The Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines （hereinafter referred to as the Guidelines） is first specialized in the field of drug safety for oral Chinese patent medicines （OCPMs） in China. Rooted in China's healthcare context， the Guidelines address the unique usage patterns and risk characteristics of OCPMs， filling a regulatory gap in the pharmacovigilance framework specific to this category. To facilitate accurate understanding and effective implementation of the Guidelines， and to promote the standardized development of pharmacovigilance practices for OCPMs， this study offered a systematic interpretation based on its three core components. In the domain of risk monitoring and reporting， the paper analyzed the rationale for multi-source information integration and clarified the criteria for identifying key products and target populations for intensive monitoring. Regarding risk assessment， the Guidelines were examined from three dimensions of formulation components， medication behaviors， and population to address complex safety issues arising from medicinal constituents， irrational use， and individual susceptibility. In the area of risk control， the analysis focused on context-based interventions and dynamic closed-loop management strategies， exploring practical pathways to shift from passive response to proactive risk mitigation. Furthermore， this paper evaluated the applied value of the Guidelines and identified implementation challenges， such as insufficient capacity at the primary-care level and limited digital infrastructure. In response， the study proposed optimization strategies including establishing a dynamic updating mechanism， strengthening training at the grassroots level， and incorporating artificial intelligence to enhance pharmacovigilance capacity. This interpretation aims to provide actionable insights for marketing authorization holders （including manufacturers）， pharmaceutical distributors， healthcare institutions， and research organizations， ultimately supporting the establishment and refinement of a full lifecycle pharmacovigilance system for OCPMs.

Steroid-induced avascular necrosis of femoral head（SANFH） is a bone and joint disease caused by prolonged and excessive steroid use. Its typical pathological features involve progressive circulatory disorders in the blood supply system of femoral head， leading to osteocyte apoptosis and bone tissue necrosis. As the disease progresses， it ultimately results in structural collapse and necrotic lesions of the femoral head， severely affecting patients' limb function and quality of life. Glucocorticoids mediate pathological damage through dual mechanisms， on the one hand， they disrupt the dynamic equilibrium between bone formation and resorption by suppressing osteoblast differentiation activity and activating osteoclastogenesis， on the other hand， they induce lipid metabolism disorders， inhibit angiogenesis， and impair endothelial cell function， thereby triggering microcirculatory disorders. Epimedii Folium and its active components exhibit multidimensional regulatory effects in SANFH prevention and treatment. Literature review reveals that it is rich in multiple active ingredients， primarily including total flavonoids of Epimedii Folium， icaritin， icariin， kaempferol， icariside Ⅱ， etc. These compounds exert multiple pharmacological effects（regulating bone metabolic homeostasis， modulating angiogenesis， correcting lipid metabolism disorders， and controlling cellular autophagy processes） through multiple signaling pathways， including Wnt/β-catenin， transforming growth factor（TGF）-β/bone morphogenetic protein（BMP）/Smad， mitogen-activated protein kinase（MAPK）， phosphoinositide 3-kinase/protein kinase B（PI3K/Akt）， osteoprotegerin/receptor activator of nuclear transcription factor-κB ligand/receptor activator of nuclear transcription factor-κB（OPG/RANKL/RANK）， etc. Based on existing research findings， this paper systematically elucidates the intervention mechanisms of active components in Epimedii Folium on key pathological processes of SANFH through the above pathways. It also deeply analyzes their regulatory roles in key nodes of different signaling pathways， aiming to provide valuable references for future clinical treatment and experimental research.

