| Objective: To objectively evaluate the clinical efficacy and safety of Hezhong Decoction combined with standard antiemetic regimen in the prevention and treatment of nausea-vomiting-anorexia induced by chemotherapy in patients with advanced colorectal cancer.Methods: A prospective,randomized and controlled study was conducted.From July1,2020 to January 1,2021,58 patients with advanced colorectal cancer were collected from the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine and the Fifth people’s Hospital of Wuhou District of Chengdu City.Using random number table method,according to the 1:1 standard,they were randomly divided into treatment group(n = 29)and control group(n = 29).The treatment group was loaded with Hezhong Decoction on the basis of the standard antiemetic regimen,while the control group was treated with simple standard antiemetic regimen.Two consecutive chemotherapy cycles were observed and followed up.By observing the main indexes of different nodes(acute and delayed nausea,vomiting and anorexia on the 1st to 5th day of chemotherapy),secondary indicators(quality of life score,nutritional risk assessment)and safety indicators,the symptom grades and effective rates of nausea-vomiting-anorexia after chemotherapy were compared between the two groups.Project support: National Administration of Traditional Chinese Medicine "Evidence-based Ability Building and Research Program for Traditional Chinese Medicine Based on Colorectal Cancer"(No.2019XZZX-ZL006).Results: 1.A total of 58 subjects completed the study,and there were no cases of elimination or shedding.There was no significant difference in age,sex,tumor pathological type,clinical stage,chemotherapy regimen,KPS,NRS2002 and other baseline indexes between the treatment group and the control group(P>0.05).2.Dominant symptoms: from the effective rate of(OR)from the first day to the fifth day of treatment,the OR of nausea,vomiting and anorexia in the treatment group were 68.9%,79.3% and 72.4% respectively,and the treatment group compared with the control group in the whole course of treatment OR,P(nausea)and P(anorexia)>0.05,the difference was not statistically significant,P(vomiting)<0.05,the difference was statistically significant.It is suggested that the Hezhong Decoction has more advantages in stopping vomiting.3.In terms of stopping vomiting: there was no significant difference in the grade of vomiting symptoms between the treatment group and the control group on the 1st and5 th day of treatment(P >0.05),but on the 2nd,3rd and 4th day,there was significant difference between the two groups(P<0.05).It shows that the Hezhong Decoction has obvious stopping vomiting effect in the delayed period(2nd,3rd and 4th day).4.Control of nausea: there was no significant difference in the grade of nausea symptoms between the treatment group and the control group on the 1st,4th and 5th day(P>0.05),but there was significant difference between the two groups on the 2nd and 3rd day(P<0.05).The curative effect of the treatment group was better than that of the control group.5.In terms of improving appetite: there was no significant difference in the grading of anorexia symptoms between the two groups on the 1st,4th and 5th day(P>0.05),but there was significant difference between the two groups on the 2nd and 3rd day(P<0.05).It is suggested that the Hezhong Decoction can improve anorexia on the2 nd and 3rd day.6.Quality of life and nutritional status: there were significant differences in KPS score and NRS2002 score between the two groups after treatment(P<0.05),suggesting that Hezhong Decoction can improve the quality of life and nutritional status of patients.7.In terms of safety: there was no significant difference in WBC,PLT,HB,NEU and ALT,AST,Cr between the two groups after treatment,that is,loading and Hezhong Decoction did not increase the toxicity of blood,liver and kidney system,and the safety was good.Conclusion: 1.In the prevention and treatment of nausea-vomiting-anorexia tract symptoms after chemotherapy,and the Hezhong Decoction has more advantages in the stopping vomiting effect,especially in the control of delayed vomiting.2.Loading Hezhong Decoction can improve the quality of life of patients,reduce nutritional risk,and which have good safety. |