1.The antitumor activity and mechanisms of piperlongumine derivative C12 on human non-small cell lung cancer H1299 cells
Hai-tao LONG ; Xue LEI ; Jia-yi CHEN ; Jiao MENG ; Li-hui SHAO ; Zhu-rui LI ; Dan-ping CHEN ; Zhen-chao WANG ; Yue ZHOU ; Cheng-peng LI
Acta Pharmaceutica Sinica 2024;59(10):2773-2781
		                        		
		                        			
		                        			 The compound (
		                        		
		                        	
2.Safety of high-carbohydrate fluid diet 2 h versus overnight fasting before non-emergency endoscopic retrograde cholangiopancreatography: A single-blind, multicenter, randomized controlled trial
Wenbo MENG ; W. Joseph LEUNG ; Zhenyu WANG ; Qiyong LI ; Leida ZHANG ; Kai ZHANG ; Xuefeng WANG ; Meng WANG ; Qi WANG ; Yingmei SHAO ; Jijun ZHANG ; Ping YUE ; Lei ZHANG ; Kexiang ZHU ; Xiaoliang ZHU ; Hui ZHANG ; Senlin HOU ; Kailin CAI ; Hao SUN ; Ping XUE ; Wei LIU ; Haiping WANG ; Li ZHANG ; Songming DING ; Zhiqing YANG ; Ming ZHANG ; Hao WENG ; Qingyuan WU ; Bendong CHEN ; Tiemin JIANG ; Yingkai WANG ; Lichao ZHANG ; Ke WU ; Xue YANG ; Zilong WEN ; Chun LIU ; Long MIAO ; Zhengfeng WANG ; Jiajia LI ; Xiaowen YAN ; Fangzhao WANG ; Lingen ZHANG ; Mingzhen BAI ; Ningning MI ; Xianzhuo ZHANG ; Wence ZHOU ; Jinqiu YUAN ; Azumi SUZUKI ; Kiyohito TANAKA ; Jiankang LIU ; Ula NUR ; Elisabete WEIDERPASS ; Xun LI
Chinese Medical Journal 2024;137(12):1437-1446
		                        		
		                        			
		                        			Background::Although overnight fasting is recommended prior to endoscopic retrograde cholangiopancreatography (ERCP), the benefits and safety of high-carbohydrate fluid diet (CFD) intake 2 h before ERCP remain unclear. This study aimed to analyze whether high-CFD intake 2 h before ERCP can be safe and accelerate patients’ recovery.Methods::This prospective, multicenter, randomized controlled trial involved 15 tertiary ERCP centers. A total of 1330 patients were randomized into CFD group ( n = 665) and fasting group ( n = 665). The CFD group received 400 mL of maltodextrin orally 2 h before ERCP, while the control group abstained from food/water overnight (>6 h) before ERCP. All ERCP procedures were performed using deep sedation with intravenous propofol. The investigators were blinded but not the patients. The primary outcomes included postoperative fatigue and abdominal pain score, and the secondary outcomes included complications and changes in metabolic indicators. The outcomes were analyzed according to a modified intention-to-treat principle. Results::The post-ERCP fatigue scores were significantly lower at 4 h (4.1 ± 2.6 vs. 4.8 ± 2.8, t = 4.23, P <0.001) and 20 h (2.4 ± 2.1 vs. 3.4 ± 2.4, t= 7.94, P <0.001) in the CFD group, with least-squares mean differences of 0.48 (95% confidence interval [CI]: 0.26–0.71, P <0.001) and 0.76 (95% CI: 0.57–0.95, P <0.001), respectively. The 4-h pain scores (2.1 ± 1.7 vs. 2.2 ± 1.7, t = 2.60, P = 0.009, with a least-squares mean difference of 0.21 [95% CI: 0.05–0.37]) and positive urine ketone levels (7.7% [39/509] vs. 15.4% [82/533], χ2 = 15.13, P <0.001) were lower in the CFD group. The CFD group had significantly less cholangitis (2.1% [13/634] vs. 4.0% [26/658], χ2 = 3.99, P = 0.046) but not pancreatitis (5.5% [35/634] vs. 6.5% [43/658], χ2 = 0.59, P = 0.444). Subgroup analysis revealed that CFD reduced the incidence of complications in patients with native papilla (odds ratio [OR]: 0.61, 95% CI: 0.39–0.95, P = 0.028) in the multivariable models. Conclusion::Ingesting 400 mL of CFD 2 h before ERCP is safe, with a reduction in post-ERCP fatigue, abdominal pain, and cholangitis during recovery.Trail Registration::ClinicalTrials.gov, No. NCT03075280.
		                        		
