1.Preventive effect of LifePort combined with polymyxin B on donor-derived infections in kidney transplantation
Xiaomin LI ; Yuewei YIN ; Chenming ZHAO ; Yalin NIU ; Kailong LIU ; Pingying GUO ; Wei LI ; Baosai LU
Organ Transplantation 2026;17(2):227-234
Objective To evaluate the effect of LifePort combined with polymyxin B in preventing donor-derived infections caused by preservation solution contamination. Methods Clinical data of 110 kidney transplant recipients were retrospectively analyzed. According to the decontamination status of preservation solution, the recipients were divided into the decontamination group (n=62) and the non-decontamination group (n=48). The general data of the two groups were compared, and the preventive effect of polymyxin B on possible donor-derived infections (p-DDI) was analyzed, especially infections associated with multidrug-resistant Gram-negative bacteria (MDR GNB). Results There were no statistically significant differences in baseline data (gender, age, preservation solution contamination status, etc.) between the decontamination group and the non-decontamination group (all P > 0.05). The overall contamination rate of preservation solution was 80.0%, and 68 contaminated samples were with single microorganism and 20 with multiple microorganisms. Coagulase-negative staphylococci, Enterococcus and Klebsiella pneumoniae were the most common microorganisms in the positive samples. Fifteen cases of preservation solution were contaminated by MDR GNB, including 10 cases in the non-decontamination group and 5 cases in the decontamination group, with no statistically significant difference between the two groups (P = 0.053). Postoperative infection-related events occurred in 69 recipients, including 39 cases in the non-decontamination group and 30 cases in the decontamination group, with the incidence rate in the non-decontamination group significantly higher than that in the decontamination group (P < 0.001). Only 10 cases of infections were identified as p-DDI, all of which were positive for preservation solution culture, including 8 cases in the non-decontamination group and 2 cases in the decontamination group (P < 0.05). There were 5 cases of p-DDI related to MDR GNB in the non-decontamination group, while no such cases occurred in the decontamination group (P < 0.05). No adverse reactions related to polymyxin B were observed, and no recipient death or renal allograft dysfunction occurred in either group. Conclusions Adding polymyxin B to the preservation fluid during hypothermic machine perfusion with LifePort before renal transplantation may reduce p-DDI and its potential adverse consequences.
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*
;
Drug Monitoring/methods*
;
Humans
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Organ Transplantation
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Immunosuppressive Agents/administration & dosage*
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Delphi Technique
3.Analysis of Clinical Efficacy of Huanglian Heye Formula Combined with Insulin Aspart in Obese Patients with Type 2 Diabetes Mellitus
Shengwei ZHANG ; Yalin CHEN ; Mingyu BA ; Zhao YAN ; Shuxun YAN
Journal of Guangzhou University of Traditional Chinese Medicine 2025;42(9):2148-2155
Objective To evaluate the clinical efficacy of Huanglian Heye Formula(composed of Nelumbinis Folium,Coicis Semen,Atractylodis Rhizoma,Glycyrrhizae Radix et Rhizoma,Coptidis Rhizoma,Crataegi Fructus,and Atractylodis Macrocephalae Rhizoma)combined with insulin aspart in treating obese patients with type 2 diabetes mellitus(T2DM)presenting damp-heat obstructing middle jiao syndrome.Methods A total of 94 obese T2DM patients with damp-heat obstructing middle jiao syndrome were treated at the Endocrinology Department of the First Affiliated Hospital of Henan University of Chinese