OBJECTIVE To systematically sort out the drugs causing drug-induced liver injury （DILI） and their relevant information， and to develop the Expert consensus on the medication catalog for drug-induced liver injury and rational drug use （hereinafter referred to as the Consensus）， so as to provide a reference for rational clinical use. METHODS Systematic searches were conducted across various literature databases， guideline retrieval websites and professional liver injury websites. Drugs identified as causing DILI from the included literature and online resources were extracted and assigned scores based on source credibility： three points for LiverTox A-class drugs and two points for B-class drugs； two points for drugs from Hepatox and guidelines； and one point for drugs from consensus and related literature sources. Drugs classified as LiverTox category A/B or with total scores ≥4 were included in the preliminary list of DILI-causing drugs. Opinions were collected and integrated from a multidisciplinary expert panel comprising 45 medical and pharmaceutical experts from 27 provinces across China through three rounds of the Delphi method （including questionnaires and discussion sessions）， and after revision， the final version of Consensus was formed. RESULTS & CONCLUSIONS This Consensus included 12 traditional Chinese medicines （TCMs） such as Polygoni Multiflori Radix and Ephedrae Herba， 151 Western medicines including amiodarone and atorvastatin， along with rational use information. For TCM， eight rational use information were included： evidence-based score， liver injury classification based on pathogenesis， liver injury classification based on biochemical abnormality pattern， clinical phenotype， laboratory examination manifestations， latency period， recovery time， and management strategies. For Western medicines， six additional items were included based on the TCM， namely liver function monitoring， discontinuation， contraindications， cautions， dose adjustments， and risk factors， totaling 14 items. This Consensus systematically compiles DILI drugs and their rational use information， which will support clinicians in enhancing the prevention， identification， and management of DILI， reducing the incidence of liver injury， and ensuring patient medication safety and efficacy.

Objective: To propose an improved method for constructing the internal quality control (IQC) framework for ELISA assays and validate its efficacy by statistically analyzing IQC data from nine blood center laboratories. Methods: 1) IQC data was collected from nine blood centers and analyzed using a domestic HBsAg ELISA detection kit as an example. 2) Differences between IQC values across batches within Blood Center 1 were assessed. 3) Statistical analyses were performed on batch usage, number of batches used, days of use, number of QC points, batch-specific means, and coefficients of variation (CV) across all nine centers. 4) Using the improved construction method for IQC framework, provisional and permanent frames were established for batches within Blood Center 1 and Blood Center 9, followed by outlier determination. Results: 1) Statistically significant differences were observed in IQC data between batches within Blood Center 1 (P<0.01). It is recommended that both the control material/reagents and the control chart framework be replaced simultaneously. 2) There were substantial differences among 9 blood centers regarding the control material/reagent lot numbers used, the number of QC runs per batch, and the QC values for identical lots. Therefore, individual laboratories should establish their own IQC chart frameworks. 3) The improved IQC framework construction method for ELISA assays is as follows: provisional frames are established via frame-shifting, using the pre-experimental mean and cumulative coefficient of variation (CV) from the preceding batch. For batches used >20 days with >20 QC points, permanent frames are constructed by aggregating in-control data accumulated over ≥20 days with ≥20 points to calculate cumulative mean and standard deviation. The provisional and permanent frames constructed by this method identified all 26 extreme outliers across Blood Centers 1 and 9 as out-of-control. Among the 218 general outliers, 10 were classified as normal by the provisional frames, while the remainder were designated as warnings or out-of-control. This method effectively monitors assay stability. Conclusion: Based on the statistical analysis of IQC practices across blood centers of varying scales, combined with the inherent characteristics of ELISA assays and the batch-to-batch instability of reagents/QC materials, it is recommended to reconstruct QC charts upon lot changes. The proposed method—utilizing frame-shifting for provisional frames and establishing permanent frames based on cumulative data—is applicable to blood center laboratories of differing sizes and effectively monitors the stability of the ELISA assay process.

