1.Clinical Research and Basic Study on Effect of Huangqin Qingre Chubi Capsule (黄芩清热除痹胶囊) on Self-Perception of Patients and Immune Inflammation in Rheumatoid Arthritis
Fanfan WANG ; Jian LIU ; Qin ZHOU ; Jianting WEN ; Yue SUN ; Mingyu HE
Journal of Traditional Chinese Medicine 2026;67(5):544-556
ObjectiveTo evaluate the comprehensive intervention effects of Huangqin Qingre Chubi Capsule (黄芩清热除痹胶囊, HQC) on self-perception of patients (SPP) and immune inflammation in patients with rheumatoid arthritis (RA), and to explore its potential mechanisms. MethodsClinical data of 452 RA patients were retrospectively collected. Patients were divided into a control group (274 cases), treated with conventional western medicine, and an observation group (178 cases), treated with HQC for at least 2 weeks in addition to conventional western medicine. The treatment duration was 2 weeks for both groups. Propensity score matching (PSM) was performed at a ratio of 1∶1 to match patients between groups. SPP including the Chinese version of the short form-36 health survey (SF-36), self-rating anxiety scale (SAS), self-rating depression scale (SDS), visual analog scale (VAS), and Chinese patient-reported index for rheumatoid arthritis (CPRI-RA), as well as immune inflammatory indicators, including erythrocyte sedimentation rate (ESR), high-sensitivity C-reactive protein (hs-CRP), rheumatoid factor (RF), anti-cyclic citrullinated peptide antibody (anti-CCP), interleukin-6 (IL-6), immunoglobulin A (IgA), immunoglobulin G (IgG), immunoglobulin M (IgM), complement C3, and complement C4, were collected before and after treatment. Spearman correlation analysis was used to assess the relationships between SPP and immune inflammatory indicators. Logistic regression, association rule analysis, and mediation analysis were performed to evaluate the effects and potential pathways of HQC on SPP and immune inflammatory indicators. Network pharmacology was applied to identify the active components and core targets of HQC in the treatment of RA, followed by molecular docking verification. In cell experiments, cells were divided into normal group, model group, 20% medicated serum group, and 80 nmol/L control group. Human synovial fibroblasts (FLS) were cultured with complete medium in the normal group, while human rheumatoid arthritis fibroblast-like synoviocytes (RA-FLS) were cultured in the model group. In the 20% medicated serum group, RA-FLS were cultured with medium containing 20% HQC-medicated serum, and in the 80 nmol/L control group, RA-FLS were cultured with complete medium containing 80 nmol/L methotrexate suspension. After 48 h of culture, cell viability was detected by cell counting kit-8 (CCK-8) assay. Levels of interleukin-1β (IL-1β), interleukin-6 (IL-6), interleukin-8 (IL-8), and interleukin-10 (IL-10) in the cell supernatant were measured by enzyme-linked immunosorbent assay (ELISA). Protein levels of matrix metalloproteinase 9 (MMP9), transcription factor AP-1 subunit (JUN), vascular endothelial growth factor A (VEGFA), and C-X-C motif chemokine ligand 8 (CXCL8) were detected by Western Blot, and cell migration ability was evaluated using Transwell assay. ResultsAfter PSM, 178 cases were included in each group. After treatment, SF-36 scores increased, while scores of SAS, SDS, VAS and CPRI-RA, levels of ESR, hs-CRP, IL-6, complement C3, and complement C4 levels decreased in both groups; IgG and IgM levels were also reduced in the observation group (P<0.05). Physical functioning (correlation coefficient -0.19, P<0.05) and social functioning (correlation coefficient -0.18, P<0.05) of SF-36 were negatively correlated with hs-CRP, while VAS score was positively correlated with hs-CRP (correlation coefficient 0.19, P<0.05). HQC showed high associations with improvements in multiple indicators of SPP and immune inflammatory, and acted as a protective factor for the improvement of several SPP; hs-CRP and ESR played partial mediating roles in the improvement of SPP induced by HQC (P<0.05). Network pharmacology analysis identified baicalein, quercetin, α1-sitosterol, β-sitosterol, stigmasterol, baicalin, and crocetin as the core active components, and JUN, IL-6, VEGFA, MMP9, IL-1β, and CXCL8 as the core targets. Molecular docking results showed strong binding affinities of quercetin with VEGFA, JUN, MMP9, IL-6, and IL-1β, of baicalin with VEGFA and MMP9, and of wogonin with CXCL8. Cell experiments demonstrated that HQC and methotrexate inhibited RA-FLS viability and migration, reduced levels of IL-1β, IL-6, and IL-8, decreased protein levels of MMP9, JUN, VEGFA, and CXCL8, and increased IL-10 levels (P<0.05). ConclusionHQC can improve SPP in RA by regulating immune inflammatory responses. Its mechanism may be related to multi-pathway and multi-target inhibition of synovial cell inflammation and migration.
