The ethical review exemption system was introduced to meet the needs of modernized ethical governance， implement hierarchical management for ethical review projects involving human subjects， and explore an ethical management model that reduces procedural supervision for specific types of research involving no greater than minimal risk. Through a comparative study， this paper seeks to elaborate on the differences between China and the United States （US） in the ethical review exemption system from multiple aspects， such as ethical regulations， risk definition， preconditions， applicable scenarios， and operational procedures. The aim is to provide references for ethical review committees to better implement the ethical review exemption system， enhance policy research， and ensure the fairness and objectivity of ethical review. Through the comparative study of the ethics review exemption system in China and the US， the following recommendations are proposed for institutions implementing the ethical review exemption system for reference. First， the system should clearly define the meaning of ethical review exemption to prevent researchers or even committee members from misunderstanding it as falling outside the scope of ethical review， thereby exposing research participants’ rights and interests to unnecessary risks. Second， the system should specifically explain the preconditions， including the requirements for research types and research risks. Among them， risks should be considered from multiple dimensions such as physiology， psychology， society， and economy. Clear explanations should be provided for involving commercial interests and sensitive personal information. Finally， the system should establish basic principles and judgment criteria for applicable scenarios， including specifying exactly what the public data refers to and legal requirements that need to be met， providing a concept of anonymization to distinguish it from deidentified information data， and clarifying the relevant regulations and ethical principles to be followed， as well as the clear requirements for informed consent.

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.

OBJECTIVE To evaluate the performance of commonly used molecular biological identification methods in differential identification of Citrobacter freundii complex(Cfc)and find out the differences in the mass spectra among the prevalent species of Cfc so as to facilitate the rapid and accurate identification.METHODS Totally 150 clinical strains were isolated from The First Medical Center of Chinese PLA General Hospital from 2015 to 2020 and were identified as Cfc by means of matrix assisted laser desorption ionization-time-of-flight mass spectrometry(MALDI-TOF MS),the genome data were obtained by the next generation sequencing and were compared with reference genome of Citrobacter species from National Center of Biotechnology Information(NCBI)based on aver-age nucleotide identity(ANI),phylogenetic analyses of rec N gene,concatenated alignments of four housekeeping genes(fusA,pyrG,leuS and rpoB as well as gyrB,rplB,fusA and leuS),core genome single nucleotide poly-morphism(coreSNP)and whole genome(WG),digital DNA-DNA hybridization(dDDH)analysis,ribosomal multilocus sequence typing(rMLST)and typical(strain)genome service(TYGS)analysis.ANI was set as the'gold standard' for the identification of the Cfc strains,and the capabilities of the various methods were evaluated.A certain number of strains of Citrobacter freundii(Cfr),Citrobacter braakii(Cbr)and Citrobacter portucalen-sis(Cpo)were randomly selected to obtain and compare the mass spectra so as to find out the differences in the mass spectra.RESULTS The identification capability of the Cfc strains is limited based on the available database for MALDI-TOF MS,Cpo was prone to be misidentified as Cfr or Cbr.The mass spectrum between Cpo and Cfr ranged between 2600 and 2660 m/z,the mass spectrum between Cpo and Cbr ranged between 5200 and 5300 m/z,showing significant difference.The concatenated alignments of four housekeeping genes gyrB,rplB,fusA and leuS,CoreSNP and WG phylogenetic analysis had high accurate rate of identification.CONCLUSIONS The meth-ods have certain limitations in identification of Cfc.The joint application of ANI with the methods such as WG phylogenetic analysis,update of mass spectrum database and timely establishment of database can achieve the ac-curate identification of the species of Cfc.

