ArchiveTo reveal the evolution trend of the objectives of policies related to the subject responsibility for drug quality and safety in China and the possible deficiencies through a quantitative analysis of policy texts, thereby providing a basis for optimizing the drug regulatory system and promoting the implementation of the subject responsibility.
This study mainly employed text mining and co-word analysis method, through utilizing ROSTCM6 software to perform word segmentation, word frequency statistics, and semantic network analysis on 37 policy documents issued at the national level between 2012 and 2025, to explore the distribution patterns of high-frequency thematic words and the characteristics of policy evolution.
The study found that the policies present characteristics of "phased evolution”: the subject words gradually transform from "quality" and "enterprise" in the initial stage to "holder" and "management", the semantic network structure has changed from loose to tight, and the focus of supervision is shifting from the "responsible subject" to the dual-track mechanism of "centralization of the responsible subject and refinement of the subject responsibility”.
China has gradually established a responsibility system covering the entire life cycle of drugs, but it still needs to further refine the definition of responsibilities and strengthen quality management.
Data integrity, as the foundation of quality control (QC) in pharmaceutical enterprises, is directly related to the reliability of drug safety and regulatory compliance. This study focuses on the current state of data management in QC laboratories, identifying the risks to data integrity, and analyzing key aspects of data collection, storage, and protection through typical case studies. Furthermore, by optimizing management processes, strengthening personnel training, and introducing advanced technological systems, a comprehensive strategy to enhance data integrity is proposed. The research confirms that the integrated application of various systems and intelligent technical tools such as the laboratory information management system, microbiological information management system, computerized maintenance management system, warehouse management system and laboratory execution system can effectively ensure full-cycle management of samples, reagents, equipment, and testing data. Case studies further validate the practical effectiveness of the proposed data integrity strategies, providing important references for quality control in pharmaceutical QC laboratories. The study indicates that as regulatory requirements continue to rise, data integrity management will evolve towards intelligent and automated approaches, thereby promoting the continuous improvement of the pharmaceutical industry's quality management system.
To establish a scientific risk assessment system, identify and quantify key risk factors affecting the quality of clinical research on innovative anti-tumor drugs, and provide a decision-making basis for quality management and risk control.
This study adopted the triangular fuzzy analytic hierarchy process (TFAHP) to construct a risk assessment indicator system consisting of 8 primary indicators and 26 secondary indicators. Expert scoring was used to determine the weight of each indicator, followed by consistency testing and comprehensive ranking analysis.
Among the primary indicators, the highest weights were assigned to clinical research ward construction and management risk (0.139 4), information and data risk (0.130 2), and safety event management (0.125 3), highlighting research environment, data management, and subject safety as key focus areas. At the secondary level, data security risk and system security risk under the category of information and data risk (both 0.065 1) ranked highest, followed by litigation risk and policy risk under legal and policy risk (both 0.059 3), together constituting the high-risk tier. The top ten indicators in overall ranking also included safety data collection, quality control, biospecimen collection and processing, and adverse events/serious adverse events (AE/SAE) documentation, reflecting expert emphasis on data integrity, legal compliance, research quality assurance, and subject safety.
TFAHP effectively identifies and quantifies multidimensional risk factors in clinical research of innovative anti-tumor drugs. This study defines high, medium, and low-risk levels and proposes corresponding preventive strategies, providing theoretical and practical guidance for improving research quality and reducing clinical trial risks.
Norovirus is one of the main pathogens causing viral diarrhea. Due to the lack of ideal in vitro cell culture models and animal models, research on the mechanisms of human norovirus (HuNoV) infection and replication, immune response, antiviral drug screening, and vaccine evaluation had been hindered. This review covers studies from 2003 to 2025, examining the feasibility, advantages, and limitations of both cell culture models and animal models. For cell models, most immortalized cell lines fail to support HuNoV replication; while intestinal organoids have successfully supported virus culture, the procedure is complex and may face ethical constraints. Human salivary gland cell lines, established in recent years, can stably support HuNoV replication and are low-cost, easy to operate, thus serving as an important alternative system. For animal models, high costs and immune responses that differ markedly from natural infections have limited their widespread use. By the summarizing and discussing these culture models, this review aims to consolidate previous findings and offer directions for improving existing models and developing new ones.
Exosomes are extracellular vesicles that can be secreted by almost all types of cells. They derived from different cell types have different characteristics and biological functions. Accumulating evidence shows that exosomes can be used for the diagnosis and treatment of diseases, and thus they have attracted considerable research interest. Despite their potential, exosomes have not been widely used in clinical practice, mainly because they have been defined as drugs in China and the United States, and are therefore required to be evaluated according to higher standards of stability and safety. This article reviews the functions and clinical applications from several different sources, and tumor-associated diagnostic biomarkers are summarized, to provide a reference for the clinical application of exosomes.
