1.Chaihu Guizhi Ganjiangtang and Its Single Active Ingredient in Treatment of Dyspepsia Caused by Chronic Cholecystitis: A Review
Wenwen YANG ; Yubei LU ; Lin CHEN ; Jing ZHANG ; Ying GAO ; Yajuan ZHANG ; Xiaoyan LI ; Jianfei YANG ; Xiaoli SHI ; Huanhuan LIN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(4):289-298
Chaihu Guizhi Ganjiangtang was first recorded in the Treatise on Cold Damage (Shang Han Lun). This prescription is composed of Bupleuri Radix, Scutellariae Radix, Cinnamomi Ramulus, Zingiberis Rhizoma, Trichosanthis Radix, Ostreae Concha, and Glycyrrhizae Radix et Rhizoma. It has the effects of soothing Lesser Yang, warming the spleen, and stimulating the generation of body fluid. It is mainly used to treat digestive tract diseases such as chronic cholecystitis (CC), irritable bowel syndrome, and non-alcoholic fatty liver disease. Dyspepsia caused by CC presents a variety of gastrointestinal symptoms such as abdominal pain, poor appetite, postprandial fullness, aversion to greasy food, soft stool, and bitter mouth, being a type of biliary dyspepsia. In modern medicine, dyspepsia caused by CC is mainly managed by medical treatment and surgical treatment. Internal medicine mainly focuses on reducing inflammation, promoting the function of gallbladder, resolving stones, alleviating spasms, and relieving the pain for CC, demonstrating definite short-term efficacy but suffering from single effects, high recurrence rate, and poor compliance. Although surgical treatment can cure cholecystitis, it is accompanied by the increased incidence of adverse events such as abdominal pain, diarrhea, and dyspepsia. Modern clinical studies have confirmed that Chaihu Guizhi Ganjiangtang can significantly alleviate the symptoms such as abdominal pain and dyspepsia of CC patients. Pharmacological studies have found that Chaihu Guizhi Ganjiangtang mainly contains active ingredients such as Bupleuri Radix saponins, baicalin, cinnamaldehyde, gingerol, Trichosanthis Radix polysaccharide, Ostreae Concha polysaccharide, and Glycyrrhizae Radix et Rhizoma total flavonoids. Chaihu Guizhi Ganjiangtang can ameliorate the symptoms of dyspepsia caused by CC by inhibiting inflammatory responses, improving gallbladder contraction and gastrointestinal motility, regulating the bile acid-intestinal flora axis and the brain-gut axis, and modulating blood lipids through multiple targets. By reviewing the previous literature, this article summarizes the research progress in the treatment of dyspepsia caused by CC with Chaihu Guizhi Ganjiangtang and its main active ingredients as well as the pathogenesis of this disease and puts forward the shortcomings and improvement strategies for the current research. The review aims to provide a reference for the further research on Chaihu Guizhi Ganjiangtang in the treatment of dyspepsia caused by CC.
2.Advances in the JAK2/STAT3 signaling pathway and its inhibitors in diffuse large B cell lymphoma
Chuanyang LU ; Qiuni CHEN ; Yuye SHI ; Yuan DENG ; Tingting JI ; Zhengyuan LIU ; Chunling WANG ; Liang YU
China Pharmacy 2026;37(5):682-688
Abnormal activation of the Janus kinase/signal transducer and activator of transcription (JAK/STAT) signaling pathway is involved in the pathogenesis of diffuse large B-cell lymphoma (DLBCL). In recent years, inhibitors targeting JAK2 and STAT3 have emerged as promising therapeutic candidates in DLBCL. This review summarizes the efficacy and safety profiles of JAK2 inhibitors (e.g., ruxolitinib) and STAT3 inhibitors (direct small-molecule inhibitors, the antisense oligonucleotide, and proteolysis targeting chimeras, etc.) in preclinical models and clinical trials. Accumulating evidence indicates that JAK2 and STAT3 inhibitors exhibit antitumor activity and are generally well tolerated in a subset of DLBCL patients. Meanwhile, the development of novel drug delivery systems has significantly enhanced the stability, bioavailability, and targeting ability of the compounds. Furthermore, JAK2 and STAT3 inhibitors may exhibit synergistic effects when combined with other therapy strategies (such as combinations with B-cell receptor signaling pathway inhibitors, immunomodulators, or other targeted drugs). However, current clinical applications are still in their early stages. Future research should concentrate on precision treatment strategies based on the genetic subtyping of DLBCL, and further refine the delivery systems for inhibitors as well as combination drug regimens to improve clinical outcomes.
