1.Clinical Observation on 45 Cases of Chronic Obstructive Pulmonary Disease in the Stable Phase with Qi Deficiency,Blood Stasis and Phlegm Obstruction Syndrome with Auxiliary Treated with Jinwei Guben Decoction (金卫固本汤) Combined with Bailing Capsule (百令胶囊)
Deyu KONG ; Xudong ZHENG ; Huimin ZHOU ; Ruitao WANG ; Benzhang ZHAO ; Jianjun WU
Journal of Traditional Chinese Medicine 2025;66(4):367-375
ObjectiveTo observe the clinical efficacy of modified Jinwei Guben Decoction (金卫固本汤, MJGD) combined with Bailing Capsule (百令胶囊, BC) in the treatment of chronic obstructive pulmonary disease (COPD) patients in the stable stage with qi deficiency, blood stasis and phlegm obstruction syndrome, in addition to conventional western medicine treatment. MethodsA total of 102 patients with stable COPD and qi deficiency, blood stasis, and phlegm obstruction syndrome were included in the study. According to the patients'preferences, they were divided into treatment group (49 cases) and control group (53 cases). The control group received conventional western medicine treatment, while the treatment group was given MJGD (1 dose daily) combined with BC (2.0 g each time, three times a day) additionally. The treatment period was 3 months, and the patients were followed up for 1 year after the treatment. The acute exacerbation frequency (mild, moderate, severe) before treatment, during treatment, at 6-month follow-up, and at 1-year follow-up was compared between groups. Additionally, the lung function indicators such as FEV1, FEV1%pred, FVC, and FEV1/FVC ratio, traditional Chinese medicine (TCM) syndrome scores, modified British Medical Research Council (mMRC) dyspnea scale, and the COPD Assessment Test (CAT) scores before and after treatment were compared. A logistic regression model was constructed to analyze the impact of MJGD combined with BC on clinical efficacy. ResultsFour patients dropped out from the treatment group and eight from the control group, leaving 45 patients of each group for statistical analysis. The number of mild and moderate acute exacerbations in the treatment group was lower than that in the control group during the treatment period, at 6-month follow-up and within 1 year of follow-up (P<0.05) .The number of severe acute exacerbations was only lower in the treatment group than in the control group at 6-month follow-up (P<0.05). Compared with that before treatment, the number of acute exacerbations of all degrees in the treatment group was significantly reduced within 1 year of follow-up (P<0.05),while only the number of mild acute exacerbations in the control group was significantly reduced within 1 year of follow-up (P<0.05). The treatment group showed significant improvement in FEV1 and FEV1%pred and FEV1/FEV, while the control group showed a significant decline in FEV1 and FVC (P<0.05). After treatment, both groups showed significant reductions in TCM syndrome scores, including coughing, sputum, wheezing, chest tightness, shortness of breath, and fatigue, as well as mMRC and CAT scores (P<0.05), with the treatment group having significantly lower scores than the control group (P<0.05). The overall clinical effective rate of in the treatment group was 93.33% (42/45), significantly higher than that of the control group, 75.56% (34/45, P<0.05). Multivariate logistic regression analysis showed that the use of MJGD combined with BC (OR = 4.68, 95%CI: 1.15 - 19.09, P = 0.03) was positively correlated with clinical efficacy. ConclusionsIn addition to conventional western medicine treatment, the combination of MJGD and BC can reduce the frequency of acute exacerbations, delay the decline of lung function, improve clinical symptoms, and significantly enhance the clinical efficacy in patients with stable COPD and qi deficiency, blood stasis, and phlegm obstruction syndrome.
