1.The mechanism research of Xiaoyan Lidan formula for the intervention of chronic intrahepatic cholestasis based on metabolomics combined with molecular docking analysis
Si-min CHEN ; Jin-hao HUANG ; De-qin WANG ; Yu-ying XIA ; Mei-qi WANG ; Run-feng SHI ; Fang-le LIU ; Chen-chen ZHU ; Chao-zhan LIN
Acta Pharmaceutica Sinica 2023;58(11):3408-3420
		                        		
		                        			
		                        			 In this study, the mechanism of Xiaoyan Lidan formula (XYLDF) against 3,5-diethoxycarbonyl-1,4-dihydro-2,4,6-collidine (DDC)-induced chronic intrahepatic cholestasis (CIHC) in mice was investigated based on metabolomics, molecular docking and pharmacological methods. In the pharmacodynamics study, a dosage of 5 g·kg-1 (clinical equivalent) XYLDF was administered in DDC-induced mice, then the effect of XYLDF against CIHC was evaluated by measuring the levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (AKP) as well as total bilirubin (TBIL) in serum and observing liver histopathological changes. All experiments were approved by the Ethical Committee Experimental Animal Center of Guangzhou University of Chinese Medicine (ZYD-2021-001). The serum metabolites of mice in each group were detected and identified based on ultra-performance liquid chromatography quadrupole time-of-flight tandem mass spectrometry, and the relevant biological pathways and molecular key targets were further enriched. Molecular docking technology was used to further evaluate the binding activity of the main active ingredients of XYLDF with potential targets. Subsequently, the 
		                        		
		                        	
2.Antimicrobial resistance of bacteria from pleural and peritoneal effusion:surveillance report from Hunan Provincial Antimicrobial Resistance Sys-tem,2012-2021
Yong-Xue TANG ; Si-Yu WANG ; Xiao-Bing XIE ; Li-Hua CHEN ; Chen-Chao FU ; Chen LI ; Yan-Ming LI ; Jun LIU ; Nan REN ; Guo-Min SHI ; Jing-Min WU ; Huai-De YANG ; Hong-Xia YUAN ; Ming ZHENG ; Xun HUANG ; An-Hua WU ; Xing-Wang NING ; Xi-Mao WEN
Chinese Journal of Infection Control 2023;22(12):1438-1451
		                        		
		                        			
		                        			Objective To understand the distribution and antimicrobial resistance changes of bacteria isolated from pleural and peritoneal effusion in Hunan Province,and provide reference for correct clinical diagnosis and rational antimicrobial use.Methods Data reported by member units of Hunan Provincial Antimicrobial Resistance Survei-llance System from 2012 to 2021 were collected.Bacteria antimicrobial resistance surveillance method was imple-mented according to technical scheme of China Antimicrobial Resistance Surveillance System(CARSS),and WHO-NET 5.6 software was used to analyze the data of bacteria isolated from pleural and peritoneal effusion as well as antimicrobial susceptibility testing results.Results From 2012 to 2021,a total of 28 934 bacterial strains were iso-lated from specimens of pleural and peritoneal effusions from member units of Hunan Provincial Antimicrobial Re-sistance Surveillance System,with 5 752 strains from pleural effusion and 23 182 from peritoneal effusion.The top five bacteria isolated from pleural effusion were Escherichia coli(n=907,15.8%),Staphylococcus aureus(n=535,9.3%),Klebsiella pneumoniae(n=369,6.4%),Staphylococcus epidermidis(n=452,7.9%),and Staphy-lococcus haemolyticus(n=285,5.0%).The detection rate of methicillin-resistant Staphylococcus aureus(MR-SA)from pleural effusion was 24.3%-39.2%,and that of methicillin-resistant coagulase negative Staphylococcus(MRCNS)was 58.8%-77.1%.The top five bacteria isolated from peritoneal effusion were Escherichia coli(n=8 264,35.6%),Klebsiella pneumoniae(n=2 074,9.0%),Enterococcus faecium(n=1 458,6.3%),Staphylo-coccus epidermidis(n=1 383,6.0%),and Pseudomonas aeruginosa(n=1 152,5.0%).The detection rate of MRSA from peritoneal effusion was 22.1%-52.4%,which presented a decreasing trend(P=0.004).The detec-tion rate of MRCNS was 60.4%-79.4%.The resistance rates of Enterobacterales from peritoneal effusion to ce-fazolin,cefuroxime,ceftriaxone and cefepime all showed decreasing trends(all P<0.05).Vancomycin-,linezo-lid-,and teicoplanin-resistant Staphylococcus strains were not found in pleural and peritoneal effusions.The resis-tance rates of Enterococcus faecium to most tested antimicrobial agents were higher than those of Enterococcus fae-calis.The resistance rates of Enterobacterales to imipenem and meropenem were ≤8.5%.The resistance rates of non-fermentative Gram-negative bacilli to imipenem and meropenem were ≤43.3%.Conclusion The data structure of Hunan Antimicrobial Resistance Surveillance System for pleural and peritoneal effusions from 2012 to 2021 is relatively complete.The constituent and antimicrobial susceptibility of isolated pathogenic bacteria vary in different years.
		                        		