Medicine from April 2022 to January 2024.The patients were randomly assigned to the control group and the observation group,with 47 patients in each group.The control group was treated with insulin aspart,and the observation group was treated with Huanglian Heye Formula plus insulin aspart,both groups were treated for 12 weeks.Changes in traditional Chinese medicine(TCM)syndrome scores,lipid metabolism parameters[total cholesterol(TC),triglycerides(TG),low-density lipoprotein cholesterol(LDL-C)],obesity indicators[waist-to-hip ratio(WHR),body mass index(BMI),glucose metabolism markers[glycated hemoglobin(HbA1c),2-hour postprandial glucose(2hPG),fasting plasma glucose(FPG)],and serological indicators(visceral adipose tissue-derived serine protease inhibitor[VASPIN],homeostasis model assessment of[3-cell function(HOMA-β)]were observed before and after treatment.Clinical efficacy and safety were evaluated.Results(1)The observation group demonstrated significantly higher total efficacy[93.62%(44/47)]compared to the control group[78.72%(37/47);the intergroup comparison(by chi-square test)showed that the efficacy in the observation group was superior to the control group(P<0.05).(2)Both groups showed reduced TCM syndrome scores(heaviness in head/body,epigastric fullness,sticky/foul-smelling stools,halitosis,dry/bitter mouth,heartburn/vomiting,yellowish urine,and emotional distress;all P<0.05),with greater improvements in the observation group(P<0.01).(3)Lipid profiles of TC,TG and LDL-C were improved in both groups(P<0.05),with more significant reductions in the observation group(P<0.01).(4)Obesity indicators(WHR,BMI)decreased in both groups(P<0.05),showing superior reductions in the observation group(P<0.05 or P<0.01).(5)Glucose metabolism markers(HbA1c,2hPG,FPG)were significantly lowered in both groups(P<0.05),with the observation group achieving better outcomes(P<0.01).(6)Serological analysis revealed increased VASPIN and HOMA-[3 levels in both groups(P<0.05),with more pronounced elevations in the observation group(P<0.01).(7)No severe adverse events occurred.The incidence of adverse reactions was 8.51%(4/47)in the observation group versus 6.38%(3/47)in the control group(P>0.05).Conclusion Huanglian Heye Formula combined with insulin aspart significantly improves clinical outcomes in obese T2DM patients with damp-heat obstructing middle jiao syndrome by protecting pancreatic[3-cell function,reducing body mass,ameliorating glucose/lipid metabolism,and modulating VASPIN expression,with demonstrated safety.
4.Formulation and Explanation of the Standards for Hospital Pharmacy Research
Yan LI ; Shiting LIU ; Yilei LI ; Wei ZHANG ; Weiyi FENG ; Yalin DONG ; Rongsheng ZHAO ; Wan-sheng CHEN ; Houwen LIN ; Jin LU ; Boxin ZHAO ; Xin HUANG ; Jiancun ZHEN
Herald of Medicine 2025;44(5):716-719
Hospital pharmacy research is significant in enhancing the level of rational drug use,improving the quality of pharmacy services,and promoting the improvement of drug treatment effects.To guarantee the standardization of hospital pharmacy research,the compilation team of"Hospital Pharmacy Research Standards"adheres to the principles of scientificity,universality,guidance,and operability,combs through the key management contents from three aspects,namely,relevant national policy docu-ments,relevant domestic and international standards and norms,and literature analysis,combines with the actual working condition of hospital pharmacy research,and formulates the standards after several rounds of opinion collection and expert argumentation.This paper analyzes the key contents of the standard,including basic requirements,research process management,and research re-sults management,to provide guidance and reference for hospital pharmacy researchers to understand the standard in-depth and further improve the standardization of hospital pharmacy research.
