1.Causal relationship between intestinal flora and esophageal cancer: A Mendelian randomization analysis
Mengmeng WANG ; Mingjun GAO ; Siding ZHOU ; Shuyu TIAN ; Yusheng SHU ; Xiaolin WANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(03):397-405
Objective To explore whether there is a causal relationship between intestinal flora and esophageal cancer. Methods Summary statistics of intestinal flora and esophageal cancer were obtained from the Genome-wide Association Studies (GWAS) database. Five methods, including inverse variance weighted (IVW), weighted median estimation, Mendelian randomization (MR)-Egger regression, single mode, and weighted mode, were used for analysis, with IVW as the main analysis method. Sensitivity analysis was used to evaluate the reliability of MR results. Results In the IVW method, Oxalobacteraceae [OR=1.001, 95%CI (1.000, 1.002), P=0.023], Faecalibacterium [OR=1.001, 95%CI (1.000, 1.002), P=0.028], Senegalimassilia [OR=1.002, 95%CI (1.000, 1.003), P=0.006] and Veillonella [OR=1.001, 95%CI (1.000, 1.002), P=0.018] were positively correlated with esophageal cancer, while Burkholderiales [OR=0.999, 95%CI (0.998, 1.000), P=0.002], Eubacterium oxidoreducens [OR=0.998, 95%CI (0.997, 0.999), P=0.038], Romboutsia [OR=0.999, 95%CI (0.998, 1.000), P=0.048] and Turicibacter [OR=0.998, 95%CI (0.997, 0.999), P=0.013] were negatively correlated with esophageal cancer. Sensitivity analysis showed no evidence of heterogeneity, horizontal pleiotropy and reverse causality. Conclusion Oxalobacteraceae, Faecalibacterium, Senegalimassilia and Veillonella increase the risk of esophageal cancer, while Burkholderiales, Eubacterium oxidoreducens, Romboutsia and Turicibacter decrease the risk of esophageal cancer. Further studies are needed to explore how these bacteria affect the progression of esophageal cancer.
2.Mechanism of Xixintang in Protecting Blood-brain Barrier in Alzheimer's Disease Model Rats Based on AQP4 Polarization
Siyuan JIA ; Yongchang DIWU ; Yuan TIAN ; Jie GAO ; Meirong WU ; Dengkun WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(9):1-10
ObjectiveThis paper aims to investigate the effects of Xixintang on aquaporin-4 (AQP4) polarity distribution, blood-brain barrier (BBB) function, and neuroinflammationin rats with Alzheimer's disease (AD), thereby revealing the potential mechanism through which this formula protects the BBB by regulating AQP4 polarization. The aim is to provide a scientific basis for clinical treatment. MethodsSixty Sprague-Dawley (SD) rats were randomly divided into a normal group, a model group, a probiotic group, a donepezil group, and an Xixintang group. The model was established by intraperitoneal injection of D-galactose (D-Gal) combined with bilateral intracerebroventricular injection of amyloid-β25-35 (Aβ25-35). The probiotic group (30.85 mg·kg-1), donepezil group (0.88 mg·kg-1), and Xixintang group (1.174 g·kg-1) received daily gavage administration, while the normal and model groups received intragastric administration with an equal volume of normal saline for one month. Cognitive ability was assessed by using the Morris water maze. BBB permeability was detected via Evans blue extravasation. The contents of interleukin-6 (IL-6), amyloid-β1-42 (Aβ1-42), and tumor necrosis factor-α (TNF-α) in the hippocampal tissues were measured by enzyme-linked immunosorbent assay (ELISA). The protein expressions of zonula occludens-1 (ZO-1), occludin, tissue inhibitor of metalloproteinase-1 (TIMP-1), matrix metalloproteinase-9 (MMP-9), and AQP4 in the hippocampal tissues were detected by western blot. The expression and co-localization levels of Aβ1-42, ionized calcium-binding adapter molecule 1 (IBA1), and AQP4/platelet endothelial cell adhesion molecule 31 (CD31) in the hippocampal region were examined by immunofluorescence. ResultsCompared with the normal group, the model group exhibited a significant decline in cognitive ability (P<0.01) and a marked increase in Evans blue extravasation in the brain (P<0.01). The expressions of ZO-1, occludin, and TIMP-1 were significantly decreased (P<0.01), while the expressions of AQP4 and MMP-9 were significantly increased (P<0.01). The co-localization level of AQP4/CD31 was significantly reduced (P<0.01), and the expressions of Aβ1-42, IL-6, TNF-α, and IBA1 were significantly elevated (P<0.01). Compared with the model group, the Xixintang group showed significant improvement in cognitive ability (P<0.01) and a significant reduction in Evans blue extravasation in the brain (P<0.01). The expressions of occludin, TIMP-1, and ZO-1 were significantly increased (P<0.05, P<0.01), while the expressions of AQP4 and MMP-9 were significantly decreased (P<0.05). The co-localization level of AQP4/CD31 was significantly enhanced (P<0.01), and the expressions of Aβ1-42, IL-6, TNF-α, and IBA1 were significantly reduced (P<0.05, P<0.01). ConclusionXixintang may improve cognitive function and alleviate AD pathology in AD model rats by regulating AQP4 polarity distribution, thereby breaking the vicious cycle of "Aβ deposition-neuroinflammation-BBB damage" and restoring the homeostasis of the microenvironment in the brain.
