1.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.
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.A study on the relationship between occupational fitness, moral dilemma and resilience of nurses in emergency department
Qian WANG ; Yan WANG ; Lihui LIU ; Deliang LIU
Chinese Journal of Practical Nursing 2023;39(23):1797-1802
Objective:To explore the correlation between nurses′ workplace adaptability, moral dilemma and resilience after suffering workplace violence in emergency department, in order to provide reference about improving the workplace adaptability and formulating intervention.Methods:A cross-section survey was conducted, we selected 248 nurses who had suffered workplace violence in the emergency department of five tertiary hospitals in Qingdao from January 2022 to January 2023 by convenient sampling method, and used self-designed general information questionnaire, moral dilemma scale, resilience evaluation scale for medical staff and nurses′ workplace adaptability scale to conduct a questionnaire survey on nurses who had suffered workplace violence, and found out the factors affecting their workplace adaptability.Results:The score of workplace adaptability of 248 nurses who had suffered workplace violence was (39.37 ± 12.77) points. Univariate analysis showed that education, length of emergency service, department or social part-time job, professional title, number of night shifts and sleep condition were the influencing factors of workplace fitness for emergency nurses ( t/ F values were -12.72 to 132.15, all P<0.05). The correlation analysis showed that the nurses′ workplace adaptability after workplace violence was negatively correlated with the scores and total scores of all dimensions of moral dilemma ( r values were -0.725 to -0.194, P<0.05), and positively correlated with the scores and total scores of all dimensions of resilience ( r values were 0.135 to 0.732, P<0.05). Multi-factor results showed that education background, department/social part-time job, working years, professional title, sleep status, moral dilemma and resilience were the influencing factors of nurses′ workplace adaptability after workplace violence ( t values were -9.25 to 15.25, P<0.05). Conclusions:Nurses with specialized education, emergency service for 1-3 years, no department/social part-time job, primary professional title, sleep disorder, higher degree of moral dilemma and low level of resilience have low occupational adaptability. Nursing managers should focus on such nurses and improve their occupational adaptability.
4.Field research on work experience and service quality of "Internet plus nursing service" led by tertiary hospitals
Qian WANG ; Yan WANG ; Suyun WANG ; Hongbing CUI ; Deliang LIU
Chinese Journal of Practical Nursing 2023;39(29):2256-2262
Objective:To understand the work experience and service quality of "Internet plus Nursing Service" led by tertiary hospitals to lay the foundation for building an "Internet plus Nursing Service" quality control index system suitable for China's national conditions.Methods:Using field research method, combining purposive sampling with open sampling, from September 2021 to February 2022, the 11 "Internet plus Nursing Service" visiting nurses from 10 residential areas in Shibei District, Shinan District, Laoshan District, Chengyang District and Jimo District of Qingdao were observed for 5 months.Results:The work experience of "Internet plus Nursing Service" visiting nurses: meeting the rigid needs of society and patients, and nurses′ professional value and satisfaction were multiplied; there were still shortcomings in the regulatory mechanism, and information technology construction needed to be continuously strengthened; there were still hidden dangers in patient safety and nurse professional safety issues. Six key factors influencing the quality of Internet plus nursing service were analyzed: non-standard preparation of articles before visiting, non-standard dress for door-to-door service, inadequate preparation for pre operation evaluation, lack of empathy during operation, weak awareness of infection prevention outside the hospital, and failure to carry out health education based on patients′ conditions after operation.Conclusions:The Internet plus nursing service model is dominated by the tertiary hospitals in Qingdao, which has realized two-way referral between the community and the superior hospitals, and has effectively improved the quality of extended care. The acceptance and satisfaction of patients and their families are high, and nurses′work enthusiasm and professional value have increased significantly. It is still necessary to establish and improve theInternet plus nursing service work standards to achieve the homogenization and diversification of nursing services, promote the comprehensive quality of community medical staff.
