1.Clinical research design and challenges of multi-conjugate vaccine and polyvalent vaccine
Hongyan LIU ; Weiwei HAN ; Mingzhi GAN ; Fengcai ZHU ; Jingxin LI
Chinese Journal of Epidemiology 2025;46(7):1304-1310
Multi-conjugate vaccine and polyvalent vaccine can reduce the number of vaccinations, improve vaccination efficiency, and provide wider protection against diseases, and can not only brings convenience to recipients but also reduce healthcare costs, making it a key focus in modern vaccine development. However, even if the components of the vaccine are derived from already approved monovalent vaccines, it must still be considered as a new vaccine and undergo randomized controlled clinical trials to evaluate their safety and efficacy in humans. Due to the inclusion of multiple antigens, clinical evaluation must consider the potential interactions between or among the components, as well as the impacts of adjuvants, preservatives, and other ingredients on the vaccines' safety and efficacy. These factors introduce certain specific challenges in the clinical evaluation of multi-conjugate vaccine and polyvalent vaccine. This article summarizes the key elements and methods of clinical study design for multi-conjugate vaccine and polyvalent vaccine in terms of safety, immunogenicity, and protective efficacy, and discuss the problems and challenges exisitng in vaccine clinical evaluation to provide reference for the standardization of clinical study design of multi-conjugate vaccine and polyvalent vaccine.
2.Comparison of short-term outcomes and 5-year overall survival between robotic and laparoscopic gastrectomy for gastric cancer
Li ZHANG ; Mingzhi CAI ; Bin LI ; Gang MA ; Xuejing ZHENG ; Ye TIAN ; Xuejun WANG ; Yong LIU ; Han LIANG
Chinese Journal of General Surgery 2025;40(8):601-606
Objective:To compare the short-term clinical outcomes of robotic gastrectomy (RG) and laparoscopic gastrectomy (LG) in treating gastric cancer, as well as the overall 5-year's survival rate.Methods:In this retrospective cohort study, 874 patients undergoing minimally invasive gastrectomy were recruited from Jan 2016 to Jan 2020 (LG: n=719; RG: n=155). A one-to-one propensity score matching analysis was applied to minimize the selection bias due to confounding factors, yielding 150 patients in each of the RG and LG groups. After matching, the short-term outcomes and 5-year overall survival were compared in the two groups. Results:The propensity score matching cohort analysis showed a similar 5-year overall survival between RG and LG groups ( P=0.235). Concerning the short-term outcomes, the RG compared to LG resulted in lower blood loss ( P=0.011), lower postoperative complications ( P=0.001), less postoperative pain ( P=0.014), earlier initiation of soft diet ( P=0.010), shorter hospital stay ( P=0.011), but higher hospitalization expenses ( P=0.004). Conclusions:RG had a similar overall survival outcome compared to LG while offering better safety and efficacy in terms of less blood loss, lower surgery complications, faster recovery, and less postoperative pain. Higher hospital expenses were the main disadvantage of RG that could limit its application.
3.Clinical research design and challenges of multi-conjugate vaccine and polyvalent vaccine
Hongyan LIU ; Weiwei HAN ; Mingzhi GAN ; Fengcai ZHU ; Jingxin LI
Chinese Journal of Epidemiology 2025;46(7):1304-1310
Multi-conjugate vaccine and polyvalent vaccine can reduce the number of vaccinations, improve vaccination efficiency, and provide wider protection against diseases, and can not only brings convenience to recipients but also reduce healthcare costs, making it a key focus in modern vaccine development. However, even if the components of the vaccine are derived from already approved monovalent vaccines, it must still be considered as a new vaccine and undergo randomized controlled clinical trials to evaluate their safety and efficacy in humans. Due to the inclusion of multiple antigens, clinical evaluation must consider the potential interactions between or among the components, as well as the impacts of adjuvants, preservatives, and other ingredients on the vaccines' safety and efficacy. These factors introduce certain specific challenges in the clinical evaluation of multi-conjugate vaccine and polyvalent vaccine. This article summarizes the key elements and methods of clinical study design for multi-conjugate vaccine and polyvalent vaccine in terms of safety, immunogenicity, and protective efficacy, and discuss the problems and challenges exisitng in vaccine clinical evaluation to provide reference for the standardization of clinical study design of multi-conjugate vaccine and polyvalent vaccine.
