1.Effect of preoperative immune checkpoint inhibitors on reducing residual lymph node metastases in patients with gastric cancer: a retrospective study
Xinhua CHEN ; Hexin LIN ; Yuehong CHEN ; Xiaodong WANG ; Chaoqun LIU ; Huilin HUANG ; Huayuan LIANG ; Huimin ZHANG ; Fengping LI ; Hao LIU ; Yanfeng HU ; Guoxin LI ; Jun YOU ; Liying ZHAO ; Jiang YU
Chinese Journal of Gastrointestinal Surgery 2024;27(7):694-701
		                        		
		                        			
		                        			Objective:To investigate the effect of immune checkpoint inhibitors on reducing residual lymph node metastasis in patients with gastric cancer.Methods:The cohort of this retrospective study comprised patients from Nanfang Hospital of Southern Medical University and the First Affiliated Hospital of Xiamen University who had undergone systemic treatment prior to gastrectomy with D2 lymphadenectomy and had achieved Grade 1 primary tumor regression (TRG1) from January 2014 to December 2023. After exclusion of patients who had undergone preoperative radiotherapy, data of 58 patients (Nanfang Hospital: 46; First Affiliated Hospital of Xiamen University: 12) were analyzed. These patients were allocated to preoperative chemotherapy (Chemotherapy group, N=36 cases) and preoperative immunotherapy plus chemotherapy groups (Immunotherapy group, N=22 cases). There were no significant differences between these groups in sex, age, body mass index, diabetes, tumor location, pathological type, Lauren classification, tumor differentiation, pretreatment depth of invasion by primary tumor, pretreatment lymph node stage, pretreatment clinical stage, mismatch repair protein status, number of preoperative treatment cycles, or duration of preoperative treatment (all P>0.05). The primary outcome measure was postoperative lymph node downstaging. Secondary outcomes included postoperative depth of invasion by tumor, number of lymph nodes examined, and factors affecting residual lymph node metastasis status. Results:Lymph node downstaging was achieved significantly more often in the Immunotherapy group than the Chemotherapy group (pN0: 90.9% [20/22] vs. 61.1% [22/36]; pN1: 4.5% [1/22] vs. 36.1% [13/36]; pN2: 4.5% [1/22) vs. 0; pN3: 0 vs. 2.8% [1/36], Z=-2.315, P=0.021). There were no significant difference between the two groups in number of lymph nodes examined (40.5±16.3 vs. 40.8±17.5, t=0.076, P=0.940) or postoperative depth of invasion by primary tumor (pT1a: 50.0% [11/22] vs. 30.6% [11/36]; pT1b: 13.6% [3/22] vs. 19.4% [7/36]; pT2: 13.6% [3/22] vs. 13.9% [5/36]; pT3: 13.6% [3/22] vs. 25.0% [9/36]; pT4a: 9.1% [2/22] vs. 11.1% [4/36], Z=-1.331, P=0.183). Univariate analysis revealed that both preoperative treatment regimens were associated with residual lymph node metastasis status in patients whose primary tumor regression was TRG1 (χ 2=6.070, P=0.014). Multivariate analysis incorporated the following factors: pretreatment depth of invasion by primary tumor, pretreatment lymph node stage, pretreatment clinical stage, number of preoperative treatment cycles, and preoperative treatment duration. We found that a combination of immunotherapy and chemotherapy administered preoperatively was an independent protective factor for reducing residual lymph node metastases in study patients whose primary tumor regression was TRG1 (OR=0.147, 95%CI: 0.026–0.828, P=0.030). Conclusion:Compared with preoperative chemotherapy alone, a combination of preoperative immunotherapy and chemotherapy achieved greater reduction of residual lymph node metastases in the study patients who achieved TRG1 tumor regression in their primary lesions.
		                        		
