1.Risk factors for simultaneous pancreas-kidney transplantation in patients with type 2 diabetes complicated by end-stage renal disease:analysis of 50 230 cases from the UNOS database
Xin-Ze XIA ; Wen-Hui LAI ; Shuai HUANG ; Zhe-Kun AN ; Xiao-Wei HAO ; Kai-Kai LYU ; Zhen-Jun LUO ; Qing YUAN ; Ming CAI
Medical Journal of Chinese People's Liberation Army 2024;49(4):371-379
Objective To compare the outcomes of transplant kidneys and patient survival between simultaneous pancreas-kidney transplantation(SPKT)recipients and deceased donor kidney transplant(DDKT)recipients in patients with type 2 diabetes mellitus(T2DM)complicated with end-stage renal disease(ESRD),and to analyze the risk factors affecting patient survival post-SPKT.Methods Clinical and prognostic data of patients who underwent kidney transplantation from January 27,2003,to January 1,2021,were retrieved from the United Network for Organ Sharing(UNOS)database.A total of 50 230 cases were selected based on inclusion criteria,with 48 669 cases in DDKT group and 1561 cases in SPKT group.Kaplan-Meier analysis was employed to compare transplant kidney and patient survival between the two groups,and propensity score matching(PSM)was utilized to balance confounding factors between the groups.Cox regression model was used to analyze independent risk factors affecting patient survival post-SPKT.Results Compared with DDKT group,recipients in SPKT group had a younger median age(P<0.001),a higher proportion of males(P<0.001),lower BMI(P<0.001),shorter dialysis and transplant waiting times(P<0.001),a higher percentage of private medical insurance(P<0.001),a lower proportion of previous transplants(P<0.001),a younger age at diabetes diagnosis(P<0.001),and a lower incidence of peripheral vascular disease(P=0.033).Compared with DDKT group,the donors in SPKT group had a younger median age(P<0.001),a higher proportion of males(P<0.001),lower BMI(P<0.001),and a lower prevalence of hypertension and diabetes history(P<0.001).In terms of transplant-related factors,the SPKT group had a shorter donor kidney cold ischemia time(P<0.001),a higher degree of HLA mismatch(P<0.001),and a lower Kidney Donor Profile Index(KDPI)(P<0.001)when compared with DDKT group.The SPKT group had lower serum creatinine levels at discharge(P<0.001),lower rates of postoperative delayed graft function(DGF)and acute rejection(AR)(P<0.001),but longer hospital stays(P<0.001)when compared with DDKT group.Kaplan-Meier survival analysis curves,both original and after propensity score matching(PSM),consistently showed significantly higher transplant kidney and patient survival rates in SPKT group compared with DDKT group(P<0.001).Cox regression model analysis indicated that recipient age,recipient race,donor age,and donor kidney cold ischemia time were independent risk factors influencing patient survival post-SPKT.Conclusions For ESRD patients with T2DM,SPKT offers improved long-term graft and patient survival rates compared with DDKT.Recipient age,recipient ethnicity,donor age,and cold ischemia time for the donor's kidney are independent risk factors affecting post-SPKT patient survival.
