1.Current Status and Optimization Strategies for Setting Objective Performance Criteria in Clinical Trials of Traditional Chinese Medicine
Jiaqi LAI ; Qian HUANG ; Xueyin CHEN ; Shaonan LIU ; Lihong YANG ; MIMAZHUOGA ; DAWA ; Zhijian LI ; Tuerxun WUFUER ; Xinfeng GUO
Journal of Traditional Chinese Medicine 2026;67(13):1461-1464
Current formulation of objective performance criteria (OPC) in traditional Chinese medicine (TCM) faces methodological challenges, including poor reporting quality, insufficient standardization of methods, limited comparability of study populations, and inadequate consideration of the genetic and environment particularities of ethnic minority populations. In response to these issues, this paper proposes optimization strategies for setting OPC in TCM, with particular attention to ethnic minority medicine. These include improving methodological techniques and statistical descriptions, ensuring transparency in meta-analyses and data sources; standardizing the estimation of point estimates and confidence intervals, and incorporating multidisciplinary expert consensus for value determination; introducing local real-world data from the same period, especially cohort study evidence, to compensate for the lack of high-quality randomized controlled trial data. Through process transparency and dynamic updating mechanisms, the credibility of OPC method can be enhanced, thereby providing methodological support for strengthening evidence-based research capacity in this field.
2.Endovascular Treatment for Acute Posterior Circulation Tandem Lesions: Insights From the BASILAR and PERSIST Registries
Wei LI ; Mohamed F. DOHEIM ; Zhongming QIU ; Tan WANG ; Zhibin CHEN ; Wenjie ZI ; Qingwu YANG ; Haitao GUAN ; Hongyu QIAO ; Wenhua LIU ; Wei HU ; Xinfeng LIU ; Jinbo HUANG ; Zhongkui HAN ; Zhonglun CHEN ; Zhenqiang ZHAO ; Wen SUN ; Raul G. NOGUEIRA
Journal of Stroke 2025;27(1):75-84
Background:
and Purpose Limited evidence exists on the effectiveness of endovascular treatment (EVT) for acute posterior circulation tandem lesion (PCTL). This study aimed to explore the role of extracranial vertebral artery (VA) stenting in patients with PCTL stroke undergoing EVT.
Methods:
Individual patient data were pooled from the BASILAR (EVT for Acute Basilar Artery Occlusion Study) and PERSIST (Posterior Circulation Ischemic Stroke) registries. Patients with PCTLs who underwent EVT were included in the present cohort and divided into the stenting and nonstenting groups based on the placement of extracranial VA stents. The primary efficacy outcome was the modified Rankin Scale (mRS) scores at 90 days and 1 year. Safety outcomes included 24-hour symptomatic intracranial hemorrhage (sICH) and all-cause mortality at 90 days and 1 year post-surgery.
Results:
A combined dataset of 1,320 patients with posterior circulation artery occlusion, including 263 (19.9%) with tandem lesions, of whom 217 (median age, 65 years; 82.9% male) met the inclusion criteria for the analysis. The stenting group had 84 (38.7%) patients, while the non-stenting group had 133 (61.3%). After adjustment for the potential confounders, extracranial VA stenting was associated with favorable shifts in mRS scores at both 90 days (adjusted common odds ratio [OR], 2.30; 95% confidence interval [CI], 1.23–4.28; P<0.01) and 1 year (adjusted OR [aOR], 2.04; 95% CI [1.05–3.97]; P=0.04), along with lower rate of mortality at both 90 days (aOR, 0.45; 95% CI [0.21–0.93]; P=0.01) and 1 year (aOR, 0.36; 95% CI [0.16–0.79]; P=0.01), with no significant difference in sICH incidence (aOR, 0.35; 95% CI [0.06–1.98]; P=0.24).
Conclusion
Extracranial VA stenting during EVT may improve functional outcomes and reduce mortality in patients with PCTL strokes.
4.Endovascular Treatment for Acute Posterior Circulation Tandem Lesions: Insights From the BASILAR and PERSIST Registries
Wei LI ; Mohamed F. DOHEIM ; Zhongming QIU ; Tan WANG ; Zhibin CHEN ; Wenjie ZI ; Qingwu YANG ; Haitao GUAN ; Hongyu QIAO ; Wenhua LIU ; Wei HU ; Xinfeng LIU ; Jinbo HUANG ; Zhongkui HAN ; Zhonglun CHEN ; Zhenqiang ZHAO ; Wen SUN ; Raul G. NOGUEIRA
Journal of Stroke 2025;27(1):75-84
Background:
and Purpose Limited evidence exists on the effectiveness of endovascular treatment (EVT) for acute posterior circulation tandem lesion (PCTL). This study aimed to explore the role of extracranial vertebral artery (VA) stenting in patients with PCTL stroke undergoing EVT.
