1.Protection efficacy of mRNA-based SARS-CoV-2 variant vaccine in non-human primates.
Dongrong YI ; Yongxin ZHANG ; Jing WANG ; Qian LIU ; Ling MA ; Quanjie LI ; Saisai GUO ; Ruifang ZHENG ; Xiaoyu LI ; Xingong LI ; Yijie DONG ; Shuaiyao LU ; Weiguo ZHANG ; Xiaozhong PENG ; Shan CEN
Acta Pharmaceutica Sinica B 2025;15(2):934-946
The rapid emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants that evade immunity elicited by vaccination has posed a global challenge to the control of the coronavirus disease 2019 (COVID-19) pandemic. Therefore, developing countermeasures that broadly protect against SARS-CoV-2 and related sarbecoviruses is essential. Herein, we have developed a lipid nanoparticle (LNP)-encapsulated mRNA (mRNA-LNP) encoding the full-length Spike (S) glycoprotein of SARS-CoV-2 (termed RG001), which confers complete protection in a non-human primate model. Intramuscular immunization of two doses of RG001 in Rhesus monkey elicited robust neutralizing antibodies and cellular response against SARS-CoV-2 variants, resulting in significantly protected SARS-CoV-2-infected animals from acute lung lesions and complete inhibition of viral replication in all animals immunized with low or high doses of RG001. More importantly, the third dose of RG001 vaccination elicited effective neutralizing antibodies against current epidemic XBB and JN.1 strains and similar cellular response against SARS-CoV-2 Omicron variants (BA.1, XBB.1.16, and JN.1) were observed in immunized mice. All these results together strongly support the great potential of RG001 in preventing the infection of SARS-CoV-2 variants of concern (VOCs).
2.Discussion on the Syndrome Differentiation and Treatment of Senile Chronic Heart Failure Complicated with Sarcopenia from Heart Water and Consumptive Disease in the Treatise on Exogenous Febrile and Miscellaneous Diseases
Journal of Guangzhou University of Traditional Chinese Medicine 2025;42(1):237-242
Senile chronic heart failure(CHF)complicated with sarcopenia can further degrade patients'quality of life,and increase the occurrence of falls,disability and mortality.Currently,western medicine preventive and treatment for sarcopenia mainly depend on nutritional support and exercise therapy,but their efficacy remained uncertain.Traditional Chinese medicine(TCM)therapy has the advantages of holism and syndrome differentiation and treatment,and its application in senile CHF complicated with sarcopenia is worthy of further exploration.This paper sorted out the relevant statements in the Treatise on Exogenous Febrile and Miscellaneous Diseases,and concluded that the clinical manifestations of senile CHF complicated with sarcopenia are similar to those of heart water and consumptive disease in the Treatise on Exogenous Febrile and Miscellaneous Diseases.The statements in Treatise on Exogenous Febrile and Miscellaneous Diseases will guide the identification of etiology and pathogenesis as well as the diagnosis and treatment for senile CHF complicated with sarcopenia.The analysis of the pathogenesis indicated that heart water and consumptive disease were induced by deficiency of heart and spleen and kidney,five kinds of overstrain and seven types of impairment,water pathogen insulting heart,and internal stagnation of blood stasis.Therefore,it is proposed that the core pathogenesis of senile CHF complicated with sarcopenia is due to the deficiency of heart,spleen and kidney yang,and water blended with blood stasis.The classical prescriptions such as Ling Gui Zhu Gan Tang,Zhenwu Tang,Sini Tang,Shenqi Pills,Jianzhong Tang and Wuling Powder can be used by modification or combination based on syndrome differentiation in treating senile CHF complicated with sarcopenia.For both of the congenital and acquired origin(spleen and kidney)of elderly patients with CHF complicated with sarcopenia are deficient,the utilization of herbs for invigorating spleen and boosting kidney on the basis of syndrome differentiation may achieve good efficacy.
