1.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
2.Prognostic value of ultrasound carotid plaque length in patients with coronary artery disease.
Wendong TANG ; Zhichao XU ; Tingfang ZHU ; Yawei YANG ; Jian NA ; Wei ZHANG ; Liang CHEN ; Zongjun LIU ; Ming FAN ; Zhifu GUO ; Xianxian ZHAO ; Yuan BAI ; Bili ZHANG ; Hailing ZHANG ; Pan LI
Chinese Medical Journal 2025;138(14):1755-1757
3.Comparative Study on Flexible Ureteroscope Guided Peritoneal Dialysis Catheter Placement
Xiaozhou HAN ; Cheng ZHAO ; Jin QIU ; Jianxin LIU ; Shan LIN ; Yong ZHANG ; Changhai TIAN ; Wang LIU ; Huajun HU
Chinese Journal of Minimally Invasive Surgery 2024;24(1):29-33
Objective To explore the feasibility of peritoneal dialysis catheter placement assisted by flexible ureteroscope.Methods A retrospective analysis was conducted on clinical data of 54 cases of end-stage renal disease receiving peritoneal dialysis catheter placement from May 2019 to March 2023.The placement method was chosen by the patient.In the conventional group,23 cases were guided by a metal guide wire for insertion of the peritoneal dialysis catheter,while in the flexible ureteroscope group,31 cases were guided by flexible ureteroscope instead of guide wire for insertion of the peritoneal dialysis catheter.The success rate of catheterization,surgical time,use of postoperative analgesic,complications related to peritoneal dialysis catheter,and postoperative creatinine decrease were compared between the two groups.Results The catheter placement was successfully performed in both groups.The total incidence of complications related to peritoneal dialysis catheter in the flexible ureteroscope group was lower than that in the conventional group[6.5%(2/31)vs.30.4%(7/23),χ2 =3.878,P =0.049].Between the conventional group and the flexible ureteroscope group,there were no statistically significant differences in the surgical time,postoperative analgesic usage,and the decrease of creatinine at 2 weeks after surgery(P>0.05).The median postoperative follow-up period was10 months(range,3-24 months)in the two groups,and there were no complications such as peritoneal leakage,intestinal perforation,or intraperitoneal bleeding.Conclusion The placement of peritoneal dialysis catheter guided by the flexible ureteroscope instead of metal guide wire is a safe,visible,and accurate method,which can reduce complications related to peritoneal dialysis catheter,and detect and manage comorbidities in the abdominal cavity.
4.Recommendations for the timing, dosage, and usage of corticosteroids during cytokine release syndrome (CRS) caused by chimeric antigen receptor (CAR)-T cell therapy for hematologic malignancies.
Sanfang TU ; Xiu LUO ; Heng MEI ; Yongxian HU ; Yang LIU ; Ping LI ; Dehui ZOU ; Ting NIU ; Kailin XU ; Xi ZHANG ; Lugui QIU ; Lei GAO ; Guangxun GAO ; Li ZHANG ; Yimei FENG ; Ying WANG ; Mingfeng ZHAO ; Jianqing MI ; Ming HOU ; Jianmin YANG ; He HUANG ; Jianxiang WANG ; Yu HU ; Weili ZHAO ; Depei WU ; Jun MA ; Yuhua LI ; Wenbin QIAN ; Xiaojun HUANG ; Weidong HAN ; Aibin LIANG
Chinese Medical Journal 2024;137(22):2681-2683
5.Continuation, reduction, or withdrawal of tofacitinib in patients with rheumatoid arthritis achieving sustained disease control: a multicenter, open-label, randomized controlled trial.
