Latest ArticlesCerebral ischemia is a common neurological disease worldwide, with complex pathophysiological mechanisms, which seriously affects the quality of life of patients after the onset of the disease. Currently, cerebral ischemia is mainly treated with drugs and surgery, and its lethality and disability rate are still at a high level due to the limitation of time window and neurological irreversibility. Therefore, finding a safe and effective drug is crucial for the treatment of cerebral ischaemia. apigenin is a naturally occurring flavonoid with a variety of biological activities, such as combating oxidative stress, anti-inflammatory and neuroprotective effects. In recent years, an increasing number of studies have demonstrated the potential therapeutic role of apigenin in cerebral ischaemia. This paper describes the mechanisms of apigenin in preventing and treating cerebral ischaemia, including anti-oxidative stress, attenuating neuroinflammation, regulating apoptosis and promoting neuroregeneration. In addition, this paper discusses the prospects and challenges for the clinical application of apigenin in the treatment of cerebral ischaemia.
Sodium-glucose cotransporter 2 (SGLT2) inhibitors, as a new class of oral antidiabetic drugs, have gained attention in the cardiovascular and metabolic fields due to their non-dependent hypoglycemic effects and cardioprotective effects. Studies have confirmed that these drugs protect myocardial cells by reconstructing the mitochondrial metabolic network in cardiomyocytes. They are widely used in patients with cardiovascular diseases and show significant efficacy. This article integrates recent research findings, systematically reviewing the mechanisms of myocardial cell protection under multidimensional regulation of mitochondrial metabolism by SGLT2 inhibitors. It expands the theoretical support for their use in cardiovascular therapy and provides references for related research directions.
In recent years, there has been an increasing trend in poisoning cases caused by improper use of sedative-hypnotic drugs, with related fatalities also rising annually. The dual characteristics of significant therapeutic effects and abuse potential have made these drugs a critical issue in global public health and clinical diagnosis and treatment. As a classic category of sedative-hypnotic agents, benzodiazepines are widely used in clinical departments such as emergency medicine, psychiatry, and cardiology. However, long-term use may lead to drug accumulation, tolerance, and dependence risks. Due to increasing social stress and accelerated population aging, the illicit use and recreational abuse of benzodiazepines persist. A growing number of individuals attempt to use these drugs to improve sleep quality or seek psychological euphoria, resulting in a significant rise in abuse and poisoning risks. This article outlines the monitoring requirements for benzodiazepines in clinical medication, introduces the latest sample pretreatment techniques, and reviews the current commonly used analytical technology systems, including the development trends of chromatography, mass spectrometry, and their hyphenated techniques. It focuses on the application value of different detection technologies in clinical monitoring, emergency treatment, and drug abuse prevention. By summarizing the development trends of emerging detection technologies, this study provides a theoretical basis and practical reference for technological advancements in clinical drug monitoring and public health regulation.
To track and follow up serious adverse event (SAE) occurring at a tertiary hospital clinical trial institution in Hunan province, analyze and summarize the occurrence and outcomes of SAEs, and propose interventions and improvement measures to standardize the handling of SAE, report them promptly, protect the safety of research participants, ensure the reliability of clinical trial data, and improve the level of clinical trials.
A total of 528 SAEs related to cancer drugs were collected from this clinical trial institution from January 2020 to December 2024 and analyzed using SPSS 25.0 software.
The results showed that the main departments where SAEs occurred were oncology (35.25%), pulmonology (21.21%), and hematology (10.04%). SAEs were mainly concentrated in phase III clinical trials, accounting for 69.51% of the total SAE cases. The SAE predominantly affected the respiratory system, hematologic system, and gastrointestinal system, with grade 3 severity being most common (46.02%). The outcomes for research participants were generally favorable, 39.77% fully recovered and 25.00% improved.
Clinical trial institutions need to strengthen drug safety monitoring, promptly evaluate SAE, enhance supervision over SAEs, and safeguard the rights and safety of research participants.
To conduct a systematic analysis of the issues identified during routine quality control of clinical trials, investigate the root causes of quality problems in the trial implementation process, and explore improvement measures to enhance quality.
Issues identified in 255 routine quality control activities across 142 clinical trials from February 2023 to May 2025 were collected. These issues were categorized, aggregated, and subjected to statistical analysis.
A total of 248 issues were identified. These were primarily concentrated at the trial implementation level, specifically: 77 (31.05%) pertained to essential document management, 74 (29.84%) to the standardization of source records, 25 (10.08%) to the proper execution of informed consent forms, 23 (9.27%) to the completeness of source data, and 15 (6.05%) to the completeness of researcher credentials. Analysis of the causes indicated that these problems were mainly associated with ineffective researcher training, lack of active participation from investigators, deficiencies in the management and training of clinical research coordinators (CRCs), and insufficient quality control practices within specialty teams.