		                        		
		                        		
		                        	
3.Incidence and prognosis of olfactory and gustatory dysfunctions related to infection of SARS-CoV-2 Omicron strain: a national multi-center survey of 35 566 population.
Meng Fan LIU ; Rui Xia MA ; Xian Bao CAO ; Hua ZHANG ; Shui Hong ZHOU ; Wei Hong JIANG ; Yan JIANG ; Jing Wu SUN ; Qin Tai YANG ; Xue Zhong LI ; Ya Nan SUN ; Li SHI ; Min WANG ; Xi Cheng SONG ; Fu Quan CHEN ; Xiao Shu ZHANG ; Hong Quan WEI ; Shao Qing YU ; Dong Dong ZHU ; Luo BA ; Zhi Wei CAO ; Xu Ping XIAO ; Xin WEI ; Zhi Hong LIN ; Feng Hong CHEN ; Chun Guang SHAN ; Guang Ke WANG ; Jing YE ; Shen Hong QU ; Chang Qing ZHAO ; Zhen Lin WANG ; Hua Bin LI ; Feng LIU ; Xiao Bo CUI ; Sheng Nan YE ; Zheng LIU ; Yu XU ; Xiao CAI ; Wei HANG ; Ru Xin ZHANG ; Yu Lin ZHAO ; Guo Dong YU ; Guang Gang SHI ; Mei Ping LU ; Yang SHEN ; Yu Tong ZHAO ; Jia Hong PEI ; Shao Bing XIE ; Long Gang YU ; Ye Hai LIU ; Shao wei GU ; Yu Cheng YANG ; Lei CHENG ; Jian Feng LIU
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2023;58(6):579-588
		                        		
		                        			
		                        			Objective: This cross-sectional investigation aimed to determine the incidence, clinical characteristics, prognosis, and related risk factors of olfactory and gustatory dysfunctions related to infection with the SARS-CoV-2 Omicron strain in mainland China. Methods: Data of patients with SARS-CoV-2 from December 28, 2022, to February 21, 2023, were collected through online and offline questionnaires from 45 tertiary hospitals and one center for disease control and prevention in mainland China. The questionnaire included demographic information, previous health history, smoking and alcohol drinking, SARS-CoV-2 vaccination, olfactory and gustatory function before and after infection, other symptoms after infection, as well as the duration and improvement of olfactory and gustatory dysfunction. The self-reported olfactory and gustatory functions of patients were evaluated using the Olfactory VAS scale and Gustatory VAS scale. Results: A total of 35 566 valid questionnaires were obtained, revealing a high incidence of olfactory and taste dysfunctions related to infection with the SARS-CoV-2 Omicron strain (67.75%). Females(χ2=367.013, P<0.001) and young people(χ2=120.210, P<0.001) were more likely to develop these dysfunctions. Gender(OR=1.564, 95%CI: 1.487-1.645), SARS-CoV-2 vaccination status (OR=1.334, 95%CI: 1.164-1.530), oral health status (OR=0.881, 95%CI: 0.839-0.926), smoking history (OR=1.152, 95%CI=1.080-1.229), and drinking history (OR=0.854, 95%CI: 0.785-0.928) were correlated with the occurrence of olfactory and taste dysfunctions related to SARS-CoV-2(above P<0.001). 44.62% (4 391/9 840) of the patients who had not recovered their sense of smell and taste also suffered from nasal congestion, runny nose, and 32.62% (3 210/9 840) suffered from dry mouth and sore throat. The improvement of olfactory and taste functions was correlated with the persistence of accompanying symptoms(χ2=10.873, P=0.001). The average score of olfactory and taste VAS scale was 8.41 and 8.51 respectively before SARS-CoV-2 infection, but decreased to3.69 and 4.29 respectively after SARS-CoV-2 infection, and recovered to 5.83and 6.55 respectively at the time of the survey. The median duration of olfactory and gustatory dysfunctions was 15 days and 12 days, respectively, with 0.5% (121/24 096) of patients experiencing these dysfunctions for more than 28 days. The overall self-reported improvement rate of smell and taste dysfunctions was 59.16% (14 256/24 096). Gender(OR=0.893, 95%CI: 0.839-0.951), SARS-CoV-2 vaccination status (OR=1.334, 95%CI: 1.164-1.530), history of head and facial trauma(OR=1.180, 95%CI: 1.036-1.344, P=0.013), nose (OR=1.104, 95%CI: 1.042-1.171, P=0.001) and oral (OR=1.162, 95%CI: 1.096-1.233) health status, smoking history(OR=0.765, 95%CI: 0.709-0.825), and the persistence of accompanying symptoms (OR=0.359, 95%CI: 0.332-0.388) were correlated with the recovery of olfactory and taste dysfunctions related to SARS-CoV-2 (above P<0.001 except for the indicated values). Conclusion: The incidence of olfactory and taste dysfunctions related to infection with the SARS-CoV-2 Omicron strain is high in mainland China, with females and young people more likely to develop these dysfunctions. Active and effective intervention measures may be required for cases that persist for a long time. The recovery of olfactory and taste functions is influenced by several factors, including gender, SARS-CoV-2 vaccination status, history of head and facial trauma, nasal and oral health status, smoking history, and persistence of accompanying symptoms.
		                        		
