1.Quality Evaluation on Huatan Pingchuan Tablets Based on National Drug Sampling and Testing
Dan LI ; Xianling YANG ; Hongyu ZHAI ; Yuhua SHEN ; Qiaosen REN ; Jing HAN ; Zhenbin FENG ; Jialiang ZHU
Herald of Medicine 2025;44(1):39-46
Objective Based on the sampling test of national drugs,the quality of Huatan Pingchuan tablets was systematically evaluated,and the quality problems were analyzed to provide references and suggestions for the quality control of this variety and to improve its quality standard.Methods A total of 157 batches of samples were tested according to the statutory standard,and based on the testing results and prescription characteristics,microscopic identification and comprehensive analysis of its quality using thin-layer chromatography,high-performance liquid chromatography,and other methods were subsequently established or improved for the exploratory research.Results The established thin-layer chromatography identification for Radix Scutellariae,as well as the content determination methods for Radix Scutellariae,Syringae Cortex,and promethazine hydrochloride,are easy to operate and have good durability and specificity and can be applied to the quality control and evaluation of Huatan Pingchuan tablets.Conclusions The overall quality of the tablets is average;some enterprises should strengthen the quality control of raw medicinal materials(decoction pieces);individual enterprises have significant differences in the quality of samples from different batches,so they need to pay attention to the quality of raw materials and the stability of production processes;the inspection items of the current standards cannot fully reflect the key quality attributes of drugs,and standards improvement work needs to be carried out.
2.Prognosis of patients with resectable pancreatic ductal adenocarcinoma treated by AG or AG combined with PD-1 inhibitor regimen and application value of CCF risk score
Junnan HUANG ; Yiyun HUANG ; Linwei XU ; Fang HAN ; Qianwei JIANG ; Yuhua ZHANG
Chinese Journal of Digestive Surgery 2025;24(5):609-616
Objective:To evaluate the prognosis of patients with resectable pancreatic ductal adenocarcinoma (PDAC) treated by gemcitabine and nab-paclitaxel (AG) or AG combined with pro-grammed death-1 (PD-1) inhibitor regimen and application value of the Cleveland Clinic Foundation (CCF) risk score.Methods:The retrospective cohort study was conducted. The clinicopathological data of 151 PDAC patients who were treated by AG regimen or AG combined with PD-1 inhibitor regimen in Zhejiang Cancer Hospital from January 2013 to March 2024 were collected. There were 84 males and 67 females, aged (64±9)years. Observation indicators: (1) comparison of clinical characteristics among resectable PDAC patients with different CCF risk score; (2) analysis of influencing factors for overall survival time of resectable PDAC patients; (3) survival of resectable PDAC patients. Comparison of measurement data with skewed distribution between groups was conducted using the Mann-Whitney U test. Comparison of count data between groups was conducted using the chi-square test. Comparison of ordinal data between groups was conducted using the rank sum test. Univariate and multivariate analyses were conducted using the Cox regression model. Kaplan-Meier method was used to calculate survival rate and plot survival curve, and Log-rank test was used for survival analysis. Results:(1) Comparison of clinical characteristics among resectable PDAC patients with different CCF risk score. Based on CCF risk score, 102 of 151 patients were classified as low risk and 49 cases were classified as intermediate-to-high risk. There were signi-ficant differences in sex, age, smoking status, alcohol consumption, hypertension, and diabetes between the two categories ( P<0.05). (2) Analysis of influencing factors for overall survival time of resectable PDAC patients. Results of multivariate analysis showed that the treatment regimen was an indepen-dent influencing factor for overall survival time of resectable PDAC patients ( hazard ratio=1.976, 95% confidence interval as 1.065?3.666, P<0.05). (3) Survival of resectable PDAC patients. The follow-up time of 151 patients was 21.8(18.7,24.2)months, and the median overall survival time was 23.3(19.0,32.4)months. The follow-up time was 22.1(18.9,30.7)months of patients treated by AG regimen and 11.2(8.1,23.3)months of patients treated by AG combined with PD-1 inhibitor regimen, respectively. The median overall survival time of the two types of patients was 24.4(17.2,31.7)months and 16.9(8.9,24.9)months. The 1-year overall survival rates were 79.1% and 60.0%, and the 2-year overall survival rates were 53.4% and 28.5%, respectively. There was a significant difference in the overall survival between the two types of patients ( hazard ratio=1.913, 95% confidence interval as 1.041?3.516, P<0.05). Of the intermediate-to-high risk patients, the follow-up time was 18.5(8.8,28.1)months of 37 patients treated by AG regimen and 8.1(7.3,9.0)months of 12 patients treated by AG combined with PD-1 inhibitor regimen. The median overall survival time of the two types of patients was 32.4(15.7,49.0)months and 8.9(5.7,12.1)months, respectively. The 1-year overall survival rates were 82.7% and 31.3%, and the 2-year overall survival rates were 66.5% and 0, respectively. There was a significant difference in the overall survival between the two types of patients ( hazard ratio=5.402, 95% confidence interval as 1.811?16.118, P<0.05). Conclusions:The treatment regimen is an independent influencing factor for overall survival in patients with resectable PDAC. Compared with the AG combined with PD-1 inhibitor regimen, AG regimen is associated with good survival of patients with resectable PDAC. For patients classified as intermediate-to-high risk based on the CCF risk score, AG regimen is assiociated with a better overall survival compared to AG combined with PD-1 inhibitor regimen.
