1.Wendantang Regulates Energy Metabolism in Treatment of Myocardial Ischemia via SIRT3/PGC-1α Pathway
Xinjun ZHANG ; Zhiqiang XIAO ; Jia LU ; Wenliang DUN ; Ning GU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(2):1-8
ObjectiveTo investigate the mechanism by which Wendantang regulates the silent information regulator 3 (SIRT3)/peroxisome proliferator-activated receptor-gamma coactivator-1α (PGC-1α) pathway to influence energy metabolism and thereby prevent and treat myocardial ischemia (MI) in a rat model of hyperlipidemia (HL). MethodsThirty SD rats were randomly assigned into five groups: control, model, low-dose (3.702 g·kg-1·d-1) Wendantang, high-dose (7.404 g·kg-1·d-1) Wendantang, and positive control (trimetazidine, 0.006 g·kg-1·d-1), with six rats in each group. The control group was fed normally, while the other groups were fed with a high-fat diet for six weeks for the modeling of HL. Subsequently, the drug intervention groups were administrated with corresponding drugs by gavage, and the control and model groups received an equivalent volume of normal saline for 14 days. One hour after the last gavage, the other groups except the control group were injected intraperitoneally with posterior pituitary hormone (30 U·kg-1) to induce MI. Electrocardiography (ECG) was employed to detect changes in the electrocardiogram. Hematoxylin-eosin staining was performed to observe cardiac pathological changes. Enzyme-linked immunosorbent assay was employed to measure the serum levels of cardiac troponin I(cTnI), myoglobin (MYO), and creatine kinase-MB (CK-MB). Colorimetry was used to determine the levels of total cholesterol (TC) and triglycerides (TG) in the serum and ATP, malondialdehyde (MDA), and superoxide dismutase (SOD) in the myocardial tissue. Western blot was employed to determine the protein levels of SIRT3, PGC-1α, adenosine monophosphate-activated protein kinase (AMPK), and phosphorylated AMPK (p-AMPK) in the myocardial tissue. Real-time PCR was employed to measure the mRNA levels of SIRT3, PGC-1α, and AMPKα in the myocardial tissue. ResultsCompared with the control group, the model group showed significant J-point deviation and elevation in the ECG image, increased heart rate, disarrangement of myocardial fibers with unclear boundaries, elevated levels of CK-MB, cTnI, MYO, TC, and TG (P<0.05, P<0.01), declined levels of SOD and ATP (P<0.01), down-regulated mRNA levels of SIRT3, PGC-1α, and AMPK (P<0.05), and down-regulated protein levels of SIRT3, PGC-1α, and p-AMPK (P<0.05). Compared with the model group, the low-dose and high-dose Wendantang groups and the trimetazidine group showed inhibited J-point deviation and elevation in the ECG image, slowed heart rate, reduced inflammatory cell infiltration, alleviated disarrangement of myocardial fibers, declined levels of CK-MB, cTnI, MYO, TC, and TG (P<0.05, P<0.01), elevated level of SOD (P<0.01), up-regulated mRNA levels of SIRT3, PGC-1α, and AMPK (P<0.05, P<0.01) and up-regulated protein levels of SIRT3, PGC-1α, and p-AMPK (P<0.05, P<0.01). ConclusionWendantang can effectively intervene in HL-associated MI in rats by reducing oxidative stress in myocardial cells, alleviating lipid metabolism disorders, and improving myocardial energy metabolism via the SIRT3/PGC-1α signaling pathway.
