OBJECTIVE To provide a reference for optimizing the market access process for over-the-counter drugs （OTC） in China. METHODS Based on literature review， questionnaire survey was designed and distributed via the Wenjuanxing platform to respondents from pharmaceutical enterprises， drug regulatory agencies， industry associations， medical institutions and universities. The collected survey data were then subjected to statistical analysis. RESULTS A total of 154 questionnaires were collected， all of which were valid. Among the respondents， 58.5% were from pharmaceutical enterprises， 18.8% were from the field of drug regulation， and the remaining 22.7% were from universities and medical institutions. More than half of the respondents had been working for 10 years or more. A total of 89.6% of the respondents called for the establishment of an independent review system for OTC. Additionally， 88.3% believed it was necessary to establish an OTC monograph system based on China’s national conditions. Meanwhile， 73.4% of respondents believed it was necessary to standardize the monograph inclusion procedures and processes， while 77.3% thought the specific process for switching prescription drugs to OTC status should be improved. Furthermore， 91.0% of the respondents considered that real-world data/evidence could contribute to simplifying the OTC market approval pathway， although challenges related to data quality and data accessibility were acknowledged. CONCLUSIONS The review cycle for China’s OTC market access mechanism is relatively long. A localized adaptation and optimization path of “institutional reconstruction-technological innovation-regulatory innovation” in a trinity is proposed to provide a decision-making basis for establishing a scientific and efficient OTC regulatory system with international experience serving as a reference.

ObjectiveTo investigate the prognostic role of radiotherapy in women aged 70 years or older with breast cancer. MethodsA total of 311 women aged 70 years or older with breast cancer undergoing breast-conserving surgery in the Second Affiliated Hospital of Nanchang University between February 28， 2011 and February 28， 2021， were divided into two groups： 183 patients in the control group were given postoperative radiotherapy， and 128 patients in the case group were not treated by radiotherapy. The nonparametric Mann-Whitney U test or χ² test was used to compare the general clinicopathological data of the two groups， the Kaplan-Meier method and log-rank test to analyze the disease-free survival （DFS） and overall survival （OS）， multivariate Cox proportional hazards regression model to examine the factors affecting DFS and OS. Additional subgroup analysis was performed. ResultsThere were no statistically significant differences between the control and case groups in age， T-stage， N-stage， tumor clinical stage， estrogen receptor （ER）， progesterone receptor （PR） and human epidermal growth factor receptor type 2 （HER2） statuses， Ki-67， tumor histological grade， tumor pathological type， and whether they received adjuvant chemotherapy or postoperative endocrine therapy （all P > 0.05）. The median follow-up was 110.0 （95%CI： 98.9， 121.1） months for the control group and 93.0 （95% CI： 86.1， 100.0） months for the case group. Differences between the two groups in DFS rate were significant （92.9% vs. 85.2%， P = 0.024）， but in OS rate insignificant （92.3% vs. 88.3%， P=0.199）. Multivariate Cox proportional hazards regression analysis showed that T-stage， N-stage （N2 and N3）， HER2 status， Ki-67， tumor histological grade （grade Ⅱ and Ⅲ）， and no radiotherapy were independent risk factors for DFS in elderly breast cancer patients （all P < 0.05）， while ER status was an independent protective factor （P < 0.05）. The independent risk factors for OS in elderly breast cancer patients included tumor stage， N-stage （N2 and N3）， HER2 status， and Ki-67 （all P < 0.05）， and ER status was an independent protective factor （P < 0.05）. Subgroup analysis revealed that in elderly hormone receptor （HR）-negative breast cancer patients， the median follow-ups of the control and case groups were 123.0 （95% CI： 116.8， 129.2） months and 88.0 （95% CI： 75.2， 100.8） months， respectively， with a statistically significant difference both in DFS （91.3% vs. 68.6%， P=0.008） and OS rates （89.1% vs. 71.4%， P=0.027）. ConclusionsPost-breast-conserving radiotherapy provides a limited survival benefit in the overall elderly breast cancer patients， but a significant survival benefit in the elderly HR-negative breast cancer patients， which suggests the need for a prospective randomized controlled trial of a stratified step-down strategy for radiotherapy in elderly breast cancer patients.