Mengyan WANG ; Yu XUE ; Fang DU ; Lili MA ; Liang-Jing LU ; Lindi JIANG ; Yi-Li TAO ; Chengde YANG ; Hui SHI ; Honglei LIU ; Xiaobing CHENG ; Junna YE ; Yutong SU ; Dongbao ZHAO ; Sheng-Ming DAI ; Jialin TENG ; Qiongyi HU
Chinese Medical Journal 2023;136(3):331-340
BACKGROUND:
Rheumatoid arthritis (RA), a chronic systemic autoimmune disease, is characterized by synovitis and progressive damage to the bone and cartilage of the joints, leading to disability and reduced quality of life. This study was a randomized clinical trial comparing the outcomes between withdrawal and dose reduction of tofacitinib in patients with RA who achieved sustained disease control.
METHODS:
The study was designed as a multicenter, open-label, randomized controlled trial. Eligible patients who were taking tofacitinib (5 mg twice daily) and had achieved sustained RA remission or low disease activity (disease activity score in 28 joints [DAS28] ≤3.2) for at least 3 months were enrolled at six centers in Shanghai, China. Patients were randomly assigned (1:1:1) to one of three treatment groups: continuation of tofacitinib (5 mg twice daily); reduction in tofacitinib dose (5 mg daily); and withdrawal of tofacitinib. Efficacy and safety were assessed up to 6 months.
RESULTS:
Overall, 122 eligible patients were enrolled, with 41 in the continuation group, 42 in the dose-reduction group, and 39 in the withdrawal group. After 6 months, the percentage of patients with a DAS28-erythrocyte sedimentation rate (ESR) of <3.2 was significantly lower in the withdrawal group than that in the reduction and continuation groups (20.5%, 64.3%, and 95.1%, respectively; P < 0.0001 for both comparisons). The average flare-free time was 5.8 months for the continuation group, 4.7 months for the dose reduction group, and 2.4 months for the withdrawal group.
CONCLUSION:
Withdrawal of tofacitinib in patients with RA with stable disease control resulted in a rapid and significant loss of efficacy, while standard or reduced doses of tofacitinib maintained a favorable state.
TRIAL REGISTRATION
Chictr.org, ChiCTR2000039799.
Humans
;
Quality of Life
;
China
;
Arthritis, Rheumatoid/drug therapy*
;
Piperidines/therapeutic use*
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Treatment Outcome
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Antirheumatic Agents/therapeutic use*
;
Pyrroles/therapeutic use*
6.Advances in the classification and treatment of isolated superior mesenteric artery dissection.
Chao Chen WANG ; Yu Dong SUN ; Xiao Long WEI ; Zai Ping JING ; Zhi Qing ZHAO
Chinese Journal of Surgery 2023;61(1):81-85
Isolated superior mesenteric artery dissection (ISMAD) has attracted more and more clinicians' attention in recent years. Patients onset of ISMAD often present with abdominal pain. The misdiagnosis or miss diagnosis is common because of the non-specific symptoms and signs, which even can endanger lives in serious cases. Imaging classification is of great significance for diagnosis and treatment of ISMAD. The Sakamoto classification and the Yun classification are two classical classified methods. However, with the further study of ISMAD, various new classifications emerge. Conservative treatment was once considered as the preferred. As the rapid development of endovascular therapy and the great progress of new devices, stenting therapy can significantly improve symptoms and achieve satisfactory long-term effects, and be even expected to become the preferred method for clinical therapy of ISMAD. However, the long-term effects of endovascular therapy still need a large number of follow-up data, and complications after stent implantation can't be ignored.
