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
With the continuous development of China's medical and health sector,the demands for scientific rigor and regulatory compliance in drug evaluation and selection within medical institutions have markedly increased. Building upon recent advancements in the pharmaceutical field and evolving national drug policies,the Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions (the Third Edition),hereinafter referred to as the “Guide”,revises and refines the drug evaluation indicators based on its first and second editions. On one hand,it employs a quantitative scoring system to enhance the differentiation of drug priorities within medical institutions,ensuring that evaluation criteria are closely aligned with national policy directions. On the other hand,it further details the scoring criteria,thereby improving operational feasibility and reducing implementation complexity in clinical practice. The Guide facilitates a quantitative scoring of drugs across five dimensions:effectiveness (28 points),safety (27 points),pharmaceutical characteristics (27 points),economy (10 points),and other attributes (8 points). This approach shifts the focus of drug evaluation back to clinical value,assisting medical institutions in conducting objective drug selection and evaluation.
Objective To investigate the regulatory mechanism of the Jianpi Huashi recipe (JPHS) in preventing and treating intestinal mucosal injury (IMI) following chemotherapy,and to provide a research basis for the clinical application of JPHS in managing IMI. Methods Active components and targets of JPHS were screened by TCMSP and the herb group identification database.IMI related targets were extracted from GEO datasets and GeneCards,OMIM,DisGeNET,and DRUG bank databases,with overlapping targets between JPHS and IMI identified.A "drug-active component-target" network and protein-protein interaction (PPI) network were constructed using Cytoscape 3.9.1 software.Molecular docking validation was performed with AutoDock software.Network pharmacology was used to predict the active components and corresponding targets of JPHS in treating IMI,and the "drug-active component-target" network was established.Key active components and core targets were verified via AutoDock.Additionally,a cyclophosphamide (CP)-induced mouse model of IMI was established.Clinical symptoms,body weight changes,spleen and thymus indices,and intestinal tissue pathological changes were observed.Enzyme-linked immunosorbent assay (ELISA) and Western blotting were used to detect the expression of cytokines and proteins related to the TNF-α signaling pathway. Results Network pharmacology analysis identified 79 active components in JPHS,which primarily regulate TNF signaling pathways mediated by core targets such as TNF-α,IL-1β,and IL-6 to exert therapeutic effects on IMI.Molecular docking showed strong binding affinity between core components of JPHS and their corresponding targets.Animal experiments revealed that,compared with the model group,JPHS pretreatment significantly increased spleen and thymus indices and ameliorated small intestinal mucosal damage to varying degrees.ELISA and Western blotting results demonstrated that JPHS markedly reduced serum levels of TNF-α,IL-1β,and IL-6,as well as the expression levels of TNF-α,IL-1β,NF-κB-p65,and p-NF-κB-p65 proteins in intestinal tissue,confirming its ameliorative effect on post-chemotherapy IMI. Conclusions JPHS exerts a protective effect against CP-induced IMI in mice by inhibiting the TNF-α signaling pathway,reflecting the holistic therapeutic characteristic of traditional Chinese medicine—treating diseases through multiple components and targets.This study provides a basis for further clinical research and experimental validation of JPHS in the treatment of post-chemotherapy IMI.
Objective To observe the toxic reactions,dose-response relationship,and severity of toxicity to the main target organs after repeated administration of lactobacillus vaginal capsules in New Zealand rabbits,and to investigate the safety and toxicity of lactobacillus vaginal capsules,providing a reference for clinical medication safety. Methods Thirty healthy non-pregnant female New Zealand rabbits were randomly divided into five groups (n=6):a negative control group (treated with medical vaseline),an excipient control group (treated with capsules containing only excipients),and small,medium,and high-doses of lactobacillus vaginal capsules (treated with 0.1,0.2,and 0.4 g · kg-1 lactobacillus vaginal capsules,respectively).The low and medium-dose groups of lactobacillus vaginal capsules were administered once a day,while the high-dose group was administered twice a day,both for 4 consecutive weeks.After the last administration,the recovery period was 4 weeks.The administration frequency and recovery period of the excipient control and negative control group were the same as those of the high-dose group. Results New Zealand rabbits were given a maximum of 0.4 g·kg-1 lactobacillus vaginal capsule for 4 consecutive weeks.There were no significant abnormalities in general clinical symptoms,ophthalmic examination,organ coefficient,urine,serum biochemistry,electrolytes,coagulation,electrocardiogram,body temperature,vaginal secretion examination,and bone marrow cell count.Although there were differences in individual hematological indicators among the groups,there was no significant time-response trend or dose-response trend.A small number of organs in the negative control group,vehicle control group,and lactobacillus vaginal capsule group showed extremely mild/mild pathological changes,and there was no significant group correlation or dose-dependent relationship in the number and severity of lesions. Conclusion After 4 consecutive weeks of vaginal administration of lactobacillus vaginal capsules to New Zealand rabbits,there was no pathological damage to the main tissues,organs,uterus,ovaries,and vaginal mucosa,and there was no significant impact or toxic effect on general physiological function indicators.
