1.Preliminary efficacy and safety of pembrolizumab combined with chemotherapy as neoadjuvant therapy for advanced temporal bone squamous cell carcinoma
Yu SI ; Yan HUANG ; Dian LIU ; Maojin LIANG ; Wenting DENG ; Yuexin CAI ; Yuebo CHEN ; Yanfang YE ; Li LING ; Zhigang ZHANG ; Suijun CHEN
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2025;60(11):1399-1406
Objective:To evaluate the safety of neoadjuvant therapy with pembrolizumab combined with 5-fluorouracil (5-FU) and cisplatin in patients with advanced temporal bone squamous cell carcinoma (TBSCC), and its impact on tumor response rate and disease-free survival (DFS).Methods:This prospective, single-arm, open-label clinical study enrolled patients with advanced (Stage Ⅲ/Ⅳ) TBSCC from Sun Yat-sen Memorial Hospital. Patients received 2-3 cycles of neoadjuvant therapy with pembrolizumab, 5-FU, and cisplatin, followed by definitive surgery. Postoperatively, patients received 6 cycles of pembrolizumab combined with radiotherapy. The primary endpoint was the 2-year disease-free survival (DFS) rate. Secondary endpoints included objective response rate (ORR) and safety indicators. Survival analysis was performed using the Kaplan-Meier method. Adverse events (AE) were assessed using the National Cancer Institute′s Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Statistical analyses were conducted using SPSS software, version 22.0.Results:From August 2021 to April 2024, 16 patients with advanced TBSCC were enrolled (13 males and 3 females), with a median age of 54 years and a median follow-up time of 2.32 years. Following neoadjuvant therapy, the objective response rate (ORR) was 64.3% (9/14), and the disease control rate (DCR) was 92.9% (13/14). The 2-year DFS rate was 86.6%. Common treatment-related adverse events (TRAE) included leukopenia (56.3%, 9/16), nausea and vomiting (50.0%, 8/16), diarrhea, oral mucositis, and elevated liver function tests (25.0%, 4/16). One patient (6.25%) experienced a grade 3 adverse event.Conclusion:Neoadjuvant pembrolizumab-chemotherapy significantly enhances objective response rate and disease-free survival in advanced TBSCC.
2.Risk evaluation of healthcare workers contracting tuberculosis in a designated tuberculosis hospital based on failure mode and effect analysis
Fengxi QIN ; Jishun WU ; Yuexin LIANG ; Yushuang CAI ; Dengcui CHEN ; Xiudong XU
Chinese Journal of Nosocomiology 2025;35(20):3156-3161
OBJECTIVE To explore the risk evaluation of healthcare workers contracting tuberculosis in a designated three-A tuberculosis hospital in Guangxi based on the failure mode and effect analysis(FMEA)method.METHODS A designated three-A tuberculosis hospital in Guangxi was selected.Healthcare workers from Jan.1,2023 to Dec.31,2023 served as the control group and received routine management,i.e.,implementing various tuberculosis prevention and control measures according to current guidelines.Healthcare workers from Jan.1,2024 to Dec.31,2024 served as the experimental group and were managed by the FMEA method.High-risk fac-tors were screened through the FMEA method,and targeted intervention strategies were formulated to priori-tize intervention for high-risk events.The incidence rate of tuberculosis among healthcare workers and the imple-mentation rate of tuberculosis infection prevention and control measures before and after FMEA intervention were compared.RESULTS The six high-risk events screened were improper use of surgical masks by patients,inade-quate respiratory hygiene practices,improper use of medical protective masks by healthcare workers,lack of full process isolation management for tuberculosis patients,unreasonable sputum collection areas and improper venti-lation and air disinfection measure setting or maintenance.After implementing a series of tuberculosis prevention and control measures,the incidence rate of tuberculosis infection among healthcare workers decreased from 1.63%before FMEA intervention to 0.30%(P=0.021).The implementation rate of tuberculosis infection prevention and control measures increased from 69.95%to 73.61%(P=0.003).CONCLUSIONS Risk evaluation based on the FMEA method can identify weaknesses in tuberculosis infection prevention among healthcare workers in desig-nated tuberculosis hospitals.Implementing multiple measures simultaneously can effectively reduce the incidence rate of tuberculosis among healthcare workers,ensure occupational safety,improve the implementation rate of tu-berculosis infection prevention and control measures and achieve scientific and precise prevention and control.
