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.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.
3. Thoracoscopic repair of congenital diaphragmatic hernia with hernia-ring pin in neonates
Xiaofeng XIONG ; Wei LU ; Fuzhong XING ; Lei YU ; Yue WANG ; Li GONG ; Yichu CHEN ; Yuji WANG ; Xuyong CHEN
Chinese Journal of Applied Clinical Pediatrics 2019;34(22):1732-1737
Objective:
To evaluate the indications and outcomes of thoracoscopic repair with hernia-ring pin (TRHP) applied in neonates with congenital diaphragmatic hernia (CDH).
Methods:
Fifty-six cases diagnosed as CDH were collected from Department of Neonatal Surgery or Cardiothoracic Surgery in Wuhan Children′s Hospital, Tongji Medical College, Huazhong University of Science and Technology from May 2013 to September 2018.Patients were divided into thoracoscopic repair (TR) group and TRHP group, and the data, including birth weight, pregnant weeks, ages at operation, hospital stay postoperatively and the number of recurrence cases were compared, between the 2 groups.The size of defect was coded into A, B, C and D grades.Status of patients was grouped into Ⅰ, Ⅱ, Ⅲ, Ⅳ, and Ⅴstages according to the defect size and complicated congenital heart disease.
Results:
There were 7 cases in TRHP group, including 3 boys and 4 girls.Four cases belonged to A-class defect and 3 cases were of B-class defect, respectively.The contents of the hernia included small intestine, colon, kidney and spleen.Six cases presented left CDH and 1 case presented right CDH.One of the left CDH cases and the 1 right CDH case had hernia sac.The right CDH neonate presented haematuria in the first day and the second day postoperatively, whose symptom disappeared after treatment.The follow-up time was (12.17±3.41) months, and no recurrent cases were found.All the cases in TRHP group belonged to Ⅰ or Ⅱ stage.There were 49 cases in the TR group.Among them, 29 cases belonged to class-A defect, 18 cases class-B defect, and 4 cases class-C defect, respectively.Cases classified into A and B defects were in stageⅠorⅡ, and cases classified into C defect were in stage Ⅲ.In those 45 cases belonged to A or B defect, 40 cases presented left CDH and 5 case presented right CDH.Among them, 5 neonates had hernia sac.The contents of the hernia included small intestine, colon, kidney and spleen.There were significant differences in the operative time [(83.47±10.28) min
4. Diagnosis and treatments in simple meconium ileus in neonates: ten-year experience in a single center
Xiaofeng XIONG ; Wei LU ; Fuzhong XING ; Lei YU ; Yue WANG ; Yuji WANG ; Xuyong CHEN
Chinese Journal of Applied Clinical Pediatrics 2019;34(11):818-822
Objective:
To improve the accuracy of the diagnosis and decrease the unnecessary surgical exploration in neonates with simple meconium ileus (SMI) by analyzing clinical characteristics of SMI.
Methods:
Forty-five neonates identified as SMI from January 2008 to May 2018 had been collected, and the data of pregnancy, birth weight, treatments, hospital stay and results of follow-up were included.The patients were divided into 2 groups: surgical group and non-surgical group.The surgical group underwent enterostomy at the end of ileum, meanwhile, the intestinal wall was biopsied for checking the existence of ganglion cells.All the neonates in the surgical group underwent stoma closure in 3 to 6 months postoperatively.The non-surgical group received fasting, intravenous nutritional support, enema with amiotol diluted into 11 or injected into the stomach by the gastric tube.They all received enema with warm salt (9 g/L) 1-2 times per day.Once the abdominal dilation was mitigated and autonomous defecation obtained, the neonates gradually began the oral feeding and weaned from the total parenteral nutrition(TPN). The 45 neonates were also divided into earlier group (from January 2008 to May 2013) and later group (from June 2013 to May 2018) according to the time of diagnosis.The relationships between the SMI treatment choice and the pregnancy, birth weight and time of diagnosis were analyzed.
