1.Study on medication adherence factors among patients with severe mental disorders in Zhuhai city based on XGBoost model
Zhongshu YE ; Yongyong TENG ; Jingju QUAN ; Yajun SUN ; Jiaju HUANG ; Yixuan WU ; Changlin HAN ; Guangchuan ZHANG
Sichuan Mental Health 2026;39(1):36-43
BackgroundLow medication compliance among patients with severe mental disorders increases the disease burden on both the patients' families and the society. Medication adherence is influenced by numerous factors. Traditional methods such as Logistic regression struggle to quantify the importance of these factors. By introducing Extreme Gradient Boosting (XGBoost) combined with Shapley Additive Explanations (SHAP), enables the quantification of the relative contribution weights of each factor, providing support for identifying the core influencing factors. ObjectiveTo explore the influencing factors of medication adherence among patients with severe mental disorders in Zhuhai, aiming to provide references for optimizing patient management strategies. MethodsExtract the data of patients with severe mental disorders who were registered on the mental health system platform in Zhuhai City from January 1, 2023 to March 31, 2025. A total of 9 329 patients were finally included for analysis. Influencing factors were screened using univariate analysis and multivariate logistic regression analysis, and an XGBoost model combined with the SHAP algorithm was constructed to quantify the importance of each influencing factor. ResultsAmong 9 329 patients, 8 446 demonstrated medication adherence, yielding an adherence rate of 90.53%. Multivariable analysis identified several risk factors significantly associated with medication non-adherence, being unmarried (OR=1.237, 95% CI: 1.019–1.502) or divorced (OR=1.389, 95% CI: 1.038–1.832), a diagnosis of mental retardation with psychiatric disorders (OR=3.025, 95% CI: 2.402–3.796) or paranoid psychosis (OR=5.117, 95% CI: 3.086–8.299), a disease duration of 2–4 years (OR=1.355, 95% CI: 1.085–1.696), 4–6 years (OR=2.143, 95% CI: 1.671–2.747), or >6 years (OR=1.681, 95% CI: 1.365–2.079), lack of guardian subsidies (OR=1.412, 95% CI: 1.099–1.801), absence of a disability certificate (OR=1.900, 95% CI: 1.588–2.282), not being enrolled in care and support groups (OR=1.384, 95% CI: 1.183–1.617) or community services (OR=1.313, 95% CI: 1.042–1.645), and not cohabiting with a guardian (OR=1.257, 95% CI: 1.048–1.501). Conversely, the enrollment in special outpatient disease programs (OR=0.716, 95% CI: 0.609–0.842) and a family history of mental illness (OR=0.713, 95% CI: 0.503–0.982) were identified as protective factors. The XGBoost model exhibited robust predictive performance, with a sensitivity of 0.433, specificity of 0.944, accuracy of 0.891, Area Under the Curve (AUC) of 0.837, and F1 value of 0.449. Feature importance ranking indicated that the top three factors were disease duration, diagnosis, and the acquisition of disability certificates. ConclusionPolicy-based support (acquisition of disability certificates, special outpatient disease enrollment) and clinical disease characteristics (disease duration, diagnosis type) are key factors affecting medication adherence among patients with severe mental disorders in Zhuhai City. [Funded by Zhuhai Medical Research Project (number, 2220009000281)]
2.Prevalence and associated factors of work-related musculoskeletal disorders among workers in a manganese enterprise
Tianzi SHAN ; Junxiang MA ; Tian CHEN ; Kang NONG ; Yucheng SUN ; Xueting WANG ; Gaoman ZHANG ; Teng MA ; Zhuoran XIA ; Fengtao CUI ; Li CHEN ; Yanyan ZHENG ; Piye NIU
Journal of Environmental and Occupational Medicine 2026;43(3):333-340
Background Work-related musculoskeletal disorders (WMSDs) are a major occupational health concern, particularly among workers exposed to adverse ergonomic conditions. Manganese production involves heavy physical demands, yet research on WMSDs among manganese workers remains limited. Objective To investigate the prevalence and influencing factors of WMSDs among manganese workers in a manganese enterprise in Guangxi. Methods A cross-sectional survey was conducted from May to June 2024 on workers at a manganese factory in Guangxi. The Chinese Musculoskeletal Disorders Questionnaire was used to collect information on demographic characteristics, distribution of musculoskeletal symptoms, and work-related exposures. χ2 test was applied to compare differences in positive WMSDs rates across groups, and logistic regression analysis was performed to identify associated factors. Results A total of 1476 workers were enrolled in the study after pre-determined inclusion and exclusion criteria. The overall prevalence of WMSDs was 34.15%. The most commonly affected body regions were the lower back (17.28%), neck (16.67%), and shoulders (13.82%). The results of logistic regression analysis indicated that female, older age, and education level of college or above were associated with a higher risk of WMSDs (P<0.05). Awkward working postures were significantly associated with WMSDs in corresponding body regions; in particular, awkward postures of the neck, upper limbs, trunk, and lower limbs were related to an increased risk of WMSDs in multiple body sites (P<0.05). In addition, poor lighting conditions, high workplace temperature, frequent or sustained arm support during work, and high job demands were associated with an increased risk of overall or site-specific WMSDs (P<0.05). Conclusion The high prevalence of WMSDs among manganese workers is closely associated with demographic characteristics, working postures, and work environment and organizational factors. Targeted ergonomic interventions focusing on high-risk body regions and key ergonomic exposures are warranted to reduce the risk of WMSDs among manganese workers.