Myasthenia gravis is an autoimmune disorder characterized by impaired neuromuscular transmission. Thymectomy is one of the therapeutic options for acetylcholine receptor antibody-positive myasthenia gravis patients. The quality of perioperative care is directly associated with surgical safety and patient outcomes. However, there is currently a lack of specialized nursing consensus or guidelines specifically addressing the care of these patients domestically or internationally. To promote the standardization and normalization of perioperative nursing care for myasthenia gravis patients undergoing thymectomy and to ensure treatment efficacy, a panel of 57 experts from relevant fields was convened. Based on evidence-based medicine and clinical practice experience, discussions were held on various aspects including condition assessment, nutritional support, medication management, and airway care, resulting in a consensus with 18 final recommendations by using the Delphi method through two rounds of expert consultation. This consensus aims to provide a scientific reference for the perioperative nursing care of myasthenia gravis patients undergoing thymectomy.

OBJECTIVE To know about the perception and current status of drug risk management among pharmacists in Chinese medical institutions， providing insights and recommendations for enhancing the drug risk management system in medical institutions. METHODS A questionnaire survey was conducted across 28 provinces， cities， and autonomous regions； stratified radom sampling was employed to study the population of medical workers and pharmaceutical professionals in medical institutions nationwide. The survey included information on the survey population， the current status of drug risk management implementation in medical institutions， the cognition， definition and process of drug risk management related concepts， and the content and mode of drug risk management work in medical institutions. Finally， suggestions were collected from various medical institutions on the system construction of drug risk management. Descriptive statistical analysis was adopted to summarize the obtained data. RESULTS A total of 446 questionnaires were collected in this survey， including 420 valid questionnaires and 26 invalid questionnaires. The questionnaire collection rate was 100%，and the effective rate was 94.17%. 51.19% of the respondents No.2020YFC2009001）。 based their understanding of drug risk management on Management Measures for Adverse Drug Reaction Reports and Monitoring， while 87.38% recognized the need for drug risk management throughout the drug use process. 63.33% of the participants stated that their medical institutions had dedicated positions related to drug risk management， with the highest proportion （72.17%） was in third-grade class A medical institutions. 66.43% reported implementing risk management across all drug use stages. Suggestions for the development of drug risk management systems in medical institutions by the research participants focused on enhancing guiding documents， clarifying concepts， establishing information-sharing mechanisms. CONCLUSIONS The overall awareness of drug risk management in China’s medical institutions is high， with practices in place across various stages in multiple forms. However， there remains a need to strengthen institutional documents， management regulations， system development， and information-sharing mechanisms to improve collaborative governance， improve drug management levels， and ensure patient safety.

ObjectiveTo analyse the implementation of mutual recognition of ethical review in a tertiary hospital， providing ideas for exploring ethical review of multicenter studies. MethodsThe ethical review of multicenter studies conducted by the hospital from 2018 to 2022 was analyzed. ResultsA total of 1，582 projects were reviewed in the hospital from 2018 to 2022， of which 773 （48.9%） were multicentre studies. In multicenter study projects， 70.4% of the studies were conducted as a participating unit. Mutual recognition of ethical review and fast review were implemented for all participating projects. After a rapid review of 24 studies， the presiding committee recommended submitting them for conference review. The reasons for the transfer to conference review included issues with the study protocol （11 projects）， informed consent （12 projects）， and other supporting documents （5 projects）. Twenty-one studies were eventually approved by the ethics committee after modification， and 3 studies were not approved by the ethics committee because the sponsor refused to modify the study protocols. ConclusionFor participating in multicentre studies， the ethics committees of participating units implement mutual recognition of ethical reviews and adopt a rapid review approach to review all study data， which can achieve both quality and efficiency.

OBJECTIVE To enhance the training quality of anticoagulation specialty clinical pharmacists， address the resource limitations of a single training base， and promote homogenization of training quality. METHODS A multi-base joint training system for anticoagulation specialty clinical pharmacists in the Beijing area was established. A mixed research method was employed， collecting data through performance comparisons， questionnaires， and qualitative interviews to compare the differences between the joint training model （experimental group， n＝16） and traditional teaching model （the control group， n＝17）. RESULTS The established joint training system encompassed a unified joint training teaching plan， the formation of a joint training teaching team， the establishment of joint theoretical teaching courses， the implementation of joint case discussions and literature presentations， as well as strengthening the assessment throughout the joint training process. Compared to the control group [theoretical assessment of （76.44±3.66） points， case assessment of （84.31±3.27） points]， the experimental group students achieved higher scores in theoretical assessment （[ 79.85±4.64） points] and case assessment （[ 88.70±5.51） points] （P＜0.05）. Through questionnaires and qualitative interviews， the trainees in experimental group were highly satisfied with the joint training model in terms of theoretical learning， communication skills， and teaching interaction. CONCLUSIONS The multi-base collaborative training system for anticoagulation specialty clinical pharmacists can integrate advantageous resources and significantly enhance the training effectiveness of anticoagulation specialty clinical pharmacists， offering value for wider promotion.