Results:
No cystic fibrosis lesions were found in 45 neonates, of which 21 and 24 neonates were in non-surgical group and surgical group, respectively.In the operation, the intestine presented similar anatomy to the total Hirschsprung′s disease.However, the ganglion was observed not only in the stricture, transitional and dilated zone of ileum, but also in the colon.There were no significant differences in the pregnancy and birth weight in both groups(
5.Clinical features of Amyand's hernia in neonates: cases report and literature review
Xiaofeng XIONG ; Wei LU ; Fuzhong XING ; Yuji WANG ; Lei YU ; Xuyong CHEN
Chinese Journal of Applied Clinical Pediatrics 2018;33(10):791-794
Objective To investigate the characteristics of Amyand's hernia (AH) in neonates in order to decrease the complications and to improve the prognosis.Methods Data about neonates with AH in Department of Neonatal Surgery,Wuhan Children's Hospital,Tongji Medical College,Huazhong University of Science and Technology,were collected from January 2010 to February 2017,and the AH cases published from 1997 to 2017 in PubMed and Wanfang Data were also reviewed.Results Twenty-two cases were collected,including 8 cases treated in Wuhan Children's Hospital,Tongji Medical College,Huazhong University of Science and Technology,and 14 cases from literature reports.In this group,4 cases underwent traditional operation and 4 cases underwent laparoscopy,respectively.All the patients underwent appendix resection and the ligation of the hernia sac.Among the 4 cases who underwent laparoscopic operation,contra-lateral hernia was found in 2 cases and pyocelia in 1 case.However,the appendix had a solid adhesion with the inguinal canal in those 4 cases and it was difficult to return the appendix to the cavity.Thus,the laparoscopy had to be terminated and the traditional procedure was carried out to separate the adhesion.In those 4 cases to whom the traditional operation was applied,1 case presented inflammation in abdomen and the contra-lateral hernia after operation.According to the pathological results of appendix,in this group,there were 3 cases,4 cases,and 1 case that presented Ⅱ,Ⅲ,Ⅳ type,respectively.In literature cases,there were 13 cases and 1 case that underwent traditional operation and laparoscopy,respectively.There were 4 cases,9 cases,and 1 case that presented Ⅱ,Ⅲ,Ⅳ type,respectively.The complications included located peritonitis (1 case),testicular torsion (1 case) and orchitis (1 case).All cases recovered smoothly.Conclusion Most of the AH cases in neonates present appendix suppuration,gangrene or perforation.The neonatal cases with AH also present obvious local infection and they are prone to develop into pyocelia in inguinal canal and abdominal cavity.In AH cases,laparoscopy has its own advantages,which not only help to make it clear if there is the contralateral hernia,but also helps to treat the complicated pyocelia in abdominal cavity,which help to avoid the residual infection efficiently.
6.Efficacy and safety of single high-dose versus multiple low-dose ATG-Fresenius induction in de novo renal transplantation
Liping CHEN ; Chunbai MO ; Jun TIAN ; Guanghui PAN ; Changxi WANG ; Jianghua CHEN ; Tao LIN ; Xiaodong ZHANG ; Yaowen FU ; Long LIU ; Zhishui CHEN ; Aimin ZHANG ; Minzhuan LIN ; Xuyong SUN ; Jinsong CHEN ; Hang LIU ; Shaoling ZHENG ; Tongyu ZHU ; Qingshan QU ; Bingyi SHI
Chinese Journal of Organ Transplantation 2017;38(11):665-670
Objective To evaluate the efficacy and safety of single bolus high dose (SD group) ATG-Fresenius induction therapy in kidney transplantation vs.multiple low dose (MD group) administration.Methods A multiple center,prospective,randomized and controlled clinical study was performed on 280 de novo renal transplant recipients from 19 centers.Patients were randomized into 2 groups as follows:SD group,a single high dose (7-9 mg/kg) of ATG-F infused as an induction agent before the vessel anastomoses;MD group,2 mg/kg of ATG-F daily administrated in postoperative 4 days.All the patients accepted maintenance immunosuppressive protocol including tacrolimus,mycophenolate and prednisone.Patients were assessed and data were collected at regular schedule clinic visits on the day 1,3,7,14,30,90,180,270 and 365.The primary end point of efficacy was therapeutic failure rate [the number of death,grafts loss and acute rejection (AR)].The event first occurred should be used in the classification of patients.The non-inferiority evaluation of the two treatment regimens was done based on treatment failure rate.The secondary end points of efficacy were the incidence of AR,delayed graft function (DGF),1-year survival rate of patients and grafts,and serum creatinine at each visiting point.The indicators for safety evaluation included hemotologic variation and incidence of adverse events.Results The therapeutic failure rate in SD group was non-inferior to the MD group (17.24% vs.23.08%).AR was the major cause of therapeutic failure and there was similar incidence of AR between SD gronp and MD group (12.07% vs.21.37%).There was no significant difference in the incidence of DGF