1.Risk factors for postoperative respiratory failure in patients with esophageal cancer and the prediction model establishment
Bo YANG ; Yue BAI ; Lili LANG ; Qun CAO ; Gongjian ZHU ; Leiyun ZHUANG ; Daqiang SUN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(03):353-359
Objective To explore the risk factors for postoperative respiratory failure (RF) in patients with esophageal cancer, construct a predictive model based on the least absolute shrinkage and selection operator (LASSO)-logistic regression, and visualize the constructed model. Methods A retrospective analysis was conducted on patients with esophageal cancer who underwent surgical treatment in the Department of Thoracic Surgery, Sun Yat-sen University Cancer Center Gansu Hospital from 2020 to 2023. Patients were divided into a RF group and a non-RF (NRF) group according to whether RF occurred after surgery. Clinical data of the two groups were collected, and LASSO-logistic regression was used to optimize feature selection and construct the predictive model. The model was internally validated by repeated sampling 1000 times based on the Bootstrap method. Results A total of 217 patients were included, among which 24 were in the RF group, including 22 males and 2 females, with an average age of (63.33±9.10) years; 193 were in the NRF group, including 161 males and 32 females, with an average age of (62.14±8.44) years. LASSO-logistic regression analysis showed that the percentage of forced expiratory volume in one second/forced vital capacity (FEV1/FVC) to predicted value (FEV1/FVC%pred) [OR=0.944, 95%CI (0.897, 0.993), P=0.026], postoperative anastomotic fistula [OR=4.106, 95%CI (1.457, 11.575), P=0.008], and postoperative lung infection [OR=3.776, 95%CI (1.373, 10.388), P=0.010] were risk factors for postoperative RF in patients with esophageal cancer. Based on the above risk factors, a predictive model was constructed, with an area under the receiver operating characteristic curve of 0.819 [95%CI (0.737, 0.901)]. The Hosmer-Lemeshow test for the calibration curve showed that the model had good goodness of fit (P=0.527). The decision curve showed that the model had good clinical net benefit when the threshold probability was between 5% and 50%. Conclusion FEV1/FVC%pred, postoperative anastomotic fistula, and postoperative lung infection are risk factors for postoperative RF in patients with esophageal cancer. The predictive model constructed based on LASSO-logistic regression analysis is expected to help medical staff screen high-risk patients for early individualized intervention.
2.Safety of teriflunomide in Chinese adult patients with relapsing multiple sclerosis: A phase IV, 24-week multicenter study.
Chao QUAN ; Hongyu ZHOU ; Huan YANG ; Zheng JIAO ; Meini ZHANG ; Baorong ZHANG ; Guojun TAN ; Bitao BU ; Tao JIN ; Chunyang LI ; Qun XUE ; Huiqing DONG ; Fudong SHI ; Xinyue QIN ; Xinghu ZHANG ; Feng GAO ; Hua ZHANG ; Jiawei WANG ; Xueqiang HU ; Yueting CHEN ; Jue LIU ; Wei QIU
Chinese Medical Journal 2025;138(4):452-458
BACKGROUND:
Disease-modifying therapies have been approved for the treatment of relapsing multiple sclerosis (RMS). The present study aims to examine the safety of teriflunomide in Chinese patients with RMS.
METHODS:
This non-randomized, multi-center, 24-week, prospective study enrolled RMS patients with variant (c.421C>A) or wild type ABCG2 who received once-daily oral teriflunomide 14 mg. The primary endpoint was the relationship between ABCG2 polymorphisms and teriflunomide exposure over 24 weeks. Safety was assessed over the 24-week treatment with teriflunomide.