		                        		
		                        		
		                        	
3.Antimicrobial resistance of Acinetobacter baumannii:surveillance report from Hunan Provincial Antimicrobial Resistance System,2012-2021
Si-Di LIU ; Li-Hua CHEN ; Chen-Chao FU ; Chen LI ; Yan-Ming LI ; Jun LIU ; Xing-Wang NING ; Guo-Min SHI ; Jing-Min WU ; Huai-De YANG ; Hong-Xia YUAN ; Ming ZHENG ; Xun HUANG ; Nan REN ; An-Hua WU
Chinese Journal of Infection Control 2023;22(12):1460-1467
		                        		
		                        			
		                        			Objective To understand the epidemiology of clinically isolated Acinetobacter baumannii(A.bauma-nnii)in Hunan Province.Methods Bacterial antimicrobial resistance surveillance was carried out according to the requirements of the technical program of National Antimicrobial Resistance Surveillance System.Clinical data of Acinetobacter spp.reported to Hunan Provincial Antimicrobial Resistance Surveillance System by multiple centers in Hunan Province from 2012 to 2021 were summarized and analyzed with reference to the standards of the American Clinical and Laboratory Standards Institute.Results A total of 169 438 strains of Acinetobacter spp.were detected during the 10-year period,with the detection rate of A.baumannii being the highest(82.74%).70 923 strains(53.63%)of carbapenem-resistant A.baumannii(CRAB)and 58 149 strains(43.97%)of carbapenem-sensitive A.baumannii(CSAB)were detected respectively.Both CRAB and CSAB were detected most frequently in the age group>70 years,which were 34.44%and 32.02%,respectively.The percentage of CRAB and CSAB detected in the intensive care unit were 34.80%and 11.31%,respectively.CRAB and CSAB were mainly isolated from spu-tum/bronchoalveolar lavage fluid,followed by pus/secretion,urine,and blood.The resistance rates of CRAB to commonly used antimicrobial agents didn't change much during the 10-year period.Resistance rates of CRAB to ceftazidime and cefepime were both>84%,to ampicillin/sulbactam and piperacillin/tazobactam were both>82%,to aminoglycosides and quinolones were both>59%,to minocycline and polymyxin B were 15.9%-25.0%and 1.3%-6.9%,respectively.CSAB were sensitive to commonly used antimicrobial agents.Conclusion The isolation rate of CRAB is high and there is no significant change in resistance to commonly used antimicrobial agents.
		                        		