3.Long-term survival outcomes and prognostic factors following radical resection of pancreatic body and tail cancer:a retrospective analysis of 992 patients
Dong XU ; Yang WU ; Kai ZHANG ; Nan LYU ; Qianqian WANG ; Pengfei WU ; Jie YIN ; Baobao CAI ; Guodong SHI ; Jianzhen LIN ; Yazhou WANG ; Lingdi YIN ; Zipeng LU ; Min TU ; Jianmin CHEN ; Feng GUO ; Jishu WEI ; Junli WU ; Wentao GAO ; Cuncai DAI ; Yi MIAO ; Kuirong JIANG
Chinese Journal of Surgery 2026;64(1):46-54
Objective:To investigate the survival outcomes and prognostic factors in patients undergoing radical resection for pancreatic body and tail cancer.Methods:A retrospective case series study was conducted on 992 patients who underwent radical resection for pancreatic body and tail cancer at the Pancreatic Center of the First Affiliated Hospital of Nanjing Medical University from January 2016 to June 2024. In this study, 577 (58.2%) were male and 415 (41.8%) were female,with an age of (65±9) years (range: 26 to 86 years). Follow-up continued until June 2024. Survival rates were estimated using the Kaplan-Meier method,and prognostic factors were identified using univariate and multivariate Cox proportional hazards models.Results:Among 992 patients,open surgery was the predominant approach (89.1%, 884/992), and radical antegrade modular pancreatosplenectomy (RAMPS) was performed in 317 patients (32.0%). Combined organ resection,venous resection,and arterial resection were performed in 23.5%, 9.3%,and 11.2% of patients,respectively. The rates of R0, R1-1 mm, and R1-direct resections were 49.8% (494/992),41.5% (412/992), and 8.7% (86/992),respectively. Stage ⅡB was the most common TNM stage (32.2%,319/992). A total of 801 patients (80.8%) received adjuvant chemotherapy. The median follow-up period was 32.0(8.8) months(range:3.2 to 105.3 months),during which 508 patients (51.2%) died. The overall median survival (OS) was 26.4 months,with 1-,3-, and 5-year survival rates of 79.0%,40.0%, and 29.0%, respectively. In the recent five years (from 2020 to 2024), the median OS improved significantly to 34.1 months compared to 20.0 months from 2016 to 2019 ( P<0.01). Histological subtype analysis showed that the median OS time was 26.7 months for pancreatic ductal adenocarcinoma (PDAC, n=855),58.9 months for invasive intraductal papillary mucinous carcinoma (IPMC, n=32),and 15.7 months for adenosquamous carcinoma of pancreas (ASCP, n=73) ( P=0.001). Among PDAC patients, adjuvant chemotherapy significantly improved survival (29.1 months vs. 14.4 months, P<0.01);in IPMC patients, adjuvant chemotherapy also extended survival (65.7 months vs. 58.9 months, P=0.047). Although ASCP patients receiving chemotherapy had a longer median OS time than those without (18.8 months vs. 8.9 months),the difference was not statistically significant ( P=0.151). Multivariate Cox regression analysis in PDAC patients indicated that adjuvant chemotherapy, R0 resection, T stage,N stage,and tumor differentiation were independent prognostic factors ( P<0.01). The median OS time by TNM stage was:not reached for stage ⅠA, 51.6 months for ⅠB, 25.5 months for ⅡA, 23.7 months for ⅡB, 23.0 months for Ⅲ, and 14.4 months for Ⅳ. The median OS time for R0,R1-1 mm,and R1-direct resections was 34.1,24.7,and 15.7 months,respectively ( P<0.01). Conclusion:Adjuvant chemotherapy,R0 resection,tumor stage,and differentiation are independent prognostic factors for pancreatic body and tail cancer.