2.Clinical Efficacy of Jinwei Pingchuan Decoction in Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease with Phlegm-heat Obstruction in Lung Syndrome
Xudong ZHENG ; Deyu KONG ; Benzhang ZHAO ; Huimin ZHOU ; Ruitao WANG ; Jianjun WU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):125-133
ObjectiveTo study the effect of Jinwei Pingchuan decoction combined with conventional Western medicine on the number of acute exacerbations, lung function, and clinical symptoms in patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) with phlegm-heat obstruction in lung syndrome. MethodsA non-randomized controlled trial was conducted to include 60 patients with acute exacerbation of COPD with phlegm-heat obstruction in lung syndrome. Patients were divided into a treatment group and a control group based on whether they received Jinwei Pingchuan decoction, with 30 patients in each group. The treatment group received Jinwei Pingchuan decoction combined with conventional Western medicine therapy, while the control group received conventional Western medicine therapy alone. Both groups received treatment for 7 days. The number of acute exacerbations and lung function indices were followed up and recorded before treatment and three months after treatment. The following outcomes were observed before and after treatment: the number of acute exacerbations, lung function indices (forced expiratory volume in one second [FEV1], percentage of predicted value [FEV1%pred], forced vital capacity [FVC], and FEV1/FVC ratio), the degree of acute exacerbation, TCM syndrome score, COPD assessment test (CAT) score, modified British Medical Research Council Dyspnea Questionnaire (mMRC) score, C-reactive protein (CRP), and white blood cell (WBC) count. ResultsAfter 3 months of follow-up, the treatment group showed a significant reduction in the number of acute exacerbations compared with the pre-treatment values (P<0.05). After treatment, the treatment group had fewer acute exacerbations than the control group (P<0.05). The degree of acute exacerbation in the treatment group improved significantly compared with the pre-treatment values (P<0.05). After treatment, the degree of acute exacerbation in the treatment group was improved compared to the control group (P<0.05). Regarding lung function, FEV1, FEV1%pred, FVC, and FEV1/FVC ratio increased significantly in the treatment group compared with the pre-treatment values (P<0.05), and similar improvements were observed in the control group (P<0.05). After treatment, FEV1 and FVC were higher in the treatment group than the control group (P<0.05). Regarding TCM syndrome scores, the scores for individual symptoms such as wheezing, cough, expectoration, chest tightness, shortness of breath, and fatigue, as well as the total score, decreased significantly in the treatment group compared with the pre-treatment values (P<0.05). In the control group, the scores for cough, expectoration, chest tightness, fatigue, and palpitation, as well as the total score, also decreased (P<0.05). After treatment, the treatment group showed significantly lower scores for wheezing, cough, chest tightness, shortness of breath, and the total score than the control group (P<0.05). Regarding the CAT score, the scores for cough, expectoration, chest tightness, climbing stairs, going out, activity, and energy, as well as the total score, decreased significantly in the treatment group compared with the pre-treatment values (P<0.05). In the control group, the scores for cough, expectoration, chest tightness, sleep, energy, and the total score decreased (P<0.05). After treatment, the treatment group showed significantly lower scores for cough, expectoration, chest tightness, activity, and going out than the control group (P<0.05). Regarding the mMRC score, CRP level, and WBC count, all these parameters decreased significantly in the treatment group compared with the pre-treatment values (P<0.05), and similar reductions were observed in the control group (P<0.05). ConclusionJinwei Pingchuan decoction can reduce the number of acute exacerbations and the degree of acute exacerbation in patients with acute exacerbation of COPD with phlegm-heat obstruction in lung syndrome. It also improves lung function and symptoms such as cough and chest tightness, thereby enhancing the quality of life of patients.
