中国科技论文统计源期刊 中文核心期刊
美国《化学文摘》《国际药学文摘》
《乌利希期刊指南》
WHO《西太平洋地区医学索引》来源期刊
日本科学技术振兴机构数据库（JST）
第七届湖北十大名刊提名奖
美国《化学文摘》《国际药学文摘》
《乌利希期刊指南》
WHO《西太平洋地区医学索引》来源期刊
日本科学技术振兴机构数据库（JST）
第七届湖北十大名刊提名奖
Generative Artificial Intelligence (GenAI) is rapidly permeating various fields of hospital pharmacy, bringing transformative opportunities to prescription review, clinical medication decision-making, patient education, and pharmacy administration. However, challenges remain in ensuring the professional accuracy of generated content, maintaining output stability, and achieving adequate controllability of model outputs. As the primary interface for human-AI interaction in healthcare, prompt design critically determines the professionalism, safety, and regulatory compliance of AI outputs. Yet, standardized prompt frameworks tailored to the complex practice scenarios of hospital pharmacy remain unavailable. Therefore, the Chinese Hospital Association Pharmaceutical Specialized Committee, the National Institute of Hospital Administration Pharmaceutical Information Expert Committee and the Chinese Association for Artificial Intelligence Bioinformatics and Artificial Life Specialized Committee led a multidisciplinary collaboration to develop the consensus. This consensus formulated 14 recommendations, proposing general principles for GenAI application in hospital pharmacy and methodologies for prompt design. It clarified the application boundaries and differentiated prompt design essentials for five core scenarios-pharmaceutical care, pharmacy education, pharmaceutical research, pharmacy administration, and popular science in pharmacy. Also, it highlighted the current limitations of GenAI applications. As the first expert consensus in the field of hospital pharmacy focusing on GenAI application and prompt engineering, it aims to provide systematic theoretical guidance and practical tools for pharmacy professionals, standardize the rational application of GenAI, enhance the quality of intelligent pharmaceutical services, and ultimately promote high-quality development of hospital pharmacy.
Objective To provide guidance and reference for promoting the scientific, standardized and efficient medication selection process in primary healthcare institutions, further aiding in “enhancing services, building capacities, and improving management”. Methods A multidisciplinary expert panel comprising pharmacists, clinicians, medical administrators and health administration officials was jointly convened by the Beijing Pharmaceutical Quality Control and Improvement Center, the Institute for Drug Evaluation of Peking University Health Science Center, the Beijing Community Prescription Review Working Group, and Peking University Third Hospital. Guided by relevant laws, regulations and policy documents, as well as the previously developed “Method for Medication Selection in Medical Institutions Based on Clinical Comprehensive Evaluation”, the panel conducted multiple rounds of expert discussions and achieved consensus through a modified Delphi process. Results A total of five recommendations were developed to standardize medication selection procedures in primary-level medical institutions, covering the initiation of medication selection, identification of candidate medicines, determination of medicines for evaluation, preparation of comprehensive evaluation information sheets, and organization of selection meetings. In particular, the recommendations optimize the criteria for identifying medicines requiring evaluation by explicitly addressing the functional characteristics and practical needs of primary-level medical institutions. In addition, ten recommendations were formulated regarding the dimensions and criteria of comprehensive medication selection evaluation, encompassing effectiveness, safety, economic value, suitability, accessibility, and innovativeness. These recommendations place special emphasis on operational feasibility in primary-level settings and on coordination of medication use across different levels of healthcare institutions. Conclusion This expert consensus is expected to contribute to the standardization, transparency, and evidence-based implementation of medication selection and evaluation processes in primary-level medical institutions.
The prevention and treatment of pediatric thrombosis have garnered growing clinical attention. In 2024, multiple Chinese institutions jointly released the "Pharmaceutical Practice Guidelines for Prevention and Treatment of Thrombotic Diseases in Children," while the American Society of Hematology/International Society on Thrombosis and Haemostasis (ASH/ISTH) also published an updated "Guidelines for the Management of Venous Thromboembolism in Pediatric Patients." Given significant differences in framework design and specific recommendations between these two guidelines, this article conducts a comparative analysis of their core principles for pediatric thrombosis management, aiming to optimize clinical decision-making for pediatric thromboembolic diseases.