2.Intelligent handheld ultrasound improving the ability of non-expert general practitioners in carotid examinations for community populations: a prospective and parallel controlled trial
Pei SUN ; Hong HAN ; Yi-Kang SUN ; Xi WANG ; Xiao-Chuan LIU ; Bo-Yang ZHOU ; Li-Fan WANG ; Ya-Qin ZHANG ; Zhi-Gang PAN ; Bei-Jian HUANG ; Hui-Xiong XU ; Chong-Ke ZHAO
Ultrasonography 2025;44(2):112-123
Purpose:
The aim of this study was to investigate the feasibility of an intelligent handheld ultrasound (US) device for assisting non-expert general practitioners (GPs) in detecting carotid plaques (CPs) in community populations.
Methods:
This prospective parallel controlled trial recruited 111 consecutive community residents. All of them underwent examinations by non-expert GPs and specialist doctors using handheld US devices (setting A, setting B, and setting C). The results of setting C with specialist doctors were considered the gold standard. Carotid intima-media thickness (CIMT) and the features of CPs were measured and recorded. The diagnostic performance of GPs in distinguishing CPs was evaluated using a receiver operating characteristic curve. Inter-observer agreement was compared using the intragroup correlation coefficient (ICC). Questionnaires were completed to evaluate clinical benefits.
Results:
Among the 111 community residents, 80, 96, and 112 CPs were detected in settings A, B, and C, respectively. Setting B exhibited better diagnostic performance than setting A for detecting CPs (area under the curve, 0.856 vs. 0.749; P<0.01). Setting B had better consistency with setting C than setting A in CIMT measurement and the assessment of CPs (ICC, 0.731 to 0.923). Moreover, measurements in setting B required less time than the other two settings (44.59 seconds vs. 108.87 seconds vs. 126.13 seconds, both P<0.01).
Conclusion
Using an intelligent handheld US device, GPs can perform CP screening and achieve a diagnostic capability comparable to that of specialist doctors.