Methods:
Individual patient data were pooled from the BASILAR (EVT for Acute Basilar Artery Occlusion Study) and PERSIST (Posterior Circulation Ischemic Stroke) registries. Patients with PCTLs who underwent EVT were included in the present cohort and divided into the stenting and nonstenting groups based on the placement of extracranial VA stents. The primary efficacy outcome was the modified Rankin Scale (mRS) scores at 90 days and 1 year. Safety outcomes included 24-hour symptomatic intracranial hemorrhage (sICH) and all-cause mortality at 90 days and 1 year post-surgery.
Results:
A combined dataset of 1,320 patients with posterior circulation artery occlusion, including 263 (19.9%) with tandem lesions, of whom 217 (median age, 65 years; 82.9% male) met the inclusion criteria for the analysis. The stenting group had 84 (38.7%) patients, while the non-stenting group had 133 (61.3%). After adjustment for the potential confounders, extracranial VA stenting was associated with favorable shifts in mRS scores at both 90 days (adjusted common odds ratio [OR], 2.30; 95% confidence interval [CI], 1.23–4.28; P<0.01) and 1 year (adjusted OR [aOR], 2.04; 95% CI [1.05–3.97]; P=0.04), along with lower rate of mortality at both 90 days (aOR, 0.45; 95% CI [0.21–0.93]; P=0.01) and 1 year (aOR, 0.36; 95% CI [0.16–0.79]; P=0.01), with no significant difference in sICH incidence (aOR, 0.35; 95% CI [0.06–1.98]; P=0.24).
Conclusion
Extracranial VA stenting during EVT may improve functional outcomes and reduce mortality in patients with PCTL strokes.
6.Clinical key issues and countermeasures of CAR-T cell therapy
Xinfeng CHEN ; Shasha LIU ; Yi ZHANG
Chinese Journal of Cancer Biotherapy 2025;32(1):9-13
Since 2017,twelve chimeric antigen receptor gene-modified T lymphocyte(CAR-T cell)products have been approved for the treatment of hematological malignancies,including relapsed/refractory acute B lymphoblastic leukemia(B-ALL),specific subtypes of B cell lymphoma,and multiple myeloma.However,CAR-T cell therapy faces numerous challenges in its clinical application,such as resistance,lengthy production cycles,high individuation and costs in hematological tumors,and tumor heterogeneity/antigen escape,insufficient infiltration capability,immunosuppressive microenvironments,and poor therapeutic response in solid tumors.With the in-depth exploration of tumor immunology and the development of genetic engineering technology,various new strategies have been attempted to enhance the efficacy and generalizability of CAR-T cell therapy.This paper presents a commentary on CAR-T cell therapy,with a focus on key clinical issues and corresponding countermeasures,providing valuable insights for future basic research and clinical transformation of CAR-T cell therapy.
7.Analysis of factors influencing efficacy of 131I therapy in papillary thyroid cancer patients with tall cell variant and tall cell features
Na HAN ; Congcong WANG ; Chenghui LU ; Jiao LI ; Xinfeng LIU ; Zengmei SI ; Guoqiang WANG ; Yingying ZHANG ; Zenghua WANG ; Fengqi LI ; Xufu WANG
Chinese Journal of Nuclear Medicine and Molecular Imaging 2025;45(11):661-665
Objective:To explore the clinicopathologic features differences between tall cell variant of papillary thyroid cancer (TCV-PTC) and PTC with tall cell features (PTC-TCF) and the factors influencing efficacy of 131I therapy in patients with TCV-PTC and PTC-TCF. Methods:A retrospective analysis was conducted on 84 patients (28 males, 56 females, age 43.5(35.0, 55.0) years) with pathologically confirmed TCV-PTC or PTC-TCF and who were treated with 131I therapy from January 2018 to June 2023 in the Department of Nuclear Medicine, the Affiliated Hospital of Qingdao University. The patients were divided into structural incomplete response (SIR) group and non-SIR group according to 131I treatment response. Data differences were analyzed by Wilcoxon rank sum test, Fisher exact test, or Mann-Whitney U test. Variables with P<0.1 were enrolled in logistic multivariate regression analysis. The ROC curve was used to obtain the cut-off value of stimulated thyroglobulin (sTg). Results:A total of 37 patients with non-SIR and 6 patients with SIR were found in TCV-PTC group ( n=43), and 33 non-SIR and 8 SIR cases were