1.Abemaciclib plus non-steroidal aromatase inhibitor or fulvestrant in women with HR+/HER2- advanced breast cancer: Final results of the randomized phase III MONARCH plus trial.
Xichun HU ; Qingyuan ZHANG ; Tao SUN ; Yongmei YIN ; Huiping LI ; Min YAN ; Zhongsheng TONG ; Man LI ; Yue'e TENG ; Christina Pimentel OPPERMANN ; Govind Babu KANAKASETTY ; Ma Coccia PORTUGAL ; Liu YANG ; Wanli ZHANG ; Zefei JIANG
Chinese Medical Journal 2025;138(12):1477-1486
BACKGROUND:
In the interim analysis of MONARCH plus, adding abemaciclib to endocrine therapy (ET) improved progression-free survival (PFS) and objective response rate (ORR) in predominantly Chinese postmenopausal women with HR+/HER2- advanced breast cancer (ABC). This study presents the final pre-planned PFS analysis.
METHODS:
In the phase III MONARCH plus study, postmenopausal women in China, India, Brazil, and South Africa with HR+/HER2- ABC without prior systemic therapy in an advanced setting (cohort A) or progression on prior ET (cohort B) were randomized (2:1) to abemaciclib (150 mg twice daily [BID]) or placebo plus: anastrozole (1.0 mg/day) or letrozole (2.5 mg/day) (cohort A) or fulvestrant (500 mg on days 1 and 15 of cycle 1 and then on day 1 of each subsequent cycle) (cohort B). The primary endpoint was PFS of cohort A. Secondary endpoints included cohort B PFS (key secondary endpoint), ORR, overall survival (OS), safety, and health-related quality of life (HRQoL).
RESULTS:
In cohort A (abemaciclib: n = 207; placebo: n = 99), abemaciclib plus a non-steroidal aromatase inhibitor improved median PFS vs . placebo (28.27 months vs . 14.73 months, hazard ratio [HR]: 0.476; 95% confidence interval [95% CI]: 0.348-0.649). In cohort B (abemaciclib: n = 104; placebo: n = 53), abemaciclib plus fulvestrant improved median PFS vs . placebo (11.41 months vs . 5.59 months, HR: 0.480; 95% CI: 0.322-0.715). Abemaciclib numerically improved ORR. Although immature, a trend toward OS benefit with abemaciclib was observed (cohort A: HR: 0.893, 95% CI: 0.553-1.443; cohort B: HR: 0.512, 95% CI: 0.281-0.931). The most frequent grade ≥3 adverse events in the abemaciclib arms were neutropenia, leukopenia, anemia (both cohorts), and lymphocytopenia (cohort B). Abemaciclib did not cause clinically meaningful changes in patient-reported global health, functioning, or most symptoms vs . placebo.
CONCLUSIONS:
Abemaciclib plus ET led to improvements in PFS and ORR, a manageable safety profile, and sustained HRQoL, providing clinical benefit without a high toxicity burden or reduced quality of life.
TRIAL REGISTRATION
ClinicalTrials.gov (NCT02763566).
Humans
;
Female
;
Fulvestrant/therapeutic use*
;
Breast Neoplasms/metabolism*
;
Aminopyridines/therapeutic use*
;
Benzimidazoles/therapeutic use*
;
Middle Aged
;
Aromatase Inhibitors/therapeutic use*
;
Aged
;
Receptor, ErbB-2/metabolism*
;
Adult
;
Letrozole/therapeutic use*
;
Antineoplastic Combined Chemotherapy Protocols/therapeutic use*
;
Anastrozole/therapeutic use*
2.Construction and validation of a predictive model for the risk of kidney injury in human immunodeficiency virus/acquired immunodeficiency syndrome patients
Xiaoyun QIN ; Guoxian LI ; Simei LUO ; Jiaguang HU ; Kai FU ; Peng ZHANG ; Xu LI ; Zhongsheng JIANG
Chinese Journal of Infectious Diseases 2025;43(2):90-97
Objective:To investigate the risk factors for kidney injury during anti-retroviral therapy (ART) with zidovudine (AZT) or tenofovir disoproxil fumarate (TDF) in human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) patients, and to construct and validate a prediction model for the risk of kidney injury in HIV/AIDS patients based on a nomogram.Methods:A total of 923 HIV/AIDS patients admitted to Liuzhou People′s Hospital between January 1st, 2004 and December 31st, 2020 were included in this study. The modeling set (647 cases) and the validation set (276 cases) were divided in a 7∶3 ratio. Risk factors were screened using the least absolute shrinkage and selection operator (LASSO) regression analysis, and a nomogram prediction model for renal impairment risk in HIV/AIDS patients was constructed based on the selected variables. The model′s predictive performance was assessed by calculating the area under the curve (AUC) using the receiver operating characteristics curve (ROC curve). The performance of this model was evaluated using calibration curves. The clinical utility of the model was assessed