3.Clinical Efficacy of Jinwei Pingchuan Decoction in Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease with Phlegm-heat Obstruction in Lung Syndrome
Xudong ZHENG ; Deyu KONG ; Benzhang ZHAO ; Huimin ZHOU ; Ruitao WANG ; Jianjun WU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):125-133
ObjectiveTo study the effect of Jinwei Pingchuan decoction combined with conventional Western medicine on the number of acute exacerbations, lung function, and clinical symptoms in patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) with phlegm-heat obstruction in lung syndrome. MethodsA non-randomized controlled trial was conducted to include 60 patients with acute exacerbation of COPD with phlegm-heat obstruction in lung syndrome. Patients were divided into a treatment group and a control group based on whether they received Jinwei Pingchuan decoction, with 30 patients in each group. The treatment group received Jinwei Pingchuan decoction combined with conventional Western medicine therapy, while the control group received conventional Western medicine therapy alone. Both groups received treatment for 7 days. The number of acute exacerbations and lung function indices were followed up and recorded before treatment and three months after treatment. The following outcomes were observed before and after treatment: the number of acute exacerbations, lung function indices (forced expiratory volume in one second [FEV1], percentage of predicted value [FEV1%pred], forced vital capacity [FVC], and FEV1/FVC ratio), the degree of acute exacerbation, TCM syndrome score, COPD assessment test (CAT) score, modified British Medical Research Council Dyspnea Questionnaire (mMRC) score, C-reactive protein (CRP), and white blood cell (WBC) count. ResultsAfter 3 months of follow-up, the treatment group showed a significant reduction in the number of acute exacerbations compared with the pre-treatment values (P<0.05). After treatment, the treatment group had fewer acute exacerbations than the control group (P<0.05). The degree of acute exacerbation in the treatment group improved significantly compared with the pre-treatment values (P<0.05). After treatment, the degree of acute exacerbation in the treatment group was improved compared to the control group (P<0.05). Regarding lung function, FEV1, FEV1%pred, FVC, and FEV1/FVC ratio increased significantly in the treatment group compared with the pre-treatment values (P<0.05), and similar improvements were observed in the control group (P<0.05). After treatment, FEV1 and FVC were higher in the treatment group than the control group (P<0.05). Regarding TCM syndrome scores, the scores for individual symptoms such as wheezing, cough, expectoration, chest tightness, shortness of breath, and fatigue, as well as the total score, decreased significantly in the treatment group compared with the pre-treatment values (P<0.05). In the control group, the scores for cough, expectoration, chest tightness, fatigue, and palpitation, as well as the total score, also decreased (P<0.05). After treatment, the treatment group showed significantly lower scores for wheezing, cough, chest tightness, shortness of breath, and the total score than the control group (P<0.05). Regarding the CAT score, the scores for cough, expectoration, chest tightness, climbing stairs, going out, activity, and energy, as well as the total score, decreased significantly in the treatment group compared with the pre-treatment values (P<0.05). In the control group, the scores for cough, expectoration, chest tightness, sleep, energy, and the total score decreased (P<0.05). After treatment, the treatment group showed significantly lower scores for cough, expectoration, chest tightness, activity, and going out than the control group (P<0.05). Regarding the mMRC score, CRP level, and WBC count, all these parameters decreased significantly in the treatment group compared with the pre-treatment values (P<0.05), and similar reductions were observed in the control group (P<0.05). ConclusionJinwei Pingchuan decoction can reduce the number of acute exacerbations and the degree of acute exacerbation in patients with acute exacerbation of COPD with phlegm-heat obstruction in lung syndrome. It also improves lung function and symptoms such as cough and chest tightness, thereby enhancing the quality of life of patients.