3.The Role of Circulating Tumor Cell as a Promising Biomarker in the Evaluation of Pulmonary Nodules: A Prospective Study
Shijie WANG ; Changdan XU ; Xiaohong XU ; Weipeng SHAO ; Guohui WANG ; Xiongtao YANG ; Liwei GAO ; Feng TENG ; Hongliang SUN ; Yue ZHAO ; Hongxiang FENG ; Guangying ZHU
Cancer Research and Treatment 2026;58(1):128-140
Purpose:
Our previous study showed that circulating tumor cell (CTC) count combined with gene mutation detection might help differentiate benign and malignant pulmonary nodules (PNs). Herein, we aimed to expand the study cohort and conduct further sequencing analysis.
Materials and Methods:
Patients with PNs were included, and CTCs were identified before operation. Low-coverage whole-genome sequencing (LC-WGS) and lung cancer-related targeted gene sequencing were performed on CTCs. The diagnostic efficacy was evaluated by receiver operating characteristic (ROC) curve. The differences in CTC counts among subgroups classified by demographic–clinical characteristics were analyzed. LC-WGS–based copy number variation (CNV) analysis and targeted gene mutation analysis were conducted.
Results:
A total of 172 patients were included. CTC count of 2.5 was identified by the ROC curves as the optimal diagnostic cutoff. The sensitivity and specificity of CTC count for differentiating benign and malignant PNs were 54.2% and 78.6%, respectively. The diagnostic sensitivity and specificity of combined CTC count, radiological nodule type, and any malignant imaging features were 84.7% and 71.4%, respectively. The CTC counts were significantly greater in patients with aggressive tumors, later stage, and spread through air spaces. CTCs from malignant cases had more CNVs than those from benign cases.
Conclusion
CTC count can be used in identifying malignant PNs. The diagnostic efficacy can be improved if combined with computed tomography imaging characteristics. Further CNV analysis might help differential diagnosis. Greater CTC count might suggest more aggressive tumors. CTC detection can provide important information and guidance for subsequent management of PNs.
4.Risk Assessment for Ramadan Fasting in People With Diabetes in Hospital-Based Diabetes Clinics Using the Updated 2026 IDF-DAR Risk Calculator
Raja Nurazni Raja Azwan ; Chin Voon Tong ; Lisa Mohamed Nor ; Marisa Khatijah Borhan ; Syarifah Syahirah Syed Abas ; Poh Shean Wong ; Ying Jie Tan ; Shartiyah Ismail ; Eunice Yi Chwen Lau ; Yueh Chien Kuan ; Noor Hafis Md Tob ; Shu Teng Chai ; Pei Lin Chan ; Xe Hui Lee ; Wei Wei Ng ; Jin Hui Ho ; Miza Hiryanti Zakaria ; Rabeah Md Zuki ; Wan Mohd Hafez Wan Hamzah ; Melissa Vergis ; Choon Peng Sun ; Vanusha Devaraja Pillai ; Chee Koon Low ; Shazatul Reza Mohd Redzuan ; Xin-Yi Ooi ; Siti Sanaa Wan Azman ; Deviga Lachumanan ; Saiful Shahrizal Shudim ; Zanariah Hussein
Journal of the ASEAN Federation of Endocrine Societies 2026;41(S1):42-43
Introduction:
The 2021 IDF-DAR risk calculator had been previously
evaluated in multiple studies and subsequently widely
accepted and applied in clinical practice as a practical
standardized tool for patient risk stratification. Recently
updated, the 2026 IDF-DAR Risk calculator enables a more individualized, evidence-related evaluation of patientrelated and disease-related risk factors, incorporating
modern diabetes technologies, including continuous
glucose monitoring (CGM), automated insulin delivery
(AID) systems, and advanced insulin formulations to
enhance risk stratification. This tool allows medical
professionals to tailor Ramadan practices based on overall
factors toward promoting safe fasting.
