1.A preclinical and first-in-human study of superstable homogeneous radiolipiodol for revolutionizing interventional diagnosis and treatment of hepatocellular carcinoma.
Hu CHEN ; Yongfu XIONG ; Minglei TENG ; Yesen LI ; Deliang ZHANG ; Yongjun REN ; Zheng LI ; Hui LIU ; Xiaofei WEN ; Zhenjie LI ; Yang ZHANG ; Syed Faheem ASKARI RIZVI ; Rongqiang ZHUANG ; Jinxiong HUANG ; Suping LI ; Jingsong MAO ; Hongwei CHENG ; Gang LIU
Acta Pharmaceutica Sinica B 2025;15(10):5022-5035
Transarterial radioembolization (TARE) is a widely utilized therapeutic approach for hepatocellular carcinoma (HCC), however, the clinical implementation is constrained by the stringent preparation conditions of radioembolization agents. Herein, we incorporated the superstable homogeneous iodinated formulation technology (SHIFT), simultaneously utilizing an enhanced solvent form in a carbon dioxide supercritical fluid environment, to encapsulate radionuclides (such as 131I,177Lu, or 18F) with lipiodol for the preparation of radiolipiodol. The resulting radiolipiodol exhibited exceptional stability and ultra-high labeling efficiency (≥99%) and displayed notable intratumoral radionuclide retention and in vivo stability more than 2 weeks following locoregional injection in subcutaneous tumors in mice and orthotopic liver tumors in rats and rabbits. Given these encouraging findings, 18F was authorized as a radiotracer in radiolipiodol for clinical trials in HCC patients, and showed a favorable tumor accumulation, with a tumor-to-liver uptake ratio of ≥50 and minimal radionuclide leakage, confirming the feasibility of SHIFT for TARE applications. In the context of transforming from preclinical to clinical screening, the preparation of radiolipiodol by SHIFT represents an innovative physical strategy for radionuclide encapsulation. Hence, this work offers a reliable and efficient approach for TARE in HCC, showing considerable promise for clinical application (ChiCTR2400087731).
2.Efficacy and safety of tegoprazan (LXI-15028) vs. esomeprazole in patients with erosive esophagitis: A multicenter, randomized, doubleblind, non-inferiority phase Ⅲ trial
Huiyun ZHU ; Qian XUE ; Yingxiao SONG ; Zhenyu ZHANG ; Xing LI ; Shengxiang LYU ; Qiang ZHAN ; Fei LIU ; Lungen LU ; Liang ZHONG ; Weixing CHEN ; Dong SHAO ; Yanbing DING ; Deliang LIU ; Xiaozhong YANG ; Zhiming HUANG ; Zhaoshen LI ; Yiqi DU
Chinese Medical Journal 2025;138(19):2464-2471
Background::An evidence gap still exists regarding the efficacy and safety of tegoprazan in patients with erosive esophagitis (EE) in China. This study aimed to verify the efficacy and safety of tegoprazan vs. esomeprazole in patients with EE in China. Methods::This study was a multicenter, randomized, double-blind, parallel, active-controlled, non-inferiority phase III trial of patients with EE randomized 1:1 to tegoprazan 50 mg/day vs. esomeprazole 40 mg/day. This study was conducted in 32 sites between October 24, 2018 and October 18, 2019. The primary endpoint was the cumulative endoscopic healing rate at week 8. The secondary endpoint included endoscopic healing rate at week 4, changes in the reflux disease questionnaire (RDQ) and gastroesophageal reflux disease health-related quality of life (GERD-HRQL) scores, and symptom improvement. Results::A total of 261 patients were randomized: 132 to the tegoprazan group and 129 to the esomeprazole group. The cumulative endoscopic healing rate at 8 weeks in the tegoprazan group was non-inferior to that of the esomeprazole group (91.1% vs. 92.8%, difference: -1.7%, 95% confidence interval [CI]: -8.5%, 5.0%, P = 0.008). There were no statistically significant differences in the changes in RDQ (total, severity, and frequency) and GERD-HRQL scores between the two groups (all P >0.05). The percentages of days without symptoms, including daytime and nighttime symptoms based on patients' diaries, were similar between the two groups (all P >0.05). In the tegoprazan and esomeprazole groups, 71.5% (93/130) and 61.7% (79/128) of the participants reported adverse events (AEs), 2.3% and 0 experienced serious AEs, while 70.0% and 60.2% had treatment-emergent AEs, respectively. Conclusion::Tegoprazan 50 mg/day demonstrated non-inferior efficacy in healing EE, symptom improvement, and quality of life, and it has similar tolerability compared with esomeprazole 40 mg/day.
