1.Clinical efficacy and safety of CLAE regimen for refractory/relapsed T cell acute lymphoblastic leukemia/lymphoma: a prospective, multicenter, single-arm study
Yan LI ; Xian ZHANG ; Xiuhua SUN ; Jia SONG ; Rong ZHANG ; Ping YANG ; Wei WAN ; Fei DONG ; Jijun WANG ; Hongmei JING
Chinese Journal of Hematology 2025;46(11):1005-1013
Objective:To evaluate the efficacy and safety of the CLAE (cladribine + cytarabine + etoposide) regimen in refractory/relapsed T cell acute lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL) .Methods:Patients with R/R T-ALL/LBL received the CLAE regimen in a prospective, multicenter, single-arm clinical study or compassionate use. From March 2019 to August 2024, data from 25 patients (18 in the study across five centers and 7 receiving compassionate treatment in Peking University Third Hospital) were collected. Outcomes included objective response rate, complete response (CR) rate, partial response (PR) rate after 1–2 cycles, bridging to allo-HSCT, progression-free survival (PFS), overall survival (OS), and treatment-related adverse effects.Results:Median age was 29 years (range, 13–63) ; 17 were male. Among the 24 evaluable patients, CR rate was 33.3% overall and 41.2% among enrolled patients. Median OS and PFS time were 199 (46–1 310) and 49 (28–1 310) days, respectively. Cumulative OS rate at 6 months, 1 year, and 2 years was (52.1±10.2) %, (29.7±9.3) %, and (27.1±9.1) %, respectively; cumulative PFS rate was (32.6±9.6) %, (24.9±8.9) %, and (23.8±8.7) %, respectively. Among patients achieving CR or PR (8 cases), median OS and PFS were not reached. Cumulative OS rate at 6 months, 1 year, and 2 years was (86.8±12.0) %, (78.3±14.6) %, and (72.9±15.7) %, respectively, and the cumulative PFS rate was (86.4±12.1) %, (74.8±15.3) %, and (72.9±15.7) %, respectively. Adverse events were mainly hematologic; no treatment-related mortality occurred. Seven patients achieving CR were bridged to allo-HSCT, with 5 remaining in continuous remission.Conclusion:The CLAE regimen is safe and effective for R/R T-ALL/LBL, facilitating CR as a bridge to allo-HSCT and potentially improving patient prognosis.
2.Clinical efficacy and safety of CLAE regimen for refractory/relapsed T cell acute lymphoblastic leukemia/lymphoma: a prospective, multicenter, single-arm study
Yan LI ; Xian ZHANG ; Xiuhua SUN ; Jia SONG ; Rong ZHANG ; Ping YANG ; Wei WAN ; Fei DONG ; Jijun WANG ; Hongmei JING
Chinese Journal of Hematology 2025;46(11):1005-1013
Objective:To evaluate the efficacy and safety of the CLAE (cladribine + cytarabine + etoposide) regimen in refractory/relapsed T cell acute lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL) .Methods:Patients with R/R T-ALL/LBL received the CLAE regimen in a prospective, multicenter, single-arm clinical study or compassionate use. From March 2019 to August 2024, data from 25 patients (18 in the study across five centers and 7 receiving compassionate treatment in Peking University Third Hospital) were collected. Outcomes included objective response rate, complete response (CR) rate, partial response (PR) rate after 1–2 cycles, bridging to allo-HSCT, progression-free survival (PFS), overall survival (OS), and treatment-related adverse effects.Results:Median age was 29 years (range, 13–63) ; 17 were male. Among the 24 evaluable patients, CR rate was 33.3% overall and 41.2% among enrolled patients. Median OS and PFS time were 199 (46–1 310) and 49 (28–1 310) days, respectively. Cumulative OS rate at 6 months, 1 year, and 2 years was (52.1±10.2) %, (29.7±9.3) %, and (27.1±9.1) %, respectively; cumulative PFS rate was (32.6±9.6) %, (24.9±8.9) %, and (23.8±8.7) %, respectively. Among patients achieving CR or PR (8 cases), median OS and PFS were not reached. Cumulative OS rate at 6 months, 1 year, and 2 years was (86.8±12.0) %, (78.3±14.6) %, and (72.9±15.7) %, respectively, and the cumulative PFS rate was (86.4±12.1) %, (74.8±15.3) %, and (72.9±15.7) %, respectively. Adverse events were mainly hematologic; no treatment-related mortality occurred. Seven patients achieving CR were bridged to allo-HSCT, with 5 remaining in continuous remission.Conclusion:The CLAE regimen is safe and effective for R/R T-ALL/LBL, facilitating CR as a bridge to allo-HSCT and potentially improving patient prognosis.
