1.Efficacy and safety of neoadjuvant sintilimab plus chemotherapy for locally advanced resectable esophageal squamous cell carcinoma
Liji CHEN ; Junjun HUANG ; Hongmei MA ; Shifa ZHANG ; Dongbao YANG ; Jiuhe SUN ; Hongfeng LIU ; Kaize ZHONG ; Haibo CAI
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(07):1071-1078
Objective To observe the efficacy and safety of neoadjuvant sintilimab combined with chemotherapy in the treatment of patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC). Methods Clinical data were collected from patients with locally advanced resectable ESCC who received neoadjuvant immunotherapy combined with chemotherapy followed by surgical treatment at the Department of Thoracic Surgery of Jining No.1 People's Hospital from April 2020 to April 2022. The endpoints included major pathological response (MPR), pathological complete response (pCR), R0 resection rate, safety, and postoperative survival. Results A total of 43 patients with ESCC who received at least one cycle of neoadjuvant immunotherapy before surgery were included. Among them, there were 31 males and 12 females with a median age of 65 years (interquartile range: 58-69). All patients successfully completed the surgery without any surgical delays. The pCR rate was 14.0% (6/43), the MPR rate was 58.1% (25/43), and the R0 resection rate was 97.7% (42/43). Patients exhibited reliable safety during neoadjuvant therapy and postoperatively. The 2-year overall survival and disease-free survival rates were 90.7% and 81.4%, respectively. Kaplan-Meier survival analysis and log-rank test revealed lower recurrence rates and better survival in the MPR patients compared to the non-MPR patients. Conclusion The combination of neoadjuvant sintilimab and chemotherapy in the treatment of patients with locally advanced resectable ESCC has demonstrated significant clinical efficacy, while also being safe and reliable.
2.Application of the Bayesian mixture model based on a principal stra-tum strategy in clinical trials
Yiwen WU ; Yue SUN ; Zixuan LU ; Jiahe PAN ; Er YU ; Hongmei WO ; Shaowen TANG ; Yang ZHAO ; Juncheng DAI ; Honggang YI
Chinese Journal of Clinical Pharmacology and Therapeutics 2025;30(7):942-949
AIM:To evaluate the application effec-tiveness of a Bayesian mixture model based on the principal stratum strategy for estimating the com-plier average causal effect(CACE)in clinical trials with non-compliance.METHODS:Using a non-infe-riority randomized controlled trial investigating a novel drug for primary type 2 diabetes mellitus(non-inferiority margin:-0.4)as a case study,the primary analysis applied a Bayesian mixture model under the monotonicity assumption to estimate CACE of between-group differences in glycated he-moglobin(HbA1c)changes within the compliant stratum,followed by non-inferiority testing.Sensi-tivity analyses included a Bayesian mixture model relaxing the monotonicity assumption and compar-ing results with per-protocol set(PPS)analysis.RE-SULTS:In the primary analysis,the posterior mean of CACE for HbA1c change in the compliant stratum was 0.081%,with a one-sided 97.5%credible inter-val lower bound of-0.124,exceeding the non-infe-riority margin(-0.4%),supporting the non-inferiori-ty efficacy of the novel drug in the compliant stra-tum(P(H1|Data)=1).Consistent findings were ob-served in PPS analyses(estimated effect:0.136%;one-sided 97.5%credible interval lower bound:-0.069%),further validating methodological robust-ness.CONCLUSION:In clinical trials with noncom-pliance as an intercurrent event,the Bayesian mix-ture model under the principal stratum strategy ef-fectively adjusts for compliance-related bias and yields conservative,robust estimates of causal ef-fects,supporting its value in efficacy evaluation un-der complex compliance scenarios.