5.Preclinical microPET imaging in tumor-bearing nude mice and pharmacokinetic studies of 18F-Alfatide II
Deliang ZHANG ; Yesen LI ; Zuoquan ZHAO ; Jie LU ; Yue WANG ; Qian YU ; Zijing LI ; Pu ZHANG ; Ruiqin CHEN ; Hua WU ; Wei FANG ; Xianzhong ZHANG ; Xiaoyuan CHEN
Chinese Journal of Nuclear Medicine and Molecular Imaging 2019;39(4):201-206
Objective To assess the imaging characteristics of 18F-Alfalide II in different tumorbearing mice and pharmacokinetics in Beagle dogs.Methods BALB/c nude mice(n-24)were used for subcutaneous tumor models(A549 and U87MG),orthotopic lung cancer models(A549)and orthotopic breast cancer models(MDA-MB-231)(n=6 in each group).18F-Alfatide II and 18F-fluorodeoxyglucose(FDG)microPET/CT images were compared in the 4 types of tumor-bearing nude mice models.18F-Alfatide II blocking experiment,biodistribution experiment and imaging studies in tumors of different growth cycles were performed in A549 subcutaneous tumor-bearing nude mice models.Pharmacokinetic experiments were carried out in Beagle dogs(n = 6)and CD-1 mice(n = 9).Two-sample t test was used to analyze the data.Results Compared with 18F-FDG,18F-Alfatide II microPET/CT images showed better imaging quality and contrast in subcutaneous A549,U87MG tumors and orthotopic A549(tumor/heart:4.50±1.17 vs 0.95±0.31;t = 4.125,P<0.01),orthotopic MDA-MB-231(tumor/muscle:6.60±1.53 vs 0.92±0.43;t = 3.984,P<0.01)transplantation nude mice models.18F-Alfatide II could specifically target A549 tumors,and the tumor uptake of 18F-Alfatide II was reduced by about 75% after pre-injection with cyclo(Arg-Gly-Asp-D-Tyr-Lys)(c(RGDyk)).18F-Alfatide II was rapidly cleared from the blood of Beagle dogs(T1/2 was(57.34±11.69)min).It was cleared in the form of prototype drug and(69.24±6.82)% of cumulative dose was excreted through the urine within 4 h after administration.Conclusions 18F-Alfatide II shows a higher target/non-target ratio than,18F-FDG in the imaging of A549,MDA-MB-231 and U87MG tumor-bearing nude mice models,which is more conducive to the diagnosis of tumor.18F-Alfatide II has excellent pharmacokinetic properties.
6.Incidence of constipation in submariners and its impact on their psychological status and life quality
Xujie ZHANG ; Chunhua JI ; Donghu WANG ; Deliang QIAN ; Hongqi LIU
Chinese journal of nautical medicine and hyperbaric medicine 2019;26(3):173-176
Objective To investigate the incidence of functional constipation ( FC) in submariners and its impact on their psychological status and life quality, so as to provide scientific evidence for submarine medical support. Methods Five hundred and ninety-two submariners were randomly chosen from a certain submarine unit, including 326 sea service personnel and 266 shore service personnel. Rome Ⅲ standard epidemiologic questionnaire ( Rome-Ⅲ MQ ) was used to investigate the incidence of FC among sea service personnel. Then, 60 subjects with FC and 120 subjects without FC were randomly selected from the sea service group for evaluation of psychological status and life quality by using self-rating anxiety scales( SAS) , self-rating depression scales( SDS) , patient assessment of quality of life questionnaire( PAC-QOL) and simplified Chinese version of SF-36 health survey ( SF-36 ) . Results Five hundred and ninety-two copies of Rome-Ⅲ MQ were recovered, and 180 copies of SAS, SDS, PAC-QOL and SF-36 were respectively retrieved in the study. The incidence of FC among the sea service group and shore service group was respectively 35. 6% (116/326) and 13. 5%(36/266) (P<0. 05). In Rome-Ⅲ MQ, significant differences could be noted in the scores of all items except the item of manual manipulation, when comparisons were made between the sea service group and the shore service group. The scores of SAS in the FC group and the non-FC group were respectively (42. 0 ± 8. 4) and (39. 1 ± 7. 1), with statistical significance (P<0. 05), while the score of SDS in the two groups was (53. 0 ± 11. 0) and (53. 2 ± 8. 9) respectively, without statistical significance (P>0. 05). The total scores of PAC-QOL in the FC group and the non-FC group were respectively 1. 0 (0. 7-1. 3) and 0. 6 (0. 4-0. 7), also with statistical significance (P<0. 05). The total scores of SF-36 in the FC group and the non-FC group were respectively 624. 3 (449. 9-700. 4) and 687. 8. 4(612. 8-729. 8) with statistical significance (P<0. 05), and significant differences could be found in various dimensions except the dimension of "emotional function". Conclusion The incidence of FC was as high as one third among the sea service personnel, which was significantly higher than that of the shore service personnel. FC could worsen the seriousness of anxiety among submariners and decrease their life quality.