RESULTS:
Eighty-two patients were assigned to variant ( n = 42) and wild type groups ( n = 40), respectively. Geometric mean and geometric standard deviation (SD) of pre-dose concentration (variant, 54.9 [38.0] μg/mL; wild type, 49.1 [32.0] μg/mL) and area under plasma concentration-time curve over a dosing interval (AUC tau ) (variant, 1731.3 [769.0] μg∙h/mL; wild type, 1564.5 [1053.0] μg∙h/mL) values at steady state were approximately similar between the two groups. Safety profile was similar and well tolerated across variant and wild type groups in terms of rates of treatment emergent adverse events (TEAE), treatment-related TEAE, grade ≥3 TEAE, and serious adverse events (AEs). No new specific safety concerns or deaths were reported in the study.
CONCLUSION:
ABCG2 polymorphisms did not affect the steady-state exposure of teriflunomide, suggesting a similar efficacy and safety profile between variant and wild type RMS patients.
REGISTRATION
NCT04410965, https://clinicaltrials.gov .
Humans
;
Crotonates/adverse effects*
;
Toluidines/adverse effects*
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Nitriles
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Hydroxybutyrates
;
Female
;
Male
;
Adult
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ATP Binding Cassette Transporter, Subfamily G, Member 2/genetics*
;
Middle Aged
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Multiple Sclerosis, Relapsing-Remitting/genetics*
;
Prospective Studies
;
Young Adult
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Neoplasm Proteins/genetics*
;
East Asian People
3.One-year seedling cultivation technology and seed germination-promoting mechanism by warm water soaking of Polygonatum kingianum var. grandifolium.
Ke FU ; Jian-Qing ZHOU ; Zhi-Wei FAN ; Mei-Sen YANG ; Ya-Qun CHENG ; Yan ZHU ; Yan SHI ; Jin-Ping SI ; Dong-Hong CHEN
China Journal of Chinese Materia Medica 2025;50(4):1022-1030
Polygonati Rhizoma demonstrates significant potential for addressing both chronic and hidden hunger. The supply of high-quality seedlings is a primary factor influencing the development of the Polygonati Rhizoma industry. Warm water soaking is often used in agriculture to promote the rapid germination of seeds, while its application and molecular mechanism in Polygonati Rhizoma have not been reported. To rapidly obtain high-quality seedlings, this study treated Polygonatum kingianum var. grandifolium seeds with sand storage at low temperatures, warm water soaking, and cultivation temperature gradients. The results showed that the culture at 25 ℃ or sand storage at 4 ℃ for 2 months rapidly broke the seed dormancy of P. kingianum var. grandifolium, while the culture at 20 ℃ or sand storage at 4 ℃ for 1 month failed to break the seed dormancy. Soaking seeds in 60 ℃ warm water further increased the germination rate, germination potential, and germination index. Specifically, the seeds soaked at 60 ℃ and cultured at 25 ℃ without sand storage treatment(Aa25) achieved a germination rate of 78. 67%±1. 53% on day 42 and 83. 40%±4. 63% on day 77. The seeds pretreated with sand storage at 4 ℃ for 2 months, soaked in 60 ℃ water, and then cultured at 25 ℃ achieved a germination rate comparable to that of Aa25 on day 77. Transcriptomic analysis indicated that warm water soaking might promote germination by triggering reactive oxygen species( ROS), inducing the expression of heat shock factors( HSFs) and heat shock proteins( HSPs), which accelerated DNA replication, transcript maturation, translation, and processing, thereby facilitating the accumulation and turnover of genetic materials. According to the results of indoor controlled experiments and field practices, maintaining a germination and seedling cultivation environment at approximately 25 ℃ was crucial for the one-year seedling cultivation of P. kingianum var. grandifolium.