3.Association of HCMV infection with types of carotid atherosclerotic plaques and poor prognosis of patients with ischemic stroke
Xiaoli ZHU ; Fei SUN ; Hongmei DIAO
Chinese Journal of Nosocomiology 2025;35(9):1332-1336
OBJECTIVE To analyze the relationship between human cytomegalovirus(HCMV)infection and types of carotid atherosclerotic plaques and poor prognosis of patients with ischemic stroke so as to provide bases for im-provement of the prognosis of the patients.METHODS A total of 102 patients with ischemic stroke who were trea-ted in Tengzhou Central People's Hospital form Jun.2022 to Jun.2023 were enrolled in the study,the enrolled pa-tients underwent carotid artery ultrasound examination,and the types of the plaques were analyzed.The peripheral blood HCMV-PP65 antigen was detected by immunofluorescent assay;the tumor necrosis factor-α(TNF-α),in-terleukin-1(IL-1),intercellular adhesion molecule-1(ICAM-1)and vascular endothelial cell adhesion molecule-1(VCAM-1)were detected by enzyme-linked immunosorbent assay,the plasma HCMV DNA viral load was detec-ted by means of real-time fluorescent quantitative polymerase chain reaction.Pearson correlation analysis was per-formed for the association of the HCMV DNA viral load with the levels of TNF-α,IL-1,ICAM-1 and VCAM-1.The incidence rates of adverse events such as intracranial hemorrhage,cerebral hernia,recurrent stroke and death were statistically analyzed within 6 months of follow-up.RESULTS Among the 102 patients,54 were positive for HCMV-PP65 antigen,and 48 were negative for HCMV-PP65 antigen.The percentage of unstable plaque,score of soft plaque,serum TNF-α level,IL-1 level,ICAM-1 level and VCAM-1 level of the positive HCMV-PP65 antigen group were 68.52%,(3.02±0.31)points,(5.03±0.53)μg/L,(5.32±0.55)μg/L,(589.48±59.67)μg/L and(1025.19±5.54)μg/L,respectively,higher than those of the negative HCMV-PP65 antigen group(P<0.05).The HCMV DNA viral load of the positive HCMV-PP65 antigen group was(4.87±0.51)× 103 copies/ml,higher than(1.42±0.16)× 103 copies/ml of the negative HCMV-PP65 antigen group(P<0.05).Pearson correlation a-nalysis showed that the levels of TNF-α,IL-1,ICAM-1 and VCAM-1 were positively correlated with the HCMV DNA viral load(P<0.05).The total incidence of poor prognosis of the positive HCMV-PP65 antigen group was 87.04%,higher than 58.33%of the negative HCMV-PP65 antigen group(P<0.05).CONCLUSIONS The detec-tion rate of unstable carotid atherosclerotic plaques of the patients positive for HCMV-PP65 antigen is higher than that of the patients negative for HCMV-PP65 antigen.The HCMV infection may aggravate the inflammatory reac-tions and tend to induce poor prognosis.
4.Clinical effectiveness assessment of a single dose of tranexamic acid for perioperative blood loss control in patients treated with craniomaxillofacial plastic and cosmetic surgery: a meta-regression analysis of registered randomized controlled trials
Chenxi LI ; Hongmei MA ; Yao LIU ; Jingfei HAN ; Mingchao DING ; Jialin SUN
Chinese Journal of Plastic Surgery 2025;41(1):52-68
Objective:To comprehensively evaluate the clinical effectiveness with respect to a single dose of tranexamic acid (TXA) given preoperatively for blood loss control in perioperative patients accepted craniomaxillofacial plastic and cosmetic surgery.Methods:Embase, PubMed, WanFang Data, VIP, China National Knowledge Infrastructure (CNKI), the Chinese Clinical Trial Registry (ChiCTR) and Cochrane Central Register of Controlled Trials (CENTRAL) were electronically retrieved to collect randomized controlled trials (RCTs) related to appraise the efficacy in perioperative craniomaxillofacial plastic and cosmetic surgery patients used TXA from inception to August 2024. Based on the result of methodological heterogeneity, corresponding paired meta-analyses were carried out with a random-effects or fixed-effects model applying R 4.0.4 software. Subgroup analysis was performed based on type of surgery, patient age, regional distribution of patients, and sample size included in the studies. A meta-regression analysis was performed on studies that reported the effect of different doses of TXA on reducing perioperative bleeding. Sensitivity analysis was performed to verify the stability of the meta result. Egger’s test was used to analyze potential