4.Huayu Mingmu Prescription Downregulates PI3K/Akt/mTOR-HIF-1α/VEGFA Signaling Pathway to Intervene in Retinal Angiogenesis of DR Rats
Xiaoqiu MA ; Lei ZHAO ; Huimin ZHOU ; Fanghui ZHENG ; Guoqing YANG ; Tao ZUO ; Xiande MA
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(8):78-87
ObjectiveTo observe the effect of Huayu Mingmu prescription on retinal angiogenesis and phosphatidylinositol 3-kinase/protein kinase B/mammalian target of rapamycin (PI3K/Akt/mTOR)-hypoxia inducible factor-1α/vascular endothelial growth factor A (HIF-1α/VEGFA) signaling pathway in diabetic retinopathy (DR) rats. MethodsSixty-four SPF-grade male SD rats were used in the study. Eleven rats were randomly selected as the normal group, while the remaining 53 rats were fed a high-sugar, high-fat diet combined with low-dose streptozotocin (STZ) intraperitoneal injection to establish a type 2 diabetes mellitus (T2DM) rat model. DR model evaluation was performed after 12 weeks of diabetes. The rats were then divided into model, low-dose, medium-dose, and high-dose groups of Huayu Mingmu prescription (9.29, 18.57, 37.14 g·kg-1), and a calcium dobesilate group (0.16 g·kg-1), with 10 rats in each group. The rats were orally administered the corresponding doses of Huayu Mingmu prescription and calcium dobesilate. The normal and model groups received equal volumes of physiological saline via gavage for 8 consecutive weeks. Retinal vascular changes were observed through fundus photography, and pathological changes in retinal tissue were evaluated using hematoxylin-eosin (HE) staining. Retinal microvascular pathological changes were examined through retinal vascular network preparation and periodic acid-Schiff (PAS) staining. Immunofluorescence (IF) was used to detect the expression of VEGFA and angiopoietin-2 (Ang-2) in retinal tissue. Western blot was employed to detect the protein expression of PI3K, Akt, mTOR, HIF-1α, VEGFA, and VEGFR2 in retinal tissue. Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR) was used to assess the mRNA expression of PI3K, Akt, mTOR, HIF-1α, VEGFA, and VEGFR2 in retinal tissue. ResultsCompared with the normal group, the model group exhibited significant pathological changes in retinal tissue, including the appearance of acellular capillaries, as well as significant endothelial cell (E) proliferation and pericyte (P) loss (P<0.01). The E/P was significantly elevated (P<0.01). Protein and mRNA expression levels of PI3K, Akt, mTOR, HIF-1α, VEGFA, and VEGFR2 in retinal tissue were significantly increased (P<0.01), and the expression of Ang-2 protein was significantly elevated (P<0.01). In contrast, retinal tissue in the treatment groups showed alleviated pathological changes, with reduced endothelial cell proliferation and pericyte loss (P<0.05, P<0.01). Among the treatment groups, the high-dose Huayu Mingmu prescription and the calcium dobesilate group exhibited a decreased E/P (P<0.01). Protein and mRNA expression levels of PI3K, Akt, mTOR, HIF-1α, VEGFA, and VEGFR2 in retinal tissue were significantly reduced (P<0.05, P<0.01), and the expression of Ang-2 protein was significantly decreased (P<0.01). ConclusionHuayu Mingmu prescription can intervene in retinal neovascularization in DR rats, delay the progression of DR, and its mechanism may be related to antagonizing the PI3K/Akt/mTOR-HIF-1α/VEGFA signaling pathway.
5.Application of the Third-generation Intracavitary Combined With Interstitial Brachytherapy Applicator Template for Cervical Cancer
Xiang ZHOU ; Xiaodan HUANG ; Huimin XU ; Yi OUYANG
Journal of Sun Yat-sen University(Medical Sciences) 2025;46(2):354-360
ObjectiveTo evaluate a third-generation applicator template for intracavitary combined with interstitial brachytherapy (IC-ISBT) suitable for locally advanced cervical cancer, aiming to improve therapeutic outcomes. MethodsA retrospective study was conducted on patients with stage IB3-ⅣB cervical cancer treated at Sun Yat-sen University Cancer Center from January 2023 to October 2023. Magnetic resonance imaging data before and after external beam radiation therapy were collected and analyzed. According to the residual tumor after external beam radiation, high-risk clinical target volumes (HR-CTV) were delineated, based on which a third-generation IC-ISBT applicator template was designed. The dosimetric and therapeutic differences between using this applicator template (template implantation group) and traditional freehand interstitial implantation (freehand implantation group) were further compared. Statistical methods were used to analyze the data from both groups to test the efficacy and safety of the two approaches. ResultsThe third-generation applicator template could accommodate different cervical structures and optimize needle path layout. The tumor volume in the template implantation group was significantly larger than in the freehand implantation group, showing statistical differences. In terms of dosimetric coverage (V100%), the template implantation group exhibited significant statistical differences compared with the freehand implantation group, demonstrating superior dose coverage. Additionally, the third-generation template showed advantages in protecting the rectum and sigmoid colon by potentially reducing high-dose points, while there were no significant differences in bladder dosimetry between the two methods. The primary cervical lesion remission rates were similar between the two groups. ConclusionThe third-generation IC-ISBT applicator template is scientifically and rationally designed, especially for patients with larger tumor volumes and later stages. It is easy to operate, highly reproducible, and shows significant advantages in dose distribution and protection of surrounding critical organs. The template has the potential to be widely applied as a routine treatment option.
