1.Neoadjuvant Sintilimab Combined with Gemcitabine and Cisplatin for Muscle-Invasive Bladder Cancer Patients Followed by Selective Bladder Sparing Surgery: A Phase 2 Trial
Zhou TONG ; Guanghou FU ; Feng ZHOU ; Xiaoyan LIU ; Xing XUE ; Hangyu ZHANG ; Yimin WANG ; Xudong ZHU ; Yang GAO ; Lulu LIU ; Xuanwen BAO ; Yi ZHENG ; Weijia FANG ; Peng ZHAO ; Baiye JIN
Cancer Research and Treatment 2026;58(2):581-590
Purpose:
This study aimed to evaluate the safety and efficacy of gemcitabine and cisplatin (GP) regimen in combination with immune checkpoint inhibitor sintilimab as neoadjuvant therapy for muscle-invasive bladder cancer (MIBC) patients and the feasibility of the following selective bladder sparing surgery.
Materials and Methods:
Patients with histopathologically confirmed urothelial carcinoma without distant metastases (T2-4a, N ≤ 1, M0, American Joint Committee of Cancer 8th) and with adequate organ function will be enrolled. The therapeutic regimen was sintilimab 200 mg once on day 8, gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 once on days 1 and 8, every 21 days for four cycles. The primary endpoint was pathologic complete response (pCR, pT0N0) rate. The secondary end points were ypT < 2 rate, R0 resection rate, event-free survival, and safety.
Results:
From May 4, 2020, to May 20, 2023, 55 patients were enrolled. Forty-six patients were evaluated for efficacy. Among the 42 patients who underwent surgery, 16 patients (38.0%) achieved pCR. Thirty-three patients (78.6%) achieved pT < 2. With a median follow-up of 15.7 months, the 1-year event-free survival was 91.3%. Notwithstanding the poor pathological baseline characteristic of a high T3-T4a proportion (39.1%), a promising bladder preservation (including 22 patients transurethral resection of bladder tumor, 5 patients partial cystectomy, and 4 surveillances) rate was achieved (67.4%). The most common grade ≥ 3 treatment-related adverse events was neutropenia (n=15, 27.3%), which was related to chemotherapy. There were no grade 3 immune-related adverse events.
Conclusion
Neoadjuvant GP plus sintilimab is a promising regimen for MIBC patients, with relatively high pT < 2 rate and triggering the emerging roles for the multi-disciplinary team decision-making for bladder sparing surgery.
2.The Overview and Future Trend of High-quality Clinical Randomized Controlled Trial of Acupuncture for Neurological Disorders
Jin YAO ; Qiongnan BAO ; Kexin WU ; Wanqi ZHONG ; Xinyue ZHANG ; Ziwen CHEN ; Zihan YIN ; Fanrong LIANG
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(4):973-981
Objective Neurological disorders,constitute the majority of acupuncture-treated ailments.By critically examining a comprehensive selection of high-quality clinical randomized controlled trials(RCTs)from both domestic and international sources,we aimed to uncover the prevailing hot research topic and potential future directions in acupuncture therapy for these conditions.Methods Four databases,including PubMed,Web of science,Cochrane Library and EMBASE were searched.The search period is set from the establishment of each database to November 30,2023.And the search content was RCTs of acupuncture for neurological diseases classified as Ⅰ and Ⅱ by the Chinese Academy of Sciences were extracted.Key aspects extracted included annual publication volume,journals,disease types,outcomes,conclusions,acupuncture methods and control groups.Results A total of 81 high-quality RCTs were identified,revealing a consistent annual publication trend of acupuncture for neurological disorders.Key journals contributing to this research were Cephalalgia,Clinical Rehabilitation and Clinical Journal Of Pain,etc.The studies predominantly focused on migraine and sequela of apoplexy with migraine days/frequency and Ashworth scale and its modifications as commonly used primary outcome indicators,respectively.Overall,there were 73 RCTs that concluded that acupuncture for neurologic disorders were effective,8 were ineffective.The acupuncture methods were diverse,encompassing acupuncture,individualized acupuncture and transcutaneous electrical nerve stimulation,etc.The control measures were also varied,featuring sham acupuncture,sham-acupoint and micro-needle,etc.Conclusion With the development of acupuncture RCTs,their international influence has expanded.Research has shifted from validation of effectiveness to exploration of mechanisms,and despite the expansion of the disease spectrum of acupuncture,acupuncture trials have yet to be regulated and standardized,and the assessment of acupuncture efficacy remains controversial and challenging for the discipline.It is recommended to promote multi-center cooperation and strengthen the training of trialists etc.to provide more high-quality clinical evidence.
