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.A preliminary exploration on safety and learning curve of laparoscopic pancreatoduodenectomy in low-flow pancreatic center
Weiqiao NIU ; Cong ZHANG ; Hanlin JIANG ; Lining HUANG ; Yijie LU ; Yaopeng XU ; Biren LIU ; Xinwei JIANG ; Jianwu WU
Journal of Clinical Medicine in Practice 2025;29(7):13-18,25
Objective To compare the safety of laparoscopic pancreatoduodenectomy(LPD)and open pancreatoduodenectomy(OPD)and analyze the learning curve and safety at different stages of LPD.Methods A retrospective analysis was conducted on the clinical data of 50 LPD patients and 54 OPD patients in the Department of Hepatopancreatobiliary Surgery of Suzhou Hospital Affiliated to Nanjing Medical University from January 2020 to June 2024,and intraoperative and postoperative conditions were compared.The Cumulative Sum(CUSUM)analysis method was used to analyze the technical nodes of the LPD learning curve.Results There were no significant differences in operation time and intraoperative blood loss between the LPD group and the OPD group(P>0.05).There was also no significant difference in the incidence rates of pancreatic fistula(grade B and C),delayed gastric emptying,postoperative bleeding,biliary fistula and intra-abdominal infection between the LPD group and the OPD group(P>0.05).A time series plot of operation time was drawn based on the patient's operation time and surgical sequence,yielding a fitted curve.Curve analysis showed initial stage and stable stage were finished at the 17th and 24th cases.The LPD learning curve could be divided into three stages:stage Ⅰ characterized as the initial stage(cases 1 to 17),stage Ⅱ characterized as the stable stage(cases 18 to 24),and stage Ⅲ characterized as the proficient stage(cases 25 to 50).The operation time in stages Ⅱ and Ⅲ was significantly shorter than that in stage Ⅰ,and the intraoperative blood loss in stage Ⅰ was significantly higher than that in stage Ⅲ(P<0.05).There was no significant difference in the incidence of complications among the three stages(P>0.05).Conclusion LPD and OPD show no significant differences in indications and safety.The LPD learning curve can be divided into three stages.As the number of surgeries completed increa-ses,the operation time of physicians gradually shortens,and the incidence of complications of patients gradually decreases.
3.Survival analysis of patients with diffuse large B-cell lymphoma after chemotherapy using Fuzheng Jiedu Formula and its mechanism of action on lymphocyte subsets
Xi LI ; Wenyi ZHOU ; Shiya ZHUANSUN ; Xinbei YUAN ; Yijie YANG ; Hua FU ; Wei SHEN ; Min XU ; Xinjin GAN ; Jiahui LU
Journal of Beijing University of Traditional Chinese Medicine 2024;47(11):1603-1611
Objective To evaluate the survival of patients with diffuse large B-cell lymphoma(DLBCL)after chemotherapy using Fuzheng Jiedu Formula and to explore the intrinsic correlation between the lymphocyte subset level and the survival of patients with DLBCL.Methods A total of 234 patients with DLBCL who had completed chemotherapy and achieved complete or partial response in the Department of Hematology,Longhua Hospital Shanghai University of Traditional Chinese Medicine and Shanghai East Hospital,Tongji University from January 1,2013,to December 31,2023,were recruited.A cohort study design was adopted,with"whether to receive continuous Fuzheng Jiedu Formula treatment for≥6 months after chemotherapy"as the exposed factor.Patients meeting this exposed factor were divided into the traditional Chinese medicine(TCM)cohort,whereas those who did not meet this exposed factor were divided into the observation cohort.The 1-and 2-year progression-free survival(PFS)rate,overall survival(OS)rate,and duration of response(DOR)of the two cohorts were compared.The survival curves of PFS and OS of the two cohorts were drawn,and subgroup survival analysis was performed to determine factors affecting disease progression.The effect of Fuzheng Jiedu Formula on lymphocyte subset count level was observed.Results The study included 126 and 108 patients in the TCM and observation cohorts,respectively.Compared with the observation cohort,the 2-year PFS rate,2-year OS rate,and DOR were increased in the TCM cohort(P<0.05).The PFS in the TCM cohort was higher than that in the observation cohort[HR=0.542,95%CI(0.345-0.853),P<0.01].The result of subgroup analysis showed that PFS in the TCM cohort was higher than that in the observation cohort in the age≥60 years,AA stage Ⅲ-Ⅳ,CD4+
