| Objective:To observe the clinical efficacy and safety of Jianpi Huatan Huoxue Anshen method in the treatment of primary intestinal cancer patients with spleen deficiency and phlegm stasis,and to provide experimental data for its clinical use.Methods:Screened according to inclusion and exclusion criteria,and 59 patients who met the criteria were divided into treatment group and control group according to their clinical treatment methods.The treatment group was treated with Jianpi Huatan Huoxue Anshen method combined with conventional Western medicine,and the control group was treated with conventional Western medicine.The curative effect observation period is a total of 6 weeks.Before and after treatment,the patients’ TCM symptoms,severe syndromes and tongue and pulse conditions,tumor markers,KPS(Karnofsky)score,blood routine,liver and kidney functions,and adverse reactions during the treatment period are collected and sorted.SPSS 21.0 statistical software was used for analysis.Results:1 Effects of Jianpi Huatan Huoxue Anshen method on TCM symptoms:Compared with the control group,the treatment group had obvious advantages in reducing TCM symptoms’ scores and improving TCM symptoms(p<0.05).Patients in the treatment group performed better overall in fatigue symptom than those in the control group(p<0.05).There were no significant differences between the two groups in terms of poor appetite,abdominal distension,abdominal pain,mucopurulent bloody stool,diarrhea,constipation,nausea and vomiting,and insomnia.(p>0.05).2 Effects of Jianpi Huatan Huoxue Anshen method on syndromes and tongue and pulse conditions:After treatment,the patients in the treatment group were more than those in the control group in the syndromes of partial phlegm dampness and partial blood stasis,and the patients in the syndrome of partial spleen deficiency were less than those in the control group.There were significant differences in the overall distributions of severe syndromes between the two groups(p<0.05);There were no significant differences in the stages distributions between the two groups(p>0.05).There were no significant differences between the two groups in the overall tongue and pulse conditions and the distributions of tongue and pulse conditions by stages(p>0.05).3 Effects of Jianpi Huatan Huoxue Anshen method on tumor markers:After treatment,there were no significant differences in Carcinoembryonic antigen(CEA)and Carbohydrate antigen 199(CA199)between the two groups(p>0.05).4 Effects of Jianpi Huatan Huoxue Anshen Method on KPS score:After treatment,the KPS score of treatment group was higher than that of control group(p<0.05);There were no significant differences between the two groups in the intra-group comparison of KPS score and improvement of KPS score(p>0.05).5 Effects of Jianpi Huatan Huoxue Anshen method on blood routine:Comparison between groups:After treatment,platelet count in the treatment group was higher than that in the control group(p<0.05),there were no significant differences in hemoglobin and white blood cells between treatment group and control group(p>0.05).Intra-group comparison:In the treatment group,platelet count was significantly lower than before treatment(p<0.05),there were no significant differences in hemoglobin and white blood cells before and after the treatment group(p>0.05);In the control group,platelet count and white blood cells were significantly lower than before treatment(p<0.05),there was no significant difference in hemoglobin(p>0.05).There was no significant difference in the occurrence of myelosuppression between the two groups during treatment(p>0.05).6 Effects of Jianpi Huatan Huoxue Anshen method on liver and kidney functions:Comparison between groups:After treatment,there were no significant differences in Alanine aminotransferase(ALT),Aspartate aminotransferase(AST),Creatinine(CREA)and Blood urea nitrogen(BUN)between the two groups(p>0.05).Intra-group comparison:the liver and kidney functions indexes of the treatment group had no significant differences before and after treatment(p>0.05);The AST index of the control group increased after treatment(p<0.05),ALT and renal function indexes had no significant differences before and after treatment(p>0.05).There were no significant differences in the occurrences of liver and kidney functions impairment between the two groups during treatment(p>0.05).7 Effects of Jianpi Huatan Huoxue Anshen Method on oral mucosa and alopecia during treatment:There were no significant differences in the incidences of oral mucosal damage and hair loss between the two groups during treatment(p>0.05).Conclusions:1 Jianpi Huatan Huoxue Anshen method has clear effects in improving the quality of life of patients with primary intestinal cancer of spleen deficiency and phlegm stasis,and improving the symptoms of TCM.2 Jianpi Huatan Huoxue Anshen Method was not found to have adverse effects on liver and kidney functions in this clinical trial,and no clear adverse reactions were found. |
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