Objective: To comprehensively evaluate the current alanine aminotransferase (ALT) screening strategies and provide a basis for their optimization. Methods: ALT test results of 21 345 blood samples were collected from 33 blood collection institutions. Multiple probability distribution functions were employed to fit the data, and the akaike information criterion (AIC) was used to determine the optimal fitting model. Based on this model, 1 million random samplings were conducted to simulate the final ALT test results of blood donors under different ALT screening strategies, eligibility criteria, and pre-donation ALT detection deviations. A decision tree was subsequently constructed for health economic analysis. Results: The log-normal distribution with a mean of 2.96 and a variance of 0.65 provided the best fit for the data. When the eligibility criteria was 50 U/L and the pre-donation detection deviation was ±20%, not conducting pre-donation testing increased blood donation by 1.14%. When the pre-donation detection deviation was ±20% and the eligibility criteria was raised from 50 U/L to 100 U/L, conducting and not conducting pre-donation testing increased blood donation by 7.59% and 6.60%, respectively. With a eligibility criteria of 50 U/L and a pre-donation detection deviation of ±20%, 1.14% of eligible blood donors would be disqualified from donating blood. Health economic analysis showed that when the eligibility criteria was adjusted to 56 U/L or higher, not conducting pre-donation ALT testing was the dominant strategy; under other conditions, conducting pre-donation testing was the dominant strategy. Conclusion: The selection of ALT testing strategies is a complex process influenced by multiple factors, and it is necessary to adopt an appropriate ALT screening strategy based on specific testing circumstances.

BACKGROUND: This study aimed to investigate programmed death-ligand 1 tumor proportion score in predicting the safety and efficacy of PD-1/PD-L1 antibody-based therapy in treating patients with advanced non-small cell lung cancer (NSCLC) in a real-world setting. METHODS: This retrospective, multicenter, observational study enrolled adult patients who received PD-1/PD-L1 antibody-based therapy in China and met the following criteria: (1) had pathologically confirmed, unresectable stage III-IV NSCLC; (2) had a baseline PD-L1 tumor proportion score (TPS); and (3) had confirmed efficacy evaluation results after PD-1/PD-L1 treatment. Logistic regression, Kaplan-Meier analysis, and Cox regression were used to assess the progression-free survival (PFS), overall survival (OS), and immune-related adverse events (irAEs) as appropriate. RESULTS: A total of 409 patients, 65.0% ( n = 266) with a positive PD-L1 TPS (≥1%) and 32.8% ( n = 134) with PD-L1 TPS ≥50%, were included in this study. Cox regression confirmed that patients with a PD-L1 TPS ≥1% had significantly improved PFS (hazard ratio [HR] 0.747, 95% confidence interval [CI] 0.573-0.975, P = 0.032). A total of 160 (39.1%) patients experienced 206 irAEs, and 27 (6.6%) patients experienced 31 grade 3-5 irAEs. The organs most frequently associated with irAEs were the skin (52/409, 12.7%), thyroid (40/409, 9.8%), and lung (34/409, 8.3%). Multivariate logistic regression revealed that a PD-L1 TPS ≥1% (odds ratio [OR] 1.713, 95% CI 1.054-2.784, P = 0.030) was an independent risk factor for irAEs. Other risk factors for irAEs included pretreatment absolute lymphocyte count >2.5 × 10 9 /L (OR 3.772, 95% CI 1.377-10.329, P = 0.010) and pretreatment absolute eosinophil count >0.2 × 10 9 /L (OR 2.006, 95% CI 1.219-3.302, P = 0.006). Moreover, patients who developed irAEs demonstrated improved PFS (13.7 months vs. 8.4 months, P <0.001) and OS (28.0 months vs. 18.0 months, P = 0.007) compared with patients without irAEs. CONCLUSIONS A positive PD-L1 TPS (≥1%) was associated with improved PFS and an increased risk of irAEs in a real-world setting. The onset of irAEs was associated with improved PFS and OS in patients with advanced NSCLC receiving PD-1/PD-L1-based therapy.
Humans ; Carcinoma, Non-Small-Cell Lung/metabolism* ; Male ; Female ; Retrospective Studies ; Middle Aged ; Lung Neoplasms/metabolism* ; Aged ; B7-H1 Antigen/metabolism* ; Programmed Cell Death 1 Receptor/metabolism* ; Adult ; Aged, 80 and over ; Immune Checkpoint Inhibitors/therapeutic use*

