1.New progress and challenges in the diagnosis and treatment of cosmetic allergy-related adverse reactions.
Chong ZHANG ; Shao Min ZHONG ; Yan WU ; Jia Hui ZHAO ; Zuo Tao ZHAO ; Yan TIAN ; Hang LI
Chinese Journal of Preventive Medicine 2023;57(4):591-596
		                        		
		                        			
		                        			In China, the current standard for cosmetic adverse reactions related skin disease (GB/T 17149.1-1997) was jointly issued by the Ministry of Health and the State Bureau of Technical Supervision in 1997, cosmetic-allergic adverse reactions include allergic contact dermatitis and photo-allergic contact dermatitis according to this standard. The increasing use and changes in cosmetic ingredients or formula lead to a significant increase for the incidence of adverse reactions as the cosmetics industry is developing rapidly in the last 20 years. In the meantime, the clinical manifestations have become more diverse. In recent years, there have been many reports on the special manifestations for cosmetic allergy and allergen test, which provide a reference for the subsequent improvement of the diagnosis and prevention.
		                        		
		                        		
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Patch Tests/adverse effects*
		                        			;
		                        		
		                        			Dermatitis, Allergic Contact/therapy*
		                        			;
		                        		
		                        			Cosmetics/adverse effects*
		                        			;
		                        		
		                        			China
		                        			;
		                        		
		                        			Incidence
		                        			;
		                        		
		                        			Allergens/adverse effects*
		                        			
		                        		
		                        	
2.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
		                        			
		                        		
		                        	
3. Dental non-metric traits of Han and Zhuang people
Chen YANG ; Lu-Fei WANG ; Hui QIAO ; Hai-Ge ZHU ; Shao-Qing WEN ; Jing-Ze TAN ; Hang ZHANG
Acta Anatomica Sinica 2023;54(3):357-367
		                        		
		                        			
		                        			 [Abstract] Objective To investigate the relationship between the Han, Zhuang and the World populations by comparing the frequency of dental non-metric traits. Methods From 2015 to 2019, ten dental non-metric traits were sampled from He’nan, Jiangsu and Guangxi Zhuang Autonmous Region, with sample size of 1785(674 He’ nan, 547 Jiangsu, 388 Guangxi Han, 176 Guangxi Zhuang). Principal component analysis, multidimensional scaling and neighbor network were carried out. Results East Asian populations could be clearly divided into two major groups, Northeast Asian and Southeast Asian. Han and Zhuang populations were close to the Northeast Asian populations, but were far from the Southeast Asian populations. There were also some north-south differences within Han populations. Conclusion Both Sundadonty and Sinodonty are existed in East Asian populations. Han and Zhuang populations dental non-metric traits are closer to the Sinodonty. 
		                        		
		                        		
		                        		
		                        	
4.Near-infrared targeted probe designed for intraoperative imaging of prostatic neurovascular bundles.
Zhan Yi ZHANG ; Fan ZHANG ; Ye YAN ; Cai Guang CAO ; Chang Jian LI ; Shao Hui DENG ; Yue Hao SUN ; Tian Liang HUANG ; Yun He GUAN ; Nan LI ; Min LU ; Zhen Hua HU ; Shu Dong ZHANG
Journal of Peking University(Health Sciences) 2023;55(5):843-850
		                        		
		                        			OBJECTIVE:
		                        			To investigate the imaging effect of a near-infrared fluorescent targeted probe ICG-NP41 on the neurovascular bundles (NVB) around the prostate in rats.
		                        		
		                        			METHODS:
		                        			A near-infrared fluorescent targeted probe ICG-NP41 was synthesized. An animal model for NVB imaging was established using Sprague-Dawley rats (250-400 g). Experiments were conducted using a custom-built near-infrared windowⅡ(NIR-Ⅱ) small animal in vivo imaging system, and images collected were processed using ImageJ and Origin. The fluorescence signal data were statistically analyzed using GraphPad Prism. The signal-to-background ratio (SBR) for NVB was quantitatively calculated to explore the effective dosage and imaging time points. Finally, paraffin pathology sections and HE staining were performed on the imaging structures.
		                        		
