1.Reflections on the conduct of cell therapy clinical trials in medical institutes
Ping JI ; Yu SHI ; Weiwei XU ; Yongsheng ZHAO ; Tao WANG ; Junhui CHEN ; Yun CHEN
Chinese Journal of Medical Science Research Management 2023;36(1):2-6
Objective:This paper introduces the concepts of " patient-centered cell therapy research management model", to provide reference for domestic medical institutions which conduct cell therapy clinical trials.Methods:We reviewed and summarized the experiences of conducting cell therapy at Peking University Shenzhen Hospital, including challenges and response plans regarding to the technology assessment, ethical evaluation risks and regulatory compliance. According to which, this paper aims to explore the reflections and practical experience of establishing a patient-centered, multi-stakeholder shared decision-making research management system.Results:The " patient-centered cell therapy research management model" ensures the reliability of research results through multi-stakeholder engagement in decision-making and management, adequate technical evaluation, effective ethical review and harmonized scientific research management, which not only meets the urgent health needs of the patient, but also promotes the standardized development of emerging technologies.Conclusions:The " patient-centered cell therapy research management model" is tailored for the cell therapy research, it is important to promote its further assessment and applications.
2.Endoscopic endonasal surgery for traumatic optic neuropathy
Zeran YU ; Zhengqiao LIU ; Hongling XU ; Ping ZENG ; Xu CHEN ; Junhui QI
International Journal of Surgery 2023;50(12):860-864
Traumatic optic neuropathy(TON) is a direct or indirect optic nerve injury after head trauma leading to vision loss and blindness. As endoscopic techniques spreading, the surgical treatment of TON is mainly accomplished by endoscopic endonasal optic canal decompression. As lack of recognition, some patients elapse the optimistic surgical time. Even after aggressive treatment, however, a full recovery of visual acuity is diminished in TON, which carries substantial burden to both the patients′ family and society. The article reviews the advances in study in the timing of surgery, prognostic factors, and complications in endoscopic surgery for TON to improve the understanding of the disease.
3.Percutaneous biliary stent combined with brachytherapy for malignant obstructive jaundice: a multicenter retrospective controlled study
Xinhui HUANG ; Songhui WU ; Ping LI ; Qiao KE ; Xiadi WENG ; Ling LI ; Dexin LIU ; Shaowu ZHUANG ; Junhui SUN ; Wuhua GUO
Chinese Journal of Hepatology 2022;30(7):702-709
Objective:To investigate the efficacy, safety and prognostic factors of percutaneous biliary stent combined with iodine-125 seed chain brachytherapy (radiotherapy) in the treatment of malignant obstructive jaundice.Methods:Data of 107 cases with malignant obstructive jaundice treated with percutaneous biliary stent implantation from January 2017 to December 2020 were retrospectively analyzed. Among them, 58 cases received biliary stent combined with iodne-125 seed chain brachytherapy (study group), and 49 cases received biliary stent implantation (control group). The changes of bilirubin, stent patency time, complications, overall survival (OS) and prognostic factors were analyzed in both groups.Results:The incidence of complications in the study group and the control group were 17.2% and 18.3% respectively, and the difference was not statistically significant ( P=0.974). Serum total bilirubin levels were decreased significantly in both groups at one month after surgery ( P<0.001). Postoperative stent patency time was significantly better in the study group (10.0±1.6 months) (95% CI: 8.2~12.5) than that in the control group (5.2±0.4 months) (95% CI: 4.1~6.0, P<0.001). The median OS was longer in the study group (11.2±1.8 months) (95% CI: 9.2~12.8) than that in the control group (8.0±1.1 months) (95% CI: 8.0~12.8, P<0.001). Multivariate analysis result showed that stent combined with brachytherapy ( HR=0.08, 95% CI:0.04~0.15, P<0.001) and receiving further anti-tumor therapy after surgery ( HR=0.27, 95% CI:0.15~0.49, P<0.001) were independent risk factors affecting the patency of biliary stents. Preoperative percutaneous transhepatic biliary drainage ( HR=0.46, 95% CI:0.28~0.74, P=0.002), stent combined with brachytherapy ( HR=0.23, 95% CI:0.14~0.39, P<0.001) and receiving further anti-tumor therapy after surgery ( HR=0.37, 95% CI:0.22~0.61, P<0.001) were independent risk factors affecting OS. Conclusion:Percutaneous biliary stent combined with brachytherapy is safe and effective in the treatment of malignant obstructive jaundice, which can significantly prolong the patency time of biliary stent and the survival time of patients.