OBJECTIVE To explore the effects of leonurine on growth arrest-specific protein-6 （GAS6）/Axl signaling pathway， and clarify its mechanism of alleviating myocardial injury in rats with coronary heart disease. METHODS The rat model of coronary heart disease was constructed； successfully modeled rats were randomly separated into model group， leonurine low- dose and high-dose groups （intragastric administration of leonurine 25， 100 mg/kg+intraperitoneal injection of normal saline 75 mg/kg）， and leonurine high-dose+GAS6/Axl signaling pathway inhibitor group （intragastric administration of leonurine 100 mg/kg+ intraperitoneal injection of R428 75 mg/kg）， with 12 rats in each group. Additional 12 normal rats were selected as control group. Each administration group was given relevant medicine； control group and model group were given a constant volume of normal saline intragastrically and intraperitoneally， once a day， for 48 consecutive days. After administration， the heart function of rats， and serum levels of inflammatory factors and myocardial injury markers were detected； the pathological morphology of myocardial tissue was observed； the myocardial cell apoptosis rate， the expressions of apoptosis and GAS6/Axl signaling pathway-related proteins were determined. RESULTS Compared with control group， model group showed disorders in the arrangement of myocardial cells and myocardial fibers， hypertrophy of myocardial cells， and nuclear condensation； left ventricular ejection fraction， left ventricular fractional shortening， ratio of early-diastolic and late-diastolic motion velocity of the mitral ring， the protein expression of GAS6， B-cell lymphoma 2/B-cell lymphoma 2 associated X protein and phosphorylated Axl/Axl ratios were decreased significantly （P＜0.05）. The levels of tumor necrosis factor-α， interleukin-1β， interleukin-6， creatine kinase isoenzyme， troponin Ⅰ and myoglobin， the cell apoptosis rate， and cleaved caspase-3/caspase-3 ratio were increased significantly （P＜0.05）. Leonurine could obviously improve the above pathological conditions and detection indicators （P＜0.05）， and the effect of leonurine high-dose group was more significant than that of leonurine low-dose group （P＜0.05）； R428 treatment could reverse the ameliorating effect of high-dose of leonurine on myocardial injury in rats with coronary heart disease （P＜0.05）. CONCLUSIONS Leonurine can alleviate myocardial injury in rats with coronary heart disease， and its mechanism of action is related to the activation of the GAS6/Axl signaling pathway.

This article systematically analyzes the historical evolution of the name， origin， medicinal parts， processing and other aspects of Euphorbiae Pekinensis Radix（EPR） by referring to the herbal medicine， medical books， prescription books and other documents of the past dynasties， combined with the relevant modern research materials， so as to provide a basis for the development and utilization of famous classical formulas containing this herbal medicine. According to research， EPR was first recorded in the Shennong Bencaojing in the name of Daji， and it is the correct name of the herbal medicine in all dynasties， there are also other aliases such as Qiongju， Hongya Daji， and Xiamaxian. The dried roots of Euphorbia pekinensis from Euphorbiaceae was the mainstream of the past dynasties. Before the Ming dynasty， the above ground parts of E. pekinensis were used as Zeqi in herbal works. However， since LI Shizhen in the Ming dynasty proposed that the origin of Zeqi should be E. helioscopia， the aerial part of EPR is no longer used as medicine. Since modern times， the roots of Knoxia valerianoides has been used as EPR， and has become the mainstream of commodities， which should be corrected. Throughout history， it has been recorded that the main producing areas were Jiangsu， Anhui， Zhejiang， Shanxi and other regions， while modern botanical survey have shown that EPR is a widespread species distributed throughout the country. In ancient times， the harvesting time of EPR was mostly the twelfth lunar month， while in modern time， it is more common to harvest in autumn and winter. The main processing methods of EPR in ancient times were vinegar processing， wine processing， and stir frying， while in modern times， it is uniformly vinegar processing. In the medicinal properties and clinical aspects， the records are basically consistent throughout history， mainly characterized by bitter taste， cold and toxic nature. Its main efficacy is expelling water retention and reducing swelling. Based on the textual research， it is suggested to choose the dried roots of E. pekinensis when famous classical formulas containing EPR， processing method can be based on the original specified prescription requirements， if the processing method is not clear， it is recommended to use vinegar-processed products as medicine.

Duchenne Muscular Dystrophy （DMD） is an X-linked recessive inherited myopathy caused by a pathogenic variant of the amyotrophic protein gene. Currently， DMD patients have needs for treatment， education， and social integration at different stages of the disease. Faced with the multiple needs of DMD patients， based on the professional value and ethics of social work， the integrative orientation of social work， and the multiple roles of social workers， social workers can build a comprehensive service system centred on DMD patients and provide multiple services. Specifically， social work intervention paths can enhance the health and well-being of DMD patients and improve their quality of life by providing various services such as in-hospital and out-of-hospital health management， psychological support， resource links， empowerment， construction of social support networks， science popularization， and policy advocacy.

