1.Chinese expert consensus on the clinical application of recombinant human thyroid-stimulating hormone (2025 edition)
Chentian SHEN ; Yushen GU ; Hui TAN ; Anren KUANG ; Sijin LI ; Yaming LI ; Jing WANG ; Ningyi JIANG ; Jian TAN ; Zhuoying WANG ; Shaoyan LIU ; Xiaoyi LI ; Jugao FANG ; Dingcun LUO ; Youben FAN ; Hui WANG ; Yuetao WANG ; Xuemei WANG ; Feng WANG ; Wei FU ; Feng SHI ; Xuegong LIU ; Zhongwei LÜ ; Yan XING ; Lin LI ; Hui YANG ; Jun XIN ; Yifan ZHANG ; Yue CHEN ; Yansong LIN ; Wei OUYANG ; Shuzhan YAO ; Changjiu ZHAO ; Xinming ZHAO ; Zairong GAO ; Dingde HUANG ; Qiang WEN ; Xingmin HAN ; Cen LOU ; Weibing MIAO ; Wei FAN ; Quanyong LUO ; Hongcheng SHI
Chinese Journal of Clinical Medicine 2026;33(5):932-944
The recombinant human thyroid-stimulating hormone (rhTSH) can be used for differentiated thyroid cancer (DTC) preparation before 131I therapy, and follow-up. Since its approval by the American Food and Drug Administration (FDA) in 1998, rhTSH has been clinically used in European countries, the United States, and other countries for nearly 30 years. In April 2024, China’s first independently developed rhTSH agent was approved. Based on clinical experience and evidence from domestic and international studies, an expert consensus on the application of rhTSH has been developed following thorough consultations among experts. The consensus offers evidence-based recommendations to guide the appropriate use of rhTSH in clinical practice.
2.Pathological diagnosis of solid pancreatic lesions with endoscopic ultrasound-guided fine needle aspiration: a series study of 311 cases
Xiaoxiao WEN ; Xiaoyi LIU ; Jinfeng CUI ; Lichao ZHANG ; Wenxuan LIU ; Haiyan YANG ; Yuan WANG ; Li YI ; Lei LOU ; Juan WANG ; Yuehong LI ; Wenxin WU ; Xianghong ZHANG
Chinese Journal of Pathology 2025;54(1):52-58
Objective:To investigate the combined application of cytology, cell block histology and immunohistochemistry to improve the diagnostic accuracy of solid pancreatic lesions in endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) samples.Methods:The pathological data of EUS-FNA in 311 cases of solid pancreatic lesions submitted to the Second Hospital of Hebei Medical University, Shijiazhuang, China from May 2019 to September 2023 were retrospectively analyzed. The cases included pancreatic ductal adenocarcinoma (PDAC, 172 cases), solid pseudopapillary neoplasm (SPN, 12 cases), neuroendocrine tumors (PNET, 14 cases) and chronic pancreatitis (113 cases). The cytological features of smears, the histology of cell block sections and the diagnostic markers in PDAC, SPN and PNET were analyzed. The diagnostic accuracies of cytology, cell block histology/immunohistochemistry and combination of the two methods for classifying these pancreatic solid lesions were evaluated.Results:Irregular arrangement of atypical (cancer) cells, anisonucleosis and nuclear atypia were the typical cytological features of PDAC, while presence of pseudopapillae with a myxoid/hyalinized fibrovascular core and low adhesion/salt-and-pepper chromatin were diagnostic features of SPN and NET, respectively. Immunohistochemical results showed that CK7 and CK19 were the most sensitive markers of pancreatic ductal epithelia, and the diffuse strong expression of S-100P (102/111, 91.9%) and aberrant expression of p53 (80/111, 72.1%) were important immunophenotypic markers of PDAC. Various degrees of CDX2 expression could be found in 66.4% PDAC. The expression of CD10, PR, vimentin, CD99 and cyclinD1 and the aberrant expression of β-catenin were the immunophenotypic features of SPN, while the expression of CgA, Syn and CD56 were indispensable immunemarkers for the diagnosis of PNET. Overall, cytology had higher sensitivity than cell block histology (93.9% versus 82.8%) and lower specificity (92.9% versus 99.1%), while the combination of the two methods significantly improved the sensitivity to 96.9% in solid pancreatic lesions. The combination of cytology and cell block histology could significantly improve the diagnostic efficacy of EUS-FNA in PDAC.Conclusions:Integrated diagnosis based on cytology (including rapid on-site evaluation), cell block histology and immunohistochemical findings could significantly improve the diagnostic yield of EUS-FNA in classifying solid pancreatic lesions.