3.Analysis of related factors for the comorbidity of allergic rhinitis and obesity among primary and secondary school students in Inner Mongolia
Chinese Journal of School Health 2026;47(1):27-31
Objective:
To investigate the factors influencing the co-prevalence of allergic rhinitis and obesity among primary and secondary school students in Inner Mongolia, so as to provide a data foundation and theoretical basis for developing targeted intervention measures.
Methods:
In September and October 2024, a stratified cluster random sampling method was employed to select 139 102 students from 539 schools across 12 leagues/cities and 103 banners/counties in Inner Mongolia Autonomous Region. Participants who were diagnosed with allergic rhinitis by a doctor at least once within one year and had a body mass index ≥ 28 kg/m 2 were considered to have comorbid conditions.
Results:
The coprevalence rate of allergic rhinitis and obesity among primary and secondary school students in Inner Mongolia was 6.4% (8 931 cases). Lasso-Logistic regression revealed that nonboarding status, higher maternal education, consuming high protein foods ≥1 time daily, occasionally or never eating breakfast, engaging in moderate to vigorous physical activity for ≥60 minutes on fewer than half of holidays, and having been exposed to second hand smoke in person within the past seven days were associated with higher odds ratios for co-prevalence of allergic rhinitis and obesity( OR = 1.23 , 1.22-1.63, 1.20, 1.19, 1.38, 1.35); being female, higher grade level, residence in flag/county/district areas, non only child status, never having consumed a full glass of alcohol, non hypertensive status, and households without pets were associated with lower co-prevalence risks ( OR =0.65, 0.67-0.77, 0.81, 0.87, 0.73, 0.41, 0.68) (all P <0.05). The ROC curve indicated an area under the curve of 0.64 for the predictive model, demonstrating satisfactory discriminatory ability. The calibration curve showed consistency between predicted and actual occurrence probabilities.
Conclusions
The co-prevalence of allergic rhinitis and obesity among primary and secondary school students in Inner Mongolia is closely associated with demographic characteristics, dietary behaviours, and lifestyle habits. Future prevention and control strategies should prioritize these factors to implement targeted interventions.
4.Mechanisms of Jiangtang No. 3 Prescription in Alleviating Adipose Tissue Insulin Resistance in Diabetic Rats via TLR4/NF-κB/NLRP3 Signaling Pathway-mediated Inflammation
Tongxun WANG ; Lantian LIU ; Runqi LI ; Haoxiang LI ; Yi ZHAO ; Tian TIAN ; Rufeng MA ; Sihua GAO ; Dandan ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(4):109-117
ObjectiveTo observe the effects of Jiangtang No. 3 prescription on inflammatory pathways and insulin resistance-related indicators in rats with type 2 diabetes mellitus (T2DM), and to elucidate its molecular mechanism in combating diabetes. MethodsA T2DM rat model was established using a high-fat diet combined with intraperitoneal injection of streptozotocin (STZ). Successfully modeled rats were randomly assigned to the model group, metformin group, and low-, medium-, and high-dose Jiangtang No. 3 prescription groups, and a normal group was also set. Daily gavage was administered for 8 weeks as follows: metformin at 0.1 g·kg-1·d-1, Jiangtang No. 3 prescription granules at 1.62, 3.24, 6.48 g·kg-1·d-1 for the respective dose groups, and sterile water for the normal and model groups. Rat body weight, fasting blood glucose (FBG), oral glucose tolerance test (OGTT), and insulin tolerance test (ITT) were measured. After drug intervention, enzyme-linked immunosorbent assay (ELISA) was used to