between SD group and MD group (12.07% vs.6.84%,P =0.1721).The 1-year patient's survival rate and 1-year graft survival rate in SD group and MD group showed no significant difference (96.55% vs.98.29%,P =0.6714;94.83% vs 98.29%,P =0.2750).The serum creatinine level showed no significant differences between two groups at each visit point.There was also no significant difference in total incidence of adverse events between the two groups.In addition,there was also no statistically significant difference in the incidence of concerned and drug-related adverse events between the two groups,including infection,hemotologic abnormality,liver or renal dysfunction,gastrointestinal disorder,etc.After ATG--F administration,peripheral blood lymphocytes in the SD and the MD group immediately decreased but nearly restored to the normal level on the postoperative day 30 and 90 respectively.No severe granulocytopenia,erythropenia or thrombocytopenia occurred in both two groups.Conclusion The efficacy and safety of single high dose of ATG-F induction are non-inferior to multiple low dose ATG-F induction,moreover,single high dose of ATG-F induction is administered more conveniently and economically.
7.Conversion from mycophenolic acid to mizoribine in renal transplant recipients with gastrointestinal tract symptoms: a prospective observational multi-center study
Bingyi SHI ; Jianxin QIU ; Weiguo SUI ; Jun TIAN ; Youhua ZHU ; Chunbo MO ; Changxi WANG ; Yingzi MING ; Zhishui CHEN ; Yaowen FU ; Zheng CHEN ; Longkai PENG ; Zhilin HU ; Tao LIN ; Xuyong SUN ; Hang LIU ; Ruiming RONG ; Ye TIAN ; Wujun XUE ; Ming ZHAO ; Guiwen FENG ; Ronghua CAO ; Decheng DENG ; Minzhuan LIN ; Xiaodong ZHANG
Chinese Journal of Organ Transplantation 2017;38(12):708-713
Objective To evaluate the effect of conversion from mycophenolic acid (MPA) to mizoribine (MZR) in renal transplant recipients with gastrointestinal tract (GI) symptoms.Methods A total of 355 renal transplant recipients with GI symptoms caused by MPA administration were enrolled from April 2015 to March 2017 in 25 different renal transplant centers in China.The symptomatic improvement of GI before (baseline) and after conversion to MZR (1,2,4 weeks) was assessed by each item of GI symptoms indication.In addition,the efficacy and safety of the conversion therapy during 12 months were determined.Results Patients showed improvement in GI symptoms including diarrhea,abdominal pain,abdominal distention and stomachache after conversion to MZR 1,2,4 weeks (P<0.05).In patients with different severity of diarrhea,conversion to MZR therapy significantly improved diarrhea (P<0.05).During 12 months,no patient experienced clinical immune rejection.We did not observe any infections,leucopenia and other serious side effects.Conclusion MZR could markedly improve GI symptoms caused by MPA administration in renal transplant recipients.
8.Clinical effects of renal transplantation with kidneys from donors dying of organophosphate poisoning
Jianhui DONG ; Haibin LI ; Xuyong SUN ; Ke QIN ; Jixiang LIAO ; Meisi LI ; Xiaodan HUANG ; Chen HUANG ; Ying HUANG ; Song CAO ; Zhao GAO ; Zhuangjiang LI ; Feng NIE ; Jianjun YANG
Chinese Journal of Tissue Engineering Research 2016;20(29):4311-4318
BACKGROUND:Delayed graft function (DGF) occurs frequently in kidney transplants from donation after cardiac death if creatinine level is high in kidney recipients. OBJECTIVE:To analyze the clinical effects of renal transplantation with kidneys from donors dying of cardiac death in organophosphate poisoning. METHODS:Data were col ected from kidney transplants from two donors dying of cardiac death in organophosphate poisoning. After some donor maintenance, donor organ were obtained and perfused with impulse type machine. Recipients were treated with intervention of immunity induction, anti-rejection drugs and infection prevention drugs during and after renal transplantation. Pathological data of donor kidney zero needle biopsy, DGF after kidney transplantation, complication rate (such as acute rejection), renal al ograft recovery situation, the survival rate of recipients and kidney transplants were col ected and analyzed. RESULTS AND CONCLUSION:Needle biopsy results from four donor kidneys showed that glomerular morphology was normal, but there were edema and degeneration in kidney tubules in some degree. Donor DGF rate was 75%(3/4), acute rejection rate was 0%(0/4), perioperative period donor kidney and recipient survival rate were 100%(4/4). Al recipients showed a good result of transplanted kidney, their creatinine and urea nitrogen were at low level, and had no proteinuria. One recipient died of severe pulmonary infection 4 months after surgery. For some organophosphate poisoning donors dying of cardiac death, donor kidney quality can be improved by suitable donor maintenance and high-quality donor kidney preservation using machine perfusion. Kidney transplants from donors dying of cardiac death in organophosphate poisoning who receive the maintenance of organ function may be a promising candidate for renal transplantation due to a severe lack of kidney donor sources.