Germination
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Seedlings/genetics*
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Water/metabolism*
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Seeds/metabolism*
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Polygonatum/genetics*
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Temperature
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Plant Proteins/genetics*
;
Plant Dormancy
4.A Dataset on Population Activity Patterns in Typical Regions of North China
Yang YI-SEN ; Liu SHENG-YU ; Mei YA-YUAN ; Zhou QUAN ; Zhao MEI-DUO ; Xu QUN ; Wu SI-ZHU
Chinese Medical Sciences Journal 2024;39(1):69-73,中插7
This data article describes the"Typical Regional Activity Patterns"(TRAP)dataset,which is based on the Tackling Key Problems in Air Pollution Control Program.In order to explore the interaction between air pollution and physical activity,we collected activity patterns of 9,221 residents with different occupations and lifestyles for three consecutive days in typical regions(Jinan and Baoding)where air pollutant concentrations were higher than those in neighboring areas.The TRAP dataset consists of two aspects of information:demographic indicators(personal information,occupation,personal habits,and living situation)and physical activity pattern data(activity location and intensity);additionally,the exposure measures of physical activity patterns are included,which data users can match to various endpoints for their specific purpose.This dataset provides evidence for exploring the attributes of activity patterns of residents in northern China and for interdisciplinary researchers to develop strategies and measures for health education and health promotion.
5.Research progress of macrophage based nanoimaging and nanobiomimetic technology in the diagnosis and treatment of atherosclerotic plaque
Yaling WU ; Yuanhui DUAN ; Rong SUN ; Zhizhen SHI ; Lijia YANG ; Sen QUN
Chinese Journal of Arteriosclerosis 2024;32(10):899-906
Macrophages play an important role in the development of inflammation,the core mechanism of athero-sclerosis.In recent years,nanotechnology has provided a new perspective for the diagnosis and treatment of atherosclerosis with its unique characteristics of biological compatibility and precise targeting.In this paper,the patholog-ical mechanism of atherosclerosis,the realization of atherosclerosis imaging by targeting macrophages with nanomaterials and the application of macrophage cell membrane biomimetic nanoparticles in anti-atherosclerosis were reviewed.
6.Prenatal Genetic Diagnosis and Origin Analysis of Rare Complete Translocation Trisomy 18
Yan-chou YE ; Wu-bin CHEN ; Xiu-jing HUANG ; Rong HUANG ; Ying HAO ; Qun FANG ; Zheng CHEN ; Xiu-lan HAO
Journal of Sun Yat-sen University(Medical Sciences) 2023;44(5):830-834
ObjectiveTo discuss the origin of rare abnormal karyotypes of fetuses with high risk of trisomy 18 revealed by non-invasive prenatal testing (NIPT) and its impact on fertility. MethodsThe cytogenetic and molecular genetic analyses were performed on the abnormal chromosomes of a prenatally diagnosed fetus with rare complete translocation trisomy 18. Using the keywords “translocation trisomy 18” or “trisomy 18 translocation” in both Chinese and English, we searched PubMed, CNKI, SinoMed, WanFang Data, CQ VIP and the Chinese Medicine database. The relevant case series were retrieved and critically appraised. ResultsG-banded karyotype analysis showed that the maternal karyotype was 46,XX,t(9;18)(q31.2;q23) and the fetal karyotype was 47, XN, t (9; 18) (q31.2;q23)mat, +18, which was a rare complete translocation type of trisomy 18. The SNP array revealed the fetus had increased copy number of chromosome 18 and two complete chromosome 18 inherited from the mother with balanced chromosomal translocation. Literature search found two children with complete translocation trisomy 18 reported abroad. Both of them had trisomy 18 phenotype and originated from the balanced translocation between parental chromosome 18 and other chromosomes. ConclusionNIPT gives an effective advance warning of trisomy 18. SNP array not only improves the detection rate of chromosomal abnormalities, but also helps identify the origin. The karyotype is still the gold standard for prenatal diagnosis.
7.Apalutamide for metastatic castration-sensitive prostate cancer: final analysis of the Asian subpopulation in the TITAN trial.