publication bias.Results:A total of 31 RCTs were included, involving 2 072 patients, with 1 051 in the TXA group and 1 021 in the placebo group. The paired meta-analysis random-effects model ( I2=90%) showed that compared with the control group, the use of TXA significantly reduced the amount of bleeding in perioperative patients[standardized mean difference ( SMD)=-1.13, 95% CI -1.47 to -0.80, P < 0.01]. Subgroup analysis revealed that TXA had a significant effect on reducing intraoperative bleeding in patients with different surgeries, ages, regions, and sample sizes. The most effective subgroups were cases in orthognathic surgery ( SMD=-1.44, 95% CI -2.07 to -0.80, P< 0.01), less than 30 year-old( SMD=-1.32, 95% CI -1.68 to -0.96, P< 0.01], Asian patients( SMD=-1.29, 95% CI -1.72 to -0.86, P< 0.01), less than 30 individuals ( SMD=-1.16, 95% CI -1.50 to -0.82, P< 0.01). The result of the meta regression showed there was no significant difference in the hemostatic effect of TXA on patients with increasing doses (5, 10, 15, 20, 25 mg/kg) ( P>0.05). Sensitivity analysis verified that the pooled values were stable and reliable. The Egger’s test indicated a certain degree of publication bias ( P < 0.01). Conclusion:Taken as a whole, existing evidence suggests that TXA can effectively reduce perioperative bleeding in patients undergoing craniofacial plastic surgery, regardless of its dosage administered. However, further clinical researches are still needed to provide more baselined data, transfusion-related indicators, and information on adverse events such as vascular embolism, in order to comprehensively evaluate and analyze the efficacy and safety of a single dose of TXA for perioperative blood loss control in patients treated with craniomaxillofacial plastic and cosmetic surgery.
5.Mixed-method Study on Regulatory Status and Standardization Issues of Centralized Decoction of Chinese Materia Medica in Hangzhou
Feiyu LI ; Guoxiu LIU ; Qianqian SUN ; Hongmei CHEN ; Yuzhou YANG ; Hanzong WANG ; Huaqiang ZHAI
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(11):6-12
Objective To analyze the current situation of quality control and regulation of centralized decoction of Chinese materia medica in Hangzhou through a mixed study combining quantitative research and qualitative research;To provide references for its standardization.Methods A self-designed questionnaire was distributed from July 20,2023 to August 10,2023 in institutions providing centralized decoction services of Chinese materia medica in different regions of Hangzhou.Using the stratified sampling method,the institutional personnel who completed the questionnaire survey were selected as the interviewees,and the semi-structured interview was used to refine the theme according to the Colaizzi seven step method.Results Totally 98 questionnaires were distributed and 96 valid questionnaires were recovered,with a valid recovery rate of 97.96%.There were significant differences in soaking time,concentration degree,and special decoction method such as decocted earlier or later of decoction pieces of Chinese materia medica among different types of institutions(P<0.05).The centralized decoction of Chinese materia medica in Hangzhou mainly involves two themes and seven sub themes:the supervision and management of the whole process of centralized decoction of Chinese materia medica(optimizing distribution of medical resources,strengthening of supervision,demanding guidance of standards),the operation of centralized decoction of Chinese materia medica(soaking time of decoction pieces of Chinese materia medica,the pretreatment operation of"decocted earlier and decocted later",the concentration treatment of Chinese materia medica decoction,and the quality control of Chinese materia medica decoction).Conclusion At present,centralized decoction of Chinese materia medica in Hangzhou still needs to be further standardized.It is recommended to strengthen the construction of shared Chinese materia medica pharmacy in the region,establish and improve the standard system of centralized decoction of Chinese materia medica decoction,and strengthen the construction of digital full chain traceability to improve the service quality and management level of centralized decoction of Chinese materia medica in Hangzhou.