3.Chinese expert consensus on integrated case management by a multidisciplinary team in CAR-T cell therapy for lymphoma.
Sanfang TU ; Ping LI ; Heng MEI ; Yang LIU ; Yongxian HU ; Peng LIU ; Dehui ZOU ; Ting NIU ; Kailin XU ; Li WANG ; Jianmin YANG ; Mingfeng ZHAO ; Xiaojun HUANG ; Jianxiang WANG ; Yu HU ; Weili ZHAO ; Depei WU ; Jun MA ; Wenbin QIAN ; Weidong HAN ; Yuhua LI ; Aibin LIANG
Chinese Medical Journal 2025;138(16):1894-1896
4.Novel CD19 Fast-CAR-T cells vs. CD19 conventional CAR-T cells for the treatment of relapsed/refractory CD19-positive B-cell acute lymphoblastic leukemia.
Xu TAN ; Jishi WANG ; Shangjun CHEN ; Li LIU ; Yuhua LI ; Sanfang TU ; Hai YI ; Jian ZHOU ; Sanbin WANG ; Ligen LIU ; Jian GE ; Yongxian HU ; Xiaoqi WANG ; Lu WANG ; Guo CHEN ; Han YAO ; Cheng ZHANG ; Xi ZHANG
Chinese Medical Journal 2025;138(19):2491-2497
BACKGROUND:
Treatment with chimeric antigen receptor-T (CAR-T) cells has shown promising effectiveness in patients with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL), although the process of preparing for this therapy usually takes a long time. We have recently created CD19 Fast-CAR-T (F-CAR-T) cells, which can be produced within a single day. The objective of this study was to evaluate and contrast the effectiveness and safety of CD19 F-CAR-T cells with those of CD19 conventional CAR-T cells in the management of R/R B-ALL.
METHODS:
A multicenter, retrospective analysis of the clinical data of 44 patients with R/R B-ALL was conducted. Overall, 23 patients were administered with innovative CD19 F-CAR-T cells (F-CAR-T group), whereas 21 patients were given CD19 conventional CAR-T cells (C-CAR-T group). We compared the rates of complete remission (CR), minimal residual disease (MRD)-negative CR, leukemia-free survival (LFS), overall survival (OS), and the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) between the two groups.
RESULTS:
Compared with the C-CAR-T group, the F-CAR-T group had significantly higher CR and MRD-negative rates (95.7% and 91.3%, respectively; 71.4% and 66.7%, respectively; P = 0.036 and P = 0.044). No significant differences were observed in the 1-year or 2-year LFS or OS rates between the two groups: the 1-year and 2-year LFS for the F-CAR-T group vs.C-CAR-T group were 47.8% and 43.5% vs. 38.1% and 23.8% (P = 0.384 and P = 0.216), while the 1-year and 2-year OS rates were 65.2% and 56.5% vs. 52.4% and 47.6% (P = 0.395 and P = 0.540). Additionally, among CR patients who underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT) following CAR-T-cell therapy, there were no significant differences in the 1-year or 2-year LFS or OS rates: 57.1% and 50.0% vs. 47.8% and 34.8% (P = 0.506 and P = 0.356), 64.3% and 57.1% vs. 65.2% and 56.5% (P = 0.985 and P = 0.883), respectively. The incidence of CRS was greater in the F-CAR-T group (91.3%) than in the C-CAR-T group (66.7%) (P = 0.044). The incidence of ICANS was also greater in the F-CAR-T group (30.4%) than in the C-CAR-T group (9.5%) (P = 0.085), but no treatment-related deaths occurred in the two groups.