determine serum levels of total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL), high-density lipoprotein cholesterol (HDL), non-esterified fatty acids (NEFA), interleukin (IL)-1β, IL-18, and insulin (INS). Hematoxylin-eosin (HE) staining was used to observe morphological changes in adipose tissue. Real-time quantitative PCR was used to detect the mRNA expression of Toll-like receptor 4 (TLR4), nuclear factor-κB (NF-κB), NOD-like receptor protein 3 (NLRP3), Caspase-1, IL-1β, IL-18, and gasdermin D (GSDMD) in adipose tissue. Western blot was used to measure the corresponding protein expression levels. ResultsCompared with the model group, Jiangtang No. 3 prescription groups exhibited significantly increased body weight (P<0.05, P<0.01), significantly reduced FBG (P<0.05, P<0.01), significant reductions in TC, TG, NEFA, and LDL (P<0.05, P<0.01), and a significant increase in HDL (P<0.01). Serum levels of inflammatory mediators IL-1β and IL-18 were significantly decreased (P<0.01), the homeostatic model assessment of insulin resistance (HOMA-IR) index was significantly reduced (P<0.05, P<0.01), and adipose tissue pathology was improved. The protein expression levels of TLR4, NF-κB, NLRP3, Caspase-1, IL-1β, IL-18, and GSDMD were markedly decreased (P<0.05, P<0.01), and the mRNA expression levels of these indicators were also significantly downregulated (P<0.05, P<0.01). Some effects were superior to those of the positive control drug metformin, and certain indicators exhibited dose-dependent improvements. ConclusionT2DM rats display significant inflammatory responses, disordered glucose and lipid metabolism, and insulin resistance. Jiangtang No. 3 prescription effectively suppresses inflammatory mediators, improves glucose and lipid metabolism and insulin resistance, and ameliorates pathological changes in adipose tissue. Its mechanism may be related to the regulation of the TLR4/NF-κB/NLRP3 signaling pathway in visceral adipose tissue, thereby influencing downstream inflammatory mediators.
5.Application of optimized combination prediction model in the prediction of hand, foot and mouth disease
Weijie TIAN ; Qian GAO ; Kun YANG ; Zhirong ZHAO ; Jian CHEN
Journal of Public Health and Preventive Medicine 2026;37(1):58-62
Objective To explore scientific and accurate prediction methods for the incidence of hand, foot, and mouth disease in the post-pandemic era, and to address modeling challenges caused by abnormal fluctuations in case numbers from 2020 to 2023. Methods The seasonal index was used to pre-process the data. The traditional seasonal autoregressive integrated moving average (SARIMA) model, singular spectrum analysis (SSA)-ARIMA model, ARIMA-Long short-term memory (LSTM) model, and SSA-ARIMA-LSTM model were used to fit the incidence from 2013 to 2023, and the incidence of hand, foot and mouth disease in 2024 was predicted. The real data collected in 2024 were used as the test set to compare the prediction performance of the models. Results The fitting performance of the constructed models was as follows: the ARIMA model had MAE=107.50 and RMSE=144.53, the SSA-ARIMA model showed MAE=2.84 and RMSE=4.33, the ARIMA-LSTM model achieved MAE=99.46 and RMSE=131.59, and the SSA-ARIMA-LSTM model had MAE=96.35 and RMSE=132.13. In terms of prediction performance, the ARIMA model resulted in MAE=151.64 and RMSE=146.70, the SSA-ARIMA model demonstrated MAE=41.22 and RMSE=57.01, the ARIMA-LSTM model yielded MAE=220.75 and RMSE=257.89, and the SSA-ARIMA-LSTM model recorded MAE=58.83 and RMSE=72.06. Conclusion The SSA-ARIMA model has the best fitting degree and the highest prediction accuracy, and is suitable for predicting the incidence trend of hand, foot and mouth disease.
