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.Expert consensus on the prevention and treatment of radiochemotherapy-induced oral mucositis.
Juan XIA ; Xiaoan TAO ; Qinchao HU ; Wei LUO ; Xiuzhen TONG ; Gang ZHOU ; Hongmei ZHOU ; Hong HUA ; Guoyao TANG ; Tong WU ; Qianming CHEN ; Yuan FAN ; Xiaobing GUAN ; Hongwei LIU ; Chaosu HU ; Yongmei ZHOU ; Xuemin SHEN ; Lan WU ; Xin ZENG ; Qing LIU ; Renchuan TAO ; Yuan HE ; Yang CAI ; Wenmei WANG ; Ying ZHANG ; Yingfang WU ; Minhai NIE ; Xin JIN ; Xiufeng WEI ; Yongzhan NIE ; Changqing YUAN ; Bin CHENG
International Journal of Oral Science 2025;17(1):54-54
Radiochemotherapy-induced oral mucositis (OM) is a common oral complication in patients with tumors following head and neck radiotherapy or chemotherapy. Erosion and ulcers are the main features of OM that seriously affect the quality of life of patients and even the progress of tumor treatment. To date, differences in clinical prevention and treatment plans for OM have been noted among doctors of various specialties, which has increased the uncertainty of treatment effects. On the basis of current research evidence, this expert consensus outlines risk factors, clinical manifestations, clinical grading, ancillary examinations, diagnostic basis, prevention and treatment strategies and efficacy indicators for OM. In addition to strategies such as basic oral care, anti-inflammatory and analgesic agents, anti-infective agents, pro-healing agents, and photobiotherapy recommended in previous guidelines, we also emphasize the role of traditional Chinese medicine in OM prevention and treatment. This expert consensus aims to provide references and guidance for dental physicians and oncologists in formulating strategies for OM prevention, diagnosis, and treatment, standardizing clinical practice, reducing OM occurrence, promoting healing, and improving the quality of life of patients.
Humans
;
Chemoradiotherapy/adverse effects*
;
Consensus
;
Risk Factors
;
Stomatitis/etiology*
3.Nigella sativa L. seed extract alleviates oxidative stress-induced cellular senescence and dysfunction in melanocytes.
Ben NIU ; Xiaohong AN ; Yongmei CHEN ; Ting HE ; Xiao ZHAN ; Xiuqi ZHU ; Fengfeng PING ; Wei ZHANG ; Jia ZHOU
Chinese Journal of Natural Medicines (English Ed.) 2025;23(2):203-213
Nigella sativa L. seeds have been traditionally utilized in Chinese folk medicine for centuries to treat vitiligo. This study revealed that the ethanolic extract of Nigella sativa L. (HZC) enhances melanogenesis and mitigates oxidative stress-induced cellular senescence and dysfunction in melanocytes. In accordance with established protocols, the ethanol fraction from Nigella sativa L. seeds was extracted, concentrated, and lyophilized to evaluate its herbal effects via 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) assays, tyrosinase activity evaluation, measurement of cellular melanin contents, scratch assays, senescence-associated β-galactosidase (SA-β-gal) staining, enzyme-linked immunosorbent assay (ELISA), and Western blot analysis for expression profiling of experimentally relevant proteins. The results indicated that HZC significantly enhanced tyrosinase activity and melanin content while notably increasing the protein expression levels of Tyr, Mitf, and gp100 in B16F10 cells. Furthermore, HZC effectively mitigated oxidative stress-induced cellular senescence, improved melanocyte condition, and rectified various functional impairments associated with melanocyte dysfunction. These findings suggest that HZC increases melanin synthesis in melanocytes through the activation of the MAPK, PKA, and Wnt signaling pathways. In addition, HZC attenuates oxidative damage induced by H2O2 therapy by activating the nuclear factor E2-related factor 2-antioxidant response element (Nrf2-ARE) pathway and enhancing the activity of downstream antioxidant enzymes, thus preventing premature senescence and dysfunction in melanocytes.
