ObjectiveBased on ultra-performance liquid chromatography-quadrupole-electrostatic field orbitrap high resolution mass spectrometry（UPLC-Q-Orbitrap-MS）， the chemical constituents of Qili Qiangxin capsules was identified， and their distribution in vivo was analyzed. MethodsUPLC-Q-Orbitrap-MS was used to detect the sample solution of Qili Qiangxin capsules， as well as the serum， brain， heart， lung， spleen， liver and kidney tissues of mice after oral administration. Using the Thermo Xcalibur 2.2 software， the compound information database was constructed， and the molecular formulas of compounds corresponding to the quasi-molecular ions were fitted. Based on the information of retention time， accurate relative molecular mass and fragments， the compounds and their distribution in vivo were analyzed by comparing with the data of reference substances and literature. ResultsA total of 233 compounds， including 70 terpenoids， 60 flavonoids， 23 organic acids， 17 alkaloids， 20 steroids， 7 coumarins and 36 others， were identified or predicted from Qili Qiangxin capsules， 73 of which were identified matching with standard substances. Tissue distribution results showed that 71， 17， 38， 33， 32， 58 and 43 migrating components were detected in blood， brain， heart， lung， spleen， liver and kidney， respectively. Thirty-seven components were absorbed into the blood and heart， including quinic acid， benzoylaconitine benzoylmesaconine and so on. Fourteen components were absorbed into the blood and six tissues， including calycosin， methylnissolin， formononetin， alisol B， alisol A and so on. ConclusionThis study comprehensively analyzes the chemical components of Qili Qiangxin capsules and their distribution in vivo. Among them， astragaloside Ⅳ， salvianolic acid B， ginsenoside Rb₁， ginsenoside Rb₃， ginsenoside Rd， ginsenoside Rg₃， calycosin-7-glucoside， and sinapine may be the important components for the treatment of heart failure， which can provide useful reference for its quality control and research on pharmacodynamic material basis.

OBJECTIVE To assess the scientific rigor， clarity and feasibility of the recommendations of the Guidelines for Evidence-based Use of Biological Agents for the Clinical Treatment of Osteoporosis （hereinafter referred to as the Guideline） through external review， in order to further revise and improve the Guideline recommendations. METHODS This study employed a cross-sectional survey research design， a convenience sampling method was adopted to select frontline medical workers in the field of osteoporosis （including clinical doctors， clinical pharmacists， and nurses） as well as patients or their family members. External review was conducted through a combination of closed-ended and open-ended electronic questionnaires to get feedback from them on the appreciation，clarity and feasibility of the 32 preliminary recommendations in the Guideline. RESULTS A total of 90 external review subjects from 15 hospitals were collected， including 45 clinical doctors， 15 clinical pharmacists， 15 nurses and 15 patients or their family members. The overall appreciation degree of recommendations was 99.38%， the overall clarity degree of recommendations was 98.92%， and the overall feasibility degree of recommendations was 99.65%. At the same time， 111 subjective suggestions were collected， which provided an important reference for the further improvement of the Guideline recommendations. Based on the above feedback， the Guideline steering committee and core expert group revised the wording of 12 draft recommendations without deletion， and finally determined 32 recommendations. CONCLUSIONS The external review provides an important basis for the final formation of the Guideline， further improves the scientific rigor， clarity and feasibility of the recommendations， and ensures the standardization， practicality and implementability of the Guideline.

OBJECTIVE To standardize the main processes and related technical links of the clinical comprehensive evaluation of drugs， and provide guidance and reference for improving the quality of comprehensive evaluation evidence and its transformation and application value. METHODS The construction of Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs was based on the standard guideline formulation method of the World Health Organization （WHO）， strictly followed the latest definition of guidelines by the Institute of Medicine of the National Academy of Sciences of the United States， and conformed to the six major areas of the Guideline Research and Evaluation Tool Ⅱ. Delphi method was adopted to construct the research questions； research evidence was established by applying the research methods of evidence-based medicine. The evidence quality classification system of the Chinese Evidence-Based Medicine Center was adopted for evidence classification and evaluation. The recommendation strength was determined by the recommendation strength classification standard formulated by the Oxford University Evidence-Based Medicine Center， and the recommendation opinions were formed through the expert consensus method. RESULTS & CONCLUSIONS The Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs covers 4 major categories of research questions， including topic selection， evaluation implementation， evidence evaluation， and application and transformation of results. The formulation of this guideline has standardized the technical links of the entire process of clinical comprehensive evaluation of drugs， which can effectively guide the high-quality and high-efficient development of this work， enhance the standardized output and transformation application value of evaluation evidence， and provide high-quality evidence support for the scientific decision-making of health and the rationalization of clinical medication.