3.Establishment of prediction model for postoperative delirium in elderly patients with mild stroke undergoing non-cardiac and non-intracranial surgery
Peng SUN ; Caijuan ZHANG ; Jinling YIN ; Xiuhua LI ; Zhaojin JIA
Chinese Journal of Anesthesiology 2024;44(10):1175-1181
Objective:To establish the prediction model for postoperative delirium in elderly patients with mild stroke undergoing non-cardiac and non-intracranial surgery.Methods:This was a nested case-control study. Seven hundred and fifty elderly patients of either sex with mild stroke, aged ≥65 yr, undergoing elective surgical procedures under general anesthesia in the Department of Gastrointestinal Surgery, Orthopedics and Urology at the Tangshan Workers Hospital from May to December 2023, were selected. The perioperative clinical data were collected. The incidence of postoperative delirium was assessed using the Confusion Assessment Scale 1-7 days after surgery or 1 day before discharge. The patients were assigned to the training set and the validation set in a ratio of 7∶3 using a simple random sampling method. Multivariate logistic regression was used to identify the risk factors for postoperative delirium, a postoperative delirium risk prediction model was established based on the risk factors, the nomogram was developed, and the receiver operating characteristic (ROC) curve, calibration curve and decision curve were plotted to assess the accuracy of the prediction model. The prediction model was verified using the validation set, and the calibration curve and ROC curve were plotted to assess the predictive performance of the model.Results:A total of 721 patients were finally included, and 108 patients developed postoperative delirium. Older age, high American Society of Anesthesiologists Physical Status classification, history of preoperative hypertension, short years of education, high preoperative Pittsburgh sleep quality index score, high preoperative National Institutes of Health Stroke Scale score, high intraoperative hypothermia, intraoperative hypotension and high postoperative numerical rating scale score were independent risk factors for postoperative delirium ( P<0.05). The area under the ROC curve of the training set prediction model was 0.996, with a sensitivity of 1.000, and specificity of 0.945. The slope of the calibration curve was close to 1, and the predicted risk of postoperative delirium was in good agreement with the actual risk. When the threshold probability of the decision curve was 0-0.9, the net return rate was higher than the null line. Validation set: In the calibration curve of the prediction model, the cohort and calibration curves were close to the ideal line, with an area under the ROC curve of 0.997, sensitivity of 1.000, and specificity of 0.962. Conclusions:Based on age, American Society of Anesthesiologists Physical Status classification, history of preoperative hypertension, years of education, preoperative Pittsburgh sleep quality index score, National Institutes of Health Stroke Scale score, intraoperative hypothermia and hypotension and postoperative numerical rating scale score, the prediction model for postoperative delirium is developed and has a good predictive performance in elderly patients with mild stroke undergoing non-cardiac and non-intracranial surgery.