6.Effect of Xixintang on Colonic Mucosal Barrier and TLR4 /NF-κB p65 Signaling Pathway in AD Model Rats Induced by D-galactose Combined with Aβ25-35
Yuan TIAN ; Yongchang DIWU ; Siyuan JIA ; Jie GAO ; Meirong WU ; Dengkun WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(10):1-11
ObjectiveThis study aims to investigate whether Xixintang could ameliorate cognitive dysfunction in an Alzheimer's disease (AD) rat model induced by D-galactose and β-amyloid (Aβ25-35), by means of repairing the colonic mucosal barrier, regulating the Toll-like receptor 4 (TLR4)/nuclear factor-κB p65 (NF-κB p65) signaling pathway, and intervening in the pathological process mediated by the gut-brain axis. MethodsSixty specific pathogen-free (SPF) male Sprague-Dawley (SD) rats were randomly divided to five groups (n=12): A control group, a model group, a donepezil group, an Xixintang group, and a probiotic group. Except for those in the control group, rats in all other groups received daily intraperitoneal injections of D-galactose for six consecutive weeks. Subsequently, aggregated Aβ25-35 was injected stereotactically into the bilateral ventricles to establish the AD model. During the intervention periods, the rats in all groups were administered their respective drugs and normal saline by gavage. The Morris water maze test was used to assess the capacity for spatial learning and memory. Hematoxylin-eosin (HE) staining was employed to observe the histopathological changes in the colon tissues. Immunofluorescence was used to detect Aβ1-41 deposition in the hippocampal region and Mucin 2 (MUC2) expression in the colonic mucosa. Western blot was performed to measure the protein expression levels of FFAR2,TLR4, NF-κB p65, occludin (OCLN), zonula occludens-1 (ZO-1), and MUC2 in the colonic tissues. Enzyme-linked immunosorbent assay (ELISA) was used to determine the contents of interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), serum amyloid A (SAA), and Aβ1-42 in the hippocampal region from the colonic tissues. The lipopolysaccharide (LPS) concentrations in colon tissues of rats were measured by using a dynamic chromogenic limulus assay. ResultsCompared with those in the control group, the rats in the model group exhibited a significantly prolonged escape latency and a markedly shorter duration in the target quadrant (P<0.01). The integrity of the colonic mucosal structure was compromised, with disordered gland arrangement and a reduced number of goblet cells. The Aβ1-42 deposition in the hippocampal region was significantly increased (P<0.01). The protein expression levels of TLR4 and NF-κB p65 in colonic tissues were significantly upregulated (P<0.01), while those of occludin and ZO-1 were downregulated (P<0.01). The contents of inflammatory factors such as IL-6, TNF-α, and SAA were significantly elevated (P<0.01), and the LPS level in the serum was markedly increased (P<0.01). In comparison to those in the model group, the rats in the Xixintang group showed a significantly shortened escape latency and a prolonged duration in the target quadrant (P<0.01). The colonic mucosal structure was ameliorated, with neat gland arrangement and an increased number of goblet cells. The Aβ1-42 deposition in the hippocampal region was reduced (P<0.01). The protein expressions of TLR4 and NF-κB p65 in the colon tissues were decreased (P<0.05,P<0.01), while the protein levels of occludin and ZO-1 were increased (P<0.01). The contents of IL-6, TNF-α, and serum amyloid A (SAA) were decreased (P<0.01), and the LPS level was reduced (P<0.01). ConclusionXixintang can significantly ameliorate cognitive dysfunction of AD model rats, by means of restoring the colonic mucosal barrier structure, reducing cerebral Aβ deposition, and suppressing peripheral and central inflammatory response. Its mechanism of action may be closely associated with the suppression of the TLR4/NF-κB signaling pathway activation, reduction of endotoxin levels, and regulation of the gut-brain axis.