3.Treatment of Obese Type 2 Diabetes Based on the Theory of"Maintaining the Sweet and Restoring the Body Fluids"
Bin LIU ; Xiru HUANG ; Deliang LIU ; Huilin LI
Journal of Nanjing University of Traditional Chinese Medicine 2025;41(4):555-560
Obese type 2 diabetes belongs to the category of"consumptive thirst"in traditional Chinese medicine,and obesity is its main cause.This paper summarizes the pathogenesis of obese type 2 diabetes from three aspects:thirst caused by fat evil,deficiency caused by fat evil,and fat evil causing various pathogens.That is to say,the congestion of fat evil produces heat and hurts Yin,lead-ing to consumptive thirst.The accumulation of ointment and fat will damage Yang in the middle energizer and hinder spleen transport.Phlegm and dampness originate from spleen deficiency,which gather in veins and generate blood stasis and heat.The com-plicated combination of phlegm,blood stasis and heat leads to the relapse or development of consumptive thirst.Based on the theory of"maintaining the sweet and restoring the body fluids",this paper skillfully uses sweet herbs and cooperates with other nature and flavors to treat the pathogenesis of"thirst,deficiency and blood stasis"caused by fat evil injuring body fluids,to achieve the purposes of clear-ing away heat and nourishing Yin,strengthening spleen and protecting middle energizer,removing turbidity and blood stasis.Finally,the body fluid is continuously produced,transported smoothly,and the consumptive thirst is relieved.
4.Treatment of Obese Type 2 Diabetes Based on the Theory of"Maintaining the Sweet and Restoring the Body Fluids"
Bin LIU ; Xiru HUANG ; Deliang LIU ; Huilin LI
Journal of Nanjing University of Traditional Chinese Medicine 2025;41(4):555-560
Obese type 2 diabetes belongs to the category of"consumptive thirst"in traditional Chinese medicine,and obesity is its main cause.This paper summarizes the pathogenesis of obese type 2 diabetes from three aspects:thirst caused by fat evil,deficiency caused by fat evil,and fat evil causing various pathogens.That is to say,the congestion of fat evil produces heat and hurts Yin,lead-ing to consumptive thirst.The accumulation of ointment and fat will damage Yang in the middle energizer and hinder spleen transport.Phlegm and dampness originate from spleen deficiency,which gather in veins and generate blood stasis and heat.The com-plicated combination of phlegm,blood stasis and heat leads to the relapse or development of consumptive thirst.Based on the theory of"maintaining the sweet and restoring the body fluids",this paper skillfully uses sweet herbs and cooperates with other nature and flavors to treat the pathogenesis of"thirst,deficiency and blood stasis"caused by fat evil injuring body fluids,to achieve the purposes of clear-ing away heat and nourishing Yin,strengthening spleen and protecting middle energizer,removing turbidity and blood stasis.Finally,the body fluid is continuously produced,transported smoothly,and the consumptive thirst is relieved.