Inflammatory bowel disease (IBD),encompassing ulcerative colitis (UC) and Crohn's disease (CD),is a chronic relapsing inflammatory disorder that poses severe health and economic burdens due to its chronic and relapsing nature.The review examines traditional therapy,biologics,and small-molecule targeted drugs,highlighting their mechanisms and clinical advancements.Special attention is given to emerging therapeutic strategies,including novel drug development targeting TNF-like ligand 1A (TL1A),interleukin-6(IL-6),interleukin-22 ( IL-22),as well as innovative modalities such as chimeric antigen receptor T-Cell immunotherapy(CAR-Tregs),mesenchymal stem cell therapy,artificial intelligence(AI)-assisted treatment,and advanced combination therapies.Major challenges in IBD treatment,including difficulties in predicting therapeutic targets,primary or secondary non-response to biologics,mucosal healing efficacy limits,drug resistance mechanisms,and long-term risks of infection,cancer,and thrombosis,are also analyzed.The future of IBD management lies in precision medicine,non-invasive monitoring,and innovative drug development using AI and omics technologies.
Inflammatory bowel disease (IBD) is a chronic,progressive,and recurrent intestinal disorder primarily characterized by ulcerative colitis and Crohn's disease.With advances in materials science and nanotechnology,targeted drug delivery systems have achieved significant breakthroughs in enhancing the targeting of lesions by therapeutic agents,improving treatment efficacy,and increasing patient compliance.These developments offer a novel approach for the precise management of IBD.This review analyzed the pathogenesis and key influencing factors of IBD while summarizing the current research status,efficacy,and safety of targeted drug delivery systems in treating this condition.The discussion included three main aspects:targeted regulation of immune cells,modulation of gut microbiota,and microenvironment-based stimuli-responsive nanoplatforms.Furthermore,we explore future directions for development to provide a scientific foundation for individualized treatment strategies for IBD.
Objective To provide a methodological reference for scientifically evaluating the rational use of proton pump inhibitors (PPIs) in clinical practice. Methods Based on the Guidelines for the Clinical Application of Proton Pump Inhibitors (2020 Edition),relevant drug instructions,clinical guidelines,expert consensus,and literature,a set of criteria for evaluating the rational use of PPIs was developed through expert discussions.The Analytic Hierarchy Process (AHP) was used to assign weights to each indicator of the evaluation criteria,and the Technique for Order Preference by Similarity to Ideal Solution (TOPSIS) was used for data processing to evaluate the rationality of the medication use.A random sample of 1 000 cases using PPIs from Tianjin Beichen Hospital in January,April,July,and October of 2024 was selected for evaluation using the AHP-TOPSIS method. Results The established evaluation criteria included four primary indicators (indication for use,dosage and administration,precautions,and other conditions) and six secondary indicators.Among the secondary indicators,the ones with the highest weights were indication for use,dosage and administration route of PPIs,and repeated administration (with weights of 0.501,0.157,and 0.157,respectively).In the 1 000 cases,the highest closeness coefficient (Ci) was 1.000 and the lowest was 0.347. Rational medication use (Ci≥0.8) accounted for 78.80%,basically rational use (0.6≤Ci<0.8) accounted for 8.80%,and irrational use (Ci<0.6) accounted for 12.40%,with differences being statistically significant (P<0.05). Conclusions The AHP-weighted TOPSIS method provides a comprehensive evaluation of the rational application of PPIs,quantifying the rationality of drug use by integrating multiple indicators.This approach makes the evaluation more hierarchical,systematic,and operational,and the results are reliable.It serves as a valuable reference for developing new clinical rational medication evaluation methods.Irrational use of PPIs still exists in our hospital,and management should be strengthened in clinical applications.