7.Effect of Xixintang on Colonic Mucosal Barrier and TLR4 /NF-κB p65 Signaling Pathway in AD Model Rats Induced by D-galactose Combined with Aβ25-35
Yuan TIAN ; Yongchang DIWU ; Siyuan JIA ; Jie GAO ; Meirong WU ; Dengkun WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(10):1-11
ObjectiveThis study aims to investigate whether Xixintang could ameliorate cognitive dysfunction in an Alzheimer's disease (AD) rat model induced by D-galactose and β-amyloid (Aβ25-35), by means of repairing the colonic mucosal barrier, regulating the Toll-like receptor 4 (TLR4)/nuclear factor-κB p65 (NF-κB p65) signaling pathway, and intervening in the pathological process mediated by the gut-brain axis. MethodsSixty specific pathogen-free (SPF) male Sprague-Dawley (SD) rats were randomly divided to five groups (n=12): A control group, a model group, a donepezil group, an Xixintang group, and a probiotic group. Except for those in the control group, rats in all other groups received daily intraperitoneal injections of D-galactose for six consecutive weeks. Subsequently, aggregated Aβ25-35 was injected stereotactically into the bilateral ventricles to establish the AD model. During the intervention periods, the rats in all groups were administered their respective drugs and normal saline by gavage. The Morris water maze test was used to assess the capacity for spatial learning and memory. Hematoxylin-eosin (HE) staining was employed to observe the histopathological changes in the colon tissues. Immunofluorescence was used to detect Aβ1-41 deposition in the hippocampal region and Mucin 2 (MUC2) expression in the colonic mucosa. Western blot was performed to measure the protein expression levels of FFAR2,TLR4, NF-κB p65, occludin (OCLN), zonula occludens-1 (ZO-1), and MUC2 in the colonic tissues. Enzyme-linked immunosorbent assay (ELISA) was used to determine the contents of interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), serum amyloid A (SAA), and Aβ1-42 in the hippocampal region from the colonic tissues. The lipopolysaccharide (LPS) concentrations in colon tissues of rats were measured by using a dynamic chromogenic limulus assay. ResultsCompared with those in the control group, the rats in the model group exhibited a significantly prolonged escape latency and a markedly shorter duration in the target quadrant (P<0.01). The integrity of the colonic mucosal structure was compromised, with disordered gland arrangement and a reduced number of goblet cells. The Aβ1-42 deposition in the hippocampal region was significantly increased (P<0.01). The protein expression levels of TLR4 and NF-κB p65 in colonic tissues were significantly upregulated (P<0.01), while those of occludin and ZO-1 were downregulated (P<0.01). The contents of inflammatory factors such as IL-6, TNF-α, and SAA were significantly elevated (P<0.01), and the LPS level in the serum was markedly increased (P<0.01). In comparison to those in the model group, the rats in the Xixintang group showed a significantly shortened escape latency and a prolonged duration in the target quadrant (P<0.01). The colonic mucosal structure was ameliorated, with neat gland arrangement and an increased number of goblet cells. The Aβ1-42 deposition in the hippocampal region was reduced (P<0.01). The protein expressions of TLR4 and NF-κB p65 in the colon tissues were decreased (P<0.05,P<0.01), while the protein levels of occludin and ZO-1 were increased (P<0.01). The contents of IL-6, TNF-α, and serum amyloid A (SAA) were decreased (P<0.01), and the LPS level was reduced (P<0.01). ConclusionXixintang can significantly ameliorate cognitive dysfunction of AD model rats, by means of restoring the colonic mucosal barrier structure, reducing cerebral Aβ deposition, and suppressing peripheral and central inflammatory response. Its mechanism of action may be closely associated with the suppression of the TLR4/NF-κB signaling pathway activation, reduction of endotoxin levels, and regulation of the gut-brain axis.
8.Comparison of clinical efficiency between neuroendoscope-assisted evacuation and navigation-assisted puncture in treating thalamic hemorrhage breaking into the ventricle
Yonghui HUANG ; Yang GAO ; Chen LI ; Puyuan ZHAO ; Tian HUAI ; Rujiang BAI ; Xuefu WANG
Chinese Journal of Clinical Medicine 2026;33(1):108-112
Objective To compare the clinical efficacy of neuroendoscope-assisted evacuation and navigation-assisted puncture drainage in treating thalamic hemorrhage breaking into the ventricle. Methods A retrospective analysis was conducted on the clinical data of 93 patients with thalamic hemorrhage breaking into the ventricle at Taihe Hospital of Wannan Medical College between January 2022 and February 2024. The patients received neuroendoscope-assisted removal of thalamic hematoma combined with contralateral extraventricular drainage (n=44, neuroendoscope group) and navigation-assisted thalamic hematoma puncture drainage combined with contralateral extraventricular drainage (n=49, navigation group), respectively. The treatment efficacy, surgical situation, and prognosis between the two groups were compared. Results The neuroendoscope group had longer operation duration, more intraoperative blood loss, higher hospitalization costs than the navigation group (P<0.05). The neuroendoscope group had higher hematoma clearance rate 3rd after surgery and shorter length of stay than the navigation group (P<0.05). There was no significant difference in the incidence of intracranial infection after surgery between the two groups. The neuroendoscope group had higher Glasgow coma scale (GCS) score at 1 week after surgery and Glasgow outcome scale (GOS) score at 3 months after surgery (P<0.01). Conclusions Compared with navigation-assisted puncture, neuroendoscope-assisted evacuation can improve the thalamic hemorrhage clearance rate, shorten the length of stay, and improve the prognosis of patients.
