1.Early assessment of responsive neurostimulation for drug-resistant epilepsy in China: A multicenter, self-controlled study.
Yanfeng YANG ; Penghu WEI ; Jianwei SHI ; Ying MAO ; Jianmin ZHANG ; Ding LEI ; Zhiquan YANG ; Shiwei SONG ; Ruobing QIAN ; Wenling LI ; Yongzhi SHAN ; Guoguang ZHAO
Chinese Medical Journal 2025;138(4):430-440
BACKGROUND:
To evaluate the efficacy and safety of the first cohort of people in China treated with a responsive neurostimulation system (Epilcure TM , GenLight MedTech, Hangzhou, China) for focal drug-resistant epilepsy in this study.
METHODS:
This multicenter, before-and-after self-controlled study was conducted across 8 centers from March 2022 to June 2023, involving patients with drug-resistant epilepsy who were undergoing responsive neurostimulation (RNS). The study was based on an ongoing multi-center, single-blind, randomized controlled study. Efficacy was assessed through metrics including median seizure count, seizure frequency reduction (SFR), and response rate. Multivariable linear regression analysis was conducted to explore the relationships of basic clinical factors and intracranial electrophysiological characteristics with SFR. The postoperative quality of life, cognitive function, depression, and anxiety were evaluated as well.
RESULTS:
The follow-up period for the 19 participants was 10.7 ± 3.4 months. Seizure counts decreased significantly 6 months after device activation, with median SFR of 48% at the 6th month (M6) and 58% at M12 ( P <0.05). The average response rate after 13 months of treatment was 42%, with 21% ( n = 4) of the participants achieving seizure freedom. Patients who have previously undergone resective surgery appear to achieve better therapeutic outcomes at M11, M12 and M13 ( β <0, P <0.05). No statistically significant differences were observed in patients' scores of quality of life, cognition, depression and anxiety following stimulation when compared to baseline measurements. No serious adverse events related to the devices were observed.
CONCLUSIONS:
The preliminary findings suggest that Epilcure TM exhibits promising therapeutic potential in reducing the frequency of epileptic seizures. However, to further validate its efficacy, larger-scale randomized controlled trials are required.
REGISTRATION
Chinese Clinical Trial Registry (No. ChiCTR2200055247).
Humans
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Female
;
Male
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Drug Resistant Epilepsy/therapy*
;
Adult
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Young Adult
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Middle Aged
;
China
;
Adolescent
;
Treatment Outcome
;
Quality of Life
;
Single-Blind Method
;
Seizures
;
Electric Stimulation Therapy/methods*
2.ResNet-Vision Transformer based MRI-endoscopy fusion model for predicting treatment response to neoadjuvant chemoradiotherapy in locally advanced rectal cancer: A multicenter study.
Junhao ZHANG ; Ruiqing LIU ; Di HAO ; Guangye TIAN ; Shiwei ZHANG ; Sen ZHANG ; Yitong ZANG ; Kai PANG ; Xuhua HU ; Keyu REN ; Mingjuan CUI ; Shuhao LIU ; Jinhui WU ; Quan WANG ; Bo FENG ; Weidong TONG ; Yingchi YANG ; Guiying WANG ; Yun LU
Chinese Medical Journal 2025;138(21):2793-2803
BACKGROUND:
Neoadjuvant chemoradiotherapy followed by radical surgery has been a common practice for patients with locally advanced rectal cancer, but the response rate varies among patients. This study aimed to develop a ResNet-Vision Transformer based magnetic resonance imaging (MRI)-endoscopy fusion model to precisely predict treatment response and provide personalized treatment.
METHODS:
In this multicenter study, 366 eligible patients who had undergone neoadjuvant chemoradiotherapy followed by radical surgery at eight Chinese tertiary hospitals between January 2017 and June 2024 were recruited, with 2928 pretreatment colonic endoscopic images and 366 pelvic MRI images. An MRI-endoscopy fusion model was constructed based on the ResNet backbone and Transformer network using pretreatment MRI and endoscopic images. Treatment response was defined as good response or non-good response based on the tumor regression grade. The Delong test and the Hanley-McNeil test were utilized to compare prediction performance among different models and different subgroups, respectively. The predictive performance of the MRI-endoscopy fusion model was comprehensively validated in the test sets and was further compared to that of the single-modal MRI model and single-modal endoscopy model.
RESULTS:
The MRI-endoscopy fusion model demonstrated favorable prediction performance. In the internal validation set, the area under the curve (AUC) and accuracy were 0.852 (95% confidence interval [CI]: 0.744-0.940) and 0.737 (95% CI: 0.712-0.844), respectively. Moreover, the AUC and accuracy reached 0.769 (95% CI: 0.678-0.861) and 0.729 (95% CI: 0.628-0.821), respectively, in the external test set. In addition, the MRI-endoscopy fusion model outperformed the single-modal MRI model (AUC: 0.692 [95% CI: 0.609-0.783], accuracy: 0.659 [95% CI: 0.565-0.775]) and the single-modal endoscopy model (AUC: 0.720 [95% CI: 0.617-0.823], accuracy: 0.713 [95% CI: 0.612-0.809]) in the external test set.