3.Study on the Correlation Between Venous Thromboembolism and Traditional Chinese Medicine Constitution Types in Elderly Frail Patients
Yan ZHOU ; Yunyu LIANG ; Jianfeng ZHUO ; Xinmei LI ; Xiaozhong LIN
Journal of Guangzhou University of Traditional Chinese Medicine 2025;42(11):2677-2682
Objective To analyze the correlation between venous thromboembolism(VTE)and traditional Chinese medicine(TCM)constitution types in elderly frail patients.Methods A retrospective study was conducted on 1 428 elderly frail patients admitted to the Second Comprehensive Department of Guangdong Provincial Hospital of Chinese Medicine from January 2019 to June 2023.Patients were divided into a venous thrombsis(VT)group(n=187)and a non-VT group(n=1 241)based on VTE occurrence.Baseline data,including age distribution,Padua scores,Wells scores,and TCM constitution types,were compared between the two groups.Multivariate logistic regression analysis was performed to identify factors for influencing VTE in elderly frail patients.Results(1)Compared with the non-VT group,the VT group had significantly higher total hospitalization costs,length of stay,age,Fried scores,Padua scores,and Wells scores,with statistically significance(P<0.001).(2)Compared with the non-VT group,the VT group had a higher proportion of high VTE-risk individuals and those with Wells scores of 2 points,with statistically significance(P<0.001).(3)The age distribution of VTE patients showed an increasing trend in the age groups of 60-69,70-79,80-89,and ≥90-year-old,with a significant difference compared to the non-VT group(P<0.001).(4)The VT group had a higher proportion of qi-deficiency,blood-stasis,and qi-depression constitutions than the non-VT group(P<0.05 or P<0.001).(5)Multivariate logistic regression analysis(after adjusting age,gender,frailty,and other scores)showed that qi-deficiency and yang-deficiency constitutions were non-susceptible,while damp-heat,blood-stasis,and qi-depression constitutions were susceptible to VTE in elderly frail patients(P<0.05 or P<0.01).Conclusion VTE in elderly frail patients is significantly correlated with TCM constitution types.Deviated constitutions are characteristic of TCM constitution types in elderly frail patients,and damp-heat,blood-stasis,and qi-depression constitutions are risk factors for VTE in this population.
4.Impact of Onset-to-Door Time on Endovascular Therapy for Basilar Artery Occlusion
Tianlong LIU ; Chunrong TAO ; Zhongjun CHEN ; Lihua XU ; Yuyou ZHU ; Rui LI ; Jun SUN ; Li WANG ; Chao ZHANG ; Jianlong SONG ; Xiaozhong JING ; Adnan I. QURESHI ; Mohamad ABDALKADER ; Thanh N. NGUYEN ; Raul G. NOGUEIRA ; Jeffrey L. SAVER ; Wei HU
Journal of Stroke 2025;27(1):140-143
5.Impact of Onset-to-Door Time on Endovascular Therapy for Basilar Artery Occlusion
Tianlong LIU ; Chunrong TAO ; Zhongjun CHEN ; Lihua XU ; Yuyou ZHU ; Rui LI ; Jun SUN ; Li WANG ; Chao ZHANG ; Jianlong SONG ; Xiaozhong JING ; Adnan I. QURESHI ; Mohamad ABDALKADER ; Thanh N. NGUYEN ; Raul G. NOGUEIRA ; Jeffrey L. SAVER ; Wei HU
Journal of Stroke 2025;27(1):140-143
6.Impact of Onset-to-Door Time on Endovascular Therapy for Basilar Artery Occlusion
Tianlong LIU ; Chunrong TAO ; Zhongjun CHEN ; Lihua XU ; Yuyou ZHU ; Rui LI ; Jun SUN ; Li WANG ; Chao ZHANG ; Jianlong SONG ; Xiaozhong JING ; Adnan I. QURESHI ; Mohamad ABDALKADER ; Thanh N. NGUYEN ; Raul G. NOGUEIRA ; Jeffrey L. SAVER ; Wei HU