Objective:To analyze the latent profiles of voice behavior among head nurses and to explore the influencing factors associated with different voice behavior categories.Methods:A convenience sampling method was used to recruit 527 head nurses from 104 medical institutions across 17 provinces in East, South, Central, North, Northwest, Southwest, and Northeast China between November 2023 and January 2024. Data were collected using a General Information Questionnaire, Voice Behavior Scale, Organizational Justice Scale, General Self-Efficacy Scale, and a Brief Personality Inventory. Latent profile analysis was conducted to identify subgroups of voice behavior, and multinomial Logistic regression was performed to explore influencing factors.Results:The score of head nurses' voice behavior was (45.84±6.88). Three latent profiles were identified: low-capacity fluctuating type, medium-capacity stable type, and high-capacity promoting type. Logistic regression analysis showed that openness personality trait, organizational justice, self-efficacy, and hospital grade were significant predictors of voice behavior profiles (all P<0.05) . Conclusions:The overall level of voice behavior among head nurses is above average, with evident heterogeneity. Nursing administrators should actively encourage voice behavior, provide timely feedback, and foster a fair organizational environment to promote a positive and constructive voice culture.

Bruton's tyrosine kinase inhibitors (BTKi) are a class of novel small-molecule targeted antitumor drugs used to treat B-cell malignancies. However, safety issues associated with BTKi may lead to treatment interruption, compromising their efficacy. To promote the standardized management of safety in BTKi treatment, Evidence-Based Pharmacy Professional Committee of the Chinese Pharmaceutical Association, Hospital Pharmacy Professional Committee of the Chinese Pharmaceutical Association, Division of Therapeutic Drug Monitoring of Chinese Pharmacological Society, Expert Committee on Lymphoma of Chinese Society of Clinical Oncology, Expert Committee on Leukemia of Chinese Society of Clinical Oncology, Integrated Cancer Cardiology Branch of China Anti-Cancer Association, Hematology Branch of the Chinese Medical Association, and Hospital Pharmacy Professional Committee of the Cross-Straits Medicine Exchange Association formulated the Evidence-based Expert Consensus on the Clinical Management of Safety of Bruton′s Tyrosine Kinase Inhibitors (2024), which was published in the Chinese Journal of Cancer Research in June 2024. It covered 9 clinical issues in the following 3 domains: (1) the management of common adverse reactions of BTKi such as bleeding, cardiovascular events, hematological toxicity, infections, rashes, diarrhea, and arthralgia; (2) the management of drug-drug interactions; (3) management guidance for special populations. This consensus provides evidence-based recommendations for the safety management of BTKi medication in clinical practice. This article provides an interpretation and evidence summary of the consensus in Chinese, aiming to facilitate its implementation in China, enhance the safety management of BTKi treatment, and improve patient outcomes.

To explore the cultivation path of excellent physicians in regional medical universities, a horizontal integration of clinical courses was performed to construct a curriculum centered on systemic diseases. Clinical courses adopted bedside rotation teaching with small class (30-40 students, 3-4 students/group). A comprehensive approach was designed and implemented, covering overall framework, organizational guarantee, teaching arrangement, teaching method, and assessment system. The effectiveness of the reform was evaluated through the comprehensive exams during the basic stage and national clinical medicine proficiency test. Despite no significant differences in the basic stage, the national clinical medicine proficiency test scores of the C2E class with teaching reform increased continuously from 2017 to 2020. The theoretical examination score of the C2E class was higher than that of regular classes 1 in 2017, 2019, and 2020. With continuous optimization, the skill examination score of the C2E class was significantly higher than that of regular class 1 in 2020. These findings highlight the effectiveness of the teaching reform and provide a foundation for the teaching reform of large class in five-year clinical medicine programs.