2.Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients (version 2024)
Yao LU ; Yang LI ; Leiying ZHANG ; Hao TANG ; Huidan JING ; Yaoli WANG ; Xiangzhi JIA ; Li BA ; Maohong BIAN ; Dan CAI ; Hui CAI ; Xiaohong CAI ; Zhanshan ZHA ; Bingyu CHEN ; Daqing CHEN ; Feng CHEN ; Guoan CHEN ; Haiming CHEN ; Jing CHEN ; Min CHEN ; Qing CHEN ; Shu CHEN ; Xi CHEN ; Jinfeng CHENG ; Xiaoling CHU ; Hongwang CUI ; Xin CUI ; Zhen DA ; Ying DAI ; Surong DENG ; Weiqun DONG ; Weimin FAN ; Ke FENG ; Danhui FU ; Yongshui FU ; Qi FU ; Xuemei FU ; Jia GAN ; Xinyu GAN ; Wei GAO ; Huaizheng GONG ; Rong GUI ; Geng GUO ; Ning HAN ; Yiwen HAO ; Wubing HE ; Qiang HONG ; Ruiqin HOU ; Wei HOU ; Jie HU ; Peiyang HU ; Xi HU ; Xiaoyu HU ; Guangbin HUANG ; Jie HUANG ; Xiangyan HUANG ; Yuanshuai HUANG ; Shouyong HUN ; Xuebing JIANG ; Ping JIN ; Dong LAI ; Aiping LE ; Hongmei LI ; Bijuan LI ; Cuiying LI ; Daihong LI ; Haihong LI ; He LI ; Hui LI ; Jianping LI ; Ning LI ; Xiying LI ; Xiangmin LI ; Xiaofei LI ; Xiaojuan LI ; Zhiqiang LI ; Zhongjun LI ; Zunyan LI ; Huaqin LIANG ; Xiaohua LIANG ; Dongfa LIAO ; Qun LIAO ; Yan LIAO ; Jiajin LIN ; Chunxia LIU ; Fenghua LIU ; Peixian LIU ; Tiemei LIU ; Xiaoxin LIU ; Zhiwei LIU ; Zhongdi LIU ; Hua LU ; Jianfeng LUAN ; Jianjun LUO ; Qun LUO ; Dingfeng LYU ; Qi LYU ; Xianping LYU ; Aijun MA ; Liqiang MA ; Shuxuan MA ; Xainjun MA ; Xiaogang MA ; Xiaoli MA ; Guoqing MAO ; Shijie MU ; Shaolin NIE ; Shujuan OUYANG ; Xilin OUYANG ; Chunqiu PAN ; Jian PAN ; Xiaohua PAN ; Lei PENG ; Tao PENG ; Baohua QIAN ; Shu QIAO ; Li QIN ; Ying REN ; Zhaoqi REN ; Ruiming RONG ; Changshan SU ; Mingwei SUN ; Wenwu SUN ; Zhenwei SUN ; Haiping TANG ; Xiaofeng TANG ; Changjiu TANG ; Cuihua TAO ; Zhibin TIAN ; Juan WANG ; Baoyan WANG ; Chunyan WANG ; Gefei WANG ; Haiyan WANG ; Hongjie WANG ; Peng WANG ; Pengli WANG ; Qiushi WANG ; Xiaoning WANG ; Xinhua WANG ; Xuefeng WANG ; Yong WANG ; Yongjun WANG ; Yuanjie WANG ; Zhihua WANG ; Shaojun WEI ; Yaming WEI ; Jianbo WEN ; Jun WEN ; Jiang WU ; Jufeng WU ; Aijun XIA ; Fei XIA ; Rong XIA ; Jue XIE ; Yanchao XING ; Yan XIONG ; Feng XU ; Yongzhu XU ; Yongan XU ; Yonghe YAN ; Beizhan YAN ; Jiang YANG ; Jiangcun YANG ; Jun YANG ; Xinwen YANG ; Yongyi YANG ; Chunyan YAO ; Mingliang YE ; Changlin YIN ; Ming YIN ; Wen YIN ; Lianling YU ; Shuhong YU ; Zebo YU ; Yigang YU ; Anyong YU ; Hong YUAN ; Yi YUAN ; Chan ZHANG ; Jinjun ZHANG ; Jun ZHANG ; Kai ZHANG ; Leibing ZHANG ; Quan ZHANG ; Rongjiang ZHANG ; Sanming ZHANG ; Shengji ZHANG ; Shuo ZHANG ; Wei ZHANG ; Weidong ZHANG ; Xi ZHANG ; Xingwen ZHANG ; Guixi ZHANG ; Xiaojun ZHANG ; Guoqing ZHAO ; Jianpeng ZHAO ; Shuming ZHAO ; Beibei ZHENG ; Shangen ZHENG ; Huayou ZHOU ; Jicheng ZHOU ; Lihong ZHOU ; Mou ZHOU ; Xiaoyu ZHOU ; Xuelian ZHOU ; Yuan ZHOU ; Zheng ZHOU ; Zuhuang ZHOU ; Haiyan ZHU ; Peiyuan ZHU ; Changju ZHU ; Lili ZHU ; Zhengguo WANG ; Jianxin JIANG ; Deqing WANG ; Jiongcai LAN ; Quanli WANG ; Yang YU ; Lianyang ZHANG ; Aiqing WEN
Chinese Journal of Trauma 2024;40(10):865-881
Patients with severe trauma require an extremely timely treatment and transfusion plays an irreplaceable role in the emergency treatment of such patients. An increasing number of evidence-based medicinal evidences and clinical practices suggest that patients with severe traumatic bleeding benefit from early transfusion of low-titer group O whole blood or hemostatic resuscitation with red blood cells, plasma and platelet of a balanced ratio. However, the current domestic mode of blood supply cannot fully meet the requirements of timely and effective blood transfusion for emergency treatment of patients with severe trauma in clinical practice. In order to solve the