4.Survival analysis of patients with diffuse large B-cell lymphoma after chemotherapy using Fuzheng Jiedu Formula and its mechanism of action on lymphocyte subsets
Xi LI ; Wenyi ZHOU ; Shiya ZHUANSUN ; Xinbei YUAN ; Yijie YANG ; Hua FU ; Wei SHEN ; Min XU ; Xinjin GAN ; Jiahui LU
Journal of Beijing University of Traditional Chinese Medicine 2024;47(11):1603-1611
Objective To evaluate the survival of patients with diffuse large B-cell lymphoma(DLBCL)after chemotherapy using Fuzheng Jiedu Formula and to explore the intrinsic correlation between the lymphocyte subset level and the survival of patients with DLBCL.Methods A total of 234 patients with DLBCL who had completed chemotherapy and achieved complete or partial response in the Department of Hematology,Longhua Hospital Shanghai University of Traditional Chinese Medicine and Shanghai East Hospital,Tongji University from January 1,2013,to December 31,2023,were recruited.A cohort study design was adopted,with"whether to receive continuous Fuzheng Jiedu Formula treatment for≥6 months after chemotherapy"as the exposed factor.Patients meeting this exposed factor were divided into the traditional Chinese medicine(TCM)cohort,whereas those who did not meet this exposed factor were divided into the observation cohort.The 1-and 2-year progression-free survival(PFS)rate,overall survival(OS)rate,and duration of response(DOR)of the two cohorts were compared.The survival curves of PFS and OS of the two cohorts were drawn,and subgroup survival analysis was performed to determine factors affecting disease progression.The effect of Fuzheng Jiedu Formula on lymphocyte subset count level was observed.Results The study included 126 and 108 patients in the TCM and observation cohorts,respectively.Compared with the observation cohort,the 2-year PFS rate,2-year OS rate,and DOR were increased in the TCM cohort(P<0.05).The PFS in the TCM cohort was higher than that in the observation cohort[HR=0.542,95%CI(0.345-0.853),P<0.01].The result of subgroup analysis showed that PFS in the TCM cohort was higher than that in the observation cohort in the age≥60 years,AA stage Ⅲ-Ⅳ,CD4+
5.Survival analysis of patients with diffuse large B-cell lymphoma after chemotherapy using Fuzheng Jiedu Formula and its mechanism of action on lymphocyte subsets
Xi LI ; Wenyi ZHOU ; Shiya ZHUANSUN ; Xinbei YUAN ; Yijie YANG ; Hua FU ; Wei SHEN ; Min XU ; Xinjin GAN ; Jiahui LU
Journal of Beijing University of Traditional Chinese Medicine 2024;47(11):1603-1611
Objective To evaluate the survival of patients with diffuse large B-cell lymphoma(DLBCL)after chemotherapy using Fuzheng Jiedu Formula and to explore the intrinsic correlation between the lymphocyte subset level and the survival of patients with DLBCL.Methods A total of 234 patients with DLBCL who had completed chemotherapy and achieved complete or partial response in the Department of Hematology,Longhua Hospital Shanghai University of Traditional Chinese Medicine and Shanghai East Hospital,Tongji University from January 1,2013,to December 31,2023,were recruited.A cohort study design was adopted,with"whether to receive continuous Fuzheng Jiedu Formula treatment for≥6 months after chemotherapy"as the exposed factor.Patients meeting this exposed factor were divided into the traditional Chinese medicine(TCM)cohort,whereas those who did not meet this exposed factor were divided into the observation cohort.The 1-and 2-year progression-free survival(PFS)rate,overall survival(OS)rate,and duration of response(DOR)of the two cohorts were compared.The survival curves of PFS and OS of the two cohorts were drawn,and subgroup survival analysis was performed to determine factors affecting disease progression.The effect of Fuzheng Jiedu Formula on lymphocyte subset count level was observed.Results The study included 126 and 108 patients in the TCM and observation cohorts,respectively.Compared with the observation cohort,the 2-year PFS rate,2-year OS rate,and DOR were increased in the TCM cohort(P<0.05).The PFS in the TCM cohort was higher than that in the observation cohort[HR=0.542,95%CI(0.345-0.853),P<0.01].The result of subgroup analysis showed that PFS in the TCM cohort was higher than that in the observation cohort in the age≥60 years,AA stage Ⅲ-Ⅳ,CD4+
6.Survival analysis of patients with diffuse large B-cell lymphoma after chemotherapy using Fuzheng Jiedu Formula and its mechanism of action on lymphocyte subsets
Xi LI ; Wenyi ZHOU ; Shiya ZHUANSUN ; Xinbei YUAN ; Yijie YANG ; Hua FU ; Wei SHEN ; Min XU ; Xinjin GAN ; Jiahui LU
Journal of Beijing University of Traditional Chinese Medicine 2024;47(11):1603-1611
