Latest ArticlesWith the deepening of drug review and approval reform and the rapid development of digital technology, it is of great significance to enhance the application of drug review data, as an important basic resource in the field of drug review, for the efficiency improvement and mode transformation of drug review. Based on the European drug regulatory data, this study analyzed data strategy, data quality, data protection, and data application, and proposed ideas on high-quality data management system, data application value release, and stakeholder collaboration mechanism, in order to provide references for the research and application of drug review data in China, promote the value release of data elements, and assist in the high-quality development of drug review digitalization and intelligence.
To optimize the extraction process for the modified new formulation of Compound Nanxing Zhitong Plaster.
Pharmacological effects were evaluated using adjuvant-induced arthritis rat models and acetic acid-induced writhing mouse models, while skin irritation was tested in rabbits. The differences in efficacy and skin safety between two extraction methods (FFNX-1: ethanol-water-ethanol extraction; FFNX-2: percolation+ethanol extraction) were compared. Active ingredient contents (including aconitine, eugenol, etc.) and dry extract yield were used as indicators to optimize extraction parameters through orthogonal experimental design.
FFNX-2 (percolation+ethanol extraction) exhibited optimal anti-swelling, anti-inflammatory and analgesic effects, along with lower skin irritation in rabbits, establishing it as the optimal extraction process for the improved new drug formulation of Compound Nanxing Zhitong Plaster.
The optimized extraction parameters were as follows: Six herbs including Caryophylli Flos extracted three times (1 h each) with 4 volumes of 50% ethanol; Arisaematis Rhizoma and Aconiti Radix extracted by percolation with 70% ethanol (particle size 2~5 mm, soaked for 24 h, flow rate 1 mL·min-1·kg-1, collecting 8 volumes of effluent). The optimized extraction process effectively retains active components while reducing toxicity risks, providing a scientific basis for the modern development of Compound Nanxing Zhitong Plaster.
To investigate the therapeutic effect of MQZZJ (total alkaloids of Strychnos) on experimental autoimmune myasthenia gravis (EAMG) rats and to elucidate its underlying mechanisms.
The EAMG rat model was established by immunizing female Lewis rats with the R97-116 peptide fragment. Rats were assigned to different groups and treated with MQZZJ (0.35, 0.7, and 1.4 mg·kg-1) or prednisone (4.2 mg·kg-1). The therapeutic effects and potential mechanisms were evaluated by monitoring the Lennon score and rotarod falling speed, measuring serum levels of acetylcholine receptor antibody (AChR-Ab), IgG, IgG1, IgG2b, IFN-γ, IL-17, and TGF-β, and detecting the CD4+/CD8+ ratio in peripheral blood lymphocytes.
MQZZJ significantly reduced the Lennon score, increased the rotarod falling speed, and reduced serum levels of AChR-Ab, IgG, and the IgG2b subtype. It also significantly decreased serum IL-17 and IFN-γ levels, increased serum TGF-β levels, and reduced the CD4+/CD8+ ratio.
MQZZJ can markedly ameliorate myasthenic symptoms in EAMG rats. The mechanism may be related to inhibiting AChR-Ab production, reducing the CD4+/CD8+ ratio, modulating immune dysfunction, and alleviating abnormal inflammation.
To investigate the effects of Danggui Buxue Decoction (DBD) on the nuclear factor erythroid 2-related factor 2/glutathione peroxidase 4 pathway, degree of lipid peroxidation, and synaptic plasticity of rats with vascular dementia (VD) induced by bilateral common carotid artery ligation (2-VO).
Sixty male SPF grade SD rats were randomly divided into sham surgery group, bilateral common carotid artery ligation VD model group, low-dose 2-VO+DBD group, medium dose 2-VO+DBD group, high-dose 2-VO+DBD group, and 2-VO+donepezil group, with 10 rats in each group. After 24 hours of modeling, continuous administration was performed for 4 weeks and samples were collected. The Morris water maze experiment and the dark avoidance experiment were used to evaluate the influence on the learning and memory ability of rats. The lipid peroxidation level was detected using a kit, and the morphology of hippocampal neurons was observed using Nissl staining. The expression of hippocampal neurons was observed using immunofluorescence staining, and the expression of pathway and synaptic plasticity-related proteins was detected using Western blotting. The mitochondria and synaptic ultrastructures of hippocampal neurons were observed using transmission electron microscopy, and the morphology and density of dendritic spines of hippocampal neurons were observed using Golgi staining.