Journal of Stroke 2025;27(1):140-143
7.Clinical characteristics of juvenile dermatomyositis in anti-nuclear matrix protein 2 antibody-positive patients and risk factors for severity: a national multicenter retrospective study
Huiyuan YANG ; Wanzhen GUAN ; Ling2 YANG ; Haimei LIU ; Xiaoqing3 LI ; Haiguo YU ; Meiping LU ; Jun YANG ; Xiaohui LIU ; Hongxia ZHANG ; Wei ZHANG ; Jihong XIAO ; Xiaozhong LI ; Guomin LI ; Hong CHANG ; Sheng HAO ; Yue DU ; Daliang XU ; Ling WU ; Wenjie ZHENG ; Li LIU ; Xinhui JIANG ; Shaohui ZHU ; Dongmei ZHAO ; Xuemei TANG ; Li SUN
Chinese Journal of Pediatrics 2025;63(12):1299-1305
Objective:To investigate the clinical characteristics and independent risk factors of severe disease in patients with anti-nuclear matrix protein (NXP) 2 antibody-positive juvenile dermatomyositis (JDM).Methods:A retrospective cohort study was conducted, including 219 anti-NXP2 antibody-positive JDM patients admitted to 23 children′s hospitals across China from July 2011 to July 2023. Patients were classified into severe and non-severe groups based on classification criteria for severe dermatomyositis. Demographic characteristics, clinical manifestations, and laboratory parameters were compared between the 2 groups using independent sample t-test, Mann-Whitney U test, or χ2 test. Univariate and multivariate Logistic regression analyses were performed to identify risk factors for severe disease. The receiver operating characteristic curve was employed to calculate optimal cut-off values. Results:Among the 219 patients, 108 were male and 111 were female, with an age at onset of 6.3 (3.5, 9.4) years. The severe group comprised 69 patients, and the non-severe group 150 patients. The severe group had significantly higher rates of fever, heliotrope rash, subcutaneous edema, periorbital edema, anti-Ro52 antibody positivity, as well as elevated levels of ferritin-to-albumin ratio (FAR), creatine kinase (CK), aspartate aminotransferase (AST), and lactate dehydrogenase (LDH) (all P<0.05). Multivariate analysis identified anti-Ro52 antibody positivity ( OR=13.26, 95% CI 1.37-128.29) and elevated FAR ( OR=1.90, 95% CI 1.09-2.31) as independent risk factors for severe anti-NXP2 antibody-positive JDM (both P<0.05). Receiver operating characteristic curve analysis revealed that a FAR cutoff value of 6.82 predicted severe disease with an area under the curve of 0.87 (95% CI 0.81-0.94, P<0.001), sensitivity of 0.85, and specificity of 0.70. All patients received glucocorticoid therapy, and the severe group received higher proportions of steroid pulse therapy, cyclophosphamide, mycophenolate mofetil, intravenous immunoglobulin, biologics, and adjuvant treatments compared to the non-severe group (all P<0.05). In terms of outcomes, 2 patients (2.9%) in the severe group died (due to neurological involvement and intestinal perforation, respectively), while the remaining patients achieved complete clinical response or remission. All patients in the non-severe group achieved remission. Conclusions:The primary clinical features of anti-NXP2 antibody-positive JDM included fever, heliotrope rash, subcutaneous edema, periorbital edema, anti-Ro52 antibody positivity, and elevated levels of CK, AST, LDH, and FAR. Furthermore, anti-Ro52 antibody positivity and a FAR>6.82 were identified as independent risk factors.
