1.Sentinel surveillance data of influenza in Hunan Province from 2014 to 2023
Xiao-Lei WANG ; Chao-Yang HUANG ; Qian-Lai SUN ; Zhi-Hong DENG ; Yi-Wei HUANG ; Shan-Lu ZHAO ; Kai-Wei LUO ; Xiang REN ; Sheng-Bao CHEN ; Zhi-Hui DAI
Chinese Journal of Infection Control 2024;23(11):1413-1420
Objective To understand the prevalence characteristics of influenza and changes of influenza virus strains,and provide reference for the prevention and control of influenza in the province.Methods Surveillance da-ta about influenza in Hunan Province from 2014 to 2023 were exported from China Influenza Surveillance Informa-tion System.Differences in the percentage of influenza-like illness(ILI)cases(percentage of influenza-like cases[ILI%]in outpatient and emergency department visits)among different years and different populations,as well as the positive rate of influenza virus in ILI specimens were compared.Results From 2014 to 2023,over 2.65 million cases of ILI were reported,with an ILI%of 4.70%.ILI%among different years presented statistically significant differences(P<0.001).People aged 0-14 years old were the main population with ILI,accounting for 82.90%.The positive rate of influenza virus in ILI specimens was 14.14%,the positive rate of influenza virus among diffe-rent years and age groups were both significantly different(both P<0.001).The main prevalent influenza strains from 2014 to 2023 included types A(H1N1),A(H3N2),B(Victoria),and B(Yamagata),alternating among di-fferent years.However,type B(Yamagata)strains were not detected from 2020 to 2023.There were basically two influenza prevalence seasons every year,namely winter-spring and summer.Conclusion People<15 years old are the main population of influenza,and the prevalence peaks are in winter-spring and summer.From 2021 to 2023,the prevalence alternates mainly among 3 types:A(H1N1),A(H3N2),and B(Victoria).
2.External rhinoplasty based on the classification of alar retraction associating with exposure of the nostrils.
Xian Cheng WANG ; Yi Wen DENG ; Yang SUN ; Xian Xi MENG ; Xiang XIONG ; Bai Rong FANG ; Xiao Fang LI ; Kai YANG ; Quan Ding YAN ; Yi TIAN
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2023;58(2):126-132
Objective: To introduce a classification of alar retraction, and to discuss the therapeutic strategy of alar retraction with cartilage graft and the satisfaction evaluation of patients after operation. Methods: A retrospective analysis was performed on 88 patients with alar retraction admitted to the Department of Plastic and Aesthetic (Burn) Surgery, the Second Xiangya Hospital of Central South University from January 2015 to December 2020, including 20 males and 68 females, aged 20 to 48 years, with an average age of 28.98 years. All patients underwent external rhinoplasty according to a series of treatment plans determined by the classification of alar retraction based on nostril exposure. Visual Analogue Scale (VAS) and Rhinoplasty Outcomes Evaluation (ROE) were used to conduct satisfaction survey before and 12 months after operation. Wilcoxon signed-rank test was used to analyze patient satisfaction. Results: A total of 88 patients were included in this study. According to the classification of alar retraction based on nostril exposure, 45 cases were mild, 23 cases were moderate, and 20 cases were severe. There were 16 cases of unilateral and 72 cases of bilateral alar retraction. The patients were followed up for 12 to 18 months, with an average of 13.37 months. The VAS score and ROE score after each type of surgery were higher than those before surgery, with statistically significant (all P<0.05). Among them, the difference in VAS score (6.75±1.29) and in ROE satisfaction (67.70±7.38) of patients with severe alar retraction were the most significant improvement. Conclusion: The classification of alar retraction based on nostril exposure in the frontal view can comprehensively evaluate the severity of alar retraction, and makes the treatment algorithms systematic and comprehensive. The satisfaction of patients is relatively high.
