| Object: This study was to observe the clinical efficacy and safety of Shen Zhe Pei Qi decoction+CF chemotherapy(DDP+5-FU)in the treatment of advanced esophageal squamous cell carcinoma(Qi deficiency phlegm and blood stasis type),and to guide clinical practice.Methods: Select the standard of 64 cases of advanced esophageal squamous cell carcinoma(Qi deficiency phlegm and blood stasis type)patients,using randomly divided into treatment group and control group of 32 cases.The treatment group was given Shen Zhe Pei Qi decoction+CF chemotherapy(DDP+5-FU),the control group was treated with CF chemotherapy(DDP+5-FU),and the 21 day was 1 cycles,and the 2 cycles were observed.Before and after treatment in the treatment of functional status score(KPS),clinical symptoms,side effects,tumor marker compounds(CA199 and CEA),blood routine,liver and kidney function were determined.The comprehensive evaluation of the efficacy and safety.Result:1)Effect of lesions: two groups of patients after treatment,the treatment group was65.6% efficiency(ER=CR+PR),the control group was 56.2% efficiency,The result of the treatment group was higher than that in the control group,but the ?2 test,no significant difference(?2=0.591,?P=0.442,?P > 0.05);the focus stability rate(CR+PR+PD)on and the results in the treatment group was 96.8%,the control group was 71.8%,the curative effect of treatment group was higher than that of the control groups,by ?2 test,there was significant difference(?2=7.585,?P=0.006, ?P<0.05).The results showed that the treatment group was better than the control group in stable the lesion of the esophageal cancer.2)TCM syndrome score: two groups of patients before and after treatment,compared the improvement of TCM syndromes,found that the total effective rate of the treatment group was 84.3%,and the total effective rate of the control group was62.5%,which was significantly different after ?2 test(?2=8.762,P=0.013,P < 0.05).After the contrast treatment,two groups of TCM syndrome scores,the t test,showed that the two groups had significant differences(t=-8.724,P=0.000,P <0.01).It shows that the treatment group is better than the control group in improving the TCM syndrome.3)Karnofsky score: comparison of two groups before and after treatment Karnofsky score improvement,17 cases in the treatment group were higher in patients with 10 cases,stable,decreased in 5 cases,control group 7 cases,16 cases were stable and decreased in 9 cases,by ?2 test,two groups had significant difference(?2=6.694,P=0.035,P < 0.05).After treatment,the mean scores of Karnofsky in two groups were compared,the treatment group was(71.87±10.29),the control group was(64.68±11.35),and the difference was statistically significant by t test(t=2.652,P=0.010,P < 0.05).The improvement of the Karnofsky score in the treatment group after the treatment was better than that of the control group.4)Adverse reaction: the rank tests,there are differences in two groups of patients with gastrointestinal reactions,bone marrow suppression,liver toxicity(P< 0.05),indicating that the treatment group of gastrointestinal reactions,bone marrow suppression,liver toxicity was lower than that of the control group.In terms of nephrotoxicity,there was no significant difference between the two groups(P >0.05)by the rank test.5)Tumor markers CEA,CA199: t test,before treatment: the CEA value of the treatment group and the control group had no significant difference(t=-0.027,P=0.979,P > 0.05).After treatment,there was no significant difference in the CEA value between the treatment group and the control group(t=-0.818,P=0.416,P >0.05),without statistical significance.Before and after treatment: treatment group and control group CEA values were decreased,compared before and after treatment within the group,there was significant difference.Before treatment,there was no significant difference in the CA199 value between the treatment group and the control group(t=0.667,P=0.507,P > 0.05).Before and after treatment,the value of CA199 in the treatment group and the control group decreased significantly.After treatment,the CA199 value of the treatment group and the control group had a significant difference(t=-2.977,P=0.004,P < 0.05).After treatment,the treatment group was better than the control group for reducing the CA199 index.6)Safety index: comparison of blood routine changes: after t test,before treatment,there was no significant difference in WBC number between treatment group and control group(t=0.770,P=0.444,P > 0.05).After treatment,the WBC value of the treatment group and the control group had a significant difference(t=2.646,P=0.010,P < 0.05),and had statistical significance.Before and after treatment: the WBC value of the treatment group decreased,but there was no statistical significance(t=0.976,P=0.333,P > 0.05).The WBC value in the control group decreased significantly,and there was a significant difference(t=3.155,P=0.002,P< 0.05).Before treatment,there was no significant difference in the PLT value between the treatment group and the control group(t=0.161,P=0.872,P > 0.05).After treatment,the PLT values of the treatment group and the control group were significantly different(t=1.667,P=0.101,P > 0.05),and there was no significant difference.Before and after treatment: the PLT value of the treatment group decreased,but there was no statistical significance(t=0.358,P=0.722,P > 0.05).The PLT value in the control group decreased significantly,and there was a significant difference(t=2.028,P=0.041,P < 0.05).The effect of the treatment group on the two indexes of WBC and PLT in blood routine after treatment was lower than that of the control group.The changes of liver and kidney function in the two groups: after the t test,there was no significant difference in the indexes of ASL,ALT,CR and BUN in the liver and kidney function of the two groups before the treatment(P > 0.05).Before and after treatment: the treatment group ASL,ALT,CR,BUN index has some changes,but the t test before and after treatment had no significant difference(P >0.05);control group ASL increased significantly(t=-3.251,P=0.002,P < 0.05),the difference was statistically significant;the control group ALT increased significantly(t=-2.518,P=0.014,P < 0.05),there was statistical significance;The indexes of CR and BUN in the control group slightly increased compared with those before treatment,but there was no difference in t test(P > 0.05).It indicates that the damage of liver function in the treatment group is lower than that in the control group.Conclusion: Shen Zhe Pei Qi decoction in the treatment of advanced esophageal squamous cell carcinoma(Qi deficiency phlegm and blood stasis type),can improve the quality of life of patients,reduce the tumor marker values,especially in stable lesions and decrease the clinical symptoms significantly better than the control group,the incidence of adverse effects was lower than that in control group,and synergistic effect on chemotherapy. |
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