2.A practice guideline for therapeutic drug monitoring of mycophenolic acid for solid organ transplants.
Shuang LIU ; Hongsheng CHEN ; Zaiwei SONG ; Qi GUO ; Xianglin ZHANG ; Bingyi SHI ; Suodi ZHAI ; Lingli ZHANG ; Liyan MIAO ; Liyan CUI ; Xiao CHEN ; Yalin DONG ; Weihong GE ; Xiaofei HOU ; Ling JIANG ; Long LIU ; Lihong LIU ; Maobai LIU ; Tao LIN ; Xiaoyang LU ; Lulin MA ; Changxi WANG ; Jianyong WU ; Wei WANG ; Zhuo WANG ; Ting XU ; Wujun XUE ; Bikui ZHANG ; Guanren ZHAO ; Jun ZHANG ; Limei ZHAO ; Qingchun ZHAO ; Xiaojian ZHANG ; Yi ZHANG ; Yu ZHANG ; Rongsheng ZHAO
Journal of Zhejiang University. Science. B 2025;26(9):897-914
Mycophenolic acid (MPA), the active moiety of both mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS), serves as a primary immunosuppressant for maintaining solid organ transplants. Therapeutic drug monitoring (TDM) enhances treatment outcomes through tailored approaches. This study aimed to develop an evidence-based guideline for MPA TDM, facilitating its rational application in clinical settings. The guideline plan was drawn from the Institute of Medicine and World Health Organization (WHO) guidelines. Using the Delphi method, clinical questions and outcome indicators were generated. Systematic reviews, Grading of Recommendations Assessment, Development, and Evaluation (GRADE) evidence quality evaluations, expert opinions, and patient values guided evidence-based suggestions for the guideline. External reviews further refined the recommendations. The guideline for the TDM of MPA (IPGRP-2020CN099) consists of four sections and 16 recommendations encompassing target populations, monitoring strategies, dosage regimens, and influencing factors. High-risk populations, timing of TDM, area under the curve (AUC) versus trough concentration (C0), target concentration ranges, monitoring frequency, and analytical methods are addressed. Formulation-specific recommendations, initial dosage regimens, populations with unique considerations, pharmacokinetic-informed dosing, body weight factors, pharmacogenetics, and drug-drug interactions are covered. The evidence-based guideline offers a comprehensive recommendation for solid organ transplant recipients undergoing MPA therapy, promoting standardization of MPA TDM, and enhancing treatment efficacy and safety.
Mycophenolic Acid/administration & dosage*
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Drug Monitoring/methods*
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Humans
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Organ Transplantation
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Immunosuppressive Agents/administration & dosage*
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Delphi Technique
3.Research progress on the histopathological growth patterns of colorectal liver metastasis
Guobao SUN ; Qian YANG ; Qingchun ZHUANG ; Binbin GAO ; Xiaogang SUN ; Wei SONG ; Dan SHA
Journal of International Oncology 2024;51(2):114-118
The histopathological growth patterns (HGPs) of colorectal cancer (CRC) liver metastasis reflect the complicated and varied interactions between tumor cells and host microenvironment. Exploring the tumor vascular and immunological features of HGPs, the relationship between HGPs and anti-tumor treatment efficacy, and HGPs prediction methods may have potential clinical aplication value for making optimal treatment strategies, evaluating patients' prognosis, and monitoring disease progression.
4.Efficacy and safety of CM310 in moderate-to-severe atopic dermatitis: A multicenter, randomized, double-blind, placebo-controlled phase 2b trial
Yan ZHAO ; Jianzhong ZHANG ; Bin YANG ; Jingyi LI ; Yangfeng DING ; Liming WU ; Litao ZHANG ; Jinyan WANG ; Xiaohong ZHU ; Furen ZHANG ; Xiaohua TAO ; Yumei LI ; Chunlei ZHANG ; Linfeng LI ; Jianyun LU ; Qingchun DIAO ; Qianjin LU ; Xiaoyong MAN ; Fuqiu LI ; Xiujuan XIA ; Hao CHENG ; Yingmin JIA ; Guoqing ZHAO ; Jinchun YAN ; Bo CHEN
Chinese Medical Journal 2024;137(2):200-208
Background::Atopic dermatitis (AD) affects approximately 10% of adults worldwide. CM310 is a humanized monoclonal antibody targeting interleukin-4 receptor alpha that blocks interleukin-4 and interleukin-13 signaling. This trial aimed to evaluate the efficacy and safety of CM310 in Chinese adults with moderate-to-severe AD.Methods::This multicenter, randomized, double-blind, placebo-controlled, phase 2b trial was conducted in 21 medical institutions in China from February to November 2021. Totally 120 eligible patients were enrolled and randomized (1:1:1) to receive subcutaneous injections of 300 mg CM310, 150 mg CM310, or placebo every 2 weeks for 16 weeks, followed by an 8-week follow-up period. The primary endpoint was the proportion of patients achieving ≥75% improvement in the Eczema Area and Severity Index (EASI-75) score from baseline at week 16. Safety and pharmacodynamics were also studied.Results::At week 16, the proportion of EASI-75 responders from baseline was significantly higher in the CM310 groups (70% [28/40] for high-dose and 65% [26/40] for low-dose) than that in the placebo group (20%[8/40]). The differences in EASI-75 response rate were 50% (high vs. placebo, 95% CI 31%–69%) and 45% (low vs. placebo, 95% CI 26%–64%), with both P values <0.0001. CM310 at both doses also significantly improved the EASI score, Investigator’s Global Assessment score, daily peak pruritus Numerical Rating Scale, AD-affected body surface area, and Dermatology Life Quality Index compared with placebo. CM310 treatment reduced levels of thymus and activation-regulated chemokine, total immunoglobulin E, lactate dehydrogenase, and blood eosinophils. The incidence of treatment-emergent adverse events (TEAEs) was similar among all three groups, with the most common TEAEs reported being upper respiratory tract infection, atopic dermatitis, hyperlipidemia, and hyperuricemia. No severe adverse events were deemed to be attributed to CM310. Conclusion::CM310 at 150 mg and 300 mg every 2 weeks demonstrated significant efficacy and was well-tolerated in adults with moderate-to-severe AD.Trial Registration::ClinicalTrials.gov, NCT04805411.