6.Chlorhexidine and Fondaparinux-Induced Kounis Syndrome: a Case Report
Fangzheng YU ; Yajing WANG ; Hang LIN ; Lifeng ZHANG ; Yuhui ZHU ; Xiaomeng SHI ; Huimin ZHOU ; Nan LIN ; Xiang GAO
JOURNAL OF RARE DISEASES 2025;4(3):334-340
Kounis syndrome is an acute coronary syndrome triggered by an allergic reaction, which is clinically rare and frequently subject to misdiagnosis or missed diagnosis. This article presents a case report of a 70-year-old male patient who developed a rash, pruritus, and chest pain following colon polyp resection. Coronary angiography revealed occlusion of the left anterior descending artery, and blood flow was restored after stent implantation. However, the patient experienced recurrent symptoms accompanied by loss of consciousness. Drug skin tests confirmed positive reactions to chlorhexidine and fondaparinux sodium, leading to a diagnosis of type Ⅱ Kounis syndrome. By avoiding allergenic drugs and combining antihistamines with symptomatic treatment to correct myocardial ischemia, the patient′s clinical symptoms significantly improved, and he eventually recovered and was discharged from the hospital. This case underscores the importance of maintaining vigilance for this syndrome in patients with allergies accompanied by chest pain and promptly identifying and avoiding allergens.
7.In vitro antibacterial effect of allicin combined with imipenem on carbapenem-resistant Klebsiella pneumoniae
ZHOU Huimin ; MA Jun ; SHEN Jin
China Tropical Medicine 2025;25(1):103-
Objective To evaluate the in vitro synergistic antimicrobial effect of allicin combined with imipenem on clinically isolated carbapenem-resistant Klebsiella pneumoniae (CRKP), providing a reference for further in vivo pharmacodynamic studies. Methods Twenty-two strains of CRKP were selected as experimental subjects based on clinical drug sensitivity results. Pulling assay together with carbapenem inhibition enhancement assay were leveraged to identify the high adherence and β-lactamase phenotypes of CRKP. The combined effect of allicin and imipenem was confirmed using the zero interaction potency (ZIP) method. The antimicrobial effects of allicin, imipenem, and their combination against CRKP were tested separately in vitro by agar paper diffusion method. The organic combination of allicin and imipenem was exploited for detecting the diameter of the CRKP inhibitory circle and minimal inhibitory concentration (MIC). The crystal violet semi-quantitative method was utilized to observe the effect of allicin combined with imipenem on CRKP biofilm formation. Results Among the 22 strains of CRKP, 6 strains exhibited high adhesion, accounting for 27.27%. The results of carbapenem inhibition enhancement demonstrated that all strains of CRKP were class A β-lactamase-producing. Allicin had a strong bactericidal effect on CRKP. According to the results of one-way ANOVA, the diameter of the circle of inhibition of allicin combined with imipenem (15.91±2.76)mm was significantly higher than that of the imipenem alone group (8.23±3.46) mm(F=46.39, P<0.001). The ZIP scoring and MIC methods confirmed that the combination of allicin and imipenem primarily exerted an additive effect. One-way ANOVA analysis of crystal violet absorbance values showed that compared to the control group (0.213±0.056), the total CRKP biofilm amount in the allicin combined with imipenem group was reduced (0.134±0.045) (F=3.211, P=0.045). Conclusions The results of bacterial inhibition experiments in vitro show that the combination of allicin and imipenem significantly increases the inhibitory ability of CRKP and inhibits biofilm formation effectively.