3.Risk evaluation of healthcare workers contracting tuberculosis in a designated tuberculosis hospital based on failure mode and effect analysis
Fengxi QIN ; Jishun WU ; Yuexin LIANG ; Yushuang CAI ; Dengcui CHEN ; Xiudong XU
Chinese Journal of Nosocomiology 2025;35(20):3156-3161
OBJECTIVE To explore the risk evaluation of healthcare workers contracting tuberculosis in a designated three-A tuberculosis hospital in Guangxi based on the failure mode and effect analysis(FMEA)method.METHODS A designated three-A tuberculosis hospital in Guangxi was selected.Healthcare workers from Jan.1,2023 to Dec.31,2023 served as the control group and received routine management,i.e.,implementing various tuberculosis prevention and control measures according to current guidelines.Healthcare workers from Jan.1,2024 to Dec.31,2024 served as the experimental group and were managed by the FMEA method.High-risk fac-tors were screened through the FMEA method,and targeted intervention strategies were formulated to priori-tize intervention for high-risk events.The incidence rate of tuberculosis among healthcare workers and the imple-mentation rate of tuberculosis infection prevention and control measures before and after FMEA intervention were compared.RESULTS The six high-risk events screened were improper use of surgical masks by patients,inade-quate respiratory hygiene practices,improper use of medical protective masks by healthcare workers,lack of full process isolation management for tuberculosis patients,unreasonable sputum collection areas and improper venti-lation and air disinfection measure setting or maintenance.After implementing a series of tuberculosis prevention and control measures,the incidence rate of tuberculosis infection among healthcare workers decreased from 1.63%before FMEA intervention to 0.30%(P=0.021).The implementation rate of tuberculosis infection prevention and control measures increased from 69.95%to 73.61%(P=0.003).CONCLUSIONS Risk evaluation based on the FMEA method can identify weaknesses in tuberculosis infection prevention among healthcare workers in desig-nated tuberculosis hospitals.Implementing multiple measures simultaneously can effectively reduce the incidence rate of tuberculosis among healthcare workers,ensure occupational safety,improve the implementation rate of tu-berculosis infection prevention and control measures and achieve scientific and precise prevention and control.
4.Preliminary efficacy and safety of pembrolizumab combined with chemotherapy as neoadjuvant therapy for advanced temporal bone squamous cell carcinoma
Yu SI ; Yan HUANG ; Dian LIU ; Maojin LIANG ; Wenting DENG ; Yuexin CAI ; Yuebo CHEN ; Yanfang YE ; Li LING ; Zhigang ZHANG ; Suijun CHEN
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2025;60(11):1399-1406
Objective:To evaluate the safety of neoadjuvant therapy with pembrolizumab combined with 5-fluorouracil (5-FU) and cisplatin in patients with advanced temporal bone squamous cell carcinoma (TBSCC), and its impact on tumor response rate and disease-free survival (DFS).Methods:This prospective, single-arm, open-label clinical study enrolled patients with advanced (Stage Ⅲ/Ⅳ) TBSCC from Sun Yat-sen Memorial Hospital. Patients received 2-3 cycles of neoadjuvant therapy with pembrolizumab, 5-FU, and cisplatin, followed by definitive surgery. Postoperatively, patients received 6 cycles of pembrolizumab combined with radiotherapy. The primary endpoint was the 2-year disease-free survival (DFS) rate. Secondary endpoints included objective response rate (ORR) and safety indicators. Survival analysis was performed using the Kaplan-Meier method. Adverse events (AE) were assessed using the National Cancer Institute′s Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Statistical analyses were conducted using SPSS software, version 22.0.Results:From August 2021 to April 2024, 16 patients with advanced TBSCC were enrolled (13 males and 3 females), with a median age of 54 years and a median follow-up time of 2.32 years. Following neoadjuvant therapy, the objective response rate (ORR) was 64.3% (9/14), and the disease control rate (DCR) was 92.9% (13/14). The 2-year DFS rate was 86.6%. Common treatment-related adverse events (TRAE) included leukopenia (56.3%, 9/16), nausea and vomiting (50.0%, 8/16), diarrhea, oral mucositis, and elevated liver function tests (25.0%, 4/16). One patient (6.25%) experienced a grade 3 adverse event.Conclusion:Neoadjuvant pembrolizumab-chemotherapy significantly enhances objective response rate and disease-free survival in advanced TBSCC.