Methodology:
This prospective multicentre observational study recruited
adults with Type 1 and Type 2 diabetes attending public
hospitals nationwide. People with diabetes (PwD) intending
to perform Ramadan fasting were invited to participate
and assessed using the 2026 IDF-DAR Risk Calculator in
the 6-week pre-Ramadan period between 30th January and
19th March 2026.
Results:
A total of 458 PwD were evaluated and stratified into low
(15.7%), moderate (41%), and high risk (43.3%) categories.
Most participants had Type 2 diabetes (83.6%), with 60.3%
having a disease duration exceeding 10 years and 43%
exhibiting poor glycemic control (hemoglobin A1c >9%).
Insulin therapy was used by 76.4% of participants, including
two individuals with Type 1 diabetes using AID systems.
Most participants reported no recent hypoglycemia (76.4%),
81.0% performed glucose monitoring, and 3.3% used CGM.
Severe comorbidities were uncommon, with 1.1% having
unstable macrovascular disease and 4.4% advanced chronic
kidney disease (estimated glomerular filtration rate <30).
Notably, 72.2% received structured Ramadan education.
Conclusion
Majority of PwD attending tertiary diabetes clinics were
in the moderate- to high-risk category and intended to
fast despite medical advice against fasting in some cases.
Although most participants were on insulin therapy,
hypoglycemia was low in the pre-Ramadan period.
Integration of modern technologies, advanced insulin
therapies, and structured education may support safer
fasting practices.
Risk Assessment
;
Diabetes Mellitus
;
Hospitals
;
Fasting
5.Isolation,identification and antimicrobial susceptibility of a strain of Haemophi-lus parasuis
Xi LIU ; Geng WANG ; Zhengdan LIN ; Xiuxiu SUN ; Xinxin JIN ; Li LI ; Junjie YANG ; Xue-ying HU ; Changqin GU ; Wanpo ZHANG ; Xiaoli LIU ; Teng YU ; Guofu CHENG
Chinese Journal of Veterinary Science 2025;45(2):219-226
Porcine arthritis,one of the common chronic diseases in large-scale pig farms,can signifi-cantly reduce the production performance of meat pigs.In this study,a strain of Haemophilus pa-rasuis(HPS)was isolated from the joint fluid of a lame pig.The HPS was analyzed in terms of se-rotypes,virulence genes,and resistance genes.Additionally,it was treated with sensitive antibiotics to provide a theoretical basis for the comprehensive prevention and treatment of arthritis in meat pigs in future production settings.A strain of HPS type 14 was isolated from the joint fluid of dis-eased pigs.The HPS isolate demonstrated sensitivity to β-lactams and tetracyclines,while florfeni-col and polymyxin effectively inhibited its growth at low concentrations.However,the bacteria ex-hibited resistance to sulfonamides and ciprofloxacin.The treatment of affected pigs with clinical ar-thritis using doxycycline and enrofloxacin injections proved effective.Compared to the infected group,in which the sick pigs experienced difficulty flexing their carpal and tarsal joints and exhibi-ted significant lameness,the pigs in the treatment group showed marked improvement.Their joints were only slightly swollen,and the clinical symptoms of arthropathy were alleviated.