Byung Ha CHUNG ; Jian HUANG ; Hiroji UEMURA ; Young Deuk CHOI ; Zhang-Qun YE ; Hiroyoshi SUZUKI ; Taek Won KANG ; Da-Lin HE ; Jae Young JOUNG ; Sabine D BROOKMAN-MAY ; Sharon MCCARTHY ; Amitabha BHAUMIK ; Anildeep SINGH ; Suneel MUNDLE ; Simon CHOWDHURY ; Neeraj AGARWAL ; Ding-Wei YE ; Kim N CHI ; Hirotsugu UEMURA
Asian Journal of Andrology 2023;25(6):653-661
The final analysis of the phase 3 Targeted Investigational Treatment Analysis of Novel Anti-androgen (TITAN) trial showed improvement in overall survival (OS) and other efficacy endpoints with apalutamide plus androgen deprivation therapy (ADT) versus ADT alone in patients with metastatic castration-sensitive prostate cancer (mCSPC). As ethnicity and regional differences may affect treatment outcomes in advanced prostate cancer, a post hoc final analysis was conducted to assess the efficacy and safety of apalutamide in the Asian subpopulation. Event-driven endpoints were OS, and time from randomization to initiation of castration resistance, prostate-specific antigen (PSA) progression, and second progression-free survival (PFS2) on first subsequent therapy or death. Efficacy endpoints were assessed using the Kaplan-Meier method and Cox proportional-hazards models without formal statistical testing and adjustment for multiplicity. Participating Asian patients received once-daily apalutamide 240 mg ( n = 111) or placebo ( n = 110) plus ADT. After a median follow-up of 42.5 months and despite crossover of 47 placebo recipients to open-label apalutamide, apalutamide reduced the risk of death by 32% (hazard ratio [HR]: 0.68; 95% confidence interval [CI]: 0.42-1.13), risk of castration resistance by 69% (HR: 0.31; 95% CI: 0.21-0.46), PSA progression by 79% (HR: 0.21; 95% CI: 0.13-0.35) and PFS2 by 24% (HR: 0.76; 95% CI: 0.44-1.29) relative to placebo. The outcomes were comparable between subgroups with low- and high-volume disease at baseline. No new safety issues were identified. Apalutamide provides valuable clinical benefits to Asian patients with mCSPC, with an efficacy and safety profile consistent with that in the overall patient population.
Male
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Humans
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Prostatic Neoplasms/pathology*
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Androgen Antagonists/therapeutic use*
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Prostate-Specific Antigen
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Castration
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Prostatic Neoplasms, Castration-Resistant/drug therapy*
8.Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: A multicenter, randomized, open-label, phase III, non-inferiority trial.
Chengyuan GU ; Zengjun WANG ; Tianxin LIN ; Zhiyu LIU ; Weiqing HAN ; Xuhui ZHANG ; Chao LIANG ; Hao LIU ; Yang YU ; Zhenzhou XU ; Shuang LIU ; Jingen WANG ; Linghua JIA ; Xin YAO ; Wenfeng LIAO ; Cheng FU ; Zhaohui TAN ; Guohua HE ; Guoxi ZHU ; Rui FAN ; Wenzeng YANG ; Xin CHEN ; Zhizhong LIU ; Liqiang ZHONG ; Benkang SHI ; Degang DING ; Shubo CHEN ; Junli WEI ; Xudong YAO ; Ming CHEN ; Zhanpeng LU ; Qun XIE ; Zhiquan HU ; Yinhuai WANG ; Hongqian GUO ; Tiwu FAN ; Zhaozhao LIANG ; Peng CHEN ; Wei WANG ; Tao XU ; Chunsheng LI ; Jinchun XING ; Hong LIAO ; Dalin HE ; Zhibin WU ; Jiandi YU ; Zhongwen FENG ; Mengxiang YANG ; Qifeng DOU ; Quan ZENG ; Yuanwei LI ; Xin GOU ; Guangchen ZHOU ; Xiaofeng WANG ; Rujian ZHU ; Zhonghua ZHANG ; Bo ZHANG ; Wanlong TAN ; Xueling QU ; Hongliang SUN ; Tianyi GAN ; Dingwei YE
Chinese Medical Journal 2023;136(10):1207-1215
BACKGROUND:
LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer.