using decision curve analysis (DCA).Results:Among 923 HIV/AIDS patients, there were 91 cases with kidney injury, including 67 in the modeling set and 24 in the validation set. AZT was used in 29 cases, and TDF was used in 62 cases. LASSO regression analysis was employed to screen seven non-zero variables, including age, ART regimen, baseline estimated glomerular filtration rate (eGFR), baseline CD4 + T lymphocyte count, baseline human immunodeficiency virus (HIV) RNA, baseline hemoglobin, and baseline aspartate aminotransferase (AST), their LASSO regression coefficient were 1.296, 0.250, 1.443, 0.240, 0.120, 0.395, and 0.002, respectively. Based on these variables, a visual nomogram model was constructed and subsequently validated. Through ROC curve analysis, the AUC for the modeling set was 0.826 (95% confidence interval ( CI) 0.767 to 0.884), with a sensitivity of 0.731 and a specificity of 0.809. For the validation set, the AUC was 0.872 (95% CI 0.807 to 0.956), with a sensitivity of 0.875 and a specificity of 0.778. The calibration curve results for the modeling set showed a mean absolute error (MAE) of 0.012 and a consistency index of 0.826, while the validation set had an MAE of 0.021 and a consistency index of 0.872. These results indicated that the model had a high goodness-of-fit, excellent calibration performance, and was reliable and stable. When the risk threshold for the modeling set ranged from 2% to 73%, the model demonstrated favorable net benefits, indicating its excellent clinical utility. Conclusion:The nomogram-based risk prediction model for kidney injury in HIV/AIDS patients is constructed using seven variables including age, ART regimen, baseline eGFR, baseline CD4 + T lymphocyte count, baseline HIV RNA, baseline hemoglobin, and baseline AST, which provides a valuable tool for early identification of individuals at risk of kidney injury and supports timely clinical interventions.
3.Research progress in prevention and treatment of radiation enteritis
Long YUANZHAOYUN ; Jiang MEIQIAO ; Yan XIANGYONG ; Yan ZHONGSHENG
Chinese Journal of Clinical Oncology 2025;52(4):207-212
In recent years,increasingly diverse methods have been employed to prevent and treat radiation enteritis(RE).Improvements in radiotherapy techniques,optimization of radiation dose fractionation,and development and use of radioprotective agents have reduced the incidence of RE,and new treatment modalities,including hormones,mucosal protectants,endoscopic treatments,and surgical interventions,together with emerging therapies,including microbiome-based treatments,stem cell transplantation,and hyperbaric oxygen therapy,have made significant progress.These new technologies and treatments exhibit potential efficacy at alleviating symptoms,protecting the intestin-al barrier,promoting tissue repair,and restoring intestinal microbiota balance.Here,we review the latest research investigating treatment and prevention of RE,exploring the optimization of radiation therapy techniques,and developing strategies for prevention and treatment,with the aim of providing a theoretical basis for more precise,comprehensive,and effective treatment options for RE.
4.Research progress in prevention and treatment of radiation enteritis
Long YUANZHAOYUN ; Jiang MEIQIAO ; Yan XIANGYONG ; Yan ZHONGSHENG
Chinese Journal of Clinical Oncology 2025;52(4):207-212
In recent years,increasingly diverse methods have been employed to prevent and treat radiation enteritis(RE).Improvements in radiotherapy techniques,optimization of radiation dose fractionation,and development and use of radioprotective agents have reduced the incidence of RE,and new treatment modalities,including hormones,mucosal protectants,endoscopic treatments,and surgical interventions,together with emerging therapies,including microbiome-based treatments,stem cell transplantation,and hyperbaric oxygen therapy,have made significant progress.These new technologies and treatments exhibit potential efficacy at alleviating symptoms,protecting the intestin-al barrier,promoting tissue repair,and restoring intestinal microbiota balance.Here,we review the latest research investigating treatment and prevention of RE,exploring the optimization of radiation therapy techniques,and developing strategies for prevention and treatment,with the aim of providing a theoretical basis for more precise,comprehensive,and effective treatment options for RE.
