1.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*
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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
2.Pituitary radiomics combined with MRI features for predicting growth hormone status in pediatric short stature
Fukun SHI ; Lan ZHANG ; Yu GAO ; Xiaoyang ZHAI ; Qian XU ; Jiaxu LIANG ; Shengli SHI ; Ling WU
Chinese Journal of Medical Imaging Technology 2025;41(7):1073-1078
Objective To observe the value of pituitary radiomics and MRI features combined model for predicting growth hormone(GH)status in pediatric short stature.Methods Totally 300 children with short stature were enrolled as training set,while other 73 cases were taken as external validation set.Based on growth hormone stimulation test,the children were divided into GH deficiency(GHD)group(n=228)and non-GHD group(n=145).The training set included 196 cases in GHD subgroup and 104 cases in non-GHD subgroup,while the validation set included 32 cases in GHD subgroup and 41 cases in non-GHD subgroup.Radiomics features of pituitary were extracted from T1WI.The key features were selected using least absolute shrinkage and selection operator(LASSO)regression,and machine learning models were subsequently constructed using support vector machine(SVM),logistic regression(LR),naive Bayes(NB)and K-nearest neighbor(KNN),respectively.Then combined models were constructed combining with MRI features,and the efficacy of each model was evaluated.Results The area under the curve(AUC)of SVM,LR,NB,and KNN radiomics model for predicting GH status in pediatric short stature was 0.860,0.831,0.838 and 0.901 in training set,0.788,0.829,0.823 and 0.770 in validation set,while of the relative combined SVM,LR,NB and KNN model was 0.924,0.903,0.859 and 0.920 in training set,and 0.827,0.881,0.836 and 0.718 in validation set.LRcombined model had the best overall performance,with sensitivity of 84.94%,specificity of 80.56%and accuracy of 83.61%in training set,and 80.95%,72.22%and 80.00%in validation set,respectively.Conclusion Pituitary radiomics and MRI features combined model could effectively predict GH status in pediatric short stature.
3.Preoperative prediction of lymphovascular invasion in breast cancer based on multimodal radiomics model combining MRI and digital mammography
Ke MAO ; Xiaoyang ZHAI ; Yaning DONG ; Sijia CHENG ; Yaqi ZANG ; Fei JIA ; Dongming HAN
Journal of Practical Radiology 2025;41(8):1319-1323
Objective To investigate the value of multimodal model integrating digital mammography(MG)and MRI radiomics features for preoperative prediction of lymphovascular invasion(LVI)status in breast cancer.Methods The clinical and imaging data from 336 patients with pathologically confirmed invasive breast cancer were retrospectively analyzed and randomly divided into a training group(235 cases)and a test group(101 cases)according to the ratio of 7∶3.Feature dimensionality reduction was carried out by Pearson correlation analysis followed by least absolute shrinkage and selection operator(LASSO)regression.Radiomics models were constructed based on MG craniocaudal(CC),dynamic contrast enhancement(DCE),T2 WI,and integrated MRI sequences;a multimodal model was further developed by incorporating clinical high-risk factors.The predictive efficiency of each model was evaluated by plotting receiver operating characteristic(ROC)curve.Results The ROC curve analysis showed that the multimodal model performed the best predictive efficiency,with area under the curve(AUC)of 0.989 and 0.861,accuracy of 0.949 and 0.782,sensitivity of 0.923 and 0.828,and specificity of 0.962 and 0.764 in the training group and test group respectively.Conclusion The multimodal model,integrating MG and MRI radiomics features,show optimal performance and can be served as a preoperative prediction of LVI status in breast cancer.