6.Association of HCMV infection with types of carotid atherosclerotic plaques and poor prognosis of patients with ischemic stroke
Xiaoli ZHU ; Fei SUN ; Hongmei DIAO
Chinese Journal of Nosocomiology 2025;35(9):1332-1336
OBJECTIVE To analyze the relationship between human cytomegalovirus(HCMV)infection and types of carotid atherosclerotic plaques and poor prognosis of patients with ischemic stroke so as to provide bases for im-provement of the prognosis of the patients.METHODS A total of 102 patients with ischemic stroke who were trea-ted in Tengzhou Central People's Hospital form Jun.2022 to Jun.2023 were enrolled in the study,the enrolled pa-tients underwent carotid artery ultrasound examination,and the types of the plaques were analyzed.The peripheral blood HCMV-PP65 antigen was detected by immunofluorescent assay;the tumor necrosis factor-α(TNF-α),in-terleukin-1(IL-1),intercellular adhesion molecule-1(ICAM-1)and vascular endothelial cell adhesion molecule-1(VCAM-1)were detected by enzyme-linked immunosorbent assay,the plasma HCMV DNA viral load was detec-ted by means of real-time fluorescent quantitative polymerase chain reaction.Pearson correlation analysis was per-formed for the association of the HCMV DNA viral load with the levels of TNF-α,IL-1,ICAM-1 and VCAM-1.The incidence rates of adverse events such as intracranial hemorrhage,cerebral hernia,recurrent stroke and death were statistically analyzed within 6 months of follow-up.RESULTS Among the 102 patients,54 were positive for HCMV-PP65 antigen,and 48 were negative for HCMV-PP65 antigen.The percentage of unstable plaque,score of soft plaque,serum TNF-α level,IL-1 level,ICAM-1 level and VCAM-1 level of the positive HCMV-PP65 antigen group were 68.52%,(3.02±0.31)points,(5.03±0.53)μg/L,(5.32±0.55)μg/L,(589.48±59.67)μg/L and(1025.19±5.54)μg/L,respectively,higher than those of the negative HCMV-PP65 antigen group(P<0.05).The HCMV DNA viral load of the positive HCMV-PP65 antigen group was(4.87±0.51)× 103 copies/ml,higher than(1.42±0.16)× 103 copies/ml of the negative HCMV-PP65 antigen group(P<0.05).Pearson correlation a-nalysis showed that the levels of TNF-α,IL-1,ICAM-1 and VCAM-1 were positively correlated with the HCMV DNA viral load(P<0.05).The total incidence of poor prognosis of the positive HCMV-PP65 antigen group was 87.04%,higher than 58.33%of the negative HCMV-PP65 antigen group(P<0.05).CONCLUSIONS The detec-tion rate of unstable carotid atherosclerotic plaques of the patients positive for HCMV-PP65 antigen is higher than that of the patients negative for HCMV-PP65 antigen.The HCMV infection may aggravate the inflammatory reac-tions and tend to induce poor prognosis.
7.Construction of an evaluation system for actual combat injury treatment ability of grassroots officers and soldiers based on analytic hierarchy process
Tianchi YANG ; Kai CAO ; Hui SHAO ; Shengkai SUN ; Hongmei LIU ; Yannan YANG
Chinese Journal of Medical Education Research 2025;24(6):757-762
Objective:In view of the incomplete evaluation system of actual combat injury treatment ability of grassroots officers and soldiers at present, this paper aims to construct a multi-dimensional evaluation system for combat injury treatment to provide theoretical guidance and evaluation means for warfighting-oriented training on combat injury treatment.Methods:Through literature review, expert consultation, and hierarchical analysis, we determined the factors to evaluate the comprehensive ability of field first aid for combat injuries of grassroots officers and soldiers from the perspective of actual combat, and then established a system for evaluating the actual combat injury treatment ability of grassroots officers and soldiers, in which the weights of factors in each dimension were determined.Results:An evaluation system of actual combat injury treatment ability of grassroots officers and soldiers was formed, which included 4 first-level indices and 16 second-level indices in tactics, strategies, treatment, and protection dimensions.Conclusions:The established evaluation system can provide a reference for actual combat injury treatment training at the grassroots level.
