1.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.
2.Progress of research on potato scab and its prevention and control.
Yue MA ; Xiu WANG ; Naiqin ZHONG ; Pan ZHAO ; Jiahe WU
Chinese Journal of Biotechnology 2025;41(10):3651-3666
In recent years, potato scab caused by pathogenic Streptomyces spp. has become widespread globally, with increasing damage severely compromising the commercial value and storability of tubers. The pathogens are transmitted through the soil and seeds of potato, while existing control technologies have demonstrated limited efficacy in preventing the colonization and spread of pathogens, which pose a critical bottleneck in the sustainable development of the potato industry. This study systematically examines the pathogen characteristics and pathogenic mechanisms, evaluates the impacts of soil nutrients and microbial community structure on disease severity, and analyzes limitations in current chemical control, biological control, and disease-resistant variety breeding approaches. We propose an integrated control strategy of disease-resistant varieties, phosphorus fertilizer reduction, fertilizer efficiency enhancement, and phosphorus-soluble antagonistic fungicides, aiming to provide novel research perspectives for achieving effective prevention and control of potato scab.
Solanum tuberosum/microbiology*
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Plant Diseases/prevention & control*
;
Streptomyces/pathogenicity*
;
Disease Resistance
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Fungicides, Industrial/pharmacology*
;
Fertilizers
;
Soil Microbiology
3.Application of macrophage-related risk model analysis based on The Cancer Genome Atlas database in the study of lung squamous cell carcinoma
Chenghuan DAO ; Jiahe WANG ; Yinli YANG ; Zhanyu PAN
Journal of China Medical University 2025;54(6):486-492
Objective To construct a macrophage-related risk assessment model,explore the impact of macrophages on the survival of patients with lung squamous cell carcinoma(LUSC),and predict immune status.Methods We downloaded the data of macrophages and LUSC from the Molecular Signatures DataBase(MSigDB)and The Cancer Genome Atlas(TCGA)database,respectively,screened for differentially expressed macrophage-related genes,and constructed a risk score model using Cox regression analysis.Based on the median value of the risk score,LUSC in the TCGA database was divided into high-and low-risk groups.Kaplan-Meier analyses,receiver operating characteristic curve analyses,clinical case characteristics,and immune analyses were used to evaluate the prognostic model.Finally,we determined the relationship between anticancer drug sensitivity and the risk score using the Genomics of Drug Sensitivity in Cancer(GDSC).Results A total of 124 macrophage-related genes were identified in LUSC.High-risk patients had shorter overall survival and higher infiltration of immunosuppressive cells.Ruxolitinib,vinorelbine,paclitaxel,and sorafenib seemingly exhibited better efficacy in low-risk patients.The mortality rate of LUSC patients decreasd with the reduction of risk scores,and CSF2 and EDN2 had a significant impact on overall survival.Conclusion In this study,we constructed a macrophage gene risk score model for predicting the prognosis of LUSC.The model genes CSF2 and END2 can be used as potential targets for subsequent studies of LUSC.
4.The application of sequential analysis for continuous post-market vaccine safety surveillance
Zixuan LU ; Musu LI ; Jiahe PAN ; Yiwen WU ; Huilin LI ; Er YU ; Hongmei WO ; Shaowen TANG ; Yang ZHAO ; Juncheng DAI ; Honggang YI
Chinese Journal of Epidemiology 2025;46(3):514-518
To explore the application of sequential analysis in post-market safety dynamic surveillance of vaccines. Under the dynamic monitoring data of vaccines post-market approval, this research introduces the fundamental principles of maximizing sequential probability ratio test (MaxSPRT) and Bayesian sequential analysis, employing R software. Through an example of dynamic safety monitoring data of vaccines post-market approval, we analyze using the MaxSPRT and Bayesian sequential analysis. The MaxSPRT identified a safety signal in week 4 ( P<0.05), while Bayesian sequential analysis indicated that the 95% highest density interval for the RR value at week 4 is 1.13-3.27, suggesting the first appearance of a safety signal at week 4. The MaxSPRT and Bayesian sequential analysis effectively leverage continuously accumulating dynamic monitoring data, thereby serving as a valuable method for post-market safety surveillance of vaccines.