5.A Dose-response Meta-analysis Between Triglyceride-glucose Index and Risk of Stroke
Li YOU ; Xinping CHI ; Yalin ZHOU ; Chunshan ZHAO ; Chunli MEI ; Bowen LIN
Chinese Circulation Journal 2025;40(6):611-618
Objectives:To quantitatively evaluate the relationship between triglyceride-glucose index and stroke risk by a dose-response meta-analysis.Methods:Prospective cohort studies on the association between triglyceride-glucose(TyG)index and stroke risk were searched by computer in China National Knowledge Infrastructure(CNKI),Wanfang Data Knowledge Service Platform,VIP,China Biomedical Literature Database,PubMed,Embase and Web of Science.The retrieval time was from the self-established database to November 7,2024.Two researchers used the Newcastle-Ottawa Scale(NOS)to evaluate literature quality and then extract relevant data for the included literatures.Stata 17.0 software was used for statistical analysis.Results:A total of 17 prospective literatures were included,involving 449 210 subjects,including 28 506 patients with stroke.The results of meta-analysis showed that the TyG index was positively correlated with the risk of stroke(HR=1.60,95%CI:1.45-1.76,P<0.05).The results of dose-response meta-analysis showed that there was a positive correlation between the TyG index and the risk of stroke,and every 1 unit increase of the TyG index,the risk of stroke increased by 20.2%.According to Egger's test,the P value is 0.962,and the P value of Begg's test is 0.967,indicating that there was no publication bias in the literature included in this study.Conclusions:There is a linear dose-response relationship between TyG index and stroke risk,and higher TyG index can increase the risk of stroke.
6.Consistency analysis of IHC and PCR-CE in the detection of microsatellite insta-bility in 735 tumor cases
Ying GUO ; Yalin CHENG ; Xiangyu ZHAO ; Xinxin YANG ; Hongxue MENG
Chinese Journal of Clinical and Experimental Pathology 2025;41(8):1050-1056
Purpose To investigate the consistency and reliability of immunohistochemistry(IHC)staining and polymerase chain reaction-capillary electrophoresis(PCR-CE)in the detection of microsatellite instability.Methods The clinical data of 735 patients with solid tumors who underwent biopsy or surgical resection were collected,and the microsatellite status of tissue samples was detected by IHC and PCR-CE.Results Among the 344 cases of colorectal cancer(CRC),IHC results showed that 290 cases(84.3%)had proficient mismatch repair(pMMR),and 54 cases(15.7%)had deficient mismatch repair(dMMR).The results of PCR-CE showed that 53 patients(15.4%)had high microsatellite instability(MSI-H),and 291 patients(84.6%)had microsatellite stable(MSS).The consistency analysis of IHC and PCR-CE results showed that the Kappa value was 0.923(P<0.001).Among the 168 cases of en-dometrial cancer(EC),IHC results showed that 42 cases(25.0%)had dMMR and 126 cases(75.0%)had pMMR;The results of PCR-CE showed that 39 cases(23.2%)had MSI-H and 129 cases(76.8%)had MSS.The consisten-cy analysis of the two methods showed that the Kappa value was 0.854(P<0.001).Among the 165 cases of gastric cancer,IHC results showed that 22(13.3%)had dMMR and 143(86.7%)had pMMR;The results of PCR-CE showed that 22 cases(13.3%)had MSI-H and 143 cases(86.7%)had MSS/low microsatellite instability(MSI-L).The consistency analysis of IHC and PCR-CE results showed that the Kappa value was 0.843(P<0.001).Among the 58 cases of head and neck squamous cell carcinoma(HNSCC),IHC results showed that 3 cases(5.2%)had dMMR and 55 cases(94.8%)had pMMR;The results of PCR-CE showed that 3 cases(5.2%)had MSI-H and 55 cases(94.8%)had MSS.The consistency analysis of the two methods showed that the Kappa value was 1.000(P<0.001).Conclusion IHC and PCR-CE have high consistency and reliability in detecting MSI status in patients with CRC,EC,gastric cancer and HNSCC,and their combined application is helpful to improve the accuracy of MSI detec-tion in patients with solid tumors.
