A Clinical Controlled Study Of Self-made Xiaozhen Formula On EGFR-TKI-related Rash

Objective: To evaluate the effectiveness of Xiaozhen formula upon skin toxicity caused by epidermal growth factor receptor tyrosine kinase inhibitor(EGFR-TKI).Clinical parameters as the rash severity,quality of life assessment,and TCM(traditional Chinese medicine)syndrome classification were used to provide a preliminary evidence for further application.Methods:Based on the sample size estimation,at least 64 patients need to be included,and random block design is performed with 4 as the block number.Patients were enrolled from January 2019 to October 2019,at the department of Oncology and Hematology from the Traditional Chinese Medicine Hospital affiliated to our University.All patients were diagnosed as non-small cell lung cancer by histopathology,genetically tested with EGFR gene-sensitive mutations and taken orally the first generation of EGFR-TKI drugs(including gefitinib,erlotinib,and icotinib).Computerized randomization was used to randomly allocate patients.A total of 32 patients in the treatment group and 32 patients in the control group were collected.There was no statistical difference in the baseline data,including gender,age,rash classification etc.The control group began to use erythromycin ointment on the same day after the rash appeared,twice a day for 4 weeks.In the treatment group,the basic principle was to nourish Yin,moisten lung,cool blood and detoxify,they began to useerythromycin ointment plus to take oral self-made Xiaozhen formula on the same day after the rash appeared.The method of erythromycin was the same as that of control group.The Xiaozhen formula was orally taken 1 dose daily(3times a day)for 4 weeks.We observed the changes of rash grade,quality of life and TCM syndrome score in the two groups before and after treatment.Rash severity were evaluated following the Common Terminology Criteria for Adverse Events(CTCAE version4.0)and Dermatology life quality index(DLQI).The TCM syndrome scores are based on the observation guidelines for acne and eczema in the "Guidelines for Clinical Research on New Chinese Medicines".SPSS 25 statistical software was used for data aggregation and analysis after data collection.Two independent sample t-tests,paired t-test,chi-square test,Fisher exact test,Wilcoxon rank sum test were used.The difference was statistically significant with P <0.05.Results:The results of paired t test showed that the TCM syndrome scores and quality of life scores of the two groups were lower than before treatment.The results of Wilcoxon rank sum test showed that the rash severity of the two groups was lower than before treatment,and there were significant differences between the groups(P<0.05).Through independent t-test analysis,there was also a significant difference between the two groups of patients after treatment with TCM syndrome scores and quality of life scores(P<0.05).Conclusion:Based on the overall concept of traditional Chinese medicine and the principle of syndrome differentiation and treatment,the Xiaozhen formula which is based on the principles of nourishing Yin,moisteninglung,cooling blood and detoxifying has a good effect on the rash caused by EGFR-TKI.It can reduce the adverse reactions of this kind of rash,relieve the symptoms of patients and improve the quality of life.It is worthy of clinical application.