ArchiveVitiligo is a common acquired, autoimmune, and chronic depigmenting skin disease. It not only significantly affects patients'quality of life, but also their mental health. Although there are various treatment options for vitiligo, their efficacy is limited and varies among individuals. As a novel topical JAK inhibitor, ruxolitinib cream is the world's first approved drug for vitiligo repigmentation. Through the "Hong Kong and Macao Medicine and Equipment Connect" policy, ruxolitinib cream has been used in some designated medical institutions in the Guangdong-Hong Kong-Macao Greater Bay Area. It was approved by the Guangdong provincial government before its formal approval in China and has accumulated certain clinical experience in China. For this reason, a working group composed of experts from pharmacy, dermatology, and other disciplines has summarized the evidence-based medical evidence. They have also comprehensively considered the current diagnosis and treatment situation in China, as well as clinical practice experience, and formulated the Medical and Pharmaceutical Expert Consensus on Ruxolitinib Cream for Vitiligo. This consensus systematically elaborates on the mechanism of action, pharmacokinetics, clinical application, and safety management of ruxolitinib cream. After several rounds of expert discussions, revisions, and voting, five recommendations were finally formed to provide guidance for the clinical application of ruxolitinib cream.
To improve the allergic reaction test method of Cattle Encephalon Glycoside and Ignotin Injection by using the direct popliteal lymph node (D-PLNA) and reporter antigen popliteal lymph node (RA-PLNA) models in mice.
In the D-PLNA model, the Cattle Encephalon Glycoside and Ignotin Injection group, normal saline control group and positive drug D-penicillamine hydrochloride control group were set up. In the RA-PLNA model, the above groups were respectively added with reporter antigens TNP-Ficoll and TNP-OVA, and 50 μL of the drug was administered to the left toe pad. On the 7th day, the mice were sacrificed, and the popliteal lymph nodes were isolated, ground to prepare lymphocyte single-cell suspensions and counted to calculate the cell index. The cell suspension was cultured in 96-well plates, and after co-incubation with stimulators, the contents of IgE and MCP-1 in the cell supernatant were determined by ELISA.
Compared with the normal saline control group, in the RA-PLNA model of mice, the number of cells in the popliteal lymph nodes on the drug administration side increased in the group added with TNP-OVA (P < 0.05), and the contents of IgE and MCP-1 both increased (P < 0.05).
Cattle encephalon glycoside and ignotin injection only caused a positive lymph node reaction in mice when TNP-OVA was added, indicating that there may be small molecule substances in Cattle Encephalon Glycoside and Ignotin Injection that cooperate with TNP-OVA to induce allergic reactions.
To establish a UPLC-MS/MS method for the determination of genotoxic impurities dimethyl sulfate (DMS)and diethyl sulfate (DES) in Finerenone bulk drug.
The analytes were separated on an Agilent Poroshell 120 HILIC-Z (100 mm × 2.1 mm, 2.7 μm) column. The mobile phase consisted of a formic acid, water, and acetonitrile solution in a volume ratio of 0.5:300:700 (v/v/v). The flow was set at 0.3 mL·min-1, with a column temperature of 30 ℃ . The target compounds were analyzed in the negative ion MRM mode.
DMS and DES showed good linear relationships within the ranges of 0.75-15.00 ng·mL-1, with correlation coefficients (r) being 0.999 9. The detection limits of the method were 0.23 μg·g-1 and the quantification limits were 0.75 μg·g-1. The recoveries were both 107.53%-109.79%. No DMS and DES were detected in 3 batches of Finerenone.
This method is accurate, specific, and sensitive. It could be used for the simultaneous determination of DMS and DES in Finerenone bulk drug, thereby providing technical support for the quality control of Finerenone.
To establish a TLC identification method and the content determination of paeoniflorin in material benchmark of Huangqi Guizhi Wuwutang.
Thin-layer chromatography was employed for the identification of Astragali Radix (Astragalus root), Cinnamomi Ramulus (cinnamon twig), Paeoniae Radix Alba (white peony root) and Zingiberis Rhizoma Recens (fresh ginger) in material benchmark of Huangqi Guizhi Wuwutang. The quantitative analysis of paeoniflorin was performed by high performance liquid chromatography (HPLC) on a Thermo Hypersil GOLD C18 column (4.6 mm × 250 mm, 5 μm). The mobile phase was acetonitrile-0.1% phosphoric acid solution (14:86) with isocratic elution; the flow rate was 1.0 mL·min-1, the detection wavelength was 230 nm, and the column temperature was 25 ℃.