4.Practice of a hemodialysis alliance in the context of closed-loop hospital management
Jing QIAN ; Mengjing WANG ; Chuhan LU ; Ping CHENG ; Li NI ; Wei LIU ; Bihong HUANG ; Zhibin YE ; Zhenwen YAN ; Qianqiu CHENG ; Chen YU ; Aili WANG ; Ai PENG ; Wei XU ; Chunlai LU ; Dandan CHEN ; Xiuzhi YU ; Liyan FEI ; Jun MA ; Jialan SHEN ; Junhui LI ; Ying LI ; Lingyun CHEN ; Weifeng WU ; Rongqiang YU ; Lihua XU ; Jing CHEN
Chinese Journal of Hospital Administration 2022;38(8):595-599
Closed-loop hospital management can effectivly cope with the COVID-19 pandemic. In order to ensure the continuity of treatments for hemodialysis patients under closed-loop management and minimize possible medical and infection risks, Huashan Hospital affiliated to Fudan University and 9 hospitals in Shanghai established a hemodialysis alliance in January 2021.The alliance optimized hemodialysis resources within the region through overall planning by preparing sites, materials and personnel shifts in advance, and establishing management systems and work processes to ensure that patients could be quickly and orderly diverted to other blood dialysis centers for uninterrupted high-quality hemodialysis services, in case that some hemodialysis centers in the alliance under closed-loop management.From November 2021 to April 2022, 317 of 1 459 hemodialysis patients in the alliance were diverted to other centers for treatment, accumulating 1 215 times/cases of treatments without obvious adverse reactions. The practice could provide a reference for medical institutions to quickly establish mutual support mode under major public health events.
5.A case report of perineal angiomyfibroblastoma
Huaizhen GENG ; Kai GUO ; Junhui HE ; Pu WANG ; Chao MA ; Hao PING
Chinese Journal of Urology 2021;42(2):152-153
Angiomyfibroblastoma (AMF)is a kind of rare benign tumour. The clinical and imaging findings of AMF are nonspecific. In October 2019, 1 case of Angiomyfibroblastoma of perineum was admitted to Heze Municipal Hospital for surgical treatment. Final pathological diagnosis was AMF. So far, neither recurrence nor metastasis has been detected for 5 months.
6.Expression of interleukin-13 and its receptors in mycosis fungoides
Cheng DING ; Ping WANG ; Jiao LIU ; Zhao LI ; Liuyu LI ; Dongyin LIU ; Junhui ZHENG ; Hong SHEN
Chinese Journal of Dermatology 2017;50(4):291-294
Objective To measure the expression of interleukin-13 (IL-13) and its receptors in mycosis fungoides (MF) lesions,and to investigate their clinical significance.Methods A total of 34 paraffin-embedded specimens of MF,which was confirmed by clinical and histopathological features,immunophenotyping and/or T-cell receptor gene rearrangements,were collected from Hangzhou Third People's Hospital between January 2010 and March 2016.According to the tumor-node-metastasis (TNM) staging system,5 patients were at stage I A,9 at stage Ⅰ B,17 at stage Ⅱ A,and 3 at stage Ⅱ B.Ten normal skin tissue specimens served as controls.Immunohistochemical study was conducted to measure the expression of IL-13,IL-13Rα1 and IL-13Rα2.Results IL-13,IL-13Rα1 and IL-13Rα2 were all expressed in atypical lymphoid cells and epidermotropic lymphoid cells in MF lesions at various stages.IL-13Rα2 was highly expressed in all the MF lesions.None of IL-13 and its receptors were expressed in normal skin tissues and lymphocytes.The expression rates of IL-13 and its receptors in MF lesions increased along with the progression of MF.Additionally,the expression rates of IL-13 (10.00% ± 3.14%),IL-13Rα1 (21.43% ± 6.88%) and IL-13Ro2 (31.14% ± 6.38%) significantly decreased in MF lesions at stage Ⅰ compared with those at stage Ⅱ (27.50% ± 11.00%,39.45% ± 9.43%,44.40% ± 11.15%,respectively,all P < 0.05),but no significant differences were observed between stage Ⅰ A and Ⅰ B,or between stage Ⅱ A and Ⅱ B (P > 0.05).Conclusion IL-13 and its receptors,especially IL-13Rα2,may be expected to serve as biomarkers for early diagnosis of MF and prediction of its biological behaviors.
