To analyze the characteristics and trends of traditional Chinese medicine (TCM) clinical trials registered in China from 2013 to 2024, and to provide a reference for the development of new TCM drugs and clinical research strategies.

All TCM clinical trials registered on the National Medical Products Administration Drug Clinical Trial Registration and Information Disclosure Platform from its inception to December 31, 2024, were retrieved. A descriptive statistical analysis was conducted from multiple dimensions, including the number of trials, phases, design types, drug dosage forms, indications (classified using ICD-11 codes), and leading institutions.

A total of 1 125 TCM clinical trials were included, accounting for 4.03% of all registered trials during the same period. From 2013 to 2024, the annual number of registered TCM clinical trials did not show a significant growth trend, and their proportion relative to all clinical trials showed a declining trend. The trials were predominantly domestic multi-center studies (99.73%), with Phase II trials constituting the highest proportion (59.20%). A randomized, double-blind, parallel-controlled design was used in 86.31% of the trials. The rates of data safety monitoring committee establishment (3.64%) and subject insurance coverage (32.09%) were low. Oral dosage forms (capsules, granules, tablets, etc.) were the most common (85.87%). Indications were concentrated in respiratory system diseases (21.69%), digestive system diseases (15.64%), and urogenital system diseases (13.51%). The geographical distribution of leading institutions was highly concentrated, with Beijing, Tianjin, and Shanghai collectively accounting for 55.64% of the total.

While progress has been made in the standardization of TCM clinical trial design in China, overall development remains slow, with challenges including low international participation, insufficient subject protection measures, and imbalanced distribution across research areas and regions. It is recommended to introduce targeted incentive policies, encourage exploration of innovative formulations and difficult-to-treat diseases, strengthen subject rights protection, and promote the high-quality and sustainable development of TCM.

To prepare a targeted delivery system of quercetin metal complex loaded with doxorubicin and to investigate its pharmaceutical properties and anti-tumor capability.

With quercetin as the ligand, the optimal bimetallic complex carrier was prepared and screened by adjusting the molar ratios of manganese to copper, and the drug-loaded nanoparticles with the best encapsulation efficiency and drug loading were screened by further adjusting the dosage of doxorubicin. Finally, the targeted drug delivery system was prepared by chondroitin sulfate modification. The physicochemical properties of the nanoparticles such as particle size, Zeta potential, infrared spectrum and ultraviolet spectrum, were characterized. Then, the in vitro drug release behavior, glutathione (GSH) degradation capability, reactive oxygen species (ROS) production capability and blood compatibility were investigated. Finally, the safety and anti-tumor activity were investigated using 3T3 and B16F10 cell lines.

The blank carrier synthesized at the optimal manganese-copper ratio of 2∶1 exhibited the best anti-tumor activity. When the dosage of doxorubicin was 0.05 mmol·L^-1, the prepared nano-delivery system had the best drug loading and encapsulation efficiency, which were (15.89±0.34)% and (90.21±0.45)%, respectively. A targeted drug delivery system was then prepared after modification with 30% chondroitin sulfate. Various characterizations confirmed the successful preparation of the bimetallic complex targeted drug delivery system, with suitable particle size and high encapsulation efficiency and drug loading. The delivery system showed good drug release under pH 5.0 condition containing 10 mmol·L^-1 GSH, and exhibited favorable GSH degradation capability, ROS production capability, blood compatibility, cytocompatibility, and tumor cytotoxicity.

In this study, a targeted drug delivery system loaded with doxorubicin metal complexes was successfully prepared by screening the metal ratio and doxorubicin dosage, followed by chondroitin sulfate modification. The system achieved high drug loading and favorable drug release behavior. This therapeutic strategy using quercetin metal complexes and doxorubicin exerts synergistic anti-tumor effects through combined chemotherapy and chemodynamic therapy, which may provide new ideas for enhancing synergistic anti-tumor efficacy.

To investigate the mechanism of the P2X purinoceptor 7 (P2X7)-NOD like receptor family pyrin domain containing 3 (NLRP3) pathway in diabetes mellitus with depression (DD).