3.A study on the application of methylation-microhaplotypes in the identification of synthetic human DNA samples
Yue WANG ; Dan WEN ; Xuan TANG ; Yi LIU ; Ruyi XU ; Siqi CHEN ; Xiaoyi FU ; Xue LI ; Yuepeng WANG ; Chudong WANG ; Weifeng QU ; Hongtao JIA ; Jienan LI ; Lagabaiyila ZHA
Chinese Journal of Forensic Medicine 2025;40(1):40-48,55
Objective Advances in synthetic DNA technology have made it much easier to fake human DNA samples.There are literature reports that fake human DNA can be synthesized by different methods and implanted in the field to confuse the investigation or mislead the trial.Therefore,distinguishing authentic human DNA from synthetic DNA and performing individual identification has become a critical scientific challenge.Methods We define a novel composite genetic marker(methylation-microhaplotype)by combining CpG sites stably hypermethylated or hypomethylated in natural human DNA and nearby immediately adjacent microhaplotype sites.A total of 19 locis were obtained according to the screening criteria,and a composite detection system for methylation-microhaplotypes was established using MPS technology.Random volunteer DNA samples were extracted and synthetic DNA samples were prepared based on whole genome amplification techniques.Population DNA samples were analyzed to evaluate forensic parameters and methylation variability of the methylation-microhaplotype markers.Comparative analyses of human and synthetic DNA were conducted to assess the markers'ability to discriminate between the two and to detect/type both components in mixed mixed samples.Results The composite detection system composed of 19 locis demonstrated high individual identification ability,achieving a cumulative individual identification probability of 0.999 999 999 996 86.12 hypermethylated locis and 7 hypomethylated locis had relatively stable methylation levels in 57 human DNA samples.According to the allele methylation rate(Ram)value,the system can effectively identify natural and synthetic DNA samples.Meanwhile,for mixed DNA samples,the presence of human and synthetic DNA samples can be found and genotyped.Conclusion Methylation-microhaplotype genetic markers,which can discover human DNA and synthetic DNA and can detect the presence and genotyping of them from mixed samples,is a potential useful tool for forensic DNA analysis.