3.Effect of walking-cognition dual-task training combined with active self-disclosure on elderly patients with acute ischemic stroke
Qinqin HU ; Xueying SHI ; Anna WANG ; Pengchao WU ; Qin ZHOU ; Jiaojiao LI ; Xing YUAN ; Jian LI
Chinese Journal of Geriatric Heart Brain and Vessel Diseases 2025;27(2):197-201
Objective To observe the effect of specialist team-led walking-cognition dual-task train-ing combined with active self-disclosure on control and balance abilities in elderly patients with acute ischemic stroke(AIS).Methods A total of 90 elderly AIS patients treated in our hospital from January 2022 to January 2024 were enrolled and randomly assigned into the control group and the observation group,with 45 cases in each group.The control group received routine walk-ing training,while the observation group received specialist team-led walking-cognition dual-task training combined with active self-disclosure intervention.Control ability,balance ability,walking ability,cognitive function and psychological status were compared between the two groups.Results After intervention,the scores of Sheikh Trunk Control Scale and Fugl-Meyer Assessment(FMA),and the static balance score,dynamic balance score and total score of Berg Balance Scale(BBS)were significantly increased in both the observation and the control groups(P<0.05),and all above scores were obviously higher in the former group than the latter one(P<0.01).The two groups also obtained notably shorter single-and dual-task walking time after intervention,but there were no statistical difference in the single-task walking time in both groups before and after intervention(P>0.05).After intervention,the observation group had significantly shorter dual-task walking time(22.87±7.36 s vs 27.52±8.71 s,P=0.008)and lower walking time cost of dual task[(11.16±4.07)%vs(25.61±7.82)%,P=0.000]when compared with the control group.After intervention,the scores of Mini-Mental Status Examination were increased,and the scores of Hamilton Depression Rating Scale and Hamilton Anxiety Rating Scale were decreased in the two groups(P<0.05).Conclusion Specialist team-led walking-cognition dual-task training com-bined with active self-disclosure intervention can effectively improve trunk control ability,balance ability,walking ability,cognitive function and psychological state in elderly AIS patients,has cer-tian clinical application value.
4.Determination of strychnine in human serum by liquid chromatography tandem mass spectrometry
Xiaohong CHEN ; Chen QIN ; Jian ZHOU
Chinese Journal of Industrial Hygiene and Occupational Diseases 2025;43(8):615-618
Objective:To establish a method for the determination of strychnine in human serum by liquid chromatography tandem mass spectrometry.Methods:In April 2024, the serum samples were extracted using alkaline ethyl acetate. Separation was achieved using a Waters HSS T3 column (100 mm×2.1 mm, 1.8 μm) with a linear gradient elution program of water/acetonitrile (containing 5 mmol/L ammonium formate and 0.1% formic acid) as the mobile phase. The analyte was detected by using electrospray ionization (ESI) in the positive multiple reaction monitoring (MRM) mode and quantified using an internal standard method.Results:A good linearity was obtained in the concentration range of 0.01~20.0 μg/L for target compound with the correlation coefficients≥0.999. The limitof detection (LOD) and the limit of quantitation (LOQ) were 0.003 μg/L and 0.01 μg/L, respectively. The average spiked recovery was 101.3%, the intra-day precision was 2.8%-5.4%, and the inter-day precision was 3.9%-6.3%, respectively.Conclusion:Liquid chromatogrphy tandem mass spectrometry method exhibits high sensitivity, strong specificity, and good accuracy, and can be used for the determination of strychnine in Homo sapiens serum.
5.Guideline for Adult Weight Management in China
