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 construct an evaluation index system for rational drug use management of key monitoring drugs,and to provide references for medical institutions.Methods The preliminary index framework was formed by researching the policies and regulations,management norms,and guiding principles related to key monitoring drugs.Two rounds of Delphi questionnaire survey were conducted with 26 experts to improve and optimize the index system.The weights of the indicators were obtained by constructing the judgment matrix by analytic hierarchy process(AHP).Results The recovery rates of the two rounds of questionnaire were both 100％,and the authority coefficient was 0.87.The key monitoring drug rational use management evaluation index system was finally constructed to include three primary indicators[ex-ante management(0.253 6),in-process management(0.503 1),and ex-post management(0.243 2)],15 secondary indicators[including prescription review(0.302 6),formulate rational drug use norms(0.133 1),supernormal early warning management(0.103 2)],and 62 tertiary indicators[inclu-ding formulate strict prescription review rules(0.152 5),pharmacists prescription intervention strength(0.085 7)and effective-ness management(0.052 5)].and the index judgment matrix passed the consistency test.Conclusion The evaluation index system for the rational drug use management of key monitoring drugs constructed can satisfy the closed loop of the supervision and management process,achieve the prior reminder,monitoring,and post-supervision,and provide references for medical institutions to ensure the refinement and standardization of the management process.

Objective To investigate the factors affecting the exposure of polymyxin B and the correlation between pharmacokinetic/pharmacodynamic(PK/PD)indexes and efficacy in patients with multidrug-resistant Gram-negative bacterial(MDR-GNB)infections.Methods This prospective study was conducted in patients who received polymyxin B to treat MDR-GNB infections in the intensive care unit of Nanjing Drum Tower Hospital,Medical College,Nanjing University from January 2021 to December 2023.Plasma concentrations of polymyxin B were analyzed using a high-performance liquid chromatography-tandem mass spectrometry,and the influencing factors of exposure were investigated.The predictive value of area under the concentration-time curve(AUC24h)and AUC24hto minimum inhibitory concentration ratio for efficacy was determined by the receiver operating characteristic curve.Results The median of AUC24h was 76.11(56.06,96.94)μg·mL-1·h in 96 patients with MDR-GNB infections.Patients in the high-dose group(≥ 150 mg·d-1)were more likely to have higher exposure of polymyxin B than those in the low-dose group(＜150 mg·d-1)(P＜0.05).The exposure in patients with renal replacement therapy was significantly de-creased(P＜0.01).However,increasing the dose in patients receiving renal replacement therapy had no significant difference on exposure.The ROC curve showed AUC24h/MIC was closely correlated with clinical efficacy in patients with MDR-GNB infections(AUCROC=0.724,P＜0.01)and the optimal cut-off value of AUC24h/MIC was 62.1.Subgroup analysis showed that the optimal cut-off values of AUC24h/MIC in patients with and without pulmonary infection were 70.8 and 61.5,respectively.The clinical effi-cacy rate was significantly higher in AUC24 h/MIC≥62.1 group,compared with those in AUC24 h/MIC＜62.1 group(72.88％vs.32.43％,P＜0.01).After treatment,the decreasing trend of inflammation indicators in AUC24 h/MIC≥ 62.1 group was superior to those in AUC24h/MIC＜62.1 group.Conclusion The dose and renal replacement therapy are the significant factors influencing the exposure of polymyxin B.AUC24 h/MIC with the target of 62.1 was the optimal exposure index to predict the efficacy in the treatment of MDR-GNB infections and the optimal threshold of AUC24h/MIC was higher in patients with pulmonary infections than in non-pulmonary patients,so therapeutic drug monitoring is recommended to adjust the AUC24h/MIC index to achieve individual-ized medication.

