The Pharmacovigilance Guideline for Clinical Application of Chinese Patent Medicine for External Use （T/CACM 1563.5—2024）， the first guideline in China specializing for the clinical safety of Chinese patent medicines for external use， was led by the Institute of Basic Research in Clinical Medicine，China Academy of Chinese Medical Sciences，and jointly developed by more than 30 research institutions of medical sciences across the country. Aiming to standardize the pharmacovigilance activities in the clinical application of Chinese patent medicines for external use，the guideline systematically categorizes potential risks and proposes prevention and control measures that cover 11 core sections of risk monitoring and reporting， signal identification，as well as assessment and control， addressing the gap in domestic and international standardization of this field. The compilation of this guideline strictly adhered to international norms and domestic regulations， involving multiple rounds of expert consultations，hybrid interviews， and evidence integration （covering literature，medical insurance，essential medicine，pharmacopoeia data， and regulatory information）. With the scope of application defined to include medical institutions， pharmaceutical manufacturers and distribution enterprises，as well as regulatory authorities， the guideline focuses on key issues such as inherent medicine risks，quality risks，off-label use，risks of combination therapy，and the safety in special populations. During the compilation，core discrepancies such as the definition of application scope and quality risk control were addressed to ensure alignment with regulations such as the Drug Administration Law of the People's Republic of China and the Good Pharmacovigilance Practice. The guideline is registered internationally （PREPARE—2022CN463）. In the future，the implementation of the guideline will be promoted through hierarchical dissemination，dynamic revision，and post-effectiveness evaluation， contributing to rational clinical use and improved patient safety.

The Pharmacovigilance Guideline for Clinical Application of Chinese Patent Medicine for External Use （T/CACM 1563.5—2024）， the first guideline in China specializing for the clinical safety of Chinese patent medicines for external use， was led by the Institute of Basic Research in Clinical Medicine，China Academy of Chinese Medical Sciences，and jointly developed by more than 30 research institutions of medical sciences across the country. Aiming to standardize the pharmacovigilance activities in the clinical application of Chinese patent medicines for external use，the guideline systematically categorizes potential risks and proposes prevention and control measures that cover 11 core sections of risk monitoring and reporting， signal identification，as well as assessment and control， addressing the gap in domestic and international standardization of this field. The compilation of this guideline strictly adhered to international norms and domestic regulations， involving multiple rounds of expert consultations，hybrid interviews， and evidence integration （covering literature，medical insurance，essential medicine，pharmacopoeia data， and regulatory information）. With the scope of application defined to include medical institutions， pharmaceutical manufacturers and distribution enterprises，as well as regulatory authorities， the guideline focuses on key issues such as inherent medicine risks，quality risks，off-label use，risks of combination therapy，and the safety in special populations. During the compilation，core discrepancies such as the definition of application scope and quality risk control were addressed to ensure alignment with regulations such as the Drug Administration Law of the People's Republic of China and the Good Pharmacovigilance Practice. The guideline is registered internationally （PREPARE—2022CN463）. In the future，the implementation of the guideline will be promoted through hierarchical dissemination，dynamic revision，and post-effectiveness evaluation， contributing to rational clinical use and improved patient safety.

Objective: To analyze the structural changes in whole blood and apheresis platelet donations in Chinese Society of Blood Transfusion (CSBT) sentinel units from 2021 to 2025, and to provide evidence for donor recruitment and blood service management. Methods: Aggregated data reported by sentinel sites were collected and stratified according to six indicators: age, sex, donation history, donation volume, donation site, and organization mode. Pearson χ test, Cramer′V coefficient, Cochran-Armitage trend test and simple linear regression were adopted for analysis. Results: A total of 16 256 973 whole blood donations and 1 576 546 apheresis platelet donations were included. Among whole-blood donations, the proportion of donors aged 18-22 years decreased from 27.30% to 10.60%. The proportion of male donors increased from 58.81% to 63.13%; the proportion of people aged 30 and above increased from 58.40% to 75.30%; the proportion of fixed locations rose from 28.37% to 36.57%; the proportion of social groups increased from 21.69% to 39.69%. The 400-mL donations decreased from 62.12% to 53.46%, while individually initiated voluntary donations remained above 50%. Apheresis platelet donations were predominantly from males, individuals aged 30-39 years, and repeat donors; 2-treatment-unit apheresis platelet donations increased from 67.19% to 74.93%, and individually initiated donations accounted for 92.97%-96.02%. Statistically significant overall annual compositional differences were observed for all six indicators (all P<0.001), whereas linear trends for some sub-categories were not statistically significant. Conclusion: In the participating CSBT sentinel units, among whole blood donations, the proportions of donors aged 18-22 years, university-organized group donations, and donations at blood mobiles decreased, whereas the proportions of organizational group donations and donations at fixed venues increased. The apheresis platelet donation cohort is relatively mature and is evolving toward a high-efficiency donation model. Individual voluntary donation remains the primary organization mode for both donation types. Strategies such as youth donor recruitment, optimized layout of fixed donation sites, and retention of repeat donors should be strengthened to improve the resilience of blood supply.