Objective To investigate the effect and mechanism of Tanshinone ⅡA (TanⅡA) on airway inflammation and remodeling in the ashmatic mice. Methods Female BALB/c mice aged 7-8 weeks were divided into three groups: control, model, and TanⅡA group. An asthma model was established using ovalbumin (OVA) sensitization and challenge. 10 mg·kg-1 TanⅡA administration began on the third day post-sensitization via oral gavage twice daily for seven consecutive days. The proportions of eosinophils, neutrophils, and monocytes in bronchoalveolar lavage fluid (BALF) were analyzed. Levels of IL-4, IL-5, IL-13, VEGF, and TGFβ1 in BALF were measured by ELISA. Histopathological changes in lung tissues were examined by HE staining; collagen deposition by Masson trichrome staining; goblet cell hyperplasia and mucus secretion by PAS staining. Western blotting was used to detect the expression levels of p38MAPK, p-p38 MAPK, MMP9, AKT, p-AKT, and Collagen Ⅰ. Immunohistochemistry was performed to assess the expression of HIF-1α and NF-κB p65 in lung tissues. Molecular docking tested the binding affinity between TanⅡA and MAPK as well as AKT. Results Compared with the control group, the model group exhibited significantly increased levels of inflammatory cytokines and cellular ratios in BALF (P<0.01), along with evident pulmonary tissue damage, collagen deposition, and goblet cell hyperplasia with excessive mucus production. Administration of TanⅡA markedly reversed these phenomena (P<0.05). Moreover, TanⅡA treatment downregulated the expression of key proteins in the MAPK/NF-κB and AKT/HIF-1α signaling pathways. Additionally, the binding energies of TanⅡA with p38 MAPK and AKT were -27.53 and -28.12 kJ·mol-1, respectively, indicating good binding capabilities. Conclusion TanⅡA can significantly alleviate airway inflammation and remodeling in asthmatic mice, characterized by reduced secretion of inflammatory cytokines and decreased ratios of eosinophils, monocytes, and neutrophils, as well as mitigated pathological injury in lung tissues. Its mechanism may involve inhibition of the p38 MAPK/NF-κB and AKT/HIF-1α signaling pathways.
Objective To investigate the dual molecular mechanisms of osthole (OST) against diarrhea. Methods An experimental diarrhea model was established in mice induced by castor oil (20 mL·kg-1). Mice were randomly divided into model control group, low-dose (37.5 mg·kg-1), medium-dose (75 mg·kg-1) and high-dose (150 mg·kg-1) OST groups and loperamide group (4 mg·kg-1). The antidiarrheal effect and intestinal motility/secretion function were evaluated using fecal morphology, excretion index (EI), ink propulsion test, and intestinal fluid accumulation test. The inhibitory effects of OST on spontaneous contraction and contractions induced by carbachol (CCh), high/low potassium were analyzed using an ex vivo jejunum experiment. The calcium channel blocking effect was detected using a calcium depletion-reperfusion model. The activities of cyclic adenosine monophosphate (cAMP)and phosphodiesterase (PDE) were determined via enzyme-linked immunosorbent assay (ELISA). The interaction between OST and PDE4B/4D was analyzed using molecular docking (Autodock Vina). Results Compared with model control group, OST significantly delayed the initial appearance time of semi-solid (high-dose: 97.67±6.93 vs. 60.25±6.51 min,P<0.01) and reduced EI (2.69±2.66 vs. 13.56±1.81, P<0.01), with efficacy comparable to loperamide. OST inhibited the small intestinal propulsion rate, intestinal fluid secretion, and jejunal contractions, showing a concentration-dependent manner, and right-shifted the Ca2+ concentration-response curve. OST up-regulated cAMP and inhibited PDE activity. Molecular docking confirmed OST’s binding affinity to PDE4B/4D (-33.05 kJ·mol-1), involving Asn567 hydrogen bonds and Phe586 π-π stacking. Conclusions OST exerts antidiarrheal effects through dual mechanisms: inhibiting calcium channels (reducing Ca2+influx) and blocking PDE4 activity (elevating cAMP). Its multi-target properties provide scientific insights for developing plant-based antidiarrheal drugs.
Objective This study comprehensively employed computer simulation molecular docking technology and surface plasmon resonance (SPR) technology to investigate the interaction between semaglutide and human serum albumin (HSA). Methods Molecular docking simulations were conducted using two software tools, Autodock Vina and Discovery Studio (DS), to reveal the structural interaction pattern between semaglutide and HSA, identifying the binding site and key amino acid residues. Additionally, to address the limitations of traditional SPR analysis methods, an innovative approach was proposed, using semaglutide as the conjugated ligand and single-cycle kinetics as the analytical method. Results In the Autodock Vina and Discovery Studio docking simulations, the affinity scores between semaglutide and HSA were -66.88 and -24.24 kJ·mol-1, respectively, indicating strong interactions. Furthermore, in the SPR-based analysis, the sensor plots from multi-cycle kinetics and single-cycle kinetics experiments both aligned with the kinetic model. Using the 1∶1 Langmuir kinetic model to fit the curves, no significant difference was observed in the binding affinity of semaglutide to HSA between the two manufacturers. Conclusions The improved SPR analysis method can measure the binding affinity more accurately and is highly consistent with the results of molecular simulation. It provides a new technical means and theoretical basis for the development of GLP-1 analogues.
