1.Ethical issues and reflections on clinical research of radiopharmaceuticals
Yonglan HU ; Li WANG ; Feng JIANG ; Jiyin ZHOU ; Zhengjun CHEN ; Jie ZHANG ; Zengrui ZHANG
Chinese Medical Ethics 2025;38(2):254-260
Radiopharmaceuticals play an important role in the diagnosis and treatment of cardiovascular and cerebrovascular diseases, malignant tumors, central nervous system diseases, and other diseases. Under the urgent need for clinical diagnosis and treatment as well as medical development, the clinical research of radiopharmaceuticals has become a hotspot in international research. By analyzing the current situation of clinical research on radiopharmaceuticals in Europe, America, and China, the ethical issues of clinical research on radiopharmaceuticals were elaborated from four aspects, including lack of relevant laws and regulations, a higher risk of radiopharmaceuticals, dilemmas in ethical review, and insufficient radiation protection. Response principles and measures were proposed from four aspects, including improving regulations and policies, enhancing radiological protection for all parties involved in the research, strengthening ethical review, and reinforcing the training of relevant personnel, to enhance the quality and level of clinical research on radiopharmaceuticals.
2.Short-term clinical effect of arthroscopic all-suture anchor nail in the treatment of rotator cuff injury
Tao BAO ; Yangyang HU ; Xuyong GONG ; Shuoguo WANG ; Liang WANG ; Jian YANG ; Wenyong FEI ; Yaojia LU ; Yuxia YANG ; Dianwei LIU ; Mengbo DANG ; Mingjun LI
Chinese Journal of Sports Medicine 2024;43(1):3-10
Objective To evaluate the short-term clinical effect of arthroscopic repair of rotator cuff injury with all-suture anchor using a prospective and single-cohort clinical trial.Methods Twenty-five patients with rotator cuff injuries(1.5 cm
3.Research Progress in the Mechanism of Astragaloside Ⅳ Against Myocardial Injury
Xuyong WANG ; Xinke ZHAO ; Hugang JIANG ; Chunling WANG ; Xiaogang ZHANG ; Yingdong LI
Chinese Journal of Information on Traditional Chinese Medicine 2024;31(4):187-191
Myocardial injury is a pathological change of myocardium caused by many factors,which can lead to the decline of cardiac function and the occurrence of cardiovascular events.Astragaloside Ⅳ is one of the main pharmacological components in Astragali Radix,which plays an anti-myocardial injury role by regulating various signaling pathways.This article reviewed the anti-myocardial injury mechanism of astragaloside Ⅳ from five aspects:inhibition of oxidative stress,inhibition of apoptosis,anti-myocardial fibrosis,improvement of myocardial energy metabolism and inhibition of myocardium inflammation,in order to provide reference for the mechanism research and clinical application of astragaloside Ⅳ in the prevention and treatment of myocardial injury.
4.Fostering organ donation culture for facilitating high-quality development of hospital-level organ donation management center in China
Qingdong SU ; Jianhui DONG ; Jixiang LIAO ; Xuyong SUN ; Quanwei HUANG ; Fangfang WANG ; Song CAO ; Zhao GAO ; Xuyang LIU
Chinese Journal of Organ Transplantation 2024;45(11):803-806
"Chinese model" of organ donation and transplantation in China has won acclaims from all over the world. Current contradictions between unbalanced and inadequate development of organ donation and transplantation and surging public demands for transplant services remain serious. And an acute shortage of donated organs is still the greatest difficulty. Improving organ donation rate per million population (PMP) and organ utilization rate has been a great challenge for organ donation teams in China. This review summarized the relevant experiences of Second Affiliated Hospital of Guangxi Medical University in fostering organ donation culture atmosphere and connotation to accelerate the high-quality development of organ donation. It was intended to provide references for disciplined construction of other organ donation management teams and promote the development of organ donation and transplantation in China.