		                        		
		                        		
		                        	
4.Analysis of laparoscopic repair of traumatic bladder neck obliteration
Xiaoyong HU ; Jianwen HUANG ; Kaile ZHANG ; Jiemin SI ; Chao DENG ; Lujie SONG ; Qiang FU
Chinese Journal of Urology 2022;43(8):614-615
		                        		
		                        			
		                        			There are few reports on laparoscopic repair of traumatic atresia of bladder neck. In this study, three patients with traumatic atresia of bladder neck were repaired by laparoscopic surgery, and the surgery was successfully completed. During postoperative follow-up, the patients had smooth urination, no urinary incontinence and sexual function damage, and laparoscopic surgery was effective in repairing traumatic atresia of bladder neck.
		                        		
		                        		
		                        		
		                        	
5.Association between coagulation function and prognosis in patients with acute pancreatitis.
Qin LI ; Chao Nan LIU ; Li Qin LING ; Xun Bei HUANG ; Si CHEN ; Jing ZHOU
Journal of Southern Medical University 2022;42(7):1006-1012
		                        		
		                        			OBJECTIVE:
		                        			To explore the correlation of coagulation function with the severity and prognosis of acute pancreatitis (AP) and identify the laboratory markers for early prediction and dynamic monitoring of the prognosis of AP.
		                        		
		                        			METHODS:
		                        			We retrospectively analyzed the clinical data of patients with AP admitted less than 72 h after onset to our hospital from December 1, 2017 to November 30, 2018. The correlation of coagulation function-related markers at admission and their changes during hospitalization with the prognosis of the patients was analyzed.
		                        		
		                        			RESULTS:
		                        			We screened the data of a total of 1260 patients with AP against the inclusion and exclusion criteria, and eventually 175 patients were enrolled in this analysis, among whom 52 patients had severe AP (SAP) and 12 patients died. Logistic regression analysis identified vWF: Ag, PT, PC, AT Ⅲ and D-dimer markers at admission as independent risk factors for predicting SAP and death. Dynamic monitoring of the changes in coagulation function-related markers in the disease course had greater predictive value of the patients' prognosis, and the indicators including vWF: Agmax, PTmax, APTTmax, TTmax, FIBmin, D-dimermax, PLTmin, PCmin, PLGmin, AT Ⅲmin, and their variations were all independent risk factors for predicting SAP and death. ROC analysis suggested that dynamic monitoring of the changes in the indicators, especially those of △vWF: Ag, △PT, △APTT, △FIB, △TT, △D-dimer, △PLT, △PC, △AT Ⅲ, △PLG, could effectively predict SAP and death in these patients (with AUC range of 0.63-0.84).
		                        		
		                        			CONCLUSION
		                        			Patients with AP have vascular endothelial injuries and coagulation disorders. The markers including vWF: Ag, PT, PC, AT Ⅲ and D-dimer at admission are independent risk factors for predicting SAP and death, and dynamic monitoring of the changes in vWF: Ag、PT、APTT、TT、FIB、D-dimer、PLT、PC、AT Ⅲ and PLG can further increase the predictive value.
		                        		
		                        		
		                        		
		                        			Acute Disease
		                        			;
		                        		
		                        			Biomarkers
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Pancreatitis/diagnosis*
		                        			;
		                        		
		                        			Prognosis
		                        			;
		                        		
		                        			ROC Curve
		                        			;
		                        		
		                        			Retrospective Studies
		                        			;
		                        		
		                        			Severity of Illness Index
		                        			;
		                        		
		                        			von Willebrand Factor
		                        			
		                        		
		                        	
6.Epidemiological investigation of tinnitus in Sichuan and Chongqing.
Jia Qiu DAI ; Ying PANG ; Zi Qi CHEN ; Si Ji WANG ; Bin PENG ; Hong XU ; Feng Hui YU ; Lin ZHU ; Xi OUYANG ; Chang Chao XIANG ; Ping LYU ; Yun HE ; Dong Bao YANG ; Qiu Tang HUANG ; Sen YANG ; Wen Xing YU ; Xia JIANG ; Hou Yong KANG
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2021;56(11):1164-1173
		                        		