Sixty Sprague Dawley (SD) rats were randomly divided into six groups (n=10 per group): control (Con), diabetes mellitus (DM), depression (Dep), diabetes mellitus with depression (DD), positive drug [metformin (0.18 g·kg^-1)+fluoxetine (1.8 mg·kg^-1)] (Y), and P2X7 inhibitor [Brilliant Blue G (BBG), 30 mg·kg^-1]. DD rat models were established using 4 weeks of high-fat diet feeding combined with intraperitoneal streptozotocin (STZ) injection, followed by 4 weeks of chronic unpredictable mild stress (CUMS) combined with single caging. Rats in the inhibitor group received daily intraperitoneal injections starting from day 15 of modeling for 14 consecutive days. After modeling and drug intervention, behavioral tests (open field test, forced swim test, Morris water maze) were used to assess depression-like behaviors and cognitive function. Serum levels of norepinephrine (NE), 5-hydroxytryptamine (5-HT), and dopamine (DA) were measured by enzyme-linked immunosorbent assay (ELISA). Immunofluorescence was performed to detect hippocampal P2X7/Iba-1, NLRP3/Iba-1, postsynaptic density protein-95 (PSD95), and synapsin-1 (SYN1). Hippocampal neuronal damage was assessed using hematoxylin-eosin (HE) and Nissl staining. Western blotting was used to measure the expression of P2X7-NLRP3 axis-related proteins (P2X7, NLRP3, apoptosis-associated speck-like protein containing a CARD (ASC), caspase-1, interleukin-1β (IL-1β) and brain-derived neurotrophic factor (BDNF).

Both BBG and the positive drug effectively attenuated the loss of body weight and elevated fasting blood glucose in DD rats. Behavioral results showed that BBG and the positive drug reduced immobility time in the forced swim test, increased total distance traveled and total activity in the open field test, shortened escape latency, and increased the time spent in the target quadrant in the Morris water maze. Pathological results demonstrated that BBG and the positive drug ameliorated neuronal damage in the hippocampal region of DD rats. Biochemical analysis results indicated that BBG and the positive drug upregulated serum levels of 5-HT, DA, and NE. Immunofluorescence and Western blot results showed that BBG could reduce the expression of P2X7 and NLRP3 in the hippocampus, while increasing the expression of PSD-95, SYN-1, and BDNF.

BBG exerts neuroprotective effects by inhibiting the P2X7/NLRP3 axis and hippocampal microglial activation, thereby ameliorating neuroinflammation and abnormal NLRP3 inflammasome activation. This leads to increased expression of synaptic-related proteins (PSD95, SYN) and BDNF in the hippocampus.

To mine the adverse events (AEs) related to bevacizumab in ovarian cancer patients from the FDA Adverse Event Reporting System (FAERS) and to reveal their clinical priority information, so as to provide a reference for clinical medication.

AE reports related to bevacizumab for ovarian cancer were collected from the FAERS database from the first quarter of 2004 (Q1) to the first quarter of 2025 (Q1). Signal mining was performed using the reporting odds ratio (ROR), proportional reporting ratio (PRR) and Bayesian Confidence Propagation Neural Network (BCPNN) methods, and clinical priority assessment of positive signals was conducted.

A total of 5 025 reports were include. Physicians were the primary reporters (60.23%), and the United States accounted for the largest proportion of reporters (36.16%). A total of 195 preferred term (PT) signals were identified, spanning 20 System Organ Classes (SOCs). General disorders and administration site conditions was the most frequently reported SOC. Common AEs included hypertension, proteinuria and neutropenia, etc. The median onset time of all AEs was 81 days. Clinical priority classification: 2 PTs were classified as strong priority, 62 PTs as moderate priority, and 131 PTs as weak priority. The strong priority PTs were intestinal perforation and gastrointestinal perforation.

Based on an extensive analysis of the post-marketing international safety database, this study identified common AEs associated with bevacizumab in ovarian cancer patients, and highlighted the need for close monitoring of intestinal perforation and gastrointestinal perforation, providing a reference for clinical medication and pharmacovigilance.

To mine the adverse drug event (ADE) signals of raltegravir and dolutegravir based on the FDA adverse event reporting system (FAERS) database, and provide references for clinical medication safety and rational drug selection.

All ADE reports of raltegravir from the fourth quarter of 2007 to the fourth quarter of 2024 and dolutegravir from the third quarter of 2013 to the fourth quarter of 2024 in the FAERS database were mined using reporting odds ratio (ROR) and proportional report ratio (PRR).