The Morris water maze experiment and the dark avoidance experiment demonstrated that DBD could enhance the learning and memory abilities of rats. The results of Nissl staining and immunofluorescence showed that after DBD administration, the number of hippocampal neurons in the VD model group of rats increased, the expression rate of Nrf2 increased, and the neuronal damage was improved. VD rats showed a decrease in GSH levels, an increase in lipid peroxide and 4-hydroxynonenal levels, and DBD administration could alleviate oxidative stress. In VD rats, the expression of NAD(P)H quinone dehydrogenase 1, GPX4, Nrf2, postsynaptic density protein 95, Synapsin1, and brain-derived neurotrophic factor proteins decreased, and all of these significantly increased after administration of high dose DBD. Transmission electron microscopy and Golgi staining showed that DBD could improve the mitochondrial structure and synaptic ultrastructure of neurons, and increase the density of dendritic spines.
DBD can exert a neuroprotective effect and improve the learning and memory abilities of VD model rats by regulating the Nrf2/GPX4 signaling pathway, inhibiting neuronal lipid peroxidation, and enhancing synaptic plasticity.
To conduct a comprehensive clinical evaluation of albutrepenonacog alfa (rIX-FP) for the treatment of hemophilia B.
Based on guidelines, literature, and publicly available data, and following the PICOS principle, rIX-FP was compared with plasma-derived FIX, standard half-life recombinant FIX (SHL rFIX), and extended half-life recombinant FIX (EHL rFIX) across five dimensions: efficacy, safety, suitability, innovation, and economy.
The evaluation results indicate that rIX-FP has potential advantages over other FIX preparations in terms of reducing the annualized bleeding rate, increasing the proportion of patients with zero bleeding events, and improving joint health, with consistent trends observed in the pediatric subgroup. The safety profile of rIX-FP is comparable to that of other recombinant FIX preparations, with no unmanageable safety risks observed. Regarding suitability, rIX-FP is available in five dosage specifications, offers flexible dosing options, and requires no special storage conditions. In terms of innovation, it utilizes albumin fusion technology to extend the half-life, thereby reducing dosing frequency and increasing trough levels. As for economy, although not yet marketed in China, international data suggest that long-term treatment (≥3 years) with rIX-FP has a cost advantage compared to SHL rFIX and rFIXFc.
Based on available evidence, rIX-FP demonstrates certain clinical advantages in the treatment of hemophilia B. However, head-to-head comparative studies and local pharmacoeconomic evaluations are still warranted.
To systematically evaluate the efficacy and safety of histone deacetylase inhibitors (HDACi) combined with exemestane compared with exemestane alone in the treatment of hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer.
Electronic databases including PubMed, Cochrane Library, Embase, Wanfang Data, CNKI, and VIP were searched for randomized controlled trials (RCTs) comparing HDACi combined with exemestane versus exemestane alone in the treatment of HR+/HER2- breast cancer. The search period began from database inception to July 10, 2025. Two reviewers independently screened the literature, extracted data, and assessed the risk of bias in the included studies. Meta-analysis was performed using RevMan 5.4.1 software.
Five RCTs involving 1 588 patients were included. The meta-analysis showed that HDACi plus exemestane group had significantly better progression-free survival [HR=0.77, 95%CI (0.67, 0.89), P=0.000 2], objective response rate [OR=1.69, 95%CI (1.15, 2.50), P=0.008], and clinical benefit rate [OR=1.39, 95%CI (1.05, 1.85), P=0.02] than the exemestane alone group. However, there was no significant difference in overall survival between the two groups [HR=0.91, 95%CI (0.63, 1.30), P=0.60]. Regarding safety, the meta-analysis showed that the overall incidence of ≥grade 3 adverse events was significantly higher in the HDACi plus exemestane group compared to the monotherapy group [OR=7.16, 95% CI (4.37, 11.74), P<0.000 01].
Current evidence suggests that in HR+/HER2- breast cancer patients, HDACi combined with exemestane significantly prolongs progression-free survival and improves objective response rate and clinical benefit compared to exemestane alone, but also significantly increases the risk of ≥grade 3 adverse events, particularly hematological toxicity and fatigue. Clinicians should carefully weigh the benefits of efficacy against the risks of adverse events when making decisions.