8.Erratum: Author correction to "The novel ER stress inducer Sec C triggers apoptosis by sulfating ER cysteine residues and degrading YAP via ER stress in pancreatic cancer cells" Acta Pharm Sin B 12 (2022) 210-227.
Junxia WANG ; Minghua CHEN ; Mengyan WANG ; Wenxia ZHAO ; Conghui ZHANG ; Xiujun LIU ; Meilian CAI ; Yuhan QIU ; Tianshu ZHANG ; Huimin ZHOU ; Wuli ZHAO ; Shuyi SI ; Rongguang SHAO
Acta Pharmaceutica Sinica B 2025;15(2):1208-1209
[This corrects the article DOI: 10.1016/j.apsb.2021.07.004.].
9.Fastest recovery after surgery during perioperative period under laparoscopic surgery of gastrointestinal tumors
Qizhi LIU ; Huimin ZHOU ; Minjun ZHOU ; Guozhong CHEN ; Cheng LI ; Junyi CHEN ; Yonggang HONG ; Nan ZHANG ; Hanrong LIU ; Xiaohuang TU
Academic Journal of Naval Medical University 2025;46(1):135-140
Objective To explore the feasibility and safety of fastest recovery after surgery(FRAS)in laparoscopic surgery of gastrointestinal tumors.Methods The clinical data of patients undergoing laparoscopic surgery for gastrointestinal tumors under FRAS and enhanced recovery after surgery(ERAS)from Jan.2023 to May 2024 were collected,and perioperative safety and medical cost were analyzed.Results A total of 87 patients were enrolled,including 43 in the FRAS group and 44 in the ERAS group.Compared with the ERAS group,the FRAS group had significantly shorter surgical time(3.0[2.5,3.5]h vs 3.0[2.5,4.0]h),first postoperative movement time([2.85±4.29]h vs[20.18±6.13]h),first postoperative oral feeding time(2.0[2.0,3.0]h vs 24.0[15.0,48.0]h),postoperative hospital stay(24.0[20.0,40.0]h vs 192.0[150.0,216.0]h),lower hospitalization costs(50 515.61[46 650.44,56 827.12]yuan vs 65 555.09[58 683.21,86 239.02]yuan),and lower medication costs(2 671.09[2 063.31,3 127.09]yuan vs 7 326.90[5 104.66,10 674.26]yuan)(all P<0.05).Conclusion It is safe and feasible to use FRAS during the perioperative period of laparoscopic radical gastrectomy for gastrointestinal tumors,and FRAS can also reduce the costs of hospitalization and medications.