5.Discussion on curative effect of electronic bronchoscope in treating tracheobronchial tuberculosis at clinical activity stage
Shenglin MO ; Yun HUANG ; Xiaohong HUANG ; Gui TANG ; Yanping SUN ; Jinyu QIN ; Tao CHEN ; Jiaguang HU ; Peng ZHANG ; Jinliang KONG ; Zhongsheng JIANG
China Medical Equipment 2025;22(6):76-80
Objective:To evaluate the clinically curative effect of intervention treatment of electronic bronchoscope in treating tracheobronchial tuberculosis at clinical activity stage.Methods:Sixty patients with tracheobronchial tuberculosis at clinical activity stage(type I,II,III and VI)who admitted to Liuzhou People's Hospital from September 2020 to September 2023 were selected,and they were divided into drug group(anti-tuberculosis drug treatment)and combination group(anti-tuberculosis drug treatment+interventional treatment with electronic bronchoscope)by the random number table method,with 30 cases in each group.The curative effects of the two groups were observed,and the negative conversion rate of sputum bacteria,clinical symptom scores(cough symptom,expectoration symptom)before and after treatment,Modified British Medical Research Council Dyspnea Scale(mMRC)score between two groups were compared,and the differences in indicators of pulmonary function such as forced expiratory volume in the first second(FEV1),forced vital capacity(FVC)and maximum voluntary ventilation(MVV)between the two groups also were compared.And then,the incidence of complications was calculated.Results:During the 1,2 and 3 months of follow-up,there were respectively 21 cases,27 cases and 30 cases occurred negative conversion of sputum bacteria in 30 patients of the combination group,and there were respectively 15 cases,18 cases and 23 cases occurred negative conversion of sputum bacteria in 30 patients of the drug group.At the 1st month of follow-up,the negative conversion rate of sputum bacteria in combination group was higher than that in drug group,while there was no statistically significant difference between the two groups(P>0.05).At the 2nd and 3rd month of follow-up,the negative conversion rate of sputum bacteria in the combination group was higher than that in the drug group,and the differences were statistically significant(x2=7.200,7.925,P<0.05).The effective rate of treatment of the combination group was 100%,which was higher than 80%of the drug group,and the difference of that between two groups was significant(x2=6.667,P<0.05).After 2 months of treatment,the mMRC score,cough symptom score and expectoration symptom score of the combination group were all lower than those of the drug group,and the differences were statistically significant(t=3.504,3.950,3.530,P<0.05).The improvement effects of FEV1,FVC and MVV of the combination group were all better than those of the drug group,and the differences were statistically significant(t=6.626,4.966,4.097,P<0.05).There was no significant difference in the incidence of complications between the two groups(P>0.05).Conclusion:Anti-tuberculosis drug therapy combined with electronic bronchoscopy intervention has a good therapeutic effect in clinically active tracheobronchial tuberculosis.
6.Discussion on curative effect of electronic bronchoscope in treating tracheobronchial tuberculosis at clinical activity stage
Shenglin MO ; Yun HUANG ; Xiaohong HUANG ; Gui TANG ; Yanping SUN ; Jinyu QIN ; Tao CHEN ; Jiaguang HU ; Peng ZHANG ; Jinliang KONG ; Zhongsheng JIANG
China Medical Equipment 2025;22(6):76-80
Objective:To evaluate the clinically curative effect of intervention treatment of electronic bronchoscope in treating tracheobronchial tuberculosis at clinical activity stage.Methods:Sixty patients with tracheobronchial tuberculosis at clinical activity stage(type I,II,III and VI)who admitted to Liuzhou People's Hospital from September 2020 to September 2023 were selected,and they were divided into drug group(anti-tuberculosis drug treatment)and combination group(anti-tuberculosis drug treatment+interventional treatment with electronic bronchoscope)by the random number table method,with 30 cases in each group.The curative effects of the two groups were observed,and the negative conversion rate of sputum bacteria,clinical symptom scores(cough symptom,expectoration symptom)before and after treatment,Modified British Medical Research Council Dyspnea Scale(mMRC)score between two groups were compared,and the differences in indicators of pulmonary function such as forced expiratory volume in the first second(FEV1),forced vital capacity(FVC)and maximum voluntary ventilation(MVV)between the two groups also were compared.And then,the incidence of complications was calculated.Results:During the 1,2 and 3 months of follow-up,there were respectively 21 cases,27 cases and 30 cases occurred negative conversion of sputum bacteria in 30 patients of the combination group,and there were respectively 15 cases,18 cases and 23 cases occurred negative conversion of sputum bacteria in 30 patients of the drug group.At the 1st month of follow-up,the negative conversion rate of sputum bacteria in combination group was higher than that in drug group,while there was no statistically significant difference between the two groups(P>0.05).At the 2nd and 3rd month of follow-up,the negative conversion rate of sputum bacteria in the combination group was higher than that in the drug group,and the differences were statistically significant(x2=7.200,7.925,P<0.05).The effective rate of treatment of the combination group was 100%,which was higher than 80%of the drug group,and the difference of that between two groups was significant(x2=6.667,P<0.05).After 2 months of treatment,the mMRC score,cough symptom score and expectoration symptom score of the combination group were all lower than those of the drug group,and the differences were statistically significant(t=3.504,3.950,3.530,P<0.05).The improvement effects of FEV1,FVC and MVV of the combination group were all better than those of the drug group,and the differences were statistically significant(t=6.626,4.966,4.097,P<0.05).There was no significant difference in the incidence of complications between the two groups(P>0.05).Conclusion:Anti-tuberculosis drug therapy combined with electronic bronchoscopy intervention has a good therapeutic effect in clinically active tracheobronchial tuberculosis.