Weiqing WANG ; Qin WAN ; Jianhua MA ; Guang WANG ; Yufan WANG ; Guixia WANG ; Yongquan SHI ; Tingjun YE ; Xiaoguang SHI ; Jian KUANG ; Bo FENG ; Xiuyan FENG ; Guang NING ; Yiming MU ; Hongyu KUANG ; Xiaoping XING ; Chunli PIAO ; Xingbo CHENG ; Zhifeng CHENG ; Yufang BI ; Yan BI ; Wenshan LYU ; Dalong ZHU ; Cuiyan ZHU ; Wei ZHU ; Fei HUA ; Fei XIANG ; Shuang YAN ; Zilin SUN ; Yadong SUN ; Liqin SUN ; Luying SUN ; Li YAN ; Yanbing LI ; Hong LI ; Shu LI ; Ling LI ; Yiming LI ; Chenzhong LI ; Hua YANG ; Jinkui YANG ; Ling YANG ; Ying YANG ; Tao YANG ; Xiao YANG ; Xinhua XIAO ; Dan WU ; Jinsong KUANG ; Lanjie HE ; Wei GU ; Jie SHEN ; Yongfeng SONG ; Qiao ZHANG ; Hong ZHANG ; Yuwei ZHANG ; Junqing ZHANG ; Xianfeng ZHANG ; Miao ZHANG ; Yifei ZHANG ; Yingli LU ; Hong CHEN ; Li CHEN ; Bing CHEN ; Shihong CHEN ; Guiyan CHEN ; Haibing CHEN ; Lei CHEN ; Yanyan CHEN ; Genben CHEN ; Yikun ZHOU ; Xianghai ZHOU ; Qiang ZHOU ; Jiaqiang ZHOU ; Hongting ZHENG ; Zhongyan SHAN ; Jiajun ZHAO ; Dong ZHAO ; Ji HU ; Jiang HU ; Xinguo HOU ; Bimin SHI ; Tianpei HONG ; Mingxia YUAN ; Weibo XIA ; Xuejiang GU ; Yong XU ; Shuguang PANG ; Tianshu GAO ; Zuhua GAO ; Xiaohui GUO ; Hongyi CAO ; Mingfeng CAO ; Xiaopei CAO ; Jing MA ; Bin LU ; Zhen LIANG ; Jun LIANG ; Min LONG ; Yongde PENG ; Jin LU ; Hongyun LU ; Yan LU ; Chunping ZENG ; Binhong WEN ; Xueyong LOU ; Qingbo GUAN ; Lin LIAO ; Xin LIAO ; Ping XIONG ; Yaoming XUE
Chinese Journal of Endocrinology and Metabolism 2025;41(11):891-907
Body weight abnormalities, including overweight, obesity, and underweight, have become a dual public health challenge in Chinese adults: overweight and obesity lead to a variety of chronic complications, while underweight increases the risks of malnutrition, sarcopenia, and organ dysfunction. To systematically address these issues, multidisciplinary experts in endocrinology, sports science, nutrition, and psychiatry from various regions have held multiple weight management seminars. Based on the latest epidemiological data and clinical evidence, they expanded the guideline to include assessment and intervention strategies for underweight, in addition to the core content of obesity management. This guideline outlines the etiological mechanisms, evaluation methods, and multidimensional management strategies for overweight and obesity, covering key areas such as diagnosis and assessment, medical nutrition therapy, exercise prescription, pharmacological intervention, and psychological support. It is intended to provide a scientific and standardized approach to weight management across the adult population, aiming to curb the rising prevalence of obesity, mitigate complications associated with abnormal body weight, and improve nutritional status and overall quality of life.
6.Chain mediating role of family care and emotional management between social support and anxiety in primary school students.
Zhan-Wen LI ; Jian-Hui WEI ; Ke-Bin CHEN ; Xiao-Rui RUAN ; Yu-Ting WEN ; Cheng-Lu ZHOU ; Jia-Peng TANG ; Ting-Ting WANG ; Ya-Qing TAN ; Jia-Bi QIN
Chinese Journal of Contemporary Pediatrics 2025;27(10):1176-1184
OBJECTIVES:
To investigate the chain mediating role of family care and emotional management in the relationship between social support and anxiety among rural primary school students.
METHODS:
A questionnaire survey was conducted among students in grades 4 to 6 from four counties in Hunan Province. Data were collected using the Social Support Rating Scale, Family Care Index Scale, Emotional Intelligence Scale, and Generalized Anxiety Disorder -7. Logistic regression analysis was used to explore the influencing factors of anxiety symptoms. Mediation analysis was conducted to assess the chain mediating effects of family care and emotional management between social support and anxiety.
RESULTS:
A total of 4 141 questionnaires were distributed, with 3 874 valid responses (effective response rate: 93.55%). The prevalence rate of anxiety symptoms among these students was 9.32% (95%CI: 8.40%-10.23%). Significant differences were observed in the prevalence rates of anxiety symptoms among groups with different levels of social support, family functioning, and emotional management ability (P<0.05). The total indirect effect of social support on anxiety symptoms via family care and emotional management was significant (β=-0.137, 95%CI: -0.167 to -0.109), and the direct effect of social support on anxiety symptoms remained significant (P<0.05). Family care and emotional management served as significant chain mediators in the relationship between social support and anxiety symptoms (β=-0.025,95%CI:-0.032 to -0.018), accounting for 14.5% of the total effect.
