ObjectiveTo evaluate the clinical efficacy and safety of Xiaozhen Formula （消疹方） in preventing skin toxicity induced by epidermal growth factor receptor inhibitors （EGFRIs） in patients with EGFR-mutant non-small cell lung cancer （NSCLC）. MethodsA randomized， double-blind， placebo-controlled， multicenter clinical study was conducted. A total of 120 patients with EGFR-mutant NSCLC from seven centers were enrolled and randomly assigned to a treatment group （60 cases） or a control group （60 cases）. On the basis of EGFRI-targeted therapy， patients in the treatment group received Xiaozhen Formula granules， whereas those in the control group received Xiaozhen Formula placebo granules， both at 10 g twice daily for 4 consecutive weeks. The primary outcomes were the grading of skin toxicity evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events （NCI-CTCAE） version 5.0 and the incidence of rash. Secondary outcomes included the time to onset and time to resolution of the highest-grade rash， the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 （EORTC QLQ-C30） scores， the Hospital Anxiety and Depression Scale （HADS） scores， and disease control rate， together with safety assessments. ResultsBased on the full analysis set （FAS）， the incidence of skin toxicity in the treatment group was 18.33% （11/60）， significantly lower than 45.00% （27/60） in the control group （P＜0.01）， with the highest severity of skin toxicity in both groups was grade 2. Among patients who developed rash， the resolution rate in the treatment group was 90.91% （10/11）， higher than that 33.33% （9/27） in the control group. The median time to resolution was 15 days （95%CI： 8-17 days） in the treatment group and it was not reached in the control group； the distribution of time to resolution differed significantly between groups （P＜0.001）. After treatment， the treatment group had higher EORTC QLQ-C30 functional scale and global health status/quality-of-life scores， and lower symptom scale， single-item scores， as well as HADS-A， and HADS-D scores than the control group （P＜0.05）. In the FAS analysis， the disease control rate （DCR） was 85.0% （51/60） in the treatment group， lower than 100.0% （60/60） in the control group （P=0.003）， whereas no significant between-group difference was observed in the per-protocol set （PPS） analysis （P=0.464）. The incidence of adverse events did not differ significantly between the two groups （P＞0.05）， and no definite safety signals related to the investigational drug were observed. ConclusionXiaozhen Formula can reduce the incidence of EGFRI-induced skin toxicity， and improve the outcome of rash regression， the patients' quality of life and psychological status in EGFR-mutant NSCLC patients.

AIM To study the epidermal growth factor (EGF) and transforming growth factor ? (TGF ?)and the epidermal growth factor receptor(EGFR)during the course of rats gastric ulcer natural cure expressing and its possible biology meaning. METHODS We injected acetic acid to make the ulcer animal model, location expression characteristic of EGF and TGF ? and EGFR were studied by immunohistochemistry. RESULTS The normal rats stomach mucosa EGF,TGF ? and EGFR all expressed weakly at masculine. EGF and TGF ? was located at cytoplasm,and EGFR expressesed at cytoplasm and cell membrane and the expression position of the three ovrlopped with each other. EGF concentrated mainly on the cervical part of gastric gland, and TGF ? and EGFR, on the cervical and base parts of the gastric gland. Positive 9 expression cells were primarily parietal[FQ(11?46,X-WZ] and neck cells of the stamook muc. For materials taken during the course of ulcer natural recovery, regular ohanges were observed in TGF, TGF ? and EGFR expression. Higher expression was found in ulcer tissunes than in normal tissues, while the expression was not detectable in necrotic tissues and rarely detectable in granlation and scar tissnes. The expression became apparant only during healing and scar stages of ulcer but not in early stage. CONCLUSION ①TGF ?/EGFR autocrine system probably plays a leading role in maintaining rats mucosa completeness under the normal circumstances; ②EGF/EGFR and TGF ?/EGFR autocrine system may have important effect on the differentiation, hyperplasia, moving of cell and restraining the gastric acidity.