| Objective: Capecitabine has been widely used as a substitute for 5-fluorouracil in the treatment of breast cancer,gastric cancer and colorectal cancer due to its simplicity and efficiency.However,capecitabine-induced hand-foot syndrome(HFS)has a high incidence,its pathogenesis is not clear,and there is a lack of effective clinical prevention and treatment,which seriously affects the quality of life of patients and the continuity of clinical treatment.Therefore,it is of great clinical significance to explore effective prevention and treatment strategies for HFS.The external treatment of traditional Chinese medicine has shown certain advantages in improving the quality of life of cancer patients and alleviating the toxic and side effects related to treatment.Based on the clinical experience of the tutor,Tongrong external washing decoction was formulated for the core pathogenesis of capecitabine-related HFS.Through this prospective clinical study,the clinical efficacy of Tongrong external washing decoction was objectively and scientifically evaluated,so as to better reflect the characteristics and advantages of TCM external treatment intervention in HFS,in order to guide clinical application.Content and method: A prospective randomized controlled clinical study design was used to study cancer patients with HFS admitted to Wei Fang Hospital of Traditional Chinese Medicine from December 2021 to December2022.A total of 60 eligible patients were screened according to inclusion and exclusion criteria.Collect the basic information of patients,such as baseline data,medication cycle,further fill in the case report form,and establish the clinical data database with Excel.According to the random number table method,60 enrolled patients were divided into test group and control group.The test group was given Tongrong external washing decoction combined with oral vitamin B6,and the control group was given warm water combined with oral vitamin B6.The efficacy was evaluated after 21 days.The main observation indexes included HFS grading,HFS local major symptom grading,KPS score and TCM syndrome score,and the safety was evaluated according to the grading criteria of adverse events.Relevant data and results were statistically analyzed by SPSS 26.0 software.Results: Baseline data(gender,age,disease type,stage,and duration of capecitabine)were comparable between the two groups at the time of enrollment(P > 0.05).(1)Curative effect of HFS: The HFS grade of both groups was lower than before(P < 0.05),and the total effective rate of experimental group was higher than that of control group,the difference was statistically significant(P < 0.05).(2)Local symptoms of HFS: the effective rates of paresthesia,erythema multiforme,dry skin and pain in experimental group were higher than those in control group,and the difference was statistically significant(P < 0.05).(3)KPS score: there was no significant difference between the experimental group and the control group in KPS efficacy(P > 0.05).(4)TCM syndrome score: After treatment,the total scores of TCM syndromes in both groups decreased compared with before(P < 0.05),and the total effective rate of TCM syndromes in experimental group was higher than that in control group,the difference was statistically significant(P < 0.05).(5)Safety indicators:patients in the two groups were generally in good condition,with no abnormal laboratory indicators affected by the test drug and no serious local toxic and side effects.Conclusion: Tongrong external washing decoction can effectively reduce the severity of HFS and relieve local symptoms of paresthesia,erythema multiforme,dry skin and pain caused by HFS.Tongrong external washing decoction can improve the TCM syndrome score of capecitabine-related HFS,and the drug is safe without obvious toxic and side effects. |
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