2.Analysis of current mental health status and stressors of new professional master's degree graduates in clinical medicine in China
Zhiqiang WANG ; Mengting ZHANG ; Wei CAO ; Junren WANG ; Jinzhong JIA ; Peiyao SHI ; Wei JIANG ; Jingrui LI
Chinese Journal of Medical Education Research 2025;24(10):1300-1306
Objective:To investigate the current situation and correlation between mental health and stressors of new professional master's degree graduates in clinical medicine, and to provide empirical support for improving student mental health.Methods:An online questionnaire survey was conducted among 3 587 fresh graduate students with master's degree in clinical medicine from 65 training institutions in China. SPSS 26.0 was used to compare and analyze the measurement data. Descriptive statistics were used to analyze the mental health using Symptom Checklist-90 (SCL-90) and the current status of stressors. The influence factors and correlation between mental health and stressors were analyzed by means of differentiation analysis and correlation analysis.Results:The SCL-90 overall mean score as well as the scores of obsessive-compulsive symptoms, interpersonal sensitivity, depression, terror, anxious, psychoticism, and hostility of new professional master's degree graduates in clinical medicine were all higher than the national norm ( P<0.05). Among the participants, 58.21% (2 088/3 587) exhibited varying degrees of symptoms listed in the SCL-90. Students from families with low per capita income and low parental education level have more prominent psychological problems. The top three stressors perceived were job seeking, research tasks, and self-ability. Students with positive SCL-90 symptoms reported significantly higher perceived stress in all three stressor dimensions compared to their symptom-negative counterparts ( P<0.001), indicating a significant correlation between mental health status and stressors. Conclusions:The mental health status of new professional master's degree graduates in clinical medicine is concerning and warrants focused attention from educational authorities, academic institutions, and families.
3.Graduate destination and employment status of Chinese medical master's graduates: an analysis based on 2023 national survey
Jingrui LI ; Peiyao SHI ; Jinzhong JIA ; Wei JIANG ; Zhisheng LIANG ; Mengting ZHANG ; Zhiqiang WANG
Chinese Journal of Medical Education Research 2025;24(6):788-794
Objective:To understand the graduation destination of newly graduated medical master's students in China and analyze their employment status.Methods:A questionnaire survey was conducted on 15 942 medical master's students who graduated in 2023. Descriptive analysis, χ2 test, and Kruskal-Wallis rank-sum test were used to understand the current situation and differences in the graduation destinations, employment units, job positions, and starting salaries of different types of medical master's graduates. Results:The employment rate of medical master's graduates was 58.21% (9 280/15 942). In terms of graduation destinations, male graduates, professional degree holders, graduates from non-"Double First-Class" universities, and nursing majors had a high proportion of confirmed employment units. Male graduates, academic degree holders, graduates from "Double First-Class" universities, and basic medical science majors had a high proportion pursuing further studies domestically. In terms of employment, the highest proportion of medical master's graduates worked in hospitals (84.92%, 6 495/7 648) and the lowest proportion worked in primary-level medical and healthcare institutions (1.02%, 78/7 648). The majority (78.07%, 5 971/7 648) held professional technical positions. Starting salaries were relatively low and ranged between 3 001 and 5 000 yuan/month, accounting for 30.99% (2 370/7 648).Conclusions:The employment rate of medical master's graduates is low, with concentrated employment units and job positions, and there is a lack of talents in primary medical institutions. Colleges and universities and education management departments should adopt policy-driven approaches to support key demographic groups and encourage employment in primary healthcare. Training programs should be timely adjusted in response to market demands and focus on cultivating the comprehensive quality and job competence of medical master's graduates. Additionally, student-centered approaches should be used to strengthen the employment guidance and career planning services.
4.Outcomes of the modified Devine + Shiraki approach in the treatment of severe concealed penis
Xuejun HUANGFU ; Zhiqiang FAN ; Jia ZHENG ; Zhonghua LIU ; Xinglei HONG ; Yifan WANG
Chinese Journal of Plastic Surgery 2025;41(11):1152-1158
Objective:To study the outcomes of the modified Devine + Shiraki surgical approach in the treatment of severe concealed penis.Methods:A retrospective analysis was conducted on the clinical data of initially treated patients with severe concealed penis admitted to the Department of Urology, Henan Provincial People’s Hospital from March 2020 to September 2022. The therapeutic effects of three surgical approaches (Devine, Shiraki, and modified Devine + Shiraki) were analyzed and compared. The Devine approach mainly focuses on eliminating the pathological morphology of the concealed penis, thoroughly releasing the penile shaft, and correcting the concealed state; the Shiraki approach emphasizes the rational distribution of skin flaps; the key of the modified Devine + Shiraki approach lies in combining the advantages of the two approaches, achieving both complete correction of the concealed state and rational distribution of skin flaps. Improvements were made to the conventional surgical sequence: skin flap distribution was pre-designed before correcting the concealed penis to avoid difficulties in skin flap arrangement caused by degloving, thereby preventing postoperative complications such as stricture rings, lymphedema, or