OBJECTIVE To develop a risk screening scale for medication adherence in anticoagulated patients and evaluate its reliability and validity， thereby providing an assessment tool for identifying medication adherence risks during anticoagulant therapy and implementing individualized interventions.METHODS Based on the protection motivation theory， a preliminary scale containing 20 items was developed through literature analysis， semi-structured interviews， expert consultation and a pilot survey. Convenience sampling was used to distribute questionnaires to patients receiving anticoagulant therapy at multiple medical institutions. Item analysis was conducted to select items. Exploratory factor analysis （EFA） and confirmatory factor analysis （CFA） were used to assess construct validity and further screen items. The New General Self-Efficacy Scale-Short Form （NGSES-SF） was used to assess criterion-related validity， and the internal consistency and split-half reliability of the scale were evaluated.RESULTS A total of 425 questionnaires were distributed， and 411 valid questionnaires were recovered， yielding an effective recovery rate of 96.71%. The final scale consisted of four dimensions：perceived severity， perceived susceptibility， response efficacy and self-efficacy， with a total of 11 items. EFA extracted four common factors， with a cumulative variance contribution rate of 68.805%. CFA showed the Chi-square degrees of freedom ratio was 1.839， the root mean square error of approximation was 0.064， the goodness-of-fit index was 0.945， the comparative fit index was 0.979， and the Tucker-Lewis index was 0.969. The total score of the scale and the scores of each dimension were significantly positively correlated with the scores of the criterion scale NGSES-SF （ P ＜0.05）， and the correlation coefficient between the total score of the scale and the total score of NGSES-SF was 0.346. The Cronbach’s α coefficient for internal consistency was 0.878， and the split-half reliability coefficient was 0.743.CONCLUSIONS The medication adherence risk screening scale for patients on anticoagulant therapy constructed in this study demonstrated good reliability and validity， which can be used to screen for medication adherence risk in patients on anticoagulant therapy， and serve as an assessment tool for stratified targeted interventions in clinical practice.

Objective:To analyze the changes and structural variations in hospitalization costs for patients with lung malignancies after the implementation of diagnosis-intervention packet (DIP) payment system, and to evaluate its effectiveness.Methods:Data from the first page of medical records and hospitalization cost data from the hospital information system of a tertiary general hospital in Henan Province were extracted for patients diagnosed with lung malignancies from 2020 to 2023. The data were divided into pre-implementation group (2020—2021) and post-implementation group (2022—2023) based on the implementation time of DIP. Chi-square test, t test, and Wilcoxon rank-sum test were used to analyze the differences in basic characteristics and hospitalization costs of patients with lung malignancies before and after the implementation of DIP. Grey relational analysis was employed to examine the internal associations between total hospitalization costs and various cost components. Structural variation analysis was used to assess the changes in the structure of hospitalization costs after the implementation of DIP. Results:A total of 14 587 hospitalized patients with lung malignancies were included, with 6 807 cases in the pre-implementation group and 7 780 cases in the post-implementation group. The average length of hospital stay decreased from (13.17±6.74) days before implementation to (12.02±6.49) days after implementation ( P<0.05). The proportion of level-four surgeries increased from 46.4% to 57.0% ( P<0.05). The average hospitalization cost per patient with lung malignancies decreased from 56 952 yuan before DIP implementation to 55 560 yuan after implementation ( P<0.05). For patients with lung malignancies diagnosed as C34.1, C34.2, C34.3, and C34.8, the top four cost components most strongly associated with total hospitalization costs were treatment costs, material costs, comprehensive medical service costs, and diagnostic costs, with correlation coefficients all>0.80. For patients with C34.9, the top four cost components most strongly associated with total hospitalization costs were treatment costs, comprehensive medical service costs, diagnostic costs, and Western medicine costs, with correlation coefficients>0.95. For patients diagnosed as C34.1, C34.2, C34.3, and C34.9, diagnostic costs, Western medicine costs, and material costs contributed significantly to the structural variation of hospitalization costs, with contribution rate of structure variation all exceeding 75%, among which Western medicine costs and material costs showed negative variation. For patients diagnosed as C34.8, treatment costs, Western medicine costs, and material costs contributed significantly to the structural variation of hospitalization costs, with contribution rate of structure variation all exceeding 80%, among which Western medicine costs showed negative variation. Conclusions:The implementation of DIP reduced the hospitalization costs for patients with lung malignancies, optimized the structure of hospitalization costs, improved the efficiency of medical services, and promoted the rational allocation of medical resources.