Oxidative Stress/drug effects*
;
Melanocytes/cytology*
;
Cellular Senescence/drug effects*
;
Nigella sativa/chemistry*
;
Plant Extracts/pharmacology*
;
Seeds/chemistry*
;
Mice
;
Animals
;
Melanins/metabolism*
;
Monophenol Monooxygenase/metabolism*
;
Humans
4.Exploration of the method and efficacy of treatments for intractable pelvic pain caused by rectal or bladder fistula
Yongmei ZHANG ; Gangcheng WANG ; Yingjun LIU ; Youchai WANG ; Guoqiang ZHANG ; Yan ZHANG ; Congqing GAO ; Cong WANG ; Zhi ZHANG ; Jun YANG ; Li JIN ; Yanping WANG ; Zhulin NIU
Chinese Journal of Oncology 2024;46(3):263-268
Objective:To explore the causes and therapeutic effects of pelvic pain caused by rectal fistula or bladder fistula after comprehensive treatment of cervical cancer and rectal cancer (radiotherapy, surgery, chemotherapy, and other treatments).Methods:A retrospective analysis was conducted on the clinical and pathological data of patients with pelvic tumors admitted to the First People's Hospital of Yinchuan City, Ningxia and the Affiliated Cancer Hospital of Zhengzhou University from June 2016 to June 2022. The causes of persistent pelvic pain in patients after comprehensive treatment was investigated, and the corresponding therapeutic effects after clinical treatment was observed.Results:Thirty-two tumor patients experienced persistent pain after comprehensive treatment, including 22 cases of cervical cancer and 10 cases of rectal cancer. The preoperative pain of the entire group of patients was evaluated using the digital grading method, with a pain score of (7.88±1.31) points. Among the 32 patients, there were 16 cases of rectovaginal fistula or ileovaginal fistula, 9 cases of vesicovaginal fistula, 5 cases of rectoperineal fistula, and 2 cases of vesicovaginorectal fistula. Thirty-two patients were initially treated with medication to relieve pain, and according to the ruptured organs, a fistula was made to the corresponding proximal intestinal canal and renal pelvis to intercept the intestinal contents and urine. However, the pain did not significantly be improved. The pain score of treatment with the above methods for one week was (8.13±1.13) points, and there was no statistically significant difference compared to preoperative treatment ( P=0.417). In the later stage, based on a comprehensive evaluation of whether the tumor had recurred, the value of organ preservation, the benefits of surgery, the balance between survival time and improving quality of life, pathological organ resection or repair was performed. The surgical methods included repair of leaks, local debridement combined with irrigation of proximal intestinal fluid, distal closure of the sigmoid colon combined with proximal ostomy, posterior pelvic organ resection, anterior pelvic organ resection, and total pelvic organ resection. One week after surgery, the patients' pain completely relieved or disappeared, with the pain score of (1.72±1.37) points, which was significantly divergent from the preoperative and initial surgical treatments ( P<0.001). Conclusions:Palliative pyelostomy and proximal enterostomy cannot effectively alleviate persistent pelvic floor pain. The fundamental way to alleviate pain is complete blocking of the inflammatory erosion of the intestinal fluid and urine.