5.Prognostic analysis of steatosis donor liver transplantation: a multicenter clinical trial
Fengqiang GAO ; Kai WANG ; Libin DONG ; Zhisheng ZHOU ; Xuyong WEI ; Li ZHUANG ; Wan LI ; Guoyue LYU ; Shusen ZHENG ; Xiao XU
Chinese Journal of Organ Transplantation 2023;44(1):23-30
Objective:To explore the early and medium-long term outcomes of steatosis donor liver transplantation(LT)for an optimal clinical application.Methods:From January 2015 to December 2020, this retrospective cohort study was conducted jointly at Shulan (Hangzhou) Hospital, First Affiliated Hospital of Zhejiang University and First Hospital of Jilin University. The relevant clinicopathological and follow-up data were collected from 1535 LT recipients. For comparison, propensity score was utilized for case-control matching of steatosis and non-steatosis donor livers. According to presence or absence of liver steatosis, the recipients were divided into two groups of steatosis donor liver (n=243) and non-steatosis donor liver (n=1292). And 1∶1 propensity score matching was made for two groups. Then early and medium-long term outcomes of two groups were examined. Counts were described as absolute numbers. Kaplan-Meier method was employed for calculating survival time and plotting survival curve and Log-rank test for survival analysis. COX regression model was utilized for univariate and multivariate analyses. Based on basic metabolic disease pre-LT, steatosis donor liver recipients were divided into three subgroups: BMI ≥25 kg/m 2 with hypertension or diabetes (n=21), BMI<25 kg/m 2 and no hypertension or diabetes (n=130) and other recipients (n=92). A comparative study was performed for determining the prognosis of subgroups according to the different characteristics of recipient and donor liver. Results:No significant inter-group difference existed in 2-year survival post-LT ( P=0.174). However, significant inter-group difference in survival existed after 2 years post-LT ( P=0.004). And 3/5-year survival rate of steatosis donor liver was 66.4% and 44.2% respectively. Both were significantly lower than those of non-steatosis donor liver. Multivariate Cox regression analysis indicated that steatosis donor liver and male recipients were independent risk factors for prognosis >2 years survival post-LT( P=0.008, P=0.004). Subgroup analysis of steatosis liver donors showed that the prognosis of patients with BMI ≥25 kg/m 2 with hypertension or diabetes was significantly worse than other subgroups (BMI <25 kg/m 2 with no hypertension or diabetes and other recipients) <2 years survival post-LT ( P=0.029, P=0.043). Conclusions:Steatosis donor liver does not affect early survival of recipients, yet reduces medium-long term survival rate of recipients notably. In steatosis donor liver recipients, early survival rate declines markedly in recipients with preoperative BMI ≥25 kg/m 2 with hypertension or diabetes as compared with BMI <25 kg/m 2 with no hypertension or diabetes group.
6.Prognosis and influencing factors of liver transplantation for hepatocellular carcinoma using steatotic donor liver: a multicenter study
Mengfan YANG ; Rui WANG ; Binhua PAN ; Renyi SU ; Siyi DONG ; Xiao XU ; Shusen ZHENG ; Xuyong WEI
Chinese Journal of Digestive Surgery 2022;21(2):237-248
Objective:To investigate the prognosis and influencing factors of liver transplantation (LT) for hepatocellular carcinoma (HCC) using steatotic donor liver.Methods:The retrospective cohort study was conducted. The clinicopathological data of 152 pairs of donors and the corresponding recipients undergoing LT for HCC in the two medical centers [89 pairs in Shulan (Hangzhou) Hospital and 63 pairs in the First Affiliated Hospital of Zhejiang University School of Medicine] from January 2015 to December 2019 were collected. Of 152 donors, there were 131 males and 21 females, aged (48±12)years, and there were 130 cases with liver mild steatosis and 22 cases with liver moderate steatosis. Of 152 recipients, there were 138 males and 14 females, aged (52±9)years. Observation indicators: (1) follow-up, overall survival and tumor recurrence free survival of recipients; (2) influencing factors for overall survival and tumor recurrence free survival of recipients; (3) construction and validation of nomogram prediction model for overall survival and tumor recurrence free survival of recipients. Follow-up was conducted using outpatient examination and telephone interview to detect survival and tumor recurrence of recipients up to December 2020. Measurement data with normal distribution were represented as Mean± SD, and measurement