Creutzfeldt-Jakob disease(CJD)is a rapidly progressive and fatal neurodegenerative disorder caused by prions,with certain infectivity and iatrogenic transmission risks.With the rapid progress and application of new dia-gnostic biomarkers and detection methods,as well as the construction and improvement of surveillance and reporting systems,the detection of CJD in patients domestically and internationally has shown an increasing trend year by year.Due to its long incubation period and heterogeneity of early symptoms,early identification and diagnosis of the disease is difficult,increasing the risk of transmission within medical institutions.Currently,there is a lack of con-sensus on the infection prevention and control of CJD.In order to timely identify and diagnose CJD as well as effec-tively block its transmission in medical institutions,this consensus summarizes 15 clinical concerns and formulates 24 specific recommendations based on the latest domestic and international research findings and clinical evidence,as well as combines with clinical practice,aiming to standardize healthcare-associated infection prevention and control measures for CJD and reduce its transmission risk in medical institutions.

Objective To analyze the literature on drug treatment pathways to sort out the development process,and to present the research status,hotspots,and trends.Methods Researches on drug treatment pathways were retrieved from the WoSCC,CNKI,Wanfang Database,and VIP Chinese Journal Database from the time of database establishment to October 312024.The CiteSpace 6.3.R1 and VOSviewer 1.6.20 were used to generate visual maps,including publications,countries,journals,institutions,authors,and keywords.Results A total of 150 papers were included,45 in Chinese and 105 in English.The number of Chinese and English research publications has increased significantly in the past five years.The United States has the largest number of publications in this field.There is relatively little cooperation among domestic research groups,but international cooperation is closer.In Chinese journals,research topics in this field mainly focus on the whole process from formulation to implementation of drug treatment pathways.Perioperative drug use,chronic drug use,and adjuvant drug use are research hotspots.In recent years,attention to clinical pharmacists and evidence-based pharmacy has increased.English journals mainly focus on cancer treatment-related research,with current research focusing on patient experience and social benefits.Conclusion Research in the field of drug treatment pathways in English journals is developing rapidly,but no core journal area has been formed specifically in this area.At present,the research on drug treatment pathways in Chinese journals is in its initial stage and is advancing rapidly,but the overall number is still relatively small,the research content and diseases involved are limited,and the research system is not perfect.Chinese researchers should pay attention to the research hotspot,broaden the research topic and further improve the quantity and quality of the research in this field.

This article analyzes the development and current status of clinical pathways(CPs)in the United States,the European Union,and Japan.CPs are standardized treatment models based on medical evidence and guidelines,aiming to improve therapeutic outcomes,reduce costs,ensure treatment consistency,enhance medical service efficiency,and increase patient satisfaction.The United States has promoted CPs since 1985,driving their development through legislation and professional associations to improve service quality and reduce medical expenditures.The European Union supports the development and evaluation of CPs through the European Pathway Association,emphasizing the improvement of patient treatment outcomes.Japan uses CPs as a tool to improve the quality of medical services,with an emphasis on multidisciplinary collaboration.All three have shown positive effects of CPs in improving medical service efficiency and reducing costs.However,they also face challenges such as overemphasis on cost control,lack of transparency,and physician cooperation.China can draw on these experiences to promote the development of CPs and enhance the quality and efficiency of medical services.

Objective To analyze the development and implementation of nutritional drug treatment pathways abroad,and to provide insights for the establishment of similar pathways in China.Methods A search was conducted in international literature and guideline databases for studies on nutritional therapy pathways up until December 1st,2024.The search focused on aspects such as pathway development methods,the composition of development teams,and implementation outcomes.Results A total of 29 relevant articles were identified,including 12 clinical practice guidelines and 17 research papers.The guidelines were all issued by the European Society for Clinical Nutrition and Metabolism,while the research papers showed significant heterogeneity,spanning multiple countries,regions,and medical conditions,primarily from developed countries in Europe and North America.The analysis reveals that nutritional therapy pathways typically include components such as nutritional assessment,formulation of nutritional plans,integration with other drug therapies,development of follow-up plans,pathway implementation teams,and the reassessment and updating of pathways.Conclusions China can benefit from the practices of developed countries,particularly those in Europe and North America.Key recommendations include the establishment of multidisciplinary teams,the promotion of a tiered treatment model,and the involvement of medical associations in forming expert groups to develop and implement nutritional drug treatment pathways,thereby enhancing the quality of nutritional treatment in China.