4.Low frequency transcranial magnetic stimulation can improve upper limb motor function in the acute phase of ischemic stroke
Tian SUN ; Zunke GONG ; Ting ZHOU ; Yonggang ZHU ; Tong SU ; Wenqi TANG ; Jie YU ; Xiuhua ZHU
Chinese Journal of Physical Medicine and Rehabilitation 2024;46(3):216-220
Objective:To explore the utility of applying low frequency transcranial magnetic stimulation (rTMS) in the acute stage of ischemic stroke in terms of improving upper limb motor function.Methods:Eighty ischemic stroke survivors in the acute stage were randomly divided into a control group and an experimental group, with 40 in each. In addition to routine rehabilitation, the experimental group was given low frequency rTMS, while the control group was provided with sham rTMS. Before and after 4-weeks of treatment, upper limb motor function was evaluated using the Fugl-Meyer rating scale (FMA), Wolf motor function tests (WMFTs), the modified Barthel index (MBI) and in terms of motor evoked potential (MEP) latency and amplitude.Results:There were no significant differences between the two groups before the treatment. Afterward, however, the average FMA, WMFT, MBI scores had improved significantly more in the experimental group, on average, as had the average MEP amplitude.Conclusion:Low frequency rTMS in the acute phase of ischemic stroke can improve upper limb motor function and ability in the activities of daily living.
5.The effects of different extracorporeal circulation temperature combined with dexmedetomidine on oxida-tive stress in patients undergoing cardiac surgery under cardiopulmonary bypass
Peng SUN ; Zhaojin JIA ; Xiuhua LI ; Xiaowei CHEN ; Runsheng WEI ; Yantao JIN ; Jiantao JIN
The Journal of Practical Medicine 2024;40(24):3521-3526
Objective To study the effects of different extracorporeal circulation temperature combined with dexmedetomidine on oxidative stress in patients undergoing cardiac surgery under cardiopulmonary bypass.Methods 240 patients who underwent cardiac surgery under cardiopulmonary bypass were selected from June 2021 to June 2024.The patients were 50 to 75 years old and did not have severe hepatic or renal insufficiency.The Mini-Mental State Examination was completed 1 day before the operation.Patients were routinely established for cardiopulmonary bypass.Patients were randomly divided into four groups(n=55):hypothermia+normal saline group(L0),hypothermia+dexmedetomidine group(L1),hyperthermia+normal saline group(H0)and hyper-thermia+dexmedetomidine group(H1).The nasopharyngeal temperature was maintained at(30±1)℃in the hypothermia group and(33±1)℃in the high-temperature group during the reflux period.Dexmedetomidine injection was intravenously injected at 1 μg/kg 10 minutes before anesthesia in L1 and H1 groups,and pumped continuously at a rate of 0.5 μg/(kg·h)until the end of surgery.L0 and H0 groups were given equal volume of normal saline until the end of operation.5 mL of central venous blood was collected before the beginning of anesthesia(T1),at the end of surgery(T2),24 h(T3)and 48 h(T4)after surgery,and serum neuron specific enolase(NSE),interleukin-6(IL-6)and tumor necrosis factor-α(TNF-α)levels were detected by ELISA.The levels of superoxide dismutase(SOD)and malondialdehyde(MDA)in serum were determined by xanthine oxidase method and thiobarbituric acid method.The Confusion Assessment Method-ICU was used to evaluate the occurrence of POD.Results 220 patients were finally enrolled,including 81 patients in POD group,with an incidence of 36.8%.Compared with NPOD group,the concentrations of NSE,IL-6,TNF-ɑ and MDA in POD group were in-creased,while the concentration of SOD was decreased.Compared with L0 group,the concentrations of NSE,IL-6,TNF-ɑ and MDA were decreased and the concentration of SOD increased in L1 group.Compared with H0 group,NSE,IL-6,TNF-ɑ and MDA concentrations in H1 group were decreased,while SOD concentration was in-creased.Compared with L0 group,concentration of NSE,IL-6,TNF-ɑ and MDA increased,while the concentra-tion of SOD decreased in H0 group.Compared with L1 group,concentration of NSE,IL-6,TNF-ɑ and MDA in-creased,while the concentration of SOD decreased in H1 group.Conclusion Hypothermia combined with dexme-detomidine during cardiopulmonary bypass can reduce oxidative stress response and POD in patients.