3.Impact of the Micra AV Leadless Pacemaker on Cardiac Function:a Real-world Study
Yalan DENG ; Wenqi PAN ; Yue WEI ; Yangyang BAO ; Yun XIE ; Changjian LIN ; Ning ZHANG ; Qi JIN ; Tianyou LING ; Liqun WU
Chinese Circulation Journal 2025;40(7):653-658
Objectives:To investigate the impact of the Micra AV leadless pacemaker on cardiac function.Methods:A total of 76 patients who received the implantation of Micra AV leadless pacemaker due to sick sinus syndrome or atrioventricular block at Ruijin Hospital,Shanghai Jiao Tong University School of Medicine from September 2022 to April 2023 were included in this study.Among them,26 patients(34.2%)had sick sinus syndrome,and 50 patients(65.8%)had atrioventricular block.The patients were followed up for 1 year postoperatively.Cardiac function was evaluated by echocardiography,and the parameters of the pacemaker were collected through the outpatient clinic programming system.Results:After a follow-up of 120(87,181)days,compared with the preoperative state,the left ventricular ejection fraction(LVEF)decreased postoperatively([66.6±5.6]%vs.[63.8±5.2]%,P<0.001),and the cardiac output increased[(4.3±1.2)L/min vs.(5.3±1.5)L/min,P<0.001].There were no statistically significant differences in various cardiac function indexes of patients with sick sinus syndrome between the postoperative and preoperative states(all P>0.05).Compared with the preoperative state,in patients with atrioventricular block,the LVEF decreased postoperatively([67.0±5.1]%vs.[63.4±4.4]%,P<0.001),the cardiac output increased([4.2±1.1]L/min vs.[5.2±1.2]L/min,P<0.001),and the left ventricular end-diastolic diameter decreased[(49.9±5.4)mm vs.(48.6±5.0)mm,P=0.044].Firth's logistic regression analysis indicated that the preoperative LVEF(for every 1%increase,OR=1.56,95%CI:1.12-2.17,P=0.001),stroke volume(for every 1 ml increase,OR=1.15,95%CI:1.04-1.28,P=0.001),body mass index(for every 1 kg/m2 increase,OR=1.49,95%CI:1.02-2.17,P=0.020),and hypertension(OR=12.71,95%CI:1.11-145.13,P=0.039)were independent risk factors for the decrease in LVEF after surgery in patients with atrioventricular block.After the implantation of the MciraTM AV leadless pacemaker,the overall atrioventricular synchrony rate was 81.2%(68.8%,89.0%).The atrioventricular synchrony rates of patients with sick sinus syndrome and those with atrioventricular block were 70.6%(59.5%,83.4%)and 82.4%(74.2%,89.3%)respectively(P<0.05).Firth's logistic regression analysis indicated that sick sinus syndrome(OR=0.26,95%CI:0.07-0.89,P=0.029)and preoperative LVEF(for every 1%increase,OR=1.18,95%CI:1.03-1.35,P=0.015)were independent predictive factors for the atrioventricular synchrony rate>80%.Conclusions:There are differences in the impacts of the Micra AV leadless pacemaker on the LVEF and atrioventricular synchrony rate between patients with sick sinus syndrome and those with atrioventricular block.The preoperative LVEF,stroke volume,body mass index,and hypertension have independent predictive effects on the decrease in postoperative LVEF in patients with atrioventricular block.Sick sinus syndrome and preoperative LVEF are independent predictive factors for the atrioventricular synchrony rate>80%after surgery.