5.Expert Consensus of Multidisciplinary Diagnosis and Treatment for Paroxysmal Nocturnal Hemoglobinuria(2024)
Miao CHEN ; Chen YANG ; Ziwei LIU ; Wei CAO ; Bo ZHANG ; Xin LIU ; Jingnan LI ; Wei LIU ; Jie PAN ; Jian WANG ; Yuehong ZHENG ; Yuexin CHEN ; Fangda LI ; Shunda DU ; Cong NING ; Limeng CHEN ; Cai YUE ; Jun NI ; Min PENG ; Xiaoxiao GUO ; Tao WANG ; Hongjun LI ; Rongrong LI ; Tong WU ; Bing HAN ; Shuyang ZHANG ; MULTIDISCIPLINE COLLABORATION GROUP ON RARE DISEASE AT PEKING UNION MEDICAL COLLEGE HOSPITAL
Medical Journal of Peking Union Medical College Hospital 2024;15(5):1011-1028
Paroxysmal nocturnal hemoglobinuria (PNH) is an acquired clonal hematopoietic stem cell disease caused by abnormal expression of glycosylphosphatidylinositol (GPI) on the cell membrane due to mutations in the phosphatidylinositol glycan class A(PIGA) gene. It is commonly characterized by intravascular hemolysis, repeated thrombosis, and bone marrow failure, as well as multiple systemic involvement symptoms such as renal dysfunction, pulmonary hypertension, swallowing difficulties, chest pain, abdominal pain, and erectile dysfunction. Due to the rarity of PNH and its strong heterogeneity in clinical manifestations, multidisciplinary collaboration is often required for diagnosis and treatment. Peking Union Medical College Hospital, relying on the rare disease diagnosis and treatment platform, has invited multidisciplinary clinical experts to form a unified opinion on the diagnosis and treatment of PNH, and formulated the
6.Risk factors of bortezomib-related peripheral neuropathy and the clinical features and electrophysiological characteristics of patients during treatment of multiple myeloma
Jingjing JIANG ; Meiling ZHOU ; Guangyu QI ; Weixin CAI ; Yuqing MIAO ; Hao XU ; Yuexin CHENG
Journal of Leukemia & Lymphoma 2023;32(2):97-102
Objective:To explore the risk factors of bortezomib-related peripheral neuropathy (BIPN) and the clinical and electrophysiological characteristics of patients in treatment of multiple myeloma (MM).Methods:The clinical data of 71 newly diagnosed MM patients treated with BD (bortezomib + dexamethasone) regimen in Yancheng First People's Hospital from March 2016 to December 2019 were retrospectively analyzed. The bone marrow morphology, immunology, cytogenetics, molecular biology (MICM), routine electrophysiological examination before and after treatment were performed. All patients were divided into the peripheral neuropathy (PN) group and the non-PN group according to the presence or not of BIPN, and the clinicopathological differences of both groups were also compared; a binary logistic regression model was used to analyze the factors affecting the occurrence of PN. The electrophysiological characteristics were summarized and fluorescence in situ hybridization (FISH) was used to detect karyotype of BIPN patients.Results:Among 71 MM patients, there were 40 cases (56.3%) of PN and 31 cases (43.7%) of non-PN. The proportion of patients at international staging system (ISS) staging Ⅲ, and the levels of IgA, IgG, IgM, serum creatinine, β 2-microglobulin (β 2-MG) in the PN group were higher than those in the non-PN group, and hemoglobin (Hb) level in the PN group was lower than that in the non-PN group, and the differences were statistically significant (both P < 0.05). Binary logistic regression analysis showed that increased IgA ( OR = 1.151, 95% CI 1.012-1.309, P = 0.033), increased IgG ( OR = 1.055, 95% CI 1.000~1.112, P = 0.049), increased IgM ( OR = 1.010, 95% CI 1.001-1.018, P = 0.022), increased serum creatinine ( OR = 1.037, 95% CI 1.011~1.065, P = 0.005), increased β 2-MG ( OR = 1.564, 95% CI 1.039-2.354, P = 0.032) were risk factors for BIPN. Among 40 patients with BIPN, 33 cases (82.5%) of sensory nerve conduction velocity (SCV) were abnormal, 23 cases (57.5%) of motor nerve conduction velocity (MCV) were abnormal; 31 cases (77.5%) showed demyelination damage, 9 cases (22.5%) had axonal damage. Among 40 patients with BIPN, 24 cases underwent FISH detection, including 19 cases (79.2%) with chromosomal mutations, of which 12 cases (50.0%) were mixed subtype abnormal. Conclusions:MM patients with high levels of β 2-MG, IgA, IgG, IgM and serum creatinine are more prone to PN when treated with bortezomib. The electrophysiology of patients with BIPN is mainly characterized by demyelination of sensory nerves.