data with skewed distribution were represented as M( IQR). Count data were described as absolute numbers. The Kaplan-Meier method was used to calculate the survival time and draw survival curve, and the Log-Rank test was used for survival analysis. The COX regression model was used for univariate and multivariate analysis. The independent risk factors were brought into the R 3.6.2 software to construct nomogram prediction model and draw the receiver operating characteristic (ROC) curve. The accuracy and discrimination of the nomogram prediction model were evaluated using the area under curve (AUC) and the calibration curve. Results:(1) Follow-up, overall survival and tumor recurrence free survival of recipients. All the 152 recipients undergoing LT for HCC using steatotic donor liver were followed up for 45.8(27.6)months, with the overall survival time and tumor recurrence free survival time of 36.5(32.3)months and 30.4(34.6)months. The 1-year, 3-year overall survival rates and tumor recurrence free rates of the 152 recipients were 73.4%, 55.8% and 62.2%, 43.4%, respectively. (2) Influencing factors for overall survival and tumor recurrence free survival of recipients. Results of univariate analysis showed that the donor liver cold ischemia time (CIT), the donor liver warm ischemia time (WIT), graft-to-recipient weight ratio (GRWR), ABO compatibility, recipient body mass index (BMI), recipient tumor diameter, recipient tumor number, recipient tumor differentiation degree, recipient preoperative alpha fetoprotein (AFP) were related factors influencing the overall survival of recipients ( hazard ratio=6.26, 1.90, 2.47, 4.08, 0.55, 5.16, 3.62, 5.28, 2.65, 95% confidence interval as 3.01?13.03, 1.07?3.38, 1.36?4.49, 2.07?8.03, 0.31?0.98, 2.56?10.42, 1.95?6.72, 1.60?17.42, 1.48?5.01, P<0.05) and the donor liver CIT, GRWR, ABO compatibility, recipient tumor diameter, recipient tumor number, recipient tumor differentiation degree, recipient preoperative AFP were related factors influencing the tumor recurrence free survival of recipients ( hazard ratio=4.24, 2.53, 4.05, 3.39, 3.10, 5.19, 2.63, 95% confidence interval as 2.50?7.21, 1.54?4.17, 2.12?7.72, 2.04?5.62, 1.91?5.03, 2.04?13.18, 1.61?4.30, P<0.05). Results of multivariate analysis showed that donor liver CIT ≥8 hours, GRWR ≥2.5%, recipient tumor diameter ≥8 cm and recipient preoperative AFP ≥400 μg/L were independent risk factors influencing the overall survival of recipients ( hazard ratio=4.21, 2.58, 4.10, 2.27, 95% confidence interval as 1.98?8.96, 1.24?5.35, 1.35?12.43, 1.13?4.56, P<0.05) and donor liver CIT ≥8 hours, GRWR ≥2.5%, recipient tumor diameter ≥8 cm, recipient tumor number ≥3 and recipient preoperative AFP ≥400 μg/L were independent risk factors influencing the tumor recurrence free survival of recipients ( hazard ratio=3.37, 2.63, 2.42, 2.12, 2.22, 95% confidence interval as 1.70?6.67, 1.40?4.96, 1.04?5.66, 1.08?4.18, 1.26?3.90, P<0.05). (3) Construction and validation of nomogram prediction model for overall survival and tumor recurrence free survival of recipients. The donor live CIT, GRWR, recipient tumor diameter, recipient preoperative AFP were used to construct nomogram prediction model for overall survival of recipients and the donor liver CIT, GRWR, recipient tumor diameter, recipient tumor number, recipient preoperative AFP were used to construct nomogram prediction model for tumor recurrence free survival of recipients. The ROC curve showed that the AUC of the nomogram prediction model for overall survival of recipients was 0.84 (95% confidence interval as 0.76?0.92, P<0.05), with the optimal diagnostic value as 7.3 and the specificity and sensitivity as 87.6% and 70.0%. The AUC of the nomogram prediction model for tumor recurrence free survival of recipients was 0.79 (95% confidence interval as 0.71?0.87, P<0.05), with the optimal diagnostic value as 5.8 and the specificity and sensitivity as 97.4% and 52.5%. The calibration curve showed that the nomogram prediction model had good distinction for high risk recipients in overall survival and tumor recurrence free survival. Conclusion:Donor liver CIT ≥8 hours, GRWR ≥2.5%, recipient tumor diameter ≥8 cm and recipient preoperative AFP ≥400 μg/L are independent risk factors influencing the overall survival of recipients who underwent LT for HCC using steatotic donor liver and donor liver CIT ≥8 hours, GRWR ≥2.5%, recipient tumor diameter ≥8 cm, recipient tumor number ≥ 3 and recipient preoperative AFP ≥400 μg/L are independent risk factors influencing the tumor recurrence free survival of recipients.