6.Study on the mechanism of Jiawei Jisheng Shenqi Decoction regulating HIF-1α/Notch pathway to improve hypoxia and antagonize liver cirrhosis
Yiling MO ; Xiaoling ZHOU ; Lin LIU ; Dongqi SUN ; Teng WU ; Yi LUO ; Bowen RUAN ; Yueming WANG ; Yao JIA
Chinese Journal of Comparative Medicine 2025;35(2):1-12
Objective To explore the mechanism of Jiawei Jisheng Shenqi Decoction in improving the hypoxic microenvironment and antagonizing liver cirrhosis.Methods In vivo experiments were conducted using a rat model of carbon tetrachloride(CCL4)-induced liver cirrhosis.Rats were divided into normal,model,colchicine,JWJSSQ low-dose,JWJSSQ medium-dose,and JWJSSQ high-dose group.Pathological changes in liver tissues in each group were examined by hematoxylin and eosin(HE)and Masson staining,changes in serum liver function were detected using test kits,levels of hyaluronic acid(HA),laminin(LN),procollagen Ⅲ(PC Ⅲ),and collagen typeⅣ(COL4)were detected by enzyme-linked immunosorbent assay(ELISA),and protein expression levels of hypoxia-inducible factor-1α(HIF-1α),Notch1,Jagged1,and α-smooth muscle actin(α-SMA)were detected by Western blot.In vitro experiments were conducted in HSC-T6 cells,and the optimal concentration of CoCl2(100 μ mol/L,200μmol/L,400 μmol/L,600 μmol/L and 800 μmol/L)in the cultured cells and the optimal concentration of drug-containing serum(5%,10%,15%,20%)were determined by Cell Counting Kit-8(CCK-8)assay.The migration ability of cells in each group was detected by scratch testing,and changes in the apoptosis rates were determined by flow cytometry.Protein expression levels of HIF-1α,Notch1,Jagged1,α-SMA,matrix metallopeptidase 9(MMP9),and tissue inhibitor of metalloproteinases 1(TIMP-1)were detected by Western blot.Results In the in vivo experiments,liver swelling,inflammatory cell infiltration,collagen deposition,and the appearance of pseudolobules were significantly increased in the model group compared with those in the normal group.Serum levels of alanine aminotransferase(ALT),aspartate aminotransferase(AST),HA,LN,PCⅢ,and COL4 were significantly increased and albumin(ALB)was significantly decreased in the model group,while liver levels of HIF-1α,Notch1,Jagged1,and α-SMA proteins were significantly increased(P<0.01).Liver swelling,inflammatory cell infiltration,and collagen deposition were significantly reduced in each treatment group compared with those in the model group,and the degree of fibrosis was reduced.Serum ALT,AST,HA,LN,PCⅢ,and COL4 were significantly decreased and ALB was significantly increased,while liver levels of HIF-1α,Notch1,Jagged1,and α-SMA proteins were also significantly decreased to varying degrees(P<0.05).In the in vitro experiments,hypoxia promoted HSC-T6 migration and reduced apoptosis,increased the protein expression levels of HIF-1α,Notch1,Jagged1,α-SMA,and TIMP-1,and reduced the expression levels of MMP9(P<0.01).Serum containing Jiawei Jisheng Shenqi Decoction inhibited HSC-T6 migration,promoted HSC-T6 apoptosis,lowered the expression of HIF-1α,Notch1,Jagged1,α-SMA,and TIMP-1 proteins,and enhanced the expression of MMP9 protein(P<0.01).The inhibitory effect of Jiawei Jisheng Shenqi on HSC-T6 cell activation was reversed by the HIF-1α agonist dimethyloxalylglycine.Conclusions Jiawei Jisheng Shenqi Decoction can improve the hypoxic microenvironment via the HIF-1α/Notch pathway,thereby exerting an anti-liver cirrhosis effect.
7.Analysis of risk factors for neurological complications in patients with Stanford type A aortic dissection
Chuanwen LI ; Qingyan SUN ; Yanqing GAN ; Xianqing LI ; Teng CAI ; Hongsheng LIU ; Liangchun NI ; Zhonghua FEI
Chinese Journal of Postgraduates of Medicine 2025;48(7):635-642
Objective:To explore how one-sided/two-sided brain blood flow affects the occurrence of neurological complications in patients with Stanford type A aortic dissection, as well as to assess the factors that contribute to the development of neurological complications.Methods:A total of 162 patients diagnosed with Stanford type A aortic dissection who had undergone ascending aorta and total aortic arch replacement at Affiliated Hospital of Jining Medical College from August 2020 to December 2023 were retrospectively reviewed. These patients were categorized into two groups based on the presence of postoperative neurological complications: a group with neurological complications comprising 77 cases and a group without neurological complications comprising 85 cases. A comparative analysis was carried out on general clinical data, surgical and brain perfusion characteristics, as well as preoperative test indicators between these two groups in order to investigate the factors influencing the occurrence of postoperative neurological complications in patients with Stanford type A aortic dissection. The data was analyzed using Logistic regression to identify the risk factors associated with postoperative neurological complications and to develop a predictive nomogram model. Calibration curves, receiver operating characteristic (ROC) curves and decision curve (DCA) were generated to assess the accuracy and predictive capability of the nomogram model.Results:In the group