5.Epidemiological analysis of newly diagnosed occupational pneumoconiosis in Guangxi Zhuang Autonomous Region from 2013 to 2022
Hengqiu LIANG ; Lexin ZHANG ; Xuedong CHEN ; Yongmei LONG ; Jing YANG ; Liqin BAO ; Shiwen HUANG
China Occupational Medicine 2024;51(4):472-475
Objective To analyze the epidemiological distribution of new occupational pneumoconiosis (hereinafter referred to as "pneumoconiosis") in Guangxi Zhuang Autonomous Region from 2013 to 2022. Methods Data of newly diagnosed pneumoconiosis cases reported in Guangxi Zhuang Autonomous Region from 2013 to 2022 were collected, and epidemiological characteristics were analyzed using descriptive analysis method. Results A total of 972 newly diagnosed pneumoconiosis cases were reported in Guangxi Zhuang Autonomous Region from 2013 to 2022. Except for mica pneumoconiosis, 12 other types of pneumoconiosis were reported. Most of the cases were males, accounting for 97.0%. The diagnosis age of the cases of 40-<60 years old accounted for 77.4%, and the dust exposure age<30 years of the cases accounted for 96.4%. Silicosis was the most common type of pneumoconiosis, followed by coal workers' pneumoconiosis, accounting for 64.6% and 27.9%, respectively. The cases of stage Ⅰ, Ⅱ and Ⅲ pneumoconiosis accounted for 77.7%, 14.9% and 7.4%, respectively. The regional distribution was mostly in Hechi City, accounting for 51.9%. Industry distribution was more common in non-ferrous metal mining, coal mining and washing industry, accounting for 64.9% in total. Most cases were reported in private enterprises and small to medium-sized enterprises, accounting for 53.7% and 76.6% respectively. The most common occupations were coal miners and drillers, accounting for 47.7% in total. Conclusion Newly diagnosed pneumoconiosis cases in Guangxi Zhuang Autonomous Region show certain clustering characteristics in terms of disease type, region, enterprise characteristics, and occupation distribution. The prevention and treatment of pneumoconiosis in small and medium-sized private enterprises in key areas and key industries should be strengthened, especially for workers over 40 years old and with less than 30 years of dust exposure.
6.Key Components of Fishy Smell of Eupolyphaga Steleophaga by Head Space-Solid Phase Microextraction-GC-MS and Odor Activity Value
Hongyan MA ; Hong FAN ; Qian LIU ; Xue LI ; Hui YE ; Dingkun ZHANG ; Yongmei GUAN ; Ming YANG ; Houlin XIA
Chinese Journal of Modern Applied Pharmacy 2024;41(1):88-96
To determine the main components of the fishy smell of the Eupolyphaga Steleophaga, and to provide a theoretical basis for deodorizing the Eupolyphaga Steleophaga.
METHODS
Head space-solid phase microextraction-gas chromatography-mass spectrometry was used to identify the components of 10 batches of Eupolyphaga Steleophaga, and area normalization method and chemometrics method were used to analyze the smelly gas of different batches. Odor activity value(OAV) was used to evaluate the contribution of odor components and identify key odor components.
RESULTS
A total of 87 volatile odor components were identified, the key fishy smell compounds(OAV≥1) were m-methylphenol, dimethyltrisulfide, 4-methylphenol, 2-methyliso-borneol, 2-etzol, 4-methylvaleric acid, iso-valeric acid, etc. Modified fishy gas composition(0.1
7.Exploration of the method and efficacy of treatments for intractable pelvic pain caused by rectal or bladder fistula
Yongmei ZHANG ; Gangcheng WANG ; Yingjun LIU ; Youchai WANG ; Guoqiang ZHANG ; Yan ZHANG ; Congqing GAO ; Cong WANG ; Zhi ZHANG ; Jun YANG ; Li JIN ; Yanping WANG ; Zhulin NIU
Chinese Journal of Oncology 2024;46(3):263-268