key problems in blood supply and blood transfusion strategies for emergency treatment of severe trauma, Branch of Clinical Transfusion Medicine of Chinese Medical Association, Group for Trauma Emergency Care and Multiple Injuries of Trauma Branch of Chinese Medical Association, Young Scholar Group of Disaster Medicine Branch of Chinese Medical Association organized domestic experts of blood transfusion medicine and trauma treatment to jointly formulate Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients ( version 2024). Based on the evidence-based medical evidence and Delphi method of expert consultation and voting, 10 recommendations were put forward from two aspects of blood support mode and transfusion strategies, aiming to provide a reference for transfusion resuscitation in the emergency treatment of severe trauma and further improve the success rate of treatment of patients with severe trauma.
3.Inter-laboratory comparison analysis of noise measurement in 91 occupational hygiene technical service organizations.
Guo Yong XU ; Ming Zhen LAI ; Dan Ying ZHANG ; Hua YAN ; Mao Sheng YAN ; Bin XIAO
Chinese Journal of Industrial Hygiene and Occupational Diseases 2022;40(11):821-825
Objective: To understand the comparability of noise measurement results of various occupational hygiene technical service organizations in Guangdong Province by conducting inter-laboratory comparison of measuring instruments and personnel operation. Methods: In October 2020, the instrument comparison and personnel comparison among 91 occupational hygiene technical service organizations engaged in noise measurement in Guangdong Province were carried out in the form of fixed-point measurement and simulated workplace measurement, and the results were analyzed and evaluated by using the robust z-ratio score. Results: In the instrument comparison, 6 organizations had 1 or 2 outliers in their z-ratio scores, 2 organizations had 2 problematic values in their z-ratio scores, and a total of 8 organizations (accounting for 8.8%) were judged as unqualified; A total of 83 organizations (accounting for 91.2%) with satisfactory z-ratio scores or only one problematic value were judged as qualified. In the personnel comparison, there were 11 organizations with 1 or 2 outliers in the z-ratio score, and 1 organization with 2 problematic values in the z-ratio score. A total of 12 organizations (13.2%) were judged as unqualified and 79 organizations (accounting for 86.8%) with satisfactory z-ratio scores or only one problematic value were judged as qualified. Through comprehensive judgment, 20 organizations (22.0%) were judged as unqualified, and 71 organizations (78.0%) were judged as qualified. There was no statistically significant difference in the qualified rates of instrument comparison results, personnel comparison results and comprehensive evaluation results of non-private organizations and private organizations (P>0.05). There was no significant difference in the qualified rates of instrument comparison results and comprehensive evaluation results of qualified organizations and unqualified organizations (P>0.05), there was significant difference in the qualified rate of personnel comparison results (P<0.05) . Conclusion: The noise measurement results of some occupational health technical service organizations in Guangdong Province are generally comparable. To carry out inter-laboratory comparison of noise instrument performance and personnel operation ability of occupational hygiene technical service organizations, can comprehensively evaluate the testing process of each organization and find out the problems existing in each organization.
