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 ; Organ Transplantation ; Immunosuppressive Agents/administration & dosage* ; Delphi Technique

Objective:To compare the enrichment effects of ultrafiltration, polyethylene glycol (PEG) precipitation, aluminum salt precipitation, and anionic membrane adsorption-elution on viruses in drinking water.Methods:Using phage MS2 as the target virus, three different concentrations of drinking water samples were prepared, and the samples were enriched by ultrafiltration 1, ultrafiltration 2, PEG precipitation, aluminum salt precipitation, and anionic membrane adsorption-elution method, respectively. Real-time fluorescence quantitative reverse transcription-polymerase chain reaction (RT-qPCR) was used to quantify MS2 nucleic acid in pre and post concentrated samples and the recovery rates of MS2 in samples with high, medium and low concentrations were compared among the five methods.Results:Comparing the MS2 enrichment recovery rates of individual enrichment method in water samples of different concentrations, ultrafiltration method 1, PEG precipitation method, aluminum salt precipitation method, and membrane adsorption-elution method were not affected by the sample concentration, and the differences of the recovery rates for the three concentration water samples among the four methods were not statistically significant ( P>0.05). The MS2 enrichment recovery rates of the five enrichment methods were significantly different in all concentration samples ( P<0.05). The recovery rates of ultrafiltration method 1 were higher in all three concentration samples, followed by aluminum salt precipitation and anionic membrane adsorption-elution, PEG precipitation were higher in high concentration samples, but lower in low and medium concentration samples, and the recovery rates of ultrafiltration method 2 were the lowest in all three concentration samples. Comparing the Ct values of MS2 in the enriched samples by five methods, the Ct values of ultrafiltration method 1 were the smallest in the three concentration water samples. There was no statistically significant difference in MS2 Ct values among the five enrichment methods in the medium and high concentration water samples ( P>0.05). In low concentration simulated water samples, only the difference of MS2 Ct value between ultrafiltration method 1 and ultrafiltration method 2 was statistically significant ( Z=16.000, P=0.016). Conclusions:Considering the operation simplicity, operation time and virus recovery rate after enrichment, ultrafiltration was the most effective method for virus enrichment in drinking water.

INTRODUCTION: Lecanemab has shown promise in treating early Alzheimer's disease (AD), but its safety and efficacy in Chinese populations remain unexplored. This study aimed to evaluate the safety and 6-month clinical outcomes of lecanemab in Chinese patients with mild cognitive impairment (MCI) or mild AD. METHODS: In this single-arm, real-world study, participants with MCI due to AD or mild AD received biweekly intravenous lecanemab (10 mg/kg). The study was conducted at Hainan Branch, Ruijin Hospital Shanghai Jiao Tong University School of Medicine. Patient enrollment and baseline assessments commenced in November 2023. Safety assessments included monitoring for amyloid-related imaging abnormalities (ARIA) and other adverse events. Clinical and biomarker changes from baseline to 6 months were evaluated using cognitive scales (mini-mental state examination [MMSE], montreal cognitive assessment [MoCA], clinical dementia rating-sum of boxes [CDR-SB]), plasma biomarker analysis, and advanced neuroimaging. RESULTS: A total of 64 patients were enrolled in this ongoing real-world study. Safety analysis revealed predominantly mild adverse events, with infusion-related reactions (20.3%, 13/64) being the most common. Of these, 69.2% (9/13) occurred during the initial infusion and 84.6% (11/13) did not recur. ARIA-H (microhemorrhages/superficial siderosis) and ARIA-E (edema/effusion) were observed in 9.4% (6/64) and 3.1% (2/64) of participants, respectively, with only two symptomatic cases (one ARIA-E presenting with headache and one ARIA-H with visual disturbances). After 6 months of treatment, cognitive scores remained stable compared to baseline (MMSE: 22.33 ± 5.58 vs . 21.27 ± 4.30, P = 0.733; MoCA: 16.38 ± 6.67 vs . 15.90 ± 4.78, P = 0.785; CDR-SB: 2.30 ± 1.65 vs . 3.16 ± 1.72, P = 0.357), while significantly increasing plasma amyloid-β 42 (Aβ42) (+21.42%) and Aβ40 (+23.53%) levels compared to baseline. CONCLUSIONS: Lecanemab demonstrated a favorable safety profile in Chinese patients with early AD. Cognitive stability and biomarker changes over 6 months suggest potential efficacy, though high dropout rates and absence of a control group warrant cautious interpretation. These findings provide preliminary real-world evidence for lecanemab's use in China, supporting further investigation in larger controlled studies. REGISTRATION ClinicalTrials.gov , NCT07034222.
Humans ; Alzheimer Disease/drug therapy* ; Male ; Female ; Aged ; Middle Aged ; Cognitive Dysfunction/drug therapy* ; Aged, 80 and over ; Amyloid beta-Peptides/metabolism* ; Biomarkers ; East Asian People