CONCLUSIONS
Social support can directly affect anxiety symptoms among rural primary school students and can also indirectly influence anxiety symptoms through the chain mediating effects of family care and emotional management. These findings provide scientific evidence for the prevention of anxiety in primary school students from multiple perspectives.
Humans
;
Female
;
Male
;
Social Support
;
Anxiety/etiology*
;
Child
;
Students/psychology*
;
Emotions
;
Logistic Models
7.Suanzaoren Decoction Alleviates Anxiety- and Depression-Like Behaviors Induced by Chronic Restraint Stress via Regulating Pyramidal Neuron Activity in Basolateral Amygdala of Mice.
Chang-Feng CHEN ; Yin-Huan GAO ; Qin FANG ; Yong-Feng ZHOU ; Yong LIU ; Jian WU ; Hao CHEN ; Lie-Cheng WANG ; Lei CHEN
Chinese journal of integrative medicine 2025;31(11):982-990
OBJECTIVE:
To elucidate the modulation mechanism of Suanzaoren Decoction (SZRD) on basolateral amygdala (BLA) neuronal activity to alleviate chronic restraint stress (CRS)-related behavioral deficits.
METHODS:
The male C57BL/6J mice were assigned to 4 groups using the complete randomization method, including control (CON, n=19), CRS (n=19), SZRD (n=21), and fluoxetine (Flu, n=22) groups. Mice were restrained for 6 h per day, over a 21-d period to establish CRS models. The CON group remained in their cages without food or water during the 6-h matching period. SZRD and Flu groups received intragastric administration of SZRD (4.68 g/kg) and Flu (20 mg/kg) daily, respectively, 30 min before restraint for 21 consecutive days. The therapeutic effects of SZRD were evaluated using behavioral tests including the tail suspension test, elevated plus maze test, and forced swimming test. The cellular Fletcher B. Judson murine osteosarcoma proto-oncogene (c-Fos) expression in the BLA was measured using immunofluorescence, while action potential (AP) firing and synaptic transmission in BLA pyramidal neurons were evaluated using whole-cell patch-clamp recordings.
RESULTS:
SZRD administration significantly increased time spent in the open arms and open-arm entries while reducing immobility time (P<0.05 or P<0.01). It downregulated CRS-induced c-Fos expression and AP firing of pyramidal neurons in the BLA (P<0.01). Additionally, SZRD selectively attenuated excitatory (P<0.01), but not inhibitory, synaptic transmission onto BLA pyramidal neurons.
CONCLUSION
SZRD alleviated CRS-induced anxiety- and depression-like behaviors in mice by modulating the excitability and synaptic transmission of BLA pyramidal neurons.
Animals
;
Drugs, Chinese Herbal/therapeutic use*
;
Depression/complications*
;
Pyramidal Cells/pathology*
;
Male
;
Mice, Inbred C57BL
;
Basolateral Nuclear Complex/pathology*
;
Restraint, Physical
;
Anxiety/complications*
;
Behavior, Animal/drug effects*
;
Stress, Psychological/physiopathology*
;
Mice
;
Proto-Oncogene Proteins c-fos/metabolism*
;
Action Potentials/drug effects*
;
Synaptic Transmission/drug effects*
8.Trends in global burden due to visceral leishmaniasis from 1990 to 2021 and projections up to 2035
Guobing YANG ; Aiwei HE ; Yongjun LI ; Shan LÜ ; Muxin CHEN ; Liguang TIAN ; Qin LIU ; Lei DUAN ; Yan LU ; Jian YANG ; Shizhu LI ; Xiaonong ZHOU ; Jichun WANG ; Shunxian ZHANG
Chinese Journal of Schistosomiasis Control 2025;37(1):35-43