Objective:To explore the causes and therapeutic effects of pelvic pain caused by rectal fistula or bladder fistula after comprehensive treatment of cervical cancer and rectal cancer (radiotherapy, surgery, chemotherapy, and other treatments).Methods:A retrospective analysis was conducted on the clinical and pathological data of patients with pelvic tumors admitted to the First People's Hospital of Yinchuan City, Ningxia and the Affiliated Cancer Hospital of Zhengzhou University from June 2016 to June 2022. The causes of persistent pelvic pain in patients after comprehensive treatment was investigated, and the corresponding therapeutic effects after clinical treatment was observed.Results:Thirty-two tumor patients experienced persistent pain after comprehensive treatment, including 22 cases of cervical cancer and 10 cases of rectal cancer. The preoperative pain of the entire group of patients was evaluated using the digital grading method, with a pain score of (7.88±1.31) points. Among the 32 patients, there were 16 cases of rectovaginal fistula or ileovaginal fistula, 9 cases of vesicovaginal fistula, 5 cases of rectoperineal fistula, and 2 cases of vesicovaginorectal fistula. Thirty-two patients were initially treated with medication to relieve pain, and according to the ruptured organs, a fistula was made to the corresponding proximal intestinal canal and renal pelvis to intercept the intestinal contents and urine. However, the pain did not significantly be improved. The pain score of treatment with the above methods for one week was (8.13±1.13) points, and there was no statistically significant difference compared to preoperative treatment ( P=0.417). In the later stage, based on a comprehensive evaluation of whether the tumor had recurred, the value of organ preservation, the benefits of surgery, the balance between survival time and improving quality of life, pathological organ resection or repair was performed. The surgical methods included repair of leaks, local debridement combined with irrigation of proximal intestinal fluid, distal closure of the sigmoid colon combined with proximal ostomy, posterior pelvic organ resection, anterior pelvic organ resection, and total pelvic organ resection. One week after surgery, the patients' pain completely relieved or disappeared, with the pain score of (1.72±1.37) points, which was significantly divergent from the preoperative and initial surgical treatments ( P<0.001). Conclusions:Palliative pyelostomy and proximal enterostomy cannot effectively alleviate persistent pelvic floor pain. The fundamental way to alleviate pain is complete blocking of the inflammatory erosion of the intestinal fluid and urine.
8.The best evidence for the management of ovarian hyper-stimulation syndrome in patients undergoing assisted reproductive therapy
Yu HE ; Zilian WANG ; Yongmei ZHANG ; Xuechun JIANG ; Xuling SHEN ; Meiling XU ; Qun WEI
Journal of Zhejiang University. Medical sciences 2024;53(5):632-640
Objective:To summarize the best evidence for the management of ovarian hyperstimulation syndrome in patients undergoing assisted reproductive therapy.Methods:Evidence related to the management of ovarian hyperstimulation syndrome in patients undergoing assisted reproductive therapy,including guidelines,clinical decision,best clinical practice,systematic evaluation,expert consensus and evidence summary and related original research were systematically searched in UpToDate,BMJ Best Practice,World Health Organization(WHO)website,Guidelines International Network(GIN),National Institute for Health and Clinical Excellence(NICE)website,National Guidelines website,American Society for Reproductive Medicine(ASRM)website,New York Academy of Sciences(NYAS)website,Joanna Briggs Institute(JBI)database,Cochrane Library,CINAHL,PubMed,Wanfang database,CNKI,and China Biomedical Literature Database from inception to May 31,2024.Two researchers independently evaluated the quality of the literature,and a senior researcher made the final decision for literature inclusion.Results:A total of 15 articles were included in the study.Following quality assessment,one article was excluded.The remaining 14 articles included 5 practice guidelines,3 systematic reviews,2 expert consensuses,1 evidence summary,and 3 from UpToDate.Ultimately,27 pieces of evidence were identified across five key aspects:risk assessment,disease monitoring,early prevention,institutional management and health education.Conclusion:The updated evidence indicates that the monitoring and prevention of ovarian hyperstimulation syndrome should start early,personalized treatment plans should be provided for patients,and the rational allocation of treatment resources needs to be promoted to enhance effective management of ovarian hyper-stimulation syndrome.