After excluding all kinds of injuries, poisoning, and operation complications, as well as other unrelated signals such as all kinds of operations and medical operations, product problems and social problems, there were 4 136 ADE reports related to raltegravir, 288 effective signals were obtained, and the signals involved 23 system organs; there were 2 119 cases of dolutegravir-related ADE reports, 165 effective signals were mined, and 22 system organs were involved. The related ADE signals with significant differences between raltegravir and dolutegravir were mainly concentrated in nervous system disorders, psychiatric disorders, infections and infestations, blood and lymphatic system diseases, pregnancy, puerperium and perinatal conditions, congenital, familial and genetic diseases, and eye diseases, etc. Dolutegravir had a higher risk of ADEs in nervous system disorders and psychiatric disorders, while raltegravir had a higher risk in other disease-related ADEs.

The study found that there is a significant difference in the risk of adverse events between raltegravir and dolutegravir in the treatment of acquired immunodeficiency syndrome, which can provide references for individualized clinical treatment.

To conduct a theoretical research of industrial innovation ecosystem to solve the problems in the development of traditional Chinese medicine industry which stem from the lack of innovation motivation and the blockage of the construction of innovation ecosystem.

This paper analyzed the evolution of the system and the changes of the role of the innovation subject in the evolution, and put forward the effective strategic choice path, so as to promote the evolution of traditional Chinese medicine industry innovation ecosystem, and to provide references for improving the innovation and competitiveness of traditional Chinese medicine industry. On the basis of clarifying the composition and interaction mode of the innovation ecosystem of traditional Chinese medicine industry, this paper analyzed the changing characteristics of innovation subjects in the three stages of system innovation evolution 1.0, 2.0 and 3.0 in Huangjing (Polygonati Rhizoma) industry of Anhui Province. Innovation individuals led by scientific research, formed by innovation producers such as universities, research and development institutions and R&D enterprises, and changed into innovation groups formed by the service of intermediary institutions, financial institutions, government and other innovation disintegrators, and then changed into innovation community, facilitated by innovation consumers composed of large enterprises and the public.

The research showed that P.rhizoma industry innovation ecosystem in Anhui Province has gone through the 1.0 stage driven by technological innovation and the 2.0 stage guided by policies, but the 3.0 stage driven by market pull has not been completed. The obstacles to its evolution arised from the insufficient product innovation of innovative producers such as R&D-oriented enterprises and hospitals, the imperfect construction of information platforms for innovative decomposers such as intermediary agencies and sales enterprises, and the failure of industrial chain collaboration caused by the absence of innovative consumers such as manufacturing enterprises and growers.

The final formation of the industrial innovation ecosystem 3.0 can only be driven by R&D enterprises promoting product innovation, intermediary agencies improving information platforms, and manufacturing enterprises leading industrial chain collaboration.

To draw on the useful experience of the breakthrough therapy designation (BTD) system in the United States (US) to provide suggestions and references for improving the BTD system in China.

Through a comparative analysis of the implementation effects of the BTD systems in China and the US, the implementation effects and gaps of the BTD systems in the two countries were revealed.

The numbers of applications for BTD recognition in China and the US were generally on the rise, but the rates of BTD recognition and approval in China were significantly lower than those in the US, which may be related to the uneven quality of the applications and the lack of policy refinement. China's BTD drugs had a shorter pre-market clinical development time, but a longer review time, reflecting the difference in the strength of clinical trial guidance between the two countries' drug regulatory agencies. In terms of clinical trial design for antitumour drugs, China preferred single-arm, non-randomised design with objective remission rate as the primary endpoint; whereas the trial designs in the US were richer and more diverse. In addition, no BTD Chinese medicine has been approved for marketing. It is recommended that China's drug regulatory agencies learn from the US experience, formulate BTD review and management standards, strengthen the leading role of reviewers, set up interdisciplinary teams, strengthen the guidance of clinical trial development and improve the efficiency of research and development and review; at the same time, strengthen the supervision of BTD-recognised medicines after superimposed conditional approval for listing, and promote the declaration and approval of BTD traditional Chinese medicines. Pharmaceutical companies should strengthen the training of R&D teams on BTD regulations and skills, improve the quality of BTD drug applications, and promote the accelerated marketing of products to meet patients' clinical needs.