Objective:To evaluate the efficacy and safety of immunotherapy combined with chemotherapy as conversion therapy for initially unresectable locally advanced esophageal squamous cell carcinoma.Methods:This retrospective case series study analyzed clinical and pathological data of 32 patients with initially unresectable locally advanced esophageal squamous cell carcinoma who received immunotherapy combined with chemotherapy at the Department of Thoracic Surgery, the Fourth Hospital of Hebei Medical University, from June 2020 to December 2024. The cohort included 27 males and 5 females, with an age ( M(IQR)) of 61(9)years (range:46 to 73 years). Five patients were diagnosed with stage Ⅲ, 27 with stage ⅣA. All patients received PD-1 inhibitor sintilimab combined with nedaplatin and albumin-bound paclitaxel. Radiological evaluations were performed every two cycles, the multidisciplinary team evaluation was conducted to determine conversion to resectable status, and patients with successful conversion underwent radical esophagectomy. Follow-up was conducted via telephone or outpatient visits every 3 to 6 months after the last treatment. The primary endpoint was R0 resection rate, secondary endpoints included objective response rate (ORR), pathological complete response (pCR) rate, major pathological response (MPR) rate, event-free survival (EFS), disease-free survival (DFS) in patients with R0 resection, overall survival (OS) and safety. Kaplan-Meier method was used to plot survival curves and estimate median EFS, DFS, OS rates and their 95% CI. The 95% CI for ORR, pCR rate, MPR rate, and downstaging rate were calculated using the Clopper-Pearson method. Results:The median treatment cycle of 2(1) (range:2 to 8). As of June 2025, the median follow-up was 32.5(13.5)months (range:6.4 to 59.1 months). Among the 32 patients, 9 experienced progression or recurrence, including 2 with liver and lymph node metastases, 2 with lung metastases, 2 with thoracic vertebral metastases, and 3 with mediastinal lymph node metastases. After conversion therapy, 29 patients underwent surgery, achieving an R0 resection rate of 84.4% (95% CI:67.2% to 94.7%), a pCR rate of 27.6% (95% CI:12.7% to 47.2%), and an MPR rate of 55.2% (95% CI:35.7% to 73.6%). Grade 3 or higher surgical complications occurred in 6.9%(2/29) of patients, and grade 3 or higher treatment-related adverse events were observed in 15.6%(5/29). Among the 32 patients, the ORR was 56.3% (95% CI:37.7% to 73.6%),the 3-year EFS rate and OS rate was 59.4% (95% CI:40.8% to 86.4%) and 59.7% (95% CI:40.0% to 89.0%) respectively. Conclusion:Immunotherapy combined with chemotherapy demonstrates high conversion rates and favorable safety in the conversion therapy of initially unresectable locally advanced esophageal squamous cell carcinoma, representing a promising treatment strategy.

[Objective]In order to explore the regulatory requirements for clinical evaluation about peripheral and pulmonary thrombus removal apparatus,the marketing status of these apparatuses in the Food and Drug Administration(FDA)of United States was searched,and the pre-marketing research contents of relevant documents were summarized and organized.Based on the current public information on their official website,the clinical trial designs of FDA's three main categories of peripheral and pulmonary thrombus removal apparatuses(aspiration catheter,thrombectomy stent and mechanical thrombus removal system)in 510(k)pre-marketing notice were sorted out,and the regulatory requirements of FDA clinical evaluation about this kind of apparatus were analyzed,which could provide references for researchers and developers of relevant products,and clinical researchers about the pre-marketing clinical evaluation of peripheral blood thrombolysis apparatus.