Humans
;
Workplace
;
Occupational Health Services
;
Organizations
;
Hygiene
;
Workforce
;
Noise, Occupational
4.Physical agent detection ability of occupational health technical service institutions in Guangdong Province
XU Guo yong CUI Jia xin LAI Ming zhen ZHANG Dan ying YAN Hua
China Occupational Medicine 2022;49(05):568-
Objective
To analyze the physical agent detection ability of occupational health technical service institutions in
Methods
Guangdong Province. A total of 92 institutions in Guangdong Province that participated in the inter laboratory
comparison of physical agents organized in 2020 were taken as the research subjects using purposive sampling method. The
, Results
certified physical factor items number of measuring instruments and measurement standards were investigated. The
, ,
certification and accreditation project on physical agents in 92 institutions with certification and accreditation rate >80.0%
, , , -
were noise high temperature ultraviolet radiation hand transmitted vibration and illumination. The certification approval rates
, , , ,
of power frequency magnetic field 1 Hz to 100 kHz electric field 1 Hz to 100 kHz magnetic field laser radiation physical
, - < ( )
labor intensity and whole body vibration were 60.0%. The certification and accreditation rate of noise 98.9% was the
, ( ) (P< ) ,
highest and that of the physical labor intensity 3.3% was the lowest 0.01 . As for the number of measuring instruments
( )
the number of noise measuring instruments accounted for the highest proportion 52.6% in 92 institutions. The number of
, (P< )
measuring instruments from the most to the least was grade A grade B and unqualified institutions 0.01 . The number of
- (P< )
measuring instruments in private institutions was greater than that in non private institutions 0.01 . In the measurement
, ,
standards some institutions that have certified power frequency electric field power frequency magnetic field and microclimate
, -
projects still used the abandoned standard. Some institutions that have certified microclimate illuminance and whole body
Conclusion ,
vibration used the wrong measurement standards. Among the physical agents the certification and accreditation
,
rate of noise is the highest and the number of noise related measuring instruments is the largest. The qualified institutions and
private institutions have greater number of certification and accreditation projects on physical agents and measuring instruments.
5.Preliminary results of multicenter studies on ABO-incompatible kidney transplantation
Hongtao JIANG ; Tao LI ; Kun REN ; Xiaohua YU ; Yi WANG ; Shanbin ZHANG ; Desheng LI ; Huiling GAN ; Houqin LIU ; Liang XU ; Zhigang LUO ; Peigen GUI ; Xiangfang TAN ; Bingyi SHI ; Ming CAI ; Xiang LI ; Junnan XU ; Liang XU ; Tao LIN ; Xianding WANG ; Hongtao LIU ; Lexi ZHANG ; Jianyong WU ; Wenhua LEI ; Jiang QIU ; Guodong CHEN ; Jun LI ; Gang HUANG ; Chenglin WU ; Changxi WANG ; Lizhong CHEN ; Zheng CHEN ; Jiali FANG ; Xiaoming ZHANG ; Tongyi MEN ; Xianduo LI ; Chunbo MO ; Zhen WANG ; Xiaofeng SHI ; Guanghui PEI ; Jinpeng TU ; Xiaopeng HU ; Xiaodong ZHANG ; Ning LI ; Shaohua SHI ; Hua CHEN ; Zhenxing WANG ; Weiguo SUI ; Ying LI ; Qiang YAN ; Huaizhou CHEN ; Liusheng LAI ; Jinfeng LI ; Wenjun SHANG ; Guiwen FENG ; Gang CHEN ; Fanjun ZENG ; Lan ZHU ; Jun FANG ; Ruiming RONG ; Xuanchuan WANG ; Guisheng QI ; Qiang WANG ; Puxun TIAN ; Yang LI ; Xiaohui TIAN ; Heli XIANG ; Xiaoming PAN ; Xiaoming DING ; Wujun XUE ; Jiqiu WEN ; Xiaosong XU
Chinese Journal of Organ Transplantation 2020;41(5):259-264