6.The effects of different extracorporeal circulation temperature combined with dexmedetomidine on oxida-tive stress in patients undergoing cardiac surgery under cardiopulmonary bypass
Peng SUN ; Zhaojin JIA ; Xiuhua LI ; Xiaowei CHEN ; Runsheng WEI ; Yantao JIN ; Jiantao JIN
The Journal of Practical Medicine 2024;40(24):3521-3526
Objective To study the effects of different extracorporeal circulation temperature combined with dexmedetomidine on oxidative stress in patients undergoing cardiac surgery under cardiopulmonary bypass.Methods 240 patients who underwent cardiac surgery under cardiopulmonary bypass were selected from June 2021 to June 2024.The patients were 50 to 75 years old and did not have severe hepatic or renal insufficiency.The Mini-Mental State Examination was completed 1 day before the operation.Patients were routinely established for cardiopulmonary bypass.Patients were randomly divided into four groups(n=55):hypothermia+normal saline group(L0),hypothermia+dexmedetomidine group(L1),hyperthermia+normal saline group(H0)and hyper-thermia+dexmedetomidine group(H1).The nasopharyngeal temperature was maintained at(30±1)℃in the hypothermia group and(33±1)℃in the high-temperature group during the reflux period.Dexmedetomidine injection was intravenously injected at 1 μg/kg 10 minutes before anesthesia in L1 and H1 groups,and pumped continuously at a rate of 0.5 μg/(kg·h)until the end of surgery.L0 and H0 groups were given equal volume of normal saline until the end of operation.5 mL of central venous blood was collected before the beginning of anesthesia(T1),at the end of surgery(T2),24 h(T3)and 48 h(T4)after surgery,and serum neuron specific enolase(NSE),interleukin-6(IL-6)and tumor necrosis factor-α(TNF-α)levels were detected by ELISA.The levels of superoxide dismutase(SOD)and malondialdehyde(MDA)in serum were determined by xanthine oxidase method and thiobarbituric acid method.The Confusion Assessment Method-ICU was used to evaluate the occurrence of POD.Results 220 patients were finally enrolled,including 81 patients in POD group,with an incidence of 36.8%.Compared with NPOD group,the concentrations of NSE,IL-6,TNF-ɑ and MDA in POD group were in-creased,while the concentration of SOD was decreased.Compared with L0 group,the concentrations of NSE,IL-6,TNF-ɑ and MDA were decreased and the concentration of SOD increased in L1 group.Compared with H0 group,NSE,IL-6,TNF-ɑ and MDA concentrations in H1 group were decreased,while SOD concentration was in-creased.Compared with L0 group,concentration of NSE,IL-6,TNF-ɑ and MDA increased,while the concentra-tion of SOD decreased in H0 group.Compared with L1 group,concentration of NSE,IL-6,TNF-ɑ and MDA in-creased,while the concentration of SOD decreased in H1 group.Conclusion Hypothermia combined with dexme-detomidine during cardiopulmonary bypass can reduce oxidative stress response and POD in patients.