7.Formulation and Explanation of the Standards for Hospital Pharmacy Research
Yan LI ; Shiting LIU ; Yilei LI ; Wei ZHANG ; Weiyi FENG ; Yalin DONG ; Rongsheng ZHAO ; Wan-sheng CHEN ; Houwen LIN ; Jin LU ; Boxin ZHAO ; Xin HUANG ; Jiancun ZHEN
Herald of Medicine 2025;44(5):716-719
Hospital pharmacy research is significant in enhancing the level of rational drug use,improving the quality of pharmacy services,and promoting the improvement of drug treatment effects.To guarantee the standardization of hospital pharmacy research,the compilation team of"Hospital Pharmacy Research Standards"adheres to the principles of scientificity,universality,guidance,and operability,combs through the key management contents from three aspects,namely,relevant national policy docu-ments,relevant domestic and international standards and norms,and literature analysis,combines with the actual working condition of hospital pharmacy research,and formulates the standards after several rounds of opinion collection and expert argumentation.This paper analyzes the key contents of the standard,including basic requirements,research process management,and research re-sults management,to provide guidance and reference for hospital pharmacy researchers to understand the standard in-depth and further improve the standardization of hospital pharmacy research.
8.Consistency analysis of IHC and PCR-CE in the detection of microsatellite insta-bility in 735 tumor cases
Ying GUO ; Yalin CHENG ; Xiangyu ZHAO ; Xinxin YANG ; Hongxue MENG
Chinese Journal of Clinical and Experimental Pathology 2025;41(8):1050-1056
Purpose To investigate the consistency and reliability of immunohistochemistry(IHC)staining and polymerase chain reaction-capillary electrophoresis(PCR-CE)in the detection of microsatellite instability.Methods The clinical data of 735 patients with solid tumors who underwent biopsy or surgical resection were collected,and the microsatellite status of tissue samples was detected by IHC and PCR-CE.Results Among the 344 cases of colorectal cancer(CRC),IHC results showed that 290 cases(84.3%)had proficient mismatch repair(pMMR),and 54 cases(15.7%)had deficient mismatch repair(dMMR).The results of PCR-CE showed that 53 patients(15.4%)had high microsatellite instability(MSI-H),and 291 patients(84.6%)had microsatellite stable(MSS).The consistency analysis of IHC and PCR-CE results showed that the Kappa value was 0.923(P<0.001).Among the 168 cases of en-dometrial cancer(EC),IHC results showed that 42 cases(25.0%)had dMMR and 126 cases(75.0%)had pMMR;The results of PCR-CE showed that 39 cases(23.2%)had MSI-H and 129 cases(76.8%)had MSS.The consisten-cy analysis of the two methods showed that the Kappa value was 0.854(P<0.001).Among the 165 cases of gastric cancer,IHC results showed that 22(13.3%)had dMMR and 143(86.7%)had pMMR;The results of PCR-CE showed that 22 cases(13.3%)had MSI-H and 143 cases(86.7%)had MSS/low microsatellite instability(MSI-L).The consistency analysis of IHC and PCR-CE results showed that the Kappa value was 0.843(P<0.001).Among the 58 cases of head and neck squamous cell carcinoma(HNSCC),IHC results showed that 3 cases(5.2%)had dMMR and 55 cases(94.8%)had pMMR;The results of PCR-CE showed that 3 cases(5.2%)had MSI-H and 55 cases(94.8%)had MSS.The consistency analysis of the two methods showed that the Kappa value was 1.000(P<0.001).Conclusion IHC and PCR-CE have high consistency and reliability in detecting MSI status in patients with CRC,EC,gastric cancer and HNSCC,and their combined application is helpful to improve the accuracy of MSI detec-tion in patients with solid tumors.
