1.Research on a SECURE nursing pathway based on action research method in preventing MDRPI
Litian LIU ; Wenli ZHAO ; Xuelian SONG ; Xiaolin ZHENG ; Yingxiao LI ; Yu LI ; Lei ZHANG ; Feifei ZHANG
China Medical Equipment 2025;22(1):90-95
Objective:To explore the applied effectiveness of the Skin and/or tissue,Education,Cooperation,Understanding,Report and Evaluate (SECURE) nursing pathway based on action research method in the prevention process of medical device-related pressure injuries (MDRPI) of patients in the Intensive Care Unit (ICU). Methods:The SECURE nursing pathway based on action research method included the establishment of a skin care team to identify problems,and the formulation of conducting intervention plan,and the development of targeting nursing interventions to prevent the occurrence of MDRPI. A total of 84 patients hospitalized in the ICU of Hebei General Hospital from March 2022 to March 2023 were selected,and they were randomly divided into a control group and an observation group,with 42 patients in each group. The control group implemented routine method to prevent MDRPI during ICU treatment,while the observation group implemented SECURE nursing pathway based on action research method to conduct prevention. The MDRPI incidence,the quality scores of ICU nursing,the scores of the Short Form Health Survey-36 (SF-36) of patients,the assessment of the improvement of MDRPI patients,and the satisfaction of patients for nursing care were compared between the two groups. Results:The MDRPI incidence during ICU treatment in the observation group was 4.76% (2/42),which was significantly lower than that in the control group,with a statistically significant difference (x2=11.052,P<0.05). The average scores for device usage,prevention assessment,positioning management and preventive nursing after nursing intervention in the observation group were respectively (88.45±2.05),(89.36±2.11),(89.25±2.15) and (91.45±2.25),all of which were significantly higher than those in the control group,with statistically significant differences (t=11.425,12.052,10.052,13.478,P<0.05). After nursing intervention,the average scores for physical function,social function,psychological function and material life as the SF-36 scale in the observation group were (85.47±2.05),(86.48±2.05),(88.46±2.15) and (90.25±2.44),respectively,which were respectively higher than those in the control group,with statistically significant differences (t=12.414,11.045,10.252,10.478,P<0.05). The occurrence time,improvement time of wound and ICU treatment time of presenting MDRPI patients in the observation group were respectively (4.05±0.54) days,(3.45±0.15) days,and (8.12±2.14) days. Compared to the control group,the occurrence time of the observation group was longer,while both the improvement time of wound and ICU treatment time of the observation group were shorter,with statistically significant differences (t=8.485,10.012,13.001,P<0.05). The satisfaction degree of nursing care of patients in the observation group was 95.24% (40/42),which was significantly higher than that in the control group (x2=12.054,P<0.05). Conclusion:The SECURE nursing pathway based on action research method,which prevents MDRPI of ICU patients,can reduce the MDRPI incidence rate of ICU patients,and enhance the work quality of nursing care for MDRPI. It is helpful to the recovery of ICU patients,which can also shorten the treatment time of ICU patients.
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.Research on a SECURE nursing pathway based on action research method in preventing MDRPI
Litian LIU ; Wenli ZHAO ; Xuelian SONG ; Xiaolin ZHENG ; Yingxiao LI ; Yu LI ; Lei ZHANG ; Feifei ZHANG
China Medical Equipment 2025;22(1):90-95
Objective:To explore the applied effectiveness of the Skin and/or tissue,Education,Cooperation,Understanding,Report and Evaluate (SECURE) nursing pathway based on action research method in the prevention process of medical device-related pressure injuries (MDRPI) of patients in the Intensive Care Unit (ICU). Methods:The SECURE nursing pathway based on action research method included the establishment of a skin care team to identify problems,and the formulation of conducting intervention plan,and the development of targeting nursing interventions to prevent the occurrence of MDRPI. A total of 84 patients hospitalized in the ICU of Hebei General Hospital from March 2022 to March 2023 were selected,and they were randomly divided into a control group and an observation group,with 42 patients in each group. The control group implemented routine method to prevent MDRPI during ICU treatment,while the observation group implemented SECURE nursing pathway based on action research method to conduct prevention. The MDRPI incidence,the quality scores of ICU nursing,the scores of the Short Form Health Survey-36 (SF-36) of patients,the assessment of the improvement of MDRPI patients,and the satisfaction of patients for nursing care were compared between the two groups. Results:The MDRPI incidence