9.A Rapid and Convenient Method for in Vivo Fluorescent Imaging of Protoscolices of Echinococcus multilocularis.
Tao YANG ; Sibo WANG ; Xuyong ZHANG ; Jie XIA ; Jun GUO ; Jixue HOU ; Hongwei ZHANG ; Xueling CHEN ; Xiangwei WU
The Korean Journal of Parasitology 2016;54(2):225-231
Human and animal alveolar echinococcosis (AE) are important helminth infections endemic in wide areas of the Northern hemisphere. Monitoring Echinococcus multilocularis viability and spread using real-time fluorescent imaging in vivo provides a fast method to evaluate the load of parasite. Here, we generated a kind of fluorescent protoscolices in vivo imaging model and utilized this model to assess the activity against E. multilocularis protoscolices of metformin (Met). Results indicated that JC-1 tagged E. multilocularis can be reliably and confidently used to monitor protoscolices in vitro and in vivo. The availability of this transient in vivo fluorescent imaging of E. multilocularis protoscolices constitutes an important step toward the long term bio-imaging research of the AE-infected mouse models. In addition, this will be of great interest for further research on infection strategies and development of drugs and vaccines against E. multilocularis and other cestodes.
Animals
;
Cestoda
;
Echinococcosis
;
Echinococcus multilocularis*
;
Echinococcus*
;
Helminths
;
Humans
;
Metformin
;
Mice
;
Models, Animal
;
Parasites
;
Vaccines
10.Construction of In Vivo Fluorescent Imaging of Echinococcus granulosus in a Mouse Model.
Sibo WANG ; Tao YANG ; Xuyong ZHANG ; Jie XIA ; Jun GUO ; Xiaoyi WANG ; Jixue HOU ; Hongwei ZHANG ; Xueling CHEN ; Xiangwei WU
The Korean Journal of Parasitology 2016;54(3):291-299
Human hydatid disease (cystic echinococcosis, CE) is a chronic parasitic infection caused by the larval stage of the cestode Echinococcus granulosus. As the disease mainly affects the liver, approximately 70% of all identified CE cases are detected in this organ. Optical molecular imaging (OMI), a noninvasive imaging technique, has never been used in vivo with the specific molecular markers of CE. Thus, we aimed to construct an in vivo fluorescent imaging mouse model of CE to locate and quantify the presence of the parasites within the liver noninvasively. Drug-treated protoscolices were monitored after marking by JC-1 dye in in vitro and in vivo studies. This work describes for the first time the successful construction of an in vivo model of E. granulosus in a small living experimental animal to achieve dynamic monitoring and observation of multiple time points of the infection course. Using this model, we quantified and analyzed labeled protoscolices based on the intensities of their red and green fluorescence. Interestingly, the ratio of red to green fluorescence intensity not only revealed the location of protoscolices but also determined the viability of the parasites in vivo and in vivo tests. The noninvasive imaging model proposed in this work will be further studied for long-term detection and observation and may potentially be widely utilized in susceptibility testing and therapeutic effect evaluation.
Animals
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Cestoda
;
Echinococcosis
;
Echinococcus granulosus*
;
Echinococcus*
;
Fluorescence
;
Humans
;
In Vitro Techniques
;
Liver
;
Mice*
;
Molecular Imaging
;
Parasites

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