AIM: To investigate the efficacy of Yangyin Yiqi Decoction combined with polyethylene glycol eye drops on dry eye disease after cataract surgery and its effect on inflammatory factors in tears.METHODS:Prospective study. A total of 104 patients(104 eyes)with dry eye disease after cataract surgery admitted to our hospital from April 2022 to March 2024 were selected and randomly divided into two groups: 52 cases(52 eyes)in the control group were treated with polyethylene glycol eye drops; 52 cases(52 eyes)in the combined group were treated with Yangyin Yiqi Decoction combined with polyethylene glycol eye drops. The dry eye symptom score, tear film stability index, tear inflammatory factor level, ocular surface disease index score(OSDI)and clinical efficacy of the two groups were compared before and after treatment.RESULTS:There were 6 cases(6 eyes)lost to follow-up, and 3 cases(3 eyes)were lost to follow-up in each group, with a loss to follow-up rate of 5.8%. The total effective rate of treatment in the combination group was significantly higher than that in the control group(94% vs 80%, P=0.037), and the Schirmer I test(SIt)and tear film break-up time(BUT)were higher than those in the control group(all P<0.05), and the dry eye symptom score, corneal fluorescein staining(FL)score, IL-1β, TNF-α, hs-CRP levels in tears and OSDI score were lower than those in the control group(all P<0.05).CONCLUSION:The combination of Yangyin Yiqi Decoction and polyethylene glycol eye drops provides an effective treatment plan for patients with dry eye disease after cataract surgery. It can effectively alleviate dry eye symptoms, reduce eye discomfort, improve tear film stability and ocular surface status, and reduce inflammatory factors in tears.

ObjectiveTo investigate the therapeutic effects of direct-acting antiviral agents (DAAs) combined regimens for hepatitis C virus (HCV) patients in Dehong Prefecture, Yunnan Province from 2022 to 2024, to analyze the characteristics of treatment failure patients, so as to provide a basis for discovering more effective treatment regimens in the future. MethodsData on HCV prevention and treatment in Dehong Prefecture was extracted from the China Disease Control and Prevention Information System. A total of 617 patients with HCV antiviral therapy were included, and the differences in variable characteristics among patients with different genotypes were analyzed using comparative statistical tests, including basic socio-demographic characteristics, biochemical testing indicators, and information on previous treatment and current treatment. In addition, the cure rate of HCV patients with diverse characteristics was compared, and the potential causes of treatment failure were explored simultaneously. ResultsThe cure rate of HCV was 96.8%, and statistically significant differences were observed in aspartate transaminase (AST) and alanine transaminase (ALT) levels, previous antiviral therapy history and initial treatment regimens among patients with different HCV genotypes (all P<0.05). Among the multi-type combination regimens, the cure rate of sofosbuvir (SOF)-containing regimens was 97.00%, that of velpatasvir (VEL)-containing regimens was 95.45%, and the cure rate of other treatment regimens, including the regimens with ribavirin (RIB) intervention, was 93.10%. Among the patients with treatment failure, 45.00% had genotype 3, 40.00% had abnormal abdominal ultrasound results, and all presented with elevated baseline AST test levels. ConclusionThe clinical treatment of HCV patients should consider the differences in genotype and biochemical test results. DAAs combined regimens for HCV have achieved a high cure rate in Dehong Prefecture and are applicable to HCV patients with diverse clinical characteristics, providing research evidence for wider application.

