1.Preoperative short-course radiotherapy followed by chemotherapy and PD-1 inhibitor administration for locally advanced rectal cancer: the initial results of a randomized controlled clinical trial (STELLAR II)
Haoyue LI ; Haitao ZHOU ; Lichun WEI ; Yinggang CHEN ; Wenjue ZHANG ; Feiyan DENG ; Ning LI ; Zheng JIANG ; Zheng LIU ; Jianwei LIANG ; Zhaoxu ZHENG ; Xianyu MENG ; Yufei LU ; Zifa LEI ; Xiaoge SUN ; Gong LI ; Yingjie WANG ; Yongwen SONG ; Shunan QI ; Hao JING ; Yirui ZHAI ; Shulian WANG ; Yexiong LI ; Yuan TANG ; Jing JIN
Chinese Journal of Oncology 2025;47(9):913-921
Objectives:To explore whether short-course radiotherapy (SCRT)-based total neoadjuvant therapy (TNT) combined with PD-1 inhibitors could further promote tumor regression and improve the prognosis.Methods:This is a prospective, multicenter, two-arm randomized controlled, seamless phase Ⅱ/Ⅲ trial for proficient mismatch repair or microsatellite stable (pMMR/MSS) locally advanced rectal cancer (LARC). Eligible patients were randomly assigned to the iTNT (TNT+PD-1) group or the TNT group. Patients in the TNT group received SCRT (5 Gy×5) followed by 4 cycles of CAPOX or 6 cycles of mFOLFOX chemotherapy, with the iTNT group receiving SCRT followed by the same regime in combination with 4 cycles of Sintilimab. Total mesorectal excision (TME) surgery or watch and wait (W&W) was performed after neoadjuvant therapy and then 2 cycles of same regimen as before were recommended. The primary endpoints are the complete response (CR) rate for phase Ⅱ trial and 3-year disease-free survival (DFS) for phase Ⅲ trial. A total of 588 patients will be enrolled for the phase Ⅱ/Ⅲ trial. Short-term efficacy and safety data from the initial 100 treated patients were analyzed as planned.Results:From 2022-8-31 to 2023-5-24 the initial 100 patients were enrolled from 10 hospitals in China, 76.0%(76/100) patients were male, and the median age was 61 years (21-74 years). More patients had tumors located in the lower rectum (78.0%, 78/100), staged T3-4 (97.0%, 97/100) and N1-2 (93.0%, 93/100), and about half of the tumors invaded the mesorectal fascia (52.0%, 52/100) and with extramural vascular invasion (51.0%, 51/100). Analyses were performed according to the per-protocal (PP) set. All patients in the iTNT group ( n=52) and the TNT group ( n=48) completed SCRT; The 4-cycle chemotherapy±Sintilimab completion rates were 86.5% and 100.0% in the iTNT and TNT groups, respectively. In the iTNT group, 82.7% (43/52), 11.5% (6/52), and 5.8% (3/52) of the patients received 4, 3, and 2 cycles of PD-1 inhibitor. After TNT, 68 patients underwent radical surgery and 15 patients achieved cCR and adopted W&W. The pathological complete response (pCR) rates were 48.5% (16/33) and 17.1% (6/35) in the iTNT and TNT groups, with CR rates of 50.0% (25/50) and 26.1% (12/46), respectively. The incidence of treatment-related grade 3-4 adverse events was 26.9% (14/52, iTNT group) and 18.8% (9/48, TNT group), with thrombocytopenia and leukopenia being the most common. Among patients receiving immunotherapy, grade 3 immunotherapy-related adverse events occurred in 2 (3.8%, 2/52) patients: one case was pancreatitis, another case was hepatitis combined with myositis and myocarditis. Conclusion:The preliminary results show that SCRT-based TNT combined with PD-1 inhibitors could further improve the CR rate for LARC without unexpected serious adverse events.