4.Long-term survival outcomes and prognostic factors following radical resection of pancreatic body and tail cancer:a retrospective analysis of 992 patients
Dong XU ; Yang WU ; Kai ZHANG ; Nan LYU ; Qianqian WANG ; Pengfei WU ; Jie YIN ; Baobao CAI ; Guodong SHI ; Jianzhen LIN ; Yazhou WANG ; Lingdi YIN ; Zipeng LU ; Min TU ; Jianmin CHEN ; Feng GUO ; Jishu WEI ; Junli WU ; Wentao GAO ; Cuncai DAI ; Yi MIAO ; Kuirong JIANG
Chinese Journal of Surgery 2026;64(1):46-54
Objective:To investigate the survival outcomes and prognostic factors in patients undergoing radical resection for pancreatic body and tail cancer.Methods:A retrospective case series study was conducted on 992 patients who underwent radical resection for pancreatic body and tail cancer at the Pancreatic Center of the First Affiliated Hospital of Nanjing Medical University from January 2016 to June 2024. In this study, 577 (58.2%) were male and 415 (41.8%) were female,with an age of (65±9) years (range: 26 to 86 years). Follow-up continued until June 2024. Survival rates were estimated using the Kaplan-Meier method,and prognostic factors were identified using univariate and multivariate Cox proportional hazards models.Results:Among 992 patients,open surgery was the predominant approach (89.1%, 884/992), and radical antegrade modular pancreatosplenectomy (RAMPS) was performed in 317 patients (32.0%). Combined organ resection,venous resection,and arterial resection were performed in 23.5%, 9.3%,and 11.2% of patients,respectively. The rates of R0, R1-1 mm, and R1-direct resections were 49.8% (494/992),41.5% (412/992), and 8.7% (86/992),respectively. Stage ⅡB was the most common TNM stage (32.2%,319/992). A total of 801 patients (80.8%) received adjuvant chemotherapy. The median follow-up period was 32.0(8.8) months(range:3.2 to 105.3 months),during which 508 patients (51.2%) died. The overall median survival (OS) was 26.4 months,with 1-,3-, and 5-year survival rates of 79.0%,40.0%, and 29.0%, respectively. In the recent five years (from 2020 to 2024), the median OS improved significantly to 34.1 months compared to 20.0 months from 2016 to 2019 ( P<0.01). Histological subtype analysis showed that the median OS time was 26.7 months for pancreatic ductal adenocarcinoma (PDAC, n=855),58.9 months for invasive intraductal papillary mucinous carcinoma (IPMC, n=32),and 15.7 months for adenosquamous carcinoma of pancreas (ASCP, n=73) ( P=0.001). Among PDAC patients, adjuvant chemotherapy significantly improved survival (29.1 months vs. 14.4 months, P<0.01);in IPMC patients, adjuvant chemotherapy also extended survival (65.7 months vs. 58.9 months, P=0.047). Although ASCP patients receiving chemotherapy had a longer median OS time than those without (18.8 months vs. 8.9 months),the difference was not statistically significant ( P=0.151). Multivariate Cox regression analysis in PDAC patients indicated that adjuvant chemotherapy, R0 resection, T stage,N stage,and tumor differentiation were independent prognostic factors ( P<0.01). The median OS time by TNM stage was:not reached for stage ⅠA, 51.6 months for ⅠB, 25.5 months for ⅡA, 23.7 months for ⅡB, 23.0 months for Ⅲ, and 14.4 months for Ⅳ. The median OS time for R0,R1-1 mm,and R1-direct resections was 34.1,24.7,and 15.7 months,respectively ( P<0.01). Conclusion:Adjuvant chemotherapy,R0 resection,tumor stage,and differentiation are independent prognostic factors for pancreatic body and tail cancer.