Objective:To study the effect of preoperative pancreatic duct stent placement in enucleation (EN) of pancreatic tumor adjacent to the main pancreatic duct (MPD).Methods:Clinical data of 56 patients with benign or borderline pancreatic tumor adjacent to the MPD undergoing EN in the Department of Hepatobiliary Surgery of the Second Hospital of Hebei Medical University from January 2022 to September 2024 were retrospectively analyzed, including 25 males and 31 females, aged (32.0±5.5) years. Among the patients, 35 (62.5%) were solid pseudopapillary neoplasm, 15 (26.8%) were neuroendocrine tumor, and 6 (10.7%) were serous cystic tumor. According to whether the pancreatic duct stent was placed through encoscopic retrograde cholangiopancreatography preoperatively, patients were divided into the stent group ( n=20, observation group) and no-stent group ( n=36, control group). The operation time, intraoperative pancreatic duct injury, tumor enucleation time and blood loss, grade B/C pancreatic fistula and postoperative hospital stay were compared between the two groups. Results:All patients underwent EN successfully. The operation time in the observation group was shorter than that in the control group [150.0 (143.5, 159.0) vs 158.0 (150.0, 180.0) min, Z=-2.08, P=0.031], and the rate of intraoperative MPD injury in the observation group was lower than that in the control group [10.0% (2/20) vs 38.9% (14/36), χ2=5.26, P=0.022]. The tumor enucleation time and blood loss were comparable between the two groups (both P>0.05). The rate of postoperative grade B/C pancreatic fistula in the observation group was lower than that in the control group [15.0% (3/20) vs 41.7% (15/36), χ2=4.19, P=0.041], and the postoperative hospital stay was also shorter in the observation group [(7.9±1.6) vs (9.3±2.1) d, t=-2.57, P=0.014]. Conclusion:Under the premise of matured endoscopic operation, preoperative pancreatic duct stent placement through ERCP in the EN of pancreatic tumor adjacent to the MPD can protect the MPD during operation, reduce the occurrence of postoperative grade B/C pancreatic fistula, and shorten the postoperative hospital stay.

