Chinese medicine (TCM) has become an important option for patients with advanced esophageal cancer (EC) who are not able to undergo surgery, radiotherapy, chemotherapy, or with disease progression after chemotherapy. The purpose of this study is to investigate the application effects of Dingxiang Guanshitong Hanhua Pills alone and its combination with Fugui Guanshitong Granules, in order to improve the quality of life of patients with advanced EC, and provide an effective TCM treatment schemes for EC.

To evaluate the effects of Dingxiang Guanshitong Hanhua Pills alone and its combination with Fugui Guanshitong Granules on survival rate and quality of life of patients with EC after 6 weeks of treatment.

A total of 109 patients with advanced EC admitted to nine centers such as the First Affiliated Hospital of Henan University of CM, Linzhou Hospital of Traditional Chinese Medicine and Jia County Hospital of Traditional Chinese Medicine from January 2020 to April 2021 were selected as the research objects and divided into the control group, experimental group 1 and experimental group 2 by block randomization method. The control group received Danggui Buxue Decoction and Guizhi Renshen Decoction Granules, the experimental group 1 received Fugui Guanshitong Granules and Dingxiang Guanshitong Hanhua Pills, the experimental group 2 received Dingxiang Guanshitong Hanhua Pills, with the course of 6 weeks in the above three groups. The survival rate after 6 weeks of treatment, Quality of Life (QOL) score, Karnofsky Performance Status (KPS) score, TCM syndrome score (dysphagia, poststernal chest pain, mucus vomiting, loss of appetite, fatigue) before and after treatment of the three groups were compared, and safety evaluation was conducted.

After 6 weeks of treatment, the survival rate was 72.7% in the control group, 88.6% in the experimental group 1, and 86.8% in the experimental group 2, and there was no statistically significant difference in the survival rates among the three groups after 6 weeks of treatment (χ²=4.036, P=0.133). There was no interaction effect of group and time on QOL score, KPS score, and TCM syndrome score (P_interaction>0.05). The main effect of group was not significant on QOL score, KPS score and TCM syndrome score (P_interclass>0.05). The main effect of time was significant on QOL score, KPS score and TCM syndrome score (P_time<0.05). There was an interaction effect of group and time on mucus vomiting score (P_interaction<0.05), the scores of loss of appetite and mucus vomiting in the experimental group 2 were significantly lower than the experimental group 1 (P<0.05). Adverse events in the three groups included diarrhea, fever, dry mouth, sore throat, inability to eat, lung infection, without serious complications. There was no significant difference in the incidence of adverse events among the three groups (χ²=0.063, P=0.969) .

All three treatment schemes can relieve the clinical symptoms and improve the quality of life of the patients with advanced EC. Moreover, the efficacy of Dingxiang Guanshitong Hanhua Pills alone on appetite loss and mucus vomiting was better than that of Danggui Buxue Decoction and Guizhi Renshen Decoction Granules and the combination of Dingxiang Guanshitong Hanhua Pills and Fugui Guanshitong Granules.

中医药已成为不能手术、放疗、化疗或化疗后疾病进展的晚期食管癌患者的重要选择，本研究旨在探讨丁香管食通含化丸单用及联合附桂管食通颗粒的应用效果，以期提高晚期食管癌患者生活质量，为食管癌的中医治疗提供疗效确切的方案。

评价丁香管食通含化丸单用及联合附桂管食通颗粒对食管癌患者治疗6周后生存率和生活质量的影响。

选取2020年1月—2021年4月河南中医药大学第一附属医院、林州市中医院、郏县中医院等9个中心收治的晚期食管癌患者109例为研究对象。利用区组随机法将晚期食管癌患者分为三组：对照组、试验1组、试验2组，各40例。对照组给予当归补血汤合桂枝人参汤颗粒；试验1组给予丁香管食通含化丸联合附桂管食通颗粒；试验2组给予丁香管食通含化丸，疗程6周。比较三组患者治疗6周后的生存率及治疗前后生活质量（QOL）评分、体力状况（KPS）评分、中医证候积分（吞咽困难、胸骨后疼痛、呕吐黏液、食欲减退、神疲乏力），并进行安全性评价。

治疗6周后，对照组生存率为72.7%，试验1组生存率为88.6%，试验2组生存率为86.8%，三组患者治疗6周后生存率比较，差异无统计学意义（χ²=4.036，P=0.133）。组别和时间对QOL评分、KPS评分、中医证候积分不存在交互作用（P_交互>0.05），组别在QOL评分、KPS评分、中医证候积分上主效应不显著（P_组间>0.05），时间在QOL评分、KPS评分、中医证候积分上主效应显著（P_时间<0.05）。组别和时间对呕吐黏液评分存在交互作用（P_交互<0.05）；且治疗6周后试验2组患者食欲减退、呕吐黏液评分均低于试验1组（P<0.05）。三组患者不良事件包括腹泻、发热、口干、咽痛、不能进食、肺部感染等，均无严重相关并发症；三组患者不良事件发生率比较，差异无统计学意义（χ²=0.063，P=0.969）。

三种治疗方案均可缓解晚期食管癌患者的临床症状，提高其生活质量，且单用丁香管食通含化丸对食欲减退、呕吐黏液的疗效优于当归补血汤合桂枝人参汤颗粒及丁香管食通含化丸联合附桂管食通颗粒。