1.A comparative study of different methods for treatment switching analysis in clinical trials.
Zhiyue LIANG ; Lishan XU ; Keke LI ; Milai YU ; Shengli AN
Journal of Southern Medical University 2025;45(5):1093-1102
OBJECTIVES:
To compare the commonly used methods for analyzing treatment switching in clinical trials to facilitate selection of optimal methods in different scenarios.
METHODS:
Based on the data characteristics of patient conversion in oncology clinical trials, we simulated the survival time of patients across different scenarios and compared the bias, mean square error and coverages of the treatment effects derived from different methods.
RESULTS:
The sample size had an almost negligible impact on the outcomes of the various methods. Compared to conventional methods, more complex methods (RPSFTM, IPCW, TSE, and IPE) resulted in lower errors across different scenarios. The IPCW method could cause a significant increase in errors in cases where the probability of conversion was high. The TSE method had the lowest error and mean squared error when the risk was low and the probability of conversion was high. The IPE method had an obvious advantage in the scenario with a low probability of conversion, but it may slightly underestimate the treatment effect when the inflation factor was small.
CONCLUSIONS
The choice of a specific method for analyzing cohort transition should be made based on considerations of both the probability of conversion and inflation factor in different scenarios.
Humans
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Clinical Trials as Topic/methods*
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Neoplasms/therapy*
2.Advancements and applications in radiopharmaceutical therapy.
Shiya WANG ; Mingyi CAO ; Yifei CHEN ; Jingjing LIN ; Jiahao LI ; Xinyu WU ; Zhiyue DAI ; Yuhan PAN ; Xiao LIU ; Xian LIU ; Liang-Ting LIN ; Jianbing WU ; Ji LIU ; Qifeng ZHONG ; Zhenwei YUAN
Chinese Journal of Natural Medicines (English Ed.) 2025;23(6):641-657
Radiopharmaceuticals operate by combining radionuclides with carriers. The radiation energy emitted by radionuclides is utilized to selectively irradiate diseased tissues while minimizing damage to healthy tissues. In comparison to external beam radiation therapy, radionuclide drugs demonstrate research potential due to their biological targeting capabilities and reduced normal tissue toxicity. This article reviews the applications and research progress of radiopharmaceuticals in cancer treatment. Several key radionuclides are examined, including 223Ra, 90Y, Lutetium-177 (177Lu), 212Pb, and Actinium-225 (225Ac). It also explores the current development trends of radiopharmaceuticals, encompassing the introduction of novel radionuclides, advancements in imaging technologies, integrated diagnosis and treatment approaches, and equipment-medication combinations. We review the progress in the development of new treatments, such as neutron capture therapy, proton therapy, and heavy ion therapy. Furthermore, we examine the challenges and breakthroughs associated with the clinical translation of radiopharmaceuticals and provide recommendations for the research and development of novel radionuclide drugs.
Humans
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Radiopharmaceuticals/therapeutic use*
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Neoplasms/radiotherapy*
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Radioisotopes/therapeutic use*
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Animals
3.Expert consensus on endodontic therapy for patients with systemic conditions
Xu XIN ; Zheng XIN ; Lin FEI ; Yu QING ; Hou BENXIANG ; Chen ZHI ; Wei XI ; Qiu LIHONG ; Chen WENXIA ; Li JIYAO ; Chen LILI ; Wang ZUOMIN ; Wu HONGKUN ; Lu ZHIYUE ; Zhao JIZHI ; Liang YUHONG ; Zhao JIN ; Pan YIHUAI ; Pan SHUANG ; Wang XIAOYAN ; Yang DEQIN ; Ren YANFANG ; Yue LIN ; Zhou XUEDONG
International Journal of Oral Science 2024;16(3):390-397
The overall health condition of patients significantly affects the diagnosis,treatment,and prognosis of endodontic diseases.A systemic consideration of the patient's overall health along with oral conditions holds the utmost importance in determining the necessity and feasibility of endodontic therapy,as well as selecting appropriate therapeutic approaches.This expert consensus is a collaborative effort by specialists from endodontics and clinical physicians across the nation based on the current clinical evidence,aiming to provide general guidance on clinical procedures,improve patient safety and enhance clinical outcomes of endodontic therapy in patients with compromised overall health.