Ulcerative colitis (UC) is a chronic, relapsing inflammatory bowel disease with an etiology that has not yet been fully elucidated. Its pathogenesis involves multiple factors, including genetic susceptibility, environmental influences, intestinal microbiota dysbiosis, and abnormal immune responses. In recent years, the incidence of UC has shown a rising trend worldwide, with particularly rapid growth in newly industrialized countries. As understanding of the disease pathophysiology deepens, the treatment strategies have evolved from traditional broad-spectrum immunosuppression to targeted and personalized therapies. The biologics and small-molecule targeted drugs have significantly transformed the therapeutic landscape for moderate-to-severe UC, including biologics such as anti-tumor necrosis factor-α antibodies, anti-interleukin-23 antibodies, and anti-integrin antibodies, as well as small molecules such as Janus kinase inhibitors, sphingosine-1-phosphate receptor antagonists, and integrin antagonists. This review focuses on novel targeted therapies, providing a reference for their clinical applications in UC patients and future research on innovative drug development.
Alzheimer's disease (AD) is a neurodegenerative disorder caused by the synergistic interplay of multiple factors. Current treatments are only able to alleviate symptoms and cannot cure or prevent it. Numerous studies have demonstrated that Chinese herbal essential oils can be administered through inhalation, topical application, and oral administration. Via multiple pathways including anti-amyloid-beta (Aβ) deposition, anti-abnormal Tau protein hyperphosphorylation, anti-oxidant stress, anti-inflammatory, anticholinesterase activity, and regulation of glucose metabolism, these oils improve the pathological features of AD, inhibit neurotoxicity and cell apoptosis, reduce neuronal damage, and ameliorate cognitive dysfunction. This paper systematically reviews the effects, molecular mechanisms, and administration routes of Chinese herbal essential oils intervening in AD, summarizes current research limitations and future development directions, and provides a reference for related basic research and new drug development.
Hepatocellular carcinoma (HCC) is characterized by its insidious onset, difficulty in early diagnosis, rapid disease progression, and poor prognosis, making it a major global health threat. Yttrium-90 transarterial radioembolization (TARE) is an emerging local treatment for liver cancer. Although its clinical application in mainland China is relatively recent, studies have shown promising clinical prospects. This article reviews the efficacy and safety of TARE in the treatment of HCC patients by reviewing literature, aiming to provide reference for clinical medication.
This expert consensus aims to standardize the review responsibilities and key points for institutional parties, including the Ethics Committees, Institutional Management Departments, and Investigators, in decentralized Clinical Trials (DCTs). As DCT approaches extend trials to participants' daily lives using digital technologies, traditional supervision faces new challenges. Based on the International Council for Harmonisation E6(R3) (ICH E6[R3]) and Chinese Good Clinical Practice (GCP) regulations, the consensus systematically outlines core review elements across the DCT lifecycle. Ethics Committees are required to focus on ethical rationale of the trial design, the substantive equivalence of electronic informed consent (eConsent), data privacy and security, and special protection of vulnerable populations. Institutional Management Departments should strengthen their review of regulatory compliance, third-party vendor management, end-to-end data quality control, and risk management. Investigators must ensure the scientific reliability of remote assessments, timely safety monitoring of trial participants, and their team's competency in implementing new technologies. The consensus emphasizes the need for a close collaboration mechanism among these three parties to promote the healthy and orderly development of DCT approaches in China while safeguarding participant rights and safety, thereby providing actionable guide for the industry.
To construct a scientifically sound four-level classification system for quality control (QC) findings in drug clinical trials, in order to optimize the clinical trial quality management system.
A four-level classification system was established by analyzing the clinical trial process, clarifying the relationship among risk assessment and improvement measures, and applying the scenario reverse verification method.
The four-level classification enabled the quantification and multi-dimensional comparison of clinical trial quality risks, as well as accurate root cause analysis of quality issues and rapid closed-loop improvement.
The optimized quality management system can efficiently identify core risks in clinical trial quality and improve the efficiency of risk assessment and corrective actions.
To evaluate the stability of the component-based Chinese medicine Yuanqin capsules in different batches.
High-performance liquid chromatography (HPLC) fingerprint for Yuanqin capsules was established, and the similarities of flavonoids components was assessed using the chromatographic fingerprint similarity evaluation system for traditional Chinese medicines, with retention time and peak area relative deviation as evaluation indices. Additionally, the contents of key flavonoids were determined and compared batches.
A total of 27 common peaks were identified, of which 14 were attributed to Iris tectorum Maxim., and 13 to Scutellaria baicalensis Georgi. Eleven chemical components were confirmed, including tectoridin, iristectorin B, iristectorin A, iridin, baicalin, glychionide A, oroxyloside, tectorigenin, wogonoside, baicalein, wogonin. The fingerprint and content determination methods showed good precision, stability, and repeatability. For the six key components (tectoridin, iristectorin B, iristectorin A, baicalin, tectorigenin, and wogonoside), the injection amounts exhibited linear relationships with peak areas within the ranges of 0.027 6~0.552, 0.006 2~0.124, 0.012 3~0.146, 0.063~1.26, 0.015 2~0.304, and 0.017 1~0.342 μg. The average recoveries rates (n=6) were 99.67% (relative standard deviation, RSD=0.87%), 100.19% (RSD=1.83%), 100.26% (RSD=0.97%), 99.74% (RSD=0.49%), 100.39% (RSD=1.78%), and 99.64% (RSD=0.96%), all meeting the testing requirements. The similarity between the 15 batches of Yuanqin capsules and the reference fingerprint ranged from 0.948 to 0.989, indicating small batch-to-batch variations in component contents and stable quality.