7.Incidence of constipation in submariners and its impact on their psychological status and life quality
Xujie ZHANG ; Chunhua JI ; Donghu WANG ; Deliang QIAN ; Hongqi LIU
Chinese journal of nautical medicine and hyperbaric medicine 2019;26(3):173-176
Objective To investigate the incidence of functional constipation ( FC) in submariners and its impact on their psychological status and life quality, so as to provide scientific evidence for submarine medical support. Methods Five hundred and ninety-two submariners were randomly chosen from a certain submarine unit, including 326 sea service personnel and 266 shore service personnel. Rome Ⅲ standard epidemiologic questionnaire ( Rome-Ⅲ MQ ) was used to investigate the incidence of FC among sea service personnel. Then, 60 subjects with FC and 120 subjects without FC were randomly selected from the sea service group for evaluation of psychological status and life quality by using self-rating anxiety scales( SAS) , self-rating depression scales( SDS) , patient assessment of quality of life questionnaire( PAC-QOL) and simplified Chinese version of SF-36 health survey ( SF-36 ) . Results Five hundred and ninety-two copies of Rome-Ⅲ MQ were recovered, and 180 copies of SAS, SDS, PAC-QOL and SF-36 were respectively retrieved in the study. The incidence of FC among the sea service group and shore service group was respectively 35. 6% (116/326) and 13. 5%(36/266) (P<0. 05). In Rome-Ⅲ MQ, significant differences could be noted in the scores of all items except the item of manual manipulation, when comparisons were made between the sea service group and the shore service group. The scores of SAS in the FC group and the non-FC group were respectively (42. 0 ± 8. 4) and (39. 1 ± 7. 1), with statistical significance (P<0. 05), while the score of SDS in the two groups was (53. 0 ± 11. 0) and (53. 2 ± 8. 9) respectively, without statistical significance (P>0. 05). The total scores of PAC-QOL in the FC group and the non-FC group were respectively 1. 0 (0. 7-1. 3) and 0. 6 (0. 4-0. 7), also with statistical significance (P<0. 05). The total scores of SF-36 in the FC group and the non-FC group were respectively 624. 3 (449. 9-700. 4) and 687. 8. 4(612. 8-729. 8) with statistical significance (P<0. 05), and significant differences could be found in various dimensions except the dimension of "emotional function". Conclusion The incidence of FC was as high as one third among the sea service personnel, which was significantly higher than that of the shore service personnel. FC could worsen the seriousness of anxiety among submariners and decrease their life quality.