4.Value of serum intestinal fatty acid binding protein and calcium levels for evaluating the effect of emergency surgical on the treatment of severe acute pancreatitis
Chinese Journal of Biochemical Pharmaceutics 2017;37(8):397-400
Objective To study the value of serum intestinal fatty acid binding protein(I-FABP) and calcium levels for evaluating the effect of emergency surgical on the treatment of severe acute pancreatitis(SAP). Methods A total of 68 firstly diagnosed as SAP from June 2014 to October 2016 were collected into this study. The arrest time was less than 72 h and they were underwent emergency endoscopic or laparoscopic surgery. The serum I-FABP and calcium levels were detected 12 hours after surgery and analyze the values of serum I-FABP and calcium levels in evaluating the clinical effects by receiver operating characteristic curve(ROC). Results There were 33 cases with excellence, 21 cases with availability and other 14 cases with no-effect, the total efficacy rate was 79.4%. The gender, age, arrest time, APACHE Ⅱ score, derum amylase, blood glucose and total cholesterol levels were no statistical differences in effective group and no-effect group.The serum I-FABP levels 12 hours after surgery in effective group were lower and calcium levels were higher than no-effect group(P<0.05).The evaluating accuracy was 0.856, sensibility was 86.5%,specificity was 92.2%,cut-off value was 368 ng/mL of serum I-FABP by ROC analysis. And they were 0.844,83.5%,86.7% and 1.96 mmol/L of serum calcium level by ROC analysis. Conclusion Serum I-FABP combined with calcium can be used for evaluating the effects of emergency surgical on the treatment of the patients with SAP.
5.Effects of Xingnaojing injection on expression of ZO-1 in blood-brain bar-rier after global ischemia-reperfusion
Zhiyue ZHONG ; Bing LI ; Ming LIU ; Hongzhi LI ; Xiaojun LIANG ; Jie SHEN
Chinese Journal of Pathophysiology 2015;(7):1320-1323
AIM:To investigate the effect of Xingnaojing (XNJ) injection on the permeability of blood-brain barrier ( BBB) and zonula occludens-1 ( ZO-1) protein expression after global ischemia-reperfusion in rats.METHODS:Improved Pulsinelli four-vessel occlusion method was adopted to establish the global ischemia-reperfusion model in the rats. Male Wistar rats were randomly divided into sham group, model group, solvent group and XNJ group.The observations were conducted at the time points of 24 h, 48 h and 72 h after ischemia reperfusion.The water content of the brain tissues was determined by dry-wet weight method, while the Evans blue ( EB) content of brain tissue was detected by spectropho-tometry.The protein levels of ZO-1 in the cerebral cortex were analyzed by Western blot.RESULTS:The water contents in the brain tissues in model group, solvent group and XNJ group were significantly higher than those in sham group ( P<0.05) 24 h after ischemia reperfusion.However, the brain water contents in model group and solvent group were signifi-cantly higher than those in XNJ group and sham group (P<0.05) 48 h and 72 h after ischemia reperfusion.The EB con-tents in the brain tissues in model group, solvent group and XNJ group were entirely higher than that in sham group 24 h af-ter ischemia reperfusion (P<0.05).The EB contents in sham group and XNJ group were significantly lower than those in model group and solvent group 48 h and 72 h after ischemia reperfusion (P<0.05).The protein expression of ZO-1 in the rat cerebral cortex in model group, solvent group and XNJ group was significantly lower than that in sham group 24 h after ischemia-reperfusion (P<0.05).Similarly, 48 h and 72 h after ischemia reperfusion, ZO-1 protein level in the cortex in sham group and XNJ group was significantly higher than that in model group and solvent group (P<0.05).CONCLU-SION:At 48 h and 72 h after global ischemia-reperfusion, Xingnaojing injection play a protective role in blood-brain barri-er and this role may be associated with the increase in ZO-1 protein expression by Xingnaojing injection.
6.The effects of Xingnaojing injection on Caveolin-1 in cortex of brain after global ischemia-reperfusion
Junfeng CHEN ; Bing LI ; Ming LIU ; Hongzhi LI ; Xiaojun LIANG ; Jie SHEN ; Zhiyue ZHONG
Chinese Journal of Emergency Medicine 2015;24(5):501-505
Objective To study the impact of Xingnaojing (XNJ) injection (a preparation of Chinese herb medicine) on the permeability of blood-brain barrier and Caveolin-1 in cortex of brain after global ischemia-reperfusion.Methods Modified Pulsinelli method for four-vessel occlusion was employed to establish the global ischemia reperfusion model in rats.Male Wistar rats were randomly (random number) divided into three groups,namely sham group,model group and XNJ group.Each group was observed at 24 h,48 h and 72 h after ischemia reperfusion.The water content of brain tissue was determined by dry/wet weight ratio,while the Evans blue (EB) concentration in brain tissue was detected by spectrophotometer.Western blot was used to detect caveolin-1 level in the cerebral cortex.Results The water contents of brain tissue in model group and XNJ group were significantly higher than that in sham group 24 hour after ischemia-reperfusion (P < 0.05).But at 48 h and 72 h after ischemia-reperfusion,the brain water content in model group was significantly higher than that in XNJ group and sham group (P < 0.05).The EB concentrations in brain tissue in model group and XNJ group were higher than that in sham group 24 h after ischemia-reperfusion (P < 0.05).EB levels in sham group and XNJ group were significantly lower than that in model group 48 h and 72 h after ischemia-reperfusion (P < 0.05).Caveolin-1 levels in cerebral cortex in sham group and XNJ group were significantly higher than that in model group 24 h,48 h and 72 h after ischemia-reperfusion (P < 0.05).Conclusions After global ischemia-reperfusion,Xingnaojing (XNJ) injection could protect blood-brain barrier in virtue of regulating caveolin-1 protein level.