7.Efficacy and safety of mitoxantrone hydrochloride liposome injection in treatment of peripheral T-cell lymphomas: a multicenter, non-interventional, ambispective cohort, real-world study (MOMENT)
Huiqiang HUANG ; Zhiming LI ; Lihong LIU ; Liang HUANG ; Jie JIN ; Hongyan TONG ; Hui ZHOU ; Zengjun LI ; Zhenqian HUANG ; Wenbin QIAN ; Kaiyang DING ; Quande LIN ; Ming HOU ; Yunhong HUANG ; Jingbo WANG ; Pengcheng HE ; Xiuhua SUN ; Xiaobo WANG ; Zunmin ZHU ; Yao LIU ; Jinhai REN ; Huijing WU ; Liling ZHANG ; Hao ZHANG ; Liangquan GENG ; Jian GE ; Ou BAI ; Liping SU ; Guangxun GAO ; Xin LI ; Yanli YANG ; Yijian CHEN ; Aichun LIU ; Xin WANG ; Yi WANG ; Liqun ZOU ; Xiaobing HUANG ; Dongping HUANG ; Shujuan WEN ; Donglu ZHAO ; Jun MA
Journal of Leukemia & Lymphoma 2023;32(8):457-464
Objective:To evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection in the treatment of peripheral T-cell lymphoma (PTCL) in a real-world setting.Methods:This was a real-world ambispective cohort study (MOMENT study) (Chinese clinical trial registry number: ChiCTR2200062067). Clinical data were collected from 198 patients who received mitoxantrone hydrochloride liposome injection as monotherapy or combination therapy at 37 hospitals from January 2022 to January 2023, including 166 patients in the retrospective cohort and 32 patients in the prospective cohort; 10 patients in the treatment-na?ve group and 188 patients in the relapsed/refractory group. Clinical characteristics, efficacy and adverse events were summarized, and the overall survival (OS) and progression-free survival (PFS) were analyzed.Results:All 198 patients were treated with mitoxantrone hydrochloride liposome injection for a median of 3 cycles (range 1-7 cycles); 28 cases were treated with mitoxantrone hydrochloride liposome injection as monotherapy, and 170 cases were treated with the combination regimen. Among 188 relapsed/refractory patients, 45 cases (23.9%) were in complete remission (CR), 82 cases (43.6%) were in partial remission (PR), and 28 cases (14.9%) were in disease stabilization (SD), and 33 cases (17.6%) were in disease progression (PD), with an objective remission rate (ORR) of 67.6% (127/188). Among 10 treatment-na?ve patients, 4 cases (40.0%) were in CR, 5 cases (50.0%) were in PR, and 1 case (10.0%) was in PD, with an ORR of 90.0% (9/10). The median follow-up time was 2.9 months (95% CI 2.4-3.7 months), and the median PFS and OS of patients in relapsed/refractory and treatment-na?ve groups were not reached. In relapsed/refractory patients, the difference in ORR between patients with different number of treatment lines of mitoxantrone hydrochloride liposome injection [ORR of the second-line, the third-line and ≥the forth-line treatment was 74.4% (67/90), 73.9% (34/46) and 50.0% (26/52)] was statistically significant ( P = 0.008). Of the 198 PTCL patients, 182 cases (91.9%) experienced at least 1 time of treatment-related adverse events, and the incidence rate of ≥grade 3 adverse events was 66.7% (132/198), which was mainly characterized by hematologic adverse events. The ≥ grade 3 hematologic adverse events mainly included decreased lymphocyte count, decreased neutrophil count, decreased white blood cell count, and anemia; non-hematologic adverse events were mostly grade 1-2, mainly including pigmentation disorders and upper respiratory tract infection. Conclusions:The use of mitoxantrone hydrochloride liposome injection-containing regimen in the treatment of PTCL has definite efficacy and is well tolerated, and it is a new therapeutic option for PTCL patients.
8.Clinical characteristics and prognosis of primary testicular diffuse large B-cell lymphoma
Shike LI ; Wenyu SHI ; Zhuo ZHANG ; Feng ZHANG ; Xiuhua SUN
Journal of China Medical University 2023;52(12):1074-1081
Objective To investigate the clinical characteristics and prognosis of primary testicular diffuse large B-cell lymphoma(PT-DLBCL).Methods The clinical data,treatment regimen and prognosis of PT-DLBCL patients were analyzed retrospectively,from the records of the Affiliated Hospital of Nantong University and the Second Affiliated Hospital of Dalian Medical University from Jan.1,2000 to Dec.31,2022.Results The median age of the 47 PT-DLBCL patients was 64 years old.The median overall survival(OS)was 41.6 months,with 1-year,3-year,and 5-year PT-DLBCL OS of 93%,77%,and 59%,respectively.Kaplan-Meier univariate analysis demonstrated that a diagnosed age≥70 years,Eastern cooperative oncology group(ECOG)score≥3,international prognostic index(IPI)score≥4,no combination of anthracycline and rituximab,a single treatment regimen,ineffective initial treatment and relapse,were asso-ciated with an adverse prognosis in PT-DLBCL(all P<0.05).Multivariate Cox regression analysis showed that an ECOG score≥3,no application of Rituximab,and an ineffective initial treatment response were independent risk factors for the poor prognosis of PT-DLBCL(all P<0.05).Conclusion PT-DLBCL is rare and associated with a poor prognosis.Early diagnosis and therapy with a combination of anthracyclines and rituximab may improve outcomes.