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 provide standardized guidance for the clinical application and management of biosimilars， and promote their widespread and rational use in clinical treatment. METHODS The design， planning， and drafting process as well as the full report of Evidence-based Guideline for the Management of Clinical Application of Biosimilars in China （2024 Edition） followed the WHO Handbook for Guideline Development （2nd edition）， which fully considered the best current evidence from evidence-based medicine， multidisciplinary expert experience， and patient preferences and values. Grading of Recommendations Assessment， Development， and Evaluation （GRADE） approach was adopted to evaluate the quality of evidence and determine the strength of recommendations. RESULTS & CONCLUSIONS Evidence-based Guideline for the Management of Clinical Application of Biosimilars in China （2024 Edition） presented 10 recommendations including 7 strong recommendations and 3 weak recommendations. The recommendations covered the entire process of clinical application and management of biosimilars. Medical institutions and relevant health regulatory departments can refer to this guideline for the scientific management of the extrapolation of unapproved indications of biosimilars. Healthcare providers can refer to this guideline for pre-treatment assessments， patient education， pre-treatment regimen before administration， and dosage regimen adjustments. Multidisciplinary medical teams can refer to this guideline to provide pharmacovigilance and patient management throughout the treatment process.

The pharmacy department of medical institutions assumes important responsibilities in the emergency response work.The standard of pharmacy administration in emergencies is formulated based on the principles of scientificity,versatility,instructiveness,and operability,through sorting out problems,collecting opinions and expert argumentation.This standard has 49 standards of 9 key elements from three aspects:emergency mechanism,emergency support,and emergency services.This article aims to introduce the construction method and formulation process of the pharmacy administration in emergency standards,and analyzes the content,to guide for improving emergency response ability of the medical institutions'pharmacy department in emergency events.

To improve patient-centered pharmaceutical management and pharmaceutical service capabilities in the pharmaceutical department of medical institutions,automation and information technology are indispensable.The Pharmacy Administration-Automation and Information Technology is one of the social organization standards of the Chinese Hospital Association as part 4-4 of Pharmaceutical Administration and Pharmaceutical Practice in Healthcare,which standardizes 32 key elements in four aspects:basic requirements for automation construction in medical institutions,construction of automation hardware equipment,construction of intelligent information platform,and quality management and continuous improvement.It can be used to guide medical institutions at all levels to select and optimize pharmacy automation equipment and information platforms.This article introduced the construction methods and contents of the pharmacy automation and information technology standards,to deepen the understanding of peers on this standard and promote its implementation.This article aimed to promote the modernization,informatization,and intelligence of pharmaceutical services in medical institutions,and improve the quality and efficiency of overall medical pharmaceutical administration and service.

Chemicals possessing reactive electrophiles can denature innate proteins leading to undesired toxicity, and the overdose-induced liver injury by drugs containing electrophiles has been one of the major causes of non-approval and withdraw by the US Food and Drug Administration (FDA). Elucidating the associated proteins could guide the future development of therapeutics to circumvent these drugs' toxicities, but was largely limited by the current probing tools due to the steric hindrance of chemical tags including the common "click chemistry" labels. Taking the widely used non-steroidal anti-inflammatory drug acetaminophen (APAP) as an example, we hereby designed and synthesized an APAP analogue using fluorine as a steric-free label. Cell toxicity studies indicated our analogue has similar activity to the parent drug. This analogue was applied to the mouse hepatocellular proteome together with the corresponding desthiobiotin-SH probe for subsequent fluorine-thiol displacement reactions (FTDRs). This set of probes has enabled the labeling and pull-down of hepatocellular target proteins of the APAP metabolite as validated by Western blotting. Our preliminary validation results supported the interaction of APAP with the thioredoxin protein, which is an important redox protein for normal liver function. These results demonstrated that our probes confer minimal steric perturbation and mimic the compounds of interest, allowing for global profiling of interacting proteins. The fluorine-thiol displacement probing system could emerge as a powerful tool to enable the investigation of drug-protein interactions in complex biological environments.