		                        			
		                        			Objectives: To investigate the prevalence and associated risk factors of tinnitus in Sichuan and Chongqing. Methods: We designed a tinnitus epidemiological questionnaire. The multi-stage stratified cluster random sampling methods was applied to obtain study subjects in six areas (Nanchong, Jiangjin, Fengdu, Yunyang, Suining and Ya'an), which were selected for epidemiological investigation. Home visit completion of epidemiological questionnaires was conducted. The trained investigators guided the respondents to fill in the tinnitus epidemiological questionnaires, and the epidemiological status of six areas on prevalence and risk factor was investigated. SPSS 22.0 software was used for statistical analysis. Results: Sampling population were 10 289, in which 9 273 were valid questionnaires. There were 4 281 males and 4 992 females, with an average age of 47.3 years, among which 34.83% (3 230/9 273) had tinnitus. 3.99% (370/9 273) were diagnosed with bothersome tinnitus. In a multivariable logistic regression mod, the following factors were associated with onsetting of tinnitus: sleep disorder [Odds Ratio(OR)=3.74] and noise exposure(OR=1.99). The risk of disease was lowest in the age of 30-40 years old, while the risk of disease was higher for people under 30 and over 40. In another multivariable logistic regression mode, the following factors were associated with having bothersome tinnitus: older people were more likely to suffer from tinnitus, sleep disorders (OR=4.68) and noise exposure (OR=1.56). Conclusions: The prevalence of tinnitus in Sichuan and Chongqing is about 34.83%, but most of the tinnitus is short-lived and has low loudness, which will not affect the patients. Only a small number of patients with tinnitus (3.99%) persist and affect their health and need treatment. The occurrence and exacerbation of tinnitus may be related to sleep, age, and noise exposure.
		                        		
		                        		
		                        		
		                        			Adult
		                        			;
		                        		
		                        			Aged
		                        			;
		                        		
		                        			Female
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Logistic Models
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		                        			Male
		                        			;
		                        		
		                        			Middle Aged
		                        			;
		                        		
		                        			Prevalence
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		                        			Risk Factors
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		                        			Surveys and Questionnaires
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		                        			Tinnitus/epidemiology*
		                        			
		                        		
		                        	
7.A multi-center retrospective study of perioperative chemotherapy for gastric cancer based on real-world data.
Xue Wei DING ; Zhi Chao ZHENG ; Qun ZHAO ; Gang ZHAI ; Han LIANG ; Xin WU ; Zheng Gang ZHU ; Hai Jiang WANG ; Qing Si HE ; Xian Li HE ; Yi An DU ; Lu Chuan CHEN ; Ya Wei HUA ; Chang Ming HUANG ; Ying Wei XUE ; Ye ZHOU ; Yan Bing ZHOU ; Dan WU ; Xue Dong FANG ; You Guo DAI ; Hong Wei ZHANG ; Jia Qing CAO ; Le Ping LI ; Jie CHAI ; Kai Xiong TAO ; Guo Li LI ; Zhi Gang JIE ; Jie GE ; Zhong Fa XU ; Wen Bin ZHANG ; Qi Yun LI ; Ping ZHAO ; Zhi Qiang MA ; Zhi Long YAN ; Guo Liang ZHENG ; Yang YAN ; Xiao Long TANG ; Xiang ZHOU
Chinese Journal of Gastrointestinal Surgery 2021;24(5):403-412
		                        		