Male
;
Female
;
Humans
;
Adult
;
Rhinoplasty
;
Retrospective Studies
;
Patient Satisfaction
;
Treatment Outcome
;
Esthetics
;
Nose/surgery*
3.Retrospective study of different types of rhinoplasty frameworks
Yiwen DENG ; Xiancheng WANG ; Yang SUN ; Kai YANG ; Zhihua QIAO ; Lewei JIN ; Quanding YAN ; Chunjie LI ; Xiang XIONG ; Xianxi MENG ; Wenbo LI
Chinese Journal of Plastic Surgery 2023;39(3):293-302
Objective:To evaluate the structural features, stability and postoperative effect of integrated framework, 1+ 1 framework, 2+ 1 framework, 4+ 1 framework, and Y-shaped nasal framework.Methods:A retrospective analysis was performed based on the clinical data of patients underwent in Department of Plastic and Aesthetic (Burn) Surgery, the Second Xiangya Hospital, Central South University from February 2019 to November 2020. According to rhinoplasty framework, the patients were divided into integrated framework group, 1+ 1 framework group, 2+ 1 framework group, 4+ 1 framework group, and Y-shaped framework group. Based on the principle of plane photography, the stability of the nasal framework was evaluated by measuring the nasal tip projection and the nasolabial angle 1 month after surgery, and 12 months after surgery. The satisfaction of patients and the incidence of postoperative complications were collected. The difference in nasolabial angle and nasal tip projection data of postoperation 1 month and postoperative 12 months among each group were analyzed by one-way analysis vaniance or Kruskal-Waliis H test.Bonferroni test or Nemenyi test was used for pairwise comparison between groups. P< 0.05 was considered statistically significant. Results:A total of 201 patients (18 males and 183 females, aged 18-46 years, average aged 26.6±5.9 years)were included in this study and followed up for 12-21 months. There were 45 patients in the integrated framework group, 45 patients in the 1+ 1 framework group, 34 patients in the 2+ 1 framework group, 35 patients in the 4+ 1 framework group, and 42 patients in the Y-shaped framework group. Four patients with Y-shaped framework had significant nasal tip supination 12 months after surgery. Among the patients with 1+ 1 framework, 1 patient showed slight columella distortion 6 months after surgery, and 3 patients showed significant nasal tip subrotation 12 months after surgery. One patient in 2+ 1 framework group developed nasal infection 92 days after surgery. No complications were found in other groups during follow-up. In terms of nasal tip projection during postoperative follow-up, the median difference of nasal tip projection between 12 months and 1 month after surgery in 2+ 1 framework group, integrated framework group, 1+ 1 framework group, and 4+ 1 framework group, and Y-shaped framework group was -0.08 cm, -0.09 cm, -0.20 cm, -0.10 cm and -0.17 cm, respectively. The difference of nasal tip projection among the five groups was statistically significant ( P<0.01). The difference between 2+ 1 framework group and 1+ 1 framework group or Y-shaped framework group was statistically significant( P<0.05). The difference between 4+ 1 framework group and 1+ 1 framework group or Y-shaped framework group was statistically significant ( P<0.05). The difference between integrated nasal framework group and 1+ 1 framework group or Y-shaped framework group was statistically significant ( P<0.05). The difference between Y-shaped framework group and 1+ 1 framework group was statistically significant ( P<0.05). In terms of nasolabial angle during postoperative follow-up, the median difference of nasolabial angle between 12 months and 1 month after surgery in 2+ 1 framework group, integrated framework group, 1+ 1 framework group, and 4+ 1 framework group, and Y-shaped framework group was -4.20°, -3.80°, -6.50°, -4.10° and -6.35°, respectively. The difference of nasolabial angle among the five groups was statistically significant ( P<0.01). The difference between 2+ 1 framework group and 1+ 1 framework group or Y-shaped framework group was statistically significant( P<0.05). The difference between 4+ 1 framework group and 1+ 1 framework group or Y-shaped framework group was statistically significant ( P<0.05). The difference between integrated nasal framework group and 1+ 1 framework group or Y-shaped framework group was statistically significant ( P<0.05). Patient satisfaction evaluation, 2+ 1 framework group had the highest satisfaction(34/34, 100.00%), followed by 4+ 1 framework group (34/35, 97.14%), integrated framework group(42/45, 93.33%), Y-shaped framework group(36/42, 85.71%), 1+ 1 framework group(37/45, 82.22%). Conclusion:The changes of nasolabial angle and nasal tip projection in 2+ 1 framework, integrated framework, and 4+ 1 framework were smaller than those in Y-shaped framework and 1+ 1 framework.2+ 1 framework was convenient and had good postoperative stability and high patient satisfaction.
