Zhongguo quanke yixue (Oct 2023)
Clinical Observation of Dingxiang Guanshitong Hanhua Pills Alone and Its Combination with Fugui Guanshitong Granules in the Treatment of Advanced Esophageal Cancer
Abstract
Background 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. Objective 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. Methods 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. Results 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 (Pinteraction>0.05). The main effect of group was not significant on QOL score, KPS score and TCM syndrome score (Pinterclass>0.05). The main effect of time was significant on QOL score, KPS score and TCM syndrome score (Ptime<0.05). There was an interaction effect of group and time on mucus vomiting score (Pinteraction<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) . Conclusion 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.
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