9.Analyses of T lymphocyte subset levels and viral loads in human immunodeficiency virus antibody-confirmed positive cases in Suzhou from 2021 to 2024
Runfang TIAN ; Qiang SHEN ; Xuerong YA ; Yue DAI ; Qian GAO
Shanghai Journal of Preventive Medicine 2026;38(3):210-215
ObjectiveTo investigate the T lymphocyte subset levels and viral loads in newly human immunodeficiency virus (HIV) antibody-confirmed positive cases in Suzhou (2021‒2024), and to analyze potential influencing factors by integrating their demographic characteristics, immune status, and viral replication patterns, thereby providing evidence for HIV/acquired immune deficiency syndrome (AIDS) prevention and control. MethodsPeripheral whole blood samples were collected from newly confirmed HIV-positive cases in Suzhou from 2021 to 2024. T lymphocyte subset analysis and viral load testing were performed, and influencing factors were identified in combination with demographic characteristics. Logistic regression models were employed to identify factors associated with CD4+T lymphocyte counts ≤350 cells·μL-1, and Spearman’s rank correlation test was used to analyze the correlation between logarithmic value of viral load and CD4+/CD8+ ratio. ResultsAmong the 3 022 confirmed HIV-positive samples, the median CD4+T lymphocyte count was 298.00 cells·μL-1, with 882 cases (29.19%) showing CD4+ T lymphocyte counts <200 cells·μL-1. The median CD8+T lymphocyte count was 1 011.00 cells·μL-1. The median CD4+/CD8+ ratio was 0.28, with 32.46% of cases exhibiting CD4+/CD8+ ratios <0.20, and there were statistically significant differences in CD4+/CD8+ ratio among different genders, age groups, marital status, and sample sources (all P<0.05). Multivariate logistic regression analyses indicated that individuals aged ≥20 years, those who were divorced or widowed, and cases identified through medical institutions had a significantly higher proportion of CD4+T lymphocyte counts ≤350 cells·µL⁻¹ compared to those aged <20 years, unmarried individuals, and cases sourced from voluntary counseling and testing (VCT) clinics, respectively. The mean logarithmic value of viral load was (4.29±1.15) copies·mL-1. The logarithmic value of viral load demonstrated a significantly negative correlation with both CD4+/CD8+ ratio (r=-0.43, P<0.001) and CD4+T lymphocyte count (r=-0.37, P<0.001). ConclusionA substantial proportion of newly diagnosed HIV/AIDS cases in Suzhou are late presenters with high viral load levels. Targeted interventions should prioritize high-risk populations through enhanced active surveillance and the implementation of combined T lymphocyte subsets analysis and viral load testing, which can enable earlier case-finding and timely antiretroviral therapy initiation.
10.Guidelines for the management of therapeutic drug monitoring
Zhengxiang LI ; Liyan MIAO ; Rong DUAN ; Xiaocong ZUO ; Xianglin ZHANG ; Zhuo WANG ; Miao YAN ; Lingli ZHANG ; Rongsheng ZHAO ; Suodi ZHAI ; Guobiao GAO ; Jinhui TIAN
China Pharmacy 2026;37(11):1381-1392
OBJECTIVE To further standardize the technical operations and management processes throughout therapeutic drug monitoring (TDM), clarify the clinical value of TDM implementation, improve the scientific validity and reliability of monitoring results, and provide a solid reference basis for the formulation and optimization of clinical individualized precision dosing regimens. METHODS The Guidelines for the Management of Therapeutic Drug Monitoring were formulated in accordance with the latest definition of guidelines by the Institute of Medicine of the National Academies and the standard guideline development methodology of the World Health Organization, and in compliance with the requirements of the appraisal of guidelines for research and evaluation. A modified Delphi method was adopted to establish the research question system; evidence-based medicine research methods were applied to systematically search multiple databases to screen the latest and most comprehensive evidence. Evidence was graded and evaluated based on the evidence grading system of the Chinese Evidence-Based Medicine Center, and the grading criteria for recommendation strength from the Oxford Centre for Evidence-Based Medicine were used to determine the recommendation strength. The recommendation opinions were formed through multidisciplinary expert consensus. RESULTS The Guidelines for the Management of Therapeutic Drug Monitoring cover four core modules, including TDM application indications, technical procedures, result interpretation and clinical application, and quality control, involving 18 primary research questions, 34 secondary research questions, and yield 82 recommendations. CONCLUSIONS The guidelines systematically standardize the key technical links and management requirements of the whole TDM process, provide scientific and operable standardized tools, help improve the standardization level of TDM work, promote the translation of monitoring results into clinical decision-making, and provide strong support for precision personalized medicine and ensuring the safety and rationality of medication use.


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