		                        		
		                        		
		                        			Female
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Adolescent
		                        			;
		                        		
		                        			SARS-CoV-2
		                        			;
		                        		
		                        			Smell
		                        			;
		                        		
		                        			COVID-19/complications*
		                        			;
		                        		
		                        			Cross-Sectional Studies
		                        			;
		                        		
		                        			COVID-19 Vaccines
		                        			;
		                        		
		                        			Incidence
		                        			;
		                        		
		                        			Olfaction Disorders/etiology*
		                        			;
		                        		
		                        			Taste Disorders/etiology*
		                        			;
		                        		
		                        			Prognosis
		                        			
		                        		
		                        	
4.Clinical characteristics of choledocholithiasis combined with periampullary diverticulum and influencing factor analysis for difficult cannulation of endoscopic retrograde cholangiopan-creatography: a report of 1 920 cases
Ping YUE ; Zhenyu WANG ; Leida ZHANG ; Hao SUN ; Ping XUE ; Wei LIU ; Qi WANG ; Jijun ZHANG ; Xuefeng WANG ; Meng WANG ; Yingmei SHAO ; Kailin CAI ; Senlin HOU ; Kai ZHANG ; Qiyong LI ; Lei ZHANG ; Kexiang ZHU ; Haiping WANG ; Ming ZHANG ; Xiangyu SUN ; Zhiqing YANG ; Jie TAO ; Zilong WEN ; Qunwei WANG ; Bendong CHEN ; Yingkai WANG ; Mingning ZHAO ; Ruoyan ZHANG ; Tiemin JIANG ; Ke LIU ; Lichao ZHANG ; Kangjie CHEN ; Xiaoliang ZHU ; Hui ZHANG ; Long MIAO ; Zhengfeng WANG ; Jiajia LI ; Xiaowen YAN ; Ling'en ZHANG ; Fangzhao WANG ; Wence ZHOU ; Wenbo MENG ; Xun LI
Chinese Journal of Digestive Surgery 2023;22(1):113-121
		                        		