Objective To evaluate the survival of patients with diffuse large B-cell lymphoma(DLBCL)after chemotherapy using Fuzheng Jiedu Formula and to explore the intrinsic correlation between the lymphocyte subset level and the survival of patients with DLBCL.Methods A total of 234 patients with DLBCL who had completed chemotherapy and achieved complete or partial response in the Department of Hematology,Longhua Hospital Shanghai University of Traditional Chinese Medicine and Shanghai East Hospital,Tongji University from January 1,2013,to December 31,2023,were recruited.A cohort study design was adopted,with"whether to receive continuous Fuzheng Jiedu Formula treatment for≥6 months after chemotherapy"as the exposed factor.Patients meeting this exposed factor were divided into the traditional Chinese medicine(TCM)cohort,whereas those who did not meet this exposed factor were divided into the observation cohort.The 1-and 2-year progression-free survival(PFS)rate,overall survival(OS)rate,and duration of response(DOR)of the two cohorts were compared.The survival curves of PFS and OS of the two cohorts were drawn,and subgroup survival analysis was performed to determine factors affecting disease progression.The effect of Fuzheng Jiedu Formula on lymphocyte subset count level was observed.Results The study included 126 and 108 patients in the TCM and observation cohorts,respectively.Compared with the observation cohort,the 2-year PFS rate,2-year OS rate,and DOR were increased in the TCM cohort(P<0.05).The PFS in the TCM cohort was higher than that in the observation cohort[HR=0.542,95%CI(0.345-0.853),P<0.01].The result of subgroup analysis showed that PFS in the TCM cohort was higher than that in the observation cohort in the age≥60 years,AA stage Ⅲ-Ⅳ,CD4+
7.Survival analysis of patients with diffuse large B-cell lymphoma after chemotherapy using Fuzheng Jiedu Formula and its mechanism of action on lymphocyte subsets
Xi LI ; Wenyi ZHOU ; Shiya ZHUANSUN ; Xinbei YUAN ; Yijie YANG ; Hua FU ; Wei SHEN ; Min XU ; Xinjin GAN ; Jiahui LU
Journal of Beijing University of Traditional Chinese Medicine 2024;47(11):1603-1611
Objective To evaluate the survival of patients with diffuse large B-cell lymphoma(DLBCL)after chemotherapy using Fuzheng Jiedu Formula and to explore the intrinsic correlation between the lymphocyte subset level and the survival of patients with DLBCL.Methods A total of 234 patients with DLBCL who had completed chemotherapy and achieved complete or partial response in the Department of Hematology,Longhua Hospital Shanghai University of Traditional Chinese Medicine and Shanghai East Hospital,Tongji University from January 1,2013,to December 31,2023,were recruited.A cohort study design was adopted,with"whether to receive continuous Fuzheng Jiedu Formula treatment for≥6 months after chemotherapy"as the exposed factor.Patients meeting this exposed factor were divided into the traditional Chinese medicine(TCM)cohort,whereas those who did not meet this exposed factor were divided into the observation cohort.The 1-and 2-year progression-free survival(PFS)rate,overall survival(OS)rate,and duration of response(DOR)of the two cohorts were compared.The survival curves of PFS and OS of the two cohorts were drawn,and subgroup survival analysis was performed to determine factors affecting disease progression.The effect of Fuzheng Jiedu Formula on lymphocyte subset count level was observed.Results The study included 126 and 108 patients in the TCM and observation cohorts,respectively.Compared with the observation cohort,the 2-year PFS rate,2-year OS rate,and DOR were increased in the TCM cohort(P<0.05).The PFS in the TCM cohort was higher than that in the observation cohort[HR=0.542,95%CI(0.345-0.853),P<0.01].The result of subgroup analysis showed that PFS in the TCM cohort was higher than that in the observation cohort in the age≥60 years,AA stage Ⅲ-Ⅳ,CD4+
8.Survival analysis of patients with diffuse large B-cell lymphoma after chemotherapy using Fuzheng Jiedu Formula and its mechanism of action on lymphocyte subsets
Xi LI ; Wenyi ZHOU ; Shiya ZHUANSUN ; Xinbei YUAN ; Yijie YANG ; Hua FU ; Wei SHEN ; Min XU ; Xinjin GAN ; Jiahui LU
Journal of Beijing University of Traditional Chinese Medicine 2024;47(11):1603-1611