Objective:To evaluate the efficacy and safety of immunotherapy combined with chemotherapy as conversion therapy for initially unresectable locally advanced esophageal squamous cell carcinoma.Methods:This retrospective case series study analyzed clinical and pathological data of 32 patients with initially unresectable locally advanced esophageal squamous cell carcinoma who received immunotherapy combined with chemotherapy at the Department of Thoracic Surgery, the Fourth Hospital of Hebei Medical University, from June 2020 to December 2024. The cohort included 27 males and 5 females, with an age ( M(IQR)) of 61(9)years (range:46 to 73 years). Five patients were diagnosed with stage Ⅲ, 27 with stage ⅣA. All patients received PD-1 inhibitor sintilimab combined with nedaplatin and albumin-bound paclitaxel. Radiological evaluations were performed every two cycles, the multidisciplinary team evaluation was conducted to determine conversion to resectable status, and patients with successful conversion underwent radical esophagectomy. Follow-up was conducted via telephone or outpatient visits every 3 to 6 months after the last treatment. The primary endpoint was R0 resection rate, secondary endpoints included objective response rate (ORR), pathological complete response (pCR) rate, major pathological response (MPR) rate, event-free survival (EFS), disease-free survival (DFS) in patients with R0 resection, overall survival (OS) and safety. Kaplan-Meier method was used to plot survival curves and estimate median EFS, DFS, OS rates and their 95% CI. The 95% CI for ORR, pCR rate, MPR rate, and downstaging rate were calculated using the Clopper-Pearson method. Results:The median treatment cycle of 2(1) (range:2 to 8). As of June 2025, the median follow-up was 32.5(13.5)months (range:6.4 to 59.1 months). Among the 32 patients, 9 experienced progression or recurrence, including 2 with liver and lymph node metastases, 2 with lung metastases, 2 with thoracic vertebral metastases, and 3 with mediastinal lymph node metastases. After conversion therapy, 29 patients underwent surgery, achieving an R0 resection rate of 84.4% (95% CI:67.2% to 94.7%), a pCR rate of 27.6% (95% CI:12.7% to 47.2%), and an MPR rate of 55.2% (95% CI:35.7% to 73.6%). Grade 3 or higher surgical complications occurred in 6.9%(2/29) of patients, and grade 3 or higher treatment-related adverse events were observed in 15.6%(5/29). Among the 32 patients, the ORR was 56.3% (95% CI:37.7% to 73.6%),the 3-year EFS rate and OS rate was 59.4% (95% CI:40.8% to 86.4%) and 59.7% (95% CI:40.0% to 89.0%) respectively. Conclusion:Immunotherapy combined with chemotherapy demonstrates high conversion rates and favorable safety in the conversion therapy of initially unresectable locally advanced esophageal squamous cell carcinoma, representing a promising treatment strategy.

[Objective]In order to explore the regulatory requirements for clinical evaluation about peripheral and pulmonary thrombus removal apparatus,the marketing status of these apparatuses in the Food and Drug Administration(FDA)of United States was searched,and the pre-marketing research contents of relevant documents were summarized and organized.Based on the current public information on their official website,the clinical trial designs of FDA's three main categories of peripheral and pulmonary thrombus removal apparatuses(aspiration catheter,thrombectomy stent and mechanical thrombus removal system)in 510(k)pre-marketing notice were sorted out,and the regulatory requirements of FDA clinical evaluation about this kind of apparatus were analyzed,which could provide references for researchers and developers of relevant products,and clinical researchers about the pre-marketing clinical evaluation of peripheral blood thrombolysis apparatus.

Surgery-based multidisciplinary comprehensive treatment is the preferred treatment strategy for local advanced esophageal cancer. Neoadjuvant chemotherapy and neoadjuvant chemoradiotherapy have been recommended by the Chinese Society of Clinical Oncology (CSCO) guideline. With the advent of immunotherapy, neoadjuvant immunotherapy combined with chemotherapy has received much attention, and the first phase Ⅲ study has also confirmed that neoadjuvant immunotherapy combined chemotherapy is a promising treatment option. This article will review the recent advances and hot spots of neoadjuvant immunotherapy combined with chemotherapy.

A variety of facial injection filler materials have been approved for market at home and abroad.The marketing approvals,clinical application literature,expert consensus or clinical application guidelines of facial injection filler products at home and abroad were collected and it was found that facial injection filler materials may cause a number of adverse reactions.The clinical application and adverse reactions of facial injection filler materials were summarized,the pre-market adverse reaction evaluation requirements of such products in the United States and China were analyzed and summarized,aiming to provide reference for relevant product developers and clinical researchers to evaluate the pre-market adverse reactions of facial injection filler materials.

Objective:To determine the expression of transmembrane protein 45A (TMEM45A) in keloid tissues and fibroblasts, and to evaluate its effect on extracellular matrix (ECM) synthesis by keloid-derived fibroblasts (KFs) .Methods:Samples of surgically excised keloid and normal foreskin tissues were collected from the Department of Dermatology and Department of Urology of Yanbian University Hospital from January 2019 to December 2020, and TMEM45A protein expression was determined in keloid tissues and KFs by Western blot analysis. KFs were divided into TMEM45A-specific small interfering RNA (siRNA) group and control siRNA group to be transfected with the TMEM45A-specific siRNA and control siRNA respectively. Then, Western blot analysis was performed to evaluate the effects of down-regulation of the TMEM45A gene on the expression of myofibroblast marker protein (α-smooth muscle actin) and ECM-related proteins.Results:Compared with normal skin tissues (1.00 ± 0.11) and fibroblasts (1.00 ± 0.20), TMEM45A expression levels significantly decreased in keloid tissues (0.26 ± 0.05) and KFs (0.41 ± 0.09), respectively ( t = 10.76, 4.75, P < 0.001, = 0.009, respectively). The expression levels of α-smooth muscle actin, ECM-related type Ⅰ collagen, type Ⅲ collagen, and fibronectin were significantly higher in the TMEM45A-specific siRNA group than in the control siRNA group ( t = -5.98, -4.57, -4.90, -7.19, P = 0.004, 0.010, 0.008, 0.002, respectively) . Conclusion:Lowly expressed TMEM45A in keloids may play an important role in the pathogenesis of keloids by promoting ECM synthesis.