Objective To evaluate the efficacy and safety of double intravenous intensified induction therapy with ustekinumab (UST) and UST/ upadacitinib (UPA) dual-targeted therapy in a biologic-refractory Crohn's disease (CD) patient complicated with erythema nodosum (EN),and to provide evidence-based insights for optimizing individualized therapeutic strategies in CD patients with concurrent extraintestinal manifestation and suboptimal response to standard biologic regimens. Methods In a case of Crohn's disease,the therapy was switched to UST,because of non-response to adalimumab(ADA).However,the patient experienced disease progression after initial UST intravenous induction,manifesting as small bowel obstruction and EN.Clinical pharmacists interpret therapeutic drug monitoring (TDM) results,evaluate treatment plans,review evidence-based guidelines,and actively participate in rounds and discussions to assist physicians in adjusting treatment plans for UST double intravenous dosing (390 mg at week 0 and 5) with UPA (15 mg qd) dual-targeted therapy.Clinical pharmacists also provide medication education and pharmaceutical follow-up to patients,dynamically monitor changes in inflammatory markers,nutritional status,imaging,and skin manifestations,and evaluate the efficacy and safety of optimized treatment strategies. Results After treatment,the patient achieved relief of bilateral foot pain,progressive regression of erythema,and improvement of small bowel obstruction and abdominal symptoms,accompanied by normalized inflammatory markers (WBC,CRP) and albumin.No serious adverse events,including infection or thrombosis,were reported during follow-up. Conclusion Clinical pharmacists played a crucial role in assisting with optimizing treatment regimens by integrating patients' individual characteristics with evidence-based practice.The intensified UST double-intravenous induction regimen demonstrated rapid alleviation of acute symptoms,while the UST/UPA dual-target combination strategy was effective through modulation of intestinal and cutaneous inflammatory pathways,providing a novel treatment option for managing biologic-refractory CD with cutaneous involvement.
Objective To summarize the pharmaceutical care for the treatment of an elderly patient with Pneumocystis jirovecii pneumonia (PJP) secondary to ulcerative colitis (UC). Methods In the inflammatory bowel disease-multidisciplinary team (IBD-MDT) consultation,pharmacists assisted physicians in formulating an anti-infective regimen for PJP,adjusting and optimizing glucocorticoid therapy,and providing in-hospital and post-discharge pharmaceutical services to the patient. Results The symptoms and indicators of severe PJP in the patient continued to improve,and the condition of UC did not recur. Conclusion In the IBD-MDT,pharmacists assist physicians in treating PJP,controlling opportunistic infections,monitoring adverse drug reactions,and actively seeking entry points for pharmaceutical care to achieve a dual improvement in the safety and effectiveness of chronic disease management.
A 15-year-old boy developed renal abnormalities,including proteinuria and hematuria,approximately one month after initiating oral mesalazine sustained-release tablets (2 g,bid) for Crohn's disease from May 2023.Renal function gradually recovered following drug withdrawal and symptomatic management.In October 2024,renal abnormalities recurred after mesalazine was reintroduced due to disease relapse.Causality assessment using both the Chinese National Center for ADR Monitoring criteria and the Naranjo algorithm rated the adverse reaction as "certain".Renal function fully recovered after discontinuing mesalazine again and initiating adjunctive therapy with Bailing capsules.Although mesalazine-induced renal injury is rare,it can be severe and clinically insidious,highlighting the importance of routine renal monitoring during treatment,particularly in adolescent.Bailing capsules may offer a supportive therapeutic option in managing drug-induced renal injury and warrant further investigation.
Borneol is a Traditional Chinese Medicine (TCM) classified as an orifice-opening agent,characterized by its ability to awaken the mind,clear heat,and relieve pain,with extensive clinical applications.In 2022,the Expert Consensus on the Rational Clinical Use and Pharmaceutical Evaluation of Borneol-Containing Chinese Patent Drugs highlighted the potential risk of long-term oral administration of borneol-containing Chinese patent drugs in depleting qi and blood,and provided specific recommendations for treatment duration.However,the consensus focused on the common issues of borneol-containing Chinese patent drugs and did not differentiate the risk variations among different borneol-containing Chinese patent drugs.This study addressed this gap by investigating the oral formulations of borneol-containing Chinese patent drugs listed in the Chinese Pharmacopoeia.A comprehensive evaluation model was established based on three dimensions:the daily intake of borneol,the formulation characteristics of borneol-containing Chinese patent drugs,and real-world adverse reaction literature.This model classified 121 borneol-containing Chinese patent drugs into low,medium,and high-risk categories.Standards for upgrading or downgrading risk levels were set,and the characteristics of borneol-containing Chinese patent drugs in each risk category were analyzed to provide rational recommendations for drug use.This research aimed to address the limitations of the consensus and provide a reference for the rational clinical use and pharmaceutical evaluation of borneol-containing Chinese patent drugs.