		                        		
		                        		
		                        	
2.Effect of preoperative immune checkpoint inhibitors on reducing residual lymph node metastases in patients with gastric cancer: a retrospective study
Xinhua CHEN ; Hexin LIN ; Yuehong CHEN ; Xiaodong WANG ; Chaoqun LIU ; Huilin HUANG ; Huayuan LIANG ; Huimin ZHANG ; Fengping LI ; Hao LIU ; Yanfeng HU ; Guoxin LI ; Jun YOU ; Liying ZHAO ; Jiang YU
Chinese Journal of Gastrointestinal Surgery 2024;27(7):694-701
		                        		
		                        			
		                        			Objective:To investigate the effect of immune checkpoint inhibitors on reducing residual lymph node metastasis in patients with gastric cancer.Methods:The cohort of this retrospective study comprised patients from Nanfang Hospital of Southern Medical University and the First Affiliated Hospital of Xiamen University who had undergone systemic treatment prior to gastrectomy with D2 lymphadenectomy and had achieved Grade 1 primary tumor regression (TRG1) from January 2014 to December 2023. After exclusion of patients who had undergone preoperative radiotherapy, data of 58 patients (Nanfang Hospital: 46; First Affiliated Hospital of Xiamen University: 12) were analyzed. These patients were allocated to preoperative chemotherapy (Chemotherapy group, N=36 cases) and preoperative immunotherapy plus chemotherapy groups (Immunotherapy group, N=22 cases). There were no significant differences between these groups in sex, age, body mass index, diabetes, tumor location, pathological type, Lauren classification, tumor differentiation, pretreatment depth of invasion by primary tumor, pretreatment lymph node stage, pretreatment clinical stage, mismatch repair protein status, number of preoperative treatment cycles, or duration of preoperative treatment (all P>0.05). The primary outcome measure was postoperative lymph node downstaging. Secondary outcomes included postoperative depth of invasion by tumor, number of lymph nodes examined, and factors affecting residual lymph node metastasis status. Results:Lymph node downstaging was achieved significantly more often in the Immunotherapy group than the Chemotherapy group (pN0: 90.9% [20/22] vs. 61.1% [22/36]; pN1: 4.5% [1/22] vs. 36.1% [13/36]; pN2: 4.5% [1/22) vs. 0; pN3: 0 vs. 2.8% [1/36], Z=-2.315, P=0.021). There were no significant difference between the two groups in number of lymph nodes examined (40.5±16.3 vs. 40.8±17.5, t=0.076, P=0.940) or postoperative depth of invasion by primary tumor (pT1a: 50.0% [11/22] vs. 30.6% [11/36]; pT1b: 13.6% [3/22] vs. 19.4% [7/36]; pT2: 13.6% [3/22] vs. 13.9% [5/36]; pT3: 13.6% [3/22] vs. 25.0% [9/36]; pT4a: 9.1% [2/22] vs. 11.1% [4/36], Z=-1.331, P=0.183). Univariate analysis revealed that both preoperative treatment regimens were associated with residual lymph node metastasis status in patients whose primary tumor regression was TRG1 (χ 2=6.070, P=0.014). Multivariate analysis incorporated the following factors: pretreatment depth of invasion by primary tumor, pretreatment lymph node stage, pretreatment clinical stage, number of preoperative treatment cycles, and preoperative treatment duration. We found that a combination of immunotherapy and chemotherapy administered preoperatively was an independent protective factor for reducing residual lymph node metastases in study patients whose primary tumor regression was TRG1 (OR=0.147, 95%CI: 0.026–0.828, P=0.030). Conclusion:Compared with preoperative chemotherapy alone, a combination of preoperative immunotherapy and chemotherapy achieved greater reduction of residual lymph node metastases in the study patients who achieved TRG1 tumor regression in their primary lesions.
		                        		