Humans
;
Mesenteric Artery, Superior
;
Treatment Outcome
;
Tomography, X-Ray Computed
;
Aortic Dissection/therapy*
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Stents
;
Endovascular Procedures
;
Retrospective Studies
7.Preliminary exploration on operation process for autologous ozonized blood transfusion
Jianjun WU ; Yan BAI ; Yanli BAI ; Zhanshan ZHA ; Jing CHEN ; Yahan FAN ; Jiwu GONG ; Shouyong HUN ; Hongbing LI ; Zhongjun LI ; Jiajin LIN ; Chunxia LIU ; Fenghua LIU ; Jiubo LIU ; Jingling LUO ; Xianjun MA ; Deying MENG ; Shijie MU ; Mei QIN ; Hui WANG ; Haiyan WANG ; Qiushi WANG ; Quanli WANG ; Xiaoning WANG ; Yongjun WANG ; Changsong WU ; Lin WU ; Jue XIE ; Pu XU ; Liying XU ; Mingchia YANG ; Yongtao YANG ; Yang YU ; Zebo YU ; Juan ZHANG ; Xiaoyu ZHOU ; Xuelian ZHOU ; Shuming ZHAO
Chinese Journal of Blood Transfusion 2023;36(2):95-100
Autologous ozonized blood transfusion(AOBT) is a therapy of re-transfusion of 100-200 mL of autologous blood after shaking and agitation with appropriate amount of oxygen-ozone in vitro. The oxidation of blood through the strong oxidation of ozone can enhance the non-specific immune response of the body, regulate the internal environment and promote health. This therapy has been increasingly applied in clinical practice, while no unified standard for the operation process in terms of ozone concentration, treatment frequency and treatment course had been established. This operation process of AOBT is primarily explored in order to standardize the operation process and ensure its safety and efficacy.
8.A phase I study of subcutaneous envafolimab (KN035) monotherapy in Chinese patients with advanced solid tumors.
Rong Rui LIU ; Shan Zhi GU ; Tie ZHOU ; Li Zhu LIN ; Wei Chang CHEN ; Dian Sheng ZHONG ; Tian Shu LIU ; Nong YANG ; Lin SHEN ; Si Ying XU ; Ni LU ; Yun ZHANG ; Zhao Long GONG ; Jian Ming XU
Chinese Journal of Oncology 2023;45(10):898-903
Objective: To evaluate the safety and antitumor activity of envafolimab monotherapy in Chinese patients with advanced solid tumors. Methods: This open-label, multicenter phase I trial included dose escalation and dose expansion phases. In the dose escalation phase, patients received subcutaneous 0.1, 0.3, 1.0, 2.5, 5.0 or 10.0 mg/kg envafolimab once weekly (QW) following a modified "3+ 3" design. The dose expansion phase was performed in the 2.5 mg/kg and 5.0 mg/kg (QW) dose cohorts. Results: At November 25, 2019, a total of 287 patients received envafolimab treatment. During the dose escalation phase, no dose-limiting toxicities (DLT) was observed. In all dose cohorts, drug-related treatment-emergent adverse events (TEAEs) for all grades occurred in 75.3% of patients, and grade 3 or 4 occurred in 20.6% of patients. The incidence of immune-related adverse reactions (irAE) was 24.0% for all grades, the most common irAEs (≥2%) included hypothyroidism, hyperthyroidism, immune-associated hepatitis and rash. The incidence of injection site reactions was low (3.8%), all of which were grades 1-2. Among the 216 efficacy evaluable patients, the objective response rate (ORR) and disease control rate (DCR) were 11.6% and 43.1%, respectively. Median duration of response was 49.1 weeks (95% CI: 24.0, 49.3). Pharmacokinetic (PK) exposure to envafolimab is proportional to dose and median time to maximum plasma concentration is 72-120 hours based on the PK results from the dose escalation phase of the study. Conclusion: Subcutaneous envafolimab has a favorable safety and promising preliminary anti-tumor activity in Chinese patients with advanced solid tumors.
Humans
;
East Asian People
;
Neoplasms/pathology*
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Antibodies, Monoclonal, Humanized/therapeutic use*
9.A phase I study of subcutaneous envafolimab (KN035) monotherapy in Chinese patients with advanced solid tumors.