Humanistic caring for patients in the operating room refers to providing the whole process of caring medical services for patients in the operating room. In order to standardize humanistic caring services for patients in the operating room of medical institutions, improve the comprehensive service level of the operating room, and enhance the surgical experience of patients, the Chinese Association for Life Care released the group standard " Humanistic Caring Management Standards for Patients in the Operating Room" in December 2023. This article interpreted the basic requirements for humanistic caring of patients in the operating room, the environment and facilities for humanistic caring, the procedures and measures for humanistic caring, and the quality management framework, aiming to assist administrators and clinical practitioners across various levels of medical institutions in accurately understanding and effectively implementing the standard, and to provide essential textual reference and practical guidance for promoting the application of the standard.

Objective Radial artery occlusion(RAO)is one of the common complications following coronary intervention via the traditional radial artery approach.This study aims to evaluate the clinical effectiveness of retrograde recanalization of occluded radial arteries through the distal transradial approach(dTRA)approach.Methods A total of 35 patients with RAO admitted to the cardiovascular department of the Anhui Chest hospital between December 2022 and April 2024,who were scheduled to undergo coronary intervention and had attempted recanalization of RAO via dTRA approach were selected.The primary result was the success rate of recanalizing RAO via dTRA.The secondary results included factors influencing the failure of recanalization via dTRA,postoperative puncture complications,and the patency rate at the 3-month follow-up.Results This study divided the patients into a successful group(29 cases,82.9％)and a failed group(6 cases,17.1％)based on whether the distal radial artery was successfully opened and occluded.The proportion of smoking(100.00％vs.17.24％,P=0.040),history of diabetes(100.00％vs.10.34％,P=0.025),and chronic total occlusion of coronary artery(83.33％vs.17.24％,P=0.030)in the failure group were higher than those in the success group,and the difference was statistically significant.The application rate of balloon tracking assisted technology in the failed group(16.67％vs.58.62％,P=0.045),and the diameter of the radial artery at 3 days after surgery[(1.63±0.13)mm vs.(2.13±0.32)mm,P=0.021]and the peak radial artery blood flow velocity at 3 days postoperatively[(0.10±0.78)m/s vs.(0.50±0.13)m/s,P＜0.001]were all lower in the successful group,and the differences were statistically significant.Logistic regression analysis 3 days after surgery showed that chronic complete occlusion of the coronary artery was an independent risk factor for surgical opening failure(OR 0.042,95％CI 0.004-0.438,P=0.008).After 3 months of follow-up,the patency rate of the successful group was 55.2％.Conclusions Retrograde recanalization of RAO via dTRA is safe and feasible,but its long-term patency rate is not high.

Severe open tibiofibular fractures account for approximately 28.1% of all open fractures. Among them, Gustilo-Anderson type IIIB/C fractures present significant clinical challenges due to associated bone and soft tissue defects, high infection rates, and risk of amputation. Inadequate preoperative assessment may lead to suboptimal emergency surgical planning or intraoperative complications. Historically, external fixation was often preferred, but this approach has been associated with limitations such as restricted joint mobility, delayed bone union, joint stiffness, and disuse osteoporosis, resulting in poor functional recovery. With advancements of debridement techniques, standardization of antibiotic use, and popularization of early soft tissue coverage, early internal fixation has gained broader acceptance. Nevertheless, controversies persist regarding the choice of fixation method, timing of definitive fixation, use of reamed versus unreamed intramedullary nailing, and necessity of fibular fixation. To standardize the diagnosis and early management of severe open tibiofibular fractures, reduce complication rates, and improve functional recovery, the Society of Microsurgery of the Chinese Medical Association organized a panel of domestic experts to develop the Evidence-based guideline for the diagnosis and early fixation of severe open tibiofibular fractures ( version 2025), using evidence-based methodology. The guidelines provided 12 recommendations covering diagnostic and early fixation strategies of severe open tibiofibular fractures, aiming to provide clinicians with scientifically grounded and standardized guidance.