5.Pre-operative risk assessment of hepatocellular carcinoma recurrence in liver transplant recipients by non-invasive detection of pre-existing genetic lesions
Suqin YANG ; Sunbin LING ; Jianhua LI ; Yan WANG ; Jiapei WANG ; Qiwei HUANG ; Fanming LIU ; Yiqi ZHUANG ; Yingyu ZHENG ; Rui WANG ; Zhe YANG ; Xiaoping ZHENG ; Kai WANG ; Zhikun LIU ; Jun CHEN ; Jianguo WANG ; Haiyang XIE ; Lin ZHOU ; Leiming CHEN ; Guoqiang CAO ; Dandan CHEN ; Junfang JI ; Bin ZHAO ; Chao JIANG ; Di LU ; Xuyong WEI ; Hangjin JIANG ; Qiaonan SHAN ; Hengbo SHI ; Yong-Zhen XU ; Shusen ZHENG ; Zhengxin WANG ; Shengda LIN ; Xiao XU
Clinical and Molecular Hepatology 2026;32(2):884-903
Background/Aims:
Liver transplantation (LT) following total hepatectomy is a life-saving treatment for hepatocellular carcinoma (HCC). The HCC recurrence after LT hinders the effectiveness of the procedure. The objective of this study is to develop a pre-operative risk stratification model based on a liquid biopsy.
Methods:
We conducted a comprehensive multi-omics study of 260 HCC patients from three centers, including clinical data, low-coverage whole-genome sequencing of cell-free DNA (cfDNA) from plasma, as well as whole-exome, single-nucleus RNA, and spatial transcriptomics from matched tumor and non-tumor tissues.
Results:
We identified cfDNA-derived copy number alteration (CNA) signatures associated with post-transplant recurrence. By integrating cfDNA-derived CNA profiles with single-cell transcriptomic data, we traced recurrence-associated cfDNA to a distinct subpopulation of malignant cells within the primary tumor. These cells were embedded in a pro-metastatic microenvironment of specialized endothelial subtypes and cancer-associated fibroblasts. Notably, most recurrence-associated lesions were detectable in cfDNA prior to liver transplantation (LT). Building on these insights, we developed the ZJU Criteria based on CNA fragments and tumor markers, a pre-LT risk prediction tool that integrates conventional clinical factors with cfDNA-derived CNA signatures, and validated it using internal and independent external cohorts.
Conclusion
Our findings suggest that post-transplant recurrence commonly originates from advanced subclones that emerge late during tumor evolution. The ZJU Criteria provides an accurate, non-invasive strategy that significantly improves pre-LT risk stratification and clinical decision-making for patients with HCC.
6.Mechanisms of Shuangshen Ningxin Capsules in Modulating NF-κB and MAPK Signaling Pathways to Reduce Cardiac Inflammation and Alleviate Myocardial Ischemia-reperfusion Injury in Rats
Shujuan XU ; Gaojie XIN ; Ce CAO ; Zixin LIU ; Yuanyuan CHEN ; Ran ZHAO ; Lu XING ; Yehao ZHANG ; Yue SHI ; Yanlei MA ; Jianhua FU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(23):83-91
ObjectiveTo investigate the effect and mechanism of Shuangshen Ningxin capsules (SSNX) in regulating the nuclear factor-κB (NF-κB) and mitogen-activated protein kinase (MAPK) pathways to inhibit inflammation and alleviate myocardial ischemia-reperfusion injury (MIRI) in rats. MethodsThe 45 healthy male Sprague-Dawley (SD) rats were divided into sham operation group, model group, and SSNX capsules group (90 mg·kg-1). The left anterior descending coronary artery was ligated to establish the MIRI model. Cardiac function was evaluated by echocardiography, and microvascular reperfusion was analyzed using contrast echocardiography. Myocardial inflammation and injury were assessed by hematoxylin and eosin (HE) staining, immunohistochemistry, and TdT-mediated dUTP nick end labeling (TUNEL). The expression levels of cardiac inflammatory cytokines, including interleukin-1α (IL-1α), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α) were detected by enzyme-linked immunosorbent assay (ELISA). Core differentially expressed genes (DEGs) and enriched pathways were screened by transcriptome sequencing. Real-time quantitative polymerase chain reaction (Real-time PCR) and Western blot were used to verify the mRNA expression of Toll-like receptor 2 (TLR2), chemokine (C-X-C motif) ligand 1 (CXCL1) and prostaglandin-endoperoxide synthase 2 (PTGS2), as well as the protein