Objective:To summarize the patient profiles and therapeutic efficacies of ABO-incompatible living-related kidney transplantations at 19 domestic transplant centers and provide rationales for clinical application of ABOi-KT.Methods:Clinical cases of ABO-incompatible/compatible kidney transplantation (ABOi-KT/ABOc-KT) from December 2006 to December 2009 were collected. Then, statistical analyses were conducted from the aspects of tissue matching, perioperative managements, complications and survival rates of renal allograft or recipients.Results:Clinical data of 342 ABOi-KT and 779 ABOc-KT indicated that (1) no inter-group differences existed in age, body mass index (BMI), donor-recipient relationship or waiting time of pre-operative dialysis; (2) ABO blood type: blood type O recipients had the longest waiting list and transplantations from blood type A to blood type O accounted for the largest proportion; (3) HLA matching: no statistical significance existed in mismatch rate or positive rate of PRA I/II between two types of surgery; (4) CD20 should be properly used on the basis of different phrases; (5) hemorrhage was a common complication during an early postoperative period and microthrombosis appeared later; (6) no difference existed in postoperative incidence of complications or survival rate of renal allograft and recipients at 1/3/5/10 years between ABOi-KT and ABOc-KT. The acute rejection rate and serum creatinine levels of ABOi-KT recipients were comparable to those of ABOc-KT recipients within 1 year.Conclusions:ABOi-KT is both safe and effective so that it may be applied at all transplant centers as needed.
6.Clinical trial of tolvaptan tablets in the treatment of heart failure with systolic dysfunction
Wu-Ming HU ; Zhen-Hua SHI ; Shi-Yong YE ; Yi-Jia XIANG ; Chun-Lai ZENG
The Chinese Journal of Clinical Pharmacology 2019;35(7):617-619
Objective To compare the clinical efficacy and safety of tolvaptan tablets and furosemide injection in the treatment of heart failure with systolic dysfunction. Methods One hundred and four patients of heart failure with systolic dysfunction were randomly divided into control group (n = 49 cases) and treatment group (n = 55 cases) . Control group received furosemide 40 mg per time, qd, intravenous bolus. Treatment group received tolvaptan 15 mg per time, qd, orally. The clinical efficacy, heart rate, pulmonary artery pressure, pulmonary capillary pressure and cardiac output, and adverse drug reactions were compared between two groups. Results After treatment, the total effective rates of treatment and control groups were 89. 09% (49 cases/55 cases) and71. 43% (35 cases/49 cases) with significant difference (P < 0. 05) .After treatment, the main indexes of treatment and control groups were compared: heart rates were (80. 15 ± 10. 04) and (84. 71 ± 9. 66) beat·min-1, pulmonary artery pressure were (21. 85 ± 4. 49) and (28. 47 ± 4. 46) mm Hg, pulmonary capillary pressure were (11. 24 ± 1. 61) and (15. 18 ± 2. 76) mm Hg, cardiac output were (1. 94 ± 0. 30) and (2. 16 ± 0. 25) L · min-1· m-2, the differences were statistically significant (all P < 0. 05) . The adverse drug reactions of treatment group were increased blood sodium, urinary frequency and dry mouth, which in control group were fatigue, thirst and muscle soreness. The total incidences of adverse drug reactions in the treatment and control groups were 12. 73% and 12. 24% without significant difference (P> 0. 05) . Conclusion Tolvaptan tablets have a definitive clinical efficacy in the treatment of heart failure with systolic dysfunction, which can effectively improve the heart rate, pulmonary artery pressure, pulmonary capillary pressure and cardiac output, without increasing the incidence of adverse drug reactions.