CONCLUSION
The MRI-endoscopy fusion model based on ResNet-Vision Transformer achieved favorable performance in predicting treatment response to neoadjuvant chemoradiotherapy and holds tremendous potential for enabling personalized treatment regimens for locally advanced rectal cancer patients.
Humans
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Rectal Neoplasms/diagnostic imaging*
;
Magnetic Resonance Imaging/methods*
;
Male
;
Female
;
Middle Aged
;
Neoadjuvant Therapy/methods*
;
Aged
;
Adult
;
Chemoradiotherapy/methods*
;
Endoscopy/methods*
;
Treatment Outcome
3.Novel autosomal dominant syndromic hearing loss caused by COL4A2 -related basement membrane dysfunction of cochlear capillaries and microcirculation disturbance.
Jinyuan YANG ; Ying MA ; Xue GAO ; Shiwei QIU ; Xiaoge LI ; Weihao ZHAO ; Yijin CHEN ; Guojie DONG ; Rongfeng LIN ; Gege WEI ; Huiyi NIE ; Haifeng FENG ; Xiaoning GU ; Bo GAO ; Pu DAI ; Yongyi YUAN
Chinese Medical Journal 2025;138(15):1888-1890
4.Recent advances, strategies, and future perspectives of peptide-based drugs in clinical applications.
Qimeng YANG ; Zhipeng HU ; Hongyu JIANG ; Jialing WANG ; Han HAN ; Wei SHI ; Hai QIAN
Chinese Journal of Natural Medicines (English Ed.) 2025;23(1):31-42
Peptide-based therapies have attracted considerable interest in the treatment of cancer, diabetes, bacterial infections, and neurodegenerative diseases due to their promising therapeutic properties and enhanced safety profiles. This review provides a comprehensive overview of the major trends in peptide drug discovery and development, emphasizing preclinical strategies aimed at improving peptide stability, specificity, and pharmacokinetic properties. It assesses the current applications and challenges of peptide-based drugs in these diseases, illustrating the pharmaceutical areas where peptide-based drugs demonstrate significant potential. Furthermore, this review analyzes the obstacles that must be overcome in the future, aiming to provide valuable insights and references for the continued advancement of peptide-based drugs.
Humans
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Peptides/pharmacology*
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Animals
;
Neoplasms/drug therapy*
;
Drug Discovery
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Neurodegenerative Diseases/drug therapy*
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Diabetes Mellitus/drug therapy*
5.Analysis of perioperative blood transfusion risk and short-term prognosis in elderly patients with hip fracture
Chongqing Medicine 2024;53(22):3401-3406
Objective To investigate the risk of perioperative blood transfusion in elderly patients with hip fracture and its impact on short-term prognosis.Methods The clinical data of elderly patients with hip fracture admitted to the orthopedic department of Shenzhen Municipal Second People's Hospital from January 2021 to November 2022 were collected.The patients were divided into the blood transfusion group and non-blood transfusion group according to whether or not having blood transfusion during perioperative period.The independent influencing factors for perioperative blood transfusion were analyzed by the univariate and multi-factorial logistic regression,and the short-term prognostic differences were compared between the two groups.Results A total of 412 elderly patients with hip fracture were included in the study.There were 257 cases of perioperative blood transfusion(blood transfusion group,62.4%),and the average blood transfusion amount was(4.1±2.52)U.The univariate analysis showed that the age,fracture type,complications(cardiac insuffi-ciency,preoperative pulmonary infection,bronchiectasis),red blood cell count,hemoglobin,red blood cell vol-ume distribution width,albumin,ASA grade,NYHA cardiac function grade,surgical mode,intraoperative blood loss volume and operative time had statistical differences between the blood transfusion group and non-blood transfusion group(P<0.05).The multivariate logistic analysis showed that preoperative low Hb level,cardiac insufficiency,intraoperative blood loss volume>200 mL and operative duration>120 min were the independent risk factors for perioperative blood transfusion in elderly patients with hip fracture.The hospitali-zation and bed rest time in the blood transfusion group were longer than those in the non-blood transfusion group,the hospitalization expenses was higher and the activity of daily living(ADL)score was lower(P<0.05).Conclusion The preoperative blood transfusion in elderly patients with hip fractures has high risk.Preopera-tive low hemoglobin level,cardiac insufficiency,intraoperative blood loss volume>200 mL and operative du-ration>120 min are the independent risk factors for perioperative transfusion in elderly patients with hip fracture and affect the short term prognosis in the patients.