4.Effects of moxibustion at Yongquan (KI 1) on cognition function and lower limb motor function in patients with post-stroke cognitive impairment of kidney essence deficiency.
Yan-Sheng YE ; Qing-Tang YANG ; Ding-Yu ZHU ; Kai-Xiang DENG ; Hui-Juan LIN ; Xin ZHANG ; Ting JI ; Meng-Zhen ZHUO ; Yu-Mao ZHANG
Chinese Acupuncture & Moxibustion 2023;43(9):1018-1022
OBJECTIVE:
To observe the effects of moxibustion at Yongquan(KI 1) on the cognitive function and lower limb motor function in patients with post-stroke cognitive impairment of kidney essence deficiency.
METHODS:
Eighty-four patients with post-stroke cognitive impairment of kidney essence deficiency were randomly divided into an observation group(42 cases,1 case dropped off)and a control group(42 cases,1 case dropped off).The control group was treated with medication,electroacupuncture,rehabilitation training and repetitive transcranial magnetic stimulation(rTMS);on the basis of the treatment as the control group,moxibustion at bilateral Yongquan(KI 1)was adopted in the observation group.Both groups were treated once a day,5 days a week with 2-day interval,4 weeks were required. The Montreal cognitive assessment (MoCA) score, mini-mental state examination (MMSE) score, Fugl-Meyer assessment-lower extremity (FMA-LE) score, Berg balance scale (BBS) score, functional independence measure (FIM) score, modified fall efficacy scale (MFES) score and scale for the differentiation of syndromes of vascular dementia (SDSVD) score before and after treatment were observed in the two groups.
RESULTS:
After treatment,the MoCA, MMSE, FMA-LE, BBS, FIM and MFES scores were higher than those before treatment in both groups (P<0.05), and the scores in the observation group were higher than those in the control group (P<0.05). After treatment,the SDSVD scores were lower than those before treatment in both groups (P< 0.05), and the SDSVD score in the observation group was lower than that in the control group (P< 0.05).
CONCLUSION
Moxibustion at Yongquan(KI 1) can improve the cognitive function and motor and balance function of lower limbs in patients with post-stroke cognitive impairment of kidney essence deficiency,reduce the risk of fall and improve the quality of life.
Humans
;
Cognition
;
Cognitive Dysfunction/therapy*
;
Dementia, Vascular
;
Kidney
;
Lower Extremity
;
Moxibustion
;
Quality of Life
;
Stroke/complications*
5.Predictive value of left ventricular ejection fraction reserve assessed by SPECT G-MPI for major adverse cardiovascular event in patients with coronary artery disease.