Objective Using Chinese patent medicines (CPMs) containing aconitum ingredients as a case study,this research aims to establish a risk warning and classification framework for CPMs containing toxic components. Methods A database was created from the National Basic Medical Insurance,Work Injury Insurance,and Maternity Insurance Drug List (2024) containing aconitum-based CPMs.Following a statistical analysis of their dosage forms and preparation processes,the daily dosage of Aconitum alkaloids was calculated.In addition,the flavor compatibility structure of the formulations was analyzed using the Tangye Jingfa map.A risk assessment scale,integrating these three factors,was developed to evaluate and classify the risk of the included varieties based on their risk scores. Results A total of 58 varieties of Chinese patent medicines were included,covering 5 dosage forms,with pills being the most prevalent (44.83%).The preparation process primarily involved the use of raw powder as medicine (67.24%) and decoction in water (27.59%).Based on the maximum recommended daily dosage,the theoretical aconitine content in 16 varieties suggested a potential risk of intoxication.Additionally,adverse drug reaction (ADR) reports were documented for 12 varieties,among which 8 formulations were predominantly composed of pungent-flavor herbs (the proportion of pungent drugs exceeds 50%).Based on the three core elements—"preparation process,daily dosage,and formula composition"-a risk assessment framework consisting of "3 categories and 7 items" was established.The rationality of the risk assessment scale was validated using Xiaojin Capsules and Guifu Dihuang Pills as examples.Ultimately,the included varieties were classified into three risk levels (high,medium,and low) for hierarchical management. Conclusions The preparation process,dosage,and compatibility structure critically determine the safety and efficacy of Aconite-based Chinese patent medicines.The integrated risk assessment system developed in this study provides a valuable framework for the safety evaluation and risk warning classification of toxic Chinese patent medicines.
Objective To establish readability metrics for Chinese package inserts of over-the-counter (OTC) and evaluate 117 package inserts of Chinese patent drugs in readability evaluation. Methods This study established readability assessment indicators for package inserts of OTC Chinese patent drugs based on domestic and international regulatory documents and guidelines,combined with the characteristics of OTC Chinese patent drugs.The indicators include three first-level indicators (text factors,non-text factors,content factors) and 24 second-level indicators (including average sentence length,proportion of medical terminology).An innovatively developed Python-based automatic readability calculation program was created to evaluate text factors automatically.This assessment indicator system was then applied to conduct readability assessment and analysis on 117 copies of package inserts. Results Among the 117 copies package inserts,the median score for readability text factors was 5.57 (5.11,6.37),the median comprehensibility score was 54.54(49.39,54.54),the median actionability score was 40.00 (40.00,40.00),and the median quantitative score for content factors was 3.5 (3.4,3.6).The median scores for Drug Basic Information,Drug Usage Guidance,and Drug Safety Information were 4.0 (4.0,4.0),3.0 (2.3,3.0),and 2.8 (2.6,3.2),respectively.The completeness and standardization of Drug Basic Information were significantly superior to those of Drug Usage Guidance and Drug Safety Information (P<0.01). Conclusions Information deficiencies,non-standardized content,and sub-optimal readability were prevalent in package inserts of OTC Chinese patent drugs.We recommend establishing an intelligent quality evaluation system for these package inserts to enhance their role in guiding patients toward safe and rational medication use.
Diabetes is becoming increasingly prevalent globally,and numerous patients still fall short of attaining the optimal glycemic control target.New hypoglycemic agents with distinct mechanisms of action from traditional ones are gradually emerging,offering more choices for diabetic patients.However,given the late introduction of new hypoglycemic drugs and specific disparities between the clinical trial population and the actual drug users,there remain significant uncertainties regarding the safety of their clinical application.While some studies have further elucidated and validated the safety profiles of these novel hypoglycemic drugs,systematic reviews are still limited.Therefore,this paper will focus on the adverse drug reactions/events (ADR/ADE) of new hypoglycemic drugs.The aim is to provide relevant evidence for the safety of their clinical selection and to facilitate the rational utilization of new hypoglycemic drugs,as well as to ensure smooth progress in pharmaceutical care during their application.
