1.Efficacy of sacubitril valsartan versus enalapril on elderly patients with chronic heart failure with reduced ejection fraction
Qingqing ZHANG ; Jiao WANG ; Yingxiao DA ; Xin LI
Chinese Journal of Geriatric Heart Brain and Vessel Diseases 2025;27(5):606-610
Objective To explore the difference in clinical efficacy of sacubitril valsartan(SV)and enalapril in the treatment of elderly patients with chronic heart failure with reduced ejection frac-tion(HFrEF).Methods A total of 126 elderly patients with chronic HFrEF admitted in our de-partment between January 2020 and January 2023 were prospectively recruited and randomly di-vided into control group(enalapril treatment,63 cases)and observation group(SV treatment,63 cases).After 3 months of treatment,the improvement rate of NYHA cardiac function grade,and changes in cardiac function indicators[6-minute walking distance(6MWD),NT-proBNP,LVEDD,LVEF],and echocardiographic indicators[left ventricular myocardial work(Tei)index,stroke volume,cardiac output(CO)]before and after treatment,adverse reactions during treat-ment and prognosis were compared between the two groups.Results The improvement rate of NYHA grade was significantly higher in the observation group than the control group(80.95%vs 65.08%,P<0.05).The results of 6MWD,LVEF,stroke volume and CO were obviously higher in both groups after treatment than before treatment(P<0.05).The results of 6MWD,LVEF,stroke volume and CO were notably higher in the observation group than the control group(P<0.01).The SBP,DBP,NT-proBNP,heart rate,LVEDD and LV Tei index were decreased after treatment in both groups,and those in the observation group were even lower than those in the control group(P<0.05,P<0.01).As of April 2024,the readmission rates due to HF was re-markably lower in the observation group than the control group(7.94%vs 20.63%,P<0.05),but no statistical difference was seen in the mortality or the incidence of adverse reactions be-tween them(P>0.05).Conclusion SV is superior to enalapril in improving the efficacy,cardiac function and cardiac load of elderly HFrEF patients,with advantages of reducing the incidence of readmission but not increasing adverse reactions.
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.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.
5.Efficacy of sacubitril valsartan versus enalapril on elderly patients with chronic heart failure with reduced ejection fraction
Qingqing ZHANG ; Jiao WANG ; Yingxiao DA ; Xin LI
Chinese Journal of Geriatric Heart Brain and Vessel Diseases 2025;27(5):606-610
Objective To explore the difference in clinical efficacy of sacubitril valsartan(SV)and enalapril in the treatment of elderly patients with chronic heart failure with reduced ejection frac-tion(HFrEF).Methods A total of 126 elderly patients with chronic HFrEF admitted in our de-partment between January 2020 and January 2023 were prospectively recruited and randomly di-vided into control group(enalapril treatment,63 cases)and observation group(SV treatment,63 cases).After 3 months of treatment,the improvement rate of NYHA cardiac function grade,and changes in cardiac function indicators[6-minute walking distance(6MWD),NT-proBNP,LVEDD,LVEF],and echocardiographic indicators[left ventricular myocardial work(Tei)index,stroke volume,cardiac output(CO)]before and after treatment,adverse reactions during treat-ment and prognosis were compared between the two groups.Results The improvement rate of NYHA grade was significantly higher in the observation group than the control group(80.95%vs 65.08%,P<0.05).The results of 6MWD,LVEF,stroke volume and CO were obviously higher in both groups after treatment than before treatment(P<0.05).The results of 6MWD,LVEF,stroke volume and CO were notably higher in the observation group than the control group(P<0.01).The SBP,DBP,NT-proBNP,heart rate,LVEDD and LV Tei index were decreased after treatment in both groups,and those in the observation group were even lower than those in the control group(P<0.05,P<0.01).As of April 2024,the readmission rates due to HF was re-markably lower in the observation group than the control group(7.94%vs 20.63%,P<0.05),but no statistical difference was seen in the mortality or the incidence of adverse reactions be-tween them(P>0.05).Conclusion SV is superior to enalapril in improving the efficacy,cardiac function and cardiac load of elderly HFrEF patients,with advantages of reducing the incidence of readmission but not increasing adverse reactions.
6.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.
7.Research advances on the regulation of microglia polarization by autophagy in ischemic stroke
Fangming WANG ; Wenxuan SHANG ; Jingwen ZHANG ; Yingxiao JI ; Litao LI
The Journal of Practical Medicine 2024;40(9):1324-1330
Ischemic stroke is feature by high incidence,high disability and high mortality.Inflammation plays an important role in the occurrence and development of ischemic stroke.Activated microglia exhibit two different phenotypes of proinflammatory(M1)and anti-inflammatory(M2),and regulating the transformation of microglia from M1 to M2 is the key to clinical benefit.Recent studies have shown that autophagy plays a key role in regulating phenotypic transformation of microglia.How to exert the regulatory role of autophagy and promote the transformation of microglia into M2 type has become a hotspot of clinical research in reducing secondary brain injury after stroke.This paper reviews the research progress of autophagy regulation of microglia polarization in ischemic stroke,aim-ing to provide a reference for further clinical and basic research in this field.