CONCLUSION
Compared with C-CAR-T-cell therapy, F-CAR-T-cell therapy has a superior remission rate but also leads to a tolerably increased incidence of CRS/ICANS. Further research is needed to explore the function of allo-HSCT as an intermediary therapy after CAR-T-cell therapy.
5.Construction and validation of a nomogram model for predicting cognitive frailty in hospitalized older adults
Yuhua LIU ; Mengya HAN ; Yan XU ; Yuhong LUO ; Chen XIN ; Guixin LIU ; Binru HAN
Chinese Journal of Nursing 2025;60(15):1811-1817
Objective A Nomogram model of cognitive frailty was constructed and validated in hospitalized older adults,providing a reference for early screening,intervention and personalized management of cognitive frailty.Methods A convenience sampling approach was employed to recruit 322 elderly inpatients from a tertiary hospital in Beijing between October 2024 and February 2025 as study participants,and data were collected using the General Information Questionnaire,the Short Form-Mini-Nutritional Assessment,the Asens Insomnia Scale,the Activity of Daily Living Rating,the Self-Rating Anxiety Scale,the Geriatric Depression Scale-15,the Social Support Rating Scale,the Frailty Phenotype scale,the Subjective Cognitive Decline Questionnaire-9,the Mini-Mental State Examination,and the Clinical Dementia Rating.Lasso-Logistic regression was used to screen the variables,R software was used to draw the nomogram model;Bootstrap method was used for internal validation.Results Lasso-Logistic regression screened 8 predictors of age,depression,anxiety,support utilization,nutritional status,literacy,physical activity,and chronic pain,with an area under the subject operating characteristic curve of 0.830(95%CI:0.787-0.873),a sensitivity of 0.764,a specificity of 0.730,an accuracy of 0.748,and a calibrated curve,Brier score,and Hosmer-Lemeshow test(P=0.774)all showed that the model fit was good.Conclusion The Lasso-Logistic regression-based nomogram model of cognitive frailty in hospitalized older adults has good predictive performance and clinical utility,and can be used as a reference for early identification and intervention of cognitive decline in hospitalized older adults.
6.Prognosis of patients with resectable pancreatic ductal adenocarcinoma treated by AG or AG combined with PD-1 inhibitor regimen and application value of CCF risk score
Junnan HUANG ; Yiyun HUANG ; Linwei XU ; Fang HAN ; Qianwei JIANG ; Yuhua ZHANG
Chinese Journal of Digestive Surgery 2025;24(5):609-616
Objective:To evaluate the prognosis of patients with resectable pancreatic ductal adenocarcinoma (PDAC) treated by gemcitabine and nab-paclitaxel (AG) or AG combined with pro-grammed death-1 (PD-1) inhibitor regimen and application value of the Cleveland Clinic Foundation (CCF) risk score.Methods:The retrospective cohort study was conducted. The clinicopathological data of 151 PDAC patients who were treated by AG regimen or AG combined with PD-1 inhibitor regimen in Zhejiang Cancer Hospital from January 2013 to March 2024 were collected. There were 84 males and 67 females, aged (64±9)years. Observation indicators: (1) comparison of clinical characteristics among resectable PDAC patients with different CCF risk score; (2) analysis of influencing factors for overall survival time of resectable PDAC patients; (3) survival of resectable PDAC patients. Comparison of measurement data with skewed distribution between groups was conducted using the Mann-Whitney U test. Comparison of count data between groups was conducted using the chi-square test. Comparison of ordinal data between groups was conducted using the rank sum test. Univariate and multivariate analyses were conducted using the Cox regression model. Kaplan-Meier method was used to calculate survival rate and plot survival curve, and Log-rank test was used for survival analysis. Results:(1) Comparison of clinical characteristics among resectable PDAC patients with different CCF risk score. Based on CCF risk score, 102 of 151 patients were classified as low risk and 49 cases were classified as intermediate-to-high risk. There were signi-ficant differences in sex, age, smoking status, alcohol consumption, hypertension, and diabetes between the two categories ( P<0.05). (2) Analysis of influencing factors for overall survival time of resectable PDAC patients. Results of multivariate analysis showed that the treatment regimen was an indepen-dent influencing factor for overall survival time of resectable PDAC patients ( hazard ratio=1.976, 95% confidence interval as 1.065?3.666, P<0.05). (3) Survival of resectable PDAC patients. The follow-up time of 151 patients was 21.8(18.7,24.2)months, and the median overall survival time was 23.3(19.0,32.4)months. The follow-up time was 22.1(18.9,30.7)months of patients treated by AG regimen and 11.2(8.1,23.3)months of patients treated by AG combined with PD-1 inhibitor regimen, respectively. The median overall survival time of the two types of patients was 24.4(17.2,31.7)months and 16.9(8.9,24.9)months. The 1-year