The institution exhibits a prominent proportion of issues related to essential document management and the standardization of source records. To reduce the occurrence of these problems and improve clinical trial quality, it is necessary to strengthen researcher training, enhance engagement, standardize CRC management, and improve the effectiveness of quality control within specialty teams.
To characterize clinical features, identify risk factors, and propose risk management strategies for drug-induced liver injury (DILI) in clinical trials.
260 drug-induced liver injury suspected unexpected serious adverse reaction (SUSAR) reports were systematically extracted from China’s National Medical Products Administration Pharmacovigilance System in Clinical Trials (January 2020-February 2025).
Key risk profiles included anticancer drug trials (86.92%), combination therapies (48.85%), elderly participants (≥50 years, 76.89%), phase Ⅲ studies (45.00%). Hospitalization/prolonged hospitalization occurred in 75.00% of cases. Sponsor-investigator causality assessments showed 91.54% concordance. Outcomes remained unresolved in 44.62% of cases, while permanent treatment discontinuation was the least frequent intervention (8.08%).
Implementation of early-warning systems, dynamic liver monitoring, standardized causality assessment, and personalized risk control should be enforced in clinical trial safety information risk management.
Dry eye disease causes eye discomfort in patients due to lack of tears or instability of the tear film and has a prevalence of 30%-50% in Asia. Conventional therapies suffer from limited efficacy and frequent drug administration, leading to continued active research and development of new drugs. This research explores the development process of 12 new dry eye drugs from 2003 to 2023, and analyzes the key successes and failures of these drugs in the context of U.S. Food and Drug Administration(FDA) guidelines. The study found that the core strategies of successful drugs included flexible adjustment of phase Ⅲ endpoints, strict adherence to one of the three FDA efficacy targets, and consistency between phase Ⅱ and phase Ⅲ trial designs. Failure cases were mostly due to deficiencies in the design of phase Ⅱ trials, such as overestimation of the efficacy of the drug due to small samples and lack of a placebo control, which led to an insufficient sample size for phase Ⅲ trials, and also due to the failure of the drug because of failure of endpoints to be adjusted in a timely manner. Dry eye drug development should be based on rigorous phase Ⅱ clinical trials, prioritize objective endpoint indicators such as the Schirmer test in phase Ⅲ studies, and set up an run-in period to reduce the placebo effect, as well as to meet the FDA's requirements on sample size and endpoint indicators, so as to effectively reduce the risk of research and development and improve the success rate of drug marketing.
To investigate the clinical efficacy of betahistine mesylate combined with oxiracetam in the treatment of patients with posterior circulation ischemic vertigo (PCIV).
This prospective study included 80 patients with PCIV who were treated at our hospital between June 2022 and June 2024. The patients were randomly assigned into two groups: the observation group (40 cases, treated with betahistine combined with oxiracetam) and the control group (40 cases, treated with betahistine monotherapy). After two weeks of treatment, the following were assessed: vertigo symptom scores [Electronystagmography (ENG) score, Visual Vertigo Analogue Scale (VVAS), and Sheikh Control Scale (SCS)], imaging indicators, and serum-related factors.
After treatment, the nystagmogram score and Visual Vertigo Analog Scale (VVAS) score of the observation group were (3.08±0.86) and (37.13±3.26) points, respectively, which decreased significantly, while the Situational Vertigo Scale (SCS) score was (82.55±7.89) points, which increased significantly (P<0.05). The average blood flow velocities of the basilar artery and vertebral artery in the observation group were significantly higher than those in the control group (P<0.05). The serum levels of endothelin-1 (ET-1) and platelet-derived growth factor-BB (PDGF-BB) decreased, and the level of nerve growth factor (NGF) increased, with the observation group showing a better effect than the control group (P<0.05). The observation group experienced 2 cases of nausea and vomiting, 2 cases of rash, 2 cases of drowsiness, and 4 cases of dizziness, while the control group had 1 case of nausea and vomiting, 1 case of rash, and 1 case of dizziness, with no drowsiness reported. The incidence of adverse reactions was higher in the observation group than in the control group (χ2=4.501, P=0.034)(P<0.05).
Betahistine mesylate combined with oxiracetam significantly improves symptoms in patients with PCIV, enhances hemodynamics, and modulates serum factors, demonstrating promising clinical application potential.
To explore the effect of tiotropium bromide combined with budesonide formoterol on elderly patients with chronic obstructive pulmonary disease (COPD).
