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 establish the scoring standard of nasal swab collection technique for internal contamination, and to test its clinical effect, so as to standardize the nasal swab collection process and improve the medical rescue ability against nuclear radiation.Methods:The scoring standard of nasal swab collection technique for internal contamination was developed on the basis of literature research, expert consultation and pre-test. It was applied for training and assessment of 55 nurses, and the difference in scores before and after training was analyzed to test the application effect.Results:The effective response rate of expert inquiry questionnaire was 93.3%, the expert familiarity 0.914, the judgment basis 0.921, and the expert authority coefficient 0.917. Finally, the technical scoring standard for nasal swab collection for internal contamination was developed through three stages of preparation, sampling and arrangement. Through practical application, the score after training (94.98±2.84) was significantly better than that before training (81.37±10.45), with statistically significant difference ( t=8.63, P<0.05). Conclusions:The scoring standard of nasal swab collection technique for internal contamination, developed in this study, is reliable, innovative and practical. It is suitable for clinical practice and training and helpful to standardize the collection process and improve the rescue ability in a nuclear emergency.

Objective To explore the application of cell block(CB)technology in the diagnosis of papillary thyroid carcinoma(PTC).Methods A total of 86 patients with thyroid nodules who were treated at Luoyang Central Hospital Affiliated to Zhengzhou University from February 2023 to December 2024 were retrospectively selected.Before the operation,all patients underwent ultrasound-guided fine needle aspiration biopsy.After the biopsy,the specimens were respectively subjected to cell smear(CS)and CB pathological examinations.Using postoperative pathology as the gold standard,the clinical application value of CS,CB,BRAFV600E gene detection,and combined detection in the preoperative diagnosis of PTC was evaluated.Results A total of 86 patients were included.Among them,42 cases were diagnosed as PTC by postoperative pathology,and 44 cases were benign lesions.The sensitivity(73.81％),specificity(97.73％),positive predictive value(96.88％),negative predictive value(79.63％),and accuracy(86.05％)of CB in the preoperative diagnosis of PTC were significantly higher than those of CS.The Kappa consistency test results showed that the consistency between CB pathological results and postoperative pathological results was better than that of CS.Receiver operating characteristic curve analysis indicated that the area under the curve(AUC)of CB was significantly higher than that of CS(0.858 vs.0.743,Z=2.391,P=0.017).Furthermore,the combination of CB and BRAFV600E gene detection further improved preoperative diagnostic performance,with a consistency with postoperative pathological results(Kappa=0.837)superior to other examination methods,and an AUC(0.918)significantly higher than other examination methods.Conclusion CB has significant clinical application value in the preoperative diagnosis of PTC,with diagnostic performance significantly superior to CS.Further combination with BRAFV600E gene detection can significantly improve preoperative diagnostic accuracy.

Objective:To observe the clinical efficacy of combined acupuncture and medication therapy in treating cerebral infarction in the acute stage and its impact on cerebral blood flow.Methods:A total of 160 patients with cerebral infarction were divided into 4 groups using the random number table method,with 40 cases in each group.Conventional treatment was given to all groups.Besides,the Chinese medication group received Tong Shen Fu Nao Wan;the acupuncture group received Xing Nao Kai Qiao(mind-refreshing and orifice-opening)needling therapy;the acupuncture-medication group received both Tong Shen Fu Nao Wan and Xing Nao Kai Qiao needling therapy.After 4 weeks of treatment,the clinical efficacy was assessed,and changes in the traditional Chinese medicine(TCM)symptom score and hemodynamics were compared among the four groups,as well as complications and adverse reactions.Results:After treatment,the acupuncture-medication group had a higher total effective rate compared to the other three groups(P<0.05).After the intervention,the National Institutes of Health stroke scale(NIHSS)score dropped in all groups(P<0.05)and was lower in the acupuncture-medication group than in the other three groups(P<0.05);all groups showed a decrease in the TCM symptom score(P<0.05),and the acupuncture-medication group was significantly lower than the other groups(P<0.05).After treatment,the blood flow velocity of the bilateral anterior cerebral artery(ACA),middle cerebral artery(MCA),and posterior cerebral artery(PCA)increased in every group(P<0.05),and the acupuncture-medication group had higher blood flow velocities compared to the other three groups(P<0.05).The acupuncture-medication group had the fewest number of complications among the four groups(P<0.05),and there was no statistical significance when comparing the adverse reactions among the groups(P>0.05).Conclusion:Compared to the separate use,the combined use of acupuncture and medication enhances the clinical efficacy,accelerates cerebral blood circulation,and boosts the recovery in treating cerebral infarction.