of patients who experienced neurological complications, there was a higher prevalence of a history of hypertension, longer operation time, extended periods of cardiopulmonary bypass, cross-clamping, brain perfusion, cooling, and rewarming, as well as increased postoperative drainage volume. Additionally, the levels of preoperative blood urea nitrogen (BUN), creatinine (Cr) and lactic acid (Lac) were elevated compared to those in the non-neurological complications group: 77.9% (60/77) vs. 52.9% (45/85), (409.99 ± 104.26) min vs. (348.29 ± 63.12) min, (223.36 ± 66.86) min vs. (179.25 ± 38.59) min, 112 (94, 133) min vs. 96 (84, 113) min, (35.23 ± 9.89) min vs. (32.14 ± 6.81) min, (82.19 ± 28.69) min vs. (68.76 ± 29.06) min, (79.30 ± 22.60) min vs. (69.54 ± 16.42) min, 806 (529, 1 127) ml vs. 663 (449, 925) ml, 6.78 (5.38, 8.84) mmol/L vs. 6.08 (4.66, 7.76) mmol/L, 86.3 (64.0, 131.9) μmol/L vs. 71.0 (55.6, 84.9) μmol/L, 2.1(1.2, 4.0) mmol/L vs. 1.5 (0.9, 2.3) mmol/L. On the other hand, the percentage of patients who underwent bilateral brain perfusion was lower, and they experienced lower lowest temperature, preoperative platelet count, and ejection fraction levels than those in the non-neurological complications group: 57.1% (44/77) vs. 75.3% (64/85), (25.69 ± 1.04) ℃ vs. (26.04 ± 0.82) ℃, (175.79 ± 58.14) ×10 9/L vs. (213.87 ± 77.29) ×10 9/L, (54.18 ± 3.84)% vs. (55.34 ± 3.56)% ( P<0.05). Multivariate Logistic regression analysis revealed that a prior history of high blood pressure, prolonged cardiopulmonary bypass duration were identified as autonomous risk factors for the development of postoperative neurological issues in individuals with Stanford type A aortic dissection, while simultaneous brain perfusion emerged as an independent protective element ( P<0.05). Subsequently, a predictive nomogram was constructed incorporating these three pivotal factors to assess the likelihood of postoperative neurological complications in patients with Stanford type A aortic dissection. The calibration curve exhibited a noteworthy level of accuracy for the nomogram predictive model ( χ2 = 9.01, P = 0.342). Additionally, the ROC curve analysis displayed an area under the curve of 0.84 (95% CI 0.78 to 0.90) for the nomogram model in predicting postoperative neurological complications in patients with Stanford type A aortic dissection, indicating a high predictive accuracy. Moreover, DCA analysis indicated that the nomogram model provided a net benefit above 0 across the spectrum of 0 to 90%. Conclusions:Postoperative neurological complications in patients with Stanford type A aortic dissection is linked to factors such as a previous history of hypertension, unilateral brain perfusion, an extended cardiopulmonary bypass duration. By developing a nomogram model that incorporates these factors, it becomes feasible to accurately forecast the likelihood of postoperative neurological complications in this patient population. This predictive tool holds significant value in facilitating proactive clinical risk evaluation and preventive measures.
8.Trends in the disease burden of neonatal congenital birth defects in China and the globe,1990-2021
Huasheng LV ; Wei JI ; Fengyu SUN ; Haoliang SHEN ; BAHETI·LAZAIYI ; Teng YUAN ; You CHEN
Journal of Xi'an Jiaotong University(Medical Sciences) 2025;46(6):1045-1052
Objective To analyze the long-term trend in the disease burden of congenital birth defects(CBDs)among neonates in China from 1990 to 2021,compare the trend with global patterns,and identify key subtypes along with their association with socioeconomic status to provide evidence for public health interventions.Methods Utilizing data from the Global Burden of Disease Study 2021(GBD 2021),we extracted indicators including disability-adjusted life years(DALYs),mortality,and prevalence for the neonatal period(<28 days)in China,encompassing ten major CBD subtypes.Joinpoint regression analysis was employed to calculate annual percent changes and estimate annual percent changes(EAPC),with comparisons of subtype composition between 1990 and 2021.Nonlinear regression was used to assess the relationship between DALYs rates and the Socio-demographic Index(SDI).Results From 1990 to 2021,DALYs rates for neonatal CBDs declined significantly both globally and in China,with China's EAPC at-4.67%[95%CI:(—5.06,—4.28)],substantially exceeding the global average of-1.70%[95%CI:(—1.75,—1.64)].Congenital heart anomalies remained the primary burden,while neural tube defects and orofacial clefts in China showed notable reductions(EAPCs of-7.25%and-11.22%,respectively).However,DALYs rates for congenital musculoskeletal and limb anomalies exceeded global expected levels.A resurgence in the prevalence was observed post-2015,with higher burdens in males.DALYs rates exhibited a negative correlation with SDI.Conclusion China has achieved significant reductions in the neonatal CBDs burden,surpassing global trends;yet challenges persist in managing congenital heart anomalies and musculoskeletal defects.Future efforts should focus on enhancing early screening,surgical interventions,and regional equity to align with global health objectives.