Objective:To develop a simple and effective subretinal injection pipeline system to enhance the accuracy and precision of subretinal injection volume control.Methods:A retrospective case series study. From May to October 2023, 18 patients (18 eyes) with submacular hemorrhage (SMH) who continuously received modified subretinal injection treatment in Department of Ophthalmology of Peking Union Medical College Hospital were included in the study. Among them, there were 10 males and 8 females. The mean age was (60.00±7.41) years. The primary causes included polypoid choroidal vasculopathy (14 cases), retinal macroaneurysm (2 cases), traumatic retinopathy (1 case), and Valsalva retinopathy (1 case). Hemorrhage affected 14 eyes of the fovea centralis. All affected eyes underwent standard three-channel 25G vitrectomy via the flat part of the ciliary body combined with modified subretinal injection of recombinant tissue plasminogen activator. The improved injection system consisted of a 1 ml syringe, a Q-Syte TM connector, a 41G subretinal microinjection needle, a converter and a viscoelastic substance control pipeline. The drug preparation time for subretinal injection (i.e., the time consumed by the system connection step), the injection time, whether bubbles occur during the injection process, and the perioperative complications were recorded and analyzed. Results:The preparation time prior to drug injection ranged from 230 to 335 seconds, while the injection completion time varied between 43 and 75 seconds. Both times decreased progressively as operator proficiency improved. Among the treated eyes, five received a target injection dose of 0.05 ml and thirteen received 0.10 ml, with all eyes achieving the preset dose accurately. No subretinal bubbles were observed during the injection procedure. Additionally, no intraoperative complications such as retinal hemorrhage or tear secondary to mechanical trauma at the injection site were recorded. Postoperatively, one eye developed anterior chamber hemorrhage, which resolved following intraocular pressure-lowering treatment. No other postoperative complications, including hemorrhage, rhegmatogenous retinal detachment, or infection, were observed in the remaining eyes.Conclusion:The retinal drug injection system developed in this study has a simple structure, safe and stable operation, can achieve precise drug injection, and effectively avoid the formation of bubbles.

Objective This study comprehensively analyzes the current implementation status and influencing factors of the"Administrative Measures for Surplus Drugs of Medical Institutions(Trial)"(referred to as the"Measures"),it helps solve the problems that have long plagued the management of surplus drugs in medical institutions.Methods Based on the framework of Health Policies Triangle,starting from the policy content,and from the perspectives of various actors,a questionnaire was designed from three dimensions:the current implementation status,the implementation effect,and the countermeasures suggestions.The management of surplus drugs in secondary and tertiary medical institutions throughout the province was investigated,then we will analyze the investigation results,evaluate the implementation effectiveness and influencing factors,and propose targeted suggestions.Results 84%of medical institutions have fully or partially implemented the measure,The implementation of the"Measures"has prevented hospitals from being subject to administrative penalties again due to surplus drugs,determined the disposal methods for surplus drugs,promoted the establishment of surplus drug management systems and directories by implementing hospitals,and clarified the varieties of surplus drugs in Shanxi Province.Conclusion The"Method"has significant implementation effects and clarified management provisions and filled the gaps in current management.The problems encountered include:The definition of surplus medicines limits the implementation of the"Measures"in secondary hospitals;The measures to reduce surplus drugs at the source have not been detailed;the awareness of the content of the"Measures"is insufficient;the collaboration among departments is lacking.It is suggested to revise and implement the"Measures"by clarifying the categories of drugs that can be charged by the unit and management rules in Shanxi Province,optimizing the definition of surplus drugs,clarifying the management regulations of each department,refining the informed consent method of patients,expanding the scope of special funds.In addition,the publicity efforts for"Measures"need to be strengthen,in order to further solve the problem of surplus drug management in medical institutions.