The linear range of paeoniflorin was 148.00-2 368.00 μg·mL-1 (r = 0.999 9). The average recovery of paeoniflorin was 98.48% (RSD = 0.95%).
The established method is sensitive, simple, reliable and suitable for the quality control in the research and development of the classic formula Huangqi Guizhi Wuwutang.
To assess uncertainty in the determination of vortioxetine concentrations in serum from patients with psychiatric disorders using HPLC-MS/MS methodology.
For the determination of vortioxetine concentration in human serum, the uncertainty introduced by repeated measurements was evaluated using the type A evaluation. The uncertainties contributed from standard weighing, purity, solution preparation, preparation of drug-containing serum, extraction recovery, matrix effect, calibration curve fitting and instrumental precision were assessed using the type B evaluation. Subsequently, the synthetic and extended uncertainties were calculated.
The extended uncertainties for low (0.6 ng·mL-1), medium (60 ng·mL-1), and high (120 ng·mL-1) concentrations of vortioxetine in human serum were 0.67, 4.10, and 10.49 ng·mL-1, respectively, when confidence probability was P = 95% (k = 2).
The method employed in this study exhibits high accuracy and is suitable for the therapeutic drug monitoring of vortioxetine. The primary source of uncertainty arises from the calibration curve fitting, with particularly elevated uncertainty values introduced at the low concentration (0.6 ng·mL -1). Implementing a rational linear range and optimizing calibration curve fitting can enhance the accuracy of measurement results.
To screen and identify the potential targets and pathways of Danthron against breast cancer based on network pharmacology, and to verify its mechanisms through transcriptomic analysis and in vitro and in vivo experiments.
Multiple databases were integrated to screen the common targets of Danthron and breast cancer for Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment analyses. CCK-8 and colony formation assays were used to evaluate cell proliferation. Transcriptome sequencing and quantitative real-time polymerase chain reaction (qPCR) were performed to analyze the expression of Cxcl10, Isg15, IL-6, Nlrp3, and Bax and other related genes. A mouse 4T1 xenograft model was established to observe and assess the antitumor effect of Danthron.
A total of 84 intersecting targets were obtained, mainly enriched in the Apoptosis, p53, PI3K-Akt, NOD-like receptor, and Cytokine signaling pathways. Danthron significantly inhibited breast cancer cell proliferation (IC50=30.05 μmol·L‐1), upregulated interferon-stimulated genes (Irf7, Isg15, Ifit1) and chemokines (Cxcl10, IL‐6), and upregulated the expression of Nlrp3 and Bax. In vivo, Danthron significantly suppressed 4T1 xenograft growth and reduced Ki-67 expression.
Danthron exerts antitumor activity against breast cancer by activating interferon responses and inflammation-apoptosis-related pathways, providing a theoretical basis for its development as a potential natural anticancer agent.
Baricitinib, a JAK1/JAK2 inhibitor, is already used to treat rheumatoid arthritis and other immune diseases. Clinical trials have demonstrated its effectiveness, but long-term use may lead to adverse drug reactions (ADRs) such as infections, thrombosis, and liver dysfunction. Real-world safety studies of baricitinib are limited. This study aims to evaluate the safety of baricitinib using the FDA Adverse Event Reporting System (FAERS) database.
This study adopted baricitinib-related report data from the FAERS database for the period from the third quarter of 2017 to the fourth quarter of 2023. Data cleaning and screening were conducted using the OpenVigil 2.1 platform, excluding duplicate and irrelevant reports. Signal detection was performed using four statistical methods, including Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR)(hereinafter referred to as ROR and PRR), to analyze the potential risks of baricitinib-related ADRs. Descriptive statistical analyses were also conducted.
From 2017 to 2023, a total of 47 776 724 adverse event reports related to baricitinib were received, and after data cleaning, 9 592 793 reports were included in the final analysis. Among these reports, female patients accounted for 61.4%, and most reports originated from the United States (45.4%). The main adverse reactions included pulmonary embolism, deep vein thrombosis, herpes zoster, and mitral valve perforation, with some signals (e.g., interstitial lung disease, ischemic stroke) not mentioned in the drug package insert. Baricitinib-related ADRs primarily involved infections, respiratory, nervous, and cardiovascular systems.