4.Risk Factors for Early Recurrence of Solitary Hepatocellular Carcinoma After Radiofrequency Ablation Based on Gd-EOB-DTPA-Enhanced MRI
Qian XU ; Lan ZHANG ; Tingting HUANG ; Yu GAO ; Xiaoyang ZHAI ; Jiacheng ZHANG ; Xu HE ; Fukun SHI
Chinese Journal of Medical Imaging 2025;33(3):238-244,259
Purpose To investigate the independent risk factors for early recurrence of solitary hepatocellular carcinoma after radiofrequency ablation based on gadoxetic acid disodium(Gd-EOB-DTPA)-enhanced MRI combined with clinical features.Materials and Methods Clinical and imaging data of hepatocellular carcinoma patients who underwent radiofrequency ablation at the First Affiliated Hospital of Henan University of Chinese Medicine from January 2019 to June 2022 were retrospectively collected.All patients underwent preoperative Gd-EOB-DTPA-enhanced MRI and were followed up for up to two years post-surgery.Univariate and multivariate Cox proportional hazards regression were performed to identify independent risk factors for recurrence after radiofrequency ablation.Results A total of 58 patients were finally included,including early recurrence group(n=22)and non-early recurrence group(n=36).Multivariate Cox regression analysis revealed that preoperative alpha-fetoprotein(AFP)levels(HR=1.103,95%CI 1.008-1.206,P=0.033),arterial-phase irregular margin enhancement(HR=4.647,95%CI 1.527-14.110,P=0.007),peritumoral arterial-phase enhancement(HR=11.575,95%CI 3.575-37.478,P=0.001)and peritumoral hepatobiliary phase hypointensity(HR=5.058,95%CI 1.129-22.668,P=0.034)were independent risk factors for early recurrence.The area under the curve for AFP combined with arterial-phase irregular margin enhancement,peritumoral arterial-phase enhancement and peritumoral hepatobiliary phase hypointensity were 0.896,0.842 and 0.860,with accuracy rates of 81.0%,84.5%and 82.8%,respectively.Conclusion Preoperative serum AFP levels,arterial-phase irregular margin enhancement,peritumoral arterial-phase enhancement and peritumoral hepatobiliary phase hypointensity are independent risk factors for early recurrence after radiofrequency ablation in hepatocellular carcinoma patients.The combination of AFP and any of these MRI features significantly improves predictive efficacy.
5.Preoperative prediction of lymphovascular invasion in breast cancer based on multimodal radiomics model combining MRI and digital mammography
Ke MAO ; Xiaoyang ZHAI ; Yaning DONG ; Sijia CHENG ; Yaqi ZANG ; Fei JIA ; Dongming HAN
Journal of Practical Radiology 2025;41(8):1319-1323
Objective To investigate the value of multimodal model integrating digital mammography(MG)and MRI radiomics features for preoperative prediction of lymphovascular invasion(LVI)status in breast cancer.Methods The clinical and imaging data from 336 patients with pathologically confirmed invasive breast cancer were retrospectively analyzed and randomly divided into a training group(235 cases)and a test group(101 cases)according to the ratio of 7∶3.Feature dimensionality reduction was carried out by Pearson correlation analysis followed by least absolute shrinkage and selection operator(LASSO)regression.Radiomics models were constructed based on MG craniocaudal(CC),dynamic contrast enhancement(DCE),T2 WI,and integrated MRI sequences;a multimodal model was further developed by incorporating clinical high-risk factors.The predictive efficiency of each model was evaluated by plotting receiver operating characteristic(ROC)curve.Results The ROC curve analysis showed that the multimodal model performed the best predictive efficiency,with area under the curve(AUC)of 0.989 and 0.861,accuracy of 0.949 and 0.782,sensitivity of 0.923 and 0.828,and specificity of 0.962 and 0.764 in the training group and test group respectively.Conclusion The multimodal model,integrating MG and MRI radiomics features,show optimal performance and can be served as a preoperative prediction of LVI status in breast cancer.
6.Risk Factors for Early Recurrence of Solitary Hepatocellular Carcinoma After Radiofrequency Ablation Based on Gd-EOB-DTPA-Enhanced MRI
Qian XU ; Lan ZHANG ; Tingting HUANG ; Yu GAO ; Xiaoyang ZHAI ; Jiacheng ZHANG ; Xu HE ; Fukun SHI
Chinese Journal of Medical Imaging 2025;33(3):238-244,259
Purpose To investigate the independent risk factors for early recurrence of solitary hepatocellular carcinoma after radiofrequency ablation based on gadoxetic acid disodium(Gd-EOB-DTPA)-enhanced MRI combined with clinical features.Materials and Methods Clinical and imaging data of hepatocellular carcinoma patients who underwent radiofrequency ablation at the First Affiliated Hospital of Henan University of Chinese Medicine from January 2019 to June 2022 were retrospectively collected.All patients underwent preoperative Gd-EOB-DTPA-enhanced MRI and were followed up for up to two years post-surgery.Univariate and multivariate Cox proportional hazards regression were performed to identify independent risk factors for recurrence after radiofrequency ablation.Results A total of 58 patients were finally included,including early recurrence group(n=22)and non-early recurrence group(n=36).Multivariate Cox regression analysis revealed that preoperative alpha-fetoprotein(AFP)levels(HR=1.103,95%CI 1.008-1.206,P=0.033),arterial-phase irregular margin enhancement(HR=4.647,95%CI 1.527-14.110,P=0.007),peritumoral arterial-phase enhancement(HR=11.575,95%CI 3.575-37.478,P=0.001)and peritumoral hepatobiliary phase hypointensity(HR=5.058,95%CI 1.129-22.668,P=0.034)were independent risk factors for early recurrence.The area under the curve for AFP combined with arterial-phase irregular margin enhancement,peritumoral arterial-phase enhancement and peritumoral hepatobiliary phase hypointensity were 0.896,0.842 and 0.860,with accuracy rates of 81.0%,84.5%and 82.8%,respectively.Conclusion Preoperative serum AFP levels,arterial-phase irregular margin enhancement,peritumoral arterial-phase enhancement and peritumoral hepatobiliary phase hypointensity are independent risk factors for early recurrence after radiofrequency ablation in hepatocellular carcinoma patients.The combination of AFP and any of these MRI features significantly improves predictive efficacy.