Rong Rui LIU ; Shan Zhi GU ; Tie ZHOU ; Li Zhu LIN ; Wei Chang CHEN ; Dian Sheng ZHONG ; Tian Shu LIU ; Nong YANG ; Lin SHEN ; Si Ying XU ; Ni LU ; Yun ZHANG ; Zhao Long GONG ; Jian Ming XU
Chinese Journal of Oncology 2023;45(10):898-903
Objective: To evaluate the safety and antitumor activity of envafolimab monotherapy in Chinese patients with advanced solid tumors. Methods: This open-label, multicenter phase I trial included dose escalation and dose expansion phases. In the dose escalation phase, patients received subcutaneous 0.1, 0.3, 1.0, 2.5, 5.0 or 10.0 mg/kg envafolimab once weekly (QW) following a modified "3+ 3" design. The dose expansion phase was performed in the 2.5 mg/kg and 5.0 mg/kg (QW) dose cohorts. Results: At November 25, 2019, a total of 287 patients received envafolimab treatment. During the dose escalation phase, no dose-limiting toxicities (DLT) was observed. In all dose cohorts, drug-related treatment-emergent adverse events (TEAEs) for all grades occurred in 75.3% of patients, and grade 3 or 4 occurred in 20.6% of patients. The incidence of immune-related adverse reactions (irAE) was 24.0% for all grades, the most common irAEs (≥2%) included hypothyroidism, hyperthyroidism, immune-associated hepatitis and rash. The incidence of injection site reactions was low (3.8%), all of which were grades 1-2. Among the 216 efficacy evaluable patients, the objective response rate (ORR) and disease control rate (DCR) were 11.6% and 43.1%, respectively. Median duration of response was 49.1 weeks (95% CI: 24.0, 49.3). Pharmacokinetic (PK) exposure to envafolimab is proportional to dose and median time to maximum plasma concentration is 72-120 hours based on the PK results from the dose escalation phase of the study. Conclusion: Subcutaneous envafolimab has a favorable safety and promising preliminary anti-tumor activity in Chinese patients with advanced solid tumors.
Humans
;
East Asian People
;
Neoplasms/pathology*
;
Antibodies, Monoclonal, Humanized/therapeutic use*
10.Clinical comprehensive evaluation of recombinant Mycobacterium tuberculosis fusion protein
Xiaofeng NI ; Sha DIAO ; Siyi HE ; Xuefeng JIAO ; Xiao CHENG ; Zhe CHEN ; Zheng LIU ; Linan ZENG ; Deying KANG ; Bin WU ; Chaomin WAN ; Binwu YING ; Hui ZHANG ; Rongsheng ZHAO ; Liyan MIAO ; Zhuo WANG ; Xiaoyu LI ; Maobai LIU ; Benzhi CAI ; Feng QIU ; Feng SUN ; Naihui CHU ; Minggui LIN ; Wei SHA ; Lingli ZHANG
China Pharmacy 2023;34(4):391-396
OBJECTIVE To evaluate the effectiveness, safety, economy, innovation, suitability and accessibility of recombinant Mycobacterium tuberculosis fusion protein (EC), and to provide evidence for selecting skin detection methods for tuberculosis infection diagnosis and auxiliary diagnosis of tuberculosis. METHODS The effectiveness and safety of EC compared with purified protein derivative of tuberculin (TB-PPD) were analyzed by the method of systematic review. Cost minimization analysis, cost-effectiveness analysis and cost-utility analysis were used to evaluate the short-term economy of EC compared with TB-PPD, and cost-utility analysis was used to evaluate the long-term economy. The evaluation dimensions of innovation, suitability and accessibility were determined by systematic review and improved Delphi expert consultation, and the comprehensive score of EC and TB-PPD in each dimension were calculated by the weight of each indicator. RESULTS The scores of effectiveness, safety, economy, innovation and suitability of EC were all higher than those of TB-PPD. The affordability scores of the two drugs were consistent, while the availability score of EC was lower than those of TB-PPD. After considering dimensions and index weight, the scores of effectiveness, safety, economy, innovation, suitability, accessibility and the comprehensive score of EC were all higher than those of TB-PPD. CONCLUSIONS Compared with TB-PPD, EC performs better in all dimensions of effectiveness, safety, economy, innovation, suitability and accessibility. However, it is worth noting that EC should further improve its availability in the dimension of accessibility.

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