4.Comparison of short-term outcomes and 5-year overall survival between robotic and laparoscopic gastrectomy for gastric cancer
Li ZHANG ; Mingzhi CAI ; Bin LI ; Gang MA ; Xuejing ZHENG ; Ye TIAN ; Xuejun WANG ; Yong LIU ; Han LIANG
Chinese Journal of General Surgery 2025;40(8):601-606
Objective:To compare the short-term clinical outcomes of robotic gastrectomy (RG) and laparoscopic gastrectomy (LG) in treating gastric cancer, as well as the overall 5-year's survival rate.Methods:In this retrospective cohort study, 874 patients undergoing minimally invasive gastrectomy were recruited from Jan 2016 to Jan 2020 (LG: n=719; RG: n=155). A one-to-one propensity score matching analysis was applied to minimize the selection bias due to confounding factors, yielding 150 patients in each of the RG and LG groups. After matching, the short-term outcomes and 5-year overall survival were compared in the two groups. Results:The propensity score matching cohort analysis showed a similar 5-year overall survival between RG and LG groups ( P=0.235). Concerning the short-term outcomes, the RG compared to LG resulted in lower blood loss ( P=0.011), lower postoperative complications ( P=0.001), less postoperative pain ( P=0.014), earlier initiation of soft diet ( P=0.010), shorter hospital stay ( P=0.011), but higher hospitalization expenses ( P=0.004). Conclusions:RG had a similar overall survival outcome compared to LG while offering better safety and efficacy in terms of less blood loss, lower surgery complications, faster recovery, and less postoperative pain. Higher hospital expenses were the main disadvantage of RG that could limit its application.
5.Real experience and needs of lymphoma patients during CAR-T therapy: a qualitative study
Lei DONG ; Fengyang HU ; Chenyang GUAN ; Ting LI ; Jin HAN ; Haoyu ZHANG ; Mingzhi ZHANG
Chinese Journal of Modern Nursing 2024;30(22):3020-3024
Objective:To explore the real experience and needs of lymphoma patients during chimeric antigen receptor T cell (CAR-T) therapy, so as to provide guidance for developing nursing intervention strategies.Methods:The phenomenological research method was used to conduct semi-structured interviews with 13 lymphoma patients receiving CAR-T therapy, and the interview data was analyzed using the Colaizzi 7-step analysis method.Results:Three themes were extracted, including diverse symptom perception (systemic symptoms such as fever and fatigue, as well as multiple system symptoms such as breathing, digestion, and nerves), complex emotional experience interweaving (coexistence of hope and doubt, changes and loss of environmental adaptability, and a variety of negative emotions), and urgent social needs (treatment related information needs, desire for medical and nursing staff's attention and help, family emotional support, and home rehabilitation continuing care) .Conclusions:Lymphoma patients experience significant physical and mental pain during CAR-T therapy. Medical and nursing staff should provide patients with comprehensive support to help them identify and improve physical discomfort symptoms, reduce psychological burden, meet physical and mental needs, and promote disease recovery.
6.Baseline Total Metabolic Tumor Volume and Total Lesion Glycolysis Measured on 18F-FDG PET-CT Predict Outcomes in T-Cell Lymphoblastic Lymphoma
Xiaoyan FENG ; Xin WEN ; Ling LI ; Zhenchang SUN ; Xin LI ; Lei ZHANG ; Jingjing WU ; Xiaorui FU ; Xinhua WANG ; Hui YU ; Xinran MA ; Xudong ZHANG ; Xinli XIE ; Xingmin HAN ; Mingzhi ZHANG
Cancer Research and Treatment 2021;53(3):837-846
Purpose:
There is no optimal prognostic model for T-cell lymphoblastic lymphoma (T-LBL). Here, we discussed the predictive value of total metabolic tumor volume (TMTV) and total lesion glycolysis (TLG) measured on 18F-fluorodeoxyglucose positron emission tomography–computed tomography (PET-CT) in T-LBL.
Materials and Methods:
Thirty-seven treatment naïve T-LBL patients with PET-CT scans were enrolled. TMTV was obtained using the 41% maximum standardized uptake value (SUVmax) threshold method, and TLG was measured as metabolic tumor volume multiplied by the mean SUV. Progression-free survival (PFS) and overall survival (OS) were analyzed by Kaplan-Meier curves and compared by the log-rank test.
Results:
The optimal cutoff values for SUVmax, TMTV, and TLG were 12.7, 302 cm3, and 890, respectively. A high SUVmax, TMTV, and TLG indicated a shorten PFS and OS. On multivariable analysis, TMTV ≥ 302 cm3, and central nervous system (CNS) involvement predicted inferior PFS, while high SUVmax, TLG and CNS involvement were associated with worse OS. Subsequently, we generated a risk model comprising high SUVmax, TMTV or TLG and CNS involvement, which stratified the population into three risk groups, which had significantly different median PFS of not reached, 14 months, and 7 months for low-risk group, mediate-risk group, and high-risk group, respectively (p < 0.001). Median OS were not reached, 27 months, and 13 months, respectively (p < 0.001).