7.Pituitary radiomics combined with MRI features for predicting growth hormone status in pediatric short stature
Fukun SHI ; Lan ZHANG ; Yu GAO ; Xiaoyang ZHAI ; Qian XU ; Jiaxu LIANG ; Shengli SHI ; Ling WU
Chinese Journal of Medical Imaging Technology 2025;41(7):1073-1078
Objective To observe the value of pituitary radiomics and MRI features combined model for predicting growth hormone(GH)status in pediatric short stature.Methods Totally 300 children with short stature were enrolled as training set,while other 73 cases were taken as external validation set.Based on growth hormone stimulation test,the children were divided into GH deficiency(GHD)group(n=228)and non-GHD group(n=145).The training set included 196 cases in GHD subgroup and 104 cases in non-GHD subgroup,while the validation set included 32 cases in GHD subgroup and 41 cases in non-GHD subgroup.Radiomics features of pituitary were extracted from T1WI.The key features were selected using least absolute shrinkage and selection operator(LASSO)regression,and machine learning models were subsequently constructed using support vector machine(SVM),logistic regression(LR),naive Bayes(NB)and K-nearest neighbor(KNN),respectively.Then combined models were constructed combining with MRI features,and the efficacy of each model was evaluated.Results The area under the curve(AUC)of SVM,LR,NB,and KNN radiomics model for predicting GH status in pediatric short stature was 0.860,0.831,0.838 and 0.901 in training set,0.788,0.829,0.823 and 0.770 in validation set,while of the relative combined SVM,LR,NB and KNN model was 0.924,0.903,0.859 and 0.920 in training set,and 0.827,0.881,0.836 and 0.718 in validation set.LRcombined model had the best overall performance,with sensitivity of 84.94%,specificity of 80.56%and accuracy of 83.61%in training set,and 80.95%,72.22%and 80.00%in validation set,respectively.Conclusion Pituitary radiomics and MRI features combined model could effectively predict GH status in pediatric short stature.
8.Bevacizumab in combination with pemetrexed and platinum for elderly patients with advanced non-squamous non-small-cell lung cancer: a retrospective analysis.
Yaru TIAN ; Hairong TIAN ; Xiaoyang ZHAI ; Hui ZHU ; Jinming YU
Frontiers of Medicine 2022;16(4):610-617
Bevacizumab, an anti-VEGF monoclonal antibody, has significantly improved the clinical outcomes of patients with advanced non-squamous NSCLC (ns-NSCLC). However, the safety and efficacy of bevacizumab for elderly patients with advanced NSCLC require further investigation. Thus, 59 patients were included in the present retrospective study, 22 patients in the bevacizumab plus pemetrexed and platinum (B + PP) group, and 37 patients in the pemetrexed and platinum (PP) group. For the entire cohort of patients, the median OS was 33.3 months, and the 1-year and 2-year overall survival rates were 88.5% and 67.8%, respectively. The median OS and 1-year and 2-year OS rates were 20.5 months, 70.3% and 0%, respectively, in the B + PP group and 33.4 months, 97.0% and 89.4%, respectively, in the PP group (P < 0.001). The incidence of grade ⩾ 3 adverse events was higher in the B + PP group than in the PP group (27.3% vs. 10.8%, respectively; P = 0.204). Univariate and multivariate analyses suggested that the receipt of ⩾ 5 cycles of first-line chemotherapy was an independent favorable prognostic factor for OS, whereas the addition of bevacizumab was an unfavorable prognostic factor. With increased toxicities, the addition of bevacizumab to PP does not improve the overall survival of elderly patients with advanced ns-NSCLC.