8.Research on the application of evaluation and warning system based on Shewhart control chart in medical device related pressure injury
Litian LIU ; Feifei ZHANG ; Zheng YUAN ; Xiaolin ZHENG ; Ran WANG ; Lei ZHANG ; Yingxiao LI ; Xiaojiao WU
China Medical Equipment 2024;21(1):205-208
Objective:To explore the effectiveness of the Shewhart control chart-based assessment and early warning system in prevention of medical device-related pressure injury(MDRPI).Methods:152 critically ill patients admitted to Hebei Central Hospital from January 2020 to December 2021 were selected and divided into a control group and an observation group based on different methods of assessing MDRPI risk,with 76 cases in each group.The control group adopted the Braden scale to assess the risk of MDRPI.The observation group adopted a safety early warning system based on Shewhart control charts to assess the risk of MDRPI in patients.Nursing measures were undertaken according to MDRPI risk grade in both groups.The occurrence of adverse events of MDRPI,nursing safety quality and nursing comprehensive quality were compared between the two groups.Results:The incidence rate of head,neck and face adverse events of MDRPI and the total incidence of adverse events of MDRPI of the patients in the observation group were lower than those in the control group(x2=4.802,5.758,P<0.05).The safety quality and comprehensive quality of nursing of 20 nurses in the observation group were higher than those in the control group(t=6.654,7.172,P<0.05).Conclusion:The application of assessment and early warning system based on Shewhart control chart in clinical nursing management can effectively reduce the incidence of MDRPI adverse events and improve the quality of nursing safety and comprehensive nursing.
9.Predictive value of anthropometric indicators for cardiovascular risk in metabolic syndrome
Qiyun LU ; Anxiang LI ; Benjian CHEN ; Qingshun LIANG ; Guanjie FAN ; Yiming TAO ; Ronghua ZHANG ; Fangfang DAI ; Xiaoling HU ; Yunwei LIU ; Yingxiao HE ; Ying ZHU ; Zhenjie LIU
Chinese Journal of Endocrinology and Metabolism 2023;39(1):26-33
Objective:To evaluate the predictive value of anthropometric indicators in predicting cardiovascular risk in the population with metabolic syndrome(MS).Methods:A cross-sectional study was used to analyze the correlation between anthropometric measures and cardiovascular risk in subjects with MS. Cardiometabolic risk was assessed with cardiometabolic risk index(CMRI). Receiver operating characteristic(ROC) curve analysis was used to assess the predictive power of anthropometric measures for cardiometabolic risk.Results:(1) The anthropometric measures [body mass index(BMI), waist-hip ratio(WHR), waist-to-height ratio(WtHR), body fat percentage(BFP), visceral fat index(VFI), conicity index(CI), a body shape index(ABSI), body roundness index(BRI), abdominal volume index(AVI)] in the MS group were significantly higher than those in the non-MS group( P<0.05). Moreover, there were significant differences in CMRI score and vascular risk between the two groups( P<0.05). (2) Logistic regression analysis showed that the cardiovascular risk was increased with the increases of BMI, VFI, WHR, WtHR, CI, BRI, and AVI after adjusting for confounding factors in the overall population, the non-MS population, and the MS population( P<0.05). (3) In the ROC analysis, the AUC values of BMI, VFI, and AVI were 0.767, 0.734, and 0.770 in the overall population; 0.844, 0.816, and 0.795 in the non-MS population; 0.701, 0.666, and 0.702 in the MS population, respectively. For the overall population and non-MS population, the optimal cut points of BMI to diagnose high cardiovascular risk were 26.04 kg/m 2 and 24.36 kg/m 2; the optimal cut points of VFI were 10.25 and 9.75; the optimal cut points of AVI were 17.3 cm 2 and 15.53 cm 2, respectively. In the MS population, the optimal cut point as a predictor of high cardiovascular risk in young and middle-aged men with MS was 27.63 kg/m 2, and the optimal cut point of AVI in women was 18.08 cm 2. Conclusion:BMI, VFI, and AVI can be used as predictors of cardiovascular risk in the general population. BMI can be used as a predicator of high cardiovascular risk in young and middle-age men with MS. AVI can be used as a predicator of high cardiovascular risk in women with MS.
10.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.

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