1.Brief introduction on the development of Chinese Pharmacopoeia 2025 Edition
HONG Xiaoxu ; SONG Zonghua ; MA Shuangcheng ; LAN Fen ; SHU Rong
Drug Standards of China 2025;26(1):001-010
The Pharmacopoeia of the People’s Republic of China 2025 edition is to be issued in March 2025. Chinese Pharmacopoeia is the basic requirements on the drug manufacture, drug testing, drug use and drug administration. The new edition Chinese Pharmacopoeia will be dramatically improved on the pharmacopoeia monographs included, establishing the standards system, standards conversion and application of drug quality control for the new technology, new method & new tool, drug control on the safety and effectiveness as well as the drug standard international harmonization. It will take important role on improving the drug quality, ensuring the safety of drugs for public use, strengthen technical support for drug administration, promoting the high-quality development of China’s medical and pharmaceutical industry. This paper introduces the development and revision of the Chinese Pharmacopoeia 2025 Edition,aim at helping the industries well understanding and implantation the new edition Chinese Pharmacopoeia.
2.The development and characteristics of general notice in Chinese Pharmacopoeia 2025 Edition
WANG Fei ; SONG Zonghua ; MA Shuangcheng ; SHU Rong
Drug Standards of China 2025;26(1):011-016
Objective: Introduce and briefly describe the status, characteristics, and writing ideas of general notice in the Chinese Pharmacopoeia 2025 edition, providing reference and suggestions for better understanding and implementation of the Chinese Pharmacopoeia 2025 edition.
Methods:This article elaborates on the content and revision of general notice in the Chinese Pharmacopoeia 2025 edition from the perspective of frame structure and main contents.
Results:Compared with other pharmacopoeias of various countries, Chinese Pharmacopoeia includes standards for traditional Chinese medicine, chemical drugs, biological products and excipients, pharmaceutical packaging materials, etc. Each section of Chinese Pharmacopoeia has its own general notice, with 34 to 48 items arranged in 11 to 12 chapters. Depending on the type of products included and the development history, the general notice in each section present differences in format and content. Given the importance and significance of the standards in Chinese Pharmacopoeia, it is necessary for the industry to coordinate and unify the general notice in various parts of Chinese Pharmacopoeia. With the introduction and revision of regulations, changes in the content of pharmacopoeias, and the application of new technologies, methods, and concepts in drug quality control, considering the unique characteristics of various drugs in quality control and supervision, Chinese Pharmacopoeia has comprehensively standardized relevant requirements. While taking into account the characteristics of the first, second, third, and fourth parts of the pharmacopoeia, it retains the characteristics of relative uniformity and the content of each part, achieving the unified standardization of the general rules of each general notice in the Chinese Pharmacopoeia 2025 edition and the coordination and consistency of common content.
Conclusion: The current version of Chinese Pharmacopoeia has undergone significant changes and improvements in both form and content. By introducing the overall situation and revised content of general notice in the Chinese Pharmacopoeia 2025 edition, pharmacopoeia users can have a deeper understanding of Chinese Pharmacopoeia and use it correctly.
3.Integrated molecular characterization of sarcomatoid hepatocellular carcinoma
Rong-Qi SUN ; Yu-Hang YE ; Ye XU ; Bo WANG ; Si-Yuan PAN ; Ning LI ; Long CHEN ; Jing-Yue PAN ; Zhi-Qiang HU ; Jia FAN ; Zheng-Jun ZHOU ; Jian ZHOU ; Cheng-Li SONG ; Shao-Lai ZHOU
Clinical and Molecular Hepatology 2025;31(2):426-444
Background:
s/Aims: Sarcomatoid hepatocellular carcinoma (HCC) is a rare histological subtype of HCC characterized by extremely poor prognosis; however, its molecular characterization has not been elucidated.
Methods:
In this study, we conducted an integrated multiomics study of whole-exome sequencing, RNA-seq, spatial transcriptome, and immunohistochemical analyses of 28 paired sarcomatoid tumor components and conventional HCC components from 10 patients with sarcomatoid HCC, in order to identify frequently altered genes, infer the tumor subclonal architectures, track the genomic evolution, and delineate the transcriptional characteristics of sarcomatoid HCCs.