The drug nanocrystals have small diameter and large specific surface area,which can improve the solubility of insoluble drugs and enhance the bioavailability of drugs.Surface modification of drug nanocrystals can achieve the targeting of specific sites,prolong the circulation time of drugs in vivo,enhance cell uptake and tumor inhibition,reduce the toxicity and side effects on normal tissues,and play a therapeutic role in target tissues.In this paper,the preparation methods of drug nanocrystals and their four targeting systems in tumor therapy are systematically reviewed,and their development and application prospects in the field of tumor therapy are discussed.It is expected to provide theoretical support and reference for the further research and development of drug nanocrystals.
Objective To establish an in vitro release test method for mometasone furoate cream and to comprehensively evaluate the consistency of in vitro release between the reference preparation and eight generic drugs manufactured in China. Methods The vertical diffusion cell was used to determine the release percent of mometasone furoate cream,and the effects of release medium,filter membrane,stirring rate,temperature,and other factors were relatively investigated to determine the difference between 8 generic drugs and the reference preparation.The release medium was 0.9% sodium chloride solution-ethanol (1:1),and the filter membrane was a 0.45 μm polyethersulfone membrane.Samples were taken at 1,3,5,7,12,and 24 hours with a sampling volume of 1 mL.The concentration of mometasone furoate was determined by high-performance liquid chromatography (HPLC) using a C16 column (250 mm×4.6 mm,5 μm),while the mobile phase was methanol-water (70:30).The detection wavelength,column temperature,flow rate,and injection volume were 254 nm,40 ℃,1.0 mL·min-1 and 20 μL,respectively. Results Methodological validation showed that the membrane inertness,specificity,sensitivity,and selectivity met the requirements.The limit of quantification of mometasone furoate was 0.2 μg·mL-1,with good linearity (r2=0.999 99) in the range of 0.2-20.0 μg·mL-1,and the recovery rate was 97.1%.The stability and repeatability were good.The release percentage of the reference preparation in 24 hours stood at 1.41%,and the release percentages of the eight generic drugs were between 1.93%-62.26%. Conclusions The in vitro release test method established in this paper exhibits good accuracy and high sensitivity,and can be applied to various generic drugs.It serves as a reference for mometasone furoate cream manufacturers,and is of great significance for optimizing the formulation,manufacturing processes,and consistency evaluation.
Objective To systematically assess the quality of compound honeysuckle granules and identify potential issues through national drug sampling,providing insights for enhanced quality control. Methods Standard testing and exploratory research were conducted on 207 batches of samples from 20 manufacturers.An HPLC-UV method was established to determine the content of honeysuckle,forsythia,and scutellaria in the preparation,as well as to develop a fingerprint profile.Additionally,an HPLC-ELSD method was developed to identify adulteration of honeysuckle with Lonicera confusa in the raw materials. Results All 207 batches complied with the standards.However,exploratory studies revealed that some samples had lower-than-proposed limits for the content of honeysuckle,forsythia,and scutellaria.Partial batches exhibited missing peaks or similarity values below the proposed threshold in the fingerprint analysis.Additionally,adulteration with Lonicera confusa was detected in some samples. Conclusion It is suggested to unify the quality control items of compound honeysuckle granules,increase the content determination of honeysuckle,Forsythia suspensa,and Scutellaria baicalensis,monitor the quality of honeysuckle in compound honeysuckle granules,and strengthen the feeding standard of raw materials.
Objective To evaluate the quality of ketoconazole cream produced by different domestic companies. Methods A comprehensive evaluation of 127 batches (94 batch numbers) of ketoconazole cream was conducted using statutory standard and exploratory research,including in-tube uniformity,related substances,antioxidant content,packaging seal integrity,in vitro release test,in vitro permeation test,rheology,and microstructure,etc. Results According to the statutory tests,the qualified rate of 127 batches was 100%.Exploratory research revealed significant differences in various research parameters,including in-tube uniformity,related substances,and antioxidant content,among samples from different enterprises.The main factors that affect the quality of ketoconazole creams were prescription technology,excipients,and packaging.The secondary factors were quality standards and internal control standards. Conclusion It was recommended that manufacturers conduct consistency evaluation as soon as possible,strictly control excipients,and improve the quality of ketoconazole cream.