		                        			
		                        			Objective:To investigate the clinical characteristics of choledocholithiasis com-bined with periampullary diverticulum and influencing factor for difficult cannulation of endoscopic retrograde cholangiopancreatography (ERCP).Methods:The retrospective case-control study was conducted. The clinical data of 1 920 patients who underwent ERCP for choledocholithiasis in 15 medical centers, including the First Hospital of Lanzhou University, et al, from July 2015 to December 2017 were collected. There were 915 males and 1 005 females, aged (63±16)years. Of 1 920 patients, there were 228 cases with periampullary diverticulum and 1 692 cases without periampullary diverticulum. Observation indicators: (1) clinical characteristics of patients with choledocholithiasis; (2) intraoperative and postoperative situations of patients undergoing ERCP for choledocholithiasis; (3) influencing factor analysis for difficult cannulation in patients undergoing ERCP for choledocholithiasis. Measurement data with normal distribution were represented as Mean±SD, and comparison between groups was conducted using the independent sample t test. Measurement data with skewed distribution were represented as M(range) or M( Q1, Q3), and com-parison between groups was conducted using the Wilcoxon rank sum test. Count data were described as absolute numbers or percentages, and comparison between groups was conducted using the chi-square test or Fisher exact probability. The Logistic regression model was used for univariate and multivariate analyses. Results:(1) Clinical characteristics of patients with choledocholithiasis. Age, body mass index, cases with complications as chronic obstructive pulmonary disease, diameter of common bile duct, cases with diameter of common bile duct as <8 mm, 8?12 mm, >12 mm, diameter of stone, cases with number of stones as single and multiple were (69±12)years, (23.3±3.0)kg/m 2, 16, (14±4)mm, 11, 95, 122, (12±4)mm, 89, 139 in patients with choledocholithiasis combined with periampullary diverticulum, versus (62±16)years, (23.8±2.8)kg/m 2, 67, (12±4)mm, 159, 892, 641, (10±4)mm, 817, 875 in patients with choledocholithiasis not combined with periampullary diver-ticulum, showing significant differences in the above indicators between the two groups ( t=?7.55, 2.45, χ2=4.54, t=?4.92, Z=4.66, t=?7.31, χ2=6.90, P<0.05). (2) Intraoperative and postoperative situations of patients undergoing ERCP for choledocholithiasis. The balloon expansion diameter, cases with intraoperative bleeding, cases with hemorrhage management of submucosal injection, hemostatic clip, spray hemostasis, electrocoagulation hemostasis and other treatment, cases with endoscopic plastic stent placement, cases with endoscopic nasal bile duct drainage, cases with mechanical lithotripsy, cases with stone complete clearing, cases with difficult cannulation, cases with delayed intubation, cases undergoing >5 times of cannulation attempts, cannulation time, X-ray exposure time, operation time were 10.0(range, 8.5?12.0)mm, 56, 6, 5, 43, 1, 1, 52, 177, 67, 201, 74, 38, 74, (7.4±3.1)minutes, (6±3)minutes, (46±19)minutes in patients with choledocholithiasis combined with periampullary diverticulum, versus 9.0(range, 8.0?11.0)mm, 243, 35, 14, 109, 73, 12, 230, 1 457, 167, 1 565, 395, 171, 395, (6.6±2.9)minutes, (6±5)minutes, (41±17)minutes in patients with choledocholithiasis not combined with periampullary diverticulum, showing significant differences in the above indicators between the two groups ( Z=6.31, χ2=15.90, 26.02, 13.61, 11.40, 71.51, 5.12, 9.04, 8.92, 9.04, t=?3.89, 2.67, ?3.61, P<0.05). (3) Influencing factor analysis for difficult cannulation in patients undergoing ERCP for choledocholithiasis. Results of multivariate analysis showed total bilirubin >30 umol/L, number of stones >1, combined with periampullary diverticulum were indepen-dent risk factors for difficult cannulation in patients with periampullary diverticulum who underwent ERCP for choledocholithiasis ( odds ratio=1.31, 1.48, 1.44, 95% confidence interval as 1.06?1.61, 1.20?1.84, 1.06?1.95, P<0.05). Results of further analysis showed that, of 1 920 patients undergoing ERCP for choledocholithiasis, the incidence of postoperative pancreatitis was 17.271%(81/469) and 8.132%(118/1 451) in the 469 cases with difficult cannulation and 1 451 cases without difficult cannula-tion, respectively, showing a significant difference between them ( χ2=31.86, P<0.05). In the 1 692 patients with choledocholithiasis not combined with periampullary diverticulum, the incidence of postopera-tive pancreatitis was 17.722%(70/395) and 8.250%(107/1 297) in 395 cases with difficult cannula-tion and 1 297 cases without difficult cannulation, respectively, showing a significant difference between them ( χ2=29.00, P<0.05). In the 228 patients with choledocholithiasis combined with peri-ampullary diverticulum, the incidence of postoperative pancreatitis was 14.865%(11/74) and 7.143%(11/154) in 74 cases with difficult cannulation and 154 cases without difficult cannulation, respectively, showing no significant difference between them ( χ2=3.42, P>0.05). Conclusions:Compared with patients with choledocholithiasis not combined with periampullary divertioulum, periampullary divertioulum often occurs in choledocholithiasis patients of elderly and low body mass index. The proportion of chronic obstructive pulmonary disease is high in choledocholithiasis patients with periampullary diverticulum, and the diameter of stone is large, the number of stone is more in these patients. Combined with periampullary diverticulum will increase the difficult of cannulation and the ratio of patient with mechanical lithotripsy, and reduce the ratio of patient with stone complete clearing without increasing postoperative complications of choledocholithiasis patients undergoing ERCP. Total bilirubin >30 μmol/L, number of stones >1, combined with periampullary diverticulum are independent risk factors for difficult cannulation in patients of periampullary diverticulum who underwent ERCP for choledocholithiasis.
		                        		