overall survival rates were 79.1% and 60.0%, and the 2-year overall survival rates were 53.4% and 28.5%, respectively. There was a significant difference in the overall survival between the two types of patients ( hazard ratio=1.913, 95% confidence interval as 1.041?3.516, P<0.05). Of the intermediate-to-high risk patients, the follow-up time was 18.5(8.8,28.1)months of 37 patients treated by AG regimen and 8.1(7.3,9.0)months of 12 patients treated by AG combined with PD-1 inhibitor regimen. The median overall survival time of the two types of patients was 32.4(15.7,49.0)months and 8.9(5.7,12.1)months, respectively. The 1-year overall survival rates were 82.7% and 31.3%, and the 2-year overall survival rates were 66.5% and 0, respectively. There was a significant difference in the overall survival between the two types of patients ( hazard ratio=5.402, 95% confidence interval as 1.811?16.118, P<0.05). Conclusions:The treatment regimen is an independent influencing factor for overall survival in patients with resectable PDAC. Compared with the AG combined with PD-1 inhibitor regimen, AG regimen is associated with good survival of patients with resectable PDAC. For patients classified as intermediate-to-high risk based on the CCF risk score, AG regimen is assiociated with a better overall survival compared to AG combined with PD-1 inhibitor regimen.
7.Quality Evaluation on Huatan Pingchuan Tablets Based on National Drug Sampling and Testing
Dan LI ; Xianling YANG ; Hongyu ZHAI ; Yuhua SHEN ; Qiaosen REN ; Jing HAN ; Zhenbin FENG ; Jialiang ZHU
Herald of Medicine 2025;44(1):39-46
Objective Based on the sampling test of national drugs,the quality of Huatan Pingchuan tablets was systematically evaluated,and the quality problems were analyzed to provide references and suggestions for the quality control of this variety and to improve its quality standard.Methods A total of 157 batches of samples were tested according to the statutory standard,and based on the testing results and prescription characteristics,microscopic identification and comprehensive analysis of its quality using thin-layer chromatography,high-performance liquid chromatography,and other methods were subsequently established or improved for the exploratory research.Results The established thin-layer chromatography identification for Radix Scutellariae,as well as the content determination methods for Radix Scutellariae,Syringae Cortex,and promethazine hydrochloride,are easy to operate and have good durability and specificity and can be applied to the quality control and evaluation of Huatan Pingchuan tablets.Conclusions The overall quality of the tablets is average;some enterprises should strengthen the quality control of raw medicinal materials(decoction pieces);individual enterprises have significant differences in the quality of samples from different batches,so they need to pay attention to the quality of raw materials and the stability of production processes;the inspection items of the current standards cannot fully reflect the key quality attributes of drugs,and standards improvement work needs to be carried out.
8.Construction and validation of a nomogram model for predicting cognitive frailty in hospitalized older adults
Yuhua LIU ; Mengya HAN ; Yan XU ; Yuhong LUO ; Chen XIN ; Guixin LIU ; Binru HAN
Chinese Journal of Nursing 2025;60(15):1811-1817
Objective A Nomogram model of cognitive frailty was constructed and validated in hospitalized older adults,providing a reference for early screening,intervention and personalized management of cognitive frailty.Methods A convenience sampling approach was employed to recruit 322 elderly inpatients from a tertiary hospital in Beijing between October 2024 and February 2025 as study participants,and data were collected using the General Information Questionnaire,the Short Form-Mini-Nutritional Assessment,the Asens Insomnia Scale,the Activity of Daily Living Rating,the Self-Rating Anxiety Scale,the Geriatric Depression Scale-15,the Social Support Rating Scale,the Frailty Phenotype scale,the Subjective Cognitive Decline Questionnaire-9,the Mini-Mental State Examination,and the Clinical Dementia Rating.Lasso-Logistic regression was used to screen the variables,R software was used to draw the nomogram model;Bootstrap method was used for internal validation.Results Lasso-Logistic regression screened 8 predictors of age,depression,anxiety,support utilization,nutritional status,literacy,physical activity,and chronic pain,with an area under the subject operating characteristic curve of 0.830(95%CI:0.787-0.873),a sensitivity of 0.764,a specificity of 0.730,an accuracy of 0.748,and a calibrated curve,Brier score,and Hosmer-Lemeshow test(P=0.774)all showed that the model fit was good.Conclusion The Lasso-Logistic regression-based nomogram model of cognitive frailty in hospitalized older adults has good predictive performance and clinical utility,and can be used as a reference for early identification and intervention of cognitive decline in hospitalized older adults.