6.Clinical Characteristics and Treatment Options of Peripheral Spondyloarthritis
Lulu ZENG ; Xiaojian JI ; Lidong HU ; Jiawen HU ; Yinan ZHANG ; Jiaxin ZHANG ; Xingkang LIU ; Shiwei YANG ; Feng HUANG
Medical Journal of Peking Union Medical College Hospital 2024;16(1):50-58
To compare the differences in clinical features and treatment choices between peripheral spondyloarthritis(pSpA) and axial spondyloarthritis(axSpA), and better understand the clinical characteristics and medication needs of pSpA. Our study is a retrospective cohort study. The patients who first visited the First Medical Center of Chinese PLA General Hospital between January 2016 and December 2022 and were diagnosed with axSpA or pSpA according to the classification criteria established by the Assessment of SpondyloArthritis International Society were selected as the study subjects. Demographic data, clinical characteristics, laboratory tests, and treatment information of these patients were obtained through the electronic medical records management system and the intelligent management system for spondyloarthritis. The research compared the distribution of swollen and tender joints between pSpA and axSpA patients, as well as that between pSpA1(excluding patients with psoriatic arthritis) and axSpA patients. Additionally, we analyzed differences in clinical features and treatment options among these groups. A total of 1639 patients were included in the study, of which 184 had pSpA(including 97 with psoriatic arthritis), and 1455 had axSpA. Compared to axSpA patients, pSpA patients had fewer male patients(62.5% pSpA patients tend to have a later onset of disease, a lower proportion of male and HLA-B27 positivity, more associated peripheral arthritis, dactylitis, psoriasis, and a more common family history of psoriasis. The disease burden in terms of treatment for pSpA is not lower than that for axSpA. Due to the presence of more peripheral symptoms, psoriasis, and higher levels of inflammation, they also require more medication.
7.Brief analysis on "the brain is the official position of gathering essence,qi,spirit and in charge of mental activity"
Yunjie YANG ; Yongxin YU ; Jing LUO ; Shiwei RUAN
Journal of Beijing University of Traditional Chinese Medicine 2024;47(9):1229-1235
Traditional Chinese medicine has a long-standing understanding of the brain;however,the theoretical foundation and treatment approach for diseases related to the brain have not been systematically organized and studied. The three treasures of essence,qi,and spirit are closely associated with the brain in humans. Based on this theory,this study explored the relationship between essence,qi,spirit,and the brain,with the intention that "the brain is the official position of gathering essence,qi,spirit,and in charge of mental activity". It investigated the theoretical implications of the brain,stating that "essence" forms the material basis of the brain's structure,"qi" is fundamental for brain function,and the "conscious spirit" corresponds to the state of the brain,residing in the heart,serving as the external manifestation of the brain,governing aspects like thoughts,consciousness,and emotions. The "primordial spirit" is the axis of the brain,which is rooted in the brain and serves as the internal core of the brain,thereby governing and regulating the central activities of human life. Essence,qi,mental activity,and primordial spirit mutually support and depend on each other,collectively maintaining the function of the brain governing the mental activity. The primordial spirit,which the brain governs,regulating and controlling the essence,qi,and couscious spirit is a specific manifestation of physiological and psychological activities in the human body. This study provides treatment strategies for clinical brainrelated disorders under the theoretical guidance that "the brain is the official position for gathering essence,qi,and spirit,and is in charge of mental activity". These strategies include " nourishing essence and marrow,supplementing qi to ascend clear,and nurturing nourishment and enriching the spirit". This study aims to contribute to the innovation and development of traditional Chinese medicine theories.
8.Perioperative application of prucalopride in robot-assisted laparoscopic radical cystectomy and urinary diversion
Fayun WEI ; Ning JIANG ; Huaying LIU ; Baofu FENG ; Shun ZHANG ; Jiarong DING ; Weidong GAN ; Shiwei ZHANG ; Hongqian GUO ; Rong YANG
Journal of Modern Urology 2024;29(5):394-398
Objective To explore the effects of prucalopride(PRUC)on the intestinal function during the perioperative period of robot-assisted laparoscopic radical cystectomy(RARC)and urinary diversion.Methods A total of 75 patients undertaking RARC with urinary diversion(orthotopic neobladder or ileal bladder)in Nanjing Drum Hospital during Jan.and Dec.2021 were divided into PRUC group(n=28)and control group(n=47)according to whether they took PRUC or not.Postoperative intestinal ventilation time and defecation time,drainage tube retention time,tolerance time for first intake of semi-flow food,postoperative hospital stay,and incidence of complications were observed and recorded in the two groups.Postoperative C-reactive protein(CRP)and neutrophil/lymphocyte ratio(NLR)were compared.Results The PRUC group had shorter intestinal ventilation time and defecation time[(47.14±16.31)h vs.(74.04±35.33)h,P<0.01;(86.14±30.47)h vs.(123.57±79.12)h,P=0.02],smaller change of ΔCRP and ΔNLR[(79.99±29.71)mg/L vs.(127.75±56.98)mg/L;(9.24±6.43)vs.(16.11±9.90),P<0.01].All complications were minor,the incidence of intestinal obstruction in PRUC group tended to decrease within 90 days after operation(P=0.38),and there was no significant difference in other complications between the two groups(P>0.05).Conclusion The perioperative use of PRUC in RARC with urinary diversion is safe and effective,which can promote the recovery of intestinal function after operation.
