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.

ObjectiveTo analyze the research hotspots and development trends in the field of spinal cord stimulation (SCS) for spinal cord injury (SCI). MethodsLiterature about SCS for SCI was retrieve from the Web of Science (WOS) Core Collection database, with a time range from January, 1999 to July, 2025. VOSviewer 1.6.20 and CiteSpace 6.4.R2 were used to analyze the annual publication volume, countries, authors, institutions, journals and keywords. ResultsA total of 636 literatures were included. From 1999 to 2025, the overall publication trend in this field showed an upward trajectory, with recent years fluctuating but tending to stabilize. The country with the most publications was the United States (429 papers), followed by Russia (98 papers) and China (70 papers). The institution with the highest number of publications was the University of California, Los Angeles (76 papers), the author with the most publications was V. Reggie Edgerton (70 papers), and the journal with the most publications was Journal of Clinical Medicine (31 papers). The most frequently cited study focused on exploring the combination of epidural spinal cord stimulation with task-specific training to restore motor function in patients with complete SCI. Keyword analysis showed that the research hotspots in this field were mainly focused on neuroregulation mechanisms, recovery of motor and autonomic nervous dysfunction, artificial intelligence, closed-loop stimulation and brain-computer interface technology innovations. In recent years, the research focus gradually shifted from basic mechanisms to personalized and precise multifunctional rehabilitation strategies. ConclusionThe field of SCS for SCI has undergone phases of basic mechanism exploration and clinical application expansion. Current research hotspots and future trends focus primarily on the development of new stimulation paradigms and combined innovative technologies.

Metabolic dysfunction-associated fatty liver disease （MAFLD） is a chronic metabolic liver disorder with complex etiologies. Different clinical phenotypes of MAFLD （such as obesity， hyperlipidemia， type 2 diabetes mellitus， the postmenopausal state， and chronic hepatitis B） have different mechanisms of action in the development and progression of MAFLD， leading to high heterogeneity in its clinical progression and prognosis. This article systematically reviews the pathogeneses and clinical features of the above five clinical phenotypes of MAFLD and elaborates on the corresponding individualized diagnosis and treatment regimens integrating traditional Chinese medicine and Western medicine， in order to provide a reference for clinical practice and improve clinical diagnosis and treatment.

AIM:To investigate the dynamic changes in ocular surface function after eyelid malignant tumor resection combined with Hughes flap reconstruction.

METHODS:A prospective self-controlled study was conducted. Patients who underwent eyelid malignant tumor resection combined with Hughes tarsoconjunctival flap reconstruction(all tumors occured in the lower eyelid)at Shanxi Eye Hospital from January 2021 to December 2023 were enrolled. The contralateral healthy eye served as control. Ocular surface examinations were performed preoperatively and at 3, 6, 9, and 12 mo postoperatively, including ocular surface disease index(OSDI), tear meniscus height(TMH), non-invasive average tear film break-up time(NiaBUT), tear film lipid layer grading, upper and lower eyelid meibomian gland dropout grading, corneal fluorescein staining, and eye redness index.

RESULTS:A total of 36 patients were enrolled. Two patients were lost to follow-up because they did not complete the scheduled follow-up period, leaving 34 patients with complete data for analysis. The cohort comprised 10 men(29%)and 24 women(71%), with a mean age of 70.08±10.92 y(range 33-81 y). Histopathological diagnoses included basal cell carcinoma(BCC)in 22 eyes(65%), sebaceous gland carcinoma(SGC)in 10 eyes(29%), and squamous cell carcinoma(SCC)in 2 eyes(6%). Tumor size ranged from 4 to 30 mm(mean 12.64±0.31 mm). According to the AJCC staging system, 14 eyes(41%), 18 eyes(53%), and 2 eyes(6%)were classified as T1b, T2b, and T3b, respectively. Preoperatively, OSDI scores were higher in surgical eyes than in contralateral healthy eyes(28.74±13.72 vs 17.47±3.02, P<0.05). OSDI scores in surgical eyes further increased at 6, 9, and 12 mo postoperatively, peaking at 9 mo(all P<0.05), whereas no significant postoperative changes were observed in contralateral healthy eyes. Compared with contralateral healthy eyes, TMH in surgical eyes increased significantly at 3 mo postoperatively and remained elevated thereafter despite a slight decline(all P<0.05). NiaBUT in surgical eyes was shorter than the preoperative value from 3 mo postoperatively onward and was lower than that in contralateral healthy eyes(all P<0.05). Eye redness index in surgical eyes were consistently higher than those in contralateral healthy eyes(all P<0.001). Tear film lipid layer grade and meibomian gland dropout grades in both the upper and lower eyelids were significantly worsened postoperatively compared with baseline(all P<0.001). Corneal fluorescein staining grades were higher in surgical eyes than in contralateral healthy eyes preoperatively(P<0.001)and were higher at 3, 6, 9, and 12 mo postoperatively than at baseline(all P<0.001).