7.Effects of adiponectin on proliferation, migration and tube formation of RF/6A cells
Kunpeng XIE ; Xin WANG ; Junhui DU ; Ping LIU
Recent Advances in Ophthalmology 2017;37(6):511-514
Objective To investigate the effects of adiponectin (APN) on proliferation,migration and tube formation of RF/6A cells,and explore the effects of APN on choroidal and retinal angiogenesis.Methods Well cultured RF/6A cells were randomly divided into the control group and three groups with different concentrations of recombinant adiponectin (5 pg · mL-1,50 pg · mL-1,500 pg · mL-1) for 1 hour.After 24 hours,cell proliferation,migration and tube formation were detected by MTT assay,wound scratch assay and seeding cells in matrigel,respectively.Results The cell proliferation in all APN groups was weaker than that of control group (P < 0.05),the cell migration area (pixels) of all APN groups was significantly smaller than that of the control group (P < 0.05),and the number of tube formation of all APN groups was significantly less than the control group (P < 0.05).Cell proliferation,migration and tube formation decreased along with the increase of APN concentration.Conclusion APN can obviously inhibit the angiogenesis process of RF/6A cells.This inhibitive effect indicates the protective role of APN in choroidal and retinal angiogenesis.
8.Forty Cases of Therapy for Mental Retardation Associated with Agitation by Ziprasidone Mesylate
Junhui PING ; Fei PAN ; Zhaoxi ZHONG ; Lina WANG ; Jingdan ZHANG ; Yonghe CAO
Herald of Medicine 2015;(7):899-902
Objective To investigate the clinical efficacy and safety of ziprasidone mesylate injection on the acute agitation symptom in mental retardation. Methods The total of 80 patients of mental retardation with acute agitation symptoms were randomly divided into two groups:the treatment group (40 patients) were intra-muscarly given with ziprasidone mesylate injection at the initial dose of 10 mg, 20 mg 4 h later, and 30 mg once on the second day and third day. And the control group (40 patients) were treated with haloperidol injection. The volume dose of haloperidol was 20 mg everyday. Other antipsychotic drugs, antimanic drugs and benzodiazepines were not allowed to be used during the observation, neither does the prophylactic use of drugs against parkinson's disease. Before and 1, 2, 4, 6, 8, 12, 24, 48, 72 h after treatment, the positive and negative scale ( PANSS) reduction rate, the end of the clinical global impression scale ( CGI) were assessed. By the end of the treatment, the adverse reactions symptom, cale ( TESS) was assessed for the safety. Results By the end of treatment PANSS reduction rate was 46. 31% in the test group and 48. 81% in the control group, the clinical improvement rate was 80. 00% in the treatment group and 82. 50% in the control group. No statistically significant difference on efficacy was found between two groups. The side reaction rate in the treatment group was 27. 5%, that in the control group was 40. 0%, there was significant difference ( P<0. 05) between two groups, but the extrapyramidal reaction in the control group was significantly more than that in the treatment group(P<0. 05). Conclusion Ziprasidone mesylate injection is effective on treating the symptoms of mental retardation, in corresponding to the effect of haloperidol injection,and with less extrapyramidal reactions.