5.Efficacy and safety of tegoprazan (LXI-15028) vs. esomeprazole in patients with erosive esophagitis: A multicenter, randomized, doubleblind, non-inferiority phase Ⅲ trial
Huiyun ZHU ; Qian XUE ; Yingxiao SONG ; Zhenyu ZHANG ; Xing LI ; Shengxiang LYU ; Qiang ZHAN ; Fei LIU ; Lungen LU ; Liang ZHONG ; Weixing CHEN ; Dong SHAO ; Yanbing DING ; Deliang LIU ; Xiaozhong YANG ; Zhiming HUANG ; Zhaoshen LI ; Yiqi DU
Chinese Medical Journal 2025;138(19):2464-2471
Background::An evidence gap still exists regarding the efficacy and safety of tegoprazan in patients with erosive esophagitis (EE) in China. This study aimed to verify the efficacy and safety of tegoprazan vs. esomeprazole in patients with EE in China. Methods::This study was a multicenter, randomized, double-blind, parallel, active-controlled, non-inferiority phase III trial of patients with EE randomized 1:1 to tegoprazan 50 mg/day vs. esomeprazole 40 mg/day. This study was conducted in 32 sites between October 24, 2018 and October 18, 2019. The primary endpoint was the cumulative endoscopic healing rate at week 8. The secondary endpoint included endoscopic healing rate at week 4, changes in the reflux disease questionnaire (RDQ) and gastroesophageal reflux disease health-related quality of life (GERD-HRQL) scores, and symptom improvement. Results::A total of 261 patients were randomized: 132 to the tegoprazan group and 129 to the esomeprazole group. The cumulative endoscopic healing rate at 8 weeks in the tegoprazan group was non-inferior to that of the esomeprazole group (91.1% vs. 92.8%, difference: -1.7%, 95% confidence interval [CI]: -8.5%, 5.0%, P = 0.008). There were no statistically significant differences in the changes in RDQ (total, severity, and frequency) and GERD-HRQL scores between the two groups (all P >0.05). The percentages of days without symptoms, including daytime and nighttime symptoms based on patients' diaries, were similar between the two groups (all P >0.05). In the tegoprazan and esomeprazole groups, 71.5% (93/130) and 61.7% (79/128) of the participants reported adverse events (AEs), 2.3% and 0 experienced serious AEs, while 70.0% and 60.2% had treatment-emergent AEs, respectively. Conclusion::Tegoprazan 50 mg/day demonstrated non-inferior efficacy in healing EE, symptom improvement, and quality of life, and it has similar tolerability compared with esomeprazole 40 mg/day.
6.Effects of different suture-occluded models of cerebral ischemia on brain regions and behaviors in mice
Deliang LIU ; Hui LIU ; Jing REN ; Xingting YANG ; Yiyang HUANG ; Leilei BAO
Journal of Navy Medicine 2024;45(6):599-605
Objective To explore the differences of brain regions and behaviors in cerebral ischemia mouse models caused by 3 suture-occluded models.Methods A total of 120 ICR mice were randomly divided into 4 groups:sham operation group,method A group(common carotid artery to internal carotid artery 8 mm),method B group(external carotid artery to internal carotid artery 10 mm),and method C group(common carotid artery to internal carotid artery 10 mm),with 30 mice in each group.After 1.5 h of cerebral ischemia and 24 of reperfusion,mice were stained with 2,3,5-triphenyltetrazolium chloride(TTC)to observe the site of cerebral ischemia and to calculate the area of ischemia.The neuromotor function of the mice was evaluated by the Longa score.The strength of the forelimb was measured by the grip test.The stamina of the mice was evaluated by the swimming test.The permeability of the blood-brain barrier was determined by the Evans blue staining.The cerebral edema was evaluated by the calculation of brain water content.Pathological changes of brain tissues were observed by hematoxylin-eosin(H-E)staining.Results TTC staining showed different sites and areas of cerebral infarcts caused by the 3 methods in mice.No significant difference was found in the infarct area between groups A and B(P>0.05),but the infarct area of method C was significantly different from that of groups A and B(all P<0.05).No infarct was detected in the sham operation group.The results of behavioral experiments of A,B,and C groups were significantly different from those of the sham operation group(all P<0.05).No significant difference was found in the Longa score between B and C groups(P>0.05),but the Longa score in A group was significantly different from that in B and C groups(both P<0.05).There was significant difference in the result of forelimb grip strength experiment between method A and C groups(P<0.05).No significant difference was found in the swimming time between B and C groups(P>0.05),but the swimming time in A group was significantly different from that in B and C groups(both P<0.05).The results of Evans blue staining,brain water content testing,and H-E staining revealed that cerebral ischemia caused by method C resulted in more severe brain damage in mice compared with methods A and B.Conclusion The 3 suture-occluded models can cause ischemia in different brain regions of cerebral ischemia mouse models,and ischemia in the cortex is more likely to cause motor dysfunction.