		                        			
		                        			Objective: To explore the effect of perioperative chemotherapy on the prognosis of gastric cancer patients under real-world condition. Methods: A retrospective cohort study was carried out. Real world data of gastric cancer patients receiving perioperative chemotherapy and surgery + adjuvant chemotherapy in 33 domestic hospitals from January 1, 2014 to January 31, 2016 were collected. Inclusion criteria: (1) gastric adenocarcinoma was confirmed by histopathology, and clinical stage was cT2-4aN0-3M0 (AJCC 8th edition); (2) D2 radical gastric cancer surgery was performed; (3) at least one cycle of neoadjuvant chemotherapy (NAC) was completed; (4) at least 4 cycles of adjuvant chemotherapy (AC) [SOX (S-1+oxaliplatin) or CapeOX (capecitabine + oxaliplatin)] were completed. Exclusion criteria: (1) complicated with other malignant tumors; (2) radiotherapy received; (3) patients with incomplete data. The enrolled patients who received neoadjuvant chemotherapy and adjuvant chemotherapy were included in the perioperative chemotherapy group, and those who received only postoperative adjuvant chemotherapy were included in the surgery + adjuvant chemotherapy group. Propensity score matching (PSM) method was used to control selection bias. The primary outcome were overall survival (OS) and progression-free survival (PFS) after PSM. OS was defined as the time from the first neoadjuvant chemotherapy (operation + adjuvant chemotherapy group: from the date of operation) to the last effective follow-up or death. PFS was defined as the time from the first neoadjuvant chemotherapy (operation + adjuvant chemotherapy group: from the date of operation) to the first imaging diagnosis of tumor progression or death. The Kaplan-Meier method was used to estimate the survival rate, and the Cox proportional hazards model was used to evaluate the independent effect of perioperative chemo therapy on OS and PFS. Results: 2 045 cases were included, including 1 293 cases in the surgery+adjuvant chemotherapy group and 752 cases in the perioperative chemotherapy group. After PSM, 492 pairs were included in the analysis. There were no statistically significant differences in gender, age, body mass index, tumor stage before treatment, and tumor location between the two groups (all P>0.05). Compared with the surgery + adjuvant chemotherapy group, patients in the perioperative chemotherapy group had higher proportion of total gastrectomy (χ(2)=40.526, P<0.001), smaller maximum tumor diameter (t=3.969, P<0.001), less number of metastatic lymph nodes (t=1.343, P<0.001), lower ratio of vessel invasion (χ(2)=11.897, P=0.001) and nerve invasion (χ(2)=12.338, P<0.001). In the perioperative chemotherapy group and surgery + adjuvant chemotherapy group, 24 cases (4.9%) and 17 cases (3.4%) developed postoperative complications, respectively, and no significant difference was found between two groups (χ(2)=0.815, P=0.367). The median OS of the perioperative chemotherapy group was longer than that of the surgery + adjuvant chemotherapy group (65 months vs. 45 months, HR: 0.74, 95% CI: 0.62-0.89, P=0.001); the median PFS of the perioperative chemotherapy group was also longer than that of the surgery+adjuvant chemotherapy group (56 months vs. 36 months, HR=0.72, 95% CI:0.61-0.85, P<0.001). The forest plot results of subgroup analysis showed that both men and women could benefit from perioperative chemotherapy (all P<0.05); patients over 45 years of age (P<0.05) and with normal body mass (P<0.01) could benefit significantly; patients with cTNM stage II and III presented a trend of benefit or could benefit significantly (P<0.05); patients with signet ring cell carcinoma benefited little (P>0.05); tumors in the gastric body and gastric antrum benefited more significantly (P<0.05). Conclusion: Perioperative chemotherapy can improve the prognosis of gastric cancer patients.
		                        		