Objective: To construct a quality control evaluation indicator system for the surveillance of common diseases among students, so as to provide a reference for the quality control of surveillance projects. Methods: Based on literature review and expert interviews, a preliminary framework and candidate indicators were developed from June to August in 2024. Twenty domain experts participated in two rounds of Delphi consultations conducted via email, providing importance ratings, judgment basis, familiarity levels, and feasibility assessments for each indicator. And a quality control evaluation indicator system for the surveillance of common diseases among students was ultimately constructed. Results: The consulted experts aged 33-53, with an average age of (45.25±5.03) years, were from government health administration departments( n =1), centers for disease control and prevention at different levels( n =16), academic and research institutions( n =3). Their work experience in school health related fields ranged from 6 to 33 years, with an average of (16.70±8.25) years. The activeness of experts in both rounds of consultation was 100%, the mean expert authority coefficient was 0.90, and the mean feasibility evaluation was 0.75. Kendall s W test showed that the expert coordination coefficient for the first round was 0.26, and for the second round, it was 0.33 ( P <0.01). After two rounds of expert consultation, a set of quality control evaluation indicators for the surveillance of common diseases among students was ultimately constructed, including 6 first level indicators, 19 second level indicators, and 37 third level indicators. Conclusion The scientifically developed evaluation indicator system facilitates high quality implementation of student common disease surveillance programs.

The Compilation Instructions for Expert Consensus on Clinical Application of Dieda Huoxue capsules systematically expound the development methods and evidence-based basis of this consensus. In view of the weak clinical application evidence and ambiguous indications of Dieda Huoxue capsules， the Institute of Basic Research in Clinical Medicine of the China Academy of Chinese Medical Sciences and Wangjing Hospital took the lead and collaborated with 33 experts from 28 medical institutions nationwide. They strictly followed the World Health Organization （WHO） guideline-making norms and the Grading of Recommendations Assessment， Development and Evaluations （GRADE） evidence-grading system and completed the compilation through multidisciplinary cooperation. The workflow included constructing clinical questions （19 items were screened by the nominal group technique）， retrieving evidence （from Chinese and English databases and grey literature）， assessing safety （integrating drug monitoring data and clinical investigations）， and forming recommendations and consensus suggestions （3 recommendations were reached via the GRADE grid method， and 16 consensus suggestions were reached by the majority vote rule）. The results indicate that the consensus clearly states that this medicine （Dieda Huoxue capsules） is applicable to conditions like traumatic injury， blood stasis-induced pain， and sudden lumbar sprains. The recommended dose is 6 capsules each time， twice a day. Combining oral administration with external application can enhance the efficacy， and elderly patients should take the medicine at intervals. Safety monitoring suggests that it should be used with caution in people with a bleeding tendency and those with an allergic constitution. The compilation process involved three rounds of reviews by internal and external experts. Literature analysis， the Delphi method， and clinical applicability tests were employed to ensure methodological rigor. The compilation instructions comprehensively present key aspects such as project approval and registration， conflict-of-interest statements， and evidence evaluation through 12 appendices， providing methodological support for the clinical translation of the consensus. In the future， it will be continuously improved through a dynamic revision mechanism.