Results:
Our results showed that the sarcomatoid HCCs had poor prognosis. The sarcomatoid tumor components and the conventional HCC components were derived from common ancestors, mostly accessing similar mutational processes. Clonal phylogenies demonstrated branched tumor evolution during sarcomatoid HCC development and progression. TP53 mutation commonly occurred at tumor initiation, whereas ARID2 mutation often occurred later. Transcriptome analyses revealed the epithelial–mesenchymal transition (EMT) and hypoxic phenotype in sarcomatoid tumor components, which were confirmed by immunohistochemical staining. Moreover, we identified ARID2 mutations in 70% (7/10) of patients with sarcomatoid HCC but only 1–5% of patients with non-sarcomatoid HCC. Biofunctional investigations revealed that inactivating mutation of ARID2 contributes to HCC growth and metastasis and induces EMT in a hypoxic microenvironment.
Conclusions
We offer a comprehensive description of the molecular basis for sarcomatoid HCC, and identify genomic alteration (ARID2 mutation) together with the tumor microenvironment (hypoxic microenvironment), that may contribute to the formation of the sarcomatoid tumor component through EMT, leading to sarcomatoid HCC development and progression.
4.Integrated molecular characterization of sarcomatoid hepatocellular carcinoma
Rong-Qi SUN ; Yu-Hang YE ; Ye XU ; Bo WANG ; Si-Yuan PAN ; Ning LI ; Long CHEN ; Jing-Yue PAN ; Zhi-Qiang HU ; Jia FAN ; Zheng-Jun ZHOU ; Jian ZHOU ; Cheng-Li SONG ; Shao-Lai ZHOU
Clinical and Molecular Hepatology 2025;31(2):426-444
Background:
s/Aims: Sarcomatoid hepatocellular carcinoma (HCC) is a rare histological subtype of HCC characterized by extremely poor prognosis; however, its molecular characterization has not been elucidated.
Methods:
In this study, we conducted an integrated multiomics study of whole-exome sequencing, RNA-seq, spatial transcriptome, and immunohistochemical analyses of 28 paired sarcomatoid tumor components and conventional HCC components from 10 patients with sarcomatoid HCC, in order to identify frequently altered genes, infer the tumor subclonal architectures, track the genomic evolution, and delineate the transcriptional characteristics of sarcomatoid HCCs.
Results:
Our results showed that the sarcomatoid HCCs had poor prognosis. The sarcomatoid tumor components and the conventional HCC components were derived from common ancestors, mostly accessing similar mutational processes. Clonal phylogenies demonstrated branched tumor evolution during sarcomatoid HCC development and progression. TP53 mutation commonly occurred at tumor initiation, whereas ARID2 mutation often occurred later. Transcriptome analyses revealed the epithelial–mesenchymal transition (EMT) and hypoxic phenotype in sarcomatoid tumor components, which were confirmed by immunohistochemical staining. Moreover, we identified ARID2 mutations in 70% (7/10) of patients with sarcomatoid HCC but only 1–5% of patients with non-sarcomatoid HCC. Biofunctional investigations revealed that inactivating mutation of ARID2 contributes to HCC growth and metastasis and induces EMT in a hypoxic microenvironment.
Conclusions
We offer a comprehensive description of the molecular basis for sarcomatoid HCC, and identify genomic alteration (ARID2 mutation) together with the tumor microenvironment (hypoxic microenvironment), that may contribute to the formation of the sarcomatoid tumor component through EMT, leading to sarcomatoid HCC development and progression.
5.Integrated molecular characterization of sarcomatoid hepatocellular carcinoma
Rong-Qi SUN ; Yu-Hang YE ; Ye XU ; Bo WANG ; Si-Yuan PAN ; Ning LI ; Long CHEN ; Jing-Yue PAN ; Zhi-Qiang HU ; Jia FAN ; Zheng-Jun ZHOU ; Jian ZHOU ; Cheng-Li SONG ; Shao-Lai ZHOU
Clinical and Molecular Hepatology 2025;31(2):426-444
Background:
s/Aims: Sarcomatoid hepatocellular carcinoma (HCC) is a rare histological subtype of HCC characterized by extremely poor prognosis; however, its molecular characterization has not been elucidated.