erectile pain. Three months after the operation, follow-up was performed to assess incision healing, presence of lymphedema or stricture rings, satisfaction with penile exposure, recurrence of the concealed state, urination patency, presence of urethral injury, and normal erectile function. A patient satisfaction survey was conducted 6 months after the operation. Measurement data with normal distribution were expressed as Mean± SD, and one-way analysis of variance was used for comparison among the three groups; categorical variables were expressed as case numbers and percentages, and chi-square test was used for comparison among the three groups. Results:Eighty, fifty, and forty-five male children were enrolled in the Devine + Shiraki group, Devine group, and Shiraki group, respectively. There were no statistically significant differences in age and body mass index (BMI) among the three groups [age: (7.6±4.5) years vs. (7.2±4.4) years vs. (6.7±4.2) years, F=0.61, P=0.546; BMI: (17.4±3.1) kg/m 2 vs. (17.7±3.2) kg/m 2 vs. (18.0±3.3) kg/m 2,F=0.57, P=0.565]. During surgery, all concealed penile shafts were completely released, and the penile skin was rationally distributed. The postoperative follow-up period ranged from 3 months to 18 months, with an average follow-up time of 13.6 months. At the 3-month postoperative follow-up, all three groups showed satisfactory wound healing with no signs of infection or skin flap necrosis; penile skin coverage was adequate, and all children demonstrated unobstructed urination without evidence of urethral injury; normal erectile function was preserved in all cases, with no reports of erectile dysfunction or pain. The recurrence rate of the concealed penis in the Devine + Shiraki group was significantly lower than that in the Devine group and Shiraki group, with a statistically significant difference [0 (0/80) vs. 6.0% (3/50) vs. 31.1% (14/45), χ2=32.88, P<0.001]; the proportion of patients without postoperative lymphedema and stricture rings in the Devine + Shiraki group was higher than that in the Devine group and Shiraki group, with a statistically significant difference [97.5% (78/80) vs. 70.0% (35/50) vs. 86.7% (39/45), χ2=20.39, P<0.001]. The Devine+ Shiraki, Devine, and Shiraki groups reported postoperative satisfaction in 76 (95.0%), 35 (70.0%), and 31 (68.9%) cases, respectively. Conclusion:The modified Devine + Shiraki surgical approach has definite efficacy, good safety, and a low incidence of complications, and can be used as an option for the treatment of severe concealed penis.
5.Comparative efficacy of Ilizarov ring external fixation and unilateral rail external fixation in the treatment of infected bone defects following surgery for tibial fractures
Kai ZHANG ; Yong LI ; Jia CHANG ; Zhiqiang LIN ; Xiaolong HUANG ; Zequn DENG ; Jian LIU ; Jiangbo HAN ; Fei TAN ; Jiankang ZENG ; Shenghu ZHOU
Chinese Journal of Trauma 2025;41(10):961-968
Objective:To compare the efficacy of Ilizarov ring external fixation and unilateral rail external fixation in the treatment of infected bone defects following surgery for tibial fractures.Methods:A retrospective cohort study was conducted to analyze the clinical data of 50 patients with infected bone defects after surgery for tibial fractures, who were admitted to the 940th Hospital of the Joint Logistics Support Force of the PLA from August 2019 to November 2021, including 37 males and 13 females, aged 19-59 years [(42.2±8.8)years]. After debridement and osteotomy, 28 patients were treated with Ilizarov ring external fixation (Ilizarov group) and 22 with unilateral rail external fixation (unilateral fixation group). All the patients in the two groups had previously undergone internal fixation with plates or Kirschner wires for tibial fracture before bone transport. Bone transport started at one week for three stages after successful infection control and osteotomy and was conducted. The following parameters were compared between the two groups: frame-wearing time and healing index after bone transport, self-rating anxiety scale (SAS) grade at 6 months after bone transport, Paley score and Association for the Study and Application of the Method of Ilizarov (ASAMI) score at the last follow-up, Hospital for Special Surgery (HSS) knee score and Baird-Jackson ankle score on admission, after external fixator removal and at the last follow-up, and incidence of postoperative complications.Results:All the patients were followed up for 28-36 months [(32.5±1.6)months]. There were no significant differences in frame-wearing time or healing index between the two groups after bone transport ( P>0.05). At 6 months after bone transport, the SAS grade in the unilateral fixation group (13 patients with mild anxiety, 8 with moderate anxiety, and 1 with severe anxiety) was better than that in the Ilizarov group (6 patients with mild anxiety, 19 with moderate anxiety, 3 with severe anxiety) ( P<0.01). No significant differences were found in the Paley score or ASAMI score between the two groups at the last follow-up ( P>0.05). There were no significant differences in HSS knee score or Baird-Jackson ankle score between the two groups on admission, after external fixator removal or at the last follow-up ( P>0.05). No significant differences were observed in the incidence of pin tract infection, poor healing, infection in the bone elongation area, or re-fracture between the two groups ( P>0.05). The incidence of postoperative axial deviation was 0 in the Ilizarov group, lower than 18% in the unilateral fixation group (4/22) ( P<0.05). Conclusion:Although Ilizarov ring external fixation and unilateral rail external fixation demonstrate comparable efficacy in the treatment of infected bone defects after surgery for tibial fractures, the former provides superior mechanical stability and postoperative axial deviation correction, while the latter offers advantages in reducing psychological burden and enhancing treatment tolerance.