7.Construction and validation of a predictive model for the risk of kidney injury in human immunodeficiency virus/acquired immunodeficiency syndrome patients
Xiaoyun QIN ; Guoxian LI ; Simei LUO ; Jiaguang HU ; Kai FU ; Peng ZHANG ; Xu LI ; Zhongsheng JIANG
Chinese Journal of Infectious Diseases 2025;43(2):90-97
Objective:To investigate the risk factors for kidney injury during anti-retroviral therapy (ART) with zidovudine (AZT) or tenofovir disoproxil fumarate (TDF) in human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) patients, and to construct and validate a prediction model for the risk of kidney injury in HIV/AIDS patients based on a nomogram.Methods:A total of 923 HIV/AIDS patients admitted to Liuzhou People′s Hospital between January 1st, 2004 and December 31st, 2020 were included in this study. The modeling set (647 cases) and the validation set (276 cases) were divided in a 7∶3 ratio. Risk factors were screened using the least absolute shrinkage and selection operator (LASSO) regression analysis, and a nomogram prediction model for renal impairment risk in HIV/AIDS patients was constructed based on the selected variables. The model′s predictive performance was assessed by calculating the area under the curve (AUC) using the receiver operating characteristics curve (ROC curve). The performance of this model was evaluated using calibration curves. The clinical utility of the model was assessed using decision curve analysis (DCA).Results:Among 923 HIV/AIDS patients, there were 91 cases with kidney injury, including 67 in the modeling set and 24 in the validation set. AZT was used in 29 cases, and TDF was used in 62 cases. LASSO regression analysis was employed to screen seven non-zero variables, including age, ART regimen, baseline estimated glomerular filtration rate (eGFR), baseline CD4 + T lymphocyte count, baseline human immunodeficiency virus (HIV) RNA, baseline hemoglobin, and baseline aspartate aminotransferase (AST), their LASSO regression coefficient were 1.296, 0.250, 1.443, 0.240, 0.120, 0.395, and 0.002, respectively. Based on these variables, a visual nomogram model was constructed and subsequently validated. Through ROC curve analysis, the AUC for the modeling set was 0.826 (95% confidence interval ( CI) 0.767 to 0.884), with a sensitivity of 0.731 and a specificity of 0.809. For the validation set, the AUC was 0.872 (95% CI 0.807 to 0.956), with a sensitivity of 0.875 and a specificity of 0.778. The calibration curve results for the modeling set showed a mean absolute error (MAE) of 0.012 and a consistency index of 0.826, while the validation set had an MAE of 0.021 and a consistency index of 0.872. These results indicated that the model had a high goodness-of-fit, excellent calibration performance, and was reliable and stable. When the risk threshold for the modeling set ranged from 2% to 73%, the model demonstrated favorable net benefits, indicating its excellent clinical utility. Conclusion:The nomogram-based risk prediction model for kidney injury in HIV/AIDS patients is constructed using seven variables including age, ART regimen, baseline eGFR, baseline CD4 + T lymphocyte count, baseline HIV RNA, baseline hemoglobin, and baseline AST, which provides a valuable tool for early identification of individuals at risk of kidney injury and supports timely clinical interventions.