7.Expression of Toll-like receptor 8 in diffuse large B-cell lymphoma and its clinical significance
Weixin CAI ; Meiling ZHOU ; Jinbo LU ; Can CHEN ; Hao XU ; Yuqing MIAO ; Yuexin CHENG
Journal of Leukemia & Lymphoma 2022;31(6):338-342
Objective:To investigate the expression of Toll-like receptor 8 (TLR8) in diffuse large B-cell lymphoma (DLBCL) and its correlation with clinicopathological characteristics and prognosis of patients.Methods:The data in the Oncomine database was used to analyze the difference of TLR8 mRNA expression between DLBCL tumor tissues and normal lymphocytes, and the result was verified in two independent subsets GSE 25638 and GSE 32018 of the NCBI-GEO database. The OSDLBCL online survival analysis tool was used to analyze the correlation of TLR8 mRNA relative expression level with overall survival (OS) and progression-free survival (PFS) of DLBCL patients. Gene ontology bioprocess (GO_BP) enrichment analysis was performed by using GSEA software. The correlation of TLR8 mRNA expression with tumor immune cell infiltration degree and immune checkpoint-related molecule expression was analyzed by TIMER online tool website. A total of 53 DLBCL patients who underwent lymph node biopsy in Yancheng No. 1 People's Hospital from June 2020 to June 2021 were selected. Immunohistochemistry was used to detect the expression of TLR8 protein, and its relationship with the clinicopathological characteristics of patients was analyzed.Results:The analysis result of data from Oncomine and GEO databases showed that the relative expression levels of TLR8 mRNA in tumor tissues of patients with DLBCL or activated B cell-like DLCBL were higher than those in normal lymphocytes (all P < 0.001). The results of OSDLBCL online survival analysis indicated that the OS ( P = 0.020) and PFS ( P = 0.004) in DLBCL patients with high TLR8 mRNA expression were worse than those in patients with low TLR8 mRNA expression. The level of TLR8 was related to the abnormal function of immune response, cytokine metabolism and DNA damage monitoring; the result of TIMER online analysis showed that the expression level of TLR8 mRNA was positively related to the degree of neutrophil infiltration ( r = 0.78, P < 0.001) and the expression of immunosuppressive molecules [HAVCR2 ( r = 0.85, P < 0.001), LAG3 ( r = 0.63, P < 0.001), CD274 ( r = 0.77, P < 0.001), TIGIT ( r = 0.32, P = 0.037), and C10ORF54 ( r = 0.34, P = 0.029)]. Among 53 DLBCL patients, 29 patients (54.7%) had low expression of TLR8 protein and 24 patients (45.3%) had high expression of TLR8 protein. There were statistical differences in the expressions of TLR8 protein in DLBCL patients with different serum lactate dehydrogenase and β 2-microglobulin levels (both P < 0.05). Conclusions:TLR8 is highly expressed in DLBCL patients, and TLR8 may be a prognostic marker of DLBCL.
8.Analysis of the registered dietitian competence assessment examination during 2017-2021 in China
Xiaoli WANG ; Yajie ZHANG ; Jing LIAO ; Aiguo MA ; Wei CAI ; Junsheng GUO ; Ya LIU ; Xiuhua SHEN ; Yuexin YANG
Chinese Journal of Clinical Nutrition 2022;30(5):300-305
Objective:To analyze the competence assessment examinations of registered dietitians in China during 2017-2021 to inform the training of dietetic professionals.Methods:A systematic review was conducted about the composition and changing trends of examination participants during 2017-2021. Participants were divided into subgroups based on gender, age, education, professional background and affiliations and the qualification rate was compared across different subgroups.Results:The number of examination participants showed an increasing trend overall, with the majority being females and aged 26-35 years. The ratio of participants with bachelor's: master's: doctor's degree was about 15: 9: 1. The proportion of participants majoring in nutrition science decreased from 32.1% to 20.3%, while that of participants majoring in other medical and food sciences increased. Among participants from healthcare institutions, a decreasing proportion of participants were with a major in nutrition science, while this proportion among participants from companies were stable at 38.8% to 50.2%. The average qualification rate was 35.7%, showing no significant differences among different gender and age groups. But the qualification rate varied significantly across subgroups with different education level, professional background, and affiliations ( P < 0.05). Subgroups with more advanced degrees showed higher qualification rate and the best rate was observed in the subgroups with professional background in nutrition science and from nutrition-related institutions. Conclusion:The training of dietetic professionals in China should be improved, lifelong learning should be promoted in nutrition practitioners, and the sustainable development of dietitians should be impelled.