9.Application of standardized exercise program based on motivation and volitional model in home-based cardiac rehabilitation of patients with acute myocardial infarction
Mei ZHANG ; Lili DAI ; Yongmei SUN ; Yue HUANG
Chinese Journal of Practical Nursing 2024;40(5):321-328
Objective:To analyze the application effect of standardized exercise program based on motivation and volitional model in home-based cardiac rehabilitation of patients with acute myocardial infarction.Methods:The method of non-simultaneous control trial was used. Using convenient sampling method, 60 patients with acute myocardial infarction treated in the Department of Cardiovascular Medicine of Huaibei People's Hospital Affiliated to Bengbu Medical College from December 2021 to April 2023 were selected as subjects. The patients were divided into two groups according to the order of admission: 30 patients admitted from December 2021 to June 2022 as the control group, and 30 patients from July 2022 to April 2023 as the observation group. The control group received routine nursing methods,on the basis of routine nursing, the observation group was intervened with the standardized exercise program based on the theoretical model of motivation and will. The differences of 6-minute walking distance, Duke Activity Status Index Score, Exercise Self-efficacy Score, compliance level of cardiac rehabilitation exercise prescription between the two groups were compared.Results:There were 23 males and 7 females in the control group with age of (58.27 ± 10.86) years old, and 24 males and 6 females in the observation group with age of (57.07 ± 10.91) years old. After 3 months of intervention, 6-minute walking distance, Duke Activity Status Index Score and Exercise Self-efficacy Score in the observation group were (565.53 ± 66.90) m, (29.80 ± 9.76) and (41.87 ± 11.76) points respectively, significantly higher than those in the control group (488.00 ± 91.94) m, (21.63 ± 7.21) and (29.80 ± 8.48) points, the differences were statistically significant ( t=3.73, 3.69, 4.56, all P<0.01). The rates of good, average, and poor compliance with cardiac rehabilitation exercise in the observation group were 56.7% (17/30), 36.7% (11/30), and 6.7% (2/30), respectively, while in the control group were 23.3% (7/30), 46.7% (14/30), and 30.0% (9/30), respectively. The difference between the two groups was statistically significant ( χ2=8.98, P<0.05). Conclusions:The application of standardized exercise program in home-based cardiac rehabilitation of patients with acute myocardial infarction can improve patients ′ exercise endurance, improve exercise self-efficacy, enhance the effect of home-based cardiac rehabilitation, and further reduce cardiovascular risk factors.
10.Clinical characteristics and outcomes of psoriasis patients with COVID-19: A retrospective, multicenter cohort study in China
Yanhua LIU ; Zhongrui XU ; Jian ZHOU ; Aijun CHEN ; Junling ZHANG ; Xiaojing KANG ; Xian JIANG ; Chengzhi LYU ; Chunrui SHI ; Yuling SHI ; Xiaoming LIU ; Fuqiu LI ; Bin YANG ; Yongmei HUANG ; Chen YU ; Gang WANG
Chinese Medical Journal 2024;137(14):1736-1743
Background::Limited information exists regarding the impact of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) infection on psoriasis patients. The objective of this study was to identify clinical factors associated with the prognosis of psoriasis following SARS-CoV-2 infection.Methods::A retrospective, multicenter study was conducted between March and May 2023. Univariable and multivariable logistic regression analyses were employed to identify factors associated with coronavirus disease 2019 (COVID-19)-related psoriasis outcomes. The study included 2371 psoriasis patients from 12 clinical centers, with 2049 of them having been infected with SARS-CoV-2.Results::Among the infected groups, lower exacerbation rates were observed in individuals treated with biologics compared to those receiving traditional systemic or nonsystemic treatments (22.3% [236/1058] vs. 39.8% [92/231] vs. 37.5% [140/373], P <0.001). Psoriasis progression with lesions (adjusted odds ratio [OR] = 8.197, 95% confidence interval [95% CI] = 5.685–11.820, compared to no lesions), hypertension (adjusted OR = 1.582, 95% CI = 1.068–2.343), traditional systemic (adjusted OR = 1.887, 95% CI= 1.263–2.818), and nonsystemic treatment (adjusted OR= 1.602, 95% CI= 1.117–2.297) were found to be associated with exacerbation of psoriasis after SARS-CoV-2 infection, but not biologics (adjusted OR = 0.931, 95% CI = 0.680–1.274, compared to no treatment), according to multivariable logistic regression analysis. Conclusions::A reduced risk of psoriasis exacerbation after SARS-CoV-2 infection was observed with biologics compared to traditional systemic and nonsystemic treatments. Significant risk factors for exacerbation after infection were identified as existing psoriatic lesions and hypertension.


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