during ICU treatment in the observation group was 4.76% (2/42),which was significantly lower than that in the control group,with a statistically significant difference (x2=11.052,P<0.05). The average scores for device usage,prevention assessment,positioning management and preventive nursing after nursing intervention in the observation group were respectively (88.45±2.05),(89.36±2.11),(89.25±2.15) and (91.45±2.25),all of which were significantly higher than those in the control group,with statistically significant differences (t=11.425,12.052,10.052,13.478,P<0.05). After nursing intervention,the average scores for physical function,social function,psychological function and material life as the SF-36 scale in the observation group were (85.47±2.05),(86.48±2.05),(88.46±2.15) and (90.25±2.44),respectively,which were respectively higher than those in the control group,with statistically significant differences (t=12.414,11.045,10.252,10.478,P<0.05). The occurrence time,improvement time of wound and ICU treatment time of presenting MDRPI patients in the observation group were respectively (4.05±0.54) days,(3.45±0.15) days,and (8.12±2.14) days. Compared to the control group,the occurrence time of the observation group was longer,while both the improvement time of wound and ICU treatment time of the observation group were shorter,with statistically significant differences (t=8.485,10.012,13.001,P<0.05). The satisfaction degree of nursing care of patients in the observation group was 95.24% (40/42),which was significantly higher than that in the control group (x2=12.054,P<0.05). Conclusion:The SECURE nursing pathway based on action research method,which prevents MDRPI of ICU patients,can reduce the MDRPI incidence rate of ICU patients,and enhance the work quality of nursing care for MDRPI. It is helpful to the recovery of ICU patients,which can also shorten the treatment time of ICU patients.
4.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.
5.An excerpt of American College of Gastroenterology guidelines:Management of acute pancreatitis(2024)
Yingxiao SONG ; Huiyun ZHU ; Yiqi DU
Journal of Clinical Hepatology 2024;40(10):1973-1975
The American College Gastroenterology(ACG)recently released the 2024 edition of Guidelines for the management of acute pancreatitis.The guidelines first discuss the diagnosis,etiology,severity,and early management of acute pancreatitis,as well as the management of complications,especially pancreatic necrosis,and then the guidelines propose the clinical decisions such as antibiotics,nutrition,endoscopy,radiology,and surgical intervention.This article makes an excerpt of the key concepts and recommendations in the guidelines.
6.Efficacy of vericiguat combined with recombinant human brain natriuretic peptide in the treatment of heart failure patients with low ejection fraction
Lingfang HUANG ; Yingxiao DA ; Song ZHOU ; Ningning DI
Journal of Clinical Medicine in Practice 2024;28(22):67-70
Objective To investigate the therapeutic effects of vericiguat in combination with recombinant human brain natriuretic peptide in patients with heart failure with reduced ejection fraction (HFrEF). Methods Seventy patients with HFrEF were enrolled and randomly divided into study group (
7.Efficacy of omeprazole and sodium bicarbonate suspension in the treatment of peptic ulcer: a multicenter clinical trial
Tun SU ; Yingxiao SONG ; Xue PAN ; Yang ZHANG ; Zhen SHEN ; Jianping LU ; Yiqi DU ; Zhaoshen LI
Chinese Journal of Digestion 2022;42(1):6-13
Objective:To evaluate the efficacy and safety of omeprazole and sodium bicarbonate suspension in the treatment of peptic ulcer.Methods:This present study was a multicenter, randomized, double-blind, double-dummy, positive drug parallel controlled phase Ⅱ clinical trial. According to different indications, the trial was divided into gastric ulcer (GU) and duodenal ulcer (DU) studies. Patients were stratified-block randomly divided with a 1∶1 ratio into experimental group and control group. The patients in the experimental group were administrated with omeprazole and sodium bicarbonate suspension omeprazole (20 mg for DU or 40 mg for GU, and 1 680 mg sodium bicarbonate) once a day. The patients in the control group received omeprazole magnesium enteric-coated tablet20 mg for DU or 40 mg for GU once a day. The treatment period was 4 weeks for DU and 8 weeks for GU. The main efficacy indicator was ulcer healing rate under endoscopy. The time of pain disappearance and the total effective rate of clinical symptom relief were used as the secondary efficacy indicators, and the incidence of adverse reactions was used as the safety indicator. The data set included full analysis set (FAS), per-protocol set (PPS) and safety set (SS). Independent sample t test, Wilcoxon rank sum test, chi square test, Fisher exact test method and non-inferiority test were used for statistical analysis. Results:Two hundred and seventy two DU patients and 237 GU patients were included in the FAS, 247 DU patients and 201 GU patients