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 early effects of birth weight at different gestational ages on blood pressure trajectory among primary school students, so as to provide evidence for incorporating gestational age birth weight into individualized early warning and intervention strategies for childhood hypertension. Methods: From May to November 2023, a purposeful sampling method was used to recruit 1 676 students in grade 1-3 from three primary schools in a certain urban district of Chongqing. Follow up assessments were conducted in May 2024(T1), November 2024(T2), and May 2025(T3). General demographic and birth related information were collected via self administered questionnaires, while height, weight and blood pressure were obtained through physical examinations. Linear mixed effects model was used to analyze the associations between birth weight at different gestational ages and blood pressure trajectories. Results: During the T1-T3 period, the systolic blood pressure of boys were 98.5 (93.0, 104.5 ),98.5 (93.5, 105.0), and 97.5 (92.5, 103.5)mmHg, respectively, while the diastolic blood pressure were 60.5 (56.5, 65.0), 61.5 ( 57.0 , 65.5), and 60.0 (56.0, 64.0)mmHg, respectively. For girls, the systolic blood pressure were 95.5 (90.0, 102.0),95.5 (90.5, 101.5), and 96.0 (90.5, 101.5)mmHg, respectively, and the diastolic blood pressure were 60.5 (56.0, 64.5 ),61.5 (57.5, 65.5), and 59.5 (56.0, 63.0)mmHg, respectively. Through Friedman test within both boys and girls, diostolic blood pressure were statistically significant across three measurements( χ 2=48.85，81.54，both P <0.01). The proportion of normal blood pressure increased , and the proportion of prehypertension and hypertension decreased with time( χ 2=39.72，25.62，both P < 0.01 ). Linear mixed effects model analysis revealed that after adjusting for age, sex, household income monthly, parental education, family history of hypertension and maternal pregnancy complications, large for gestational age had significantly higher trajectories of systolic ( β = 1.50) and diastolic( β =0.94) blood pressure compared to appropriate for gestational age(both P <0.01). Conclusion Large for gestational age is associated with elevated blood pressure trajectories during school age, and it may be considered as an early indicator for individualized screening and intervention for childhood hypertension.

OBJECTIVE To systematically analyze the population pharmacokinetics （PPK） studies of lacosamide and expound the influential factors of its pharmacokinetics in different populations. METHODS PPK studies of lacosamide were collected by searching the databases， such as Web of Science， PubMed， Embase， Metasearch， CNKI， Wanfang Data and VIP， both in Chinese and English. Relevant data were extracted， and the Prediction Model Risk of Bias Assessment Tool was used to evaluate the quality of the PPK models in the included studies. RESULTS Among 8 studies ultimately included， 6 were retrospective studies and 2 were prospective studies； 5 studies involved pediatric patients. Seven studies adopted a one-compartment model， while 1 study utilized a two-compartment model. Four studies had a model quality rating of grade A， two of grade B and two of grade C， respectively. Body weight， renal function， and hepatic enzyme inducers were significant covariates influencing PPK of lacosamide. CONCLUSIONS The existing PPK studies of lacosamide are predominantly conducted in pediatric populations. Pharmacokinetic variability is mainly influenced by body weight， renal function， and hepatic enzyme inducers. However， most PPK studies have not conducted external validation， and the generalizability of the models remains to be confirmed.

Based on the opening-closing-pivot theory， this paper proposes that adolescent bipolar disorder is closely associated with taiyin （太阴）， shaoyang （少阳）， and jueyin （厥阴） channels. The principal pathogenesis involves dysfunction of the opening function of taiyin， impaired pivot function of shaoyang， and failure of the closing function of jueyin. Accordingly， the therapeutic principles include regulating taiyin to restore the ascending and descending movement of qi， harmonizing shaoyang to facilitate the pivot mechanism， and balancing yin and yang to reinforce the closing and storing function of jueyin. In clinical practice， Yihuang Powder （益黄散） and Tongxie Important Formula （痛泻要方） are commonly prescribed to regulate the qi movement of taiyin and restore its ascending and transporting functions， while Xiaochaihu Decoction （小柴胡汤） and Sini Powder （四逆散） are used to regulate the shaoyang pivot， and Wumei Pill （乌梅丸）， Danggui Sini Decoction （当归四逆汤）， and Huanglian Ejiao Decoction （黄连阿胶汤） combined with Shaoyao Gancao Decoction （芍药甘草汤） are employed to harmonize the jueyin closing mechanism. In addition， traditional daoyin （导引） exercise yi jin jing （易筋经） is incorporated to simultaneously regulate the body and mind by guiding internal regulation through external movement， thereby calming the body and tranquilizing the mind.