Objective:To investigate the risk factors of secondary primary cancer (SPC) after cervical cancer and to construct a nomogram model for predicting the prognosis.Methods:The data of 3 790 patients with primary cervical cancer from the 3rd edition of the International Classification of Diseases Oncology (ICD-O-3) number C53.9 between 2000 and 2020 in the Surveillance, Epidemiology and End Results (SEER) database were retrospectively analyzed, and SPC occurred in 2 036 cases out of 3 790 patients. Standardized incidence rate (SIR) of patients with cervical cancer was calculated by using SEER*Stat software; Cox proportional hazards model was used to make the univariate and multivariate analysis on the influencing factors of the overall survival (OS) in patients with SPC after cervical cancer. By using the "rms" package of R software, nomogram models for predicting 1-, 3-, and 5-year OS rates in SPC patients after cervical cancer were constructed based on prognostic independent influencing factors. The prediction efficacy and consistency of the model were verified by using the receiver operating characteristic (ROC) curve and the calibration curve.Results:The cervical cancer patients with the age of diagnosis of 20-34 years old (SIR: 1.76, 95% CI: 1.57-1.98), black race (SIR: 1.75, 95% CI: 1.61-1.90), the interval period of 2 primary tumors: 6-11 months (SIR: 1.69, 95% CI: 1.50-1.90), histologic grade Ⅳ (SIR: 1.62, 95% CI: 1 30-2.00), chemotherapy (SIR: 1.63, 95% CI: 1.56-1.71), radiotherapy (SIR: 1.59, 95% CI: 1.53-1.66), unmarried (SIR: 1.47, 95% CI: 1.41-1.54) had high SIR. Multivariate Cox regression analysis results of 2 036 SPC patients after cervical cancer showed that unmarried, SEER stage of regional lesion phase, distant metastasis phase and unknown, histologic grade of Ⅱ, Ⅲ, Ⅳ and the unknown, unknown lymph node dissection, other sites expert for lymphoma in SPC sites were independent risk factors of OS in SPC patients after cervical cancer (all P < 0.05); receiving surgery for SPC (compared to those not receiving surgery, HR = 0.38, 95% CI: 0.32-0.45, P = 0.001), radiotherapy (compared to those not receiving radiotherapy or unknown, HR = 0.66, 95% CI: 0.56-0.78, P = 0.001), and chemotherapy (compared to those not receiving chemotherapy or unknown, HR = 0.86, 95% CI:0.74-0.99, P = 0.034) were independent protective factors of OS in SPC patients after cervical cancer. The results of Kaplan-Meier survival analysis showed that the differences in the OS of SPC patients after cervical cancer with different marriage status, SEER stage, histologic grade, lymph node dissection, surgery for SPC, primary sites of SPC and whether receiving radiochemotherapy were all statistically significant (all P < 0.001). Based on the 8 variables including marital status, SEER stage, histologic grade, whether lymph nodes have been cleared, whether SPC has been treated with surgery, radiotherapy, chemotherapy, and the primary sites of SPC, a nomogram model for predicting the 1-, 3- and 5-year OS rates of SPC patients after cervical cancer was established. The results of ROC curve analysis showed that the area under the curve of the model for predicting 1-, 3-, and 5-year OS rates was 0.841, 0.847, and 0.847, respectively. The calibration curves showed a good consistency between the predicted results of model and the actual results. Conclusions:A prognostic prediction nomogram model for SPC after cervical cancer constructed based on the data in the SEER database has a high clinical application value and calibration.

Objective:To develop and validate a diagnostic model for pancreatic benign and malignant tumors using radiomics technology.Methods:A retrospective analysis was conducted on the clinical data of 113 patients with pancreatic tumors who underwent surgical treatment at the Hepatobiliary and Pancreatic Surgery Departments of the Second Hospital and the First Hospital of Hebei Medical University from January 2020 to December 2022. There were 59 male and 54 female patients, aged (55.3±16.8) years. Preoperative enhanced thin-slice computed tomography (CT) data and postoperative pathological diagnosis results were collected. Data from 74 patients at the Second Hospital were selected, and according to the random classification principle of 7∶3, the data of 52 patients were determined as the training set for model construction, while the remaining 22 patients' data served as the internal validation set. Data from 39 patients at the First Hospital of Hebei Medical University were used as the external validation set to assess the generali-zability of the established model. The region of interest in the lesions on CT images was analyzed using three-dimensional radiomics feature extraction, and the top 5 features were selected using feature selection methods. Radiomics models were established for the selected features using 17 classifiers. The performance of the models was evaluated using the area under curve (AUC) of the receiver operating characteristic (ROC).Results:Two hundred and fifty-five models were established with 15 feature selection methods and 17 classifiers. 7 models with the AUC greater than 0.7 were selected, among which the best one was LASSO-K neighbors classifier model, constructed using the LASSO feature selection method and the k-nearest neighbors algorithm, achieving AUC values of 0.933 (95% CI: 0.859-0.984) in the training set, 0.973 (95% CI: 0.896-1.000) in the validation set, and 0.774 (95% CI: 0.624-0.908) in the external validation set, with satisfactoryclassification and generalization ability. Conclusion:The radiomics-based diagnostic model for pancreatic benign and malignant tumors can effectively distinguish the benignancy and malignancy of tumors. The LASSO-K neighbors classifier model demonstrated high accuracy and reliability in this study.