were included in the PPS, and 272 DU patients and 235 GU patients were included in the SS. The results of FAS analysis showed that after 4 weeks treatment, the healing rate of DU under endoscopy in the experimental group was 91.91% (125/136) and that in the control group was 94.85% (129/136), and the difference was not statistically significant ( P>0.05). After 8 weeks treatment the healing rate of GU under endoscopy in the experimental group was 86.44% (102/118) and that in the control group was 87.39% (104/119), and the difference was not statistically significant ( P>0.05). The results of non-inferiority analysis showed the lower limit of 95% confidence interval of difference in effective rate between the two groups was over -10% (-8.84% for DU and -9.54% for GU), which indicated that the effective rate of experimental group was not inferior to that of the control group. The results of PPS analysis were consistent with the results of FAS. The results of FAS analysis showed the median time of abdominal pain disappearance of DU patients in the experimental group and the control group was both 6 d, and the difference was not statistically significant ( P>0.05). The median time of abdominal pain disappearance of GU patients in the experimental group and the control group was both 8 d, and the difference was not statistically significant ( P>0.05). After 4 weeks of treatment, the total effective rates of clinical symptom relief of DU of the trial group and the control group were 95.59% (130/136) and 97.79% (133/136), respectively, and the difference was not statistically significant ( P>0.05). After 8 weeks of treatment, the total effective rates of clinical symptom relief of GU of the experimental group and the control group were 95.76% (113/118) and 93.28% (111/119), respectively, and the difference was not statistically significant ( P>0.05). The results of SS analysis showed that the incidence of adverse reactions of DU patients in the trial group and the control group was 5.15% (7/136) and 2.21% (3/136), respectively, and the difference was not statistically significant ( P>0.05). The incidence of adverse reactions of GU patients in the experimental group and the control group was 12.71% (15/118) and 6.84% (8/117), respectively, and the difference was not statistically significant ( P>0.05). Conclusions:Omeprazole and sodium bicarbonate suspension is not inferior to omeprazole magnesium enteric-coated tablet in healing efficacy under endoscopy in peptic ulcer, and has a good safety.
8.Clinical value of acute gastrointestinal injury score in assessing the severity and prognosis of acute pancreatitis
Dongjie FAN ; Yanbo ZENG ; Yuanhang DONG ; Pingping ZHANG ; Yingxiao SONG ; Zhaoshen LI ; Yiqi DU
Chinese Journal of Pancreatology 2021;21(2):89-93
Objective:To investigate the predictive value of acute gastrointestinal injury (AGI) score for the severity of acute pancreatitis (AP), infectious pancreatic necrosis and patients′ death.Methods:Clinical data of 719 patients with AP were collected from the AP database of the National Clinical Research Center for Digestive System Diseases from January 2016 to June 2018. According to the severity of the disease, they were divided into MAP group (506 cases), MSAP group (112 cases) and SAP group (101 cases). AGI, APACHEⅡ, MCTSI and BISAP scores were calcululated in the three groups. Receiver operating characteristic curve (ROC) was drawn and the area under the curve (AUC) was calculated. The predictive value of the above four scoring systems for the hospitalization days, disease severity, infectious pancreatic necrosis and death was analyzed, respectively.Results:There were no cases of infectious pancreatic necrosis or death in the MAP group, but there were 9 cases of infectious pancreatic necrosis and 2 deaths in the MSAP group and 19 cases of infectious pancreatic necrosis and 8 deaths in the SAP group. There was a strong correlation between AGI score and AP patients′ hospitalization days ( r=0.619). AUC of AGI, APACHEⅡ, MCTSI and BISAP score in predicting the AP patients′ severity (MSAP+ SAP) was 0.967 (95% CI 0.951-0.982), 0.769(95% CI 0.720-0.899), 0.842(95% CI 0.809-0.875), 0.862 (95% CI0.832-0.893). AUC for forecasting infectious pancreatic necrosis was 0.803, 0.677, 0.692, 0.724, and the 95% CI was 0.724-0.882, 0.573-0.781, 0.582-0.636, 0.801-0.812. AUC for predicting death in patients with AP were 0.915, 0.597, 0.659, 0.812, and the 95% CI were 0.843-0.986, 0.444-0.751, 0.498-0.698 and 0.882-0.926. AGI score had the highest predictive value, followed by BISAP score, and the correlation between these two scores was the closest. The predictive value of AGI combined with BISAP score for infectious pancreatic necrosis and patient death (AUC were 0.837, 0.942, 95% CI were 0.770-0.903, 0.897-0.987) was better than that of AGI and BISAP score alone. Conclusions:AGI score combined with BISAP score is more effective in predicting the severity of AP, the occurrence of infectious pancreatic necrosis or patient death.