Objective To systematically analyze the trends and dynamic characteristics of clinical trials for innovative drugs in China from 2020 to the first half of 2025, and to provide data-informed insights for policy formulation and industry decision-making. Methods Data on innovative drug clinical trials initially disclosed from January 1, 2020, to June 30, 2025, were extracted from the PharmaGo database (Pharmcube). Estimates of China's disease burden for 2023 were obtained from the University of Washington’s Global Burden of Disease (GBD) database. The analysis covered multiple dimensions: trends in trial volume, drug type, trial phase, disease area distribution, alignment with disease burden, and geographical distribution of sponsors and major research institutions. Results The number of innovative drug clinical trials in China showed sustained growth. Over 80% of trials were sponsored by domestic entities, and more than half were in Phase I. Biological products and chemical drugs accounted for comparable proportions. Nearly 60% of trial projects focused on oncology, endocrine/metabolic diseases, and hematologic/immune disorders, which collectively represented less than 25% of the total disease burden. In contrast, cardiovascular and cerebrovascular diseases, comprising less than 5% of trials, accounted for over 26% of the disease burden. The geographical distribution of both sponsors and primary research institutions was highly concentrated, with the top five provinces responsible for more than 70% of trial projects. Conclusions China's innovative drug clinical trials continue to increase in number, dominated by domestically developed drugs and early-phase studies. A significant mismatch exists between R&D focus and disease burden, and trial resources are heavily concentrated in coastal regions. It is recommended that policymakers encourage more clinical value-driven drug development and promote regionally balanced allocation of trial resources. Enterprises, in turn, should consider optimizing their R&D pipelines based on disease burden, thereby fostering efficient and balanced growth of the innovative drug sector.
Objective To establish an in vivo and in vitro microdialysis method for the simultaneous determination of gastrodin (Gas) and parishin B (PB) from Gastrodia elata, as well as four brain neurotransmitters, using high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). Methods Both forward (loss) and reverse (gain) dialysis approaches were applied in combination with HPLC-MS/MS to investigate the probe recovery rates of Gas, PB and the neurotransmitters glutamate (Glu), γ-aminobutyric acid (GABA), valine (Val), and 5-hydroxytryptamine (5-HT) in vitro and in vivo. Factors influencing probe recovery, including perfusion flow rate, drug concentration, number of probe uses, and stability, were systematically evaluated to optimize the analytical method. Results The effects of different perfusion flow rates (1.5, 2.0 and 2.5 μL·min-1) indicated an inverse relationship between flow rate and probe recovery. Considering sample volume requirements, 2.0 μL·min-1 was selected for subsequent experiments. Probe recovery remained consistent across different drug concentrations in both in vitro and in vivo settings, suggesting that recovery is independent of concentration. Furthermore, probe stability was maintained within 8 hours. Each probe could be reused up to three times after prior recovery calibration. Conclusions The established microdialysis method is suitable for conducting pharmacokinetic-pharmacodynamic (PK-PD) studies of gastrodin and parishin B from ultrafine powder of Gastrodia elata in the brain.
The pharmacological effects of compound Danshen dripping pills (CDDP) in the treatment of diabetic retinopathy (DR) are attributed to various bioactive constituents, including saponins, phenolic acids, and diterpene quinones. Researches indicate that CDDP exerts therapeutic effects against DR through multiple pathways, such as protecting vascular endothelial cells, inhibiting pathological neovascularization, improving hemorheology, regulating blood lipid levels, and promoting the repair of retinal microstructure. However, the precise mechanisms underlying its preventive and therapeutic actions in DR remain incompletely understood. This review provides an overview of recent advances in the pharmacodynamic material basis, pharmacological activities, and associated mechanisms of CDDP. It aims to offer a scientific foundation for the clinical application and further development of CDDP, as well as for the research and development of novel therapies for diabetic retinopathy.