		                        		
		                        		
		                        	
3.Risk factors for recurrence of lower-extremity arteriosclerosis obliterans in patients after interventional surgery
Hexin ZHANG ; Suhong YE ; Chuqi ZHU
Chinese Journal of Primary Medicine and Pharmacy 2023;30(11):1634-1639
		                        		
		                        			
		                        			Objective:To investigate the risk factors for the recurrence of lower-extremity arteriosclerosis obliterans in patients after interventional surgery.Methods:The clinical data of 98 patients with lower-extremity arteriosclerosis obliterans who received treatment in Lishui Municipal Central Hospital from January 2021 to January 2022 were retrospectively analyzed. They were randomly divided into a recurrent group ( n = 36) and a non-recurrent group ( n = 62). The immediate efficacy of interventional therapy and the follow-up were determined in each group. Clinical data, triglyceride, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol levels, neutrophil/lymphocyte ratio, and fasting blood glucose level were compared between the two groups. The risk factors for the recurrence of lower-extremity arteriosclerosis obliterans after interventional surgery were further analyzed using logistic regression analysis. Results:The success rate of interventional surgery for aortoiliac artery, superficial femoral artery, and inferior genicular artery were 95.35% (41/43), 97.73% (43/44), and 95.83% (46/48), respectively. Twelve-month follow-up results showed that the patency rate of lower-extremity vessels decreased with time ( P < 0.05). There was a significant difference in Trans-Atlantic Inter Society Consensus (TASC) classification between the two groups (11/26/18/7 vs. 4/5/10/17, χ2 = 18.33, P < 0.05). Ankle-brachial index (ABI) in the recurrence group was significantly lower than that in the non-recurrence group [(0.77 ± 0.12) vs. (0.40 ± 0.02), t = 18.31, P < 0.05]. There were no significant differences in triglyceride, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and fasting blood glucose levels between the two groups (all P < 0.05). The neutrophil/lymphocyte ratio (NLR) in the non-recurrent group was significantly lower than that in the recurrent group [(1.98 ± 0.28) vs. (13.18 ± 0.50), t = 15.25, P < 0.05]. Logistic regression analysis results showed that ABI ( OR = 1.459, 95% CI: 1.163-1.832), TASC classification ( OR = 1.344, 95% CI: 1.090-1.658), surgical method ( OR = 1.392, 95% CI: 1.140-1.700) and NLR ( OR = 1.474, 95% CI: 1.184-1.836) were the influential factors of recurrence of lower-extremity arteriosclerosis obliterans (all P < 0.05). Conclusion:ABI, TASC classification, surgical methods, and NLR are the influential factors of lower-extremity arteriosclerosis obliterans after interventional surgery. The above indexes should be closely monitored in clinical practice to maintain the effects of interventional surgery.
		                        		
		                        		
		                        		
		                        	
4.Effect of adequate amount of tranexamic acid before operation on blood loss and safety in posterior lumbar fusion with multiple segments
Jianru YUAN ; Yufen YANG ; Hongying ZHANG ; Moxuan LIU ; Hui YAN ; Hexin WEI ; Jiandong WANG
Chinese Journal of Blood Transfusion 2021;34(1):43-47
		                        		
