1.Study on patients’medicine instruction regulatory system in the European Union and the enlightenment
Sihan YUAN ; Rong JIANG ; Yujie ZHENG ; Haiqi LI ; Yixuan CHEN ; Rong SHAO
China Pharmacy 2025;36(3):269-274
OBJECTIVE To provide reference for the establishment and improvement of the regulatory system of patients’ medicine instructions in China. METHODS Through searching the official website of the European Medicines Agency (EMA) and related literature, the definition, basic nature, and content of patients’ medicine instructions in the European Union were introduced, and the characteristics of the management system of patients’ medicine instructions in the European Union were analyzed in terms of the management department, approval and change procedures, readability requirements and information accessibility requirements. At the same time, the pilot situation of patients’ medicine instructions in China, as well as problems in the paths of classification and management, readability of content, and information timeliness were analyzed to put forward suggestions. RESULTS & CONCLUSIONS European Union had a dedicated department for the management of medicine instructions; the approval and change procedures for patients’ medicine instructions were clear, the readability requirements were detailed, the readability verification program with patient participation was established, and multi-channel and timely information disclosure was adopted. It is recommended that China establish a mechanism to categorize and manage professionals’ and patients’ medicine instructions, guide multiple parties to participate in the design of patients’ medicine instructions and refine the readability requirements, and improve the mechanism for disclosure of medicine instructions to enhance the timeliness of medication information.
2.Research progress of Dexamethasone intravitreal implants in the treatment of diabetic macular edema
Xiaoting YUAN ; Jiao HUANG ; Xiaojuan CHENG ; Rong LI ; Lishuai XU
International Eye Science 2025;25(1):82-87
Diabetic macular edema(DME), a serious complication of diabetic retinopathy(DR), is a chronic condition caused by multiple factors. Throughout its progression, inflammatory factors and vascular endothelial growth factor(VEGF)play a critical role. Anti-VEGF drugs have shown significant effectiveness in the treatment of DME; however, some patients may experience persistent DME after injection or require frequent injections. Dexamethasone intravitreal implants(DEX implants)serve as a sustained-release implant characterized by a reasonable release profile and high bioavailability. They offer safe, effective, and prolonged anti-inflammatory effects, aiding in the repair of retinal barrier and reduction of exudation. To further enhance patients' visual quality, exploring the efficacy of DEX implants in combination with existing treatment regimens has great clinical significance. This review primarily discusses the research advancements in DEX implants, focusing on their pharmacological properties, indications for use, and their combination with existing drugs and treatment methods. It also evaluates the advantages and disadvantages of combination therapy or switching to DEX implants compared to current standard treatments, aiming to provide guidance for personalized treatment options for patients with DME.
3.Comparison of nutritional intervention effects at different initiation time in patients with respiratory diseases at nutritional risk
Lihong WANG ; Yuan CUI ; Shaoye HUO ; Yunhua ZHAO ; Yuhuan WEI ; Rong JIANG ; Chunhai SHAO
Chinese Journal of Clinical Medicine 2025;32(2):268-275
Objective To assess the effect of early nutritional intervention on the patients with respiratory diseases at nutritional risk. Methods A total of 130 patients with respiratory disease who were hospitalized in Shanghai Fifth People’s Hospital, Fudan University between May 2023 and December 2024 and had a nutritional risk screening 2002 score ≥3 points. Based on the initiation time of nutritional intervention, patients were divided into an early group (≤5 days, n=65) and a late group (>5 days, n=65). Results In the early group, prealbumin (P-ALB) and retinol-binding protein (RBP) levels were significantly higher (P<0.01), C-reactive protein (CRP), procalcitonin (PCT) levels were significantly lower after intervention (P<0.05). Compared with the late group, the hospital costs were lower and hospital stays were shorter in the early group (P<0.001). Spearman analysis showed ALB, P-ALB, and total protein (TP) were negatively correlated with hospital costs (r=-0.37, -0.20, and-0.22, P<0.05). RBP, ALB, P-ALB, and lymphocyte count (LYM) were negatively correlated with CRP (r=-0.30, -0.26, -0.37, -0.18, P<0.01), RBP, ALB, P-ALB, hemoglobin (HB), and TP were negatively correlated with PCT (r=-0.23,-0.36, -0.40, -0.30, -0.19, P<0.05). Conclusions For patients with respiratory diseases, early nutritional assessment should be underwent, and for patients with nutritional risk screening 2002 score ≥3 points, early nutritional intervention could improve the nutritional status and alleviate inflammatory response, promote recovery, shorten the hospital stays.
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.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.
7.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.
