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.

Objective:To investigate the predictive value of regional leptomeningeal collateral (rLMC) score on CT angiography (CTA) for the outcome after endovascular therapy in patients with late window anterior circulation stroke.Methods:Patients with acute anterior circulation large vessel occlusive stroke received endovascular treatment 6 to 24 h after onset in the Department of Neurology, the First Affiliated Hospital of Soochow University from January 2018 to July 2021 were enrolled retrospectively. At 3 months after onset, the outcome was evaluated according to the modified Rankin Scale. A score of ≤ 2 was defined as good outcome, and a score of >2 was defined as poor outcome. The clinical data, non-enhanced CT and CTA parameters of the patients were collected. Multivariate logistic analysis was used to determine the independent influencing factors of poor outcomes after endovascular treatment. Results:A total of 74 patients with acute anterior circulation large vessel occlusive stroke treated with endovascular treatment in the late window were enrolled. Their age was 64.41±12.98 years, 43 were males (58.1%). The baseline National Institutes of Health Stroke Scale (NIHSS) score was 13.18±5.22, and the median time from onset to puncture was 527.5 min. Fifty-three patients (71.6%) chose direct thrombectomy and 21 (28.4%) chose intravenous thrombolysis and bridging thrombectomy. Thirty-six patients (48.6%) had a good outcome and 38 (51.4%) had a poor outcome, including 4 (5.4%) died. Univariate analysis showed that there were significant differences in age, atrial fibrillation, fasting blood glucose, NIHSS score, Alberta Stroke Program Early CT Score (ASPECTS), rLMC score and clot burden score between the good outcome group and the poor outcome group (all P<0.05). Multivariate logistic regression analysis showed that higher ASPECTS (odds ratio 0.352, 95% confidence interval 0.157-0.791; P=0.012) and rLMC score (odds ratio 0.550, 95% confidence interval 0.329-0.919; P=0.022) were the independent predictors of good outcomes after endovascular therapy. Conclusion:ASPECTS and rLMC scores were the independent predictors of clinical outcomes after endovascular therapy in patients with late window anterior circulation large vessel occlusive stroke. It had certain guiding value for the decision-making of endovascular treatment in such patients.

Objective:To investigate the expression of costimulatory molecule OX40 in peripheral CD4 +CD25 +CD127 low regulatory T (Treg) cells and its clinical significance in patients with acute cerebral infarction (ACI). Methods:Seventy-five patients with first-onset ACI, admitted to our hospital from April 2019 to December 2019, and 36 age- and gender-matched volunteers (control group) were selected in this study. OX40 expression on CD4 +CD25 +CD127 low Treg cells in peripheral blood samples in the two groups were analyzed by immunofluorescent labeling and flow cytometry. Correlations of OX40 +Treg cell percentage with National Institute of Health stroke scale (NIHSS) scores, ischemic penumbra volume, core infarct volume, and infarct volume in the patient group were analyzed. The changes of OX40 +Treg cell percentage in the patient group before and after endovascular treatment or intravenous thrombolysis were compared. Results:As compared with that in the control group, the Treg cell percentage in peripheral blood samples of the patient group was significantly decreased, while OX40 +Treg cell percentage was significantly increased ( P<0.05). OX40 +Treg cell percentage was positively correlated with NIHSS scores in ACI patients ( r s=0.271, P=0.018). Meanwhile, OX40 +Treg percentage was significantly correlated with ischemic penumbra volume, core infarct volume, and infarct volume in the patient group ( r s=0.435, P=0.000; r s=0.343, P=0.003; r s=0.245, P=0.034). OX40 +Treg cell percentage in ACI patients 7 d after endovascular treatment was significantly decreased as compared with that before treatment ( P<0.05); OX40 +Treg percentage in ACI patients 3 and 7 d after intravenous thrombolysis was significantly decreased as compared with that before treatment ( P<0.05). Conclusion:OX40 is abnormally expressed on peripheral Treg cells in ACI patients, and is closely correlated with neurological deficits, imaging features and reperfusion therapy.