5.Surgical transmural ablation of atrial fibrillation based on visualization analysis of CiteSpace and VOSviewer
Xaokang TU ; Hongduan LIU ; Haoyu TAN ; Hao ZHANG ; Qingchun SONG ; Benli YANG ; Long SONG ; Liming LIU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(03):446-453
Objective To analyze the current status and hotspots of surgical transmural ablation of atrial fibrillation using CiteSpace and VOSviewer. Methods The Web of Science Core Collection database was used as the data source. The CiteSpace 5.8.R3 and VOSviewer software were used to analyze the related studies on surgical transmural ablation of atrial fibrillation about the authors, countries/institutions, literature co-citation and keywords. Results A total of 109 articles were enrolled. Damiano RJ was the most prolific researcher, while Cox JL was the author with the highest number of citations. The United States was the leading country in this research field. The University of Washington was an important institution in the study of atrial fibrillation transmural ablation. The main hotpots were the effectiveness of surgical ablation, especially Cox-maze procedure, selection of the energy source of surgical ablation, combination of surgical and catheter ablations, and pulmonary vein isolation. Conclusion This study visualizes the current research status of surgical ablation of atrial fibrillation. How to improve the effectiveness and transmurality of surgical ablation is a hot research topic in the surgical treatment of atrial fibrillation. The combination of electrophysiology mapping and surgical ablation may be the development direction in the surgical treatment of atrial fibrillation.
6.Expression and clinical significance of basement membrane genes in endometrial carcinoma
Congyu YANG ; Qingchun DENG ; Jiaming LIU
Journal of China Medical University 2024;53(5):451-457
Objective To explore the expression levels and clinical significance of basement membrane genes in endometrial carcinoma and the prognostic value of a prediction model.Methods The mRNA expression matrix and clinical data for endometrial carcinoma were obtained from The Cancer Genome Atlas(TCGA)database,and basement membrane genes were obtained from a previous study.Prognostic genes were screened using univariate and multivariate Cox regression analyses based on differentially expressed genes(DEGs).A prognostic model was constructed,and the relationship of these genes with clinical factors was analyzed.The biological functions and pathways of the DEGs were assessed using functional enrichment analyses.The mRNA expression of prognostic genes was verified using real-time polymerase chain reaction(PCR).Results The prognostic model composed of ACHE,COL12A1,and CD44was significantly associated with clinical factors.Real-time PCR results showed that the expression levels of ACHEand COL12A1mRNA differed signifi-cantly between normal endometrial cells and endometrial carcinoma cells(P<0.05).Conclusion The constructed model based on three basement membrane genes can accurately predict the prognosis of patients with endometrial carcinoma and provide potential targets for clinical treatment.
7.Elevation of lactate dehydrogenase in Amanita oberwinkleran poisoning and prognostic analysis
Qingchun HE ; Juan YANG ; Min DAI ; Shanhong PENG ; Xiangmin LI
Chinese Journal of Emergency Medicine 2024;33(10):1434-1438
Objective:To investigate the clinical characteristics, changes in lactate dehydrogenase (LDH) levels, and prognosis in cases of Amanita oberwinklerana poisoning.Methods:A retrospective analysis was conducted on the clinical data of 12 patients who were diagnosed with Amanita oberwinklerana poisoning at Xiangya Changde Hospital between January 2019 and December 2022. The analysis included an assessment of clinical manifestations, renal function changes, LDH levels, and patient prognosis. All statistical analyses were performed using SPSS25.0 Comparisons of ratios between groups were performed using the t test, correlation analyses were performed using scatter diagram and Pearson correlation method, P<0.05 was considered statistically significant. Results:The latency period for symptom onset ranged from 6 to 18 hours, with early symptoms primarily consisting of nausea and vomiting. Three patients developed anuria in the early stage. All patients experienced acute kidney injury (AKI) accompanied by mild liver injury. LDH levels were significantly elevated compared to other types of mushroom poisoning cases ( P < 0.01), with a mean peak value exceeding 2000 U/L. While no correlation was found between LDH levels and kidney injury severity, a positive correlation was observed between LDH levels and length of the course. All 12 patients recovered following dialysis treatment, with recovery periods ranging from 20 to 60 days. No cases of chronic renal failure or mortality were reported. Conclusions:Amanita oberwinklerana poisoning primarily causes acute renal injury. A significant elevation in LDH levels may serve as a potential marker for this type of poisoning. LDH levels did not correlate with kidney injury severity, while positively corrected with the length of the course. All patients in this study achieved good prognosis with full renal recovery.