2.Preoperative short-course radiotherapy followed by chemotherapy and PD-1 inhibitor administration for locally advanced rectal cancer: the initial results of a randomized controlled clinical trial (STELLAR II)
Haoyue LI ; Haitao ZHOU ; Lichun WEI ; Yinggang CHEN ; Wenjue ZHANG ; Feiyan DENG ; Ning LI ; Zheng JIANG ; Zheng LIU ; Jianwei LIANG ; Zhaoxu ZHENG ; Xianyu MENG ; Yufei LU ; Zifa LEI ; Xiaoge SUN ; Gong LI ; Yingjie WANG ; Yongwen SONG ; Shunan QI ; Hao JING ; Yirui ZHAI ; Shulian WANG ; Yexiong LI ; Yuan TANG ; Jing JIN
Chinese Journal of Oncology 2025;47(9):913-921
Objectives:To explore whether short-course radiotherapy (SCRT)-based total neoadjuvant therapy (TNT) combined with PD-1 inhibitors could further promote tumor regression and improve the prognosis.Methods:This is a prospective, multicenter, two-arm randomized controlled, seamless phase Ⅱ/Ⅲ trial for proficient mismatch repair or microsatellite stable (pMMR/MSS) locally advanced rectal cancer (LARC). Eligible patients were randomly assigned to the iTNT (TNT+PD-1) group or the TNT group. Patients in the TNT group received SCRT (5 Gy×5) followed by 4 cycles of CAPOX or 6 cycles of mFOLFOX chemotherapy, with the iTNT group receiving SCRT followed by the same regime in combination with 4 cycles of Sintilimab. Total mesorectal excision (TME) surgery or watch and wait (W&W) was performed after neoadjuvant therapy and then 2 cycles of same regimen as before were recommended. The primary endpoints are the complete response (CR) rate for phase Ⅱ trial and 3-year disease-free survival (DFS) for phase Ⅲ trial. A total of 588 patients will be enrolled for the phase Ⅱ/Ⅲ trial. Short-term efficacy and safety data from the initial 100 treated patients were analyzed as planned.Results:From 2022-8-31 to 2023-5-24 the initial 100 patients were enrolled from 10 hospitals in China, 76.0%(76/100) patients were male, and the median age was 61 years (21-74 years). More patients had tumors located in the lower rectum (78.0%, 78/100), staged T3-4 (97.0%, 97/100) and N1-2 (93.0%, 93/100), and about half of the tumors invaded the mesorectal fascia (52.0%, 52/100) and with extramural vascular invasion (51.0%, 51/100). Analyses were performed according to the per-protocal (PP) set. All patients in the iTNT group ( n=52) and the TNT group ( n=48) completed SCRT; The 4-cycle chemotherapy±Sintilimab completion rates were 86.5% and 100.0% in the iTNT and TNT groups, respectively. In the iTNT group, 82.7% (43/52), 11.5% (6/52), and 5.8% (3/52) of the patients received 4, 3, and 2 cycles of PD-1 inhibitor. After TNT, 68 patients underwent radical surgery and 15 patients achieved cCR and adopted W&W. The pathological complete response (pCR) rates were 48.5% (16/33) and 17.1% (6/35) in the iTNT and TNT groups, with CR rates of 50.0% (25/50) and 26.1% (12/46), respectively. The incidence of treatment-related grade 3-4 adverse events was 26.9% (14/52, iTNT group) and 18.8% (9/48, TNT group), with thrombocytopenia and leukopenia being the most common. Among patients receiving immunotherapy, grade 3 immunotherapy-related adverse events occurred in 2 (3.8%, 2/52) patients: one case was pancreatitis, another case was hepatitis combined with myositis and myocarditis. Conclusion:The preliminary results show that SCRT-based TNT combined with PD-1 inhibitors could further improve the CR rate for LARC without unexpected serious adverse events.