10.Comparison of the efficacy and construction of prediction model for relapse free survival in breast cancer based on diabetes mellitus type 2
Wenkao ZHOU ; Hesen HUANG ; Yimei PAN ; Lingyan HUANG ; Mingshan WANG ; Fangli ZHAO ; Ya WANG ; Huimin TANG
Journal of International Oncology 2025;52(5):295-303
Objective:To construct univariate and multivariate relapse free survival (RFS) prediction models for breast cancer patients with diabetes mellitus type 2 (T2DM) and to compare and select the model with higher predictive performance.Methods:A total of 912 breast cancer patients treated at the First Affiliated Hospital of Dalian Medical University from January 2010 to December 2016 were included, of which 202 patients had T2DM and 710 patients did not. Kaplan-Meier survival curve was drawn based on whether patients had T2DM, and log-rank test was performed based on whether patients had T2DM. All patients were randomly divided into a training set ( n=640) and a validation set ( n=272) at a ratio of 7∶3. Univariate and multivariate Cox proportional risk regression models were used to analyze RFS in breast cancer patients with the survival package. The "rms" package was employed to construct univariate and multivariate RFS prediction models for breast cancer patients with T2DM. Clinical decision curves and calibration curves were used to validate the models. The receiver operator characteristic (ROC) curve was used to compare and analyze the prediction performance of the two models. Results:There were no statistically significant differences between the training set and the validation set patients in terms of age, T2DM, surgical approach, axillary management methods, T stage, N stage, molecular sub-type, estrogen receptor (ER) 1, ER2, progesterone receptor (PR) , ER and PR consistency, Ki67, human epidermal growth factor receptor 2 (HER2) (all P>0.05) . There was a statistically significant difference in histological grade ( χ2=7.59, P=0.022) . Survival analysis showed that the 5-year RFS rate was 83.7% in patients with T2DM and 92.3% in patients without T2DM ( χ2=16.61, P<0.001) . Univariate analysis revealed that age ( HR=1.04, 95% CI: 1.03-1.06, P<0.001) , T2DM ( HR=2.31, 95% CI: 1.49-3.55, P<0.001) , surgical approach ( HR=2.39, 95% CI: 1.20-4.77, P=0.013) , axillary management methods ( HR=2.62, 95% CI: 1.72-3.98, P<0.001) , T stage (T 2: HR=2.13, 95% CI: 1.36-3.31, P<0.001; T 3: HR=6.90, 95% CI: 3.35-14.22, P<0.001) , N stage (N 2: HR=3.87, 95% CI: 2.12-7.07, P<0.001; N 3: HR=8.61, 95% CI: 4.71-15.75, P<0.001) , molecular sub-type (Luminal B: HR=2.74, 95% CI: 1.17-6.36, P=0.019; HER2 +: HR=3.64, 95% CI: 1.38-9.58, P=0.009; TNBC: HR=4.40, 95% CI: 1.71-11.34, P=0.002) , ER1 (>10%: HR=0.57, 95% CI: 0.37-0.90, P=0.016) , ER2 ( HR=0.57, 95% CI: 0.37-0.89, P=0.015) , and PR ( HR=0.56, 95% CI: 0.37-0.86, P=0.008) were all factors influencing RFS in breast cancer patients. Multivariate analysis demonstrated that age ( HR=1.04, 95% CI: 1.02-1.06, P<0.001) , T2DM ( HR=1.82, 95% CI: 1.16-2.85, P=0.009) , T stage (T 2: HR=1.60, 95% CI: 1.01-2.54, P=0.046; T 3: HR=2.64, 95% CI: 1.22-5.72, P=0.014) , N stage (N 2: HR=3.72, 95% CI: 2.01-6.88, P<0.001; N 3: HR=5.34, 95% CI: 2.78-10.25, P<0.001) , and ER1 (>10%: HR=0.63, 95% CI: 0.39-0.99, P=0.046) were independent factors influencing RFS in breast cancer patients. Based on the 10 and 5 variables with P<0.05 in the univariate and multivariate analyses respectively, the nomograms of the univariate and multivariate prediction models were constructed to evaluate the influence of factors such as T2DM on the postoperative RFS of breast cancer patients. Clinical decision curves and calibration curves indicated that both models had high predictive value for RFS in breast cancer patients, and the predictive results were highly consistent with the actual observed results. ROC curve analysis showed that there was no statistically significant difference in the area under the curve (AUC) of the two models for predicting the RFS rates of breast cancer patients in the training set and validation set at 36, 60, and 84 months (all P>0.05) , indicating that the predictive efficacy of the two models was comparable. The multivariate model is more suitable for clinical application because it uses fewer variables. Conclusions:Breast cancer patients with T2DM have poorer prognosis. Age, T2DM, T stage, N stage, and ER1 are independent factors influencing postoperative RFS in breast cancer patients. The multi-factor prediction model of RFS in breast cancer patients based on T2DM is more suitable for clinical application due to its higher predictive efficacy and fewer variables.

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