found in PTC-TCF group ( n=41). Univariate analysis revealed that sTg differed significantly between non-SIR patients and SIR patients in TCV-PTC group ( Z=-2.81, P=0.003), while no significant differences observed for sex, age, multifocality, capsular invasion, T stage, N stage, B-Raf proto-oncogene, serine/threonine-protein kinase (BRAF) V600E mutation, initial recurrence risk, number of metastatic lymph nodes, maximum tumor diameter ( Z values: from -0.74 to -0.11, all P>0.05). In TCV-PTC group, sTg also differed significantly between non-SIR patients and SIR patients ( Z=-4.40, P<0.001), while the other clinical factors above and the proportion of tall cells showed no significant difference ( Z values: from -1.90 to -0.22, all P>0.05). The logistic regression analysis confirmed sTg as an independent risk factor of SIR in both TCV-PTC group (odds ratio ( OR) = 25.156, 95% CI: 2.245-281.812, P=0.009) and PTC-TCF group ( OR=19.214, 95% CI: 2.537-145.502, P=0.004). The ROC curve indicated that the cut-off value of sTg for predicting SIR was 20.75μg/L in TCV-PTC group and 18.55μg/L in PTC-TCF group. Conclusions:sTg is the independent risk factor for predicting the poor prognosis of patients with TCV-PTC (sTg≥20.75μg/L) and PTC-TCF (sTg≥18.55μg/L). However, other clinical characteristics show no statistical difference between TCV-PTC group and PTC-TCF group, suggesting that the invasiveness of PTC-TCF may not be lower than that of TCV-PTC, which close attention should be paid to in clinical practice.
8.Application of three-dimensional U-shaped residual coordinated attention network in early detection of small intestinal polyps
Zijun GAO ; Xinfeng ZHANG ; Xiao CHEN ; Xiangsheng LI ; Xiaomin LIU
Chinese Journal of Preventive Medicine 2025;59(10):1756-1762
Objective:To establish a three-dimensional U-shaped residual coordinated attention network (URCA-Net) based on enhanced CT images for small bowel polyp detection and analyze its application effectiveness in intelligent detection of small bowel polyps.Methods:Abdominal CT data of patients with small bowel polyps were collected from the Air Force Medical Center between June 2019 and July 2023. All patients underwent bowel preparation followed by thin-slice spiral CT scanning to obtain enhanced CT arterial phase images. The data were randomly divided into training, validation and test sets in an 8∶1∶1 ratio. The URCA-Net deep learning model was used for small bowel polyp segmentation. The training set was used for model parameter training, the validation set for hyperparameter adjustment and monitoring of model generalization performance and the test set for final unbiased evaluation of the model. An early intelligent detection model for small bowel polyps was constructed, and its performance was evaluated. Evaluation metrics included pixel-level metrics for the segmentation task [Dice Similarity Coefficient (DSC)], as well as sensitivity and precision for polyp detection. A two-stage segmentation strategy was adopted: the first stage segmented the small bowel region to remove external interference, and the second stage performed polyp segmentation within the small bowel region.Results:A total of 78 subjects were included in the study, with an average age of (54±7) years. A total of 23 400 scan images were extracted, including 136 hyperplastic polyps, 298 hamartomatous polyps, 14 adenomatous polyps, and 4 cancerous polyps. On the test set, the average DSC for the first stage (small bowel segmentation) and the second stage (polyp segmentation) was 0.790 and 0.314, respectively. In the second stage task (polyp segmentation based on small bowel region), the polyp segmentation DSC increased to 0.701, with a precision of 0.836 (95% CI: 0.700-0.972) and a sensitivity of 0.759 (95% CI: 0.631-0.888) for polyp detection. Conclusion:The URCA-Net deep learning technique demonstrates good auxiliary diagnostic effectiveness in small bowel polyp detection and can provide a reference for screening and detection of small bowel polyps. The model is capable of generating high-quality segmentation results, which could facilitate evaluating polyp lesion morphology and provide support for downstream tasks such as preoperative navigation and risk prediction.