Yuanqin capsules exhibit good quality consistency. The established HPLC fingerprint and content determination method can provide a basis for the quality control of Yuanqin capsules.
To evaluate the anti-inflammatory and analgesic effects of Naizilai Granules (NZL) and to preliminarily investigate the underlying mechanisms.
The anti-inflammatory and analgesic effects of NZL were evaluated in mice using the acetic acid-induced writhing test as well as the egg white-induced paw edema model. Serum levels of tumor necrosis factor-α (TNF-α), interleukin-12 (IL-12), and interleukin-1 beta (IL-1β) were quantified by enzyme-linked immunosorbent assay (ELISA). In lipopolysaccharide (LPS)-stimulated RAW264.7 macrophages, the inhibitory effect of NZL on inflammation was assessed. Additionally, the cytokine levels (IL-12, IL-1β and TNF-α) in cell supernatants were measured, and the protein expression of cyclooxygenase-2 (COX-2) and prostaglandin E2 (PGE2) was detected by Western blot (WB).
The acetic acid-induced writhing test demonstrated a significant reduction in the number of writhes in NZL-treat groups compared to the model group. In the egg white-induced paw edema model, NZL treatment groups showed markedly decreased paw swelling compared to the model group. Furthermore, NZL effectively inhibited the LPS-induced inflammation in RAW264.7 cells and decreased the expression levels of IL-12, IL-1β, and TNF-α in cell supernatants. Additionally, there was a marked reduction in the expression of COX-2 and PGE2.
NZL exhibits analgesic and anti-inflammatory effects.
At present, the anticoagulant therapy for acute ischemic stroke (AIS) has been controversial. Argatroban, as a relatively safe novel anticoagulant, is widely used in the treatment of AIS. This study aims to systematically summarize the clinical efficacy and safety of argatroban combined with antiplatelet drugs for AIS.
CNKI, WanFang Data, VIP, PubMed, Embase, Web of Science, and the Cochrane Library were searched for randomized controlled trials (RCTs) on argatroban combined with antiplatelet drugs for acute ischemic stroke, with a search period from inception to June 2024. Two researchers independently screened the literature according to inclusion and exclusion criteria, evaluated the quality of the included studies, extracted data. Meta-analysis and subgroup analysis were performed using statistical software.
A total of 40 RCTs involving 3 864 patients were included. Meta-analysis results showed that Argatroban combined with antiplatelet drugs improved clinical efficacy [odds ratio (OR)=3.51, 95% confidence interval (CI) (2.84, 4.32), Z=11.73 (P<0.000 01)], enhanced the ability of daily living [mean difference (MD)=9.81, 95%CI (8.57, 11.05), P<0.000 01], Z=15.54 (P<0.000 01), improved the degree of clinical neurological deficit [MD=-2.55, 95%CI (-2.88, -2.22), Z=15.09 (P<0.000 01)], coagulation parameters showed no significant abnormalities, with activated partial thromboplastin time (APTT) [MD=0.94, 95%CI (-0.29, 2.18), Z=1.50 (P=0.13)], fibrinogen (FIB) [MD=-0.31, 95%CI (-0.92, 0.30), Z=0.99 (P=0.31)], and the risk of adverse reactions was not increased [OR=0.84, 95%CI (0.63, 1.14), Z=1.12 (P=0.26)].
In the current treatment of AIS, the combination of antiplatelet drugs and argatroban can improve the clinical efficacy, enhance daily living ability, restore neurological function, improve prognosis, and potentially reduce disability rate. However, more rigorous and multi-center, large sample and high-quality studies are still needed to provide more objective and systematic evidence regarding the clinical efficacy, bleeding risk, specific dose, and application type of argatroban in stroke.
To compare the clinical efficacy and cost-effectiveness of desvenlafaxine succinate (DVS) and toludesvenlafaxine hydrochloride (TDVH) in the treatment of major depressive disorder (MDD) using the matching-adjusted indirect comparison (MAIC) method.
Based on a multicenter, randomized, double-blind, positive-controlled clinical trial, data from 177 DVS patients were included and compared with the publicly available summary data from the TDVH Phase Ⅲ trial. MAIC was used to perform weighted matching on baseline characteristics, and changes in the 17-item Hamilton Rating Scale for Depression (HAMD-17), Hamilton Anxiety Rating Scale (HAMA), and Clinical Global Impression-Severity Scale (CGI-S) scores were compared between the two groups. The total treatment cost and cost per unit improvement were calculated.
The improvement rates in HAMD-17, HAMA, and CGI-S scores were 66.1%, 50.6%, and 57.3% in the DVS group, compared with 59.8%, 58.1%, and 49.0%, respectively, in the TDVH group. Both the total treatment cost and the cost per unit improvement were lower for DVS than those for TDVH.
DVS demonstrated advantages in efficacy and cost-effectiveness, indicating greater economic accessibility and providing a reference for drug selection and reimbursement decision-making in MDD treatment.
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