		                        		
		                        		
		                        			Chemotherapy, Adjuvant
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		                        			Female
		                        			;
		                        		
		                        			Gastrectomy
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Male
		                        			;
		                        		
		                        			Neoadjuvant Therapy
		                        			;
		                        		
		                        			Neoplasm Staging
		                        			;
		                        		
		                        			Prognosis
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		                        			Retrospective Studies
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		                        			Stomach Neoplasms/surgery*
		                        			
		                        		
		                        	
8.Risk Factors for Patients Using Intraoperative Vasopressor Infusions During Carotid Body Tumor Excision.
Si CHEN ; Jing Jing XU ; Guang Chao GU ; Yue Lun ZHANG ; Jiang SHAO ; Rong ZENG ; Xiao Jun SONG ; Yu Guang HUANG ; Yue Hong ZHENG
Acta Academiae Medicinae Sinicae 2021;43(2):199-204
		                        		
		                        			
		                        			Objective To investigate the risk factors for patients using intraoperative vasopressor infusions during carotid body tumor(CBT)excision.Patients' mean arterial pressure(MAP)and heart rate(HR)fluctuations as well as their requirements for vasoactive agents during surgery were assessed. Methods The patients receiving CBT excision in Peking Union Medical College Hospital from May 1,2013 to July 31,2017 were included for a retrospective cohort study.The potential factors of intraoperative requirement for vasopressor infusions were investigated using univariate analysis and Logistic multivariate analysis.Furthermore,the relationships of Shamblin types of CBT with intraoperative MAP/HR fluctuations and requirements for vasoactive agents were analyzed. Results A total of 108 patients with 116 CBTs were included.Univariate analysis revealed that maximum tumor diameter >4 cm,intraoperative internal carotid artery injury,internal carotid artery reconstruction,malignant pathology,advanced Shamblin types(type Ⅱ and Ⅲ),estimated blood loss ≥400 ml,and operation duration >4 hours were associated with intraoperative requirements for vasopressor infusions.Logistic analysis showed that Shamblin type Ⅲ(OR=2.286,95% CI=1.324-14.926,P=0.016)and operation duration >4 hours(OR=3.874,95% CI=1.020-14.623,P=0.046)were risk factors for intraoperative requirements for vasopressor infusions during CBT surgery.In addition,Shamblin type Ⅲ was associated with intraoperative abnormal HR elevation and requirements for vasopressors.Conclusions Shamblin type Ⅲ and operation duration>4 hours are risk factors for intraoperative requirements of patients for using vasopressor infusions during CBT surgery.Shamblin type Ⅲ is associated with intraoperative abnormal HR elevation and requirements for vasopressors.
		                        		
		                        		
		                        		
		                        			Carotid Body Tumor
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Retrospective Studies
		                        			;
		                        		
		                        			Risk Factors
		                        			;
		                        		
		                        			Treatment Outcome
		                        			;
		                        		
		                        			Vascular Surgical Procedures
		                        			
		                        		
		                        	
9.Clinical Recommendations for Perioperative Immunotherapy-induced Adverse Events in Patients with Non-small Cell Lung Cancer.
Jun NI ; Miao HUANG ; Li ZHANG ; Nan WU ; Chunxue BAI ; Liang'an CHEN ; Jun LIANG ; Qian LIU ; Jie WANG ; Yilong WU ; Fengchun ZHANG ; Shuyang ZHANG ; Chun CHEN ; Jun CHEN ; Wentao FANG ; Shugeng GAO ; Jian HU ; Tao JIANG ; Shanqing LI ; Hecheng LI ; Yongde LIAO ; Yang LIU ; Deruo LIU ; Hongxu LIU ; Jianyang LIU ; Lunxu LIU ; Mengzhao WANG ; Changli WANG ; Fan YANG ; Yue YANG ; Lanjun ZHANG ; Xiuyi ZHI ; Wenzhao ZHONG ; Yuzhou GUAN ; Xiaoxiao GUO ; Chunxia HE ; Shaolei LI ; Yue LI ; Naixin LIANG ; Fangliang LU ; Chao LV ; Wei LV ; Xiaoyan SI ; Fengwei TAN ; Hanping WANG ; Jiangshan WANG ; Shi YAN ; Huaxia YANG ; Huijuan ZHU ; Junling ZHUANG ; Minglei ZHUO
Chinese Journal of Lung Cancer 2021;24(3):141-160
		                        		