Objective To investigate the global burden of visceral leishmaniasis (VL) from 1990 to 2021 and predict the trends in the burden of VL from 2022 to 2035, so as to provide insights into global VL prevention and control. Methods The global age-standardized incidence, prevalence, mortality and disability-adjusted life years (DALYs) rates of VL and their 95% uncertainty intervals (UI) were captured from the Global Burden of Disease Study 2021 (GBD 2021) data resources. The trends in the global burden of VL were evaluated with average annual percent change (AAPC) and 95% confidence interval (CI) from 1990 to 2021, and gender-, age-, country-, geographical area- and socio-demographic index (SDI)-stratified burdens of VL were analyzed. The trends in the global burden of VL were projected with a Bayesian age-period-cohort (BAPC) model from 2022 to 2035, and the associations of age-standardized incidence, prevalence, mortality, and DALYs rates of VL with SDI levels were examined with a smoothing spline model. Results The global age-standardized incidence [AAPC = -0.25%, 95% CI: (-0.25%, -0.24%)], prevalence [AAPC = -0.06%, 95% CI: (-0.06%, -0.06%)], mortality [AAPC = -0.25%, 95% CI: (-0.25%, -0.24%)] and DALYs rates of VL [AAPC = -2.38%, 95% CI: (-2.44%, -2.33%)] all appeared a tendency towards a decline from 1990 to 2021, and the highest age-standardized incidence [2.55/105, 95% UI: (1.49/105, 4.07/105)], prevalence [0.64/105, 95% UI: (0.37/105, 1.02/105)], mortality [0.51/105, 95% UI: (0, 1.80/105)] and DALYs rates of VL [33.81/105, 95% UI: (0.06/105, 124.09/105)] were seen in tropical Latin America in 2021. The global age-standardized incidence and prevalence of VL were both higher among men [0.57/105, 95% UI: (0.45/105, 0.72/105); 0.14/105, 95% UI: (0.11/105, 0.18/105)] than among women [0.27/105, 95% UI: (0.21/105, 0.33/105); 0.06/105, 95% UI: (0.05/105, 0.08/105)], and the highest mortality of VL was found among children under 5 years of age [0.24/105, 95% UI: (0.08/105, 0.66/105)]. The age-standardized incidence (r = -0.483, P < 0.001), prevalence (r = -0.483, P < 0.001), mortality (r = -0.511, P < 0.001) and DALYs rates of VL (r = -0.514, P < 0.001) correlated negatively with SDI levels from 1990 to 2021. In addition, the global burden of VL was projected with the BAPC model to appear a tendency towards a decline from 2022 to 2035, and the age-standardized incidence, prevalence, mortality and DALYs rates were projected to be reduced to 0.11/105, 0.03/105, 0.02/105 and 1.44/105 in 2035, respectively. Conclusions Although the global burden of VL appeared an overall tendency towards a decline from 1990 to 2021, the burden of VL showed a tendency towards a rise in Central Asia and western sub-Saharan African areas. The age-standardized incidence and prevalence rates of VL were relatively higher among men, and the age-standardized mortality of VL was relatively higher among children under 5 years of age. The global burden of VL was projected to continue to decline from 2022 to 2035.
9.Intelligent handheld ultrasound improving the ability of non-expert general practitioners in carotid examinations for community populations: a prospective and parallel controlled trial
Pei SUN ; Hong HAN ; Yi-Kang SUN ; Xi WANG ; Xiao-Chuan LIU ; Bo-Yang ZHOU ; Li-Fan WANG ; Ya-Qin ZHANG ; Zhi-Gang PAN ; Bei-Jian HUANG ; Hui-Xiong XU ; Chong-Ke ZHAO
Ultrasonography 2025;44(2):112-123
Purpose:
The aim of this study was to investigate the feasibility of an intelligent handheld ultrasound (US) device for assisting non-expert general practitioners (GPs) in detecting carotid plaques (CPs) in community populations.