Objective To conduct an evaluation system for specific plasminogen activators and comprehensively assess their value in acute myocardial infarction thrombolytic therapy,providing a reference for clinical medication decisions and drug selection by medical institutions. Methods The method of Delphi expert consultation and the Analytic Hierarchy Process were employed to define evaluation indicators and assign weight distributions.Subsequently,qualitative and quantitative analyses were conducted to evaluate drug safety,efficacy,cost-effectiveness,innovation,suitability,and accessibility.These analyses referenced drug instructions,clinical guidelines,and databases such as China National Knowledge Infrastructure(CNKI),Wanfang Database(Wanfang),VIP Database for Chinese Technical Periodicals(VIP),PubMed,Embase,and the Cochrane Library. Results A clinical application evaluation system for specific plasminogen activators was established,comprising six primary indicators and thirty secondary indicators.The weight ranking of the primary indicators is as follows:safety (23.10%),efficacy (22.14%),accessibility (14.01%),suitability (13.99%),economy(13.97%),and innovation (12.79%).Based on this evaluation system,four specific plasminogen activator tenecteplase (TNK-tPA),alteplase (tPA),reteplase (rPA),and pro-urokinase (pro-UK) were scored at 73.2,71.1,69.7,and 61.7 points,respectively. Conclusions Specific plasminogen activators overall show good efficacy,safety,and innovation,with clear pharmacological actions,high vascular recanalization rates,and low bleeding risks.However,the current equipment rate of these drugs in medical institutions needs to be improved.The drug prices are still at a relatively high level which limits patient affordability,and there are differences in the appropriateness of use among drugs due to different administration methods.
Objective To accelerate the construction of a drug information traceability system,this study is dedicated to designing an economical,lightweight,and versatile code-scanning device that enables the rapid identification of drug traceability codes across various scenarios,thereby enhancing the code-scanning efficiency of medical institutions. Methods By leveraging the network communication between the ESP32 microcontroller and the computer server,the image captured by the ESP32 device is transmitted to the server.Subsequently,the opencv image-processing library is employed for image preprocessing,including conversion into a grayscale image,followed by recognition utilizing the pyzbar barcode-recognition library to extract drug traceability code information. Results This application allows users to acquire drug traceability codes successfully.Practical tests demonstrate that the barcode recognition rate of this study is remarkably high,with the recognition speed predominantly maintained within 10 milliseconds. Conclusion The collaborative approach between the ESP32 microcontroller and the computer server,as adopted in this study,has effectively achieved the scanning and recognition of drug traceability codes,offering a reference model for the development of drug information traceability systems.
Objective To explore the construction pathway and application efficacy of smart pharmacies in outpatient services.The initiative aims to enhance pharmacy operational efficiency,optimize medication management,reduce hospital operational costs,and improve medication safety and healthcare experiences through technology-enabled solutions. Methods This study details how the outpatient pharmacy at the First Affiliated Hospital of USTC (Anhui Provincial Hospital) leverages automated equipment,intelligent systems,and smart management,this study establishes a comprehensive smart system covering the entire medication workflow: inventory monitoring,storage environment surveillance,prescription review,prescription task distribution,prescription dispensing,unit-dose packaging,prescription verification,medication guidance,and medication traceability. Results Through deep integration of automated equipment,intelligent systems,and smart management,approximately 40% of the outpatient pharmacy's dispensing volume and 37% of drug varieties were automated.With the intelligent prescription review system,prescription review coverage reached 100%,with a 98% success rate in intervening against irrational prescriptions.Compared to traditional manual dispensing,the average prescription processing time was reduced from 2 min to 32 s per patient,and the average patient waiting time decreased from 40 min to 6.9 min.Medication guidance coverage reached 100%,with patient satisfaction exceeding 95%.Furthermore,the smart pharmacy implementation achieved an inventory turnover rate of ≤8 days for over 85% of medications,significantly outperforming the national evaluation standards for tertiary public hospitals.With 9 routine dispensing windows,daily prescription processing capacity exceeded 8 000 prescriptions,serving over 5 000 patients per day,while maintaining a dispensing error rate ≤0.001%.These advancements significantly improved service efficiency and capacity without compromising. Conclusion By integrating advanced technologies and reengineering workflows,smart pharmacies achieve highly efficient,precise,and safe outpatient pharmaceutical services.