		                        			
		                        			【Objective】 To investigate the effect of adequate amount of tranexamic acid(TXA)before operation on blood loss and safety in posterior lumbar fusion with multiple segments. 【Methods】 A retrospective analysis was conducted on 105 patients with lumbar spinal stenosis, submitted to our hospital for multilevel PLIF, from March 2017 to December 2019. According to the intervention method, they were divided into control group, group A and group B (n =30, 39 and 36, respectively). TXA was not used in the control group. Dripping of saline solution(100 mL) containing TXA 2g and 1g was given in Group A and Group B, and extra intravenous pumping of TXA [10 mg/(kg·h)] during surgery was conducted in Group B besides the pre-operation dripping of TXA. Total blood loss, dominant blood loss, recessive blood loss, intraoperative blood loss, postoperative drainage volume, transfusion rate and hemoglobin (Hb), hematocrit (Hct), prothrombin time international standardized ratio (PT - INR), platelet count (Plt), D - dimer (D - D), C-reactive protein (CRP), neutrophil percentage (NP), alanine aminotransferase (ALT), and blood urea nitrogen (BUN) before and after operation were compared in the three groups. Postoperative drug-related adverse events were traced. 【Results】 1)The total blood loss, dominant blood loss(mL), intraoperative blood loss(mL), drainage volume(mL) within and after 24h after surgery, and the transfusion rate(%) in group A and B were 892.6±193.5 vs 887.7±320.8, 409.1±109.2 vs, 408.6±98.3, 193.7±69.3 vs 189.6±65.6, 130.5±53.4 vs 128.3±53.5, 63.1±17.6 vs 60.9±13.5 and 7.7 (3/39) vs 8.3 (3/36), respectively, which were significantly lower than that in group C as 1 296.8±329.2, 807.6±231.5, 270.9±65.5, 365.4±127.8, 172.3±66.4 and 36.7(11/30), respectively (P< 0.05). There were no significant differences in the above indexes between group A and group B (P < 0.05). The differences in recessive blood loss was not significant by groups(P<0.05). 2) Compared with pre-operation, the levels of Hb, Hct and Plt in the three groups at 3d after operation decreased: Hb(g/L) 91.5±14.0, 107.6±16.4 and 105.9±17.1; Hct(%) 25.6±3.1, 31.2±3.9 and 30.5±4.4; Plt(×109/L)146.6±31.8, 172.8 ±40.1 and 169.7±39.5(P < 0.05); while D-D, CRP and NP increased: D-D(mmol/L)365.6±67.1, 280.9±50.5 and 286.1±53.1; CRP(mg/L): 65.4±22.0, 53.4±19.6 and 56.8±17.7; NP(%): 87.3±15.6, 73.1±13.7, and 71.9±11.8(P < 0.05), and Pt-INR, ALT and BUN showed no significant changes (P > 0.05). The changes of Hb, Hct, Plt, D-D, CRP and NP in group A and B were significantly lower than those in group C at 3 days after operation [Hb (g/L) : 107.6±16.4, 105.9±17.1, 91.5±14.0; Hct (%) : 31.2±3.9, 30.5±4.4, 25.6±3.1; Plt (×109/L) : 172.8 ±40.1, 169.7±39.5, 146.6±31.8; D-D (mmol/L) : 280.9±50.5, 286.1±53.1, 365.6±67.1; CRP (mg/L) : 53.4±19.6, 56.8±17.7, 65.4±22.0; NP (%) : 73.1±13.7, 71.9±11.8, 87.3±15.6] (P < 0.05), and no significant differences in the above index were noticed between group A and B(P> 0.05).3)No lower limb deep vein thrombosis nor pulmonary embolism were found in group A and group B after operation, and all the incisions were healed in the first stage, and no serious complications such as drug allergy, cardiovascular and cerebrovascular accident, epidural hematoma, epilepsy occurred. 【Conclusion】 The preoperative TXA administration with sufficient single dose showed equivalent hemostatic effect in comparison with intraoperative continuous administration additional to preoperative dripping, which is simple and convenient and does not increase the risk of thrombosis.
		                        		
		                        		
		                        		
		                        	
5.A retrospective safety study on screening of the samples in the clinical biobank of Beijing Hospital.
HeXin LI ; XiaoKun TANG ; SiYuan XU ; XuanMei LUO ; GaoYuan SUN ; HongTao XU ; PengJun ZHANG ; Fei XIAO
Chinese Journal of Preventive Medicine 2021;55(9):1149-1152
		                        		
		                        			
		                        			To investigate whether the laboratory specimens preserved in Beijing Hospital Biobank during a specific period had been contaminated by SARS-Cov-2 through a cross-sectional study, and to establish a retrospective biobank safety screening system. Laboratory specimens were collected from the Department of Respiratory and Critical Care Medicine and the Fever Clinic of Beijing Hospital from November 1, 2019 to January 22, 2020, nucleic acid and serological antibody testing were performed for SARS-CoV-2 in these specimens (including 79 serum, 20 urine, 42 feces and 21 bronchoalveolar lavage fluid specimens). The safety of the stored samples during this period was defined by negative and positive results. Both the nucleic acid test and serological antibody test showed negative for SARS-CoV-2, indicating that these specimens were safely stored in the biobank. High-risk specimens collected in our hospital during the early stage of the COVID-19 outbreak are free of SARS-CoV-2, and a safety screening strategy for the clinical biobank is established to ensure the biosafety of these samples.
		                        		