Methods:
This prospective parallel controlled trial recruited 111 consecutive community residents. All of them underwent examinations by non-expert GPs and specialist doctors using handheld US devices (setting A, setting B, and setting C). The results of setting C with specialist doctors were considered the gold standard. Carotid intima-media thickness (CIMT) and the features of CPs were measured and recorded. The diagnostic performance of GPs in distinguishing CPs was evaluated using a receiver operating characteristic curve. Inter-observer agreement was compared using the intragroup correlation coefficient (ICC). Questionnaires were completed to evaluate clinical benefits.
Results:
Among the 111 community residents, 80, 96, and 112 CPs were detected in settings A, B, and C, respectively. Setting B exhibited better diagnostic performance than setting A for detecting CPs (area under the curve, 0.856 vs. 0.749; P<0.01). Setting B had better consistency with setting C than setting A in CIMT measurement and the assessment of CPs (ICC, 0.731 to 0.923). Moreover, measurements in setting B required less time than the other two settings (44.59 seconds vs. 108.87 seconds vs. 126.13 seconds, both P<0.01).
Conclusion
Using an intelligent handheld US device, GPs can perform CP screening and achieve a diagnostic capability comparable to that of specialist doctors.
10.Assessment of efficacy and safety of first-line EGFR-TKI combined with radiotherapy in EGFR-mutant lung cancer with brain metastases
Xin YIN ; Yanhua ZHOU ; Weili YI ; Jian HUANG ; Mengting LAI ; Zhili CHEN ; Dongning HUANG ; Li QIN
Chinese Journal of Radiation Oncology 2025;34(11):1102-1110
Objective:To evaluate the efficacy and safety of combining third-generation epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKI) with brain radiotherapy in patients with newly diagnosed EGFR mutation-positive non-small cell lung cancer (NSCLC) with brain metastases. Methods:A retrospective analysis was performed on the clinical data of patients with newly diagnosed EGFR-mutant NSCLC with brain metastases who received first-line treatment with third-generation EGFR-TKI with or without brain radiotherapy at the Fourth Affiliated Hospital of Guangxi Medical University between January 2018 and December 2022. Patients treated with EGFR-TKI plus brain radiotherapy were assigned to the combination group, while those treated with EGFR-TKI alone were assigned to the monotherapy group. Intracranial progression-free survival (iPFS), progression-free survival (PFS), overall survival (OS), intracranial disease control rate (iDCR), intracranial objective response rate (iORR), and adverse events were compared between groups. Subgroup analyses were performed according to EGFR exon 19 deletion (19del) and exon 21L858R mutation status. Survival was estimated using the Kaplan-Meier method, with the log-rank test applied for group comparisons and univariate analysis, while multivariate analysis was conducted using Cox proportional hazards regression model. Results:A total of 107 patients were included: 57 (53%) in the monotherapy group and 50 (47%) in the combination group. The combination therapy significantly improved iORR (80% vs. 60%, P=0.023), prolonged median OS (37.7 vs. 31.6 months, P=0.004), and extended median iPFS (21.8 vs. 16.7 months, P=0.018). The iDCR was 100% in both groups, and the difference in median PFS was not statistically significant (18.6 vs. 15.2 months, P=0.086). In the 19del subgroup ( n=53), patients in the combination group had longer OS ( P=0.028) and iPFS ( P=0.028). In the 21L858R subgroup ( n=54), the median OS was also longer in the combination group ( P=0.050). Multivariate analysis identified TKI monotherapy and an Eastern Cooperative Oncology Group (ECOG) performance status score=2 as independent adverse prognostic factors for iPFS, while TKI monotherapy, age ≥65 years, ECOG score=2, and >3 brain metastases were the independent adverse prognostic factors for OS. The incidence of adverse events did not differ significantly between groups (all P>0.05). Conclusions:First-line combination therapy with third-generation EGFR-TKI and cranial radiotherapy provides superior efficacy and acceptable safety compared with EGFR-TKI monotherapy in patients with EGFR-mutant lung adenocarcinoma and brain metastases. Both EGFR 19del and 21L858R mutation subgroups benefit from the combined treatment approach.

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