5.The application of sequential analysis for continuous post-market vaccine safety surveillance
Zixuan LU ; Musu LI ; Jiahe PAN ; Yiwen WU ; Huilin LI ; Er YU ; Hongmei WO ; Shaowen TANG ; Yang ZHAO ; Juncheng DAI ; Honggang YI
Chinese Journal of Epidemiology 2025;46(3):514-518
To explore the application of sequential analysis in post-market safety dynamic surveillance of vaccines. Under the dynamic monitoring data of vaccines post-market approval, this research introduces the fundamental principles of maximizing sequential probability ratio test (MaxSPRT) and Bayesian sequential analysis, employing R software. Through an example of dynamic safety monitoring data of vaccines post-market approval, we analyze using the MaxSPRT and Bayesian sequential analysis. The MaxSPRT identified a safety signal in week 4 ( P<0.05), while Bayesian sequential analysis indicated that the 95% highest density interval for the RR value at week 4 is 1.13-3.27, suggesting the first appearance of a safety signal at week 4. The MaxSPRT and Bayesian sequential analysis effectively leverage continuously accumulating dynamic monitoring data, thereby serving as a valuable method for post-market safety surveillance of vaccines.
6.Application of macrophage-related risk model analysis based on The Cancer Genome Atlas database in the study of lung squamous cell carcinoma
Chenghuan DAO ; Jiahe WANG ; Yinli YANG ; Zhanyu PAN
Journal of China Medical University 2025;54(6):486-492
Objective To construct a macrophage-related risk assessment model,explore the impact of macrophages on the survival of patients with lung squamous cell carcinoma(LUSC),and predict immune status.Methods We downloaded the data of macrophages and LUSC from the Molecular Signatures DataBase(MSigDB)and The Cancer Genome Atlas(TCGA)database,respectively,screened for differentially expressed macrophage-related genes,and constructed a risk score model using Cox regression analysis.Based on the median value of the risk score,LUSC in the TCGA database was divided into high-and low-risk groups.Kaplan-Meier analyses,receiver operating characteristic curve analyses,clinical case characteristics,and immune analyses were used to evaluate the prognostic model.Finally,we determined the relationship between anticancer drug sensitivity and the risk score using the Genomics of Drug Sensitivity in Cancer(GDSC).Results A total of 124 macrophage-related genes were identified in LUSC.High-risk patients had shorter overall survival and higher infiltration of immunosuppressive cells.Ruxolitinib,vinorelbine,paclitaxel,and sorafenib seemingly exhibited better efficacy in low-risk patients.The mortality rate of LUSC patients decreasd with the reduction of risk scores,and CSF2 and EDN2 had a significant impact on overall survival.Conclusion In this study,we constructed a macrophage gene risk score model for predicting the prognosis of LUSC.The model genes CSF2 and END2 can be used as potential targets for subsequent studies of LUSC.
7.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.
8.Self close intubation ileostomy in the prevention of anastomotic leakage of anterior resection after neoadjuvant chemoradiation in patients of low rectal carcinoma
Changling TANG ; Zhe PAN ; Caizhao LIN ; Jianjiang LIN ; Jiahe XU
Chinese Journal of General Surgery 2014;29(7):531-533
Objective To explore the safety and applicability of a temporary protective ileostomy that closes itself in the prevention of anastomotic leakage following anterior resection after chemoradiation for rectal cancer.Methods From Oct 2010 to Oct 2013,54 cases of middle or low rectal carcinoma were admitted.Protective ileostomy was created to prevent anastomotic leakage.Patients were divided into two groups receiving respectively intubation ileostomy (group A,28 cases),and conventional ileostomy (group B,26 cases).Results The mean time for anus to restore defecation was identical in the two groups.The period of protection of the anastomosis,was 21 d (15 ~ 35 d) in group A.The rate of spontaneous closure of the stoma after removal of the tube was 100%.The stoma was reduced after 3 to 6 months in group B and major complication developed in one case in this group.Conclusions Temporary ileostomy prevents anastomotic leakage of anterior resection in patients of rectal carcinoma receiving preoperative neoadjuvant chemoradiotherapy.Intubation ileostomy is effective and safe in prevention of anastomotic leakage saving stoma reduction procedures.

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