expression of Caspase-3, cleaved Caspase-3, p-NF-κB/NF-κB, phosphorylated extracellular signal-regulated kinase 1/2 (p-ERK1/2/ERK1/2) and p-p38 MAPK/p38 MAPK. ResultsCompared with the sham operation group, the ejection fraction (EF), fractional shortening (FS), stroke volume (SV) and cardiac output (CO) of the model group were significantly decreased (P<0.01), the peak time of myocardial perfusion was prolonged (P<0.01), hypoxia-inducible factor (HIF)-1α and α-smooth muscle actin (SMA) expression increased (P<0.01), the concentrations of inflammatory factors IL-1α, IL-6, TNF-α, TLR2, CXCL1 and PTGS2 increased (P<0.01), and the expression of cleaved Caspase-3, p-NF-κB/NF-κB, p-ERK1/2/ERK1/2 and p-p38 MAPK/p38 MAPK proteins was significantly increased (P<0.01). SSNX could improve cardiac function (P<0.05, P<0.01), and significantly shorten the peak time of myocardial perfusion (P<0.01). Moreover, it could also down-regulate HIF-1α and a-SMA expression (P<0.05, P<0.01), and reduce the concentrations of IL-1α, IL-6, TNF-α (P<0.01), and the mRNA expression of TLR2, CXCL1 and PTGS2 (P<0.01). Additionally, SSNX inhibited the apoptosis rate (P<0.01) and significantly reduced the expression of Cleaved Caspase-3, p-NF-κB/NF-κB, p-ERK1/2/ERK1/2 and p-p38 MAPK/p38 MAPK proteins (P<0.01). ConclusionSSNX can alleviate cardiac inflammation by regulating the NF-κB and MAPK signaling pathways, thereby effectively preventing and alleviating myocardial reperfusion injury.
7.Outcome after spleen-preserving distal pancreatectomy by Warshaw technique for pancreatic body cancer
Endi ZHOU ; Guodong SHI ; Hongyuan SHI ; Kai ZHANG ; Jishu WEI ; Min TU ; Zipeng LU ; Feng GUO ; Jianmin CHEN ; Kuirong JIANG ; Wentao GAO
Annals of Hepato-Biliary-Pancreatic Surgery 2025;29(2):177-186
Background:
s/Aims: Distal pancreatectomy with splenectomy (DPS) is a common surgical procedure for pancreatic body cancer.However, spleen-preserving distal pancreatectomy (SPDP) utilizing the Warshaw technique (WT) in malignancies is generally not favored due to concerns about inadequate resection. This study aims to assess the feasibility and oncologic outcomes of employing SPDP with WT in pancreatic body cancer.
Methods:
We conducted a retrospective analysis comparing 21 SPDP patients with 63 DPS patients matched by propensity score from January 2018 to November 2022. Clinical outcomes and follow-up data were analyzed using R.
Results:
Both groups exhibited similar demographic, intraoperative, and pathological characteristics, with the exception of a reduced number of total lymph nodes (p = 0.006) in the SPDP group. There were no significant differences in the rates of postoperative complications, recurrence, or metastasis. Local recurrence predominantly occurred in the central region as opposed to the spleen region.There were no cases of isolated recurrences in the splenic region. Median overall survival and recurrence-free survival times were 51.5 months for SPDP vs 30.5 months for DPS and 18.7 months vs 16.8 months, respectively (p > 0.05). The incidence of partial splenic infarction and left-side portal hypertension in the SPDP group was 28.6% (6/21) and 9.5% (2/21), respectively, without necessitating splenic abscess puncture, splenectomy, or causing bleeding from perigastric varices.
Conclusions
SPDP did not negatively impact local recurrence or survival rates in selected pancreatic body cancer patients. Further studies are necessary for validation.
8.Outcome after spleen-preserving distal pancreatectomy by Warshaw technique for pancreatic body cancer
Endi ZHOU ; Guodong SHI ; Hongyuan SHI ; Kai ZHANG ; Jishu WEI ; Min TU ; Zipeng LU ; Feng GUO ; Jianmin CHEN ; Kuirong JIANG ; Wentao GAO
Annals of Hepato-Biliary-Pancreatic Surgery 2025;29(2):177-186
Background:
s/Aims: Distal pancreatectomy with splenectomy (DPS) is a common surgical procedure for pancreatic body cancer.However, spleen-preserving distal pancreatectomy (SPDP) utilizing the Warshaw technique (WT) in malignancies is generally not favored due to concerns about inadequate resection. This study aims to assess the feasibility and oncologic outcomes of employing SPDP with WT in pancreatic body cancer.