To analyze the clinical features and risk factors of tirzepatide-associated ketoacidosis using real-world data, thereby providing evidence for safer clinical use.
A systematic literature search was conducted in both Chinese and English databases from inception until August 31, 2025, to identify case reports on tirzepatide-induced ketoacidosis. Data were also extracted from the FDA Adverse Event Reporting System (FAERS) spanning January 2004 to June 2025. Disproportionality analysis using the reporting odds ratio (ROR) was employed for signal detection, and descriptive statistics was applied to summarize the demographic, clinical, treatment, and outcome variables.
Fourteen published case reports and 229 cases from the FAERS were included. A higher proportion of cases occurred in females (78.57% in case reports; 51.96% in FAERS). Ketoacidosis often developed early during treatment (median time: 5 weeks), with common clinical features including nausea, vomiting, abdominal pain, dehydration, and metabolic acidosis. Significant signals were detected linking tirzepatide to various forms of ketoacidosis, particularly starvation ketoacidosis (ROR=107.36, 95%CI: 71.75~160.63) and euglycemic diabetic ketoacidosis (ROR=3.52, 95%CI: 2.51~4.93). Concomitant use of sodium-glucose co-transporter 2 inhibitors (SGLT-2i) was most frequently reported (52 cases). Most patients recovered after drug discontinuation and supportive care, although four fatal cases were documented in FAERS.
Tirzepatide is associated with a significant risk of ketoacidosis, particularly in female patients, non-diabetic state, and those using SGLT-2i concurrently. Enhanced vigilance, patient education, and early intervention are recommended to mitigate the risk of serious metabolic adverse events.
To analyze the current supply-demand matching in prescription drug information dissemination based on supply-demand balance theory, explore public satisfaction with this dissemination, and propose improvement recommendations to enhance the effectiveness of prescription drug information dissemination.
On the supply side, in-depth interviews were conducted with eight pharmaceutical companies using the interview survey method. On the demand side, an online questionnaire survey was administered, and descriptive statistics and an analysis of fit across four dimensions-relevance, accessibility, appropriateness, and quality-applied to the results.
Pharmaceutical companies utilize multiple online and offline channels for information provision, but these are primarily limited to disease popularization. On the demand side, 560 valid questionnaires were collected, with 66.8% of respondents expressing a strong willingness to access prescription drug information. The public generally demonstrates higher demand for information on health supplements and common-disease prescription drugs, while placing greater emphasis on precautionary information such as adverse reactions and contraindications.
Current prescription drug information dissemination exhibits a supply-demand mismatch. Recommendations include establishing a mechanism to distinguish prescription drug information from advertising, enhancing public education on prescription drug science popularization, and strengthening regulatory oversight over prescription drug information on new media platforms to promote supply-demand balance.
Trastuzumab Deruxtecan has broad application prospects in the treatment of HER2-related tumors. The analysis of patent information can facilitate the research and innovation of this class of drugs. Through patent search and literature review, the molecular patents for the trastuzumab component have expired. The related patents for the linker and the cytotoxic drug remain valid. All the related patents of trastuzumab deruxtecan are valid, and its patent layout structure is reasonable. A progressive application strategy of "structure-process-indication-combination therapy" has been adopted to continuously extend the patent life. From the perspective of patent analysis, this provides new drug research pathways for innovative entities. First, make full use of the antibody drugs whose patent terms have expired; second, retain the GGFG tetrapeptide in the linker and substantially improve the molecular structure of other parts. Taking trastuzumab rezetecan as an example, through creative structural modifications, this strategy is expected to break through the patent barriers of trastuzumab deruxtecan.
China's drug patent term compensation system has officially been implemented, but numerous hot-button issues remain unresolved in practice. This paper delves into several key problems through specific case studies, offering reflections and recommendations on corporate patent strategy and term compensation application approaches. It begins by introducing the legal origins of the drug patent term compensation system, including practices in countries such as the United States, Japan, and Europe. Then, it elaborates on the legal framework of China's system regarding scope of application, compensation duration, calculation methods, and eligibility criteria. Subsequently, it focuses on analyzing practical operational challenges in China, such as the definition of "new drugs", the meaning of "one drug", whether claims encompass new drug technical solutions, and protection scope limitations, while proposing corresponding solutions. Finally, based on legal significance, it provides enterprises with multiple patent strategy recommendations and adjustments to new drug application strategies, aiming to help them better safeguard their rights under the drug patent term compensation system.