8.Simultaneous determination of 13 aromatic amine compounds in workplace air by high performance liquid chromatography
Weimin XIE ; Ruibo MENG ; Zuofei XIE ; Jing YUAN ; Jiaheng HE ; Jiawen HU ; Weifeng RONG
China Occupational Medicine 2025;52(2):182-187
Objective To establish a liquid chromatography method for the simultaneous determination of 13 aromatic amine compounds (AAs) in workplace air. Methods A total of 13 AAs in both vapor and aerosol phases were collected in workplace air using a new GDH-6 sampling tube. Samples were desorbed and eluted with methanol, separated using a Symmetry Shield™ RP18 reversed-phase liquid chromatography column, and detected with a diode array detector. Quantification was performed using an external standard method. Results The linear range of the 13 AAs measured by this method was 0.02-373.60 μg/L with the correlation coefficients greater than 0.999 0. The minimum detection concentration was 0.09-14.37 μg/m3, and the minimum quantitative concentration was 0.31-47.90 μg/m3 (both calculated based on sampling 15.0 L of air and 3.0 mL of elution volume). The average desorption and elution efficiency ranged from 97.46% to 101.23%. The within-run relative standard deviation (RSD) was 0.10%-5.99%, and the between-run RSD was 0.17%-2.71%. Samples could be stably stored in sealed conditions at 2-8 ℃ for more than seven days. Conclusion This method is suitable for the simultaneous determination of 13 AAs in workplace air, including both vapor and aerosol phases.
9.Simultaneous determination of four thiol derivatives in workplace air by gas chromatography
Ruibo MENG ; Jing YUAN ; Jiawen HU ; Jiaheng HE ; Jingjing QIU ; Zuokan LIN ; Ziqun ZHANG ; Weifeng RONG ; Banghua WU
China Occupational Medicine 2025;52(2):188-192
Objective To establish a method for simultaneous determination of four high-molecular-weight thiol derivatives (TDs) in workplace air by gas chromatography. Methods The four kinds of vapor-phase macromolecular TDs (1-pentanethiol, 1-hexanethiol, 1-benzyl mercaptan, and n-octanethiol) in the workplace air were collected using the GDH-1 air sampling tubes, desorbed with anhydrous ethanol, separated on a DB-FFAP capillary column, and determined by flame ionization detector. Results The quantitation range of the four TDs was 0.30-207.37 mg/L, with the correlation coefficients greater than 0.999 00. The minimum detection mass concentrations and minimum quantitation mass concentrations were 0.18-0.32 and 0.60-1.05 mg/m3, respectively (both calculated based on the 1.5 L sample and 3.0 mL desorption solvent). The mean desorption efficiencies ranged from 87.07% to 103.59%. The within-run and between-run relative standard deviations were 1.92%-8.22% and 1.89%-8.45%, respectively. The samples can be stored at room temperature or 4 ℃ for three days and up to 7 days at -18 ℃. Conclusion This method is suitable for the simultaneous determination of four vapor-phase TDs in workplace air.
10.Efficacy and safety of different daily doses of aspirin in prevention of preeclampsia:a meta-analysis
Xiaoxia SHI ; Yan BAI ; Liting RONG ; Yuanjie DU ; Lijuan YUAN
China Pharmacy 2025;36(21):2733-2737
OBJECTIVE To compare the efficacy and safety of different daily doses of aspirin in the prevention of preeclampsia (PE). METHODS The case-control studies and prospective randomized controlled trials on aspirin with daily dose ≥ 100 mg (trial group) vs. <100 mg (control group) in the prevention of PE were retrieved from PubMed, Medline, Embase, the Cochrane Library, CNKI, China Biomedical Literatue Database and Wanfang Data from base-building to January 2025. After literature screening, data extraction and quality evaluation, meta-analysis was performed by using RevMan 5.3 software. RESULTS A total of 11 literatures were included, involving 3 052 pregnant women. Meta-analysis showed the incidence of PE [RR=0.63, 95%CI (0.53,0.76), P<0.000 01], gestational hypertension [RR=0.69, 95%CI (0.50,0.94),P=0.02], preterm birth [RR=0.56, 95%CI (0.47,0.66), P<0.000 01], and intrauterine growth retardation [RR=0.73,95%CI (0.61,0.87),P=0.000 5] in trial groups were significantly lower than control group. The incidence of postpartum hemorrhage between the two groups had no statistically significant difference [RR=1.17, 95%CI (0.90,1.53),P=0.25]. Subgroup analysis showed that the incidence of PE in Chinese pregnant women taking 150 mg of aspirin was significantly higher than taking 100 mg of aspirin [RR=3.40, 95%CI (1.29, 8.93), P=0.01]; but there was no significant difference between the two groups in the incidences of postpartum hemorrhage, preterm birth (P>0.05). CONCLUSIONS Aspirin with daily dose ≥100 mg is more effective in preventing PE than daily dose <100 mg, with lower rates of gestational hypertension, preterm birth, and intrauterine growth retardation. It does not increase the risk of postpartum hemorrhage. For pregnant women in China, daily dose 100 mg of aspirin may be more effective in preventing PE than 150 mg.

Result Analysis
Print
Save
E-mail