8.Predictive value of dual-energy CT quantitative parameters in determining breast cancer molecular subtypes and EGFR expression
Bing SUN ; Yinshi ZHENG ; Kunpeng FENG ; Mu YUAN ; Hongmei CHEN ; Wenqi HUANG
Chinese Journal of Endocrine Surgery 2025;19(2):213-217
Objective:To explore the predictive potential of dual-energy CT (DECT) quantitative parameters in identifying breast cancer molecular subtypes and the expression of the epidermal growth factor receptor (EGFR) .Methods:A cohort of 97 breast cancer patients, treated between Jun. 2022 and Jun. 2024 were selected. The study compared DECT parameters-such as iodine concentration (IC) , normalized iodine concentration (NIC) , spectral curve slope (λ HU) , and effective atomic number (Z eff) in both arterial and venous phases across different molecular subtypes. A multiclass logistic regression model was employed to assess the parameters' value in predicting molecular subtypes, while a binary logistic regression model was used to evaluate their predictive value for EGFR expression. Results:Multiple Logistic regression analysis showed that after adjusting for confounder age and family history, IC ( OR=1.72, 2.78, 3.05) , NIC ( OR=2.52, 1.94, 2.93) , λ HU ( OR=2.08, 2.54, 3.17) and Z eff ( OR=2.03, 2.30, 2.37) at arterial stage were independently correlated with the molecular subtypes of breast cancer ( P<0.05) . Binary logistic regression analysis, adjusted for tumor size and lymph node metastasis, identified arterial phase IC ( OR=3.45) , NIC ( OR=2.73) , λ HU ( OR=2.59) , and Z eff ( OR=1.76) as independent risk factors for EGFR-positive breast cancer ( P<0.05) . Conclusion:DECT quantitative parameters, particularly arterial phase IC, NIC, λ HU, and Zeff, offer valuable insights into the molecular subtyping of breast cancer and EGFR expression, thereby assisting in the development of personalized treatment strategies.
9.Effect of LncRNA NORAD on macrophage apoptosis via sponging miR-20a-5p in Mycobacterium tuberculosis infection
Hongmei SUN ; Huanhuan CHENG ; Xianglong KONG ; Jianchang XUE
Chinese Journal of Infection and Chemotherapy 2025;25(5):549-556
Objective To investigate the effect of long non-coding RNA non-coding RNA-activated by DNA damage(LncRNA NORAD)on macrophage apoptosis induced by Mycobacterium tuberculosis infection via sponging microRNA-20a-5p(miR-20a-5p).Methods Healthy subjects(n=50)who came for health checkup,patients with active tuberculosis(n=50)and individuals with asymptomatic M.tuberculosis infection(n=50)were enrolled from Hebei Chest Hospital from March 2022 to April 2023.Venous blood samples were collected to prepare serum samples.The expression levels of LncRNA NORAD,miR-20a-5p,and inflammatory factors in the serum were measured.Human monocyte line THP-1 was induced to differentiate into macrophages and assigned into Control group,Model group,transfection of NORAD empty vector group(sh-NC group),transfection of sh-NORAD vector group(sh-NORAD group),co-transfection of sh-NORAD and miR-20a-5p inhibitor empty vector group(sh-NORAD+miR-20a-5p inhibitor NC group),co-transfection of sh-NORAD and miR-20a-5p inhibitor vector group(sh-NORAD+miR-20a-5p inhibitor group),transfection of miR-20a-5p empty vector group(miR-NC group),and transfection of miR-20a-5p vector group(miR-20a-5p mimics group).The expression levels of LncRNA NORAD and miR-20a-5p(qRT PCR method),cell proliferation ability(CCK-8 kit method),cell apoptosis(flow cytometry method),inflammatory factor levels(ELISA method),and protein expression levels of BCL2-Associated X(Bax),B-cell lymphoma-2(Bcl-2),and cleaved caspase 3 in cells were detected.The targeted relationship between LncRNA NORAD and