Objective To explore the protective effects of nuciferine against LPS-triggered endothelial inflammation and elucidate the underlying molecular mechanisms in HUVECs. Methods HUVECs were cultured in vitro and pre-treated with escalating concentrations of nuciferine (0.6, 1.25, 2.5, 5, 10, 20 μmol·L-1) for 24 hours, followed by 12-hour stimulation with LPS (1 μg·mL-1). Cell viability was assessed via CCK-8 assay to determine the optimal nuciferine concentration (10 μmol·L-1), which was then used for subsequent experiments. HUVECs were randomized into four groups: blank control group; nuciferine group (10 μmol·L-1); LPS group (1 μg·mL-1); LPS (1 μg·mL-1) + nuciferine (10 μmol·L-1). Quantitative real-time PCR (qRT-PCR) and enzyme-linked immunosorbent assay (ELISA) were performed to quantify mRNA and protein levels of inflammatory cytokines, including interleukin-1β (IL-1β), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α). Western blotting was employed to analyze protein expression of cyclooxygenase-2 (COX2), inducible nitric oxide synthase (iNOS), B-cell lymphoma-2 (Bcl-2), Bcl-2-associated X protein (Bax), cleaved caspase-3 (c-caspase-3), Toll-like receptor 4 (TLR4), IκB kinase β (IKKβ), nuclear factor of kappa light polypeptide gene enhancer in B-cells inhibitor α (IκBα), and nuclear factor κB p65 subunit (p65). Immunofluorescence staining was used to visualize p65 nuclear translocation. Results Compared with the control group, LPS stimulation significantly reduced cell viability (P<0.01), upregulated mRNA and protein levels of IL-1β, IL-6, and TNF-α, increased protein expression of COX2 and iNOS (P<0.01), and elevated the Bax/Bcl-2 ratio and c-caspase-3 levels (P<0.01). In contrast, co-treatment with nuciferine and LPS significantly attenuated LPS-induced cytotoxicity (P<0.05), suppressed pro-inflammatory cytokine production, mitigated apoptosis, and downregulated the Bax/Bcl-2 ratio and cleaved c-caspase-3 levels (P<0.05). Conclusion Nuciferine exerts protective effects against LPS-induced endothelial inflammation and apoptosis via suppression of the TLR4/NF-κB cascade, offering mechanistic insights and potential therapeutic strategies for sepsis.
Objective To identify the blood-entering components of Cichorium glandulosum (CG) that ameliorate cholestatic liver injury, and to clarify its pharmacodynamic substances and mechanisms. Methods The active components of CG were determined using high performance liquid chromatography-ultraviolet spectrophotometry (HPLC-UV), and the systemic exposure of these components was analyzed by profiling the constituents absorbed into the rat blood. The effective components were screened using the cell counting kit-8 (CCK-8). An α-Naphthyl-isothiocyanate (ANIT)-induced mouse model of intrahepatic cholestasis (IHC) was established, mouse have been divided into normal control, model control, and small-, medium-, and large-dose esculin groups (20, 40, and 80 mg·kg-1). Liver histopathological changes were assessed using haematoxylin and eosin (HE) staining, and serum biochemical markers (ALT, AST, ALP, TBA and T-BiL) were measured. The expression levels of miR-200b and the apoptosis-related gene(Bcl2) and proteins(Bcl2, c-caspase 3) were detected by RT-qRCR and immunohistochemistry, respectively. Hepatocyte apoptosis was assessed by TUNEL assay. Results HPLC-UV analysis identified several active components in CG, including esculin, esculetin, lactucin, cichoric acid, and lactupicrin. However, only esculin, cichoric acid, and lactucin were confirmed to be absorbed into the systemic circulation in rats. In vitro, only esculin significantly ameliorated ANIT-induced injury in HepG2 cells(P<0.01). In vivo, a large dose of esculin alleviated liver histopathology, inhibit hepatocyte apoptosis, significantly reduced serum levels of ALT, AST, ALP, TBA, and T-BiL (P<0.05). It also down-regulated the expression of miR-200b in liver tissue(P<0.01). Concurrently, it upregulated both mRNA and protein expression of Bcl2 (P<0.01). Conclusion Esculin is one of the bioactive substances critical to the anti-cholestatic effect of CG, and its mechanism may be to alleviate hepatocyte injury by inhibiting the miR-200b-Bcl2/caspase 3 apoptotic signaling pathway.
Objective To introduce the design ideas and functions of the intelligent dispensing check system of pharmacy intravenous admixture services (PIVAS) independently developed by our hospital, and to evaluate its application effect. Methods Based on the visual AI analysis technology, the data of drug varieties, quantities and label images were collected in the PIVAS dispensing stage, and a set of intelligent dispensing verification system integrating drug verification, user information management, dispensing operation prompts, refund reminders and statistical analysis functions was constructed by combining hardware equipment such as cameras and code scanners and software systems connected to the hospital intranet. Evaluate the application value of the system by comparing the performance indicators before and after its application. Results After the implementation of the intelligent liquid dispensing verification system, visual recognition related mixing errors were significantly reduced (P<0.05),and the error detection accuracy of the intelligent liquid dispensing verification system was 97.67%;The reported loss amount due to allocation errors has significantly decreased from (258.96±53.31) yuan per month before the system application to (76.23±23.19) yuan per month after the system application (P<0.05);There was no significant change in PIVAS dispensing efficiency before and after the application of intelligent dispensing verification system;The satisfaction rate of department employees has significantly increased from 70% to 95% (P<0.05). Conclusion The PIVAS intelligent liquid dispensing check system significantly improves the accuracy and safety of liquid dispensing, greatly reduces the work intensity of employees, and provides an efficient, accurate and intelligent solution for quality control management, which has high application value.