3.Analysis of literature case reports on hemolytic anemia induced by piperacillin-tazobactam
Zhilian XU ; Ying ZHENG ; Feiyan HE
Chinese Journal of Pharmacoepidemiology 2024;33(6):688-696
Objective To discuss the occurrence and characteristics of hemolytic anemia induced by piperacillin-tazobactam to provide a reference for clinically safe drug use.Methods PubMed,Web of Science,CNKI,WanFang Data,and VIP were electronically searched to collect case reports of hemolytic anemia induced by piperacillin-tazobactam from inception to December 2023,and statistical analysis was conducted on patients'basic information,drug use,hemolytic anemia,complications and outcomes.Results A total of 27 patients were included in 25 literature,including 14 males(51.85%)and 13 females(48.15%),aged from 4 days to 77 years old,and the time of first occurrence of hemolytic anemia ranged from 24 h to 18 days.The minimum hemoglobin level of hemolytic anemia was determined in 25 cases,ranging from 27 to 113 g·L-1,of which 14 cases were severe or extremely severe anemia(<60 g·L-1).After drug withdrawal,antibiotic change,and symptomatic supportive treatment,the hemolytic anemia of 25 patients(92.59%)was improved or recovered.Among them,the anemia of 1 patient was improved after stopping piperacillin-tazobactam,but the patient died of multiple organ failure 15 days after drug withdrawal.The other two patients of anemia did not improve,and eventually discharged themselves or died clinically.Conclusion Hemolytic anemia is a rare adverse reaction of piperacillin-tazobactam,and the clinical symptoms have no obvious specificity.Hemoglobin levels should be monitored in clinical use,and once the abnormality is found,if it is clear that piperacillin-tazobactam is the suspicious drug,it should be promptly discontinued,and measures such as red blood cell transfusion should be taken if necessary.
4.Research progress in TACE-based combination therapy for primary hepatocellular carcinoma
Zhengfang XIAO ; Youbing ZHENG ; Feiyan DENG ; Siqian ZHENG ; Hongwei SUN ; Yanyan LIU ; Ligong LU
Journal of Interventional Radiology 2024;33(6):688-692
Liver cancer is a prevalent and highly malignant cancer worldwide,with 90%of cases being hepatocellular carcinoma,presenting a significant risk to human health.As early-stage liver cancer often lacks specific manifestations,most patients with liver cancer are already in the middle and late stage of the disease when liver cancer is diagnosed,thus,missing the opportunity for optimal radical treatment.However,the exploration of the treatment for middle and advanced primary hepatocellular carcinoma has never ceased.In recent years,transarterial chemoembolization(TACE)has been included in the standard treatment regimens for primary hepatocellular carcinoma.With the advancement of multidisciplinary comprehensive treatment,various treatment options to reduce the burden of liver cancer lesion with satisfactory therapeutic results have been reported and have been widely used in clinical practice,e.g.hepatic artery infusion chemotherapy(HAIC),targeted therapy,and immunotherapy in combination with TACE,which have significantly improved the overall survival of patients with liver cancer.This paper aims to make a comprehensive review about the latest progress of combination use of TACE and other therapies in reducing tumor burden and improving patient survival in the treatment of primary hepatocellular carcinoma,and to summarize the key issues in combination therapy that require more in-depth research.(J Intervent Radiol,2024,33:688-692)
5.Design and development of nursing care planning section of clinical decision support system
Caoyuan WANG ; Rong WANG ; Zheng LIN ; Zejuan GU ; Feiyan ZHANG ; Chunhong GAO ; Shuangshuang XING ; Lixia XIA ; Yuan ZHOU ; Xiaotong CAO ; Keyu CHEN ; Lei YANG
Chinese Journal of Practical Nursing 2021;37(3):223-228
Objective:To provide reference for the development of a more intelligent and systematic nursing clinical decision support system based on the concept of precision nursing and data sharing, the nursing plan module of clinical decision support system.Methods:An evidence-based knowledge base was constructed based on the nursing process and the standardized nursing terminologies; the nursing plan module was designed according to clinical needs, and the logical reasoning rules were formulated from the generation, sequencing and stopping of nursing problems, objectives, measures and activities, and finally the nursing plan module of clinical decision support system was formed.Results:The nursing plan module of clinical decision support system included the basic information of patients, positive evaluation items and weight values, nursing problems, objectives, measures and activities, etc. the module could automatically deduce the nursing plan according to the patient's individual characteristic index (positive evaluation item), and sort the nursing problems and corresponding measures and activities according to the generation time, weight value and correlation degree. It could automatically distinguish nursing problems, goals, measures and the time of activity stop, and realize intelligent decision-making.Conclusion:The interface of nursing plan module of this system is clear and logical reasoning rules are rigorous. It breaks through the bottleneck of nursing decision-making based on personal professional knowledge and experience in clinical situation for a long time, which can ensure the homogeneity of nursing plan and improve the correctness of decision-making.