miR-20a-5p was validated.Results Compared with healthy subjects,the patients with active tuberculosis and asymptomatic M.tuberculosis infection had significantly higher serum levels of inflammatory factors and expression of LncRNA NORAD,and significantly lower miR-20a-5p.Compared with Control group,Model group had significantly higher LncRNA NORAD level,cell proliferation ability,Bcl-2 protein expression,and inflammatory factor levels,but significantly lower miR-20a-5p level,apoptosis rate,and Bax and cleaved caspase 3 protein expression(P<0.05).Compared with the sh-NC group,the sh-NORAD group had significantly lower LncRNA NORAD level,Bcl-2 protein expression,inflammatory factor levels,and cell proliferation ability,but significantly higher miR-20a-5p level,apoptosis rate,and Bax and cleaved caspase 3 protein expression(P<0.05).Compared with the sh-NORAD+miR-20a-5p inhibitor NC group,the sh-NORAD+miR-20a-5p inhibitor group had significantly higher inflammatory factor levels,Bcl-2 protein expression,and cell proliferation ability,but significantly lower miR-20a-5p level,apoptosis rate,and Bax and cleaved caspase 3 protein expression(P<0.05).Compared with the miR-NC group,the miR-20a-5p mimics group had significantly increased inflammatory cytokines and proliferation ability,and significantly reduced apoptosis rate(P<0.05).The targeted relationship between LncRNA NORAD and miR-20a-5p was further confirmed through experiments.Conclusions LncRNA NORAD is overexpressed in macrophages induced by M.tuberculosis.Silencing the expression of LncRNA NORAD can target the downregulation of miR-20a-5p expression,thereby inhibiting the inflammatory response of macrophages induced by M.tuberculosis and promoting cell apoptosis.
10.Predictive value of dual-energy CT quantitative parameters in determining breast cancer molecular subtypes and EGFR expression
Bing SUN ; Yinshi ZHENG ; Kunpeng FENG ; Mu YUAN ; Hongmei CHEN ; Wenqi HUANG
Chinese Journal of Endocrine Surgery 2025;19(2):213-217
Objective:To explore the predictive potential of dual-energy CT (DECT) quantitative parameters in identifying breast cancer molecular subtypes and the expression of the epidermal growth factor receptor (EGFR) .Methods:A cohort of 97 breast cancer patients, treated between Jun. 2022 and Jun. 2024 were selected. The study compared DECT parameters-such as iodine concentration (IC) , normalized iodine concentration (NIC) , spectral curve slope (λ HU) , and effective atomic number (Z eff) in both arterial and venous phases across different molecular subtypes. A multiclass logistic regression model was employed to assess the parameters' value in predicting molecular subtypes, while a binary logistic regression model was used to evaluate their predictive value for EGFR expression. Results:Multiple Logistic regression analysis showed that after adjusting for confounder age and family history, IC ( OR=1.72, 2.78, 3.05) , NIC ( OR=2.52, 1.94, 2.93) , λ HU ( OR=2.08, 2.54, 3.17) and Z eff ( OR=2.03, 2.30, 2.37) at arterial stage were independently correlated with the molecular subtypes of breast cancer ( P<0.05) . Binary logistic regression analysis, adjusted for tumor size and lymph node metastasis, identified arterial phase IC ( OR=3.45) , NIC ( OR=2.73) , λ HU ( OR=2.59) , and Z eff ( OR=1.76) as independent risk factors for EGFR-positive breast cancer ( P<0.05) . Conclusion:DECT quantitative parameters, particularly arterial phase IC, NIC, λ HU, and Zeff, offer valuable insights into the molecular subtyping of breast cancer and EGFR expression, thereby assisting in the development of personalized treatment strategies.

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