CONCLUSION: After lower eyelid malignant tumor resection combined with Hughes flap reconstruction, evaporative dry eye is the predominant phenotype. Meibomian gland dropout in both upper and lower eyelids appears irreversible within 12 mo postoperatively, and corneal epithelial damage and ocular surface inflammation persist over time.

Objective: To analyze the epidemiological characteristics and spatio-temporal clustering characteristics of pulmonary tuberculosis (PTB) in Yulin City, Shaanxi Province from 2007 to 2024, so as to provide the evidence for optimizing regional PTB prevention and control strategies. Methods: Registration data of PTB cases in Yulin City from 2007 to 2024 were collected from the Tuberculosis Management Information System of the China Disease Prevention and Control Information System. The average annual percent change (AAPC) and annual percent change (APC) were used to analyze the trends in PTB registration rates. Descriptive epidemiological methods were used to analyze the temporal, spatial and population distribution characteristics. Spatio-temporal scan analysis was used to analyze the spatio-temporal clustering characteristics. Results: A total of 35 874 PTB cases were registered in Yulin City from 2007 to 2024. The registered incidence decreased from 80.41/105 in 2007 to 38.53/105 in 2024 (AAPC=-3.916%, P<0.05). Downward trends were observed from 2007 to 2016 and from 2019 to 2022 (APC=-4.440%, -19.361%, both P<0.05). March used to be the peak of disease incidence, with a seasonal index of 1.78, while February used to be the trough, with a seasonal index of -1.38. The average annual registered incidence rates were relatively high in Zhouxian County, Wubu County, and Suide County, at 89.02/105, 82.52/105 and 79.61/105, respectively. There were 21 672 registered PTB cases among males, accounting for 60.41%, and 14 202 cases among females, accounting for 39.59%. The higher registered cases were observed in groups aged 15 to <25 years and ≥65 years, with 9 400 and 7 950 cases, accounting for 26.20% and 22.16%, respectively. The proportion of population aged ≥65 years increased from 16.97% in 2007 to 43.24% in 2024, with an increase of 154.80%. Farmers were the predominant occupation, with 24 477 cases, accounting for 68.23%. Spatio-temporal scan analysis showed that the primary clusters consistently included Qingjian County, Suide County, Zizhou County, and Wubu County from 2007 to 2015, 2016 to 2019, 2020 to 2022 and 2023 to 2024. Mizhi County was incorporated into the clusters from 2016 to 2019 and 2020 to 2022, while Jiaxian County was further added from 2023 to 2024. The specific cluster periods were from January 2007 to June 2011, November 2017 to August 2019, March 2020 to July 2021, and February 2023 to July 2024, respectively. Conclusions From 2007 to 2024, the registered incidence of PTB in Yulin City showed an overall declining trend. March marked the peak of disease onset. Males, the elderly aged ≥65 years and farmers were the high-incidence population. Persistent spatio-temporal clustering was observed in the southern regions, including Qingjian County, Suide County, Zizhou County, Wubu County, and Mizhi County.

Objective To explore the advantages and limitations of different evaluation methods for medical quality.Methods The rank sum ratio method(RSR),rank sum ratio method after principal component analysis(RSR-after-PCA),and technique for order preference by similarity to ideal solution(TOPSIS)were used to comprehensively evaluate the surgical medical quality in a hospital,respectively.The results of the three evaluation methods were compared.Results The result of Kendall's coefficient of concordance showed high consistency among the three evaluation methods(Kendall's W=0.879,χ2=26.364,P=0.003),although there were significant differences in the evaluation outcomes for some departments.Conclusion Each evaluation method is capable of objectively evaluating the overall situation of a department,but it also has certain limitations and scope of application.The appropriate method should be selected based on the purpose of analysis and data distribution.The evaluation indexes in hospitals are dispersed,but may be correlated to some extent.RSR-after-PCA can overcome these problems and is more suitable for the comprehensive evaluation of multiple indexes in hospitals.