4.Pathological diagnosis of solid pancreatic lesions with endoscopic ultrasound-guided fine needle aspiration: a series study of 311 cases
Xiaoxiao WEN ; Xiaoyi LIU ; Jinfeng CUI ; Lichao ZHANG ; Wenxuan LIU ; Haiyan YANG ; Yuan WANG ; Li YI ; Lei LOU ; Juan WANG ; Yuehong LI ; Wenxin WU ; Xianghong ZHANG
Chinese Journal of Pathology 2025;54(1):52-58
Objective:To investigate the combined application of cytology, cell block histology and immunohistochemistry to improve the diagnostic accuracy of solid pancreatic lesions in endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) samples.Methods:The pathological data of EUS-FNA in 311 cases of solid pancreatic lesions submitted to the Second Hospital of Hebei Medical University, Shijiazhuang, China from May 2019 to September 2023 were retrospectively analyzed. The cases included pancreatic ductal adenocarcinoma (PDAC, 172 cases), solid pseudopapillary neoplasm (SPN, 12 cases), neuroendocrine tumors (PNET, 14 cases) and chronic pancreatitis (113 cases). The cytological features of smears, the histology of cell block sections and the diagnostic markers in PDAC, SPN and PNET were analyzed. The diagnostic accuracies of cytology, cell block histology/immunohistochemistry and combination of the two methods for classifying these pancreatic solid lesions were evaluated.Results:Irregular arrangement of atypical (cancer) cells, anisonucleosis and nuclear atypia were the typical cytological features of PDAC, while presence of pseudopapillae with a myxoid/hyalinized fibrovascular core and low adhesion/salt-and-pepper chromatin were diagnostic features of SPN and NET, respectively. Immunohistochemical results showed that CK7 and CK19 were the most sensitive markers of pancreatic ductal epithelia, and the diffuse strong expression of S-100P (102/111, 91.9%) and aberrant expression of p53 (80/111, 72.1%) were important immunophenotypic markers of PDAC. Various degrees of CDX2 expression could be found in 66.4% PDAC. The expression of CD10, PR, vimentin, CD99 and cyclinD1 and the aberrant expression of β-catenin were the immunophenotypic features of SPN, while the expression of CgA, Syn and CD56 were indispensable immunemarkers for the diagnosis of PNET. Overall, cytology had higher sensitivity than cell block histology (93.9% versus 82.8%) and lower specificity (92.9% versus 99.1%), while the combination of the two methods significantly improved the sensitivity to 96.9% in solid pancreatic lesions. The combination of cytology and cell block histology could significantly improve the diagnostic efficacy of EUS-FNA in PDAC.Conclusions:Integrated diagnosis based on cytology (including rapid on-site evaluation), cell block histology and immunohistochemical findings could significantly improve the diagnostic yield of EUS-FNA in classifying solid pancreatic lesions.
5.Determination of potential genotoxic impurities in baritinib by GC
Zhao LI ; Gang LONG ; Wen LAN ; Jinfeng ZHENG ; Yanming LIU ; Xiaoyi SHI
Drug Standards of China 2025;26(2):232-236
Objective:A GC method was established for the determination of three potential genotoxic impuri-ties methyl ethanesulfonate,ethyl ethanesulfonate and isopropyl ethanesulfonate in baritinib raw materials.Methods:The chromatography was performed on Agilent J&W DB-1701(30 m×0.25 mm,1.0 μm)col-umn.The heating procedure was the initial temperature of 100℃,maintained for 3 min,at the rate of 5℃per minute to 180℃,maintained for 2 min,and then at the rate of 30℃per minute to 240℃,maintained for 5 min.The temperature of the injector was 240℃.The shunt ratio was 1∶10.The carrier gas was helium with a flow rate of 2.0 mL per minute.The temperature of the detector was 260℃and the injection volume was 2 μL.Results:The specificity,linearity and range,limit of quantification and detection,accuracy,pre-cision,repeatability and stability of the method meet the requirements.Conclusion:The analytical method is simple,accurate,sensitive and reproducible,and can be used for quality control of three potential genotoxic impurities in baritinib.