4.New insights and research directions of tomographic imaging technology in the diagnosis and treatment of lens trauma
Wen XU ; Geng WANG ; Yong WANG ; Xuemin LI ; Guangbin ZHANG ; Xiangjia ZHU ; Haiying JIN ; Lixia LUO ; Wei FAN ; Yune ZHAO ; Jiangyue ZHAO ; Ayong YU ; Haike GUO ; Yongzhen BAO ; Yongxiang JIANG ; Ce SHI
Chinese Journal of Experimental Ophthalmology 2025;43(3):204-210
Lens injury is an important etiological factor in the reduction of visual function following ocular trauma.Currently, there are no clear standards for the classification of lens injury, and comprehensive diagnostic tools are lacking.This deficiency leads to numerous controversies and challenges in critical areas, such as diagnosis and preoperative evalution, timing of surgery, surgical strategy, and assessment of postoperative prognosis.Tomographic imaging technology, such as computed tomography, magnetic resonance imaging, optical coherence tomography, has introduced a new dimension to the evaluation of lens injury, which is crucial for assessing the transparency, texture, location, morphology, and integrity of the lens, as well as the zonules and nearby intraocular structures.However, the use of tomographic imaging technology is somewhat limited due to the limitations of relying on a single method.With the ongoing advancement of imaging technologies and the rapid development of big data and artificial intelligence, tomographic imaging will become an increasingly essential tool in the future management of lens injury.Our expert group reviewed the epidemiological characteristics and classification of lens injury and the major challenges currently faced in the diagnosis and treatment of lens injury, and provided expert recommendations mainly focusing on the application, shortcomings and limitations of current tomographic imaging technology in the diagnosis and treatment of lens injury, and future development directions.
5.Research on the operational efficiency of traditional Chinese medicine hospitals in China's Yangtze River Economic Belt in the context of high-quality development
Yi-fan MOU ; Jia-ying SUN ; Jin-ping LUO ; Bao-xuan ZHANG ; Ming-hui GENG ; Wen-qiang YIN ; Zhong-ming CHEN ; Dong-ping MA
Chinese Journal of Health Policy 2025;18(1):66-72
Objective:Based on the background of high-quality development,we analyze the operational efficiency of traditional Chinese medicine(TCM)hospitals in China's Yangtze River Economic Belt in 2021 and explore the impact of external environmental factors on operational efficiency,so as to provide a reference for promoting the high-quality development of TCM hospitals in the Yangtze River Economic Belt.Methods:The three-stage DEA model was used to analyze the operational efficiency of TCM hospitals in 11 provinces and cities in the Yangtze River Economic Zone in China in 2021.Results:After three-stage DEA analysis,the values of comprehensive efficiency,pure technical efficiency and scale efficiency of TCM hospitals in China's Yangtze River Economic Belt are 0.976,0.986 and 0.990,respectively.5 provinces and cities,Shanghai,Jiangsu,Hunan,Chongqing and Guizhou,are efficient before and after the adjustment,and the comprehensive efficiency of Zhejiang,Anhui,Hubei,Jiangxi,Sichuan and Yunnan have increased compared with that before the adjustment.Ranking of the average value of the comprehensive efficiency of TCM hospitals operation in the three major city clusters of the Yangtze River Economic Belt after adjustment:Chengdu-Chongqing city cluster(0.998)>city cluster in the Yangtze River Delta(0.964)>city cluster in the middle reaches of the Yangtze River(0.962).Conclusion:The operational efficiency of TCM hospitals in the Yangtze River Economic Zone has been underestimated,and the comprehensive efficiency is mainly affected by scale efficiency;there are differences in the operational efficiency of TCM hospitals in the three major urban agglomerations,and balanced development is needed between regions;the operational efficiency of TCM hospitals is affected by the external environment,and it is necessary to improve the external environment;it is necessary to strengthen the construction of digital and informatization of TCM,and to pay attention to the role of talents in TCM,so as to promote the high-quality development of TCM hospitals.