Objectives To describe the Epstein Barr virus (EBV) infection of children in Hefei, analyze its epidemiological characteristics, and explore the factors affecting EBV infection. Methods The children as the outpatient in the department of our hospital were recruited as the research subjects from June 2018 to June 2021. Epidemiological data of the research subjects were collected from medical records and the laboratory tests were performed to detect the related serological indicators of EBV. The distribution characteristics of different serological antibodies of EBV were described. According to the types of serological antibodies, all research subjects were divided into three states: primary infection, previous infection and non-infection. Logistics regression was used to analyze the factors affecting the infection status. Results There were 480 children in this study. The mean age and body mass index of all research subjects were 8.7±1.5 years and 20.78±3.2kg/m2, respectively. There were 276 boys(57.50%) and 204 girls(42.50%). 67 children(12.92%) were positive for VCA-IgM antibody. 326 children(67.92%) were positive for VCA-IgG antibody. 290 children(60.42%) were positive for NA-IgG antibody and 25 children(5.21%) were positive for EA-IgG antibody. There was no significant distribution difference of serological antibodies in gender, season of onset, disease duration, fever, angina and enlargement of lymph nodes. However, there were significant distribution differences of serological antibodies among different body mass index(χ²=50.207, P<0.001) and age(χ²=48.295, P<0.001). According to the types of serological antibodies, all research subjects were divided into three states. There were 78(16.25%) children with primary infection, 335(69.79%) with previous infection and 67(13.96%) with non-infection. Only age was the main factor affecting infection status by Logistic regression analysis(P_{primary infection vs. non-infection}<0.001, OR_{primary infection vs. non-infection}=0.580; P_{previous infection vs. non-infection}=0.038, OR_{previous infection vs. non-infection}=2.347). Conclusion The previous infection by EBV is the mainly infection type in children aged 6 to 12 year. The positive VCA-IgG antibody accounts for the most in previous infection. Age is the important influencing factor on EB infection. The younger the age, the higher the probability of primary infection. Besides, the positive VCA-IgM antibody is the main pattern of primary infection in children.

Objective:To investigate the clinical application value of radiochemotherapy conversion therapy in unresectable locally advanced esophageal cancer.Methods:A total of 298 patients with unresectable locally advanced esophageal cancer who received radiochemotherapy with or without surgery from 2010 to 2016 were screened in the U.S. Surveillance, Epidemiology, and End Results (SEER) 18 oncology database, and the patients were divided into the conversion therapy group (received surgery after radiotherapy, 83 cases) and the radiochemotherapy group (215 cases) according to whether they were operated after radiotherapy. A 1∶1 propensity matching analysis was conducted on the two groups of patients using R language. The information of age, gender, race, T stage, G stage, pathological type and N stage of the patients in the two groups before and after matching was compared. The Kaplan-Meier method was used for survival analysis to compare the cancer specific survival and overall survival (OS) between the two groups before and after matching. A multivariate Cox proportional hazards model was used to analyze the influencing factors of prognosis of patients with unresectable locally advanced esophageal cancer.Results:There were statistically significant differences in gender, race, G stage, pathological type, T stage, and N stage between the conversion therapy group and the radiochemotherapy group before matching (all P < 0.05). There was no statistically significant difference in clinicopathological characteristics between the conversion therapy group and the radiochemotherapy group after matching (all P > 0.05). Before matching, the median OS time of patients in the conversion therapy group was 23 months; the 1-year, 2-year, 3-year, and 5-year OS rates were 68.9%, 42.9%, 24.7%, and 19.8%, respectively; the 1-year, 2-year, 3-year, and 5-year cancer specific survival rates were 68.9%, 45.0%, 28.0%, and 28.0%, respectively. The median OS time of patients in the radiochemotherapy group was 12 months; the 1-year, 2-year, 3-year and 5-year OS rates were 44.5%, 20.5%, 14.0%, and 6.0%, respectively; the 1-year, 2-year, 3-year and 5-year cancer specific survival rates were 46.4%, 21.8%, 14.9%, and 9.1%, respectively. Compared with the radiochemotherapy group, patients in the conversion therapy group had a better cancer specific survival ( χ2 = 15.01, P = 0.001) and OS ( χ2 = 14.85, P < 0.001). After matching, cancer specific survival ( χ2 = 5.06, P = 0.024) and OS ( χ2 = 6.12, P = 0.013) of the conversion therapy group were still superior to the radiochemotherapy group. The results of multivariate Cox regression analysis showed that the cancer specific survival risk and overall survival risk in the radiochemotherapy group were 1.874 times (95% CI 1.275-2.755, P = 0.001) and 1.790 times (95% CI 1.235-2.593, P = 0.002) higher than those in the conversion therapy group. Conclusions:Radiochemotherapy conversion therapy can improve the prognosis of patients with unresectable locally advanced esophageal cancer.