6.A study on the application of methylation-microhaplotypes in the identification of synthetic human DNA samples
Yue WANG ; Dan WEN ; Xuan TANG ; Yi LIU ; Ruyi XU ; Siqi CHEN ; Xiaoyi FU ; Xue LI ; Yuepeng WANG ; Chudong WANG ; Weifeng QU ; Hongtao JIA ; Jienan LI ; Lagabaiyila ZHA
Chinese Journal of Forensic Medicine 2025;40(1):40-48,55
Objective Advances in synthetic DNA technology have made it much easier to fake human DNA samples.There are literature reports that fake human DNA can be synthesized by different methods and implanted in the field to confuse the investigation or mislead the trial.Therefore,distinguishing authentic human DNA from synthetic DNA and performing individual identification has become a critical scientific challenge.Methods We define a novel composite genetic marker(methylation-microhaplotype)by combining CpG sites stably hypermethylated or hypomethylated in natural human DNA and nearby immediately adjacent microhaplotype sites.A total of 19 locis were obtained according to the screening criteria,and a composite detection system for methylation-microhaplotypes was established using MPS technology.Random volunteer DNA samples were extracted and synthetic DNA samples were prepared based on whole genome amplification techniques.Population DNA samples were analyzed to evaluate forensic parameters and methylation variability of the methylation-microhaplotype markers.Comparative analyses of human and synthetic DNA were conducted to assess the markers'ability to discriminate between the two and to detect/type both components in mixed mixed samples.Results The composite detection system composed of 19 locis demonstrated high individual identification ability,achieving a cumulative individual identification probability of 0.999 999 999 996 86.12 hypermethylated locis and 7 hypomethylated locis had relatively stable methylation levels in 57 human DNA samples.According to the allele methylation rate(Ram)value,the system can effectively identify natural and synthetic DNA samples.Meanwhile,for mixed DNA samples,the presence of human and synthetic DNA samples can be found and genotyped.Conclusion Methylation-microhaplotype genetic markers,which can discover human DNA and synthetic DNA and can detect the presence and genotyping of them from mixed samples,is a potential useful tool for forensic DNA analysis.
7.Determination of potential genotoxic impurities in baritinib by GC
Zhao LI ; Gang LONG ; Wen LAN ; Jinfeng ZHENG ; Yanming LIU ; Xiaoyi SHI
Drug Standards of China 2025;26(2):232-236
Objective:A GC method was established for the determination of three potential genotoxic impuri-ties methyl ethanesulfonate,ethyl ethanesulfonate and isopropyl ethanesulfonate in baritinib raw materials.Methods:The chromatography was performed on Agilent J&W DB-1701(30 m×0.25 mm,1.0 μm)col-umn.The heating procedure was the initial temperature of 100℃,maintained for 3 min,at the rate of 5℃per minute to 180℃,maintained for 2 min,and then at the rate of 30℃per minute to 240℃,maintained for 5 min.The temperature of the injector was 240℃.The shunt ratio was 1∶10.The carrier gas was helium with a flow rate of 2.0 mL per minute.The temperature of the detector was 260℃and the injection volume was 2 μL.Results:The specificity,linearity and range,limit of quantification and detection,accuracy,pre-cision,repeatability and stability of the method meet the requirements.Conclusion:The analytical method is simple,accurate,sensitive and reproducible,and can be used for quality control of three potential genotoxic impurities in baritinib.
8.Construction and application of anticoagulant pharmacy service model based on the integrated theory of health behavior change
Xiabing LIANG ; Baohua FAN ; Zhiping WEN ; Xiaoyi WANG
China Pharmacy 2024;35(23):2948-2953
OBJECTIVE To establish anticoagulation pharmaceutical service model based on the integrated theory of health behavior change (ITHBC),and analyze its effects. METHODS Referring to relevant literature and soliciting opinions from 8 experts from departments such as pharmacy,respiratory medicine,and vascular surgery,a anticoagulation pharmaceutical service model based on ITHBC was ultimately formed. VTE inpatients were selected from The First Affiliated Hospital of Shihezi University from December 2023 to June 2024 as the research subjects. They were randomly assigned into intervention group (58 cases) and control group (60 cases) using a random number table method. The intervention group implemented pharmacist-led anticoagulant pharmaceutical service model based on ITHBC,while the control group adopted a conventional anticoagulant pharmaceutical service model. The anticoagulation-related outcomes of two groups were compared after 3 months:anticoagulation compliance rate,the incidence of adverse drug reactions,the score of medication adherence and compliance rate of anticoagulant prescription;economic evaluation was conducted. RESULTS After implementing ITHBC-based anticoagulant pharmaceutical services for 3 months,the intervention group had higher anticoagulation compliance rate,score of medication adherence,and compliance rate of anticoagulant prescription than the control group (P<0.05). There was no statistically significant difference in the total incidence of adverse drug reactions between the two groups (P>0.05). For every 1% point increase in anticoagulant compliance rate,the hospital needed to invest 4.35 yuan additionally in anticoagulant pharmaceutical service fees. Compared with China's per capita gross domestic product (GDP,89358 yuan) in 2023,the incremental cost-effectiveness ratio value that increased the anticoagulation compliance rate by 50% is far less than one time of per capita GDP. CONCLUSIONS The pharmacist-led anticoagulant pharmaceutical service model based on ITHBC can effectively improve the outcomes of anticoagulant therapy for VTE patients,enhance medication compliance,improve patients' awareness and recognition of adverse drug reactions to anticoagulants,and has certain economic and social benefits.
