| With the advent of aging population,economic development and living standards,the incidence of colon cancer will continue to show an upward trend.The prevention and treatment of colon cancer is becoming the hot spot of traditional Chinese and western medicine research at present.In recent years,there were many reports on the clinical research of traditional Chinese medicine combined with chemotherapy in the treatment of colon cancer.However,the overall researches are lack of standardization.Therefore,we conducted a multicenter,random,double-blind,controlled clinical study in accordance with GCP principle to evaluate the efficacy and safety of Fufangchangtai,a traditional Chinese medicine with the effect of invigorating Spleen and replenishing Qi and detoxifying,in the treatment of colon cancer.Objective:To evaluate the efficacy and safety of Fufangchangtai granule combined with chemotherapy in the treatment of colon cancer.Methods:Patients with colon cancer in II-IV stage were randomly divided into two groups.Group A was treated with standard chemotherapy and oral administration of Fufangchangtai granule twice a day for 6 months.Group B was treated with standard chemotherapy and oral administration of Fufangchangtai granule simulator twice a day for 6 months.The main research indexes included 1-year survival rate,progression-free survival time,disease-free survival time,tumor changes,quality of life score,immune function related indexes,blood routine,liver and kidney function and so on.All cases were followed up for 1 year.Results:After 3 years of study,210 cases completed the study and 30 cases fell off.There were 103 cases in Fufangchangtai granule combined chemotherapy group(group A)and 107 cases in Fufangchangtai granule simulator combined chemotherapy group(group B).1.Survival outcome:79 patients in group A survived for 1 year,accounting for 77.00%,69 cases developed progress or death,accounting for 66.99%,1 case had tumor recurrence,accounting for 0.97%.In group B,79 cases(73.83%)achieved one year survival outcome,and 71 cases developed or died.Death occurred in 66.36%,and tumor recurrence occurred in 1 case(0.93%).There was no significant difference in the incidence of survival outcome between the two groups(P>0.05).The median survival time of group A and group B was 17 months and 15 months,respectively.There was no significant difference(P =0.6246).The median time to disease progress or death outcome index in HR=0.806,95%CI:0.333-1.956.Group A and group B was 3.90 months and 4.00 months,respectively.There was no significant difference(P=0.7661),HR=0.954,95%CI:0.681-1.335.2.TCM syndromes:the grade and score of TCM syndromes after 1 month,2 months,3 months,4 months,5 months and 6 months in the two groups were significantly higher than those before treatment(P<0.05).From 4 months after treatment,the change rate of nausea and vomiting score in group A was less than that in group B,the difference was statistically significant(P<0.05).3.Quality of life:after 6 months of treatment,the quality of life score of group A was significantly higher than that of group B(P<0.05).After 6 months of treatment,the scores of fatigue and constipation in group A were significantly lower than those in group B(P<0.05).4.Immune function:there was no significant difference in immune function between the two groups after 1,2,3,4 and 5 months after treatment(P>0.05).After 6 months of treatment,the value of CD3+(T cells)in group A was higher than that before treatment,while that in group B was lower than that before treatment.There was no significant difference between the two groups(P>0.05),and the difference between the two groups was statistically significant(P<0.05).5.Safety:no serious adverse events occurred in both groups.The incidence of adverse events was 23.3%in group A and 34.58%in group B.There was no significant difference between the two groups(P>0.05).The side effects of chemotherapy included blood system toxicity,digestive tract toxicity,peripheral neurotoxicity,hand and foot syndrome,hepatorenal toxicity,alopecia and so on.There was no significant difference between the two groups(P>0.05).Conclusion:1.Efficacy:Fufangchangtai granule combined with chemotherapy in the treatment of colon cancer patients compared with placebo combined chemotherapy,the median survival time has a longer trend;After 4 months of continuous administration,Fufangchangtai granule could improve the TCM syndrome score of nausea and vomiting compared with placebo.After 6 months of continuous administration,Fufangchangtai granule could improve the quality of life of the patients compared with placebo,among which fatigue and constipation were significantly improved.After 6 months of continuous administration,Fufangchangtai granule increased CD3(T cell)value and improved immune function compared with placebo.2.Safety:Fufangchangtai granule compared with placebo,did not increase adverse events and adverse reactions to chemotherapy,indicating that it is safe to take. |
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