8.Analysis of the prevalence status and clinical characteristics of the hepatitis D virus in the Xinjiang region
Zhuanguo WANG ; Xu WU ; Jing DOU ; Feng GUO ; Zhonghui NING ; Rong ZHANG ; Qiang XU ; Xiaobo WANG ; Hongfeng WANG ; Binfang ZENG ; Li YANG ; Xiaozhong WANG
Chinese Journal of Hepatology 2025;33(11):1058-1063
Objective:To investigate the prevalence status and the clinical characteristics of hepatitis D virus (HDV) among patients chronically infected with hepatitis B virus (HBV) in the Xinjiang region.Methods:A cross-sectional study was conducted. Serum samples from 1 830 patients with chronic HBV infection who visited the Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region from December 2022 to October 2023 were collected. All sera were tested for anti-HDV IgG and IgM. Sera positive for anti-HDV IgG or IgM were selected for HDV RNA detection. HDV RNA-positive sera were sequenced to determine the HDV genotype. Age, gender, HBV course, and anti-HBV treatment status were used as scoring items based on the propensity score matching (PSM) method. Chronic HBV patients with negative anti-HDV were matched in a ratio of 1∶1. The clinical characteristics of anti-HDV -positive-patients were analyzed. The t-test was used for comparison between groups of normally distributed continuous data. The Wilcoxon signed-rank test was used for comparison between groups of skewness distribution. The χ2 test was used for comparison between groups of enumeration data. Results:The positive detection rates of anti-HDV IgG, anti-HDV IgM, and HDV RNA in 1 830 cases with chronic HBV infection were 2.24% (41/1 830), 1.09% (20/1 830), and 1.69% (31/1 830), respectively. All HDV RNA-positive patients had HDV genotype 1. Two anti-HDV-positive patients had negative hepatitis B surface antigen (HBsAg). Gender, age, HBV course, and anti-HBV treatment status had no significant difference. The quantification of HBsAg, liver biochemical indexes (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and total bile acids), the proportion of patients with liver cirrhosis, and alpha-fetoprotein were significantly higher in the anti-HDV-positive group than in those in the anti-HDV-negative group ( P<0.05). Conclusion:The prevalence rate of HDV in chronic HBV-infected patients at a single center in the Xinjiang region was 2.24%, with the primary genotype being 1. Furthermore, overlap infection should be paid attention to because it might aggravate liver damage.
9.Association Between Neutrophil to High-density Lipoprotein Cholesterol Ratio and Incidence of Cardiovascular Disease in Patients With Metabolic Associated Fatty Liver Disease
Guizhong FANG ; Lin WEN ; Xinyu WANG ; Shuting FENG ; Ying ZHOU ; Shuohua CHEN ; Guangjian LI ; Xiaozhong JIANG ; Shouling WU ; Shan WANG
Chinese Circulation Journal 2025;40(6):605-610
Objectives:This study aims to investigate the relationship between neutrophil to high-density lipoprotein cholesterol ratio(NHR)and incidence of cardiovascular disease(CVD)among individuals with metabolic associated fatty liver disease(MAFLD).Methods:We conducted a prospective cohort study utilizing health check-up data from 2006 to 2007 at Kailuan General Hospital and its 10 affiliated hospitals.The study population consisted of employees and retirees diagnosed with MAFLD,excluding those with incomplete neutrophil and high-density lipoprotein cholesterol data or a history of heart failure,myocardial infarction,cerebral hemorrhage,or cerebral infarction.CVD was defined as the presence of heart failure,myocardial infarction,cerebral hemorrhage,or cerebral infarction.Annual follow-ups were conducted from 2006,new-onset CVD cases identified through discharge records from the 11 Kailuan Group hospitals and records from municipal social insurance agencies,the final follow up date was December 31,2022.NHR was calculated as the ratio of neutrophil