Objective:To explore the diagnostic efficacy of percutaneous lymphatic contrast ultrasound (LCEUS) combined with clinicopathological features in the diagnosis of breast cancer sentinel lymph node (SLN).Methods:A total of 135 breast cancer patients who underwent sentinel lymph node biopsy and axillary lymph node radical resection were prospectively collected in the Affiliated Hospital of Nanjing University of Chinese Medicine from July 2018 to June 2021, and the breast masses and SLNs were evaluated by routine ultrasound, contrast-enhanced ultrasound and LCEUS within one week before surgery. The surgeons recorded the patients′ clinical characteristics before surgeries, and the pathology of the masses and SLNs were recorded after surgeries. Univariate analysis and multivariate Logistic regression analysis were used to explore the correlation between ultrasound clinicopathological features of breast cancer and SLN metastasis, then to establish a model, and evaluate the diagnostic efficacy of the model.Results:Univariate analysis showed that SLN metastasis of breast cancer was associated with age, axillary palpation of enlarged lymph nodes, pathological type of mass, clear hilum of lymph nodes, cortical thickening of lymph nodes, marginal blood flow in lymph nodes, and the appearances of LCEUS(all P<0.05). Multivariate Logistic regression analysis showed age, palpation of axillary lymph nodes and the appearances of LCEUS were independent predictors of SLN properties, the OR values were 6.90 ( P=0.030), 16.06 ( P<0.001) and 12.71 ( P<0.001), respectively. The regression equation was Logit(P)=0.887+ 1.932× axillary lymph node palpation + 2.776× marginal blood flow + 2.542×LCEUS. Conclusions:LCEUS combined with marginal blood flow in lymph nodes and palpation of axillary lymph nodes can help to determine the SLN state.

Objective To analyze the effect of missing data in population based viral load (PVL) survey in HIV infected men who have sex with men (MSM) sampled in 16 cities in China.Methods The database of 3 virus load sampling survey conducted consecutively in HIV infected MSM population in 16 large cities (Beijing,Shanghai,Nanjing,Hangzhou,Wuhan,Chongqing,Kunming,Xi' an,Guangzhou,Shenzhen,Narning,Urumuqi,Harbin,Changchun,Chengdu and Tianjin) during 2013-2015 was used.SPSS 17.0 software was used to describe distribution of the missing data and analyze associated factors.Results A total of 12 150 HIV infected MSM were randomly selected for the surveys,in whom,9 141 (75.2％) received virus load tests,while 3 009 (24.8％) received no virus load tests,whose virus load data missed.The virus load data missing rates in MSM with or without access to antiretroviral therapy (ART) were 11.5％ (765/6 675) and 39.4％ (2 060/5 223) respectively,and the virus load data missing rates were 21.9％ (1 866/8 523) and 28.4％ (959/3 374),respectively,in local residents and non-local residents (migrants).Conclusions The analysis indicated that the data missing occurred in the virus load survey in HIV infected MSM population.ART status and census registering status were the main influencing factors.Data missing could influence the accurate evaluation of community viral load (CVL) and population viral load (PVL) levels in HIV infected MSM in China.

Objective To develop a HIV infection risk assessment tool for men who have sex with men (MSM) based on Delphi method.Methods After an exhaustive literature review,we used Delphi method to determine the specific items and relative risk scores of the assessment tool through two rounds of specialist consultation and overall consideration of the opinions and suggestions of 17 specialists.Results The positivity coefficient through first and second round specialist consultation was 100.0％ and 94.1％,respectively.The mean of authority coefficients (Cr) was 0.86.Kendall's W coefficient of the specialist consultation was 0.55 for the first round consultation (x2=84.426,P＜0.001) and 0.46 for the second round consultation (x2=65.734,P＜0.001),respectively,suggesting that the specialists had similar opinions.The final HIV infection risk assessment tool for MSM has 8 items.Conclusions The HIV infection risk assessment tool for MSM,developed under the Delphi method,can be used in the evaluation of HIV infection risk in MSM and individualized prevention and intervention.However,the reliability and validity of this risk assessment tool need to be further evaluated.