Latest ArticlesUlcerative 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.
To prevent and control the risk of excipients in intrathecal drugs and strengthen their management.
Information of excipients in approved intrathecal drugs abroad was collected, the quality requirements of regulatory agencies for intrathecal drugs in various countries were listed, literature on the safety of excipients in intrathecal drugs was searched and sorted out, and the impact of intrathecal drugs on medication safety was analyzed.
The quality requirements for intrathecal drugs are stricter than those for ordinary injections, with fewer types and quantities of excipients. Regulatory agencies in various countries specified that intrathecal drugs must not contain preservatives, and the threshold of bacterial endotoxin per kg of body mass in a single hour period is much lower than that for ordinary injections. The information on excipients for intrathecal drugs in the US "Inactive Ingredient Search for Approved Drug Products" is an important reference for excipient selection during formulation development.
The safety and regulation of excipients in intrathecal injections are critical to ensuring the clinical safety of these high-risk formulations. It is recommended that drug regulatory agencies, research and development departments, and manufacturing enterprises collectively enhance their attention to the excipients used in intrathecal injections. By improving the regulatory framework, promoting safety research, and strengthening lifecycle management, the risk associated with excipients can be systematically assessed and controlled, thereby better safeguarding patient medication safety.
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