Yi Han ZHOU ; Yao LU ; Jing Jing MENG ; Tian Tian MOU ; Yu Jie BAI ; Shuang ZHANG ; Ya Qi ZHENG ; Qiu Ju DENG ; Jian JIAO ; Zhi CHANG ; Xiao Fen XIE ; Ming Kai YUN ; Hong Zhi MI ; Xiang LI ; Xiao Li ZHANG
Chinese Journal of Cardiology 2023;51(6):626-632
Objective: To evaluate the prognostic value of left ventricular ejection fraction (LVEF) reserve assessed by gated SPECT myocardial perfusion imaging (SPECT G-MPI) for major adverse cardiovascular event (MACE) in patients with coronary artery disease. Methods: This is a retrospective cohort study. From January 2017 to December 2019, patients with coronary artery disease and confirmed myocardial ischemia by stress and rest SPECT G-MPI, and underwent coronary angiography within 3 months were enrolled. The sum stress score (SSS) and sum resting score (SRS) were analyzed by the standard 17-segment model, and the sum difference score (SDS, SDS=SSS-SRS) was calculated. The LVEF at stress and rest were analyzed by 4DM software. The LVEF reserve (ΔLVEF) was calculated (ΔLVEF=stress LVEF-rest LVEF). The primary endpoint was MACE, which was obtained by reviewing the medical record system or by telephone follow-up once every twelve months. Patients were divided into MACE-free and MACE groups. Spearman correlation analysis was used to analyze the correlation between ΔLVEF and all MPI parameters. Cox regression analysis was used to analyze the independent factors of MACE, and the optimal SDS cutoff value for predicting MACE was determined by receiver operating characteristic curve (ROC). Kaplan-Meier survival curves were plotted to compare the difference in the incidence of MACE between different SDS groups and different ΔLVEF groups. Results: A total of 164 patients with coronary artery disease [120 male; age (58.6±10.7) years] were included. The average follow-up time was (26.5±10.4) months, and a total of 30 MACE were recorded during follow-up. Multivariate Cox regression analysis showed that SDS (HR=1.069, 95%CI: 1.005-1.137, P=0.035) and ΔLVEF (HR=0.935, 95%CI: 0.878-0.995, P=0.034) were independent predictors of MACE. According to ROC curve analysis, the optimal cut-off to predict MACE was a SDS of 5.5 with an area under the curve of 0.63 (P=0.022). Survival analysis showed that the incidence of MACE was significantly higher in the SDS≥5.5 group than in the SDS<5.5 group (27.6% vs. 13.2%, P=0.019), but the incidence of MACE was significantly lower in the ΔLVEF≥0 group than in theΔLVEF<0 group (11.0% vs. 25.6%, P=0.022). Conclusions: LVEF reserve (ΔLVEF) assessed by SPECT G-MPI serves as an independent protective factor for MACE, while SDS is an independent risk predictor in patients with coronary artery disease. SPECT G-MPI is valuable for risk stratification by assessing myocardial ischemia and LVEF.
Humans
;
Male
;
Middle Aged
;
Aged
;
Coronary Artery Disease/diagnostic imaging*
;
Stroke Volume
;
Myocardial Perfusion Imaging
;
Retrospective Studies
;
Ventricular Function, Left
;
Myocardial Ischemia
6.Retrospective study of different types of rhinoplasty frameworks
Yiwen DENG ; Xiancheng WANG ; Yang SUN ; Kai YANG ; Zhihua QIAO ; Lewei JIN ; Quanding YAN ; Chunjie LI ; Xiang XIONG ; Xianxi MENG ; Wenbo LI
Chinese Journal of Plastic Surgery 2023;39(3):293-302
Objective:To evaluate the structural features, stability and postoperative effect of integrated framework, 1+ 1 framework, 2+ 1 framework, 4+ 1 framework, and Y-shaped nasal framework.Methods:A retrospective analysis was performed based on the clinical data of patients underwent in Department of Plastic and Aesthetic (Burn) Surgery, the Second Xiangya Hospital, Central South University from February 2019 to November 2020. According to rhinoplasty framework, the patients were divided into integrated framework group, 1+ 1 framework group, 2+ 1 framework group, 4+ 1 framework group, and Y-shaped framework group. Based on the principle of plane photography, the stability of the nasal framework was evaluated by measuring the nasal tip projection and the nasolabial angle 1 month after surgery, and 12 months after surgery. The satisfaction of patients and the incidence of postoperative complications were collected. The difference in nasolabial angle and nasal tip projection data of postoperation 1 month and postoperative 12 months among each group were analyzed by one-way analysis vaniance or Kruskal-Waliis H test.Bonferroni test or Nemenyi test was used for pairwise comparison between groups. P< 0.05 was considered statistically significant. Results:A total of 201 patients (18 males and 183 females, aged 18-46 years, average aged 26.6±5.9 years)were included in this study and followed up for 12-21 months. There were 45 patients in the integrated