9.Application of three-dimensional U-shaped residual coordinated attention network in early detection of small intestinal polyps
Zijun GAO ; Xinfeng ZHANG ; Xiao CHEN ; Xiangsheng LI ; Xiaomin LIU
Chinese Journal of Preventive Medicine 2025;59(10):1756-1762
Objective:To establish a three-dimensional U-shaped residual coordinated attention network (URCA-Net) based on enhanced CT images for small bowel polyp detection and analyze its application effectiveness in intelligent detection of small bowel polyps.Methods:Abdominal CT data of patients with small bowel polyps were collected from the Air Force Medical Center between June 2019 and July 2023. All patients underwent bowel preparation followed by thin-slice spiral CT scanning to obtain enhanced CT arterial phase images. The data were randomly divided into training, validation and test sets in an 8∶1∶1 ratio. The URCA-Net deep learning model was used for small bowel polyp segmentation. The training set was used for model parameter training, the validation set for hyperparameter adjustment and monitoring of model generalization performance and the test set for final unbiased evaluation of the model. An early intelligent detection model for small bowel polyps was constructed, and its performance was evaluated. Evaluation metrics included pixel-level metrics for the segmentation task [Dice Similarity Coefficient (DSC)], as well as sensitivity and precision for polyp detection. A two-stage segmentation strategy was adopted: the first stage segmented the small bowel region to remove external interference, and the second stage performed polyp segmentation within the small bowel region.Results:A total of 78 subjects were included in the study, with an average age of (54±7) years. A total of 23 400 scan images were extracted, including 136 hyperplastic polyps, 298 hamartomatous polyps, 14 adenomatous polyps, and 4 cancerous polyps. On the test set, the average DSC for the first stage (small bowel segmentation) and the second stage (polyp segmentation) was 0.790 and 0.314, respectively. In the second stage task (polyp segmentation based on small bowel region), the polyp segmentation DSC increased to 0.701, with a precision of 0.836 (95% CI: 0.700-0.972) and a sensitivity of 0.759 (95% CI: 0.631-0.888) for polyp detection. Conclusion:The URCA-Net deep learning technique demonstrates good auxiliary diagnostic effectiveness in small bowel polyp detection and can provide a reference for screening and detection of small bowel polyps. The model is capable of generating high-quality segmentation results, which could facilitate evaluating polyp lesion morphology and provide support for downstream tasks such as preoperative navigation and risk prediction.
10.Endovascular Treatment for Acute Posterior Circulation Tandem Lesions: Insights From the BASILAR and PERSIST Registries
Wei LI ; Mohamed F. DOHEIM ; Zhongming QIU ; Tan WANG ; Zhibin CHEN ; Wenjie ZI ; Qingwu YANG ; Haitao GUAN ; Hongyu QIAO ; Wenhua LIU ; Wei HU ; Xinfeng LIU ; Jinbo HUANG ; Zhongkui HAN ; Zhonglun CHEN ; Zhenqiang ZHAO ; Wen SUN ; Raul G. NOGUEIRA
Journal of Stroke 2025;27(1):75-84
Background:
and Purpose Limited evidence exists on the effectiveness of endovascular treatment (EVT) for acute posterior circulation tandem lesion (PCTL). This study aimed to explore the role of extracranial vertebral artery (VA) stenting in patients with PCTL stroke undergoing EVT.
Methods:
Individual patient data were pooled from the BASILAR (EVT for Acute Basilar Artery Occlusion Study) and PERSIST (Posterior Circulation Ischemic Stroke) registries. Patients with PCTLs who underwent EVT were included in the present cohort and divided into the stenting and nonstenting groups based on the placement of extracranial VA stents. The primary efficacy outcome was the modified Rankin Scale (mRS) scores at 90 days and 1 year. Safety outcomes included 24-hour symptomatic intracranial hemorrhage (sICH) and all-cause mortality at 90 days and 1 year post-surgery.
Results:
A combined dataset of 1,320 patients with posterior circulation artery occlusion, including 263 (19.9%) with tandem lesions, of whom 217 (median age, 65 years; 82.9% male) met the inclusion criteria for the analysis. The stenting group had 84 (38.7%) patients, while the non-stenting group had 133 (61.3%). After adjustment for the potential confounders, extracranial VA stenting was associated with favorable shifts in mRS scores at both 90 days (adjusted common odds ratio [OR], 2.30; 95% confidence interval [CI], 1.23–4.28; P<0.01) and 1 year (adjusted OR [aOR], 2.04; 95% CI [1.05–3.97]; P=0.04), along with lower rate of mortality at both 90 days (aOR, 0.45; 95% CI [0.21–0.93]; P=0.01) and 1 year (aOR, 0.36; 95% CI [0.16–0.79]; P=0.01), with no significant difference in sICH incidence (aOR, 0.35; 95% CI [0.06–1.98]; P=0.24).
Conclusion
Extracranial VA stenting during EVT may improve functional outcomes and reduce mortality in patients with PCTL strokes.

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