Objective To establish a quality management and evaluation system for the pharmacy intravenous admixture service (PIVAS) to ensure patient medication safety. Methods A three-tier PIVAS quality control system at the hospital-department-unit levels was constructed based on the structure-process-outcome (SPO) three-dimensional quality model. A set of quantitative quality control evaluation indicators for PIVAS was formulated through literature review and team discussions. By defining quality control indicators and clarifying responsibilities at each level, the study aimed to achieve stratified and refined management, enable dynamic continuous improvement, and facilitate long-term data tracking for PIVAS quality control. Results Following the implementation of quality control management, the hospital-level inspection score for PIVAS improved from 79 to 93. The department-level and unit-level quality control scores increased significantly from (71.0±3.6) and (100.0±3.9) to (94.7±2.5) and (140.7±4.6), respectively (P<0.05). Post-intervention metrics showed a reduction in the number of internal and external discrepancies, as well as in instances of non-compliant residual quantities. Improvements were also observed in the timeliness and accuracy of infusion delivery by support staff. Furthermore, clinical department satisfaction rates rose from (78.7±5.0)% to (91.7±3.5)% (P<0.05). Conclusion The three-tier (hospital-department-unit) PIVAS quality control system developed in this study, grounded in the SPO theory, comprehensively addresses critical risk points across the entire intravenous admixture workflow. It establishes clear evaluation criteria for PIVAS quality management and has proven effective in enhancing the overall level of PIVAS quality control.
Objective To establish a standardized and rational workflow for the dispensing and management of good clinical practice (GCP) trial intravenous drugs by implementing a centralized pharmacy intravenous admixture service (PIVAS) model in the first affiliated hospital of Guangxi medical university, thereby exploring an enhanced management approach for these critical preparations. Methods Building on the operational experience of our hospital's PIVAS, a detailed analysis of key steps and essential considerations were conducted in the workflow for dispensing GCP trial intravenous drugs. A retrospective statistical analysis was performed, comparing data from departmental dispensing in 2023 (control group) with data from centralized PIVAS dispensing in 2024 (observation group). Metrics assessed included dispensing errors, contamination incidents, occupational exposure risks, labor costs, and operational efficiency. Results Centralizing GCP trial intravenous drug dispensing within the PIVAS significantly improved process standardization and safety outcomes. Specifically, internal procedural discrepancies decreased by 3 instances, dispensing errors were reduced by 1 case, and cross-contamination events dropped by 6 cases (P<0.05). This model enhanced drug safety and reliability, contributing to the integrity and authenticity of trial data. Conclusion Utilizing the PIVAS for GCP trial intravenous drug dispensing ensures both the rational use of medications and a safer, more controlled preparation environment. It represents a significant advancement in the management level of GCP trial drug dispensing and serves as a pivotal strategy for elevating overall hospital GCP compliance and quality standards.
Objective To compare the differences between intelligent and manual dispensing modes for antineoplastic drugs in terms of finished infusion quality and environmental contamination risk, thereby providing practical evidence to support the adoption of intelligent dispensing systems. Methods Finished infusions were assessed for dose accuracy (using the weighing method), sterility (via media fill tests), and insoluble particulate levels (by light obscuration) under both dispensing modes. Environmental contamination risk was evaluated by measuring antineoplastic drug residues on infusion bag surfaces, personnel protective equipment (PPE), and within the dispensing environment using high-performance liquid chromatography-tandem mass spectrometry. Results The absolute dispensing error was lower in the machine group compared to the manual group, although statistical significance depended on the drug tested [cisplatin: (0.22±0.19)% vs. (1.56±0.95)%, P<0.05; carboplatin: (0.28 ±0.20)% vs. (4.40±0.61)%, P<0.05; irinotecan: (1.83±0.28)% vs. (2.71±2.42)%, P>0.05]. The machine group also showed better intra-group consistency. No bacterial contamination was detected in finished infusions from either group. Insoluble particulate levels complied with the Chinese Pharmacopoeia (2020 edition) in both groups. Antineoplastic drug residues on infusion bag surfaces, PPE, and in the dispensing environment were consistently lower in the machine group, with the significance of the difference varying by drug. The machine group again demonstrated superior consistency across all residue measurements. Conclusions The intelligent dispensing mode offers a more precise and safer approach to antineoplastic drug preparation. This study provides valuable evidence to support the wider implementation of intelligent dispensing systems in pharmacy intravenous admixture services.