7.Effect of continuous intravenous infusion of low-dose heparin on preventing thrombosis during perioperative period of simultaneous pancreas-kidney transplantation
Meisi LI ; Jianhui DONG ; Pengfei QIAO ; Jihua WU ; Ke QIN ; Liugen LAN ; Hongliang WANG ; Zhuangjiang LI ; Haibin LI ; Zhao GAO ; Xuyong SUN
Chinese Journal of Organ Transplantation 2021;42(4):234-238
Objective:To evaluate the efficacy and safety of continuous infusion of low-dose intravenous (Ⅳ) heparin during perioperative period of simultaneous pancreas-kidney (SPK) transplantation for donation after citizen death (DCD) donor to prevent pancreatic thrombosis post-transplantation.Methods:From January 2015 to August 2019, 46 DCD donors undergoing SPK were divided into retrospective cohort groups 1 ( n=27) and 2 ( n=19). Group 1 received aspirin enteric-coated tablets only at Day 1 post-SPK. In Group 2, 5-7 days of continuous infusion of heparin 260 IU per hour at Day 1 post-SPK was followed by a daily intake of aspirin enteric-coated tablets of 100 mg. Incidence of thrombus, recovery of graft function and adverse reactions of anticoagulant therapy were observed. Results:Thrombosis occurred in (5.3%, 1/19 vs 14.8%, 4/27) in heparin and non-heparin groups. Thrombosis and graft loss were significantly lower in heparin group than those in non-heparin group ( P<0.05). Conclusions:Continuous infusion of low-dose heparin vein is effective and safe in preventing thrombosis after SPK transplantation.
8.Investigation of proper treatment for giant omphalocele with liver protrusion in neonates
Xiaofeng XIONG ; Wei LU ; Fuzhong XING ; Lei YU ; Yue WANG ; Yuji WANG ; Xuyong CHEN ; Yan ZHOU
Chinese Journal of Applied Clinical Pediatrics 2021;36(2):122-127
Objective:To investigate the proper choice and improve the survival rate in neonates suffering from giant omphalocele (GO)with liver protrusion by analyzing the clinical characteristics, different treatments and outcomes.Methods:Neonates with GO admitted in Department of Neonatal Surgery in Wuhan Children′s Hospital were retrospected from January 2009 to May 2019.The treatment methods include: (1) repaired with similar silo-bag by staged operation; (2) one-stage repair with patch or not; (3) delayed repair by conservative treatment for some time (from 2 to 8 weeks) firstly.Data included gestational age, gender, birth weight, average diameter of omphalocele, contents of omphalocele, associated malformation, treatment method, duration of ventilator use and clinical outcome.These neonates were divided into 2 groups according to the contents of protrusion: group with liver protrusion and group with liver and other organs protrusion.Clinical data were summarized and compared between different groups.Results:Sixteen cases were collected, including 9 males and 7 females.The average age was (1.25±0.45) d (1-2 days), the average birth weight was (2.48±0.37) kg, and pregnant week was (36.23±1.17) weeks.The average diameter of the omphalocele was (9.88±3.30) cm, ranging from 5 cm to 15 cm.Seven cases were belonged to the group with liver protrusion, cases undergone one-stage repair, delayed repair were 6 cases and 1 case, respectively.There were 9 cases in group with liver and other organs protrusion, and the protruded organs included liver, intestine, colon or spleen.Among them, cases needed one-stage repair, delayed repair and silo-bag repair were 3 cases, 3 cases, 3 cases, respectively.Cases needed respiratory machine were 3 cases (42.8%) and 8 cases (88.89%) in group with liver protrusion and group with liver and other organs protrusion, respectively.Neonates had a longer time of needing respiratory machine in group with liver protrusion, comparing with the neonates in group with liver and other organs protrusion[(30.67±19.0) h vs.