framework group, 45 patients in the 1+ 1 framework group, 34 patients in the 2+ 1 framework group, 35 patients in the 4+ 1 framework group, and 42 patients in the Y-shaped framework group. Four patients with Y-shaped framework had significant nasal tip supination 12 months after surgery. Among the patients with 1+ 1 framework, 1 patient showed slight columella distortion 6 months after surgery, and 3 patients showed significant nasal tip subrotation 12 months after surgery. One patient in 2+ 1 framework group developed nasal infection 92 days after surgery. No complications were found in other groups during follow-up. In terms of nasal tip projection during postoperative follow-up, the median difference of nasal tip projection between 12 months and 1 month after surgery in 2+ 1 framework group, integrated framework group, 1+ 1 framework group, and 4+ 1 framework group, and Y-shaped framework group was -0.08 cm, -0.09 cm, -0.20 cm, -0.10 cm and -0.17 cm, respectively. The difference of nasal tip projection among the five groups was statistically significant ( P<0.01). The difference between 2+ 1 framework group and 1+ 1 framework group or Y-shaped framework group was statistically significant( P<0.05). The difference between 4+ 1 framework group and 1+ 1 framework group or Y-shaped framework group was statistically significant ( P<0.05). The difference between integrated nasal framework group and 1+ 1 framework group or Y-shaped framework group was statistically significant ( P<0.05). The difference between Y-shaped framework group and 1+ 1 framework group was statistically significant ( P<0.05). In terms of nasolabial angle during postoperative follow-up, the median difference of nasolabial angle between 12 months and 1 month after surgery in 2+ 1 framework group, integrated framework group, 1+ 1 framework group, and 4+ 1 framework group, and Y-shaped framework group was -4.20°, -3.80°, -6.50°, -4.10° and -6.35°, respectively. The difference of nasolabial angle among the five groups was statistically significant ( P<0.01). The difference between 2+ 1 framework group and 1+ 1 framework group or Y-shaped framework group was statistically significant( P<0.05). The difference between 4+ 1 framework group and 1+ 1 framework group or Y-shaped framework group was statistically significant ( P<0.05). The difference between integrated nasal framework group and 1+ 1 framework group or Y-shaped framework group was statistically significant ( P<0.05). Patient satisfaction evaluation, 2+ 1 framework group had the highest satisfaction(34/34, 100.00%), followed by 4+ 1 framework group (34/35, 97.14%), integrated framework group(42/45, 93.33%), Y-shaped framework group(36/42, 85.71%), 1+ 1 framework group(37/45, 82.22%). Conclusion:The changes of nasolabial angle and nasal tip projection in 2+ 1 framework, integrated framework, and 4+ 1 framework were smaller than those in Y-shaped framework and 1+ 1 framework.2+ 1 framework was convenient and had good postoperative stability and high patient satisfaction.
7.Consensus of experts on the medical risk prevention for the patients with cardiovascular diseases during dental treatment (2022 edition).
Jing ZHANG ; Guan Hua SU ; Xiao Dong ZHANG ; Kai XU ; Zuo Min WANG ; Xu Liang DENG ; Ya Qin ZHU ; Yong Jin CHEN ; Cheng Zhi GAO ; Hong XIE ; Xuan PAN ; Lin YIN ; Bao Hua XU ; Wei FEI ; Jian ZHOU ; Dan SHAO ; Zhi Hong ZHANG ; Kai ZHANG ; Xia WANG ; Xiang CHENG ; Xiao WANG ; Li Li CHEN
Chinese Journal of Stomatology 2022;57(5):462-473
With the aging process of population in the society, the prevalence of cardiovascular diseases (CVD) in China is increasing continuously and the number of dental patients with CVD is increasing gradually too. Due to the lack of guidelines for dental patients with CVD in our country, how to implement standardized preoperative evaluation and perioperative risk prevention remains a problem to be solved for dentists at present. The present expert consensus was reached by combining the clinical experiences of the expert group of the Fifth General Dentistry Special Committee, Chinese Stomatological Association and respiratory and cardiology experts in diagnosis and treatment for CVD patients, and by systematically summarizing the relevant international guidelines and literature regarding the relationship between CVD and oral diseases and the diagnosis and treatment of dental patients with heart failure, hypertension and antithrombotic therapy. The consensus aims to provide, for the dental clinicians, the criteria on diagnosis and treatment of CVD in dental patients in China so as to reduce the risk and complications, and finally to improve the treatment levels of dental patients with CVD in China.