Objective To establish a quantitative method for simultaneous analysis of multiple trace cytotoxic drugs, determine the residual concentrations of 15 cytotoxic drugs in hospital environments, evaluate the occupational exposure level of medical staff, and provide a scientific basis for establishing an occupational exposure prevention and control system. Methods Fifteen commonly used cytotoxic drugs were selected as monitoring targets. Based on their physicochemical properties and ionization modes, four groups of analytical methods were developed using high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). Environmental contamination by cytotoxic drugs in four hospitals in Suzhou was evaluated from four dimensions: the over-standard rate, total residue per unit preparation volume, residual maximum in high-risk areas per unit volume, and residue levels of high-risk drugs per unit volume. Results The limit of quantification for the 15 target cytotoxic drugs ranged from 0.05-0.4 ng·mL-1, with a linear correlation coefficient r>0.99, precision (RSD) ≤16.7%, and accuracy (RE) within ±15%. Overall, cytotoxic drug residues in the pharmacy intravenous admixture services (PIVAS) of the four hospitals (H1-H4) were controllable, yet contamination was concentrated in core areas-specifically, biosafety cabinets and pass-through windows were identified as high-risk zones. Notable contamination was observed in the biosafety cabinets of H2, while H1 showed relatively high ifosfamide residues in its pass-through window. Cyclophosphamide, ifosfamide and docetaxel were classified as high-residue-risk drugs, whereas paclitaxel and fluorouracil exhibited elevated residues on pass-through windows and personal protective equipment. Multi-dimensional assessment revealed differences in prevention and control levels among hospitals: H4 had the lowest over-standard rate (2.1%) and the lowest residue levels per unit preparation volume, whereas H2 had the highest over-standard rate (16.4%). Conclusions This study indicates that cytotoxic drug residues in hospital environments are concentrated in core areas such as biosafety cabinets and pass-through windows, with notable variations among different drugs. Multi-dimensional evaluation demonstrates clear disparities in prevention and control measures across hospitals. Future efforts should focus on enhanced disinfection in high-residue-risk areas, optimization of protective protocols, and dissemination of effective low-residue management practices to systematically reduce occupational exposure risks for healthcare workers.
Chronic hepatitis B constitutes a major global public health challenge. Current therapeutic modalities, including nucleos(t)ide analogues and interferons, while capable of curbing viral replication, fail to eradicate covalently closed circular DNA (cccDNA). This limitation, combined with a low functional cure rate, makes the achievement of comprehensive functional remission an arduous feat. The functional cure of hepatitis B is meticulously defined as the sustained negativity of hepatitis B surface antigen (HBsAg) for no less than 24 weeks post-treatment, undetectable levels of serum hepatitis B virus DNA (HBV DNA), restoration of normal liver function, and discernible improvements in pathological and histological manifestations. This end goal represents the nucleus of contemporary research endeavors into chronic hepatitis B. In recent years, remarkable strides have been made in the research and development of novel pharmaceuticals that target distinct phases of the hepatitis B virus life cycle and modulate immune responses. By precisely targeting viral replication mechanisms or invigorating the host's immune defenses, these innovative drugs exhibit promising potential for augmenting the functional cure rate. This paper systematically summarizes various drugs targeting the functional cure of hepatitis B in recent years, delves into new strategies to improve the functional cure rate of hepatitis B, and provides a theoretical foundation for achieving a comprehensive functional cure of hepatitis B.
Senile osteoporosis and cardiovascular disease exhibit significant comorbidity, and the cardiovascular safety of anti-osteoporosis drugs poses a critical challenge in clinical decision-making. This article systematically reviews the potential cardiovascular impacts of four major classes of drugs (encompassing six specific agents) used for treating senile osteoporosis, categorized by mechanism, aiming to provide evidence-based guidance for safe pharmacotherapy in elderly osteoporotic patients. Evidence synthesis from the past five years identified that bisphosphonates show inconclusive cardiovascular protective effects, though intravenous formulations may increase atrial fibrillation risk; denosumab is associated with elevated risk of adverse cardiovascular events compared to bisphosphonates; selective estrogen receptor modulators increase venous thromboembolism and fatal stroke risks, yet may confer indirect cardiovascular benefits via lipid profile improvement; parathyroid hormone analogs require vigilance for transient dizziness and palpitations; romosozumab may heighten ischemic risk in cardiovascularly vulnerable populations, necessitating rigorous clinical history evaluation; excessive calcium supplementation (>1 200 mg/day) remains controversial for cardiovascular risk, while standard-dose vitamin D has not been consistently linked to significant cardiovascular harm. Elderly osteoporotic patients require individualized balancing of skeletal benefits against cardiovascular risks.