6.Outcomes of the modified Devine + Shiraki approach in the treatment of severe concealed penis
Xuejun HUANGFU ; Zhiqiang FAN ; Jia ZHENG ; Zhonghua LIU ; Xinglei HONG ; Yifan WANG
Chinese Journal of Plastic Surgery 2025;41(11):1152-1158
Objective:To study the outcomes of the modified Devine + Shiraki surgical approach in the treatment of severe concealed penis.Methods:A retrospective analysis was conducted on the clinical data of initially treated patients with severe concealed penis admitted to the Department of Urology, Henan Provincial People’s Hospital from March 2020 to September 2022. The therapeutic effects of three surgical approaches (Devine, Shiraki, and modified Devine + Shiraki) were analyzed and compared. The Devine approach mainly focuses on eliminating the pathological morphology of the concealed penis, thoroughly releasing the penile shaft, and correcting the concealed state; the Shiraki approach emphasizes the rational distribution of skin flaps; the key of the modified Devine + Shiraki approach lies in combining the advantages of the two approaches, achieving both complete correction of the concealed state and rational distribution of skin flaps. Improvements were made to the conventional surgical sequence: skin flap distribution was pre-designed before correcting the concealed penis to avoid difficulties in skin flap arrangement caused by degloving, thereby preventing postoperative complications such as stricture rings, lymphedema, or erectile pain. Three months after the operation, follow-up was performed to assess incision healing, presence of lymphedema or stricture rings, satisfaction with penile exposure, recurrence of the concealed state, urination patency, presence of urethral injury, and normal erectile function. A patient satisfaction survey was conducted 6 months after the operation. Measurement data with normal distribution were expressed as Mean± SD, and one-way analysis of variance was used for comparison among the three groups; categorical variables were expressed as case numbers and percentages, and chi-square test was used for comparison among the three groups. Results:Eighty, fifty, and forty-five male children were enrolled in the Devine + Shiraki group, Devine group, and Shiraki group, respectively. There were no statistically significant differences in age and body mass index (BMI) among the three groups [age: (7.6±4.5) years vs. (7.2±4.4) years vs. (6.7±4.2) years, F=0.61, P=0.546; BMI: (17.4±3.1) kg/m 2 vs. (17.7±3.2) kg/m 2 vs. (18.0±3.3) kg/m 2,F=0.57, P=0.565]. During surgery, all concealed penile shafts were completely released, and the penile skin was rationally distributed. The postoperative follow-up period ranged from 3 months to 18 months, with an average follow-up time of 13.6 months. At the 3-month postoperative follow-up, all three groups showed satisfactory wound healing with no signs of infection or skin flap necrosis; penile skin coverage was adequate, and all children demonstrated unobstructed urination without evidence of urethral injury; normal erectile function was preserved in all cases, with no reports of erectile dysfunction or pain. The recurrence rate of the concealed penis in the Devine + Shiraki group was significantly lower than that in the Devine group and Shiraki group, with a statistically significant difference [0 (0/80) vs. 6.0% (3/50) vs. 31.1% (14/45), χ2=32.88, P<0.001]; the proportion of patients without postoperative lymphedema and stricture rings in the Devine + Shiraki group was higher than that in the Devine group and Shiraki group, with a statistically significant difference [97.5% (78/80) vs. 70.0% (35/50) vs. 86.7% (39/45), χ2=20.39, P<0.001]. The Devine+ Shiraki, Devine, and Shiraki groups reported postoperative satisfaction in 76 (95.0%), 35 (70.0%), and 31 (68.9%) cases, respectively. Conclusion:The modified Devine + Shiraki surgical approach has definite efficacy, good safety, and a low incidence of complications, and can be used as an option for the treatment of severe concealed penis.