7.Field investigation of a mumps outbreak and evaluation of vaccine effectiveness in a remote village school
XU Yuxiang, KONG Deliang, LYU Yuling, LIAO Meiting, LI Yuhua, SHEN Wenhao, HUANG Guohua
Chinese Journal of School Health 2023;44(11):1716-1719
Objective:
To investigate the outbreak of mumps in a remote village school of Zhaoqing City, to evaluate and vaccine effectiveness ( VE ) of mumps containing vaccine (MuCV), so as to provide reference for the formulation of epidemic prevention and control strategies.
Methods:
Through on site case investigations and interviews, case data and epidemic related epidemiological information were obtained. Descriptive and retrospective cohort studies were used to analyze the epidemic characteristics, explore risk factors, and evaluate the protective effect of vaccines.
Results:
Totally 166 cases of mumps were found, and all of them were students. The total attack rate was 7.79% and the outbreak lasted for 60 days. The first case occurred on October 11th and the last case occurred on December 9th in 2018. Most of the cases aged from 10 to 13 years old, accounting for 66.27%. There were 96 male patients and 70 female patients, with no statistically significant sex difference in the incidence rate ( χ 2=2.40, P >0.05). Involving 28 classes, 11 of which had an incidence rate more than 10%, mainly distributed in grades 2, 4 and 6. There were statistically significant differences in incidence rates among different grades ( χ 2=96.89, P <0.01) and different floors ( χ 2=67.35, P < 0.01 ), with the third floor higher than the other floors. Twelve out of 58 boarding pupils were cases, and boarding pupils were 1.89 times higher in risk of contracting mumps than day students ( RR=1.89, 95%CI =1.10-3.23). Pupils without being given the shot of MuCV were higher in the infection rate than those having the shot ( χ 2=5.70, P <0.05), and the VE % was 35% (95% CI = 7%- 55%). The VE % of one dose was 34% (4%-54%), while the effectiveness of protection was declined with time ( χ 2 trend =6.53, P < 0.05). The effectiveness of vaccine almost diasappeared six years after the shot ( χ 2=1.12, P >0.05).
Conclusion
Delayed case report and isolation, low rate of receiving MuCV, and decreasing effectiveness of one shot MuCV are closely assocaited with the outbreak and ongoing spread of the epidemic.
8.Clinical features of liver injury induced by anti-tuberculosis drugs and related risk factors
Deliang HUANG ; Wei DAI ; Jun CHEN ; Xiaoguang YE
Journal of Clinical Hepatology 2021;37(10):2369-2375
Objective To investigate the clinical features of liver injury induced by anti-tuberculosis drugs and related risk factors. Methods A total of 129 patients who were diagnosed with liver injury induced by anti-tuberculosis drugs in Shenzhen Third People's Hospital from January 2017 to December 2018 were enrolled and divided into abnormal liver function group with 51 patients (39.53%) and drug-induced liver injury (DILI) group with 78 patients (60.47%), and among these 129 patients, 13 (10.08%) had liver failure. A retrospective analysis was performed for their laboratory markers as well as treatment and prognosis data. The chi-square test was used for comparison of categorical data between two groups; the independent samples t -test was used for comparison of normally distributed continuous data between two groups, and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups. The multivariable logistic regression model was used to investigate the risk factors for DILI and liver failure. Results There were significant differences between the DILI group and the abnormal liver function group in chronic HBV co-infection ( χ 2 =5.616, P =0.018), asymptomatic liver injury ( χ 2 =9.451, P =0.002), liver failure ( χ 2 =9.453, P =0.002), need to adjust anti-tuberculosis regimen ( χ 2 =16.787, P < 0.001), time to identification of liver injury ( Z =-4.001, P < 0.001), time to liver function recovery ( Z =-1.735, P < 0.001), and hepatic encephalopathy ( χ 2 =4.114, P =0.043). The multivariate logistic regression analysis showed that time to identification of liver injury > 8 weeks (odds ratio [ OR ]=3.94, 95% confidence interval [ CI ]: 1.02-15.25, P =0.047) and asymptomatic liver injury ( OR =7.64, 95% CI : 1.63-35.86, P =0.010) were independent risk factors for DILI; chronic HBV co-infection ( OR =14.42, 95% CI : 2.66-78.09, P =0.002) and time to identification of liver injury > 8 weeks ( OR =11.97, 95% CI : 2.03-70.50, P =0.006) were independent risk factors for liver failure, while albumin ≥35 g/L ( OR =0.07, 95% CI : 0.01-0.51, P =0.010) was a protective factor. Conclusion Anti-tuberculosis drugs may induce severe liver injury, and HBV co-infection, asymptomatic liver injury, long time to identification of liver injury, and low albumin level may increase the risk of severe liver injury. Regular follow-up, liver function monitoring, appropriate nutritional support, and HBV screening are important for reducing the risk of liver injury during anti-tuberculosis therapy.