		                        		
		                        		
		                        			Biological Specimen Banks
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		                        			COVID-19
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		                        			Cross-Sectional Studies
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		                        			Hospitals
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		                        			Humans
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		                        			Retrospective Studies
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		                        			SARS-CoV-2
		                        			
		                        		
		                        	
6.Quality assessment of global lung cancer screening guidelines and consensus
Yingjie SHI ; Jiang LI ; Yaohan MENG ; Lin XIANG ; Ruijie YAN ; Yongle ZHAN ; Hexin YUE ; Yu JIANG ; Ni LI ; Juan ZHANG ; Jie HE
Chinese Journal of Epidemiology 2021;42(2):241-247
		                        		
		                        			
		                        			Objective:To understand the research progress and quality of lung cancer screening guidelines and consensus in China and abroad, and to provide reference for the formulation of high-quality lung cancer screening guidelines in China.Methods:Databases including PubMed, Medline, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure, SinoMed, VIP and Wanfang Data were searched, websites and important references were also searched by hand retrieval. The Appraisal of Guidelines for Research & Evaluation Ⅱ(AGREE Ⅱ) and Reporting Items for Practice Guidelines in Healthcare (RIGHT) were used to assess the quality of newly published or updated guidelines and consensus.Results:A total of 9 guidelines and consensus published between 2015 and 2020 were included in this study, with countries including the United States, China, Canada, Saudi Arabia and South Africa. The field of scope and purpose and clarity of presentation scored relatively high but the rigor of development and applicability scored low. Five guidelines were judged to be A-level, all of which were published abroad, and the remaining four were B-level, including three guidelines and consensus issued by China and 1 guideline issued by South Africa. The report rate of RIGHT were higher in basic information and background, lower in review and quality assurance, funding and declaration and management of interests. There were 5 guidelines with a good level and 4 guidelines and consensus with a moderate level. The best overall quality guidelines were those published by the American College of Chest Physicians in 2018 and by the Canadian Task Force on Preventive Health Care in 2016.Conclusions:The number of countries and institutions that issue lung cancer screening guidelines and consensus had been increasing gradually, but the quality in China remained low. It is necessary to develop high-quality lung cancer screening guidelines suitable for China's national conditions in combination with evidence-based methods to guide practice.
		                        		
		                        		
		                        		
		                        	
7.Data standard and data sharing in clinical cohort studies
Hexin YUE ; Yongle ZHAN ; Feng BIAN ; Yifang ZHANG ; Luting GUI ; Yingjie SHI ; Yaohan MENG ; Juan ZHANG ; Yu JIANG
Chinese Journal of Epidemiology 2021;42(7):1299-1305
		                        		
		                        			
		                        			Data standard plays an important role in the process of data collection, Integration and sharing in clinical cohort studies, and more attention have been paid to it. This paper summarizes the 5 international proven data standard model, analyze their characteristics and development status, and match their data modules with the general data set of the clinical cohorts to evaluate the international data standard models' applicability and provide reference for the development and improvement of the data standard model for clinical cohort studies in China.
		                        		