to high-density lipoprotein cholesterol,and the MAFLD cohort(n=28 952)was stratified into four groups by NHR quartiles:Q1 group(NHR<1.97,n=7 241),Q2 group(1.97≤NHR<2.57,n=7 235),Q3 group(2.57≤NHR<3.36,n=7 240),and Q4 group(NHR≥3.36,n=7 236).The Kaplan-Meier method was employed to plot survival curves for new-onset CVD,and the cumulative incidences of CVD across different NHR quartiles groups were determined.Intergroup comparisons were made using the log-rank test,and a multifactorial Cox proportional hazards regression model was used to assess the association between NHR quartiles and the risk of new-onset CVD in the MAFLD population.Results:The average follow-up duration was(14.03±3.99)years,during which 4 666 new CVD cases were recorded among the study population.The number of CVD cases across Q1 group to Q4 group were 1 061,1 167,1 186 and 1 252,respectively,with an overall incidence density of 11.5 cases per 1 000 person-years.The incidence densities for Q1 group to Q4 group were 10.4,11.4,11.7 and 12.5 cases per 1 000 person-years,respectively.The multifactorial Cox proportional hazards regression analysis revealed that higher NHR quartiles were associated with an increased relative risk of new-onset CVD(Q2 group:HR=1.13,95%CI:1.04-1.23;Q3 group:HR=1.15,95%CI:1.05-1.25;Q4 group:HR=1.22,95%CI:1.12-1.33).Conclusions:The risk of new-onset cardiovascular disease in individuals with MAFLD escalates with increasing NHR.
10.Efficacy and safety of tegoprazan (LXI-15028) vs. esomeprazole in patients with erosive esophagitis: A multicenter, randomized, doubleblind, non-inferiority phase Ⅲ trial
Huiyun ZHU ; Qian XUE ; Yingxiao SONG ; Zhenyu ZHANG ; Xing LI ; Shengxiang LYU ; Qiang ZHAN ; Fei LIU ; Lungen LU ; Liang ZHONG ; Weixing CHEN ; Dong SHAO ; Yanbing DING ; Deliang LIU ; Xiaozhong YANG ; Zhiming HUANG ; Zhaoshen LI ; Yiqi DU
Chinese Medical Journal 2025;138(19):2464-2471
Background::An evidence gap still exists regarding the efficacy and safety of tegoprazan in patients with erosive esophagitis (EE) in China. This study aimed to verify the efficacy and safety of tegoprazan vs. esomeprazole in patients with EE in China. Methods::This study was a multicenter, randomized, double-blind, parallel, active-controlled, non-inferiority phase III trial of patients with EE randomized 1:1 to tegoprazan 50 mg/day vs. esomeprazole 40 mg/day. This study was conducted in 32 sites between October 24, 2018 and October 18, 2019. The primary endpoint was the cumulative endoscopic healing rate at week 8. The secondary endpoint included endoscopic healing rate at week 4, changes in the reflux disease questionnaire (RDQ) and gastroesophageal reflux disease health-related quality of life (GERD-HRQL) scores, and symptom improvement. Results::A total of 261 patients were randomized: 132 to the tegoprazan group and 129 to the esomeprazole group. The cumulative endoscopic healing rate at 8 weeks in the tegoprazan group was non-inferior to that of the esomeprazole group (91.1% vs. 92.8%, difference: -1.7%, 95% confidence interval [CI]: -8.5%, 5.0%, P = 0.008). There were no statistically significant differences in the changes in RDQ (total, severity, and frequency) and GERD-HRQL scores between the two groups (all P >0.05). The percentages of days without symptoms, including daytime and nighttime symptoms based on patients' diaries, were similar between the two groups (all P >0.05). In the tegoprazan and esomeprazole groups, 71.5% (93/130) and 61.7% (79/128) of the participants reported adverse events (AEs), 2.3% and 0 experienced serious AEs, while 70.0% and 60.2% had treatment-emergent AEs, respectively. Conclusion::Tegoprazan 50 mg/day demonstrated non-inferior efficacy in healing EE, symptom improvement, and quality of life, and it has similar tolerability compared with esomeprazole 40 mg/day.

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