Aged
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Antineoplastic Combined Chemotherapy Protocols/adverse effects*
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Bevacizumab/adverse effects*
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Carcinoma, Non-Small-Cell Lung/drug therapy*
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Humans
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Lung Neoplasms/drug therapy*
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Pemetrexed/adverse effects*
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Platinum/therapeutic use*
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Retrospective Studies
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Treatment Outcome
9.Clinical impact of transjugular intrahepatic portosystemic shunt on refractory hepatic sinus obstruction syndrome caused by Gynura segetum
Rutao XU ; Kewei ZHANG ; Mingzhe CUI ; Weixiao LI ; Dongbin ZHANG ; Kai LIANG ; Xiaoyang FU ; Junping LIU ; Zhenhua JIANG ; Shuiting ZHAI
Chinese Journal of Hepatobiliary Surgery 2022;28(7):491-494
Objective:To study the treatment outcomes of transjugular intrahepatic portal shunt (TIPS) on refractory hepatic sinus obstruction syndrome (HSOS) caused by Gynura segetum.Methods:The clinical data of 15 patients with refractory HSOS caused by Gynura segetum treated at the Department of Vascular Surgery, Henan Provincial People's Hospital from January 2017 to April 2021 were retrospectively analyzed. There were 7 males and 8 females, with ages ranging from 30 to 85 years, mean ± s. d. (61.2±14.1) years. Albumin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, glutamyl transferase, and portal vein pressure were compared before and after TIPS. The liver function and renal function of these patients were followed up.Results:When compared with pre-operation, the albumin, alanine aminotransferase, aspartate aminotransferase and other indexes were significantly improved after TIPS (all P<0.05). The portal vein pressure of 15 patients significantly decreased from the preoperative volume of (41.7±3.5) cmH 2O (1 cmH 2O=0.098 kPa) to (28.3±4.4) cmH 2O ( t=10.41, P<0.001). The preoperative liver function was Child-Pugh grade A in 1 patient, grade B in 8 patients, grade C in 6 patients. The postoperative Child-Pugh grading was grade A in 14 patients and grade B in 1 patient. Ascites, gastrointestinal bleeding, abdominal pain, abdominal distention and spontaneous peritonitis all disappeared in these 15 patients. Postoperative hepatic encephalopathy developed in 2 patients and hepatic myelopathy in 1 patient. Conclusion:TIPS for treatment of HSOS caused by Gynura segetum resulted in a rapid recovery of liver function, rapid symptomatic relief, with a low incidence of hepatic encephalopathy/hepatic myelopathy.
10.Expert consensus of anti-tumor drugs prescription review: kidney cancer
Min LIU ; Wei MIAO ; Chao ZHANG ; Jie ZHANG ; Yuanyuan DAI ; Mei DONG ; Jiang LIU ; Hongbing HUANG ; Qing ZHAI ; Yuguo LIU ; Ting XU ; Ping HUANG ; Wenzhou ZHANG ; Gang JIANG ; Junling CAO ; Lixia WANG ; Yancai SUN ; Mingyan JIANG ; Yongning LYU ; Xiaoyang LU ; Maobai LIU ; Ningsheng LIANG ; Zhu DAI ; Yanqing SONG ; Pengmei LI ; Guangxuan LIU ; Zhiying HAO ; Dunwu YAO ; Guiru LI ; Shujia KONG ; Ruixiang XIE ; Jianhua WANG ; Qing WEI ; Lechuan JIA ; Mei LI ; Jun MENG ; Fang CAO ; Hongzhe SHI ; Dan YAN ; Zaixian BAI ; Chen WANG ; Guohui LI ; Jie HE
Adverse Drug Reactions Journal 2021;23(6):285-292
Kidney cancer usually requires multidisciplinary individualized treatments. No matter what kind of treatment, drugs are essential. According to the "six-step process" (prescription legitimacy review, patient basic information evaluation review, treatment protocol review, organ function and laboratory index review, pretreatment review, and unconventional prescription review) in prescription review proposed by the anti-tumor drug prescription review expert group and referring to domestic and foreign kidney cancer guidelines and drug instructions in recent years, this consensus selects 9 targeted drugs and 4 immunotherapeutic drugs that are currently commonly used in China and elaborates the key review points in patient basic information evaluation review, treatment protocol review, and organ function and laboratory index review of kidney cancer drug treatment, in order to provide reference for clinical front-line pharmacists to review prescriptions of kidney cancer patients and promote rational drug use in clinic.

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