7.Effect of Lycium Barbarum polysaccharides on immune function of erythrocytes in immunosuppressed mice
Zhen-Hua HUANG ; Xiang-Liang DENG ; Kai-Min ZHANG ; Liu-Ting LAI ; Ming-Hua HU ; Fang-Li MA ; Xia LUO ; Lian ZHOU
Chinese Journal of Immunology 2018;34(2):214-217
Objective:To investigate the effect of Lycium Barbarum polysaccharides on immune function of erythrocytes in doxorubicin-treated mice.Methods:BALB/c mice were treated with doxorubicin and used as immunosuppression model.The mice were treated with Lycium Barbarum polysaccharides(62.5,125,250 mg/kg) for 7 days,the normal control mice and model control mice were also used in this study.Expression level of CD59 molecule in erythrocytes was analyzed with flow cytometry.The Band-3 level was analyzed by Coomassie Brilliant Blue method.The NKEF-A and NKEF-B expression level in erythrocytes was analyzed by Western blot.The killing activity of NK cells was analyzed with flow cytometry.Results: The level of Band-3,NKEF-A and NKEF-B was decrease in erythrocytes of doxorubicin-treated mice.The killing activity of NK cells was also decrease in the mice when the expression level of CD59 molecule was not change obviously.Lycium Barbarum polysaccharides treatment could promote the recovery of Band-3, NKEF-A and NKEF-B in erythrocytes of the mice.Conclusion:Lycium Barbarum polysaccharides can promote the recovery of immune function of erythrocytes in doxorubicin-treated mice.
8. The preliminary report of a registration clinical trial of proton and heavy ion irradiation
Jiade LU ; Ming YE ; Xiaomao GUO ; Shen FU ; F. Michael MOYERS ; Qing ZHANG ; Jingfang MAO ; Lin KONG ; Wen Chien HSI ; Kambiz SHAHNAZI ; Jingfang ZHAO ; Zhen ZHANG ; Xiumei MA ; Songtao LAI ; Xiaomeng ZHANG ; Ningyi MA ; Yunsheng GAO ; Xin CAI ; Xiyin GUAN ; Junhua ZHANG ; Bin WU ; Jingyi CHENG ; Yin-xiang-zi SHENG ; Wei REN ; Jun ZHAO ; Lining SUN ; Guoliang JIANG
Chinese Journal of Oncology 2018;40(1):52-56
Objective:
To verify the safety and efficacy of IONTRIS particle therapy system (IONTRIS) in clinical implementation.
Methods:
Between 6.2014 and 8.2014, a total of 35 patients were enrolled into this trial: 31 males and 4 females with a median age of 69 yrs (range 39-80). Ten patients had locally recurrent head and neck tumors after surgery, 4 cases with thoracic malignancies, 1 case with hepatocellular carcinoma, 1 case with retroperitoneal sarcoma, and 19 cases with non-metastatic prostate carcinomas. Phantom dose verification was mandatory for each field before the start of radiation.
Results:
Twenty-two patients received carbon ion and 13 had proton irradiation. With a median follow-up time of 1 year, all patients were alive. Among the 16 patients with head and neck, thoracic, and abdominal/pelvic tumors, 2, 1, 12, and 1 cases developed complete response, partial response, stable disease, or disease progression, respectively. Progression-free survival rate was 93.8% (15/16). Among the 19 patients with prostate cancer, biological-recurrence free survival was 100%. Particle therapy was well tolerated in all 35 patients. Twenty-five patients (71.4%) experienced 33 grade 1 acute adverse effects, which subsided at 1 year follow-up. Six (17.1%) patients developed grade 1 late adverse effects. No significant change in ECOG or body weight was observed.
Conclusions
IONTRIS is safe and effective for clinical use. However, long term follow-up is needed to observe the late toxicity and long term result.