		                        		
		                        		
		                        	
5.Study on immunogenic cell death related proteins in nasopharyngeal carcinoma patients before and after radiotherapy
Jinhua LONG ; Lu XU ; Weili WU ; Xiuling LUO ; Xiaoxiao CHEN ; Cui LONG ; Linmei ZENG ; Xianhuai JIN ; Wei WANG ; Chunyan SHAO ; Wei XIONG ; Feng JIN ; Zhu ZENG
Chinese Journal of Radiation Oncology 2023;32(10):886-891
		                        		
		                        			
		                        			Objective:To explore the effect of clinical conventional fractionated dose radiation on the expression levels of immunogenic cell death (ICD) related proteins in patients with nasopharyngeal carcinoma (NPC).Methods:A total of 38 newly-treated NPC patients admitted to the Affiliated Cancer Hospital of Guizhou Medical University from November 2020 to December 2021 were enrolled, all of whom received induction chemotherapy and concurrent chemoradiotherapy, and another 20 healthy volunteers were selected as controls for a prospective study. The contents of ICD related proteins, namely calreticulin (CRT), high mobility group box 1 protein (HMGB-1) and heat shock protein 70 (HSP70) and the proportion of dendritic cell (DC) in the peripheral blood of patients were detected before treatment, after induction chemotherapy and after concurrent chemoradiotherapy, respectively. The correlation between the above indicators, general clinical data and short-term efficacy was analyzed by statistical methods such as t-test and analysis of variance (ANOVA). Results:The levels of HSP70 and HMGB-1 in peripheral blood of NPC patients before treatment were higher than those of healthy controls (both P<0.05). After concurrent chemoradiotherapy, the content of CRT was significantly higher than that before treatment ( P<0.05), whereas the difference before and after induction chemotherapy and the difference before and after concurrent chemoradiotherapy were not significantly correlated with the short-term efficacy of NPC patients. HSP70 level was significantly decreased after concurrent chemoradiotherapy ( P<0.001). There were no significant differences in the content of HMGB-1 after induction chemotherapy and concurrent chemoradiotherapy (both P>0.05). Conclusion:NPC patients receiving TPF regimen (docetaxel+cisplatin+fluorouracil) for induction chemotherapy and sequential cisplatin concurrent chemotherapy may induce ICD in NPC cells, and CRT has potential value in reflecting the clinical efficacy of NPC.
		                        		
		                        		
		                        		
		                        	
6.Finite element analysis of the graft stresses after anterior cruciate ligament reconstruction.
Shuang REN ; Hui Juan SHI ; Jia Hao ZHANG ; Zhen Long LIU ; Jia Yi SHAO ; Jing Xian ZHU ; Xiao Qing HU ; Hong Shi HUANG ; Ying Fang AO
Journal of Peking University(Health Sciences) 2021;53(5):865-870
		                        		
		                        			OBJECTIVE:
		                        			To explore the stress distribution characteristics of the graft after anterior cruciate ligament (ACL) reconstruction, so as to provide theoretical reference for the surgical plan of ACL reconstruction.
		                        		
		                        			METHODS:
		                        			Based on 3D MRI and CT images, finite element models of the uninjured knee joint and knee joint after ACL reconstruction were established in this study. The uninjured knee model included femur, tibia, fibula, medial collateral ligament, lateral collateral ligament, ACL and posterior cruciate ligament. The ACL reconstruction knee model included femur, tibia, fibula, medial collateral ligament, lateral collateral ligament, ACL graft and posterior cruciate ligament. Linear elastic material properties were used for both the uninjured and ACL reconstruction models. The elastic modulus of bone tissue was set as 17 GPa and Poisson' s ratio was 0.36. The material properties of ligament tissue and graft were set as elastic modulus 390 MPa and Poisson's ratio 0.4. The femur was fixed as the boundary condition, and the tibia anterior tension of 134 N was applied as the loading condition. The stress states of the ACL of the intact joint and the ACL graft after reconstruction were solved and analyzed, including tension, pressure, shear force and von Mises stress.
		                        		