Immunotherapy has been widely used in cancer treatment in recent years and functions by stimulating the immune system to kill tumor cells. Radiation therapy (RT) uses radiation to induce DNA damage and kill tumor cells. However, this activates the body's immune system, promoting the release of tumor-related antigens from inactive dendritic cells, which stimulates the recurrence and metastasis of tumors in immune system tissues. The combination of RT and immunotherapy has been increasingly evaluated in recent years, with studies confirming the synergistic effect of the two antitumor therapies. Particularly, the combination of RT by dose adjustment with different immunotherapies has positive implications on antitumor immunity as well as disease prognosis compared with respective monotherapies. This review summarizes the current research status, progress, and prospects of RT combined with immunotherapy in cancer treatment. It additionally discusses the prevalent concerns regarding the dose, time window, and toxicity of this combination therapy.
Humans ; Neoplasms/radiotherapy* ; Immunotherapy/methods* ; Combined Modality Therapy ; Radiotherapy/methods*

The cyclic guanosine monophosphate-adenosine monophosphate synthase-stimulator of interferon genes (cGAS-STING) pathway is a cornerstone of host innate immunity, playing a central role in detecting cytosolic double-stranded DNA of both endogenous and exogenous origins. Upon activation, cGAS synthesizes the second messenger 2'3'-cyclic GMP-AMP (cGAMP), which binds and activates STING to trigger downstream immune responses, including the production of type I interferons and proinflammatory cytokines. Emerging studies highlight the cGAS-STING pathway as a promising therapeutic target for preventing and treating diverse pathologies, with particularly transformative potential in anticancer therapies. In this review, we dissect the key findings, functions, and associated components of the cGAS-STING pathway. In addition, we emphasize the factors that upregulate or downregulate the pathway, as well as the role of the cGAS-STING pathway in health and disease. By integrating mechanistic insights with clinical perspectives, this review aims to bridge fundamental discoveries with therapeutic applications of cGAS-STING biology.
Humans ; Nucleotidyltransferases/metabolism* ; Membrane Proteins/metabolism* ; Animals ; Immunity, Innate/physiology* ; Signal Transduction/physiology* ; Neoplasms/metabolism*

OBJECTIVES: To investigate the clinical features and prognosis of children with non-Down-syndrome-related acute megakaryoblastic leukemia (non-DS-AMKL). METHODS: A retrospective analysis was conducted on the medical data of 17 children with non-DS-AMKL who were admitted to Children's Hospital of The First Affiliated Hospital of Zhengzhou University from January 2013 to December 2023, and their clinical features, treatment, and prognosis were summarized. RESULTS: Among the 17 children with non-DS-AMKL, there were 8 boys and 9 girls. Fourteen patients had an onset age of less than 36 months, with a median age of 21 months (range:13-145 months). Immunophenotyping results showed that 16 children were positive for CD61 and 13 were positive for CD41. The karyotype analysis was performed on 16 children, with normal karyotype in 6 children and abnormal karyotype in 9 children, among whom 5 had complex karyotype and 1 had no mitotic figure. Detected fusion genes included EVI1, NUP98-KDM5A, KDM5A-MIS18BP1, C22orf34-BRD1, WT1, and MLL-AF9. Genetic alterations included TET2, D7S486 deletion (suggesting 7q-), CSF1R deletion, and PIM1. All 17 children received chemotherapy, among whom 16 (94%) achieved complete remission after one course of induction therapy, and 1 child underwent hematopoietic stem cell transplantation (HSCT) and remained alive and disease-free. Of all children, 7 experienced recurrence, among whom 1 child received HSCT and died of graft-versus-host disease. At the last follow-up, six patients remained alive and disease-free. CONCLUSIONS Non-DS-AMKL primarily occurs in children between 1 and 3 years of age. The patients with this disorder have a high incidence rate of chromosomal abnormalities, with complex karyotypes in most patients. Some patients harbor fusion genes or gene mutations. Although the initial remission rate is high, the long-term survival rate remains low.
Humans ; Male ; Female ; Leukemia, Megakaryoblastic, Acute/etiology* ; Child, Preschool ; Infant ; Child ; Retrospective Studies ; Prognosis ; Down Syndrome/complications*