7.Comparative efficacy of Ilizarov ring external fixation and unilateral rail external fixation in the treatment of infected bone defects following surgery for tibial fractures
Kai ZHANG ; Yong LI ; Jia CHANG ; Zhiqiang LIN ; Xiaolong HUANG ; Zequn DENG ; Jian LIU ; Jiangbo HAN ; Fei TAN ; Jiankang ZENG ; Shenghu ZHOU
Chinese Journal of Trauma 2025;41(10):961-968
Objective:To compare the efficacy of Ilizarov ring external fixation and unilateral rail external fixation in the treatment of infected bone defects following surgery for tibial fractures.Methods:A retrospective cohort study was conducted to analyze the clinical data of 50 patients with infected bone defects after surgery for tibial fractures, who were admitted to the 940th Hospital of the Joint Logistics Support Force of the PLA from August 2019 to November 2021, including 37 males and 13 females, aged 19-59 years [(42.2±8.8)years]. After debridement and osteotomy, 28 patients were treated with Ilizarov ring external fixation (Ilizarov group) and 22 with unilateral rail external fixation (unilateral fixation group). All the patients in the two groups had previously undergone internal fixation with plates or Kirschner wires for tibial fracture before bone transport. Bone transport started at one week for three stages after successful infection control and osteotomy and was conducted. The following parameters were compared between the two groups: frame-wearing time and healing index after bone transport, self-rating anxiety scale (SAS) grade at 6 months after bone transport, Paley score and Association for the Study and Application of the Method of Ilizarov (ASAMI) score at the last follow-up, Hospital for Special Surgery (HSS) knee score and Baird-Jackson ankle score on admission, after external fixator removal and at the last follow-up, and incidence of postoperative complications.Results:All the patients were followed up for 28-36 months [(32.5±1.6)months]. There were no significant differences in frame-wearing time or healing index between the two groups after bone transport ( P>0.05). At 6 months after bone transport, the SAS grade in the unilateral fixation group (13 patients with mild anxiety, 8 with moderate anxiety, and 1 with severe anxiety) was better than that in the Ilizarov group (6 patients with mild anxiety, 19 with moderate anxiety, 3 with severe anxiety) ( P<0.01). No significant differences were found in the Paley score or ASAMI score between the two groups at the last follow-up ( P>0.05). There were no significant differences in HSS knee score or Baird-Jackson ankle score between the two groups on admission, after external fixator removal or at the last follow-up ( P>0.05). No significant differences were observed in the incidence of pin tract infection, poor healing, infection in the bone elongation area, or re-fracture between the two groups ( P>0.05). The incidence of postoperative axial deviation was 0 in the Ilizarov group, lower than 18% in the unilateral fixation group (4/22) ( P<0.05). Conclusion:Although Ilizarov ring external fixation and unilateral rail external fixation demonstrate comparable efficacy in the treatment of infected bone defects after surgery for tibial fractures, the former provides superior mechanical stability and postoperative axial deviation correction, while the latter offers advantages in reducing psychological burden and enhancing treatment tolerance.