9.MiR-216a expression in acute pancreatitis patients with lung injury and its effect on the permeability of endothelial cell
Huiyun ZHU ; Yingxiao SONG ; Xiangyu KONG ; Yiqi DU
Chinese Journal of Pancreatology 2020;20(4):250-253
Objective:To explore the expression of miR-216a in patients with acute pancreatitis (AP) associated with acute lung injury (ALI) and its influence on endothelial cells permeability.Methods:40 AP patients admitted in Department of Gastroenterology of the First Affiliated Hospital of Navy Medical University from December 2015 to March 2016 were collected and were classified into AP with ALI (AP-ALI group, n=13) and AP without ALI (AP group, n=27) according to the presence or absence of ALI. 8 normal volunteers were enrolled in the control group. Blood samples were collected and the plasma samples were separated. Plasma RNA was extracted. miR-216a level in plasma was detected by RT-PCR. Plasma exosomes were extracted by exosome extraction kit and identified by the electron microscopy. Exosome RNA was extracted. miR-216a level in exosome was detected by RT-PCR. Plasma exosomes of AP-ALI patients were co-cultured with human umbilical vein endothelial cells (HUVEC, AP-ALI-HUVEC group) and anti-miR-216a transfected HUVECs (AP-ALI-anti-miR-216a HUVEC group) for 24 hours, respectively, and untreated HUVECs served as control group. Trans-endothelium electrical resistance (TEER) was measured by Millicell Ers-2 epithelial volt-ohmmeter to evaluate the cell permeability. Results:RT-PCR results showed that the expression level of plasma miR-216a in AP-ALI group (14.45±1.64) was significantly higher than that in AP group (11.08±1.6) and the control group (5.37±1.54) ( P<0.01). Under electron microscope, plasma exosomes were goblet like vacuoles, with the size of about 50-90 nm. The plasma exosomal miR-216a level in the AP-ALI group (14.03±1.58) was significantly higher than that in the AP group (10.86±1.31) and the control group (5.01±0.79), and the difference was statistically significant ( P<0.01). The resistance value of HUVEC in the control group was referred as 1, and the resistance ratio of HUVEC in AP-ALI-HUVEC group was 0.74±0.04, which was significantly lower than that of HUVEC in AP-ALI-anti-miR-216a HUVEC group (1.02±0.08), the difference was statistically significant ( P<0.01). Conclusions:miR-216a was highly expressed in plasma exosomes of AP patients with ALI. miR-216a can increase endothelial cell permeability, which may be associated with ALI during AP.
10.Two cases of aldosterone-and cortisol-producing adenoma
Jianyu TAN ; Qingfeng CHENG ; Qifu LI ; Yingxiao ZHANG ; Qin YANG ; Zhipeng DU ; Shumin YANG ; Wenwen HE ; Ying SONG ; Jinbo HU ; Yi YANG ; Yao ZHANG ; Yunfeng HE ; Xin GOU
Chinese Journal of Endocrine Surgery 2019;13(4):346-348
More and more cases of aldosterone-and cortisol-producing adenoma (A/CPA) have been reported in recent years.In order to further understand the clinical characteristics of patients with A/CPA,we report 2 cases of A/CPA treated in our hospital,and analyzes them in combination with domestic reports.We recommend that clinicians routinely perform Low Dose Dexamethasone Suppression Test on every primary aldosteronism patient prior to adrenal vein sampling (AVS) or adrenal adenoma surgery to rule out the possibility of Cushing's syndrome so as to avoid the wrong judgment of AVS results and avoid adrenal hypofunction or adrenal crisis after operation.


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