9.A Dose-response Meta-analysis Between Triglyceride-glucose Index and Risk of Stroke
Li YOU ; Xinping CHI ; Yalin ZHOU ; Chunshan ZHAO ; Chunli MEI ; Bowen LIN
Chinese Circulation Journal 2025;40(6):611-618
Objectives:To quantitatively evaluate the relationship between triglyceride-glucose index and stroke risk by a dose-response meta-analysis.Methods:Prospective cohort studies on the association between triglyceride-glucose(TyG)index and stroke risk were searched by computer in China National Knowledge Infrastructure(CNKI),Wanfang Data Knowledge Service Platform,VIP,China Biomedical Literature Database,PubMed,Embase and Web of Science.The retrieval time was from the self-established database to November 7,2024.Two researchers used the Newcastle-Ottawa Scale(NOS)to evaluate literature quality and then extract relevant data for the included literatures.Stata 17.0 software was used for statistical analysis.Results:A total of 17 prospective literatures were included,involving 449 210 subjects,including 28 506 patients with stroke.The results of meta-analysis showed that the TyG index was positively correlated with the risk of stroke(HR=1.60,95%CI:1.45-1.76,P<0.05).The results of dose-response meta-analysis showed that there was a positive correlation between the TyG index and the risk of stroke,and every 1 unit increase of the TyG index,the risk of stroke increased by 20.2%.According to Egger's test,the P value is 0.962,and the P value of Begg's test is 0.967,indicating that there was no publication bias in the literature included in this study.Conclusions:There is a linear dose-response relationship between TyG index and stroke risk,and higher TyG index can increase the risk of stroke.
10.Phylogenetic analysis and pathogenesis study of a new deletion mutation causing inherited FⅩ deficiency
Dongyan FU ; Xiaomei LU ; Yalin YU ; Lidong ZHAO ; Lei WANG ; Jia YANG ; Jiawei ZHENG ; Duanyang WANG ; Linhua YANG ; Gang WANG
Chinese Journal of Hematology 2024;45(10):902-908
Objective:To analyze the F10 gene mutations in a Chinese pedigree affected with the deficiency of the hereditary coagulation factor X (FX), resulting from a new deletion mutation, and to study the associated molecular pathogenesis.Methods:Next generation sequencing (NGS) was performed to screen the genetic mutations in the proband which were then verified by Sanger sequencing. The FX activity (FX∶C) of probands and their family members was detected using the blood clotting method, and the mutation sites of the family members were analyzed using Sanger sequencing. The pathogenicity of the mutation site was predicted by using the online bioinformatics software, Mutation Taster. The SWISS-MODEL software was used for stimulating the three-dimensional models of the wild-type and mutant proteins for analyzing the influence of the mutation site on the structure and function of the proteins, and for analyzing the difference between the catalytic residues of the wild-type and the mutant proteins. The level of the F10 gene mRNA was quantitatively analyzed by qRT-PCR (quantitative reverse transcription polymerase chain reaction) method by constructing plasmids, transfecting human embryonic kidney 293T cells (HEK 293T), and analyzing the splicing of the mutated site by RT-PCR method. The levels of FⅩ∶Ag in cell lysates and cell culture media (both inside and outside the cells) were detected by the ELISA (enzyme linked immunosorbent assay) method.Results:A medium-grade factor X deficiency with a 36.42% FⅩ∶C ratio was detected in the proband by the coagulation method. NGS analysis demonstrated a heterozygous deletion mutation in exon 8:c.902_919del (p.Ala301_Glu306del) in the proband. Sanger sequencing analysis indicated that some members of the family (mother and grandfather) were also carriers of the corresponding deletion mutation. Online bioinformatics software predicted the pathogenic nature of the c.902_919del mutation, with a pathogenic score of 0.999. The 3D protein structure model analysis indicated that the c.902_919del mutation resulted in the disappearance of a segment of β-fold in the protein structure, thereby shortening the preceding segment of the β-fold and a subsequent loss of hydrogen bonds between adjacent amino acids with no significant difference in the side chain conformation of the key catalytic residues compared to the wild-type. mRNA splicing analysis indicated the absence of alternative splicing changes in the mutation, and qRT-PCR results indicated the absence of a statistically significant difference between the mRNA levels of F10 gene and wild-type mRNA in cells expressing c.902_919del mutant. The ELISA results indicated that there was no statistically significant difference in the FX∶Ag levels of the mutant cell culture medium and the lysate.Conclusions:In this pedigree, the heterozygous mutation in exon 8 of F10 gene (c.902_919del, p.Ala301_Glu306del) caused the hereditary factor Ⅹ deficiency.

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