Objective: To investigate the knowledge, attitudes, practices (KAP) and the situation of home blood pressure monitoring (HBPM) among hypertension patients in rural areas of Shanghai Municipality, so as to provide a basis for enhancing blood pressure management in this population. Methods: From June to October 2021, hypertension patients under management in Luodian Town and Luojing Town of rural areas of Shanghai Municipality were selected as survey subjects using a multistage random sampling method. Demographic information, KAP related to hypertension, and HBPM status were collected through questionnaire surveys. Patients were categorized into short disease duration (≤5 years), medium disease duration (6-10 years), and long disease duration (≥11 years) groups. KAP and HBPM status across different disease duration groups were analyzed statistically. Results: A total of 2 894 hypertensive patients were surveyed, including 1 317 (45.51%) males and 1 577 (54.49%) females. The median age was 69.00 (interquartile range, 10.00) years. There were 610 cases with short disease duration, accounting for 21.08%; 629 cases with medium duration, accounting for 21.73%; and 1 655 cases with long duration, accounting for 57.19%. The awareness of "hypertension control measures" was relatively high (97.89%), while awareness of "hypertension complications" was relatively low (71.70%). The adherence rate of "not perceiving difficulty in remembering to take medication on time and in correct doses" was relatively low (78.89%), and the proportion of participants who "walked ≥10 minutes per session at least once in the past 7 days" was relatively high (80.48%). A total of 1 209 cases (41.78%) engaged in HBPM, including 233 cases with short disease duration (19.27%), 252 cases with medium disease duration (20.84%), and 724 cases with long disease duration (59.88%). Compared with long disease duration hypertension patients, those with short disease duration had a alower awareness of "principles of pharmacological treatment for hypertension", a lower adherence rate of "medication should not be stopped after blood pressure control", and a lower proportion of providing their blood pressure measurement results to doctors (all P<0.017). However, they had higher proportions of alcohol consumption and daily salt intake >6 g/d (both P<0.017). Conclusions Short disease duration hypertension patients exhibit poorer performance in hypertension-related KAP and HBPM compared to long disease duration patients in rural areas of Shanghai Municipality. It is recommended to implement tailored health education based on disease duration, promote HBPM, and enhance blood pressure control rate.

PURPOSE: To investigate the protective effect of sub-hypothermic mechanical perfusion combined with membrane lung oxygenation on ischemic hypoxic injury of yorkshire brain tissue caused by traumatic blood loss. METHODS: This article performed a random controlled trial. Brain tissue of 7 yorkshire was selected and divided into the sub-low temperature anterograde machine perfusion group (n = 4) and the blank control group (n = 3) using the random number table method. A yorkshire model of brain tissue injury induced by traumatic blood loss was established. Firstly, the perfusion temperature and blood oxygen saturation were monitored in real-time during the perfusion process. The number of red blood cells, hemoglobin content, NA⁺, K⁺, and Ca²⁺ ions concentrations and pH of the perfusate were detected. Following perfusion, we specifically examined the parietal lobe to assess its water content. The prefrontal cortex and hippocampus were then dissected for histological evaluation, allowing us to investigate potential regional differences in tissue injury. The blank control group was sampled directly before perfusion. All statistical analyses and graphs were performed using GraphPad Prism 8.0 Student t-test. All tests were two-sided, and p value of less than 0.05 was considered to indicate statistical significance. RESULTS: The contents of red blood cells and hemoglobin during perfusion were maintained at normal levels but more red blood cells were destroyed 3 h after the perfusion. The blood oxygen saturation of the perfusion group was maintained at 95% - 98%. NA⁺ and K⁺ concentrations were normal most of the time during perfusion but increased significantly at about 4 h. The Ca²⁺ concentration remained within the normal range at each period. Glucose levels were slightly higher than the baseline level. The pH of the perfusion solution was slightly lower at the beginning of perfusion, and then gradually increased to the normal level. The water content of brain tissue in the sub-low and docile perfusion group was 78.95% ± 0.39%, which was significantly higher than that in the control group (75.27% ± 0.55%, t = 10.49, p < 0.001), and the difference was statistically significant. Compared with the blank control group, the structure and morphology of pyramidal neurons in the prefrontal cortex and CA1 region of the hippocampal gyrus were similar, and their integrity was better. The structural integrity of granulosa neurons was destroyed and cell edema increased in the perfusion group compared with the blank control group. Immunofluorescence staining for glail fibrillary acidic protein and Iba1, markers of glial cells, revealed well-preserved cell structures in the perfusion group. While there were indications of abnormal cellular activity, the analysis showed no significant difference in axon thickness or integrity compared to the 1-h blank control group. CONCLUSIONS Mild hypothermic machine perfusion can improve ischemia and hypoxia injury of yorkshire brain tissue caused by traumatic blood loss and delay the necrosis and apoptosis of yorkshire brain tissue by continuous oxygen supply, maintaining ion homeostasis and reducing tissue metabolism level.
Animals ; Perfusion/methods* ; Disease Models, Animal ; Brain Injuries/etiology* ; Swine ; Male ; Hypothermia, Induced/methods*