9.Eligibility of C-BIOPRED severe asthma cohort for type-2 biologic therapies.
Zhenan DENG ; Meiling JIN ; Changxing OU ; Wei JIANG ; Jianping ZHAO ; Xiaoxia LIU ; Shenghua SUN ; Huaping TANG ; Bei HE ; Shaoxi CAI ; Ping CHEN ; Penghui WU ; Yujing LIU ; Jian KANG ; Yunhui ZHANG ; Mao HUANG ; Jinfu XU ; Kewu HUANG ; Qiang LI ; Xiangyan ZHANG ; Xiuhua FU ; Changzheng WANG ; Huahao SHEN ; Lei ZHU ; Guochao SHI ; Zhongmin QIU ; Zhongguang WEN ; Xiaoyang WEI ; Wei GU ; Chunhua WEI ; Guangfa WANG ; Ping CHEN ; Lixin XIE ; Jiangtao LIN ; Yuling TANG ; Zhihai HAN ; Kian Fan CHUNG ; Qingling ZHANG ; Nanshan ZHONG
Chinese Medical Journal 2023;136(2):230-232
10.Comparison of mental health status of pregnant women with assisted reproductive technology and natural pregnancy
Lina LI ; Qiang SUN ; Chunming CUI ; Xiuhua XU ; Huihua WANG
Chinese Journal of Practical Nursing 2022;38(1):40-45
Objective:To explore whether assisted reproductive technology (ART) can affect the mental health of pregnant women during pregnancy.Methods:Convenient sampling method was used to select 500 pregnant women who underwent prenatal examination in Dalian Women and Children′s Medical Group from July 2019 to July 2020, including 193 cases of ART pregnant women (observation group) and 307 cases of natural pregnant women (control group). PEM-D psychosomatic holistic diagnosis and treatment system combined with Symptom Checklist- 90 (SCL-90), 7- item Generalized Anxiety Disorder Scale (GAD-7), 9-item Patient Health Questionnaire (PHQ-9) and Pittsburgh Sleep Quality Index (PSQI) were used to evaluate and compare the mental health status between the two groups.Results:The total score of SCL-90 in the observation group was (154.34 ± 14.42), which was significantly higher than that in the control group (142.42 ± 14.39), the difference was statistically significant ( t=5.35, P<0.05). The scores of anxiety, depression and paranoia in the observation group were (2.17 ± 0.47), (2.15 ± 0.68), (1.78 ± 0.45), which were significantly higher than those in the control group (1.95 ± 0.52), (1.77 ± 0.55), (1.58 ± 0.39), the differences were statistically significant ( t=2.86, 3.88, 3.20, all P<0.015). The scores of GAD-7 and PHQ-9 in the observation group were (6.72 ± 2.44), (5.43 ± 2.54), which were significantly higher than those in the control group (5.76 ± 2.47), (3.74 ± 1.66), the differences were statistically significant ( t=2.52, 3.57, both P<0.05). There was no significant difference in PSQI scores between the two groups ( P>0.05). Conclusions:ART affects the mental health of pregnant women, especially increases the level of depression and anxiety. We should provide corresponding psychological support and help for these pregnant women to reduce their depression and anxiety level.

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