Through the latest database, this study reflects the real-world safety data of baricitinib over a longer time period. The research found that the main adverse reactions of baricitinib include infections, pulmonary embolism, and herpes zoster, and for the first time identified previously unreported risk signals, such as interstitial pneumonia and atrial fibrillation. This study provides updated evidence for both the academic community and clinical practice, offering guidance for patient management in future clinical applications. In clinical practice, special attention should be paid to the safety of elderly patients and high-risk groups to ensure rational use.
To first systematically mine and characterize the real-world drug safety signals of the EZH2 inhibitor tazemetostat using the FDA Adverse Event Reporting System (FAERS) database, to provide evidence-based support for clinical risk management.
A dual-algorithm validation framework (Reporting Odds Ratio, ROR + Proportional Reporting Ratio, PRR) was applied to analyze 1 225 reports listing tazemetostat as the primary suspected drug submitted between Q1 2020 and Q1 2025. False positives were controlled using χ2 > 4. After excluding Preferred Terms (PTs) related to the drug's indication and non‐drug-related System Organ Classes (SOCs), 94 valid signals (involving 1 690 reports) were ultimately identified.
(1) Twenty- four signals (25.5% of total signals) not listed in the current drug package insert were detected. Strong signals included dysgeusia (ROR = 17.39, 95%CI = 13.00-23.27), parosmia (ROR = 10.91, 95%CI = 4.53-26.25), and decreased red blood cell count (ROR=6.94, 95%CI = 4.11-11.73). (2) The most frequently reported signals were fatigue (12.8%), nausea (9.3%), and diarrhea (7.6%). (3) Multisystem toxicity was observed, primarily involving the gastrointestinal system (33.08%), general reactions (25.21%), and nervous system (9.23%).
This is the first comprehensive pharmacovigilance study of tazemetostat reveals its potential to induce multisystem toxicity, mediated through neurosensory pathways and bone marrow hematopoietic homeostasis. The identification of unlisted signals challenges the traditional view that EZH2 inhibitor toxicity is confined to proliferative tissues. These findings provide crucial real-world evidence supporting the theory of systemic toxicity for epigenetic drugs and hold significant value for optimizing clinical drug monitoring strategies during tazemetostat therapy.
To systematically investigate the folk cognition, application methods, and resource situation of Artemisia verlotiorum Lamotte in the Luofu Mountain area, Guangdong Province.
A combination of literature research and ethnobotanical investigation was adopted.
Artemisia verlotiorum Lamotte has extremely high folk cognition locally (96.00% among residents, 100.00% among medical staff). Its applications span multiple areas of folk custom and healthcare: residents commonly use it to make making Ai cakes (88.00%), foot baths (52.00%), and postpartum bathing (48.00%), reflecting profound dietary and health-preserving traditions. Medical staff widely apply it to treat gynecological conditions (e.g., dysmenorrhea 58.93%, uterine cold 41.07%), internal diseases (stomach cold 35.71%), and rheumatic diseases (32.14%), reflecting characteristics of syndrome differentiation and treatment based on traditional Chinese medicine theory. The survey also found a high prevalence of Artemisia verlotiorum Lamotte cultivation (88.00%), including large-scale planting. Through the survey of medical workers, it was found that although this traditional knowledge faces the challenge of inheritor faultage (98.18% of them lack inheritors), most medical workers (72.73%) still have a strong willingness to organize and preserve this experiential knowledge.
Artemisia verlotiorum Lamotte integrates folk identity with practical medicinal utility. Future efforts should focus on its resource protection, sustainable utilization, and the effective inheritance of related traditional medical knowledge.
To investigate the off-label use of pregabalin in the outpatient department of a hospital, analyze the types, reasons, and potential risks of such usage, and provide reference for improving the safety and rationality of its use.
A total of 2 183 outpatient prescriptions containing pregabalin issued between May 2023 and April 2024 were selected.Patient basic information, demographics, clinical diagnoses, and concomitant medications were recorded.
Among the 2 183 prescriptions, 421 (19.29%) involved off-label use.The primary categories included off-label indications (94.06%), off-label patient populations (1.66%), and concomitant medications (4.28%). Additionally, 281 prescriptions (12.87%) were deemed irrational, mainly due to inappropriate indications (26 cases) and altered dosing frequency (255 cases).