BACKGROUND: The protective effect of mesenchymal stem cells (MSCs) on cardiac ischemia-reperfusion (I/R) injury has been widely reported. Dental pulp-derived mesenchymal stem cells (DP-MSCs) have therapeutic effects on various diseases, including diabetes and cirrhosis. This study aimed to determine the therapeutic effects of DP-MSCs on I/R injury and elucidate the underlying mechanism. METHODS: Myocardial I/R injury model mice were treated with DP-MSCs or a miR-19a-3p mimic. The infarct volume, fibrotic area, pyroptosis, inflammation level, and cardiac function were measured. Cardiomyocytes exposed to hypoxia-reoxygenation were transfected with the miR-19a-3p mimic, miR-19a-3p inhibitor, or negative control. Pyroptosis and protein expression in the interferon regulatory factor 8/mitogen-activated protein kinase (IRF-8/MAPK) pathway were measured. RESULTS: DP-MSCs protected cardiac function in cardiac I/R-injured mice and inhibited cardiomyocyte pyroptosis. The upregulation of miR-19a-3p protected cardiac function, inhibited cardiomyocyte pyroptosis, and inhibited IRF-8/MAPK signaling in cardiac I/R-injured mice. DP-MSCs inhibited cardiomyocyte pyroptosis and the IRF-8/MAPK signaling by upregulating the miR-19a-3p levels in cardiomyocytes injured by I/R. CONCLUSION DP-MSCs protected cardiac function by inhibiting cardiomyocyte pyroptosis through miR-19a-3p under I/R conditions.
Animals ; MicroRNAs/metabolism* ; Pyroptosis/genetics* ; Mesenchymal Stem Cells/metabolism* ; Myocytes, Cardiac/cytology* ; Mice ; Male ; Mice, Inbred C57BL ; Dental Pulp/cytology* ; Myocardial Reperfusion Injury/therapy* ; MAP Kinase Signaling System/physiology*

BACKGROUND: The burden of breast cancer for older adults has been rising with the increasing population aging. This study aims to describe the burden of breast cancer in older adults worldwide, analyze the temporal trends for older breast cancer incidence, and assess the socioeconomic inequalities of breast cancer incidence and mortality with human development index (HDI) levels, which will provide valuable information in preventing and controlling the increasing breast cancer burden in older women. METHODS: The incidence and mortality rates of specific cancer types in older individuals in 2022 were sourced from the Global Cancer Today database. Trends in breast cancer incidence acquired from the Cancer Incidence in Five Continents (CI5) database. HDI and other risk factors were obtained from the United Nations. We used a generalized linear model to estimate the rate ratio and 95% confidence interval (CI) between HDI levels and breast cancer burden in older people. RESULTS: It was estimated approximately 1,058,466 newly diagnosed breast cancer cases and 383,774 breast cancer deaths in women ≥60 years, accounting for 18.9% and 12.7% of global cancer cases and deaths. The age-standardized incidence rate (ASIR) and age-standardized mortality rate (ASMR) were 172.9 and 57.7 per 100,000, ranking first and second among all cancer incidence and mortality in older women. The highest ASIR and ASMR were four-fold higher than the lowest, with ASIR ranging from a peak of 399.1 per 100,000 in Australia-New Zealand to a low of 90.6 per 100,000 in South Central Asia, and ASMR varying from a high of 118.6 per 100,000 in Melanesia to a low of 28.8 per 100,000 in East Asia. The largest increases in ASIR from 1998-2002 to 2013-2017 were observed in South Korea, China, and Estonia. The corresponding estimated 5-year average percentage changes (EAPC) were 6.01%, 2.89%, and 1.93%, respectively. CONCLUSIONS The global burden of breast cancer in older women is increasing fast and varies greatly across countries. Effective prevention strategies are essential to address the increasing breast cancer burden for older women.
Humans ; Female ; Breast Neoplasms/epidemiology* ; Aged ; Incidence ; Middle Aged ; Registries ; Aged, 80 and over ; Risk Factors