Using the random number table method, the patients with COPD admitted to our hospital from January 2020 to November 2023 were divided into two groups: the control group received conventional treatment and used budesonide formoterol; the other group received the same treatment as the control group plus tiotropium bromide, serving as the experimental group. The blood gas analysis indicators, inflammation-related indicators, quality of life, clinical efficacy, and safety were compared between the two groups.
After treatment, arterial partial pressure of oxygen (PaO2), generic quality of life inventory 74 (GQOLI-74) scores in the experimental group increased, while partial pressure of carbon dioxide (PaCO2), interleukin-6 (IL-6), C-reactive protein (CRP) and procalcitonin (PCT) decreased, which were more significant than those in the control group(P<0.05). The experimental group’s overall efficacy rate was 98.33%, significantly better than the control group’s 80.00% (P<0.05). There was no statistically significant difference in adverse reactions between the experimental group (15.00%) and the control group (10.00%) (P>0.05).
Tiotropium bromide in combination with budesonide formoterol can effectively regulate blood gas analysis and the level of inflammation, improve quality of life and enhance clinical efficacy.
To observe the clinical efficacy and safety of combination of sintilimab injection and chemotherapy on patients with advanced gastric cancer.
Patients with advanced gastric cancer in gastrointestinal tumor center of the hospital were retrospectively analyzed and divided into control group and treatment group. Control group was given XELOX chemotherapy regimen (intravenous drip of 130 mg·m-2 oxaliplatin injection on the 1st day of each cycle; oral administration of 1 000 mg·m-2 capecitabine tablets in the morning and evening, continuous medication from the 1st day to the 14th day of each cycle, 21 days as a cycle). On the basis of control group, treatment group was given 200 mg of sintilimab injection by intravenous drip on the 1st day of each cycle, and were treated no more than 8 cycles (21 days as a cycle), and received maintenance regimen (control group was given single drug treatment, 1 000 mg·m-2 capecitabine tablets orally in the morning and evening, for 14 consecutive days and 7 days of discontinuation, 21 days as a cycle; on the basis of control group, treatment group was given 200 mg of sintilimab injection, intravenous drip, on the first day of each cycle, 21 days as a cycle) after disease control. The patients were followed up until death. The remission rate, blood markers including matrix metalloproteinase-9 (MMP-9), neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) and survival prognosis were compared between the two groups, and the safety was evaluated.
A total of 86 patients with advanced gastric cancer were selected from the hospital information system. According to the different treatment regimens, they were classified into control group and treatment group, with 43 cases in each group. After excluding those who changed the drug dose or changed the treatment method due to personal reasons during treatment process, 38 cases were included in control group and 42 cases were included in treatment group. After treatment, the levels of MMP-9 in treatment group and control group were (230.74±54.37) and (311.95±69.76) μg·L-1, the NLR were 1.44±0.37 and 1.82±0.47, the PLR were 134.42±17.55 and 162.46±17.17, respectively, and there were statistical significantly differences in the above indexes between treatment group and control group (all P<0.05). The objective remission rates in treatment group and control group were 54.76% (23 cases/42 cases) and 31.58% (12 cases /38 cases), and the disease control rates were 96.83% (40 cases/42 cases) and 78.95% (30 cases/38 cases), respectively, the above indicators in treatment group were statistically significantly different from those in control group (all P<0.05). The median progression-free survival [95% confidence interval (CI)] values in treatment group and control group were 19.00 (95%CI: 16.89-21.11) and 12.00 (95%CI: 12.74-17.26) months, and the median overall survival (95%CI) values were 25.00 (95%CI: 23.78-26.22) and 20.00 (95%CI: 16.98-23.02) months, respectively, the above indicators revealed statistical significantly differences between treatment group and control group (all P<0.05). The incidence rates of myelosuppression in treatment group and control group were 45.24% (19 cases/42 cases) and 60.53% (23 cases/38 cases), and the incidence rates of gastrointestinal reaction were 35.71% (15 cases/42 cases) and 39.47% (15 cases/38 cases), and incidence rates of liver function injury were 26.19% (11 cases/42 cases) and 21.05% (8 cases/38 cases), and the incidence rates of hand-foot syndrome were 21.43% (9 cases/42 cases) and 15.79% (6 cases/38 cases), and the incidence rates of neurotoxicity were 40.48% (17 cases/42 cases) and 52.63% (20 cases/38 cases), and the incidence rates of thyroid dysfunction were 7.14% (3 cases/42 cases) and 0.00% (0 cases/38 cases), respectively, without statistical significantly differences (all P>0.05).
The application of sintilimab injection combined with XELOX chemotherapy regimen in patients with advanced gastric cancer can effectively enhance the remission rate, reduce the levels of serum MMP-9, NLR and PLR, and improve the survival prognosis, with good safety.
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