Based on the opening-closing-pivot theory， this paper proposes that adolescent bipolar disorder is closely associated with taiyin （太阴）， shaoyang （少阳）， and jueyin （厥阴） channels. The principal pathogenesis involves dysfunction of the opening function of taiyin， impaired pivot function of shaoyang， and failure of the closing function of jueyin. Accordingly， the therapeutic principles include regulating taiyin to restore the ascending and descending movement of qi， harmonizing shaoyang to facilitate the pivot mechanism， and balancing yin and yang to reinforce the closing and storing function of jueyin. In clinical practice， Yihuang Powder （益黄散） and Tongxie Important Formula （痛泻要方） are commonly prescribed to regulate the qi movement of taiyin and restore its ascending and transporting functions， while Xiaochaihu Decoction （小柴胡汤） and Sini Powder （四逆散） are used to regulate the shaoyang pivot， and Wumei Pill （乌梅丸）， Danggui Sini Decoction （当归四逆汤）， and Huanglian Ejiao Decoction （黄连阿胶汤） combined with Shaoyao Gancao Decoction （芍药甘草汤） are employed to harmonize the jueyin closing mechanism. In addition， traditional daoyin （导引） exercise yi jin jing （易筋经） is incorporated to simultaneously regulate the body and mind by guiding internal regulation through external movement， thereby calming the body and tranquilizing the mind.

ObjectiveTo provide a clinical reference for rational selection of the methods for common bile duct closure after laparoscopic common bile duct exploration （LCBDE） in patients with recurrent choledocholithiasis （RCL）. MethodsA retrospective analysis was performed for the clinical data of 121 patients with RCL who underwent LCBDE in the Department of Hepatopancreatobiliary Surgery， The Affiliated Hospital of North China University of Science and Technology， from February 2022 to December 2025， and according to the method for common bile duct closure， the patients were divided into primary duct closure group （PDC group with 58 patients） and T-tube drainage group （TTD group with 63 patients）. The two groups were compared in terms of time of operation， drainage volume on day 1 after surgery， total bilirubin level on day 3 after surgery， time to diet after surgery， time to drainage tube removal after surgery， common bile duct diameter at 1 week after surgery， length of postoperative hospital stay， total hospitalization costs， and complications， and the risk factors for postoperative complications were analyzed. The independent-samples t test or the Mann-Whitney U test was used for comparison of continuous data between groups， and the chi-square test or the Fisher’s exact test was used for comparison of categorical data between groups. The multivariate Logistic regression analysis was used to identify influencing factors for postoperative complications. ResultsCompared with the TTD group， the PDC group had a significantly shorter time of operation ［48.50 （39.00 — 59.25） min vs 55.00 （46.00 — 69.00） min， Z=-2.726， P=0.006］， a significantly lower level of total bilirubin on day 3 after surgery ［17.25 （14.43 — 21.30） μmol/L vs 20.06 （16.40 — 29.30） μmol/L， Z=-2.950， P=0.003］， a significantly shorter time to diet after surgery ［1 （1 — 1） d vs 1 （1 — 2） d， Z=-4.506， P<0.001］， a significantly shorter time to drainage tube removal after surgery ［7 （7 — 7） d vs 8 （8 — 9） d， Z=-9.693， P<0.001］， a significantly shorter length of postoperative hospital stay ［8 （8 — 8） d vs 10 （9 — 11） d， Z=-8.960， P<0.001］， and significantly lower total hospitalization costs ［21 750 （20 369 — 23 310） yuan vs 24 889 （23 438 — 26 920） yuan， Z=-5.572， P<0.001］， and common bile duct diameter at 1 week after surgery in the PDC group was closer to the normal physiological anatomical structure of the biliary tract compared with that in the TTD group ［1.0 （0.9 — 1.1） cm vs 1.0 （1.0 — 1.1） cm， Z=-2.064， P=0.039］. Compared with the TTD group， the PDC group had significantly lower incidence rates of total complications （10.34% vs 26.98%， P=0.024） and electrolyte disturbance （1.72% vs 15.87%， P=0.006）. The multivariate logistic regression analysis showed that common bile duct diameter <1.3 cm before surgery and total bilirubin level ≥21.0 μmol/L before surgery were independent risk factors for postoperative complications， while primary duct closure was an independent protective factor against postoperative complications （P<0.05）. ConclusionUnder the premise of strict control of indications， PDC after LCBDE for RCL patients can accelerate recovery and reduce complications and hospitalization costs， thereby demonstrating greater advantages in clinical application.

With the rapid development of bioscience and biotechnology， xenotransplantation offers a new possibility for alleviating organ shortage， yet it also faces numerous ethical challenges. This paper discussed the major ethical issues involved in the clinical research of xenotransplantation， including the assessment of risk-benefit ratio， animal ethics， the particularity of informed consent， equity， conflicts in social ethical concepts， and other aspects. It was proposed that carrying out xenotransplantation clinical research requires comprehensive consideration of various factors. That is， it is necessary to adhere to the principle of “strict management and prudent development” while strengthening whole-process safety control， improve the relevant legal and regulatory system while building a full-chain supervision framework， establish and perfect ethical review committees while reinforcing the multi-level review and supervision mechanism， enhance animal welfare protection while following the ethical principle of reduction， replacement， and refinement， optimize the informed consent procedure while implementing continuous and dynamic informed consent， promote coordinated global governance while popularizing public science education， to ensure that the clinical research of xenotransplantation advances steadily on an ethically and morally sound track.

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.