8.The application of contrast-enhanced ultrasound guided radioactive 125I seed implantation for the treatment of metastatic liver cancer with Iso-echo imaging
Pu SHAO ; Qingchun LI ; Dongyan YANG ; Baodong GAI
Chinese Journal of Endocrine Surgery 2023;17(6):765-766
Radioactive 125I seed implantation has definite curative effect in the treatment of local liver cancer. Currently, percutaneous implantation guided by CT, nuclear magnetism or ultrasound can be adopted, which is safe and minimally invasive. However, the images of some patients with metastatic liver cancer show isodensity or iso-echo imaging under CT or ultrasound, which is easy to miss diagnosis and treatment, seriously affecting the quality of life of patients. A case of terminal cholangiocarcinoma of the biliary tract with metastasis to the liver was admitted to China-Japan Union Hospital of Jilin University. Ultrasound image showed iso-echo, and radio 125I seed implantation was performed under the guidance of contrast-enhanced ultrasound. The operation was completed according to the preoperative treatment plan.
9.High glucose inhibition of miR-126-5p promotes renal tubular epithelial cell injury
Qiong JIANG ; Ting YANG ; Zhaofei LI ; Yan ZHOU ; Qingchun LI ; Xiaohui CHEN ; Mingjie HE ; Aimin ZHONG
Journal of Chinese Physician 2023;25(12):1829-1834
Objective:To explore the differential expression profile of miRN in the development of diabetes nephropathy (DN), and further explore the mechanism of miR-126-5p involved in high glucose induced injury of renal tubular epithelial cells.Methods:Firstly, we downloaded existing chip data from the Gene Expression Integrated Database (GEO) and used GEO2R, miRanda, gene ontology (GO) analysis, and Kyoto Encyclopedia of Genes and Genomes (KEGG) analysis to mine differential miRNAs. Subsequently, a high glucose induced HK-2 cell injury model was used and divided into three groups: high glucose model group, si-HOTAIR group, and si HOTAIR+ miR-126-5p inhibitor group. The three groups of cells were sequentially transfected with siRNA-NC, siRNA-HOTAIR, and siRNA-HOTAIR+ miR-126-5p mimic, and cultured in a medium containing 60 mmol/L glucose. Flow cytometry was used to detect changes in apoptosis levels in each group, while cell counting kit-8 (CCK-8) was used to detect changes in cell proliferation.Results:Through data mining analysis using GEO, it was found that compared to ordinary mice, DN mice had 74 upregulated miRNAs and 80 downregulated miRNAs in their kidney tissue. Enrichment analysis results showed that miRNAs could target signaling pathways such as Wnt, PKG, MAPK, and Rap1, and miR-126-5p was significantly downregulated. In the high glucose induced HK-2 cell injury model, the experimental results showed that the inhibitory effect on cell proliferation activity was more significant at a high glucose concentration of 60 mmol/L ( P<0.05); High glucose stimulation significantly reduced the expression of miR-126-5p ( P<0.05). The results of flow cytometry showed that compared with the high glucose model group, the apoptosis rate of the si-HOTAIR group significantly decreased ( P<0.05), while the apoptosis rate of the si-HOTAIR+ miR-126-5p inhibitor group significantly increased ( P<0.05). The CCK-8 experiment showed that compared with the high glucose model group, the cell viability of the si-HOTAIR group significantly increased ( P<0.05); The cell viability of the si-HOTAIR+ miR-126-5p inhibitor group was inhibited ( P<0.05). Conclusions:miR-126-5p can inhibit high glucose induced apoptosis in HK-2 cells and protect them.
10.Anesthesia management of advanced gallbladder cancer with ultrasound-guided radioactive 125I particle implantation: a case report
Zichen SONG ; Baodong GAI ; Dongyan YANG ; Peng CHEN ; Qingchun LI
Chinese Journal of Endocrine Surgery 2022;16(6):767-768
Ultrasound-guided radioactive 125I particle implantation for the treatment of advanced gallbladder cancer is susceptible to factors such as ribs, respiratory activity, and biliary reflex, which brings great inconvenience to the operation. We reported one case of gallbladder cancer patients with unclear ultrasound imaging under general anesthesia mechanical ventilation and successful transplantation after sustained inflation with general anesthesia in order to providing basis of clinical diagnosis and treatment.

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