Objective:To explore the safety and feasibility of laparoscopic pancreaticoduodenectomy (LPD) combined with portal vein system resection and reconstruction.Methods:The clinical data of 26 patients with pancreatic head cancer or distal bile duct malignant tumors who underwent reconstructive LPD combined with portal vein resection in the Department of Hepatobiliary Surgery of the Second Hospital of Hebei Medical University from January 2016 to December 2023 were retrospectively analyzed, including 13 males and 13 females, aged 63.0 (57.2, 66.0) years. The clinical data of the patients, including the operation time, intraoperative blood loss and blood transfusion, blood flow interruption time, postoperative complications, intensive care unit (ICU) admission time, and hospital stay were recorded.Results:All 26 patients had completed the operation successfully. The operation time was (483.65±118.00) min, the intraoperative blood loss was 1 100 (625, 2 750) ml, the intraoperative blood transfusion was 600 (438, 1 050) ml, and the portal vein system blockade time was (35.00±6.00) min. There were 5 cases (19.2%, 5/26) with laparotomy, 5 cases (19.2%%, 5/26) with repair after partial resection of the portal vein system, 12 cases (46.1%, 12/26) with end-to-end anastomosis of the portal venous system, and 9 cases (34.6%, 9/26) with artificial vascular replacement. There was 1 case of grade B pancreatic fistula (3.8%, 1/26), 3 cases of bile leakage (11.5%, 3/26), 1 case of gastric paralysis (3.8%, 1/26), 3 cases of intestinal obstruction (11.5%, 3/26), 2 cases of abdominal infection (7.7%, 2/26), 2 cases of postoperative bleeding (7.7%, 2/26), 1 case of secondary surgery (3.8%, 1/26), and 1 case of perioperative death (3.8%, 1/26). The postoperative hospital stay was 14.00 (12.00, 20.75) d, the ICU length of stay was 3.0 (1.0, 6.5) d, the tumor length diameter was 4.00 (3.00, 5.38) cm, and the number of positive lymph nodes was 1.0(0.5, 3.5).Conclusion:LPD reconstructed with portal system resection is a safe and effective treatment of patients with pancreatic head cancer or distal bile duct malignancy.

Objective This study comprehensively analyzes the current implementation status and influencing factors of the"Administrative Measures for Surplus Drugs of Medical Institutions(Trial)"(referred to as the"Measures"),it helps solve the problems that have long plagued the management of surplus drugs in medical institutions.Methods Based on the framework of Health Policies Triangle,starting from the policy content,and from the perspectives of various actors,a questionnaire was designed from three dimensions:the current implementation status,the implementation effect,and the countermeasures suggestions.The management of surplus drugs in secondary and tertiary medical institutions throughout the province was investigated,then we will analyze the investigation results,evaluate the implementation effectiveness and influencing factors,and propose targeted suggestions.Results 84%of medical institutions have fully or partially implemented the measure,The implementation of the"Measures"has prevented hospitals from being subject to administrative penalties again due to surplus drugs,determined the disposal methods for surplus drugs,promoted the establishment of surplus drug management systems and directories by implementing hospitals,and clarified the varieties of surplus drugs in Shanxi Province.Conclusion The"Method"has significant implementation effects and clarified management provisions and filled the gaps in current management.The problems encountered include:The definition of surplus medicines limits the implementation of the"Measures"in secondary hospitals;The measures to reduce surplus drugs at the source have not been detailed;the awareness of the content of the"Measures"is insufficient;the collaboration among departments is lacking.It is suggested to revise and implement the"Measures"by clarifying the categories of drugs that can be charged by the unit and management rules in Shanxi Province,optimizing the definition of surplus drugs,clarifying the management regulations of each department,refining the informed consent method of patients,expanding the scope of special funds.In addition,the publicity efforts for"Measures"need to be strengthen,in order to further solve the problem of surplus drug management in medical institutions.