		                        			BACKGROUND:
		                        			Perioperative treatment has become an increasingly important aspect of the management of patients with non-small cell lung cancer (NSCLC). Small-scale clinical studies performed in recent years have shown improvements in the major pathological remission rate after neoadjuvant therapy, suggesting that it will soon become an important part of NSCLC treatment. Nevertheless, neoadjuvant immunotherapy may be accompanied by serious adverse reactions that lead to delay or cancelation of surgery, additional illness, and even death, and have therefore attracted much attention. The purpose of the clinical recommendations is to form a diagnosis and treatment plan suitable for the current domestic medical situation for the immune-related adverse event (irAE).
		                        		
		                        			METHODS:
		                        			This recommendation is composed of experts in thoracic surgery, oncologists, thoracic medicine and irAE related departments (gastroenterology, respirology, cardiology, infectious medicine, hematology, endocrinology, rheumatology, neurology, dermatology, emergency section) to jointly complete the formulation. Experts make full reference to the irAE guidelines, large-scale clinical research data published by thoracic surgery, and the clinical experience of domestic doctors and publicly published cases, and repeated discussions in multiple disciplines to form this recommendation for perioperative irAE.
		                        		
		                        			RESULTS:
		                        			This clinical recommendation covers the whole process of prevention, evaluation, examination, treatment and monitoring related to irAE, so as to guide the clinical work comprehensively and effectively.
		                        		
		                        			CONCLUSIONS
		                        			Perioperative irAE management is an important part of immune perioperative treatment of lung cancer. With the continuous development of immune perioperative treatment, more research is needed in the future to optimize the diagnosis and treatment of perioperative irAE.
		                        		
		                        		
		                        		
		                        	
10.Protocol on transcranial alternating current stimulation for the treatment of major depressive disorder: a randomized controlled trial
Wang HONG-XING ; Wang KUN ; Zhang WEN-RUI ; Zhao WEN-FENG ; Yang XIAO-TONG ; Wang LI ; Penn MAN ; Sun ZHI-CHAO ; Xue QING ; Jia YU ; Li NING ; Dong KAI ; Zhang QIAN ; Zhan SHU-QIN ; Min BAO-QUAN ; Fan CHUN-QIU ; Zhou AI-HONG ; Song HAI-QING ; Yin LU ; Si TIAN-MEI ; Huang JING ; Lu JIE ; Leng HAI-XIA ; Ding WEI-JUN ; Liu YUAN ; Yan TIAN-YI ; Wang YU-PING
Chinese Medical Journal 2020;133(1):61-67
		                        		
		                        			
		                        			Background:Transcranial alternating current stimulation (tACS) offers a new approach for adult patients with major depressive disorder (MDD).The study is to evaluate the efficacy and safety of tACS treating MDD.Methods:This is an 8-week,double-blind,randomized,placebo-controlled study.Ninety-two drug-naive patients with MDD aged 18 to 65 years will receive 20 daily 40-min,77.5-Hz,15-mA sessions of active or sham tACS targeting the forehead and both mastoid areas on weekdays for 4 consecutive weeks (week 4),following a 4-week observation period (week 8).The primary outcome is the remission rate defined as the 17-item Hamilton depression rating scale (HDRS-17) score ≤7 at week 8.Secondary outcomes are the rates of response at weeks 4 and 8 and rate of remission at week 4 based on HDRS-17,the proportion of participants having improvement in the clinical global impression-improvement,the change in HDRS-17 score (range,0-52,with higher scores indicating more depression) over the study,and variations of brain imaging and neurocognition from baseline to week 4.Safety will be assessed by vital signs at weeks 4 and 8,and adverse events will be collected during the entire study.Discussion:The tACS applied in this trial may have treatment effects on MDD with minimal side effects.
		                        		
		                        		
		                        		
		                        	
            
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