7.Clinical study of de novo hepatitis B virus infection after pediatric living liver transplantation
Zhiyue TU ; Liying SUN ; Zhijun ZHU ; Lin WEI ; Wei QU ; Zhigui ZENG ; Ying LIU ; Enhui HE ; Liang ZHANG ; Dong WANG ; Yuwei SONG
Organ Transplantation 2015;(4):245-248,267
Objective To investigate the clinical characteristics,prevention and treatment strategy of de novo hepatitis B virus (HBV)infection after pediatric living liver transplantation.Methods In total,106 pediatric recipients undergoing living liver transplantation in Organ Transplantation Center of Affiliated Beijing Friendship Hospital of Capital Medical University and Organ Transplantation Center of Tianjin First Center Hospital from July 2010 to July 2014 were enrolled in this study.All surgeries were performed by the same surgical team.According to preoperative test outcomes of donor HBV serological markers,all recipients were divided into the positive (n =45)and negative (n =61)antibody to hepatitis B core antigen (anti-HBc)donor liver groups (positive group and negative group),and the prevalence of de novo HBV infection was compared between two groups.The risk factors of de novo HBV infection in the positive group were analyzed to elucidate the clinical characteristics of de novo HBV infection in affected children.Results The incidences of de novo HBV infection in positive and negative group were 18% (8 /45 )and 2% (1 /61 )respectively.The risk factors of de novo HBV infection in recipients with positive anti-HBc were negative anti-HBs before transplantation and absence of antiviral therapy post-transplantation in recipients (both in P <0.05 ).The median interval between time of onset and time of liver transplantation was 12 months (8-48 months).Seven cases were treated with lamivudine and the remaining two cases were left untreated.All nine recipients survived.Conclusions Application of positive anti-HBc donor liver have a risk of HBV infection in recipients after pediatric liver transplantation.Absence of postoperative nucleoside analogue therapy and negative anti-HBs before transplantation acts as risk factors of de novo HBV infection in the recipients with positive anti-HBc donor liver.After liver transplantation,nucleoside analogue therapy is recommended for the pediatric recipients with positive anti-HBc donor liver to prevent the incidence of de novo HBV infection.Besides,hepatitis B vaccine should be administered prior to liver transplantation.
8.Experimental Establishment of Life Cycle of Clonorchis sinensis
Chi LIANG ; Xuchu HU ; Zhiyue LV ; Zhongdao WU ; Xinbing YU ; Jin XU ; Huanqin ZHENG
Chinese Journal of Parasitology and Parasitic Diseases 1987;0(02):-
Objective To establish and maintain the life cycle of Clonorchis sinensis in laboratory.Methods Adult worms and eggs of Clonorchis sinensis were collected from naturally infected cats.Eggs were ingested by freshwater snails in aquarium.When the cercariae were released from infected snails, they invaded into freshwater fishes.From the 30th day on after the release of cercariae, the infection rate and metacercariae density in freshwater fishes were determined.Results After 95 days the infected snails began shedding cercariae in a temperature range of 24.3-37.2 ℃, and no cercariae were found under 20 ℃.The infection rate in the snails Parafossarulus striatulus and Alocinma longicornis was 12.5% and 18.0%, respectively.Metacercariae were found in fish at 30 days after cercariae infection, and matured metacercariae were detected in 45 days.The number of metacercariae per gram of fish meat in Pseudorasbora parva, Ctenopharyngodon idellus, Rhodeus sinensis, Hypophthalmichthys nobilis, Cirrhinus molitorella, Carassius auratus, Cyprinus carpio and Oreochromis niloticus was 1 792, 16, 8, 6, 5, 4, 4, and 2, respectively.Rats and cats were fed with metacercariae from fish to receive adult worms.Conclusion Life cycle of Clonorchis sinensis has been established and maintained in the laboratory.

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