| Objective:The clinical efficacy of Jiawei Guipi Decoction in the treatment of cancer-related insomnia with deficiency of both heart and spleen and the changes of carcinoembryonic antigen,hemoglobin and albumin were observed through clinical trials.Methods:100 patients with cancer-related insomnia from Yangzhou Hospital of Traditional Chinese Medicine from May 2021 to December 2021 were enrolled in the study and randomly divided into a control group and a treatment group,with 50 cases in each.Both groups of patients received conventional medical oncology treatment and symptomatic treatment before participating in the study.the control group was treated with Estazolam Tablets,while the treatment group was treated with Jiawei Guipi Decoction,and the observation was carried out after 14 days of continuous treatment.Pittsburgh sleepquality index,HAMA anxiety Scale and the TCM syndrome scores of the patients were calculated before and after treatment,carcinoembryonic antigen,hemoglobin and albumin of the patients were checked before and after treatment.Data were collected,summarized and sorted,and SPSS 26.0 software was used for statistical analysis.Results:（1）A total of 100 patients with deficiency of both heart and spleen type of cancer-related insomnia were included in this study,10 cases were excluded,and the final effective cases were 90 cases,45 cases in the control group and 45 in the treatment group.（2）There was no significant difference in gender,age,marital status,occupational background,education level,tumor type and clinical stage between the two groups of patients（P>0.05）.Before treatment,there were no significant differences in the clinical data of PSQI scores and total scores,TCM syndrome scores,anxiety level,quality of life（KPS score）,and laboratory test items（carcinoembryonic antigen,hemoglobin,albumin）between the two groups of patients.（P>0.05）.（3）After treatment,Pittsburgh sleepquality index scores and total scores in the control group and the treatment group were all decreased compared with those before tretment（P<0.05）.There was no significant difference between the data of the groups（P>0.05）.the TCM syndrome scores in the control group had no significant changes compared with those before treatment（P>0.05）,while the TCM syndrome scores in the treatment group were significantly lower than those before treatment（P<0.05）,and the TCM syndrome scores in the treatment group decreased more than those in the control group.（P<0.05）.The anxiety symptoms in the control group were not significantly relieved after treatment（P>0.05）,the anxiety in the treatment group was alleviated after treatment（P<0.05）.And there was a significant difference in anxiety between the two groups after treatment（P<0.05）.the Karnofsky score in the control group did not increase significantly compared with that before treatment（P>0.05）,while the Karnofsky score in the treatment group increased significantly after treatment,and the quality of life improved（P<0.05）.After treatment,there were no significant changes in the levels of hemoglobin,albumin and carcinoembryonic antigen in the control group（P>0.05）.The level of carcinoembryonic antigen did not change significantly in the treatment group（P>0.05）,but the levels of hemoglobin and albumin were higher than those before treatment,and the difference was statistically significant（P<0.05）.The incidence of adverse reactions in the two groups during the treatment period was 22.22%and 0.00%,and there was a significant difference in the incidence of adverse reactions（P<0.05）.Conclusions:（1）Jianpi Yangxin Decoction can alleviate the symptoms of insomnia and can significantly relieve the anxiety state of patients（2）Jianpi Yangxin Decoction has a good effect on improving TCM syndromes in patients,especially in relieving restless sleep at night,mental fatigue,dizziness and loose stools.（3）Jianpi Yangxin decoction can increase the levels of hemoglobin and albumin in patients,but has no significant effect on the level of CEA.（4）The efficacy of Jianpi Yangxin Decoction and estazolam in improving the sleep quality of patients is similar,and Jianpi Yangxin Decoction has better safety and lower incidence of adverse reactions. |
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