Creutzfeldt-Jakob disease(CJD)is a rapidly progressive and fatal neurodegenerative disorder caused by prions,with certain infectivity and iatrogenic transmission risks.With the rapid progress and application of new dia-gnostic biomarkers and detection methods,as well as the construction and improvement of surveillance and reporting systems,the detection of CJD in patients domestically and internationally has shown an increasing trend year by year.Due to its long incubation period and heterogeneity of early symptoms,early identification and diagnosis of the disease is difficult,increasing the risk of transmission within medical institutions.Currently,there is a lack of con-sensus on the infection prevention and control of CJD.In order to timely identify and diagnose CJD as well as effec-tively block its transmission in medical institutions,this consensus summarizes 15 clinical concerns and formulates 24 specific recommendations based on the latest domestic and international research findings and clinical evidence,as well as combines with clinical practice,aiming to standardize healthcare-associated infection prevention and control measures for CJD and reduce its transmission risk in medical institutions.

Pediatric urological non-Hodgkin lymphoma is relatively rare.When a single renal or ureteral tumor with multiple lymph node or bone metastases is present, it is very easy to be misdiagnosed as urinary tumor with metastasis, resulting in unnecessary radical nephrectomy. This paper reports two cases of non-Hodgkin lymphoma presenting with single urinary nodules. Case 1 was diagnosed with a 4.5cm tumor in the right kidney due to fever and fatigue. CT and PET-CT showed multiple bone destruction and lymph node metastasis. Renal biopsy was performed and ALK-positive anaplastic large cell lymphoma was diagnosed. Chemotherapy was effective for 6 months. Case 2 was diagnosed with left hydronephrosis due to intermittent low back pain for 2 weeks. Ultrasound examination revealed ureteral dilation with left hydronephrosis and low echo occupying of the lower ureter. The patient had sudden blurred vision before surgery. MRI examination revealed space occupying in the right optic nerve frame, and PET-CT found multiple bone, lymph nodes and nerve invasion. A lymph node biopsy was performed and Burkitt lymphoma was diagnosed. After 6 months of chemotherapy and radiotherapy, the tumor shrank significantly.

Artificial intelligence(AI)has emerged as a cutting-edge technology leading the future and is a key engine for China's development.In the innovation and research of medical devices,AI has provided critical support in the areas of intelligent diagnostic assistance,intelligent therapeutic assis-tance,intelligent monitoring,life support,et al.Ma-chine learning-enabled device software functions(ML-DSFs)have become an essential component of many medical devices.Recently,the United States Food and Drug Administration(FDA)released a draft guidance titled"Marketing Submission Rec-ommendations for a Predetermined Change Con-trol Plan for Artificial Intelligence/Machine Learn-ing(AI/ML)-Enabled Device Software Functions(Draft)."that aimed to provide a forward-looking approach to foster the development of ML medical devices.By supporting iterative updates through modifications,this approach ensures the continu-ous safety and effectiveness of the devices.This guidance represents the latest in regulatory direc-tion and is especially beneficial for enhancing the quality and efficiency of clinical trials for AI prod-ucts.Therefore,we plan to provide a detailed intro-duction and interpretation of the guidance,with the aim of learning from international advanced regulatory concepts and experiences to promote the development of ML-DSFs with more profound international influence.