6.Research progress on the role and mechanism of high mobility group box protein 1 after spinal cord injury
Xin XUE ; Chang-zheng YIN ; Jin-hui CHEN ; Lu-rong HUANG ; Xin ZHENG ; Yi-min LI ; Guo-bao XIAO ; Ping ZHANG ; Jian-hua ZHAO
Journal of Regional Anatomy and Operative Surgery 2025;34(10):918-923
High mobility group box protein 1(HMGB1)is one of the most widely expressed protein member in the HMGs family,which is well known for its involvement in the body inflammatory response.Previous researches have found that it plays a significant role in cell migration,immune identification and neuroprotection.Spinal cord injury is a disease that causes severe damage to the nervous system,and neural circuits are disrupted after a spinal cord injury,which leads to many conditions including ischemia and hypoxia,inflammatory responses,demyelinating lesions,and glial scar formation that are detrimental to nerve regeneration and repair,making it one of the most difficult diseases to treat in the modern spinal surgery field.HMGB1 is upregulated after spinal cord injury,thereby regulating neuroinflam-matory responses,and participating in the neuronal apoptosis,promoting neuronal regeneration,and inducing neural stem cell differentiation and migration,which plays an important role in the process of neural function recovery.This paper summarizes the structure and function of HMGB1,as well as its role in spinal cord injury,in order to provide direction for founding therapeutic target for neurological function recovery after spinal cord injury.
7.The Overview and Future Trend of High-quality Clinical Randomized Controlled Trial of Acupuncture for Neurological Disorders
Jin YAO ; Qiongnan BAO ; Kexin WU ; Wanqi ZHONG ; Xinyue ZHANG ; Ziwen CHEN ; Zihan YIN ; Fanrong LIANG
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(4):973-981
Objective Neurological disorders,constitute the majority of acupuncture-treated ailments.By critically examining a comprehensive selection of high-quality clinical randomized controlled trials(RCTs)from both domestic and international sources,we aimed to uncover the prevailing hot research topic and potential future directions in acupuncture therapy for these conditions.Methods Four databases,including PubMed,Web of science,Cochrane Library and EMBASE were searched.The search period is set from the establishment of each database to November 30,2023.And the search content was RCTs of acupuncture for neurological diseases classified as Ⅰ and Ⅱ by the Chinese Academy of Sciences were extracted.Key aspects extracted included annual publication volume,journals,disease types,outcomes,conclusions,acupuncture methods and control groups.Results A total of 81 high-quality RCTs were identified,revealing a consistent annual publication trend of acupuncture for neurological disorders.Key journals contributing to this research were Cephalalgia,Clinical Rehabilitation and Clinical Journal Of Pain,etc.The studies predominantly focused on migraine and sequela of apoplexy with migraine days/frequency and Ashworth scale and its modifications as commonly used primary outcome indicators,respectively.Overall,there were 73 RCTs that concluded that acupuncture for neurologic disorders were effective,8 were ineffective.The acupuncture methods were diverse,encompassing acupuncture,individualized acupuncture and transcutaneous electrical nerve stimulation,etc.The control measures were also varied,featuring sham acupuncture,sham-acupoint and micro-needle,etc.Conclusion With the development of acupuncture RCTs,their international influence has expanded.Research has shifted from validation of effectiveness to exploration of mechanisms,and despite the expansion of the disease spectrum of acupuncture,acupuncture trials have yet to be regulated and standardized,and the assessment of acupuncture efficacy remains controversial and challenging for the discipline.It is recommended to promote multi-center cooperation and strengthen the training of trialists etc.to provide more high-quality clinical evidence.