		                        			RESULTS:
		                        			Except for rats in the control group (n=2), right-sided NVB of the rats injected with ICG-NP41 (n=2 per group) were all observed in NIR-Ⅱ fluorescence mode 2 h and 4 h after administration. At 2 h and 4 h, average SBR of cavernous nerve in 2 mg/kg group in fluorescence mode was 1.651±0.142 and 1.619±0.110, respectively, both higher than that in white light mode (1.111±0.036), with no significant difference (P>0.05); average SBR of 4 mg/kg group in fluorescence mode were 1.168±0.066 and 1.219±0.118, respectively, both higher than that in white light mode (1.081±0.040), with no significant difference (P>0.05). At 2 h and 4 h, the average SBR of 2 mg/kg and 4 mg/kg groups in fluorescence mode were higher than that of the control group (SBR=1), the average SBR of the 2 mg/kg group was higher than that of the 4 mg/kg group, and all the above with no significant difference (P>0.05). The average diameter of the nerve measured by full width at half maxima method was about (178±15) μm. HE staining of paraffin sections showed the right major pelvic ganglion.
		                        		
		                        			CONCLUSION
		                        			The near-infrared fluorescent targeted probe ICG-NP41 can be used for real-time imaging of the NVB around the prostate in rats, providing a potential feasible solution for localizing NVB in real time during nerve-sparing radical prostatectomy.
		                        		
		                        		
		                        		
		                        			Male
		                        			;
		                        		
		                        			Rats
		                        			;
		                        		
		                        			Animals
		                        			;
		                        		
		                        			Prostate/diagnostic imaging*
		                        			;
		                        		
		                        			Paraffin
		                        			;
		                        		
		                        			Indocyanine Green
		                        			;
		                        		
		                        			Rats, Sprague-Dawley
		                        			;
		                        		
		                        			Fluorescent Dyes
		                        			
		                        		
		                        	
5.Signaling Mechanism for Modulation by GLP-1 and Exendin-4 of GABA Receptors on Rat Retinal Ganglion Cells.
Tao ZHANG ; Hang-Ze RUAN ; Yong-Chen WANG ; Yu-Qi SHAO ; Wei ZHOU ; Shi-Jun WENG ; Yong-Mei ZHONG
Neuroscience Bulletin 2022;38(6):622-636
		                        		
		                        			
		                        			Glucagon-like peptide-1 (GLP-1) is expressed in retinal neurons, but its role in the retina is largely unknown. Here, we demonstrated that GLP-1 or the GLP-1 receptor (GLP-1R; a G protein-coupled receptor) agonist exendin-4 suppressed γ-aminobutyric acid receptor (GABAR)-mediated currents through GLP-1Rs in isolated rat retinal ganglion cells (GCs). Pre-incubation with the stimulatory G protein (Gs) inhibitor NF 449 abolished the exendin-4 effect. The exendin-4-induced suppression was mimicked by perfusion with 8-Br-cAMP (a cAMP analog), but was eliminated by the protein kinase A (PKA) inhibitor Rp-cAMP/KT-5720. The exendin-4 effect was accompanied by an increase in [Ca2+]i of GCs through the IP3-sensitive pathway and was blocked in Ca2+-free solution. Furthermore, when the activity of calmodulin (CaM) and CaM-dependent protein kinase II (CaMKII) was inhibited, the exendin-4 effect was eliminated. Consistent with this, exendin-4 suppressed GABAR-mediated light-evoked inhibitory postsynaptic currents in GCs in rat retinal slices. These results suggest that exendin-4-induced suppression may be mediated by a distinct Gs/cAMP-PKA/IP3/Ca2+/CaM/CaMKII signaling pathway, following the activation of GLP-1Rs.
		                        		