Objective To develop an erythrocyte-based delivery system for butyrylcholinesterase(BChE)that is capable of prophylaxis against organophosphorus nerve agents.Methods Recombinant BChE was produced and analyzed for oligomerization via polyacrylamide gel electrophoresis(PAGE)and Western blotting.A modified hypotonic preswelling method was employed to prepare BChE-loaded erythrocytes.The drug loading capacity and encapsulation efficiency were quantified using enzyme-linked immunosorbent assay(ELISA).Catalytic activity was assessed in vitro with an activity detection kit.The system was characterized via scanning electron microscopy(SEM),flow cytometry and a hematology analyzer.Results Recombinant BChE predominantly existed as dimers(85％dimer,15％monomer).The optimized volume ratio of erythrocytes to hypotonic solution was determined as 1:7.Compared with native and empty erythrocytes,BChE-loaded erythrocytes exhibited significantly higher catalytic activity(P＜0.001).The mean corpuscular volume of BChE-loaded erythrocytes increased(P＜0.001),while the mean content of corpuscular hemoglobin and hemoglobin in erythrocytes per 100 mL decreased(P＜0.001).SEM revealed no morphological differences(biconcave disc shape).Hypotonic preswelling moderately increased erythrocyte apoptosis(P＜0.001),but no statistical difference was observed between BChE-loaded and hypotonic-treated erythrocytes(P＞0.05).CD47 expression remained unchanged compared to native erythrocytes(P＞0.05).Conclusion The modified hypotonic preswelling method can generate BChE-loaded erythrocytes that retain the characteristics of native erythrocytes while conferring catalytic activity,offering a novel strategy for clinical intervention against organophosphorus poisoning.

ObjectiveTo analyze the trend of incidence, mortality rate and survival rate of breast cancer among women with registered residence in Xiaoshan District of Hangzhou City in Zhejiang Province from 2014 to 2023, and to provide a basis for improving breast cancer prevention and control strategies. MethodsData on the incidence and mortality of breast cancer among women with registered residence in Xiaoshan District from 2014 to 2023 were collected through Zhejiang Chronic Disease Monitoring and Management System. The crude incidence and mortality rate, as well as the age-standardized incidence and mortality rate using both the 2000 Chinese standard population (abbreviated as “Chinese ASR”) and Segi’s 1960 world standard population (“world ASR”) were calculated. Joinpoint model was employed to analyze the trends in incidence and mortality rate, while R software (version 4.1.1) was used to analyze the 5-year relative survival rate to assess the survival status of breast cancer patients. ResultsFrom 2014 to 2023, the crude incidence rate, the Chinese age-standardized incidence rate (ASIRC) and the world age-standardized incidence rate (ASIRW) of breast cancer among women with registered residence in Xiaoshan District were from 70.00/100 000 to 128.35/100 000, from 52.92/100 000 to 94.29/100 000, and from 40.82/100 000 to 72.07/100 000, respectively, with the corresponding average annual percentage changes (AAPC) of 5.80%, 4.63% and 4.71%, respectively, showing a significant increasing trend over the decade (all P<0.05). The incidence rate of breast cancer among people aged 30‒<40 years old or 50‒<75 years old exhibited a significant increase trend from 2014 to 2023 (all P<0.05). The crude mortality rate of breast cancer in female was from 7.75/100 000 to 12.34/100 000, the ASMRC of breast cancer in female was from 4.62/100 000 to 7.53/100 000, and the ASMRW of breast cancer in female was from 3.58/100 000 to 5.71/100 000, and the AAPC had no statistically significance. However, the mortality rate of breast cancer was increased with age (P<0.001). The 5-year age-standardized relative survival rate of breast cancer in female in Xiaoshan District was significantly higher in the 2016‒2018 period (94.46%) compared to the 2013‒2015 period (91.02%) (P<0.05). ConclusionFrom 2014 to 2023, the annual incidence of breast cancer among women with registered residence in Xiaoshan District of Hangzhou City in Zhejiang Province showed an increasing trend, while the change in mortality rate was not statistically significant. The 5-year survival rate of breast cancer in female was at a high level, indicating notable achievements in comprehensive prevention and control efforts. It is essential to continue to strengthen public awareness campaigns for breast cancer prevention and control, control breast cancer risk factors, actively carry out early diagnosis and treatment of breast cancer among target groups, and improve the quality of life for breast cancer patients.

Currently,there are practical and technical difficulties in the construction of clinical ques-tions in the development of clinical practice guidelines.Clinicians or guideline developers seldom construct clin-ical questions based the actual case scenario,leading to some information loss between structured and actual clinical connotation.To overcome this challenge,we proposed a case-guided questions construction approach,and carried out case research and verification in the formulation of the guideline.We found that this method could more efficiently and scientifically assist the formulation of clinical questions,and provide reference for clinicians or guideline developers.