6.Effects of CCR3(Chemokine receptor-3) on Muc5ac in airway of asthmatic mice
Tao WANG ; Jianyong ZHANG ; Xiudan WANG ; Feiyan ZHENG ; Hongxia YANG
Chinese Journal of Immunology 2015;(8):1019-1023
Objective:To investigate the effects of CCR3 on Muc5ac in the airway of asthmatic mice.Methods: Fifty clean BALB/c mice were randomly divided into control group,asthmatic group,dexamethasone treatment group,SB328437 treatment group, vehicle-control group.Total cells and differential inflammatory cells were counted in BALF, the levels of IL-4 and TNF-αwere determined by ELISA,lung tissue HE staining the expressions of Mucin5ac(Muc5ac) and CCR3 in lung tissue were detected by immu-neohistochemical staining and RT-PCR.Results:The total cells,eosinophil,monocytes and lymphocyte cells in BALF,the levels of IL-4,TNF-αin BALF ,the goblet cell of airway wall,the expression of Muc5ac and CCR3 positive staining IOD in the airway and the expression of Muc5ac and CCR3 mRNA lung tissue obviously decreased in SB328437 treatment group and DEX treatment group which compared with asthmatic mice model group ( P<0.05 ) .Conclusion: SB328437 can inhibit the expression of CCR3 in pulmonary tissue,furtherly inhibit the expression and secretion of Muc5ac and control the airway inflammation.
7.Study on the exocellular polysaccharide of Ureaplasma urealyticum biofilm in vitro
Minting HUANG ; Chun LU ; Guoxing ZHU ; Peiying FENG ; Wei LAI ; Xiaomin YE ; Feiyan LIN ; Jinfen ZHENG ; Han MA ; Meirong LI
Chinese Journal of Microbiology and Immunology 2012;32(4):335-339
Objective To investigate the extracellular polysaccharide distribution and components of Ureaplasma urealyticum (Uu) after biofilm having been developed in.Methods The standard serotype 3 and serotype 14 belong to biovar Parvo,and the standard serotype 4 and serotype 8 belong to biovar T960 were employed to form biofilrns in vitro.Scanning electron microscope and confocal laser scanning microscope were used to analysis the biofilms and extracellular polysaccharide.We used combination of two different labeled lectins,Canavalia ensiformis(FITC-ConA) and Erythrina cristagalli(ECA) which bind to specific polysaccharide residues to visualize extracellular polysaccharide in biofilms,and average uorescence intensity was evaluated Results All the strains can form the biofilmsin vitro.The biofilm was honeycomb-Like structures mainly,and extracellular polymeric substances accounts for majority of proportions.All the extracellular polysaccharide could be combined with FITC-ConA and ECA,and the total average fluorescence intensity of FITC-ConA was higher than ECA( P<0.001 ).Conclusion Ureaplasma urealyticum biofilm is honeycomb-like structures mainly.The extracellular polysaccharide contains,galactose,and N-acetyl glucan residual,and the glucose,mannose residual are the main components.
8.Effects of low frequency electric stimulation at bilateral mastoid processes on motor function and cerebral blood flow of children with cerebral palsy
Guoxiang PANG ; Guanzhong HUANG ; Aihua ZHENG ; Feiyan LI
Chinese Journal of Physical Medicine and Rehabilitation 2003;0(02):-
Objective To explore the effects of low frequency electric stimulation at bilateral mastoid processes on motor function and cerebral blood flow of children with cerebral palsy (CP). Methods Ninety children with CP were randomly divided into two groups: an electric stimulation group (group 1) and an conventional rehabilitation control group (group 2), thirty healthy children served as the normal control group. The children of group 1 were treated with FES in addition to the routine rehabilitation treatment. The children of group 2 were given of the routine rehabilitation treatment only. All the patients were treated successively with the above protocol for 3 months. The clinical effect and motor development were evaluated with the gross motor function measure (GMFM), and the blood flow velocities of anterior cerebral artery (ACA), middle cerebral artery (MCA), posterior cerebral artery (PCA) were measured by transcranial doppler (TCD) ultrasound before and after treatment. Results In group 1, significant or some improvement were achieved in 19 and 24 CP children, respectively, with an effective rate of 95.6% . In group 2, significant or some improvement were achieved in 10 and 27 CP children, respectively, with an effective rate of 82.2%. There was significant difference between the two groups with regard to the significant effective rate (P

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