		                        		
		                        		
		                        	
7.Influence of prior percutaneous coronary intervention on outcome of coronary artery bypass grafting: A multi-center clinical study
Hongwei JIANG ; Hang ZHANG ; Wen CHEN ; Fangjing ZHENG ; Yongfeng SHAO ; Yongxiang QIAN ; Guoxiang WANG ; Mingqiu LI ; Qingsheng YOU ; Zhiyong LIU ; Yong WANG ; Zhenya SHEN ; Wei LI ; Demin LI ; Su HUANG ; Chongjun ZHONG ; Rui WANG ; Xin CHEN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2022;29(11):1436-1441
		                        		
		                        			
		                        			Objective     To investigate the influence of prior percutaneous coronary intervention (PCI) on the outcome of coronary artery bypass grafting (CABG). Methods     Clinical data of 5 216 patients from Jiangsu Province CABG registry who underwent primary isolated CABG from 2016 to 2019 were retrospectively analyzed. Patients were divided into a PCI group (n=673) and a non-PCI group (n=4 543) according to whether they had received PCI treatment. The PCI group included 491 males and 182 females, aged 62.6±8.2 years, and the non-PCI group included 3 335 males and 1 208 females, aged 63.7±8.7 years. Multivariable logistic regression and propensity score matching (PSM) were used to compare 30-day mortality, incidence of major complications and 1-year follow-up outcomes between the two groups. Results     Both in original cohort and matched cohort, there was no statistical difference in the 30-day mortality [14 (2.1%) vs. 77 (1.7%), P=0.579; 14 (2.1%) vs. 11 (1.6%), P=0.686], or the incidence of major complications (myocardial infarction, stroke, mechanical ventilation≥24 h, dialysis for new-onset renal failure, deep sternal wound infection and atrial fibrillation) (all P>0.05). The rate of reoperation for bleeding in the PCI group was higher than that in the non-PCI group [19 (2.8%) vs. 67 (1.5%), P=0.016; 19 (2.8%) vs. 7 (1.0%), P=0.029]. Both in original cohort and matched cohort, there was no statistical difference in 1-year survival rate between the two groups [613 (93.1%) vs. 4 225 (94.6%), P=0.119; 613 (93.1%) vs. 630 (95.2%), P=0.124], while the re-admission rate in the PCI group was significantly higher than that in the non-PCI group [32 (4.9%) vs. 113 (2.5%), P=0.001; 32 (4.9%) vs. 17 (2.6%), P=0.040]. Conclusion     This study shows that a history of PCI treatment does not significantly increase the perioperative mortality and major complications of CABG, but increases the rate of cardiogenic re-admission 1 year postoperatively.
		                        		
		                        		
		                        		
		                        	
8.Inhibitory effect of ZhuJing pill variant formula medicated serum on H 2O 2-induced epithelial-mesenchymal transition of human RPE cells and its mechanism
Yan SHAO ; Yuanzhong ZHANG ; Ning YANG ; Li HANG ; Chunming CHEN ; Min LI ; Xinrong XU
Chinese Journal of Experimental Ophthalmology 2022;40(11):1013-1022
		                        		