8.Research on the association of breast cancer patients'prognosis with internal mammary sentinel lymph node biopsy
Ruijie JIA ; Zhiqiang SHI ; Qi ZHANG ; Yongjin LU ; Junsheng ZHENG ; Jing SUN ; Zhao BI ; Xiao SUN ; Yongsheng WANG ; Pengfei QIU
China Oncology 2025;35(4):394-403
Background and purpose:Internal mammary sentinel lymph node biopsy(IMSLNB)is a minimally invasive diagnostic technique for regional lymph nodes in breast cancer,which can provide accurate lymph staging and guide adjuvant treatment decision,but its clinical application has been controversial.The purpose of this study was to investigate the prognosis of IMSLNB in early breast cancer.Methods:In this study,a retrospective cohort of 7 949 patients with breast cancer from January 1,2016 to December 31,2021 was analyzed.After applying propensity score matching,the patients were divided into IMSLNB group and no-IMSLNB group,and the regional recurrence-free survival(RRFS),local recurrence-free survival(LRFS),distant metastasis-free survival(DMFS),disease-free survival(DFS)and overall survival(OS)of the two groups were compared.This study was approved by the Clinical Research Ethics Committee of the Affiliated Tumor Hospital of Shandong First Medical University(approval number:SDTHEC20130324).Results:A total of 990 patients were included in the final analysis(330 in the IMSLNB group and 660 in the no-IMSLNB group).IMSLN metastasis was found in 54 patients in the IMSLNB group,including 47 patients with axillary lymph node(ALN)metastasis and 7 patients with IMSLN metastasis only.The IMSLN transfer rate was 16.4%.The median follow-up of 41 months showed that the IMSLNB group demonstrated better 3-year DFS[98.4%vs 94.2%,hazard ratio(HR)=0.509;95%CI:0.312-0.828,P=0.007]and 5-year DFS(92.5%vs 87.3%,HR=0.214,95%CI:0.206-0.222,P=0.011)compared with no-IMSLNB group.However,no significant differences were observed in 3-year OS(99.1%vs 99.4%,HR=0.618,95%CI:0.231-1.655,P=0.338)or 5-year OS(98.5%vs 99.1%,HR=0.52,95%CI:0.51-0.53,P=0.392)between the two groups.The 3-year RRFS in the IMSLNB group was better compared with the no-IMSLNB group(99.09%vs 97.73%,HR=0.066;95%CI:0.061-0.071,P=0.048),while no significant differences were observed in 3-year LRFS(99.70%vs 98.19%,HR=0.209;95%CI:0.201-0.217,P=0.130)or DMFS(95.76%vs 96.06%,HR=0.865,95%CI:0.858-0.872,P=0.820)between the two groups.The exploratory subgroup analysis of DFS revealed that patients in the following subgroups could significantly benefit from IM-SLNB(P<0.05):diagnosis age(≤50 years),premenopausal status,BMI(≤24),lymphovascular invasion(LVI,present),tumor location(lateral),molecular subtype[hormone receptor positive(HR+)/human epidermal growth factor receptor 2 negative(HER2-)],histological type(invasive ductal carcinoma),and axillary lymph node status(positive).Conclusion:IMSLNB can provide more accurate regional lymph node staging for early breast cancer,help optimize adjuvant radiotherapy strategies,and improve patients'DFS and RRFS.It can be promoted as a minimally invasive staging technique for regional lymph nodes.
9.Research on the association of breast cancer patients'prognosis with internal mammary sentinel lymph node biopsy
Ruijie JIA ; Zhiqiang SHI ; Qi ZHANG ; Yongjin LU ; Junsheng ZHENG ; Jing SUN ; Zhao BI ; Xiao SUN ; Yongsheng WANG ; Pengfei QIU
China Oncology 2025;35(4):394-403
Background and purpose:Internal mammary sentinel lymph node biopsy(IMSLNB)is a minimally invasive diagnostic technique for regional lymph nodes in breast cancer,which can provide accurate lymph staging and guide adjuvant treatment decision,but its clinical application has been controversial.The purpose of this study was to investigate the prognosis of IMSLNB in early breast cancer.Methods:In this study,a retrospective cohort of 7 949 patients with breast cancer from January 1,2016 to December 31,2021 was analyzed.After applying propensity score matching,the patients were divided into IMSLNB group and no-IMSLNB group,and the regional recurrence-free survival(RRFS),local recurrence-free survival(LRFS),distant metastasis-free survival(DMFS),disease-free survival(DFS)and overall survival(OS)of the two groups were compared.This study was approved by the Clinical Research Ethics Committee of the Affiliated Tumor Hospital of Shandong First Medical University(approval number:SDTHEC20130324).Results:A total of 990 patients were included in the final analysis(330 in the IMSLNB group and 660 in the no-IMSLNB group).IMSLN metastasis was found