| Objective:Based on the the theory of "Qi deficiency and blood stasis",To evaluate the clinical efficacy of Qishen-Zhuyu Decoction in the treatment of chemotherapy-related Qi deficiency blood stasis type hand-foot syndrome by comparing of the changes in grade of the chemotherapy-related HFS score,TCM syndrome(qi deficiency and blood stasis)score,pain score and physical performance status(KPS)before and after treatment.Methods: The 72 eligible cases from December 2021 to December 2022 were divided into treatment and control groups by random number table method,with 36 cases in each group.The control group was treated with methylcobalamin capsules orally(0.5mg/time,3times/day)on the basis of the original basic treatment,and the treatment group was treated with oral Chinese medicine Qishen-Zhuyu Decoction(1 dose/day,3 times/day)on the basis of the control group.After 21 days,the changes in grade of the chemotherapy-related HFS score,TCM syndrome(qi deficiency and blood stasis)score,pain score and physical performance status(KPS)score were evaluated.Results:1.Baseline data: There were no significant differences in gender,age and course between the treatment group and the control group(P>0.05),indicating that the two groups were comparable.2.Efficacy of TCM syndrome: The overall effective rate of the efficacy of TCM symptoms in the treatment group was better than that of the control group(91.43% VS73.53%,P<0.05),and the single scores of TCM symptoms in the treatment group were also better than those in the control group(P<0.05).3.Efficacy of local grading: After treatment,both groups could reduce HFS grade(P<0.05),and the treatment group was better than the control group(88.57% VS50.00%,P<0.05).4.Pain efficacy: After treatment,the pain relief of HFS in both groups(P<0.05),and the treatment group had better HFS pain relief than the control group(P<0.05).5.KPS efficacy: After treatment,the KPS scores of both the treatment group and the control group improved(P<0.05),and the treatment group improved the KPS score better than the control group(P<0.05).6.Safety indicators: During the clinical observation,the ECG,blood routine,liver and kidney function,and blood glucose of the two groups were normal,and no serious adverse reactions occurred.Conclusion:1.Qishen-Zhuyu Decoction is effective in reducing the grading of hand-foot syndrome and superior to methylcobalamin in improving clinical symptoms.2.Qishen-Zhuyu Decoction which has a significant effect on improving the TCM symptoms of chemotherapy-related Qi deficiency and blood stasis hand-foot syndrome,and is superior to methylcobalamin in improving the single scores of TCM symptoms(numbness of hands and feet,dry skin,pain,fatigue,shortness of breath,lazy speech,and Skin nail error).3.Qishen-Zhuyu Decoction can improve the quality of life of patients.4.The safety of Qishen-Zhuyu Decoction was good,and no abnormal adverse reactions were seen during the observation period. |