Cardiovascular Diseases/prevention & control*
;
China/epidemiology*
;
Consensus
;
Dental Care
;
Humans
;
Oral Medicine
8.Application of the Mathieu combined tunnel technique for repairing glans dehiscence after failed hypospadias repair.
Qi-Gen XIE ; Kai XIA ; Xiang-Ping LI ; Peng LUO ; Zuo-Qing LI ; Cheng SU ; Chun-Hua DENG
Asian Journal of Andrology 2022;24(3):311-316
Repairing glans dehiscence after failed hypospadias repair is challenging for pediatric surgeons. Here, we introduced and evaluated a newly modified Mathieu technique, Mathieu combined tunnel (MCT), which involves multiple custom-designed flaps for the shortage of flap source material after repeated operations; we also constructed a tunnel to avoid the glans incision that may carry new risks of dehiscence. This retrospective study included 26 patients who were consecutively admitted to the First Affiliated Hospital of Sun Yat-Sen University (Guangzhou, China) for glans dehiscence repair after failed hypospadias repair from October 2014 to October 2020; sixteen patients underwent surgery using the MCT (MCT group) and ten patients underwent surgery using the tubularized incised plate (TIP) technique (TIP group). The operative time, blood loss, postoperative complications, normal urethral meatus rate, success rate, and Hypospadias Objective Penile Evaluation (HOPE) score were compared between the two groups. The MCT group achieved an overall satisfactory penile appearance and voiding function, with a higher rate of normal urethral meatus (15/16, 93.8%) and a lower rate of glans dehiscence (1/16, 6.2%), compared with the TIP group (70.0% and 30.0%, respectively). However, these differences were not statistically significant, possibly because of the limited number of patients (all P > 0.05). Mean postoperative HOPE scores were similar in the MCT group (mean ± standard deviation: 8.83 ± 0. 89) and TIP group (8.94 ± 0.57) (P > 0.05). No significant differences were found between the two groups in terms of blood loss and success rate, nor in the rates of various complications (e.g., fistula, urethral stricture, and glans dehiscence). In conclusion, the MCT technique appears to be feasible and reliable for repairing glans dehiscence after failed hypospadias repair.
Child
;
Female
;
Humans
;
Hypospadias/surgery*
;
Infant
;
Male
;
Retrospective Studies
;
Treatment Outcome
;
Urethra/surgery*
;
Urologic Surgical Procedures, Male/methods*
9.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
10.Overview of reported transcutaneous electrical acupoint stimulation effects on pain mediators
Kai-Feng DENG ; Ri-Lan CHEN ; Zi-Long LIAO ; Guo-Xiang WANG ; Ying ZHU
Journal of Acupuncture and Tuina Science 2021;19(1):78-82
Literatures on pain intervention with transcutaneous electrical acupoint stimulation (TEAS) were collected by searching the databases both in Chinese and English, and summarized to understand the research progress of TEAS effects on pain mediators in recent years. This will provide a more objective and scientific theoretical basis for clinical practice of TEAS to treat pain syndrome, thus promoting the clinical application of TEAS. Our literature analysis indicated that TEAS effectively regulated the release levels of various pain factors such as prostaglandin, 5-hydroxytryptamine, interleukins, substance P and tumor necrosis factor-α to achieve the analgesic effects by affecting the conduction pathways. TEAS is a safe, non-invasive and effective treatment for pain syndrome. However, further research is necessary due to the lack of rigor of the current clinical trial design.

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