8.Analysis of the occurrence time and risk factors of anemia in AIDS patients caused by HAART regimen containing zidovudine
Haiyan YAN ; Wenming HE ; Guoxian LI ; Keyu LUO ; Xiangsong QIN ; Huifen WEI ; Peng ZHANG ; Zhongsheng JIANG
China Pharmacy 2023;34(21):2620-2624
OBJECTIVE To investigate the occurrence time and risk factors of anemia in patients with acquired immune deficiency syndrome (AIDS) after taking highly active antiretroviral therapy (HAART) containing zidovudine. METHODS The clinical data of 2 150 AIDS patients who were followed up in the care clinic of Liuzhou People’s Hospital from January 1, 2010 to December 31, 2022 were collected. The occurrence time of anemia was analyzed retrospectively, and the risk factors of anemia were analyzed by univariate analysis and binary Logistic regression analysis. RESULTS A total of 854 AIDS patients receiving HAART containing zidovudine were collected, and 107 patients (12.53%) developed anemia. Most of them (63.55%) developed anemia within 3 months after treatment. Baseline hemoglobin [OR=2.944, 95%CI (1.195, 7.501), P=0.019], baseline CD4+ T lymphocyte count [OR=2.472, 95%CI (1.117, 5.469), P=0.026] and baseline human immunodeficiency virus-ribonucleic acid (HIV-RNA) [OR=4.299, 95%CI (1.905, 9.705), P<0.001] was associated with anemia. CONCLUSIONS The median time of anemia in AIDS patients receiving HAART containing zidovudine is the second month after initiation of treatment. Baseline hemoglobin≤110 g/L, baseline CD4+ T lymphocyte E-mail:1315775863@qq.com count≤100 /mm3, and baseline HIV-RNA≥100 000 copies/mL are independent risk factors for anemia in these patients.
9.Prevalence of Autism Spectrum Disorder in China: A Nationwide Multi-center Population-based Study Among Children Aged 6 to 12 Years.
Hao ZHOU ; Xiu XU ; Weili YAN ; Xiaobing ZOU ; Lijie WU ; Xuerong LUO ; Tingyu LI ; Yi HUANG ; Hongyan GUAN ; Xiang CHEN ; Meng MAO ; Kun XIA ; Lan ZHANG ; Erzhen LI ; Xiaoling GE ; Lili ZHANG ; Chunpei LI ; Xudong ZHANG ; Yuanfeng ZHOU ; Ding DING ; Andy SHIH ; Eric FOMBONNE ; Yi ZHENG ; Jisheng HAN ; Zhongsheng SUN ; Yong-Hui JIANG ; Yi WANG
Neuroscience Bulletin 2020;36(9):961-971
This study aimed to obtain the first national estimate of the prevalence of autism spectrum disorder (ASD) in Chinese children. We targeted the population of 6 to 12-year-old children for this prevalence study by multistage convenient cluster sampling. The Modified Chinese Autism Spectrum Rating Scale was used for the screening process. Of the target population of 142,086 children, 88.5% (n = 125,806) participated in the study. A total of 363 children were confirmed as having ASD. The observed ASD prevalence rate was 0.29% (95% CI: 0.26%-0.32%) for the overall population. After adjustment for response rates, the estimated number of ASD cases was 867 in the target population sample, thereby achieving an estimated prevalence of 0.70% (95% CI: 0.64%-0.74%). The prevalence was significantly higher in boys than in girls (0.95%; 95% CI: 0.87%-1.02% versus 0.30%; 95% CI: 0.26%-0.34%; P < 0.001). Of the 363 confirmed ASD cases, 43.3% were newly diagnosed, and most of those (90.4%) were attending regular schools, and 68.8% of the children with ASD had at least one neuropsychiatric comorbidity. Our findings provide reliable data on the estimated ASD prevalence and comorbidities in Chinese children.
10.Relationship between BIM deletion polymorphism and paclitaxel intrinsic resistance in breast cancer
Hongling LIANG ; Jianqing HUANG ; Tianen JIN ; Hongshen LI ; Ming JIANG ; Zhongsheng CHEN ; Hui LAN ; Xiaojun TAN
The Journal of Practical Medicine 2018;34(4):531-534
Objective The role of this essay is to explore the relationship of BIM deletion polymorphism and paclitaxel intrinsic resistance in breast cancer. Methods Human breast cancer cell lines were screened by techniques of PCR and gene sequencing to detect BIM deletion polymorphism.MTS was used to detect the cytotoxic effects of paclitaxel in different cell lines. Meanwhile,levels of BIM mRNA and protein were detected by rtPCR and Western Blot. Results Comparing with the wild type cell line(MCF7),T47D was a deletion cell line with BIM deletion polymorphism and resistant to paclitaxel(T47D vs.MCF-7,IC50>30le vs.IC50=0.16 vs.02 μmol/L). Moreover,the ratio of BIM EXON3 to EXON4 was significantly increased and the level of functional BIM protein was down-regulated in T47D compared with MCF7(P < 0.05). Conclusion BIM deletion polymorphism might initiate intrinsic resistance to paclitaxel therapy in breast cancer.

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