Methods:
We conducted a retrospective analysis comparing 21 SPDP patients with 63 DPS patients matched by propensity score from January 2018 to November 2022. Clinical outcomes and follow-up data were analyzed using R.
Results:
Both groups exhibited similar demographic, intraoperative, and pathological characteristics, with the exception of a reduced number of total lymph nodes (p = 0.006) in the SPDP group. There were no significant differences in the rates of postoperative complications, recurrence, or metastasis. Local recurrence predominantly occurred in the central region as opposed to the spleen region.There were no cases of isolated recurrences in the splenic region. Median overall survival and recurrence-free survival times were 51.5 months for SPDP vs 30.5 months for DPS and 18.7 months vs 16.8 months, respectively (p > 0.05). The incidence of partial splenic infarction and left-side portal hypertension in the SPDP group was 28.6% (6/21) and 9.5% (2/21), respectively, without necessitating splenic abscess puncture, splenectomy, or causing bleeding from perigastric varices.
Conclusions
SPDP did not negatively impact local recurrence or survival rates in selected pancreatic body cancer patients. Further studies are necessary for validation.
9.Effect of Modified Shibaotang on Serum Sex Hormone Levels in Patients with Male Late-onset Hypogonadism of Kidney Essence Deficiency Syndrome Complicated with Diabetes Mellitus
Yi SHAN ; Shaokang CHEN ; Zhenfu SHI ; Haifeng XU ; Yi LU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(1):227-233
ObjectiveTo observe the effect of modified Shibaotang on serum sex hormone levels in patients with male late-onset hypogonadism of kidney essence deficiency syndrome complicated with diabetes mellitus. MethodsA total of 60 patients with male late-onset hypogonadism of kidney essence deficiency syndrome complicated with diabetes mellitus,who met the inclusion criteria and were admitted to Yinchuan Hospital of Traditional Chinese Medicine from October 2022 to October 2023,were selected and randomly divided into an observation group and a control group,with 30 patients in each group. Both groups continued their original treatments,including blood glucose lowering and blood lipid regulation. The observation group was treated with modified Shibaotang,while the control group was treated with testosterone undecanoate capsules. The treatment lasted for 12 weeks. The changes in traditional Chinese medicine (TCM)syndrome scores,partial androgen deficiency in aging males (PADAM)symptom scores,glucose metabolism indexes [fasting plasma glucose (FPG),2-hour postprandial glucose (2 h PG),glycosylated hemoglobin (HbA1c)],and serum sex hormone indexes [sex hormone-binding globulin (SHBG),free testosterone (FT),total testosterone (TT),prolactin (PRL),luteinizing hormone (LH),follicle stimulating hormone (FSH),estrogen (E2)] were compared between the two groups before and after treatment. Safety was also evaluated. Results(1)Clinical efficacy comparison:After treatment,the clinical efficacy in both groups was similar,and there was no statistically significant difference between the two groups. (2)TCM syndrome score and PADAM symptom score comparison:After treatment,both groups showed a significant reduction in TCM syndrome scores and PADAM symptom scores (P<0.01),and the observation group showed a significantly greater reduction compared to the control group (P<0.05). (3)Glucose metabolism indexes comparison:After treatment,the levels of FPG,2 h PG,and HbA1c were significantly reduced in both groups (P<0.01),and there was no statistically significant difference between the two groups regarding FPG,2 h PG,and HbA1c levels after treatment. (4)Serum sex hormone indexes comparison:After treatment,the levels of FT,TT,PRL,LH,and FSH were significantly increased in both groups (P<0.01),while E2 levels were significantly decreased (P<0.01). There was no statistically significant difference between the two groups in the levels of FT,TT,PRL,LH,FSH,and E2 after treatment. There was also no significant difference in SHBG levels within or between the groups before and after treatment. During the clinical observation,neither group exhibited any obvious adverse reactions. ConclusionModified Shibaotang can significantly improve the clinical symptoms of male late-onset hypogonadism of kidney essence deficiency syndrome complicated with diabetes mellitus,reduce blood glucose,and increase sex hormone levels. The mechanism may involve the inhibition of aromatase transformation in adipocytes,promotion of GnRH production,and regulation of the hypothalamic-pituitary-gonadal axis function.
10.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

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