METHODS:
We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels.
RESULTS:
On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]).
CONCLUSION:
LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT04563936.
Humans
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Male
;
Antineoplastic Agents, Hormonal/therapeutic use*
;
East Asian People
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Gonadotropin-Releasing Hormone/agonists*
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Goserelin/therapeutic use*
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Prostate-Specific Antigen
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Prostatic Neoplasms/drug therapy*
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Testosterone
9.Application of 3D printing technology in the precise functional reconstruction of jaws
Journal of Prevention and Treatment for Stomatological Diseases 2023;31(6):381-388
With the development of computer-aided surgery and rapid prototyping via 3D printing technology, digital surgery has rapidly advanced in clinical practice, especially in the field of oral and maxillofacial surgery. 3D printing technology has been applied to the functional restoration and reconstruction of the jawbone. Before surgery, a 3D digital model is constructed through software to plan the scope of the osteotomy, shape the bone graft and plan the placement of the implant. Additionally, 3D models of personalized surgical instrument guides are printed prior to surgery. With these 3D-printed models and guides, accurate excision of the jaw tumor, accurate placement of the grafted bone and precise placement of implants can be achieved during surgery. Postoperative evaluation of accuracy and function shows that 3D printing technology can aid in achieving the biomechanical goals of simultaneous implant placement in jaw reconstruction, and in combination with dental implant restoration, the technology can improve patients' postoperative occlusal and masticatory functions. Nevertheless, 3D printing technology still has limitations, such as time-consuming preparation before surgery. In the future, further development of 3D printing technology, optimization of surgical plans, and alternative biological materials are needed. Based on domestic and foreign literature and our research results, we have reviewed the process and clinical application prospects of jaw reconstruction via 3D printing technology to provide a reference for oral and maxillofacial surgeons.
10.Construction of clinical comprehensive evaluation index system of anti-lung cancer drugs and empirical study
Sisi LIN ; Liping CHEN ; Qiyun JIANG ; Jianwei XUAN ; Qun ZHANG
China Pharmacy 2023;34(11):1313-1319
OBJECTIVE To construct a comprehensive evaluation index system for anti-lung cancer drugs, and to provide a basis for drug selection and rational clinical use. METHODS Based on the Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs (2021 edition for trial use), a preliminary evaluation index system framework and an index preselection pool were initially formulated through literature analysis. The evaluation indices were then selected and modified by using the Delphi method. The weights of each index were determined through expert scoring and relevant calculations, thereby establishing a comprehensive evaluation index system for anti-lung cancer drugs. Referred to Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions, scoring detailed rules for clinical comprehensive evaluation indexes of anti-lung cancer drugs were formulated. The constructed comprehensive evaluation index system and scoring detailed rules were applied to conduct empirical evaluation of the anti-lung cancer drug pembrolizumab. RESULTS The constructed comprehensive evaluation index system for anti-lung cancer drugs included 6 primary indicators and 15 secondary indicators. The weights of the primary indicators were as follows: safety (18), efficacy (38), economy (15), innovation (9), suitability (10), and accessibility (10). The scoring detailed rules for the comprehensive evaluation index system for anti-lung cancer drugs had been preliminarily established. The results of empirical evaluation showed that the comprehensive evaluation score (61 points) of pembrolizumab combined with chemotherapy regimen was higher than that of the monotherapy chemotherapy regimen (56 points). The former demonstrated superior efficacy, innovation and suitability compared to the latter, while the latter exhibited better safety and economy. CONCLUSIONS The constructed comprehensive evaluation index system for anti-lung cancer drugs has the potential for generalizability and practical application, providing a reference basis for rational clinical drug use.


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