9.Report of 6 cases of lymphoproliferative disorders after liver transplantation
Hui ZHANG ; Yandong SUN ; Feng WANG ; Dan LIU ; Bin ZHUANG ; Jianhong WANG ; Dahong TENG ; Jinzhen CAI
Chinese Journal of Organ Transplantation 2025;46(2):161-165
This study reports the diagnosis and treatment of six cases of post-transplant lymphoproliferative disorder (PTLD) in liver transplant recipients, confirmed at the Affiliated Hospital of Qingdao University between August 2017 and May 2023. The report includes details on anti-rejection therapy, Epstein-Barr virus (EBV) and cytomegalovirus (CMV) infections, imaging findings, histopathological results, treatment courses, and prognoses. By summarizing the clinical experience in the diagnosis and management of PTLD following liver transplantation, this study aims to provide valuable insights and references for the clinical diagnosis and treatment of this condition.
10.Phase Ⅲ, multicenter, randomized comparative study of LY01005 and Zoladex ? for patients with premenopausal breast cancer
Xiying SHAO ; Qingyuan ZHANG ; Zhaofeng NIU ; Man LI ; Jingfen WANG ; Zhanhong CHEN ; Ruizhen LUO ; Guangdong QIAO ; Jianguo WANG ; Liyuan QIAN ; Ronghua YANG ; Zhendong CHEN ; Jian WANG ; Yumin YAO ; Jianghua OU ; Tao SUN ; Qiao CHENG ; Yongsheng WANG ; Jian HUANG ; Hongying ZHAO ; Wuyun SU ; Zhong OUYANG ; Yu DING ; Lilin CHEN ; Sumei YANG ; Mengsheng CUI ; Aimin ZANG ; Enxiang ZHOU ; Peizhi FAN ; Jing ZHANG ; Qiang LIU ; Yuee TENG ; Hui LI ; Jianyun NIE ; Jin YANG ; Xiaojia WANG ; Zefei JIANG
Chinese Journal of Oncology 2025;47(4):340-348
Background:To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex ? in Chinese patients with premenopausal breast cancer. Methods:From October 2020 to November 2021, 188 premenopausal breast cancer patients were enrolled in 34 hospitals and randomized 1:1 to receive either LY01005 or Zoladex ? every 28 days for a total of three injections. All patients concomitantly received oral tamoxifen (TAM). The primary efficacy endpoint was cumulative probability of maintaining menopausal level [oestradiol (E2) ≤30 pg/ml] from day 29 to day 85. The second efficacy endpoint included changes in E2, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) compared with the baseline. Pharmacokinetics (PK), pharmacodynamics (PD), and safety were analyzed. The study also evaluated the pharmacokinetic and pharmacodynamic characteristics of LY01005. Results:A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex ?. Cumulative probabilities of maintaining menopausal level (E2≤30 pg/ml) from day 29 to day 85 were 93.1% for LY01005 and 86.3% for Zoladex ?. The between-group difference was 6.8% (95% CI: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex ? group. Changes in E2, LH, and FSH levels compared with the baseline were equivalent between the two groups (E2: 89.34% to 90.23% vs. 82.11% to 85.02%; LH: 88.89% to 95.52% vs. 89.70% to 97.02%; FSH: 75.36% to 80.85% vs.73.07% to 80.24%, respectively). After three consecutive doses of LY01005, the LH and FSH levels of the subjects showed a transient increase after the first dose, reached a peak on the second day and then started to decrease. The LH and FSH reached a lower level and remained at or below that level until the 85th day. Both treatments were well-tolerated. Conclusion:LY01005 is as effective as Zoladex ? in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.


Result Analysis
Print
Save
E-mail