| Objective:This study was conducted to evaluate the clinical efficacy of Sore Fu Tang in the treatment of oral mucositis due to Yin deficiency and fire after chemotherapy for malignant tumours,and to provide a new protocol and basis for the treatment of this chemotherapy complication in clinical Chinese medicine.Methods:According to the principle of randomized control,72 patients with yin-deficiency and fire-flourishing oral catarrh caused by malignant tumor chemotherapy were divided into treatment group and control group,36 patients in each group.During the trial,one patient in each group was excluded due to non-compliance with disease progression,and the final number of effective cases in both the treatment and control groups was 35.In the treatment group,(1)self-formulated sore recovery soup was administered orally,(2)Rehabilitative New Liquid was administered with gargling;in the control group,Rehabilitative New Liquid was administered with gargling.After 14 days of treatment,statistical analysis was carried out to compare the TCM symptom scores,changes in the classification of oral mucositis,KPS scores and safety-related indicators between the two groups before and after treatment to assess the efficacy and safety.Study results:1.The efficacy of the treatment group on the symptoms of oral ulcer or erosion,pain,fever in the hands and feet,hot flushes and night sweats,dry mouth and throat,and soreness and weakness of the waist and knees was better than that of the control group,while the efficacy of the two symptoms of dizziness and tinnitus and insomnia and dreaminess did not differ significantly between the two groups.2.Both the treatment group and the control group were able to reduce the total score of the TCM symptoms,but the reduction in the total score of the Yin deficiency and fire symptoms was significantly greater in the treatment group than in the control group,that is,the treatment group was more effective in the overall treatment of the Yin deficiency and fire symptoms.3.At the completion of the treatment,the overall effective rate of Yin Deficiency and Fire Evidence was higher in the treatment group than in the control group,that is,the treatment group had better efficacy in the treatment of Chinese medicine symptoms compared to the control group.4.At the end of the treatment course,the decrease in oral mucositis classification was greater in the treatment group than in the control group,while the efficacy of the treatment group was more prominent in the comparison of the efficacy of oral mucositis lesions between the two.5.At the end of the treatment course,the treatment group was able to significantly improve the KPS scores of the patients,while the control group did not have any significant improvement in KPS scores.Combined with the results of the comparison of the efficacy of the KPS scores of the two groups,it indicates that the treatment group can improve the quality of life of the patients with chemotherapeutic oral mucositis,while the control group had no significant effect on the improvement of quality of life.6.Throughout the trial,the safety indicators of all patients were stable without abnormalities,and there were no significant differences in safety-related indicators before and after treatment by statistical analysis,indicating that the drugs in this trial were safe and effective.Conclusion: The results of the study showed that the treatment group was more effective than the control group in reducing the TCM syndrome score,oral mucositis classification and KPS score in the oral mucositis caused by yin deficiency and fire in malignant tumour patients treated with chemotherapy,and no significant toxic side effects occurred,indicating that the clinical efficacy of Sore Fu Tang in the treatment of oral mucositis caused by yin deficiency and fire in malignant tumours after chemotherapy is more advantageous. |
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