		                        			
		                        			Objective:To study the effect of ZhuJing pill variant formula medicated serum on hydrogen peroxide (H 2O 2)-induced epithelial-mesenchymal transition (EMT) of human retinal pigment epithelial (ARPE-19) cells and its mechanism. Methods:Thirty female SPF grade SD rats aged 2 months old were selected.The rats were randomized into blank control group and Zhujing pill variant formula group according to random number table method, with 15 in each group, which were intragastrically administered with normal saline and ZhuJing pill variant formula solution for 7 days accordingly to prepare blank control serum and medicated serum.ZhuJing pill variant formula medicated serum was prepared with SD rats.ARPE-19 cells were divided into normal control group, model control group, blank serum group as well as 2.5%, 5.0% and 10.0% medicated serum groups, SB216763 group and SB216763+ medicated serum group.Normal and blank control groups were cultured in normal culture medium, while the other six groups were cultured in blank rat serum medium, medicated serum medium of corresponding concentration, 10 μmol/L SB216763 medium and 10 μmol/L SB216763+ 10.0% medicated serum medium, respectively.Normal control group was routinely cultured, while the other groups were routinely cultured for 24 hours, and then added with H 2O 2 with the final concentration of 200 μmol/L for 24 hours.Cell viability was assessed by cell counting kit-8 (CCK-8) assay, and cell migration ability was detected by Transwell assay.Intracellular reactive oxygen species (ROS) level was detected by dichloro-dihydro-fluorescein diacetate (DCFH-DA) assay, and MDA level was identified by sulfhydryl barbituric acid assay.The expression levels of Nrf2 pathway related proteins including nuclear factor erythroid 2-related factor 2 (Nrf2), heme oxygenase-1 (HO-1), quinone oxidoreductase 1 (NQO-1) and EMT-related proteins including transforming growth factor-β2 (TGF-β2), protein kinase B (AKT), glycogen synthase kinase-3β (GSK-3β), snail family zinc finger 1 (SNAIL1), α-smooth muscle actin (α-SMA), epithelial cadherin (E-cadherin) in cells were measured by western blot assay.The use and care of animals complied with Regulations for the Administration of Affairs Concerning Experimental Animals. Results:There was no significant difference in cell survival rate among blank serum group, 2.5%, 5.0% and 10.0% medicated serum groups ( F=0.163, P>0.05). The cell survival rates were (100.50±5.91)%, (60.87±4.30)%, (73.27±4.46)%, (80.73±5.67)% and (89.90±4.97)% in normal control group, model control group, 2.5%, 5.0% and 10.0% medicated serum groups, and the number of migrating cells was (84.67±8.33), (222.33±13.58), (215.67±10.02), (174.67±10.60), (143.67±8.02) and (107.67±6.66) pcs/visual field in normal control group, model control group, blank serum group, 2.5%, 5.0% and 10.0% medicated serum groups, respectively, with significant differences among the groups ( F=26.628, 99.289; both at P<0.01). The contents of ROS and MDA in model control group were significantly increased in comparison with normal control group (both at P<0.01). The contents of ROS and MDA of 2.5%, 5.0% and 10.0% medicated serum groups were significantly decreased in comparison with model control group (all at P<0.01). The relative expression levels of SNAIL1, α-SMA, TGF-β2, p-AKT and p-GSK-3β proteins were significantly higher and the relative expression level of E-cadherin protein was significantly lower in model control group compared with normal control group, 2.5%, 5.0% and 10.0% medicated serum groups (all at P<0.05). Compared with normal control group, the relative expression level of cytoplasmic Nrf2 in model control group was decreased, while the relative expression levels of nuclear Nrf2, HO-1 and NQO-1 were increased, and the differences were statistically significant (all at P<0.05). Compared with model control group, the relative expression levels of cytoplasmic Nrf2 in 2.5%, 5.0% and 10.0% medicated serum groups were reduced, and the relative expression levels of nuclear Nrf2, HO-1 and NQO-1 were enhanced, and the differences were statistically significant (all at P<0.01). Compared with model control group, the relative expression level of cytoplasmic Nrf2 in SB216763 group was decreased, and the relative expression level of nuclear Nrf2 was increased, and the differences were statistically significant (both at P<0.05). Compared with SB216763 group, the relative expression levels of cytoplasmic Nrf2, SNAIL1 and α-SMA in SB216763+ medicated serum group were decreased, and the relative expression levels of nuclear Nrf2 and E-cadherin protein were increased, and the differences were statistically significant (both at P<0.05). Conclusions:ZhuJing pill variant formula medicated serum can inhibit H 2O 2-induced EMT in ARPE-19 cells.The mechanism may be related to the inhibition of AKT/GSK-3β pathway and the activation of Nrf2 signaling pathway.
		                        		
		                        		
		                        		
		                        	
9.Efficacy comparison of posterior atlas uniaxial and polyaxial screw instrumentation and fusion with bone graft for Gehweiler type IIIb atlas fracture
Zhenghong YU ; Jia SHAO ; Kun GAO ; Kezheng MAO ; Hang FENG ; Xiuru ZHANG ; Yanzheng GAO
Chinese Journal of Trauma 2022;38(9):797-805
		                        		