9.Nodal marginal zone lymphoma with elevated monoclonal IgM: report of 1 case and review of literature
Weixin CAI ; Meiling ZHOU ; Ling SHU ; Jinbo LU ; Lingling WANG ; Ya XU ; Hao XU ; Yuexin CHENG
Journal of Leukemia & Lymphoma 2022;31(12):725-729
Objective:To investigate the clinicopathological features, diagnosis, differential diagnosis and treatment of nodal marginal zone lymphoma (NMZL) with elevated monoclonal IgM.Methods:The clinical data of one NMZL patient with elevated monoclonal IgM treated at Yancheng No.1 People's Hospital in July 2020 were retrospectively analyzed, and the related literature was analyzed.Results:The patient was a 57-year-old female and the main clinical manifestations were fatigue and bone pain in left rib. Serum immunofixation electrophoresis showed IgM-κ type M proteinemia, bone marrow cytology showed a few plasmacytoid lymphocytes, bone marrow biopsy and immunohistochemistry showed B-cell non-Hodgkin lymphoma, bone marrow genetic testing showed MYD88 L265p and CXCR4 were both negative, postoperative pathology result of retroperitoneal lymph node biopsy was marginal zone lymphoma (mature small B type, prone to NMZL),and immunohistochemistry results: CD3, CD5, CD138, κ, λ, CD10, Cyclin D1 were negative, CD20, Pax-5, CD23 (FDC), bcl-2 were positive; Ki-67 positive index < 5%. The final diagnosis was NMZL with elevated monoclonal IgM. Partial remission was achieved after 8 cycles of reduced-dose CHOP regimen; thalidomide was used in the maintenance treatment, the disease condition was stable until August in 2021 and the follow-up was continuing.Conclusions:NMZL with elevated monoclonal IgM is relatively rare. Its diagnosis should be differentiated from Waldenstr?m macroglobulinemia and other inert B-cell lymphomas. Currently, there is no standard treatment and following the principle of individualized treatment can improve the prognosis of patients.
10.Familial Waldenstrom macroglobulinemia: report of 6 cases and review of literature
Guangyu QI ; Meiling ZHOU ; Weixin CAI ; Xu LI ; Tianrong CHEN ; Yuqing MIAO ; Hao XU ; Yuexin CHENG
Journal of Leukemia & Lymphoma 2022;31(2):99-102
Objective:To investigate the familial inheritances, clinical features, treatments and outcomes of familial Waldenstrom macroglobulinemia (WM) patients.Methods:The clinical manifestations, laboratory examinations, diagnosis and treatments, and follow-up data of 6 familial WM patients who were admitted to Yancheng No.1 People's Hospital from June 2002 to July 2019 were retrospectively analyzed, and the literature was reviewed.Results:Among 6 WM patients, 4 patients had dizziness and fatigue at the onset, 1 patient had recurrent low-grade fever and abnormal sweating as the first manifestations, 1 patient was hospitalized due to pulmonary infection, and WM was found later. Two brothers of the patients were diagnosed with WM, another 2 brothers of the patients had IgM-type monoclonal gammopathy of undetermined significance (MGUS) during the physical examination. All the 6 patients were middle-aged/elderly men, with a median age of 63 years old (51-70 years old). The median follow-up time were 71.5 months (4-217 months), and by the end of the follow-up (June 2020), 2 cases died of pulmonary infection, and 1 of them developed acute myeloid leukemia; the other 4 cases were in regular chemotherapy. Two IgM-MGUS patients were followed up without symptoms.Conclusions:WM patients have familial aggregation, and their clinical manifestations are highly heterogeneous. Patients with family history may have poor prognosis. It is necessary to strengthen the awareness of WM and family history screening.

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