Objective:To identify the prognostic value of the Revised 15-item Myelodysplastic Syndrome-specific frailty scale (FS-15) in Chinese patients with myelodysplastic syndromes (MDS) .Methods:This retrospective study analyzed 812 patients with newly diagnosed MDS admitted to the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College from August 2016 to June 2023. Patients were assessed using the FS-15 and subsequently categorized into frail and non-frail groups. Clinical and laboratory characteristics, as well as overall survival (OS), were compared between these groups.Results:① The median patient age was 55 years ( IQR 45–64), with a median follow-up of 22.5 months (95% CI: 20.2–24.9) and a median OS of 43.3 months (95% CI: 36.8–49.8). The median FS-15 score was 0.42, with a cutoff value of 0.44. Male patients demonstrated higher median FS-15 scores than female patients (0.42 vs 0.38, P=0.006). In both the Revised International Prognostic Scoring System (IPSS-R; P=0.001) and Molecular International Prognostic Scoring System (IPSS-M; P=0.014) stratifications, FS-15 scores were significantly higher in the very high-risk group compared with the very low-risk group. ② The median OS was 54.7 months (95% CI: 47.5–NA) and 31.5 months (95% CI: 22.9–41.0) in the nonfrail ( n=452) and frail groups ( n=360), respectively ( P<0.001). The 3-year OS rates were (63.2 ± 3.2) % and (46.4 ± 3.6) % for the non-frail and frail groups, with 5-year OS rates of (49.9 ± 4.7) % and (32.0 ± 4.3) %, respectively ( P<0.001). ③Subgroup analysis revealed that nonfrail patients demonstrated significantly higher 3-year OS rates than frail patients in both the IPSS-M low-risk and very high-risk groups (all P<0.05). Similarly, nonfrail patients demonstrated superior 3-year OS rates compared with frail patients in the IPSS-R very low-risk, low-risk, and high-risk groups (all P<0.05). ④Among patients receiving hypomethylating agent therapy, the overall response rate was significantly higher in the non-frail group than in the frail group (86.7% vs 64.6%, P=0.007). Moreover, the frail group experienced higher rates of treatment-related adverse events, including febrile neutropenia (67.1% vs 47.4%, P=0.016) and liver function abnormalities (30.0% vs 14.5%, P=0.023), compared with the non-frail group. Conclusion:The FS-15 frailty score is a feasible and effective tool for assessing frailty in patients newly diagnosed with MDS in China and serves as a valuable prognostic indicator.

Objective:To analyze the changes and structural variations in hospitalization costs for patients with lung malignancies after the implementation of diagnosis-intervention packet (DIP) payment system, and to evaluate its effectiveness.Methods:Data from the first page of medical records and hospitalization cost data from the hospital information system of a tertiary general hospital in Henan Province were extracted for patients diagnosed with lung malignancies from 2020 to 2023. The data were divided into pre-implementation group (2020—2021) and post-implementation group (2022—2023) based on the implementation time of DIP. Chi-square test, t test, and Wilcoxon rank-sum test were used to analyze the differences in basic characteristics and hospitalization costs of patients with lung malignancies before and after the implementation of DIP. Grey relational analysis was employed to examine the internal associations between total hospitalization costs and various cost components. Structural variation analysis was used to assess the changes in the structure of hospitalization costs after the implementation of DIP. Results:A total of 14 587 hospitalized patients with lung malignancies were included, with 6 807 cases in the pre-implementation group and 7 780 cases in the post-implementation group. The average length of hospital stay decreased from (13.17±6.74) days before implementation to (12.02±6.49) days after implementation ( P<0.05). The proportion of level-four surgeries increased from 46.4% to 57.0% ( P<0.05). The average hospitalization cost per patient with lung malignancies decreased from 56 952 yuan before DIP implementation to 55 560 yuan after implementation ( P<0.05). For patients with lung malignancies diagnosed as C34.1, C34.2, C34.3, and C34.8, the top four cost components most strongly associated with total hospitalization costs were treatment costs, material costs, comprehensive medical service costs, and diagnostic costs, with correlation coefficients all>0.80. For patients with C34.9, the top four cost components most strongly associated with total hospitalization costs were treatment costs, comprehensive medical service costs, diagnostic costs, and Western medicine costs, with correlation coefficients>0.95. For patients diagnosed as C34.1, C34.2, C34.3, and C34.9, diagnostic costs, Western medicine costs, and material costs contributed significantly to the structural variation of hospitalization costs, with contribution rate of structure variation all exceeding 75%, among which Western medicine costs and material costs showed negative variation. For patients diagnosed as C34.8, treatment costs, Western medicine costs, and material costs contributed significantly to the structural variation of hospitalization costs, with contribution rate of structure variation all exceeding 80%, among which Western medicine costs showed negative variation. Conclusions:The implementation of DIP reduced the hospitalization costs for patients with lung malignancies, optimized the structure of hospitalization costs, improved the efficiency of medical services, and promoted the rational allocation of medical resources.