Methods:
In this study, we conducted an integrated multiomics study of whole-exome sequencing, RNA-seq, spatial transcriptome, and immunohistochemical analyses of 28 paired sarcomatoid tumor components and conventional HCC components from 10 patients with sarcomatoid HCC, in order to identify frequently altered genes, infer the tumor subclonal architectures, track the genomic evolution, and delineate the transcriptional characteristics of sarcomatoid HCCs.
Results:
Our results showed that the sarcomatoid HCCs had poor prognosis. The sarcomatoid tumor components and the conventional HCC components were derived from common ancestors, mostly accessing similar mutational processes. Clonal phylogenies demonstrated branched tumor evolution during sarcomatoid HCC development and progression. TP53 mutation commonly occurred at tumor initiation, whereas ARID2 mutation often occurred later. Transcriptome analyses revealed the epithelial–mesenchymal transition (EMT) and hypoxic phenotype in sarcomatoid tumor components, which were confirmed by immunohistochemical staining. Moreover, we identified ARID2 mutations in 70% (7/10) of patients with sarcomatoid HCC but only 1–5% of patients with non-sarcomatoid HCC. Biofunctional investigations revealed that inactivating mutation of ARID2 contributes to HCC growth and metastasis and induces EMT in a hypoxic microenvironment.
Conclusions
We offer a comprehensive description of the molecular basis for sarcomatoid HCC, and identify genomic alteration (ARID2 mutation) together with the tumor microenvironment (hypoxic microenvironment), that may contribute to the formation of the sarcomatoid tumor component through EMT, leading to sarcomatoid HCC development and progression.
6.Short- to medium-term safety and efficacy of the implantable Corheart 6 left ventricular assist system in patients with end-stage heart failure
Zhibing QIU ; Xiaochun SONG ; Liangpeng LI ; Hongwei SHI ; Liqiong XIAO ; Yunzhang WU ; Xiaosong RONG ; Jidan FAN ; Liang WEI ; Xin CHEN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(05):639-645
Objective To investigate the efficacy and safety of the Corheart 6 left ventricular assist system in patients with end-stage heart failure. Methods A retrospective study was conducted on patients with end-stage heart failure who were treated with Corheart 6 left ventricular assist system from March 2022 to June 2024 in 4 hospitals in Jiangsu Province. The efficacy of the device was evaluated by comparing changes in clinical indicators at preoperative, discharge, 3-month postoperative, and 6-month postoperative timepoints, including the New York Heart Association (NYHA) functional classification, left ventricular ejection fraction (LVEF), and left ventricular end-diastolic diameter (LVEDD). The safety of the device was assessed by analyzing the intraoperative position and orientation of the blood pump inlet cannula, as well as the incidence of adverse events. Results In this study, 39 patients were collected, including 34 males and 5 females with a mean age of (56.4±12.5) years, ranging from 20 to 75 years. There was no operative death. There was no death in postoperative 3 months with a survival rate of 100.0%. There were 3 deaths in 6 months postoperatively, with a survival rate of 92.3%. All patients had a preoperative NYHA cardiac function classification of class Ⅳ. The NYHA cardiac function class of the patients improved (P<0.05) at discharge, 3 and 6 months after surgery when compared to the preoperative period. LVEF was significantly higher at 3 months after surgery than that during the preoperative period (P<0.05). LVEDD was significantly smaller at discharge, 3 and 6 months after surgery than that during the preoperative period (P<0.05). The safety evaluation's findings demonstrated that all 39 patients' intraoperative blood pump inlet tubes were oriented correctly, the artificial blood vessel suture sites were appropriate, there were no instances of device malfunction or pump thrombosis, or instances of bleeding or hemolysis, and the rate of the remaining adverse events was low. Conclusion With a low rate of adverse events and an excellent safety profile, the Corheart 6 left ventricular assist system can efficiently enhance cardiac function in patients with end-stage heart failure. It also has considerable clinical uses.
7.Association between prolactin/testosterone ratio and breast cancer in Chinese women.