9.The preliminary report of a registration clinical trial of proton and heavy ion irradiation
Jiade LU ; Ming YE ; Xiaomao GUO ; Shen FU ; F.Michae MOYERS ; Qing ZHANG ; Jingfang MAO ; Lin KONG ; Chien Wen HSI ; Kambiz SHAHNAZI ; Jingfang ZHAO ; Zhen ZHANG ; Xiumei MA ; Songtao LAI ; Xiaomeng ZHANG ; Ningyi MA ; Yunsheng GAO ; Xin CAI ; Xiyin GUAN ; Junhua ZHANG ; Bin WU ; Jingyi CHENG ; Yin?xiang?zi SHENG ; Wei REN ; Jun ZHAO ; Lining SUN ; Guoliang JIANG
Chinese Journal of Oncology 2018;40(1):52-56
Objective To verify the safety and efficacy of IONTRIS particle therapy system ( IONTRIS) in clinical implementation. Methods Between 6.2014 and 8.2014, a total of 35 patients were enrolled into this trial:31 males and 4 females with a median age of 69 yrs ( range 39?80) . Ten patients had locally recurrent head and neck tumors after surgery, 4 cases with thoracic malignancies, 1 case with hepatocellular carcinoma, 1 case with retroperitoneal sarcoma, and 19 cases with non?metastatic prostate carcinomas. Phantom dose verification was mandatory for each field before the start of radiation. Results Twenty?two patients received carbon ion and 13 had proton irradiation. With a median follow?up time of 1 year, all patients were alive. Among the 16 patients with head and neck, thoracic, and abdominal/pelvic tumors, 2, 1, 12, and 1 cases developed complete response, partial response, stable disease, or disease progression, respectively. Progression?free survival rate was 93.8% (15/16). Among the 19 patients with prostate cancer, biological?recurrence free survival was 100%. Particle therapy was well tolerated in all 35 patients. Twenty?five patients (71.4%) experienced 33 grade 1 acute adverse effects, which subsided at 1 year follow?up. Six ( 17.1%) patients developed grade 1 late adverse effects. No significant change in ECOG or body weight was observed. Conclusions IONTRIS is safe and effective for clinical use. However, long term follow?up is needed to observe the late toxicity and long term result.
10.The preliminary report of a registration clinical trial of proton and heavy ion irradiation
Jiade LU ; Ming YE ; Xiaomao GUO ; Shen FU ; F.Michae MOYERS ; Qing ZHANG ; Jingfang MAO ; Lin KONG ; Chien Wen HSI ; Kambiz SHAHNAZI ; Jingfang ZHAO ; Zhen ZHANG ; Xiumei MA ; Songtao LAI ; Xiaomeng ZHANG ; Ningyi MA ; Yunsheng GAO ; Xin CAI ; Xiyin GUAN ; Junhua ZHANG ; Bin WU ; Jingyi CHENG ; Yin?xiang?zi SHENG ; Wei REN ; Jun ZHAO ; Lining SUN ; Guoliang JIANG
Chinese Journal of Oncology 2018;40(1):52-56
Objective To verify the safety and efficacy of IONTRIS particle therapy system ( IONTRIS) in clinical implementation. Methods Between 6.2014 and 8.2014, a total of 35 patients were enrolled into this trial:31 males and 4 females with a median age of 69 yrs ( range 39?80) . Ten patients had locally recurrent head and neck tumors after surgery, 4 cases with thoracic malignancies, 1 case with hepatocellular carcinoma, 1 case with retroperitoneal sarcoma, and 19 cases with non?metastatic prostate carcinomas. Phantom dose verification was mandatory for each field before the start of radiation. Results Twenty?two patients received carbon ion and 13 had proton irradiation. With a median follow?up time of 1 year, all patients were alive. Among the 16 patients with head and neck, thoracic, and abdominal/pelvic tumors, 2, 1, 12, and 1 cases developed complete response, partial response, stable disease, or disease progression, respectively. Progression?free survival rate was 93.8% (15/16). Among the 19 patients with prostate cancer, biological?recurrence free survival was 100%. Particle therapy was well tolerated in all 35 patients. Twenty?five patients (71.4%) experienced 33 grade 1 acute adverse effects, which subsided at 1 year follow?up. Six ( 17.1%) patients developed grade 1 late adverse effects. No significant change in ECOG or body weight was observed. Conclusions IONTRIS is safe and effective for clinical use. However, long term follow?up is needed to observe the late toxicity and long term result.

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