(106.25±69.36) h, P=0.021], and the risk rate to use respiratory machine was 5.143(95% CI: 0.727-36.368). There were no dead cases in group with liver protrusion.Three cases were dead in group with liver and other organs protrusion.All the patients were followed from 3 months to 4 years, and hernia in abdominal wall was found in 5 cases, including 1 case in group with liver protrusion and 4 cases in group with liver and other organs protrusion.If the dead cases had been excluded, the rate of hernia was 66.7% (4/6 cases) in group with liver and other organs protrusion. Conclusions:Individual treatment should be emphasized in neonates suffering from GO with liver protrusion.Neonates with single liver protrusion have a better prognosis than those with liver and other organs protrusion.One-stage repair is recommended in the former, and the delayed repair is highly recommended in the latter.The accessory liver should be considered when GO neonates presenting liver protrusion.
9.Interpretation of Guide to the Quality and Safety of Organs for Transplantation(6th edition): identification and referral of potential donors
Jianhui DONG ; Xuyang LIU ; Hongliang WANG ; Jixiang LIAO ; Dongge YANG ; Qingdong SU ; Haisheng LU ; Liugen LAN ; Haibin LI ; Ning WEN ; Ke QIN ; Xuyong SUN
Organ Transplantation 2020;11(3):395-
Organ shortage is one of the important factors restricting the development of human organ transplantation. The identification and referral of potential donors determine the total scale of organ donation. Whether potential donors can be identified and referred is the most important reason for the difference of organ donation rates in different regions. This paper interprets the chapter of the identification and referral of potential donors in the Guide to the Quality and Safety of Organs for Transplantation (6th edition) issued by European Union in order to provide reference for the staff of organ procurement organization and related medical personnel in China and improve the organ donation rate in China.
10.Meta-analysis of treatment strategies for post-hepatectomy recurrent hepatocellular carcinoma:salvage liver transplantation or repeat hepatectomy
Hongliang WANG ; Xuyong SUN ; Jianhui DONG ; Liugen LAN ; Jihua WU ; Haibin LI ; Zhuangjiang LI
Chinese Journal of Hepatobiliary Surgery 2019;25(7):513-517
Objective To evaluate the effectiveness of salvage liver transplantation ( SLT) versus repeat hepatectomy (RH) in post-hepatectomy recurrent hepatocellular carcinoma. Methods Data from 1 January 1990 to 31 July 2018 were retrieved from the Cochrane library, PubMed, EMbase, Wan Fang Data, CBM, CNKI, VIP and other databases. The collected publications were all on case-control studies comparing SLT with RH for post-hepatectomy recurrent hepatocellular carcinoma. The literatures’ quality and the data of each study were evaluated and analyzed using RevMan. Relative risk (RR) and 95% confidence interval (CI) were used. Results Five articles which included 525 patients were enrolled. There were no signifi-cant differences between SLT and RH on the 1-, 3-and 5-year overall survival (P>0. 05 for all). Howev-er, for the 1-year (RR=2. 86, 95% CI: 1. 37~5. 97, P<0. 05), 3-year (RR=2. 57, 95% CI: 0. 99~6. 70, P=0. 05), and 5-year disease-free survivals (RR=4. 79, 95% CI: 1. 88~12. 25, P<0. 05), PLT was significantly better than RH. Conclusion The effectiveness of SLT was superior to RH in the treatment of post-heptectomy recurrent hepatocellular carcinoma. However, considering the similar overall survival rates, RH is still an important treatment option for post-hepatectomy recurrent hepatocellular carcinoma because of liver donor shortage.

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