Objective To explore the value of the corrected-size ratio(c-SR)value of intracranial volume computed tomography angiography(CTA)in predicting the risk of intracranial aneurysm rupture.Methods A total of 81 patients with aneurysms who had follow-up records were selected.Among them,39 patients with unruptured aneurysms and underwent regular follow-ups,while 9 patients with unruptured aneurysms opted for surgical intervention.Additionally,surgery was performed on 33 patients with ruptured aneu-rysms.Three-dimensional reconstruction of CTA was performed to obtain the morphological parameters of aneurysms.The initial size ratio(SR)value of aneurysm and the follow-up SR value or postoperative c-SR value were obtained.The changes in SR values of unruptured aneurysms were analyzed,the preoperative SR values and postoperative c-SR values of aneurysms were analyzed.Finally,the correla-tion between the intial SR value of unruptured aneurysms and the c-SR value of ruptured aneurysms was compared.Results No sig-nificant difference was observed between the initial SR value of unruptured aneurysms and the follow-up SR value(P>0.05).Simi-larly,no significant difference was noted between the preoperative SR value of unruptured aneurysms and the postoperative c-SR value(P>0.05).The preoperative SR value of ruptured aneurysms differed significantly from the postoperative c-SR value(P<0.05).There was a significant difference between the initial SR value of unruptured aneurysms and the postoperative c-SR value of ruptured aneurysms(P<0.05).The receiver operating characteristic(ROC)curve analysis was performed on the initial SR value of unrup-tured aneurysms and the postoperative c-SR value of ruptured aneurysms.The area under the curve(AUC)was 0.860 and the best cut-off value was 1.045.Conclusion Unruptured aneurysms remain stable for an extended period of time,exhibiting no significant change in morphological parameters.It can be concluded that surgical intervention does not affect the SR value of aneurysms.In the case of subarachnoid hemorrhage caused by ruptured aneurysms,the parent artery become thinner,then the preoperative SR value of ruptured aneurysms may be exaggerated,which results in the distortion of the preoperative SR value of ruptured aneurysms.However,the postoperative c-SR value is the true SR value before the rup-ture of aneurysms.

Objective To explore the value of the corrected-size ratio(c-SR)value of intracranial volume computed tomography angiography(CTA)in predicting the risk of intracranial aneurysm rupture.Methods A total of 81 patients with aneurysms who had follow-up records were selected.Among them,39 patients with unruptured aneurysms and underwent regular follow-ups,while 9 patients with unruptured aneurysms opted for surgical intervention.Additionally,surgery was performed on 33 patients with ruptured aneu-rysms.Three-dimensional reconstruction of CTA was performed to obtain the morphological parameters of aneurysms.The initial size ratio(SR)value of aneurysm and the follow-up SR value or postoperative c-SR value were obtained.The changes in SR values of unruptured aneurysms were analyzed,the preoperative SR values and postoperative c-SR values of aneurysms were analyzed.Finally,the correla-tion between the intial SR value of unruptured aneurysms and the c-SR value of ruptured aneurysms was compared.Results No sig-nificant difference was observed between the initial SR value of unruptured aneurysms and the follow-up SR value(P>0.05).Simi-larly,no significant difference was noted between the preoperative SR value of unruptured aneurysms and the postoperative c-SR value(P>0.05).The preoperative SR value of ruptured aneurysms differed significantly from the postoperative c-SR value(P<0.05).There was a significant difference between the initial SR value of unruptured aneurysms and the postoperative c-SR value of ruptured aneurysms(P<0.05).The receiver operating characteristic(ROC)curve analysis was performed on the initial SR value of unrup-tured aneurysms and the postoperative c-SR value of ruptured aneurysms.The area under the curve(AUC)was 0.860 and the best cut-off value was 1.045.Conclusion Unruptured aneurysms remain stable for an extended period of time,exhibiting no significant change in morphological parameters.It can be concluded that surgical intervention does not affect the SR value of aneurysms.In the case of subarachnoid hemorrhage caused by ruptured aneurysms,the parent artery become thinner,then the preoperative SR value of ruptured aneurysms may be exaggerated,which results in the distortion of the preoperative SR value of ruptured aneurysms.However,the postoperative c-SR value is the true SR value before the rup-ture of aneurysms.

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.

The paper reports a 32-year-old female acute myeloid leukemia patient who developed graft-versus-host disease after paternal hematopoietic stem cell transplantation, which subsequently led to renal thrombotic microangiopathy. She subsequently required a kidney transplant from the same donor 5 years later due to renal failure. Considering that both the bone marrow and kidney were from the same donor and the recovery of renal function was favorable, immunosuppressive therapy was discontinued after a short course of anti-rejection treatment, with maintained stable kidney function. This case suggests that under the condition of high chimerism, allogeneic hematopoietic stem cell transplantation and kidney transplantation from the same donor can achieve immune tolerance, potentially improving solid organ transplantation success rate. The findings provide a novel therapeutic approach for solid organ transplantation following allogeneic hematopoietic stem cell transplantation.