Conclusion
Baseline SUVmax, TMTV, and TLG measured on PET-CT are strong predictors of worse outcome in T-LBL. A risk model integrating these three parameters with CNS involvement identifies patients at high risk of disease progression.
7.Baseline Total Metabolic Tumor Volume and Total Lesion Glycolysis Measured on 18F-FDG PET-CT Predict Outcomes in T-Cell Lymphoblastic Lymphoma
Xiaoyan FENG ; Xin WEN ; Ling LI ; Zhenchang SUN ; Xin LI ; Lei ZHANG ; Jingjing WU ; Xiaorui FU ; Xinhua WANG ; Hui YU ; Xinran MA ; Xudong ZHANG ; Xinli XIE ; Xingmin HAN ; Mingzhi ZHANG
Cancer Research and Treatment 2021;53(3):837-846
Purpose:
There is no optimal prognostic model for T-cell lymphoblastic lymphoma (T-LBL). Here, we discussed the predictive value of total metabolic tumor volume (TMTV) and total lesion glycolysis (TLG) measured on 18F-fluorodeoxyglucose positron emission tomography–computed tomography (PET-CT) in T-LBL.
Materials and Methods:
Thirty-seven treatment naïve T-LBL patients with PET-CT scans were enrolled. TMTV was obtained using the 41% maximum standardized uptake value (SUVmax) threshold method, and TLG was measured as metabolic tumor volume multiplied by the mean SUV. Progression-free survival (PFS) and overall survival (OS) were analyzed by Kaplan-Meier curves and compared by the log-rank test.
Results:
The optimal cutoff values for SUVmax, TMTV, and TLG were 12.7, 302 cm3, and 890, respectively. A high SUVmax, TMTV, and TLG indicated a shorten PFS and OS. On multivariable analysis, TMTV ≥ 302 cm3, and central nervous system (CNS) involvement predicted inferior PFS, while high SUVmax, TLG and CNS involvement were associated with worse OS. Subsequently, we generated a risk model comprising high SUVmax, TMTV or TLG and CNS involvement, which stratified the population into three risk groups, which had significantly different median PFS of not reached, 14 months, and 7 months for low-risk group, mediate-risk group, and high-risk group, respectively (p < 0.001). Median OS were not reached, 27 months, and 13 months, respectively (p < 0.001).
Conclusion
Baseline SUVmax, TMTV, and TLG measured on PET-CT are strong predictors of worse outcome in T-LBL. A risk model integrating these three parameters with CNS involvement identifies patients at high risk of disease progression.
8.Accurate Detemination of Isotopic Abundance of Intracellular Metabolites of Saccharopolysporaerythraea Based on Ultra Performance Liquid Chromatography-Triple Quadrupole Mass Spectrometry
Han MOU ; Ming HONG ; Xiaoyun LIU ; Minchao LI ; Mingzhi HUANG ; Ju CHU ; Yingping ZHUANG ; Siliang ZHANG
Chinese Journal of Analytical Chemistry 2017;45(9):1264-1270
A method for measuring 13C isotopic abundance of intracellular metabolites of Saccharopolysporaerythraea by ultra-high performance liquid chromatography (UPLC)-triple quadrupole mass spectrometry was established.First, the chromatographic conditions of UPLC were optimized, and then the MS conditions such as unique tube lens voltage, collision energy, and ion pair were optimized.On the bases of length of the parent and daughter ions carbon chains and whether the daughter ions contain 13C atoms, the one-to-one method, one-to-many method and SIM method were established for measuring 13C isotopic abundance.Then these methods were used to measure naturally labeled intracellular metabolite standards and 13C labeled samples, and according to the gap between the experimental value and the theoretical value, the best method was established for each metabolite of different characteristics.The results showed that one-to-one method was most effective for measuring the metabolites of daughter ions not containing 13C atoms represented by sugar phosphates, one-to-many method was the best for measuring the metabolites of both parent and daughter ions containing 13C short carbon chains represented by carboxylic acids, SIM method could play a role in measuring the metabolites of both parent and daughter ions containing 13C long carbon chains represented by coenzyme A.This method had a good measurement precision and could be applied to the measurement of Saccharopolysporaerythraea intracellular metabolites, which contributed to the consequent study of metabolic mechanism and the efficient expression of erythromycin.
