1.The impact of coronary artery calcification on the long-term outcomes after chronic total occlusion percutaneous coronary intervention
Lihua XIE ; Changdong GUAN ; Zhongwei SUN ; Jie QIAN ; Fan WU ; Jingang CUI ; Yunfei HUANG ; Jue CHEN ; Fenghuan HU ; Jie ZHAO ; Yuejin YANG ; Shubin QIAO ; Kefei DOU ; Weixian YANG ; Yongjian WU ; Lei SONG
Chinese Journal of Cardiology 2025;53(12):1375-1382
Objective:Investigate the impact of calcification on the long-term outcomes of patients with coronary chronic total occlusion (CTO) after percutaneous coronary intervention (PCI).Methods:A retrospective cohort study was conducted. Patients who underwent PCI and had at least one CTO lesion at Fuwai Hospital between January 2010 and December 2013 were consecutively enrolled. Calcification was evaluated by coronary angiography, and patients were divided into two groups: moderate/severe calcification group and non/mild calcification group. Clinical follow-up was completed up to 5 years. Incidence of PCI-related complications and immediate procedural outcomes were compared between two groups, and the primary endpoint was the target lesion failure (TLF) at 5 years after PCI. Clinical follow-up endpoint events were analyzed using Kaplan-Meier survival analysis with log-rank test, and Cox multivariate regression model was used to evaluate the relationship between calcification and TLF.Results:The study included 2 659 CTO patients with an age of (57.2±10.5) years, of whom 442 (16.6%) were female, and among whom 13.5% (360/2 659) had moderate/severe calcification. Compared with the non/mild calcification group, the moderate/severe calcification group had a higher incidence of PCI-related complications (43.2% (156/361) vs. 32.5% (772/2 374), P<0.001) and procedural failure (34.3% (124/361) vs. 24.3% (577/2 374), P<0.001). Additionally, the moderate/severe calcification group showed a higher risk of the primary endpoint event (TLF) during the 5-year follow-up (19.8% vs. 15.3%, log-rank P=0.028). Higher incidence of cardiac death was observed in moderate/severe calcification group (5.7% vs. 2.7%, log-rank P=0.003). Cox multivariate regression analysis revealed that moderate/severe calcified plaques remained an independent risk factor for 5-year TLF after CTO-PCI ( HR=1.34, 95% CI: 1.01-1.79, P=0.043). Conclusion:Compared with CTO patients with non/mild calcification, those with moderate/severe calcification have higher procedural failure and complication rates, as well as poorer long-term prognosis, mainly due to an increase in cardiac death.
2.Efficacy of a New Intramedullary Fixation System Proximal Femoral Universal Nail in the Treatment of Intertrochanteric Femoral Fractures in Elderly Patients
Yuan CAO ; Jixing FAN ; Zengzhen CUI ; Zhongwei YANG ; Yang LV ; Yun TIAN ; Fang ZHOU
Chinese Journal of Minimally Invasive Surgery 2025;25(6):329-334
Objective To evaluate the efficacy of proximal femoral universal nail(PFUN),a new type of intramedullary fixation system,in the treatment of acute unilateral intertrochanteric femoral fracture in elderly patients.Methods From January 2022 to January 2024,200 patients with acute unilateral femoral intertrochanteric fracture were treated in our department.After closed traction reduction,PFUN was implanted with small incisions.Unified rehabilitation plan was adopted after surgery.The functional evaluation was performed by using the Harris hip score system at the last follow-up.Results The operation time was 25-182 min(median,63.0 min).The intraoperative blood loss was 10-750 ml(median,50.0 ml).Intraoperative blood transfusion(suspension of red blood cells)was required in 40 cases(20%).The postoperative hospital stay was 1-15 d(mean,4.0±1.9 d).The postoperative femoral neck-shaft angle was 116.7°-140.1°(mean,132.4°±5.5°).The quality of fracture reduction on the first day after surgery showed 140 cases as excellent,54 cases acceptable,and 6 cases poor.Complications occurred in 13 cases,including superficial wound infection in 2 cases,who were cured by regular wound dressing change and antibiotic treatment,lower extremity deep vein thrombosis in 8 cases,who were given low molecular weight heparin anticoagulation treatment until improvement,pneumonia in 2 cases and urinary tract infection in 1 case,who were cured or improved after specialist treatment.At one month after surgery,the hip joint X-ray showed blurred fracture lines,callus formation at the fracture site,and no internal fixation failure.There was no internal fixation failure within 3 months after surgery.At six months after surgery,all fractures achieved healing without any failure of internal fixation.All the 200 cases were followed up for 12-29 months(mean,16.1±2.7 months).One case experienced internal fixation failure,and underwent head and neck screw resection,internal fixation removal and hip replacement.At the last follow-up,the postoperative recovery was satisfactory.The Harris score of hip joint was 70-94 points(mean,88.8±2.8 points),including 103 cases as excellent,92 cases good,and 5 cases fair,with an excellent and good rate of 97.5%(195/200).Conclusion PFUN is effective in the treatment of intertrochanteric femoral fractures in elderly patients,with reliable fixation,rapid postoperative recovery,and low failure rate of internal fixation,especially suitable for unstable cases with internal or external wall fractures.