9.Platelet transfusion practice and related outcomes in patients with veno-arterial extracorporeal membrane oxygenation: a three-year retrospective study
Yi ZHU ; Xufeng CHEN ; Jinsong ZHANG ; Yong MEI ; Jinru LV ; Gang ZHANG ; Deliang HU ; Wei LI ; Huazhong ZHANG ; Feng SUN ; Juan WU ; Yongxia GAO ; Xihua HUANG ; Hui ZHANG
Chinese Journal of Emergency Medicine 2021;30(10):1177-1181
Objective:To study the application of blood products in patients with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) and evaluate its effect on the prognosis.Methods:A total of 83 adult patients treated with VA-ECMO in the Emergency Department of the First Affiliated Hospital of Nanjing Medical University from January 2017 to January 2020 were grouped by survival to explore the risk factors of 28-day mortality using binary logistic regression, and the threshold was calculated by ROC curve.Results:Platelet transfusion ( OR=2.506, 95% CI: 1.142-5.499) and non-myocarditis disease ( OR=6.881, 95% CI: 1.615-29.316) were the risk factors of 28-day mortality in adult VA-ECMO patients. The threshold of platelet transfusion was 0.427 mL/(kg·d) (sensitivity 78.4%, specificity 69.6% , AUC 0.735). Conclusions:The increased platelet transfusion is related to the poor prognosis of adult patients with VA-ECMO. Refractory myocarditis patients are better treated with VA-ECMO.
10.Analysis of early volume balance and prognosis of severe cardiogenic shock patients treated with veno-arterial extracorporeal membrane oxygenation
Feng SUN ; Xufeng CHEN ; Jinsong ZHANG ; Yong MEI ; Jinru LV ; Wei LI ; Deliang HU ; Gang ZHANG ; Huazhong ZHANG ; Yuan GUO ; Juan WU ; Yongxia GAO ; Xihua HUANG ; Hui ZHANG
Chinese Journal of Emergency Medicine 2021;30(10):1182-1186
Objective:To analyze the early volume characteristics of patients with severe cardiogenic shock treated with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) and the relationship between their early volume and the prognosis.Methods:This study reviewed patients of Emergency Medical University , treated with VA-ECMO and screened the patients with severe cardiogenic shock and VA-ECMO running more than 72 h for further study. The basic condition of the patients was recorded, and the fluid balance in the first 72 h was analyzed. The patients were grouped according to their fluid balance in the first 72 h. The gender, age, survival rate, continuous renal replacement therapy (CRRT) rate, intra-aortic balloon pump (IABP) rate, and invasive mechanical ventilation rate were compared between the two groups, and the relative risk to the prognosis was calculated. The prognosis was compared between the two groups. Results:Totally 77 patients with severe cardiogenic shock were enrolled. Forty-one cases survived, with an overall survival rate of 53.2%. The volume balance at 48-72 h and the total volume balance at the first 72 h were different between the survival and dead groups. Compared with the positive balance group, patients in the negative balance group were less likely to receive CRRT or invasive mechanical ventilation during the first 72 h. Patients in the negative balance group during the first 72 h had a better survival rate, and their relative risk of survival was 1.81 (95% confidence interval: 1.101, 2.985). However, there was no significant difference in survival rate according to every 24 h fluid balance.Conclusions:Patients with severe cardiogenic shock treated with VA-ECMO who had negative total volume balance during the first 72 h are more likely to survive and less likely to require CRRT or invasive mechanical ventilation.


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