		                        		
		                        		
		                        	
8.Application of AGREEⅡ in evaluating quality of esophageal cancer screening practice guidelines
Xuan LIU ; Yifang ZHANG ; Yongle ZHAN ; Hexin YUE ; Luting GUI ; Feng BIAN ; Yuping WANG ; Yu JIANG
Chinese Journal of Epidemiology 2021;42(7):1312-1317
		                        		
		                        			
		                        			High-quality clinical practice guidelines are of great significance for standardizing the clinical diagnosis and treatment process and improving the overall quality of health care. The Appraisal of Guidelines for Research & Evaluation InstrumentⅡ (AGREEⅡ) is one of the recognized tools for the evaluation of the quality of clinical practice guidelines. It has been translated into Chinese and is widely used in guideline formulation and quality evaluation. This article intends to take the comparatively high-quality clinical practice guidelines in the field of esophageal cancer screening in China, i.e. "Expert Consensus on Early Esophageal Cancer and Precancerous Lesion Screening in China (2019, Xinxiang)" as an example, to interpret the use of AGREEⅡ item by item, which might provide a reference for medical and health workers to better understand and use the assessment tool.
		                        		
		                        		
		                        		
		                        	
9.Study on the operation process and construction standard of an esophageal cancer screening cohort study
Xuan LIU ; Yifang ZHANG ; Yongle ZHAN ; Hexin YUE ; Luting GUI ; Feng BIAN ; Wenqiang WEI ; Yu JIANG
Chinese Journal of Epidemiology 2021;42(8):1504-1508
		                        		
		                        			
		                        			One of the most cost-effective measures in cancer prevention on cancer is to advocate to be aware of the disease, consciously changing negative behaviors, and taking the initiative to participate in regular physical checkup programs. Esophageal cancer is one of the malignant tumors accompanied by a heavy disease burden in China. Routine screening, early diagnosis, and treatment are the critical points of preventing and treating the disease. Cohort studies help understand the natural history and risk factors of esophageal cancer and identify high-risk groups of the disease. This paper intends to discuss the construction specifications of the multi-dimensional dynamic follow-up shared cohort for esophageal cancer by studying the risk factors, monitoring, and collecting biological sample information, providing references for developing a standardized and unified screening cohort research procedure, and necessary standards on esophageal cancer in the future.
		                        		
		                        		
		                        		
		                        	
10.Theoretical and Clinical Evidences of Dispelling Wind and Eliminating Dampness Therapy for Allergic Rhinitis
Xiao-yang ZHANG ; Zeng-lin LIAN ; Jin-lv SUN ; Qing SUN ; Zhen WANG ; Xin-yi LIAN
Chinese Journal of Experimental Traditional Medical Formulae 2020;26(20):198-205
		                        		
		                        			
		                        			The pathological mechanism of allergic rhinitis (AR) involves hierarchically acute and chronic reactions among antigens, immunocytes, immunoglobulins and inflammatory factors. AR, which is characterized by heterogeneity, reacts differently to the current treatment on diverse individuals. Some patients receive unsatisfying clinical outcomes after the treatment. Chinese herbal medicine has become a frequent option to treat AR because it can improve clinical symptoms with excellent safety. The description of Biqiu in ancient Chinese medical literatures is very similar to the clinical manifestation of AR. The major pathogeneses of Biqiu included infection of wind-cold pathogens, deficiency and cold in the lung, and evil depression into heat and wind. Therefore, in modern traditional Chinese medicine (TCM), Biqiu is considered as an integration of AR, allergic sinusitis and vasomotor rhinitis. According to the pathogenesis and clinical manifestations of Biqiu (including AR), this disease belongs to wind disease in TCM. But modern TCM focuses on deficiency of internal organs and ignores wind evil in syndrome differentiation, contrary to the fact that wind medicine is always used in treating AR. This even leads to an abnormal phenomenon that clinical studies attach little importance to syndrome differentiation. In this paper, we started from the phenomenon that wind medicine is always used in TCM for AR, considering TCM literatures and the study results of modern therapy for wind diseases, and put forward the ideas as follows: AR belongs to exogenous wind disease in TCM, and wind pathogen is the major pathogen, in clinical syndrome differentiation, we should attach more importance to wind evil, and dispelling wind and eliminating dampness is the key to treatment. Meanwhile, based on the fact that most of the classical prescriptions with good effectiveness for AR originated from 
		                        		
		                        	
            
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