in 54 patients in the IMSLNB group,including 47 patients with axillary lymph node(ALN)metastasis and 7 patients with IMSLN metastasis only.The IMSLN transfer rate was 16.4%.The median follow-up of 41 months showed that the IMSLNB group demonstrated better 3-year DFS[98.4%vs 94.2%,hazard ratio(HR)=0.509;95%CI:0.312-0.828,P=0.007]and 5-year DFS(92.5%vs 87.3%,HR=0.214,95%CI:0.206-0.222,P=0.011)compared with no-IMSLNB group.However,no significant differences were observed in 3-year OS(99.1%vs 99.4%,HR=0.618,95%CI:0.231-1.655,P=0.338)or 5-year OS(98.5%vs 99.1%,HR=0.52,95%CI:0.51-0.53,P=0.392)between the two groups.The 3-year RRFS in the IMSLNB group was better compared with the no-IMSLNB group(99.09%vs 97.73%,HR=0.066;95%CI:0.061-0.071,P=0.048),while no significant differences were observed in 3-year LRFS(99.70%vs 98.19%,HR=0.209;95%CI:0.201-0.217,P=0.130)or DMFS(95.76%vs 96.06%,HR=0.865,95%CI:0.858-0.872,P=0.820)between the two groups.The exploratory subgroup analysis of DFS revealed that patients in the following subgroups could significantly benefit from IM-SLNB(P<0.05):diagnosis age(≤50 years),premenopausal status,BMI(≤24),lymphovascular invasion(LVI,present),tumor location(lateral),molecular subtype[hormone receptor positive(HR+)/human epidermal growth factor receptor 2 negative(HER2-)],histological type(invasive ductal carcinoma),and axillary lymph node status(positive).Conclusion:IMSLNB can provide more accurate regional lymph node staging for early breast cancer,help optimize adjuvant radiotherapy strategies,and improve patients'DFS and RRFS.It can be promoted as a minimally invasive staging technique for regional lymph nodes.
10.Analysis on the current status and characteristic of clinical trials for oral diseases in China
Jia JU ; Yihuan LIU ; Hongxu YANG ; Shuibing LIU ; Huan ZHANG ; Zhiqiang SHI ; Yuanming SUN ; Bin FENG
Chinese Journal of Stomatology 2025;60(4):394-402
Objective:To understand the current status and characteristics of clinical trials for oral diseases in China, for the purpose of providing a reference for the research and development of oral diseases in China.Methods:Retrieving the information on clinical trials related to oral diseases registered on the "Platforms for drug clinical trial registration and information" of the National Medical Products Administration from the date of the database establishment to December 31, 2024. The number of clinical trials, type of drugs, trial phases, indication, trial scope, design types were statistically analyzed.Results:As of December 31, 2024, a total of 578 drug clinical trials for oral disease were registered, accounting for 2.1% (578/27 905) of the clinical trials disclosed on the platform during the same period. Bioequivalence clinical trials accounted for the highest proportion [73.9% (427/578)], followed by Phase Ⅰ [9.0% (52/578)], Phase Ⅱ [8.0% (46/578)], and Phase Ⅲ [4.5% (26/578)]. The 578 clinical trials involved 149 types of trial drugs, mainly chemical drugs, among which 127 were developed by domestic pharmaceutical enterprises and 27 by international pharmaceutical enterprises (the five investigational drugs have undergone clinical trials by both domestic and international pharmaceutical companies). The project leader units of the 578 drug clinical trials were distributed in 27 provinces, autonomous regions, municipalities, and Hong Kong Special Administrative Region. Excluding 427 bioequivalence clinical trials, the project leader units of 151 new drug clinical trials showed a significant aggregation phenomenon, and only three specialized oral hospitals have served as project leader units for drug clinical trials.Conclusions:The number of drug clinical trials for oral disease in China has generally shown an increasing trend, but there are still problems such as small number of clinical trials, low proportion of investment in new drug development and international multicenter trials, concentrated indications of clinical trials and insufficient clinical trial experience in specialized oral medical institutions. Enhancing the enthusiasm and innovation capabilities of domestic pharmaceutical enterprises in the research and development of oral diseases drugs, exploring the advantages of traditional Chinese medicine/natural medicine resources for oral diseases, and establishing a clinical research system in specialized oral medical institutions are of great significance for the development of oral drugs.

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