Objective To evaluate the survival of patients with diffuse large B-cell lymphoma(DLBCL)after chemotherapy using Fuzheng Jiedu Formula and to explore the intrinsic correlation between the lymphocyte subset level and the survival of patients with DLBCL.Methods A total of 234 patients with DLBCL who had completed chemotherapy and achieved complete or partial response in the Department of Hematology,Longhua Hospital Shanghai University of Traditional Chinese Medicine and Shanghai East Hospital,Tongji University from January 1,2013,to December 31,2023,were recruited.A cohort study design was adopted,with"whether to receive continuous Fuzheng Jiedu Formula treatment for≥6 months after chemotherapy"as the exposed factor.Patients meeting this exposed factor were divided into the traditional Chinese medicine(TCM)cohort,whereas those who did not meet this exposed factor were divided into the observation cohort.The 1-and 2-year progression-free survival(PFS)rate,overall survival(OS)rate,and duration of response(DOR)of the two cohorts were compared.The survival curves of PFS and OS of the two cohorts were drawn,and subgroup survival analysis was performed to determine factors affecting disease progression.The effect of Fuzheng Jiedu Formula on lymphocyte subset count level was observed.Results The study included 126 and 108 patients in the TCM and observation cohorts,respectively.Compared with the observation cohort,the 2-year PFS rate,2-year OS rate,and DOR were increased in the TCM cohort(P<0.05).The PFS in the TCM cohort was higher than that in the observation cohort[HR=0.542,95%CI(0.345-0.853),P<0.01].The result of subgroup analysis showed that PFS in the TCM cohort was higher than that in the observation cohort in the age≥60 years,AA stage Ⅲ-Ⅳ,CD4+
9.Survival analysis of patients with diffuse large B-cell lymphoma after chemotherapy using Fuzheng Jiedu Formula and its mechanism of action on lymphocyte subsets
Xi LI ; Wenyi ZHOU ; Shiya ZHUANSUN ; Xinbei YUAN ; Yijie YANG ; Hua FU ; Wei SHEN ; Min XU ; Xinjin GAN ; Jiahui LU
Journal of Beijing University of Traditional Chinese Medicine 2024;47(11):1603-1611
Objective To evaluate the survival of patients with diffuse large B-cell lymphoma(DLBCL)after chemotherapy using Fuzheng Jiedu Formula and to explore the intrinsic correlation between the lymphocyte subset level and the survival of patients with DLBCL.Methods A total of 234 patients with DLBCL who had completed chemotherapy and achieved complete or partial response in the Department of Hematology,Longhua Hospital Shanghai University of Traditional Chinese Medicine and Shanghai East Hospital,Tongji University from January 1,2013,to December 31,2023,were recruited.A cohort study design was adopted,with"whether to receive continuous Fuzheng Jiedu Formula treatment for≥6 months after chemotherapy"as the exposed factor.Patients meeting this exposed factor were divided into the traditional Chinese medicine(TCM)cohort,whereas those who did not meet this exposed factor were divided into the observation cohort.The 1-and 2-year progression-free survival(PFS)rate,overall survival(OS)rate,and duration of response(DOR)of the two cohorts were compared.The survival curves of PFS and OS of the two cohorts were drawn,and subgroup survival analysis was performed to determine factors affecting disease progression.The effect of Fuzheng Jiedu Formula on lymphocyte subset count level was observed.Results The study included 126 and 108 patients in the TCM and observation cohorts,respectively.Compared with the observation cohort,the 2-year PFS rate,2-year OS rate,and DOR were increased in the TCM cohort(P<0.05).The PFS in the TCM cohort was higher than that in the observation cohort[HR=0.542,95%CI(0.345-0.853),P<0.01].The result of subgroup analysis showed that PFS in the TCM cohort was higher than that in the observation cohort in the age≥60 years,AA stage Ⅲ-Ⅳ,CD4+
10.Progress in the Diagnosis and Treatment of Infantile Epileptic Spasm Syndrome
Lu ZHENG ; Ting YANG ; Chaoyang CHEN ; Ran WEI ; Xuanling ZHANG ; Yijie MA ; Ying ZHOU
JOURNAL OF RARE DISEASES 2024;3(2):260-268
Infantile epileptic spasm syndrome(IESS)is a new concept proposed recently.IESS is a unique and age-specific refractory epilepsy syndrome.The recent advances in molecular biology,neuroimmunol-ogy and the in-depth study of anti-epileptic mechanism in antiepileptic drugs have led to the achievements in the definition and treatment of infantile epileptic spasm.At present,the use of traditional antiepileptic drugs is de-creasing,while the use of new antiepileptic drugs is increasing.In this paper,based on the relevant literature in recent years,the authors discuss the pathogenesis,epidemiology,etiology,diagnosis,treatment,therapeutic drugs,clinical progress,efficacy,and safety of infantile epileptic spasm,hoping to introduce the latest status in research and achievements of IESS.

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