9.Study on the management model of elderly patients with hypertension by multi-disciplinary comprehensive management team of tertiary hospital collaborated with community pharmacists
Dan HAN ; Li NIE ; Meihua WANG ; Jinli WU ; Simin YAN ; Fuchao LI ; Yun QIAN ; Youli XI
China Pharmacy 2024;35(16):2033-2037
OBJECTIVE To explore the effects of multi-disciplinary comprehensive management team of tertiary hospital collaborated with the pharmacists from community health service center (hereinafter referred to as “community pharmacists”) on elderly patients with hypertension in the community. METHODS Elderly patients with hypertension from May 2020 to May 2021 in Yuhua Community Health Service Center of Nanjing were divided into control group (76 cases) and observation group (76 cases) according to the management style. The control group was treated with regular community medical services and the observation group received regular community medical services plus pharmaceutical care provided by the comprehensive management team collaborated with community pharmacists. The compliance, blood pressure control status and hypertension-related complications were compared between 2 groups before management and after 24 months of management. RESULTS After 24 months of management, the compliance and blood pressure compliance rates in both groups were higher than before management; meanwhile, the observation group was significantly higher than control group at the corresponding period (P<0.05 or P< 0.01). The blood pressure levels of both groups were significantly lower than before management, and the systolic blood pressure as well as the incidences of the whole complications and cerebrovascular injury in the observation group were significantly lower than control group at the 583867635@qq.com corresponding period (P<0.05). There was statistical significance in the effects of the rate of reaching the standard of blood pressure on the complications (P<0.01). CONCLUSIONS The hypertension management mode of comprehensive management team collaborated with community pharmacists can significantly improve the compliance and blood pressure compliance rate of elderly patients with hypertension, and reduce the incidence of hypertension-related complications.
10.Expert opinions on operation rules of Morita therapy outpatient service
Jiangbo LI ; Zucheng WANG ; Yuhua CUI ; Yingzhi LU ; Weijie QU ; Haiyin ZHANG ; Fuqiang MAO ; Fengqing QIE ; Wanghong SHI ; Qinfeng ZHANG ; Lingyi PAN ; Ling ZHANG ; Jianzhong LI ; Guangcheng CUI ; Tongxian CHEN ; Xiuqing MA ; Wei RONG ; Jianjun ZHANG ; Qingfang ZHONG ; Yanchi ZHANG ; Boquan ZHANG ; Xinrui WANG ; Wenyou MA ; Qingtao REN ; Yongfa JING ; Huanzhong LIU ; Zhenjian YU ; Laitian ZHAO ; Tianming HAN ; Xue HAN
Chinese Mental Health Journal 2024;38(1):68-72
Morita therapy has been bom for more than 100 years.Inpatient Morita therapy is highly oper-able and easy to master.It can improve many refractory neuroses through four-stage treatment.But more neuroses are treated in outpatient clinics,and Morita therapy cannot be used in hospitalized patients.Therefore,the formula-tion of expert opinions on outpatient operations is particularly important.This paper is based on domestic and for-eign references,and after many discussions by domestic Morita therapy experts,and then drew up the first version of the expert opinions on operation of outpatient Morita therapy.Meanwhile the operation rule of Morita therapy in three stages of outpatient treatment was formulated:in the etiological analysis stage,under the theoretical guidance of Morita therapy,analyze the pathogenic factors,to improve treatment compliance and reduce resistance;during the operating stage,guide patients to engage in constructive and meaningful actions,realizing the achievement of letting nature take its course principle;in the cultivating character and enriching life stage,pay attention to positive infor-mation,expanding the scope and content of actions,improving the ability to adapt to complex life,and preventing recurrence caused by insufficient abilities.It will lay a foundation for the promotion of Morita therapy in domestic outpatient clinics,so that more patients with neurosis and other psychological diseases could receive characteristic Morita therapy treatment in outpatient clinics.

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