		                        			RESULTS:
		                        			The maximum compressive stress (6.34 MPa), von Mises stress (5.9 MPa) and shear stress (1.83 MPa) of the reconstructed ACL graft were all at the anterior femoral end. It was consistent with the position of maximum compressive stress (8.77 MPa), von Mises stress (8.88 MPa) and shear stress (3.44 MPa) in the ACL of the intact knee joint. The maximum tensile stress of the graft also appeared at the femoral end, but at the posterior side, which was consistent with the position of the maximum tensile stress of ACL of the uninjured knee joint. More-over, the maximum tensile stress of the graft was only 0.88 MPa, which was less than 2.56 MPa of ACL of the uninjured knee joint.
		                        		
		                        			CONCLUSION
		                        			The maximum compressive stress, von Mises stress and shear stress of the ACL graft are located in the anterior femoral end, and the maximum tensile stress is located in the posterior femoral end, which is consistent with the position of the maximum tensile stress of the ACL of the uninjured knee joint. The anterior part of ACL and the graft bore higher stresses than the posterior part, which is consistent with the biomechanical characteristics of ACL.
		                        		
		                        		
		                        		
		                        			Anterior Cruciate Ligament Injuries/surgery*
		                        			;
		                        		
		                        			Anterior Cruciate Ligament Reconstruction
		                        			;
		                        		
		                        			Biomechanical Phenomena
		                        			;
		                        		
		                        			Femur/surgery*
		                        			;
		                        		
		                        			Finite Element Analysis
		                        			;
		                        		
		                        			Humans
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		                        			Knee Joint/surgery*
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		                        			Tibia/surgery*
		                        			
		                        		
		                        	
7.Immunogenicity and safety of a recombinant fusion protein vaccine (V-01) against coronavirus disease 2019 in healthy adults: a randomized, double-blind, placebo-controlled, phase II trial.
Ya-Jun SHU ; Jian-Feng HE ; Rong-Juan PEI ; Peng HE ; Zhu-Hang HUANG ; Shao-Min CHEN ; Zhi-Qiang OU ; Jing-Long DENG ; Pei-Yu ZENG ; Jian ZHOU ; Yuan-Qin MIN ; Fei DENG ; Hua PENG ; Zheng ZHANG ; Bo WANG ; Zhong-Hui XU ; Wu-Xiang GUAN ; Zhong-Yu HU ; Ji-Kai ZHANG
Chinese Medical Journal 2021;134(16):1967-1976
		                        		
		                        			BACKGROUND:
		                        			Innovative coronavirus disease 2019 (COVID-19) vaccines, with elevated global manufacturing capacity, enhanced safety and efficacy, simplified dosing regimens, and distribution that is less cold chain-dependent, are still global imperatives for tackling the ongoing pandemic. A previous phase I trial indicated that the recombinant COVID-19 vaccine (V-01), which contains a fusion protein (IFN-PADRE-RBD-Fc dimer) as its antigen, is safe and well tolerated, capable of inducing rapid and robust immune responses, and warranted further testing in additional clinical trials. Herein, we aimed to assess the immunogenicity and safety of V-01, providing rationales of appropriate dose regimen for further efficacy study.
		                        		
		                        			METHODS:
		                        			A randomized, double-blind, placebo-controlled phase II clinical trial was initiated at the Gaozhou Municipal Centre for Disease Control and Prevention (Guangdong, China) in March 2021. Both younger (n = 440; 18-59 years of age) and older (n = 440; ≥60 years of age) adult participants in this trial were sequentially recruited into two distinct groups: two-dose regimen group in which participants were randomized either to follow a 10 or 25 μg of V-01 or placebo given intramuscularly 21 days apart (allocation ratio, 3:3:1, n = 120, 120, 40 for each regimen, respectively), or one-dose regimen groups in which participants were randomized either to receive a single injection of 50 μg of V-01 or placebo (allocation ratio, 3:1, n = 120, 40, respectively). The primary immunogenicity endpoints were the geometric mean titers of neutralizing antibodies against live severe acute respiratory syndrome coronavirus 2, and specific binding antibodies to the receptor binding domain (RBD). The primary safety endpoint evaluation was the frequencies and percentages of overall adverse events (AEs) within 30 days after full immunization.
		                        		