9.Survival outcomes of bladder cancer with non-pure urothelium:a propensity score matching analysis
Yulin ZHANG ; Jiazheng LI ; Zihan ZHAO ; Xiaogong LI ; Shiwei ZHANG ; Gutian ZHANG ; Hongqian GUO ; Rong YANG
Journal of Modern Urology 2024;29(8):673-679
Objective To compare the survival outcomes of bladder cancer with non-pure urothelium(BCa with n-pU)and bladder cancer with pure urothelium(BCa with pU)treated with robot-assisted radical cystectomy(RARC).Methods Clinical data of BCa patients treated with RARC in Nanjing Drum Tower Hospital during Oct.2014 and Mar.2022 were retrospectively analyzed.The patients were divided into n-pU group and pU group.After the baseline differences between groups were balanced with propensity score matching(PSM),the overall survival(OS)and recurrence-free survival(RFS)curve were plotted using Kaplan-Meier method and compared using Log-rank test.Univariate and multivariate analysis were performed with Cox model to identify the influencing factors of prognosis.Based on the results,a secondary grouping was performed to compare the survival differences between subgroups and further investigate the prognostic factors.Results After PSM,there were 53 pairs of BCa patients.There were no significant differences in the baseline data between the pU and n-pU groups(P<0.05).Regardless of T stage,there were no significant differences in OS and RFS between the two groups(P=0.217,P=0.109).Univariate Cox regression analysis showed that T stage(>T2)was a significant risk factor of OS and RFS(P<0.05).In the early pathological stage(≤T2),there were no significant differences in OS and RFS(P=0.565,P=0.344).In the advanced pathological stage(>T2),the OS and RFS of n-pU were significantly worse than those of pU patients(P=0.025,P=0.034).Conclusion The prognosis of BCa patients with n-pU who received RARC is significantly correlated with pathological status.At>T2 stage,n-pU patients have worse prognosis than pU patients in the same pathological status.
10.Analysis of clinical characteristics and risk factors for adverse outcomes in type 2 diabetic mellitus patients with COVID-19
Qianqian YANG ; Shiwei LIU ; Ruixue DUAN ; Wanrong DOU ; Jie YANG ; Xiaoqin CHEN ; Linlin GAO
Chinese Journal of Clinical Nutrition 2024;32(1):35-43
Objective:The purpose of this study is to explore the clinical characteristics of Coronavirus Disease 2019 (COVID-19) in patients with type 2 diabetes mellitus (T2DM), and analyze the risk factors for adverse outcomes.Methods:2 052 patients diagnosed with COVID-19 who were hospitalized in Shanxi Bethune Hospital between December 1, 2022 and March 20, 2023 were included. They were divided into diabetes group ( n=70) and non-diabetes group ( n=1 982) according to the presence or absence of comorbid T2DM. The two groups were matched at 1:1 via propensity score matching. Clinical characteristics and laboratory examination results of the two groups were compared. According to the outcomes during hospitalization, the two groups were further divided into two subgroups respectively. Univariate analysis and subsequent binary Logistic regression was used to analyze the risk factors of adverse outcomes in patients with COVID-19 and type 2 diabetes. Results:After the propensity score matching, the most common comorbid condition in diabetes group and non-diabetes group was hypertension. The proportion of patients with severe or critical disease in diabetes group was higher compared with non-diabetes group. The levels of hemoglobin A1c (HbA1c), fasting blood glucose (FBG), blood urea, IL-4, IL-6, IL-10, IFN-γ and TNF-α were significantly higher in the diabetes group ( P<0.05). Logistic regression analysis within the diabetes group showed that hypertension ( OR=3.640, 95% CI: 3.156 to 4.290), FBG>11 mmol/L ( OR=3.283, 95% CI: 1.416 to 7.611), HbA1c>10% ( OR=2.718, 95% CI: 1.024 to 7.213) were independent risk factors for adverse outcomes in patients with COVID-19 and type 2 diabetes(all P<0.05). Conclusions:Compared with the non-diabetes group, patients with COVID-19 and T2DM have worse inflammatory response and higher levels of inflammatory cytokines. The elevated levels of FBG and HbA1c are related to the adverse outcome in patients with COVID-19 and T2DM.

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