9.Conduction of a prostate cancer whole-cell vaccine modified by mice HSP70 and GM-CSF
Qi MA ; Junfeng CHEN ; Junhui JIANG ; Ping WANG ; Zhaohui JIANG ; Yue CHENG
China Modern Doctor 2015;(19):1-4,11
Objective To construct a whole-cell vaccine modified by mice HSP70 and GM-CSF in prostate cancer. Methods Sequence fragments carrying mice Hspa1a coupled with C-myc or Csf2 coupled with V5 tag were constructed by chemical synthesis and PCR amplification , then both fragments were cloned into the vector pMD-18T. After se quencing, fragments described above were cloned into pLenti6.3_MCS lentiviral vector. The lentiviral expression vectors were named as pLenti6.3_MCS_Hspa1a_cMyc and pLenti6.3_MCS_Csf2_V5. These vectors were transfected or co-transfected into mice prostate cancer cell line RM-1 and proteins were detected by Western blotting. Following irradia-tion of 10 Gy, cells lost proliferative ability and were frozen and then stored. Results Recombinant lentiviral vectors pLenti6.3_MCS_Hspa1a_cMyc and pLenti6.3_MCS_Csf2_V5 were successfully constructed and GM-CSF, HSP70 or both expression in the transfected RM-1 cells were verified by Western blotting. Conlusion The RM-1 whole-cell vaccines modified by HSP70 and GM-CSF have been successfully constructed, which facilitate further investigation of the action mechanisms of whole-cell antigen and immune enhancement.
10.Association analysis between T helper type 17 cells, regulatory T cells and mycosis fungoides
Zhao LI ; Ping WANG ; Xiuli HOU ; Dongyin LIU ; Mei WANG ; Junhui ZHENG
Chinese Journal of Dermatology 2014;47(9):637-641
Objective To investigate the changes of T helper type 17 (Thl7) cells and regulatory T (Treg) cells in different stages of mycosis fungoides.Methods Flow cytometry was performed to determine the percentage of Treg and Th17 cells in peripheral blood from 28 patients with mycosis fungoides (MF),13 patients with large plaque parapsoriasis (PP),17 patients with lichen planus (LP) and 10 healthy human controls,and immunohistochemistry to detect the expressions of forkhead box protein 3 (FOXP3) and interleukin (IL)-17 in tissue specimens from 40 patients with MF,13 with PP,17 with LP and 10 healthy human controls.Statistical analysis was carried out by one-way analysis of variance and Pearson correlation analysis.Results As far as the percentage of Treg cells in peripheral blood was concerned,MF,PP and LP patients were significantly higher than the healthy controls (8.09% ± 1.68%,6.53% ± 1.67% and 2.84 % ± 1.16% vs.1.01% ± 0.35,all P< 0.05),PP patients were higher than LP patients and healthy controls (both P < 0.05),and LP patients were higher than healthy controls (P < 0.05).The percentage of Th17 cells in peripheral blood was significantly increased in MF patients compared with PP patients,LP patients and healthy controls (3.22% ± 0.82% vs.2.46% ± 0.79%,1.38% ± 0.47% and 0.59% ± 0.30%,all P < 0.05).Elevated expression rate of FOXP3 was observed in MF,PP and LP lesions as compared with normal skin (14.94% ± 4.46%,11.95% ± 4.72%,6.32% ± 2.81% vs.3.43% ± 1.79%,all P < 0.05),and in MF and PP lesions compared with LP lesions (both P < 0.05),but no significant difference was observed between MF and PP lesions (P > 0.05).There was a significant increase in the expression rate of IL-17 in MF lesions compared with PP lesions,LP lesions and normal skin (15.89% ± 4.27% vs.12.02% ± 3.34%,4.84% ± 1.93% and 2.62% ± 0.89%,all P < 0.05).The Th17/Treg ratio in peripheral blood was significantly lower in MF and PP patients than in LP patients and healthy controls (0.41 ± 0.11 and 0.39 ± 0.12 vs.0.50 ± 0.06 and 0.57 ± 0.19,all P < 0.05).A positive correlation was observed between the proportion of Thl7 cells and Treg cells (r =0.423,P < 0.05) in patients with early-stage MF,but not in those with tumor-stage MF.The proportion of Th17 cells decreased,but that of Treg cells continuously increased in patients with tumor-stage MF.However,no significant difference was noted in the proportion of Thl7 cells or Treg cells among patients with different stages of MF.Conclusion The imbalance between Treg and Th17 cells may be involved in the occurrence and development of MF.

Result Analysis
Print
Save
E-mail