		                        			RESULTS:
		                        			V-01 provoked substantial immune responses in the two-dose group, achieving encouragingly high titers of neutralizing antibody and anti-RBD immunoglobulin, which peaked at day 35 (161.9 [95% confidence interval [CI]: 133.3-196.7] and 149.3 [95%CI: 123.9-179.9] in 10 and 25 μg V-01 group of younger adults, respectively; 111.6 [95%CI: 89.6-139.1] and 111.1 [95%CI: 89.2-138.4] in 10 and 25 μg V-01 group of older adults, respectively), and remained high at day 49 after a day-21 second dose; these levels significantly exceed those in convalescent serum from symptomatic COVID-19 patients (53.6, 95%CI: 31.3-91.7). Our preliminary data show that V-01 is safe and well tolerated, with reactogenicity predominantly being absent or mild in severity and only one vaccine-related grade 3 or worse AE being observed within 30 days. The older adult participants demonstrated a more favorable safety profile compared with those in the younger adult group: with AEs percentages of 19.2%, 25.8%, 17.5% in older adults vs. 34.2%, 23.3%, 26.7% in younger adults at the 10, 25 μg V-01 two-dose group, and 50 μg V-01 one-dose group, respectively.
		                        		
		                        			CONCLUSIONS:
		                        			The vaccine candidate V-01 appears to be safe and immunogenic. The preliminary findings support the advancement of the two-dose, 10 μg V-01 regimen to a phase III trial for a large-scale population-based evaluation of safety and efficacy.
		                        		
		                        			TRIAL REGISTRATION
		                        			http://www.chictr.org.cn/index.aspx (No. ChiCTR2100045107, http://www.chictr.org.cn/showproj.aspx?proj=124702).
		                        		
		                        		
		                        		
		                        			Aged
		                        			;
		                        		
		                        			Antibodies, Viral
		                        			;
		                        		
		                        			COVID-19/therapy*
		                        			;
		                        		
		                        			COVID-19 Vaccines
		                        			;
		                        		
		                        			Double-Blind Method
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Immunization, Passive
		                        			;
		                        		
		                        			Recombinant Fusion Proteins
		                        			;
		                        		
		                        			SARS-CoV-2
		                        			
		                        		
		                        	
8.China experts' consensus on preventive and interceptive orthodontic treatments of malocclusions of children.
Xiao-Bing LI ; Quan-Fu YE ; Hong HE ; Hai-Ping LU ; Min ZHU ; Ruo-Ping JIANG ; Shu-Juan ZOU ; Xiang-Long HAN ; Li ZHOU ; Ke CHEN ; Xiao YUAN ; Jun-Mei ZHANG ; Li-Jun TAN ; Chang YIN ; Zhou HE ; Ang LI ; Bin CHENG ; Wen-Hua RUAN ; Fang HUANG ; Juan LIU ; Lan MA ; Rui ZOU ; Fang YANG ; Wei-Bing ZHANG ; Yu-Lou TIAN ; Bei-Zhan JIANG ; Lin-Qin SHAO ; Yang HUANG ; Li-Qin TANG ; Li GAO ; Chen-Chen ZHOU
West China Journal of Stomatology 2021;39(4):369-376
		                        		
		                        			
		                        			Malocclusion is one of the three most common oral diseases reported by World Health Organization(WHO). In China, its incidence rate is rising. Malocclusion seriously affects the dental and maxillofacial function, facial appearance and growth development of nearly 260 million children in China, and what is more, it affects their physical and mental health development. Malocclusion occurrence is related to genetic and environmental factors. Early treatment of malocclusion can create a good dental and maxillofacial development environment, correct abnormal growth and control the adverse effects of abnormal genetic factors. It can effectively reduce the prevalence of children's malocclusion and enhance their physical and mental health. This is an urgent need from the economic perspective of our society, so it has great practical and social significance. Experts from the project group "standard diagnose and treatment protocols for early orthodontic intervention of malocclusions of children" which initiated by China National Health Institute of Hospital Administration wrote the "China Experts' Consensus on Preventive and Interceptive Orthodontic Treatments of Malocclusions of Children", which aims to guide and popularize the clinical practice, improve the clinical theory and practice level, and accelerate the disciplinary development of early treatment of children's malocclusion in China. The consensus elaborates the harmfulness of malocclusion and the necessity of early treatment, and brings up the principles and fundamental contents. Based on the law of dental and maxillofacial development, this paper puts forward the guiding suggestions of preventive and interceptive treatments in different stages of dental development ranging from fetus to early permanent dentition. It is a systematic project to promote and standardize the early treatment of malocclusion. Through scientific and comprehensive stratified clinical practice and professional training, the clinical system of early treatment of malocclusion in China will eventually be perfected, so as to comprehensively care for children's dental and maxillofacial health, and improve their oral and physical health in China.
		                        		