Creutzfeldt-Jakob disease(CJD)is a rapidly progressive and fatal neurodegenerative disorder caused by prions,with certain infectivity and iatrogenic transmission risks.With the rapid progress and application of new dia-gnostic biomarkers and detection methods,as well as the construction and improvement of surveillance and reporting systems,the detection of CJD in patients domestically and internationally has shown an increasing trend year by year.Due to its long incubation period and heterogeneity of early symptoms,early identification and diagnosis of the disease is difficult,increasing the risk of transmission within medical institutions.Currently,there is a lack of con-sensus on the infection prevention and control of CJD.In order to timely identify and diagnose CJD as well as effec-tively block its transmission in medical institutions,this consensus summarizes 15 clinical concerns and formulates 24 specific recommendations based on the latest domestic and international research findings and clinical evidence,as well as combines with clinical practice,aiming to standardize healthcare-associated infection prevention and control measures for CJD and reduce its transmission risk in medical institutions.

Artificial intelligence(AI)has emerged as a cutting-edge technology leading the future and is a key engine for China's development.In the innovation and research of medical devices,AI has provided critical support in the areas of intelligent diagnostic assistance,intelligent therapeutic assis-tance,intelligent monitoring,life support,et al.Ma-chine learning-enabled device software functions(ML-DSFs)have become an essential component of many medical devices.Recently,the United States Food and Drug Administration(FDA)released a draft guidance titled"Marketing Submission Rec-ommendations for a Predetermined Change Con-trol Plan for Artificial Intelligence/Machine Learn-ing(AI/ML)-Enabled Device Software Functions(Draft)."that aimed to provide a forward-looking approach to foster the development of ML medical devices.By supporting iterative updates through modifications,this approach ensures the continu-ous safety and effectiveness of the devices.This guidance represents the latest in regulatory direc-tion and is especially beneficial for enhancing the quality and efficiency of clinical trials for AI prod-ucts.Therefore,we plan to provide a detailed intro-duction and interpretation of the guidance,with the aim of learning from international advanced regulatory concepts and experiences to promote the development of ML-DSFs with more profound international influence.

Objective To predict the lymphovascular invasion(LVI)status of breast cancer patients based on digital breast tomo-synthesis(DBT)intratumoral and peritumoral radiomics nomogram.Methods A total of 192 breast cancer patients from 2 institu-tions were retrospectively selected,in which institution 1 was used for train(n=113)and test(n=49),while institution 2 was used for external validation(n=30).Radiomics features were extracted and selected based on intratumoral and peritumoral 1 mm regions from DBT images.Different machine learning algorithms were used to construct intratumoral,peritumoral,and combined intratumoral and peritumoral models,respectively.Patient clinical data were analyzed by both univariate and multivariate logistic regression analy-ses to identify independent risk factors for the clinical imaging model.The performance of the models was evaluated using the receiver operating characteristic(ROC)curve.The radiomics features with the optimal diagnostic performance and the selected clinical imaging features were combined to construct a comprehensive clinical-radiomics model,and a nomogram was drawn.Results The combined intratumoral and peritumoral model was the optimal radiomics model.Maximum tumor diameter[odds ratio(OR)=1.486,P=0.014],suspicious malignant calcifications(OR=2.898,P=0.015),and axillary lymph node(ALN)metastasis(OR=3.615,P<0.001)were independent risk factors for LVI positive.Furthermore,the area under the curve(AUC)of the comprehensive clinical-radiomics model in the training set,test set and external valida-tion set was 0.889,0.916,and 0.862,respectively,which was higher than those of the combined intratumoral and peritumoral model(0.858,0.849,0.844)and the clinical imaging model(0.743,0.759,0.732).Conclusion The predictive nomogram,derived from both radiomics and clinical imaging features,is relatively accurate in identifying future LVI occurrence in breast cancer,demonstra-ting its potential as an assistive tool for clinicians to devise individualized treatment regimes.