8.Expert consensus on evaluation index system construction for new traditional Chinese medicine(TCM) from TCM clinical practice in medical institutions.
Li LIU ; Lei ZHANG ; Wei-An YUAN ; Zhong-Qi YANG ; Jun-Hua ZHANG ; Bao-He WANG ; Si-Yuan HU ; Zu-Guang YE ; Ling HAN ; Yue-Hua ZHOU ; Zi-Feng YANG ; Rui GAO ; Ming YANG ; Ting WANG ; Jie-Lai XIA ; Shi-Shan YU ; Xiao-Hui FAN ; Hua HUA ; Jia HE ; Yin LU ; Zhong WANG ; Jin-Hui DOU ; Geng LI ; Yu DONG ; Hao YU ; Li-Ping QU ; Jian-Yuan TANG
China Journal of Chinese Materia Medica 2025;50(12):3474-3482
Medical institutions, with their clinical practice foundation and abundant human use experience data, have become important carriers for the inheritance and innovation of traditional Chinese medicine(TCM) and the "cradles" of the preparation of new TCM. To effectively promote the transformation of new TCM originating from the TCM clinical practice in medical institutions and establish an effective evaluation index system for the transformation of new TCM conforming to the characteristics of TCM, consensus experts adopted the literature research, questionnaire survey, Delphi method, etc. By focusing on the policy and technical evaluation of new TCM originating from the TCM clinical practice in medical institutions, a comprehensive evaluation from the dimensions of drug safety, efficacy, feasibility, and characteristic advantages was conducted, thus forming a comprehensive evaluation system with four primary indicators and 37 secondary indicators. The expert consensus reached aims to encourage medical institutions at all levels to continuously improve the high-quality research and development and transformation of new TCM originating from the TCM clinical practice in medical institutions and targeted at clinical needs, so as to provide a decision-making basis for the preparation, selection, cultivation, and transformation of new TCM for medical institutions, improve the development efficiency of new TCM, and precisely respond to the public medication needs.
Medicine, Chinese Traditional/standards*
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Humans
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Consensus
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Drugs, Chinese Herbal/therapeutic use*
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Surveys and Questionnaires
9.Differences in intestinal absorption characteristics of Rubus multibracteatus extract in normal and inflammatory pain model rats by in-vitro everted intestine sac method.
Ming-Li BAO ; Qing ZHANG ; Yang JIN ; Yi CHEN ; Jian-Qing PENG ; Si-Ying CHEN ; Zhi-Jie MA ; Jian LIAO ; Jing HUANG ; Zi-Peng GONG
China Journal of Chinese Materia Medica 2025;50(16):4690-4704
This study compared the differences in intestinal absorption characteristics of eleven active components in Rubus multibracteatus(RM) extract(protocatechuic acid, tiliroside, scutellarin, luteoloside, astragalin, epicatechin, catechin, xanthotoxin, p-coumaric acid, caffeic acid, and apigenin-7-O-glucuronide) between normal rats and inflammatory pain model rats using the in-vitro everted intestinal sac model. The RM extract was administered at absorption concentrations of 25.0, 50.0, and 100.0 mg·mL~(-1). The contents of the eleven components in intestinal absorption solution samples were quantified by ultra-performance liquid chromatography-tandem mass spectrometry(UPLC-MS/MS), and their cumulative absorption(Q) and absorption rate constant(K_a) were calculated to evaluate the absorption characteristics of these components in normal rats and inflammatory pain model rats. The results show that except for catechin, epicatechin, and caffeic acid, the cumulative absorption-time curves of the other eight components(protocatechuic acid, tiliroside, scutellarin, luteoloside, astragalin, xanthotoxin, p-coumaric acid, and apigenin-7-O-glucuronide) exhibit an upward trend without saturation, with correlation coefficients(R~2) all > 0.9, indicating linear absorption. However, the overall absorption of all components is not dose-dependent with increasing concentration, suggesting that their absorption mechanisms are not solely passive diffusion. In both normal and model rats, the jejunum shows the highest absorption for all components except xanthotoxin. The overall absorption of seven components(excluding protocatechuic acid, caffeic acid, apigenin-7-O-glucuronide, and luteoloside) in normal rats is better than that in model rats across all intestinal segments. These findings indicate that the pathological state of inflammatory pain alters the intestinal absorption of RM extract, and its mechanism needs further investigation.