		                        		
		                        		
		                        			Child
		                        			;
		                        		
		                        			China/epidemiology*
		                        			;
		                        		
		                        			Consensus
		                        			;
		                        		
		                        			Dental Care
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Malocclusion/prevention & control*
		                        			;
		                        		
		                        			Orthodontics, Interceptive
		                        			
		                        		
		                        	
9.Usage of Chinese Herbs in Cancer Patients in Southern China: A Survey.
Shao-Quan XIONG ; Yu CHEN ; Li-Juan WANG ; Pan-Pan LYU ; Wan LIAO ; Cui WANG ; Jian-Long KE ; Xi ZHU ; Jin-Yang WANG ; Xian-Ying SHEN ; Guang-Ping LI ; Li-Zhu LIN
Chinese journal of integrative medicine 2021;27(7):502-508
		                        		
		                        			OBJECTIVE:
		                        			To study the use of Chinese medicine (CM) in cancer patients in southern China.
		                        		
		                        			METHODS:
		                        			A total of 1,950 cancer patients finished questionnaires in four provinces in southern China. The survey included socio-demographic and clinical characteristics of participants, dosage forms, efficacy, and side effects.
		                        		
		                        			RESULTS:
		                        			The study results showed that cancer patients with higher education (>12 years) were more likely to accept the treatment of Chinese herbs. There were 54.61% (1,065 cases) of patients chose Chinese herbs for the initial treatment and 14.46% (282 cases) chose Chinese herbs as monotherapy. Most patients (54.51%, 1,063 cases) continuously used CM for more than 6 months, and a few of them (212 cases) used CM for up to 3 years. All kinds of dosage forms of CM had been used, including CM decoction, CM patent prescription and CM injection. Concerning the efficacy in the view of patients, 40.31% (786 cases) believed that it would be effective to take Chinese herbs before they starting the anti-cancer treatment, and the percentage increased to 81.08% after 1-month CM treatment. The effect of Chinese herbs was mainly demonstrated by symptom relief and improvement of quality of life, and 8.31% (162 cases) of patients experienced control of tumor growth and decreased tumor markers. Furthermore, only 14.31% (279 cases) participants reported that they experienced side effects during CM treatment.
		                        		
		                        			CONCLUSION
		                        			This large scale investigation reflects the current situation of domestic CM usage objectively and comprehensively, which might provide new ways for cancer treatment.
		                        		
		                        		
		                        		
		                        	
10.Treatment of Sepsis with Chinese Medicine: A Review Based on NF-κB Signaling Pathway
Chao HU ; Ping ZHU ; Miao JIANG ; Qian ZHANG ; Wen-xiu XU ; Li-ping OUYANG ; Xiao SHAO ; Kang SHEN ; Sai-long CHEN
Chinese Journal of Experimental Traditional Medical Formulae 2021;27(19):216-224
		                        		
		                        			
		                        			Sepsis, a common critical disease in the intensive care unit(ICU), features high morbidity and mortality. At present, it is mainly tackled with western medicine, which may trigger a series of problems like antibiotic resistance, adverse hormonal reactions, and high cost after a long-term use. Therefore, exploring new efficient, safe, and cheap drugs and treatment modes has become the focus of our research at this stage. By virtue of unique advantages including "the concept of holism and individualized treatment based on syndrome differentiation", Chinese medicine has accumulated quite rich experience in the prevention and treatment of sepsis. In recent years, research on the regulation of Chinese medicine on nuclear transcription factor-
		                        		
		                        	
            
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