Alzheimer's disease (AD) is a progressive neurodegenerative disorder characterized pathologically by the formation of senile plaques and neurofibrillary tangles. The accumulation of misfolded proteins can activate innate immune responses, leading to the release of inflammatory mediators that exacerbate the severity and progression of AD. The cyclic GMP-AMP synthase (cGAS)-stimulator of interferon genes (STING) axis is a pivotal innate immune signaling pathway that detects cytoplasmic DNA and initiates immune responses.The cGAS-STING pathway triggers type I interferon-mediated neuroinflammation, which contributes to the pathogenesis of AD. In this review, we first outline the key components of the cGAS-STING signaling pathway and recent mechanistic insights into how AD-related pathological factors activate cGAS-STING to participate in AD pathogenesis. Finally, we summarize the latest advances in therapeutic strategies targeting the cGAS-STING pathway for AD treatment. This review highlights that targeting the cGAS-STING axis represents a novel potential therapeutic approach for AD.
Objective To establish and validate a reporter gene assay based on design of experiments (DOE) principles for measuring the biological activity of insulin glargine. Methods Using HEK293 cells (HEK293/IRL-Luc) stably transfected with the insulin receptor gene, STAT5b response element, and luciferase reporter gene. Key assay parameters (cell density, drug dilution factor, and drug incubation time) were optimized via response surface methodology. The method was validated in accordance with ICH Q2(R2) and the General Chapters of the Chinese Pharmacopoeia (2020 Edition), assessing specificity, precision, accuracy, linearity and repeatability. Results The optimized assay conditions were as follows: cell density ranging from 1.4×105 to 4.6×105 cells per mL, drug incubation time of 16 hours, and two-fold serial dilutions of the drug starting from an initial concentration of 600 nmol·L-1. Validation results demonstrated high specificity; precision with repeatability (GCV≤10%) and intermediate precision (GCV<12%); accuracy with relative bias and its confidence intervals within ±12% across the potency range of 64%-156%; and excellent linearity (R2=0.9908). Conclusions The reporter gene assay optimized based on DOE and established in this study features straightforward operation and accurate results, enhances detection throughput and reproducibility, and demonstrates strong consistency with the mouse blood glucose method. It provides an in vitro alternative approach compliant with the "3R" principles for the quality control of recombinant human insulin products.
As a mainstream oral preparation to promote leukocytosis in China, Leucogen is widely used in clinical practice for the prevention and treatment of leukopenia, thrombocytopenia, aplastic anemia and other related conditions. In order to improve drug quality control, Chinese Pharmacopoeia Commission had led the enhancement of the national drug standards for leucogen and its tablets, which have been newly included in the 2025 edition of Chinese Pharmacopoeia (Volume Ⅱ). This study focused on analyzing the revision and improvement process of related substances and dissolution tests, and clarified the rationale and procedures behind the enhancement and establishment of the pharmacopoeia standards for leucogen and leucogen tablets, while also providing a reference for the improvement of other drug standards and the establishment of pharmacopoeia standards.
Objective To establish a comprehensive evaluation system for ophthalmic Chinese patent medicines, aiming to provide scientific and standardized support for drug assessment, quantify pharmaceutical attributes, and define clinical value. Methods Based on general drug selection principles, we developed an evaluation scale for ophthalmic Chinese patent medicines, integrating the characteristics of traditional Chinese medicine diagnosis and treatment as well as the specialized features of ophthalmology. The scientific validity, rationality, and feasibility of the scale were assessed and verified using expert questionnaire consultation, analytic hierarchy process, and empirical research methods. Results A comprehensive evaluation scale for ophthalmic Chinese patent medicines was established, consisting of six first-level dimensions ranked by importance as follows: safety, effectiveness, economy, suitability, accessibility, and innovation. Additionally, 24 second-level dimensions and 81 third-level criteria were included to refine the evaluation framework. Conclusions The comprehensive evaluation scale for ophthalmic Chinese patent medicines developed in this study took into account both the features of Chinese patent medicines and the clinical requirements of ophthalmology. It demonstrated high feasibility and could be applied to drug selection, procurement decision-making, clinical medication reference, and other pharmaceutical management tasks related to ophthalmic Chinese patent medicines.