Objective To evaluate the suitability and accessibility of the national Class 1.1 new drug imrecoxib,and provided reference for rational use of drugs in clinical practice.Methods Constructing a suitability and accessibility evaluation system for the national Class 1.1 new drug imrecoxib based on the Delphi method and evaluated through a survey questionnaire.Results After two rounds of expert inquiries,the authority coefficient of the experts was 0.795,the coefficient of variation of the third level indicator of expert opinions was 0.15,and the coordination coefficient was 0.244.Finally,the evaluation index system for the suitability and accessibility of nonsteroidal anti-inflammatory drugs was determined.The evaluation index system including 2 primary indicators,8 secondary indicators,and 39 tertiary indicators.173 survey questionnaires were distributed in total.The results indicate that in terms of suitability,imrecoxib has good suitability in both drug use and drug technology characteristics;In terms of accessibility,the price level of imrecoxib is relatively low,and its affordability,accessibility,and patient acceptability are good.Conclusions This study comprehensively evaluated the suitability and accessibility of the national Class 1.1 new drug imrecoxib,provided a reference basis for clinical rational use and regulatory decision-making.

Objective In order to provide a better reference and basis for the selection of reasonable hypoglycemic drugs for clinical treatment,the study conducted a comprehensive clinical evaluation of the innovator sodium-glucose transporters 2(SGLT-2)inhibitors,based on A Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions(the Second Edition).Methods The real-world studies,randomized controlled trials,Meta-analysis/systematic review,drug clinical use guidelines,expert consensus and drug description evaluation evidence were collected,and the included drugs were assigned and evaluated from five dimensions:pharmaceutical characteristics,efficacy,safety,economy and other attributes.Results All SGLT-2 inhibitors had evaluation scores above 75,with dagaglifloztin tablets having the highest score of 84.6,and canaglifloztin having the lowest score of 75.1.Conclusions All five original SGLT-2 inhibitors showed good clinical utility,the difference is that the participating original drugs have different advantageous intervals in clinical use.The results show that dagliflozin has the most ideal clinical utility,and its clinical use should be safer and more effective.Due to the short time on the market and insufficient evidence-based reasons,the advantages of clinical use of proline hemegliflozin are not obvious compared with other evaluated drugs.

Objective To analyze the literature on drug treatment pathways to sort out the development process,and to present the research status,hotspots,and trends.Methods Researches on drug treatment pathways were retrieved from the WoSCC,CNKI,Wanfang Database,and VIP Chinese Journal Database from the time of database establishment to October 312024.The CiteSpace 6.3.R1 and VOSviewer 1.6.20 were used to generate visual maps,including publications,countries,journals,institutions,authors,and keywords.Results A total of 150 papers were included,45 in Chinese and 105 in English.The number of Chinese and English research publications has increased significantly in the past five years.The United States has the largest number of publications in this field.There is relatively little cooperation among domestic research groups,but international cooperation is closer.In Chinese journals,research topics in this field mainly focus on the whole process from formulation to implementation of drug treatment pathways.Perioperative drug use,chronic drug use,and adjuvant drug use are research hotspots.In recent years,attention to clinical pharmacists and evidence-based pharmacy has increased.English journals mainly focus on cancer treatment-related research,with current research focusing on patient experience and social benefits.Conclusion Research in the field of drug treatment pathways in English journals is developing rapidly,but no core journal area has been formed specifically in this area.At present,the research on drug treatment pathways in Chinese journals is in its initial stage and is advancing rapidly,but the overall number is still relatively small,the research content and diseases involved are limited,and the research system is not perfect.Chinese researchers should pay attention to the research hotspot,broaden the research topic and further improve the quantity and quality of the research in this field.