Off-label use of pregabalin is prevalent in the dermatology outpatient department of the hospital. However, significant irrational prescribing practices exist.The hospital should refine and enforce relevant systems, enhance physician training and patient education, and conduct in‐depth specialized prescription reviews and risk assessments to ensure medication safety and rational use.
To evaluate the efficacy of sintilimab plus bevacizumab combined with hepatic arterial infusion chemotherapy (HAIC) for advanced hepatocellular carcinoma (HCC) and explore their effects of this combined regimen on macrophage function and phenotype.
Patients with advanced HCC admitted to a hospital from September 2022 to May 2024 were prospectively selected and randomly divided into a control group and an observation group, with 50 cases in each group.The control group received HAIC alone, while the observation group received HAIC combined with sintilimab and bevacizumab. The differences in short-term clinical efficacy, functional indices, and adverse reactions between the two groups were compared.A 6-month follow-up was conducted on patients in both groups after the end of treatment to evaluate long-term efficacy.
After treatment, the observation group exhibited higher disease control rate (DCR), objective response rate (ORR), median progression-free survival (PFS), mean overall survival (OS), macrophage count, proportion of anti-tumor phenotype (M1 type) macrophages, and counts of CD3+, CD4+, and CD8+ T lymphocytes compared to the control group (all P < 0.05). The observation group also showed lower levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), proportion of immunosuppressive phenotype (M2 type) macrophages, and interleukin-6 (all P < 0.05). The incidence of adverse reactions was lower in the observation group, though the difference was not statistically significant (all P > 0.05).
The combination of sintilimab and bevacizumab with HAIC in the treatment of advanced hepatocellular carcinoma can effectively improve short-term and long-term clinical efficacy, improve liver function, regulate macrophage function and phenotype, and enhance the cellular immune function of patients.
To investigate the initial and subsequent treatment strategies for NSCLC with concurrent EGFR mutations and PD-L1 expression, and to summarize the diagnostic and therapeutic approaches so as to provide references for treatment decisions for such patients.
The treatment plan of a patient with NSCLC harboring EGFR mutations and PD-L1 expression was analyzed.
The patient was diagnosed with adenocarcinoma of the right lung with EGFR mutations and expression of PD-L1.The initial treatment plan was osimertinib combined with pemetrexed and carboplatin, and the patient ultimately achieved a progression-free survival (PFS) of 39 months from September 2020 to December 2023. On December 27, 2023, re-examination revealed chronic disease progression, and the regimen was adjusted to osimertinib combined with bevacizumab. On March 12, 2024, the patient experienced disease progression, with no significant changes in genetic testing. Chemotherapy was considered for reinitiation, and we selected the treatment regimen of "pemetrexed + carboplatin + sintilimab + anlotinib". After one cycle, a follow-up CT scan demonstrated a partial response (PR), and PR was maintained after the second cycle.
This study reports a case of advanced NSCLC with EGFR mutations and PD-L1 expression. In the treatment of this patient, an individualized diagnosis and treatment plan was formulated through literature review and relevant genetic testing. By combining immunotherapy, chemotherapy and anti-angiogenic drugs, the patient's disease was effectiveI resistance are complex and vary based on individual patient differences and tumor locations. After disease progression, re-genetic testing may clarify the resistance mechanisms and guide clinical treatment to achieve better efficacy and precision treatment.
To optimize the discharge medication dispensing process, shorten patients' waiting time for medications, and improve patients'medical service experience.
The discharge medication dispensing process was comprehensively reconstructed by implementing measures such as introducing a medication pickup medication pickup check-in system, issuing doctor's orders for "pre -discharge medications" one day in advance, and prescribing doctor's orders for "same -day discharge medications" during off-peak hours. The patients' queuing time for medications and satisfaction with pharmaceutical care were compared before and after the optimization.
After the process reconstruction and optimization, the average time from payment to medication pickup at the window for patients decreased significantly. The average time from check-in to medication pickup was only 5.5 min, patients'satisfaction scores were significantly improved.
Optimization based on the traditional discharge medication dispensing process has significantly shortened the queuing time for patients picking up discharge medications, improved their medical experience, and enhanced patients'satisfaction with pharmaceutical care.