Objective To analyze the characteristics of adverse drug events (ADEs) in pediatrics in Sichuan Province, and to provide evidence for the safety of clinical medication use in pediatrics. Methods The 57 098 adverse drug events of pediatric patients reported to the National Adverse Drug Reaction Monitoring Network by the institutions in Sichuan Province from 2017 to 2023 were retrieved, and EXCEL was used for retrospective analysis of demographic characteristics, medication information, clinical manifestations, the impact on the original disease and prognosis. Results The age group with the highest number of reports was 3-6 years (14 142 cases, 24.77%). The top 3 suspected drugs by total reported cases were antimicrobial agents (31 469 cases, 50.80%), traditional Chinese medicine injections (7 287 cases, 1.76%) and respiratory system drugs (5 496 cases, 8.87%). For serious cases, the top 3 were antimicrobial agents (2 749 cases, 39.51%), antineoplastic drugs (1 887 cases, 27.12%), and psychotropic drugs (356 cases, 5.12%). In pediatric ADEs, traditional Chinese medicine injections account for a relatively high proportion of total cases but a low proportion of serious cases, whereas antineoplastic drugs show a low proportion of total cases but a relatively high proportion of serious cases. Among combination therapies, electrolytes, acid-base balance agents, and nutritional drugs ranked first (14 001/24 001, 58.34%), primarily consisting of normal saline and glucose injections. Analysis of clinical manifestations showed that blood and lymphatic system disorders were more prevalent in serious reports than in total reports. Most cases had favorable outcomes (recovery rate: 42.37%; improvement rate: 54.93%), while severe ADEs had a recovery rate of 23.81% and an improvement rate of 65.60%. Conclusions Attention should be paid to medication safety risks across different pediatric age groups, with a particular focus on the use of antimicrobial and antineoplastic drugs. Enhanced monitoring of pediatric medication is recommended.
Objective To explore the innovative application of a smart pharmacy navigation system in outpatient pharmacy services and evaluate its effectiveness in optimizing patient flow, improving pharmaceutical service efficiency, and enhancing medication adherence. Methods A smart pharmacy navigation system integrating route planning, real-time navigation, medication waiting reminders, and medication guidance was developed. A pre-post randomized controlled design was employed to compare changes in patient navigation time, queue waiting time, medication adherence, and patient satisfaction before and after system implementation. Data collection covered both peak and off-peak periods. Results During peak hours, the navigation time in the control and experimental groups was (543.12±124.79)s and (307.32±88.48) s, respectively, representing a 43.42% reduction (P<0.01). The queue waiting time was (482.75±135.29) s and (242.15±68.86) s, respectively, reflecting a 49.83% reduction (P<0.01). During off-peak hours, the navigation time in the control and experimental groups was (418.90±82.68) s and (185.83±58.99) s, respectively, showing a 55.63% reduction (P<0.01). The queue waiting time was (301.01±87.45) s and (179.18±52.09) s, respectively, indicating a 40.47% reduction (P<0.01). The proportion of patients with high medication adherence in the experimental group significantly increased compared to the control group (42.59% vs. 27.22%, P<0.01), and the overall patient satisfaction score was significantly higher in the experimental group [(4.53±0.54) vs. (3.76±0.74), P<0.01]. Conclusions The smart pharmacy navigation system effectively reduces patient visit duration, enhances medication adherence, and improves patient satisfaction through precise navigation and full-process management. It provides strong technological support for smart pharmacy development and has promising clinical application prospects.
As the responsible entity for drug clinical trials, the sponsor's quality management system is directly related to the protection of subjects' rights, the reliability of trial data and the scientific validity of trial outcomes. This paper, based on the current Good Clinical Practice regulations in China and combined with the analysis of inspection practices, systematically analyzed the key points in current clinical trial inspection regarding the sponsor's quality management. Accordingly, this paper discussed the challenges and issues faced by sponsors in quality management,integrating the latest concepts of ICH E6(R3) to outline the development direction of sponsor quality management, with the aim of continuously enhancing the overall quality level of drug clinical trials in China.
Objective Under the new circumstances of medical technology innovation, and based on the reform of the review and approval system for clinical trials, this study aims to analyze and discuss the key points of project approval review for innovative anti-tumor drug clinical trials from the perspective of the drug clinical trial institution (hereinafter referred to as "institution"). The goal is to proactively address potential management risks arising from accelerated innovation. Methods Through literature review, policy interpretation and work experience, we examined the regulatory requirements for the traditional project approval review responsibilities of institutions. We further analyzed the compliance challenges arising from the new reforms in the key aspects of institutional project review under the priority evaluation and approval system. Results Currently, the National Medical Products Administration (NMPA) adopts flexible and diverse approaches in approving registration clinical trials for innovative drugs. Institutions should focus on the five key attributes of the core "approval documents": specificity, phase-based nature, comprehensive validity, rationality, and necessity. Additionally, institutions must accurately identify risk points and formulate tailored review strategies. Conclusions Under the flexible and diverse access way implemented by NMPA, institutions should actively explore the establishment of an efficient and universally applicable review mechanism. This mechanism should encompass considerations of multiple attributes of "approval documents", such as specificity, phase-based nature, and comprehensive validity, as well as evaluations of the rationality and necessity of clinical trials. Thus, institutions can ensure the high-quality development and high-level safety of clinical trials across multiple dimensions.