8.Comparison of continuous lumbar plexus block with different concentrations of dexmedetomidine added to ropivacaine for postoperative analgesia in elderly patients undergoing hip replacement
Deliang ZENG ; Fangxiang ZHANG ; Xiangdi YU ; Qian ZHAO ; Jing PENG ; Guoqin XU
Chinese Journal of Anesthesiology 2017;37(1):84-87
Objective To compare the efficacy of continuous lumbar plexus block (LPB) with different concentrations of dexmedetomidine added to ropivacaine for postoperative analgesia in elderly patients undergoing hip replacement.Methods Sixty elderly patients of both sexes,aged 65-85 yr,weighing 50-71 kg,of American Society of Anesthesiologists physical status Ⅱ or Ⅲ,scheduled for elective total hip replacement,were divided into 2 groups (n =30 each) using a random number table:0.5 μg/ml dexmedetomidine+0.1% ropivacaine group (group D1) and 1.0 μg/ml dexmedetomidine + 0.1% ropivacaine group (group D2).Lumbar-sacral plexus block combined with general anesthesia was used.At the end of operation,LPB pump was started and set up to deliver a 4 ml bolus dose with a 30 min lockout interval and background infusion at a rate of 8 ml/h.The analgesia solution contained 0.5 μg/ml dexmedetomidine and 0.1% ropivacaine in group D1 and 1.0 μg/ml dexmedetomidine and 0.1% ropivacaine in group D2.Postoperative analgesia lasted for 48 h,and the visual analogue scale score was maintained ≤ 3.Patientcontrolled intravenous analgesia (PCIA) pump was connected when break-through pain happened.PCIA solution contained morphine 50 mg diluted to 50 ml in 0.9% sodium chloride.PCIA pump was set up to deliver a 1 ml bolus dose with a 5 min lockout interval and no background infusion.When the visual analogue scale score >3,the patient-controlled LPB pump was used first,and 15 min later if analgesia was still ineffective,PCIA pump was applied.The number of patients in whom analgesia was effective and occurrence of adverse reactions were recorded.Results Compared with group D1,the rate of effective analgesia was significantly increased,and the incidence of nausea,vomiting and pruritus was decreased in group D2 (P< 0.05).No bradycardia,hypotension,over-sedation,respiratory depression,urinary retention or local skin infection was found in the two groups.Conclusion Continuous LPB with 1.0 μg/ml dexmedetomidine added to 0.1% ropivacaine provides better efficacy for postoperative analgesia in elderly patients undergoing hip replacement.
9.Effect of dexmedetomidine combined with ropivacaine for continuous lumbar plexus block in early recov-ery of patients undergoing total hip arthroplasy
Deliang ZENG ; Fangxiang ZHANG ; Yi MA ; Xiangdi YU ; Qian ZHAO ; Jing PENG ; Guoqin XU
The Journal of Clinical Anesthesiology 2016;32(12):1165-1168
Objective To explore the effect of dexmedetomidine combined with ropivacaine for continuous lumbar plexus block on the quality of early recovery in patients undergoing total hip ar-throplasty.Methods Sixty patients (35 males and 25 females)with ASA physical status Ⅱ or Ⅲ, aged 65-84 years,undergoing total hip replacement were randomly assigned to dexmedetomidine com-bined with ropivacaine group (group D)or ropivacaine group (group C).All patients received ropiva-caine which was administered via continuous lumbar plexus block as patient-controlled analgesia (PCA)after surgery.The PCA were programmed with a background infusion 8 ml/h of ropivacaine, bolus dose was 4 m1 and the block time was 30 min;the patients in group C received 0.2% ropiva-caine,and the patients in group D received 0.1% ropivaciane combined with 1 μg/ml of dexmedeto-midine by the way of intravenous infusion.In addition,all patients received another patient-controlled intravenous analgesia (PCIA)with 1 mg/ml of morphine for relieving the explosive pain.The PCIA was programmed with a lobus dose of morphine 1 mg without background dose,the block time was 5 min.Consumption of morphine and visual analog scale (VAS)score,muscle strength and maximum flexion and abduction of hip joint were recorded at the time points of 6,12,24 and 48 h after opera-tion.The side-effect reactions such as nausea,vomiting,drowsiness and itching were recorded.The sleep quality was assessed with Pittsburgh sleep quality index (PSQI)on day 1 before operation,day 1 and day 7 after operation.Results The consumption of morphine in group D was significantly fewer than group C (P <0.05).Compared with group C,muscle strength and maximum flexion and abduc-tion of hip joint in group D were increased at 6,12,24 and 48 h after operation (P <0.05 ).PSQI scores were decreased on the day 1 and day 7 after operation.The incidence of delirium,nausea and vomiting,drowsiness and itching in group D were decreased (P <0.05).Conclusion 0.1% ropiva-ciane continuous lumbar plexus block combined with 1 μg/ml of dexmedetomidine by the way of in-travenous infusion could provide satisfied analgesia for the operation of total hip arthroplasty;the sleep quality is improved,the functional exercise of hip joint is promoted.

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