Objective To systematically analyze the market access characteristics of Traditional Chinese Medicine (TCM) formula granules,to explore influencing factors such as the standard system,therapeutic indications,inter-provincial registration,and price competition affect market access to provide empirical insights for policy formulation and industry practices and to support the high-quality development of the TCM formula granule sector. Methods Using China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd.as the sample enterprise,this study adopts a mixed research method combining document mining and quantitative price index analysis.It examines market access characteristics and influencing factors from four dimensions: standard system,therapeutic indication distribution,inter-provincial registration,and price competition. Results A total of 986 TCM formula granule products were included in the analysis.Among them,48.2% were national standard (GB) products,registered in more than 29 provinces,while 51.8% were provincial standard (SB) products,mainly registered in 17 to 27 provinces.The therapeutic indications were concentrated in areas such as heat-clearing (17.4%),tonifying deficiency (15.3%),and promoting blood circulation (9.1%),with the top ten indications accounting for 83.9% of all products.Inter-provincial registration was primarily concentrated in several provinces,such as Guangdong,Jiangsu,and Anhui.Regarding price competition,69.5% of products selected through centralized procurement were priced below the market median. Conclusions The market access of TCM formula granules is influenced by several factors,including the maturity of quality standards,clinical value,regional resource allocation,and pricing mechanisms.Enterprises should strengthen evidence-based evaluation and differentiated strategies,while policies should accelerate standard harmonization and promote value-based payment to ensure accessibility and sustainable development.
Objective To discuss the construction and implementation process of a full-process quality management system based on pre-initiation risk assessment for clinical trial projects in a tertiary hospital,and to evaluate its effectiveness in improving project quality. Methods By statistically analyzing common issues and their causes under the original quality management model,risk factors before the initiation of clinical trial projects were accurately identified,risk levels were determined,and risk management and control strategies were formulated and implemented. Results After adopting full-process quality management measures based on pre-initiation risks,the quality scores of 135 clinical trial projects were significantly improved compared to the quality scores of 127 projects that did not adopt risk management (P<0.05).Issues related to clinical trial conditions and compliance,clinical trial process records,and data traceability were reduced by more than 20%. Conclusions The full-process quality management system based on pre-initiation risks achieves a double guarantee of "prevention beforehand and control afterwards",effectively identifies and prevents risks during the implementation of clinical trial projects,significantly reduces the incidence of issues during the conduct of clinical trial projects,and improves quality control efficiency.It is crucial for ensuring the quality,compliance,and safety of clinical trials.
Objective To analyze the status of decentralized clinical trial (DCT) technology in non-rare diseases,and to discuss the concerns and countermeasures in the implementation process. Methods By convenient sampling,drug clinical trial projects carried out by four large public Grade III hospitals in Guangdong Province from 2021 to 2024 were selected as research objects and descriptive statistical analysis was carried out using SPSS 29.0 software.The technical application of DCT elements was analyzed in six aspects:electronic informed consent,direct to patient,remote visits,direct delivery of samples,remote monitoring of safety data,and digital medical technology. Results A total of 422 drug clinical trials were included,of which 165 (39.1%) involved remote visit technology,14.5% remote monitoring of safety data,10.4% direct mail of samples,6.4% digital medical technology,3.6% direct access to clinical trial drugs,and 0.9% involved electronic informed consent.In addition,the proportion of DCT elements used in international multi-center clinical trials was higher than that in domestic multi-center clinical trials in five aspects:remote visits,safety data monitoring,direct delivery of samples,digital medical technology,and direct access to experimental drugs.Regarding remote visits,direct to patient,direct delivery of samples,and digital medical technology,the proportion of cardiovascular system diseases and circulatory system diseases using the above DCT elements is relatively high,65.2%,17.4%,17.4%,4.3%,respectively. Conclusions There are great differences in applying different DCT elements in clinical trials of non-rare diseases.At present,remote visits and remote safety data monitoring are widely used.Overall,the application rate of DCT elements is relatively low and needs continuous promotion and popularization.Based on the concept of "patient-centered",the promotion and application of DCT in clinical trials in China should be promoted with the goal of quality assurance and efficiency improvement of clinical trials.