		                        			
		                        			Objective:To compare the efficacy of posterior atlas uniaxial and polyaxial screw instrumentation and fusion with bone graft for Gehweiler type IIIb atlas fracture.Methods:A retrospective cohort study was performed to analyze the clinical data of 36 patients with Gehweiler type IIIb atlas fracture admitted to Henan Provincial People′s Hospital from January 2015 to October 2020. There were 29 males and 7 females, with age range of 23-82 years [(48.8±15.5)years]. All patients were treated with posterior atlas screw-rod internal fixation and fusion with bone graft, of which 14 received atlas uniaxial screw internal fixation (uniaxial screw group) and 22 received atlas polyaxial screw internal fixation (polyaxial screw group). The operation time and intraoperative blood loss were compared between the two groups. The atlas fracture union rate and atlantoaxial posterior arch bone fusion rate were compared between the two groups at 3 months and 6 months after operation. The anterior atlantodental interval (ADI), basion-dens interval (BDI) and lateral mass displacement (LMD) were compared between the two groups to evaluate the reduction of fracture fragments before operation, at 1, 3, 6 months after operation and at the last follow-up. At the same time, the visual analogue scale (VAS) and neck dysfunction index (NDI) were compared between the two groups to evaluate neck pain and functional recovery. The postoperative complications were observed.Results:All patients were followed up for 12-44 months [(27.2±9.9)months]. There was no significant difference in operation time or intraoperative blood loss between the two groups (all P>0.05). The atlas fracture union rate and atlantoaxial posterior arch bone fusion rate were 85.7% (12/14) and 78.6% (11/14) in uniaxial screw group at 3 months after operation, insignificantly different from those in polyaxial screw group [72.7% (16/22) and 77.3% (17/22)] (all P>0.05). All patients in the two groups achieved bone union and fusion at 6 months after operation. There was no significant difference in ADI between the two groups before and after operation (all P>0.05). The BDI in the two groups did not differ significantly before operation ( P>0.05), but a significantly higher value was found in uniaxial screw group at 1, 3, and 6 months after operation and at the last follow-up [(5.9±1.3)mm, (5.8±1.3)mm, (5.9±1.2)mm and (5.8±1.2)mm] than in polyaxial screw group [(3.1±0.6)mm, (3.1±0.6)mm, (3.1±0.6)mm and (3.1±0.6)mm] (all P<0.01). The two groups did not differ significantly before operation ( P>0.05), but LMD at 1, 3, and 6 months after operation and at the last follow-up was (1.6±0.8)mm, (1.5±0.8)mm, (1.5±0.7)mm and (1.5±0.9)mm in uniaxial screw group, significantly lower than that in polyaxial screw group [(4.8±1.6)mm, (4.6±1.6)mm, (4.9±1.6)mm and (4.9±1.6)mm] (all P<0.01). There was no significant difference in VAS between the two groups before operation ( P>0.05). The VAS at 1, 3, and 6 months after operation and at the last follow-up was 3.0(3.0, 4.0)points, 2.0(1.0, 2.0)points, 1.0(0.8, 2.0)points and 1.0(0.0, 1.3)points in uniaxial screw group and was 3.5(3.0, 4.0)points, 2.0(2.0, 3.0)points, 2.0(1.0, 2.0)points and 2.0(1.0, 3.0)points in polyaxial screw group. In comparison, the VAS scored much lower in uniaxial screw group than in polyaxial screw group at 6 months after operation and at the last follow-up (all P<0.01). There was no significant difference in NDI between the two groups before operation ( P>0.05). The NDI at 1, 3, and 6 months after operation and at the last follow-up was 34.9±6.3, 23.4±6.2, 13.9±2.7 and 9.4±2.8 in uniaxial screw group and was 33.2±6.1, 24.4±6.3, 18.1±4.1 and 12.7±3.2 in polyaxial screw group, showing a significantly lower NDI in uniaxial screw group than in polyaxial screw group at 6 months after operation and at the last follow-up (all P<0.01). The complication rate was 21.4% (3/14) in uniaxial screw group when compared to 22.7% (5/22) in polyaxial screw group ( P>0.05). Conclusion:For Gehweiler type IIIb atlas fracture, both techniques can attain atlas fracture union and atlantoaxial posterior arch bone fusion, but the posterior atlas uniaxial screw instrumentation and fusion is superior in reduction of atlas fracture displacement and lateral mass separation, neck pain relief and functional improvement.
		                        		
		                        		
		                        		
		                        	
10.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
		                        			
		                        		
		                        	
            
Result Analysis
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