OBJECTIVE: To explore the relationship between serum complement levels at diagnosis and prognosis in patients with aggressive non-Hodgkin lymphoma(NHL). METHODS: The clinical data of 102 patients with aggressive non-Hodgkin lymphoma diagnosed in the First Hospital of Lanzhou University from February 2017 to March 2023 were selected to analyze the correlation between serum complement C3 and C4 levels and prognosis of patients with aggressive NHL at the time of initial diagnosis. The optimal cut-off point of C3 and C4 were obtained by calculating the Jorden index through the receiver operating characteristic（ROC） curve, and 102 patients were divided into low C3 group (C3< 1.07) and high C3 group (C3≥1.07), low C4 group (C4< 0.255) and high C4 group (C4≥0.255). The effects of serum C3 and C4 levels on the prognosis of these patients were analyzed. RESULTS: ROC curve analysis showed that the area under the curve (AUC) of C3 and C4 in predicting the prognosis of aggressive NHL patients was 0.634 (95%CI ：0.525-0.743；P =0.025) and 0.651 (95%CI ：0.541-0.761；P =0.012), respectively. The optimal cut-off points for C3 and C4 were 1.07 and 0.255, respectively. K-M survival analysis showed that groups with high C3 and C4 levels had shorter progression-free survival (PFS) (P =0.0079; P =0.0092) and overall survival (OS) (P =0.021; P =0.021). Multivariate Cox analysis showed that high level serum complement C3 (HR=2.37, 95%CI : 1.07-5.24, P =0.034) and age ≥60 years (HR=2.34, 95%CI : 1.11-4.95, P =0.025) were independent risk factors for PFS in patients with aggressive NHL. High level complement C3 (HR=2.37, 95%CI : 1.09-5.13, P =0.029) and age ≥60 years at diagnosis (HR=2.40, 95%CI : 1.13-5.13, P =0.024) were independent risk factors for OS in patients with aggressive NHL. CONCLUSION The level of serum complement C3 at diagnosis is one of the prognostic factors in patients with aggressive NHL.
Humans ; Lymphoma, Non-Hodgkin/blood* ; Prognosis ; Complement C3/metabolism* ; Complement C4/metabolism* ; ROC Curve ; Male ; Female ; Middle Aged ; Adult ; Aged

Salmonellosis represents a global epidemic, and the emergence of extensively drug-resistant (XDR) Salmonella and its sustained transmission worldwide constitutes a significant public health concern. Flagellum-mediated motility serves as a crucial virulence trait of Salmonella that guides the pathogen toward the epithelial surface, enhancing gut colonization. Artemisia argyit essential oil, a traditional herb extract, demonstrates efficacy in treating inflammation-related symptoms and diseases; however, its effects on flagellum assembly and expression mechanisms in anti-Salmonella activity remain inadequately explored. This study aimed to elucidate the mechanism by which Artemisia argyit essential oil addresses Salmonella infections. Network pharmacological analysis revealed that Traditional Chinese Medicine (TCM) Artemisia argyit exhibited anti-Salmonella infection potential and inhibited flagellum-dependent motility. The application of Artemisia argyit essential oil induced notable motility defects through the downregulation of flagellar and fimbriae expression. Moreover, it significantly reduced Salmonella-infected cell damage by interfering with flagellum-mediated Salmonella colonization. In vivo studies demonstrated that Artemisia argyit essential oil administration effectively alleviated Salmonella infection symptoms by reducing bacterial loads, inhibiting interleukin-1 beta (IL-1β), IL-6, and tumor necrosis factor-alpha (TNF-α) production, and diminishing pathological injury. Gas chromatography-mass spectrometry (GC-MS) analysis identified forty-three compounds in Artemisia argyit essential oil, with their corresponding targets and active ingredients predicted. Investigation of an in vivo model of Salmonella infection using the active ingredient demonstrated that alpha-cedrene ameliorated Salmonella infection. These findings suggest the potential application of Artemisia argyit essential oil in controlling Salmonella, the predominant food-borne pathogen.
Artemisia/chemistry* ; Oils, Volatile/chemistry* ; Animals ; Flagella/drug effects* ; Salmonella Infections/microbiology* ; Humans ; Mice ; Anti-Bacterial Agents/pharmacology* ; Salmonella/pathogenicity*