Animals
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Rats
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Intestinal Absorption/drug effects*
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Male
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Rats, Sprague-Dawley
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Drugs, Chinese Herbal/metabolism*
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Disease Models, Animal
;
Pain/metabolism*
;
Intestines/drug effects*
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Intestinal Mucosa/metabolism*
10.Comparative analysis of the efficacy of laparoscopic hiatal hernia repair combined with Toupet or Dor fundoplication for esophageal hiatal hernia
Sheng-Chang LIANG ; Jin-Lian WANG ; Yi-Bin GUO ; Qi ZHANG ; Yu-Peng ZHANG ; Ting-Bao CAO ; Kun-Peng QU
Medical Journal of Chinese People's Liberation Army 2025;50(9):1122-1128
Objective To investigate the postoperative efficacy of laparoscopic hiatal hernia repair(LHHR)combined with Toupet or Dor fundoplication for the treatment of esophageal hiatal hernia(HH).Methods A retrospective analysis was conducted on the case data of HH patients who underwent LHHR combined with Toupet(Toupet group,n=53)and Dor(Dor group,n=53)fundoplication between December 2018 and December 2022 in Department of General Surgery of Gansu Provincial Hospital.Intraoperative and postoperative recovery outcomes of both groups were observed.We analyzed and compared the incidence of dysphagia and gastroesophageal reflux disease questionnaire(GERD-Q)scores at preoperative and postoperative intervals of 1 month,6 months,and 1 year.The incidence of postoperative complications and the 1-year recurrence rate were compared between the two groups.Additionally,factors influencing postoperative dysphagia within the first month were examined.Results The differences between the two groups in operation time,intraoperative bleeding,postoperative ventilation time,postoperative extubation time and hospitalization time were not statistically significant(P>0.05).There was no significant difference in the incidence of immediate postoperative dysphagia in two groups(P>0.05).Furthermore,the differences between the two groups in the incidence of postoperative complications,such as bloating,abdominal pain and diarrhea,were not statistically significant(P>0.05).The incidence of dysphagia in Toupet group was higher than that in Dor group at 1 month postoperatively,and the difference was statistically significant(P=0.017);but the difference in the incidence of dysphagia between the two groups at 6 months and 1 year postoperatively was not statistically significant(P=0.767,1.000).The results of binary logistic regression analysis showed that both surgical procedure(OR=2.613,95%CI 1.141-5.983,P=0.023)and esophageal contractile reserve function(OR=2.921,95%CI 1.203-7.095,P=0.018)were independent risk factors for the incidence of dysphagia in patients with HH at 1 month after surgery.Compared with the preoperative period,the GERD-Q symptom scores were lower in both groups at 1 month,6 months,and 1 year postoperatively,and the difference was statistically significant(P<0.05);but there was no statistically significant difference between the groups at the same time point(Fintergroup=0.334,P=0.565).The difference between the two groups in 1-year postoperative recurrence rates was not statistically significant(P>0.05).Conclusions LHHR combined with Toupet or Dor fundoplication are both safe and effective surgical procedures for the treatment of HH,with excellent reflux control,fewer complications and lower recurrence rates,but Toupet fundoplication is more likely to have postoperative short-term dysphagia than Dor fundoplication.

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