9.A Case Report of Multidisciplinary Management of a Patient with Schimke Immuno-Osseous Dysplasia
Juan DING ; Wei WANG ; Juan XIAO ; Yan ZHANG ; Huijuan ZHU ; Wen ZHANG ; Peng GAO ; Limeng CHEN ; Wei LYU ; Xuan ZOU ; Xiaoyi ZHAO ; Hongmei SONG ; Mingsheng MA
JOURNAL OF RARE DISEASES 2024;3(4):465-470
Schimke immuno-osseous dysplasia (SIOD)caused by
10.Polycystic ovary syndrome is positively correlated with periodontitis:a prospective study
Dangli HU ; Feng ZHANG ; Huijun LI ; Xiaoyi XU ; Ping WEN ; Zheng ZHENG ; Jilong YAO
Journal of Southern Medical University 2024;44(1):36-44
Objective To explore the correlation between polycystic ovary syndrome(PCOS)and periodontitis in light of cytokines levels,sex hormone levels and metabolism-related indicators and their changes during progression of the two diseases.Methods Twenty healthy subjects and 40 patients diagnosed with PCOS underwent full-mouth periodontal examinations to obtain full-mouth plaque score(FMPS),gingival bleeding index of probing(BOP),probing depth(PD),and clinical attachment level(CAL).The participants were divided into Group A without periodontitis or PCOS(n=15),Group B with PCOS but without periodontitis(n=28),Group C with periodontitis but without PCOS(n=5),and Group D with both diseases(n=12).Serum levels of luteinizing hormone/follicle stimulating hormone(LH/FSH),testosterone,prolactin,progesterone and estradiol,and the levels of interleukin 6(IL-6),IL-17A,tumor necrosis factor α and matrix metalloproteinase 8(MMP-8)in both serum and saliva samples were measured at the time of enrolment and at 3 and 6 months after enrolment and compared among the 4 groups.Results Serum MMP-8 level was significantly higher in Group B than in Group A(P<0.05).Salivary MMP-8 level was significantly higher in Group D than in Group B(P<0.05).Salivary MMP-8,LH,and LH/FSH levels and serum and salivary IL-6 and progesterone levels all tended to increase in the 6 months after enrollment(OR>1,P<0.05).During the follow-up period,serum IL-6 levels differed significantly between the non-PCOS groups(A and C)and PCOS groups(B and D)(P<0.05);serum IL-6 and salivary MMP-8 levels differed significantly between the non-periodontitis groups(A and B)and periodontitis groups(C and D)(P<0.05).Spearman correlation analysis indicated positive correlations of LH and LH/FSH with PD(P<0.05);testosterone and LH/FSH were positively correlated with serum MMP-8 levels(P<0.05),and PD,BOP and FMPS were positively correlated with salivary MMP-8 levels(P<0.01).Conclusion There is a correlation between PCOS and periodontitis,and their progression is accompanied by changes in serum and salivary levels of pro-inflammatory cytokines and serum sex hormones.

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