9.The expression of ABCC4/MRP4 and ABCC5/MRP5 gene in the NK/T cell lymphoma and its relationship with clinical efifcacy
Ruping LI ; Lijuan HAN ; Xudong ZHANG ; Mingzhi ZHANG ; Tengteng HU ; Beibei QIN ; Jianguo WEN
China Oncology 2014;(1):8-14
Background and purpose: Natural killer/T cell lymphoma in poor effects, the production of multidrug resistance is one of the reasons to reduce the chemotherapy effect or failure. This study aimed to discuss the multidrug resistance associated protein 4 (ABCC4/MRP4) gene and multidrug resistance associated protein 5 (ABCC5/MRP5) gene expression in NK/T cell lymphoma SNK-6, YTS cell lines and NK/T cell lymphoma tissues, and the relationship between the level of ABCC4/MRP4, ABCC5/MRP5 gene expression and the clinical efifcacy. Methods:Real-time lfuorescence quantitative PCR (Real time-PCR) and immunohistochemical method (IHC) were used to detect the ABCC4/MRP4, ABCC5/MRP5 gene and protein expression. Results:Compared with the normal NK cells, ABCC4/MRP4 and ABCC5/MRP5 gene in SNK-6, YTS cell lines were highly expressed (P<0.05); Compared with rhinitis tissues, the expression of ABCC4/MRP4, ABCC5/MRP5 gene was higher in the NK/T cell lymphoma tissues (P<0.05);The expression level of ABCC4/MRP4 and ABCC5/MRP5 gene was negative correlation with clinical efifcacy (P<0.05). Conclusion: The expression of ABCC4/MRP4 and ABCC5/MRP5 gene affects the of clinical efifcacy of NK/T cell lymphoma.
10.Clinical analysis of 156 patients with gastrointestinal stromal tumors receiving imatinib therapy.
Li ZHANG ; Mingzhi CAI ; Jingyu DENG ; Xiaona WANG ; Baogui WANG ; Ning LIU ; Yuan PAN ; Rupeng ZHANG ; Qinghao CUI ; Han LIANG
Chinese Journal of Gastrointestinal Surgery 2014;17(4):331-334
OBJECTIVETo evaluate the impact of primary site, NIH risk and imatinib treatment on the prognosis of patients with gastrointestinal stromal tumors(GIST).
METHODSClinicopathological data of 156 adult patients with GIST treated by imatinib in the Cancer Institute and Hospital of Tianjin Medical University from January 2006 to December 2010 were retrospectively analyzed. According to NIH risk classification, 30 patients were at moderate risk and 126 at high risk. Sixty-seven patients had advanced GIST. Prognosis of patients with different primary tumor site, different NIH risk and different treatment was compared respectively.
RESULTSImatinib therapy was well tolerated in all the patients. Eighty-nine cases received radical operation and adjuvant imatinib treatment. Among 67 advanced GIST cases, 26 received radical operation and adjuvant imatinib treatment, 27 received palliative operation and adjuvant imatinib treatment, and 14 received simple adjuvant imatinib treatment without operation. All the patients had routine follow-up, ranging from 9 to 56(median 27) months. The overall survival (OS) rate was 96% in 1-year, 86% in 2-year, and 71% in 3-year. The OS rate was 95% in 1-year, 77% in 2-year, and 65% in 3-year for patients at high risk, and all 100% in 1-, 2-, 3-year for patients at moderate risk, the differences was statistically significant (P=0.001). The OS rate was 97% in 1-year, 90% in 2-year, and 84% in 3-year for patients with gastric GIST, and 95% in 1-year, 69% in 2-year, and 52% in 3-year for patients with non-gastric GIST, the difference was significant(P=0.000). The OS rate was 98% in 1-year, 95% in 2-year, and 90% in 3-year for patients undergoing radical resection and adjuvant imatinib therapy. For 67 advanced GIST patients with imatinib therapy, none had complete remission, 41 had part remission, 15 had stable disease, indicating 56 advanced GIST cases(83.6%) obtaining clinical benefit. The OS rate was 91% in 1-year, 58% in 2-year, and 43% in 3-year.
CONCLUSIONSThe prognosis of high, and non-gastric and advanced GIST patients is poor. Radical resection combined with early imatinib treatment can improve the prognosis of GIST patients.
Antineoplastic Agents ; therapeutic use ; Benzamides ; therapeutic use ; Combined Modality Therapy ; Follow-Up Studies ; Gastrointestinal Neoplasms ; drug therapy ; pathology ; Gastrointestinal Stromal Tumors ; drug therapy ; Humans ; Imatinib Mesylate ; Piperazines ; therapeutic use ; Prognosis ; Pyrimidines ; therapeutic use ; Retrospective Studies ; Survival Rate

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