Qian CAI ; Xiaohan TIAN ; Yuyi TANG ; Han CONG ; Jie LIU ; Song ZHAO ; Rong MA ; Jianli WANG ; Jiang ZHU
Chinese Medical Journal 2024;137(3):368-370
8.Research advances in diagnosis and treatment for war trauma to lower urinary tract and external genitalia
Guo-Rong YANG ; Kai-Kai LYU ; Yang-Yang WU ; Tao SONG ; Qing YUAN
Medical Journal of Chinese People's Liberation Army 2024;49(3):335-342
In recent years,with the continuous innovation of modern war mode,weapons and protective equipment,the mechanism and mode of war trauma have also produced great changes.The widespread use of bulletproof vest and improvised explosive devices has led to increasing incidence of genitourinary trauma.The pattern of genitourinary trauma has also transformed from internal structures(kidney,ureters,bladder)to external structures(scrotum,testes,penis,urethra),suggesting that the research focus of genitourinary system war trauma should be gradually transformed to trauma research of lower urinary tract and external genitalia.This article reviews the incidence,treatment and prognosis of genitourinary trauma in several modern wars,and mainly describes the relevant conditions of lower urinary tract and external genitalia trauma and the relevant progress in the treatment in recent years.
9.Application of scaffolding-based flipped classroom in Infectious Disease Nursing
Fei ZHAO ; Zhiyan BAO ; Rong CHEN ; Leyao XIAO ; Fenlian ZENG ; Xia LIU ; Chunmei YAO ; Kangyan LIU ; Shuozhen CHEN ; Song LI ; Ping YANG
Chinese Journal of Medical Education Research 2024;23(3):401-405
Objective:To explore the effects of the scaffolding-based flipped classroom approach in the teaching of Infectious Disease Nursing. Methods:We assigned 152 students of nursing and midwifery majors of grade 2018 (experimental group) to be taught using the scaffolding-based flipped classroom approach and 182 students of grade 2017 (control group) to be taught using the traditional lecture method. Teaching effects were evaluated through students' exam performance and a questionnaire survey. Numerical data were analyzed using the χ2 test and t test with the use of SPSS 18.0, and text data were processed using NVivo 11 for thematic analysis. Results:The experimental group and control group showed significant differences in the interim exam score (83.19±7.96 vs. 79.62±3.14, P<0.001) and final exam score (78.47±6.92 vs. 73.16±8.24, P<0.001). The students of grade 2018 had a high level of participation in online learning. The questionnaire results showed that the scaffolding-based flipped classroom was well recognized in terms of students' overall perception, perceived course quality, perceived value of learning, and satisfaction and the open-ended question, with low scores for learner complaints and loyalty. Conclusions:The scaffolding-based flipped classroom is feasible in the teaching of Infectious Disease Nursing, which can improve students' academic performance and overall competence.
10.Risk factors and prediction model for periprosthetic femoral fracture after total knee arthroplasty in the elderly
Meng ZHU ; Xue-Yu HU ; Ting-Ting ZHAO ; Rong QIU ; Ke LEI ; Yao SONG
Journal of Regional Anatomy and Operative Surgery 2024;33(2):157-161
Objective To investigate the risk factors of periprosthetic femoral fracture(PFF)after total knee arthroplasty(TKA)in the elderly and to construct a predictive model for the prevention of PFF after clinical operation.Methods The clinical data of 537 elderly patients who underwent TKA in the orthopedic department of the First Affiliated Hospital of Air Medical University from October 2016 to October 2021 were retrospectively analyzed.The occurrence of PFF during the follow-up period was statistically analyzed and the clinical data were collected.Binary Logistic regression was used to analyze the risk factors of PFF after TKA in the elderly,and a predictive model of PFF after TKA in the elderly was constructed based on the risk factors.Receiver operating characteristic(ROC)curve and Hosmer-Lemeshow(H-L)were used to test the discrimination and calibration of prediction model.Results The patients were followed up for 12 to 72 months after discharge,with a median time of 47 months.During the follow-up period,31 patients(5.77%)developed PFF.Age,osteoporosis,Parkinson's disease and anterior femoral notch(AFN)were the risk factors for PFF after TKA in the elderly(P<0.05),and cross fixation of prosthesis and bone cement fixation were the protective factors(P<0.05).The results of H-L test showed that the risk prediction model of PFF after TKA in the elderly had good calibration(P>0.05).ROC curve analysis showed that the risk prediction model of PFF after TKA in the elderly has high discrimination(area under the curve was 0.858,95%CI:0.826 to 0.887),the sensitivity was 83.87%,the specificity was 88.34%.Conclusion The risk of PFF after TKA in the elderly is high,and prevention should be carried out according to the high risk factors.The prediction model constructed based on the high risk factors has good prediction efficiency.

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