3.Efficacy of a New Intramedullary Fixation System Proximal Femoral Universal Nail in the Treatment of Intertrochanteric Femoral Fractures in Elderly Patients
Yuan CAO ; Jixing FAN ; Zengzhen CUI ; Zhongwei YANG ; Yang LV ; Yun TIAN ; Fang ZHOU
Chinese Journal of Minimally Invasive Surgery 2025;25(6):329-334
Objective To evaluate the efficacy of proximal femoral universal nail(PFUN),a new type of intramedullary fixation system,in the treatment of acute unilateral intertrochanteric femoral fracture in elderly patients.Methods From January 2022 to January 2024,200 patients with acute unilateral femoral intertrochanteric fracture were treated in our department.After closed traction reduction,PFUN was implanted with small incisions.Unified rehabilitation plan was adopted after surgery.The functional evaluation was performed by using the Harris hip score system at the last follow-up.Results The operation time was 25-182 min(median,63.0 min).The intraoperative blood loss was 10-750 ml(median,50.0 ml).Intraoperative blood transfusion(suspension of red blood cells)was required in 40 cases(20%).The postoperative hospital stay was 1-15 d(mean,4.0±1.9 d).The postoperative femoral neck-shaft angle was 116.7°-140.1°(mean,132.4°±5.5°).The quality of fracture reduction on the first day after surgery showed 140 cases as excellent,54 cases acceptable,and 6 cases poor.Complications occurred in 13 cases,including superficial wound infection in 2 cases,who were cured by regular wound dressing change and antibiotic treatment,lower extremity deep vein thrombosis in 8 cases,who were given low molecular weight heparin anticoagulation treatment until improvement,pneumonia in 2 cases and urinary tract infection in 1 case,who were cured or improved after specialist treatment.At one month after surgery,the hip joint X-ray showed blurred fracture lines,callus formation at the fracture site,and no internal fixation failure.There was no internal fixation failure within 3 months after surgery.At six months after surgery,all fractures achieved healing without any failure of internal fixation.All the 200 cases were followed up for 12-29 months(mean,16.1±2.7 months).One case experienced internal fixation failure,and underwent head and neck screw resection,internal fixation removal and hip replacement.At the last follow-up,the postoperative recovery was satisfactory.The Harris score of hip joint was 70-94 points(mean,88.8±2.8 points),including 103 cases as excellent,92 cases good,and 5 cases fair,with an excellent and good rate of 97.5%(195/200).Conclusion PFUN is effective in the treatment of intertrochanteric femoral fractures in elderly patients,with reliable fixation,rapid postoperative recovery,and low failure rate of internal fixation,especially suitable for unstable cases with internal or external wall fractures.
4.The impact of coronary artery calcification on the long-term outcomes after chronic total occlusion percutaneous coronary intervention
Lihua XIE ; Changdong GUAN ; Zhongwei SUN ; Jie QIAN ; Fan WU ; Jingang CUI ; Yunfei HUANG ; Jue CHEN ; Fenghuan HU ; Jie ZHAO ; Yuejin YANG ; Shubin QIAO ; Kefei DOU ; Weixian YANG ; Yongjian WU ; Lei SONG
Chinese Journal of Cardiology 2025;53(12):1375-1382
Objective:Investigate the impact of calcification on the long-term outcomes of patients with coronary chronic total occlusion (CTO) after percutaneous coronary intervention (PCI).Methods:A retrospective cohort study was conducted. Patients who underwent PCI and had at least one CTO lesion at Fuwai Hospital between January 2010 and December 2013 were consecutively enrolled. Calcification was evaluated by coronary angiography, and patients were divided into two groups: moderate/severe calcification group and non/mild calcification group. Clinical follow-up was completed up to 5 years. Incidence of PCI-related complications and immediate procedural outcomes were compared between two groups, and the primary endpoint was the target lesion failure (TLF) at 5 years after PCI. Clinical follow-up endpoint events were analyzed using Kaplan-Meier survival analysis with log-rank test, and Cox multivariate regression model was used to evaluate the relationship between calcification and TLF.Results:The study included 2 659 CTO patients with an age of (57.2±10.5) years, of whom 442 (16.6%) were female, and among whom 13.5% (360/2 659) had moderate/severe calcification. Compared with the non/mild calcification group, the moderate/severe calcification group had a higher incidence of PCI-related complications (43.2% (156/361) vs. 32.5% (772/2 374), P<0.001) and procedural failure (34.3% (124/361) vs. 24.3% (577/2 374), P<0.001). Additionally, the moderate/severe calcification group showed a higher risk of the primary endpoint event (TLF) during the 5-year follow-up (19.8% vs. 15.3%, log-rank P=0.028). Higher incidence of cardiac death was observed in moderate/severe calcification group (5.7% vs. 2.7%, log-rank P=0.003). Cox multivariate regression analysis revealed that moderate/severe calcified plaques remained an independent risk factor for 5-year TLF after CTO-PCI ( HR=1.34, 95% CI: 1.01-1.79, P=0.043). Conclusion:Compared with CTO patients with non/mild calcification, those with moderate/severe calcification have higher procedural failure and complication rates, as well as poorer long-term prognosis, mainly due to an increase in cardiac death.
5.Results of annual professional proficiency testing for standardized residency training and related influencing factors
Yitong GONG ; Liqin ZOU ; Ping ZHAO ; Zhongwei LIU ; Qiuping YAO ; Fan FAN ; Qian CHEN
Chinese Journal of Medical Education Research 2024;23(4):572-576
Objective:To analyze the results of the practice test and formal test of the annual professional proficiency test for residents in 2022, to investigate related influencing factors and the effectiveness of the practice test, and to propose the measures for improving the results of the annual professional proficiency test.Methods:The scores of the annual professional proficiency test were analyzed for 202 residents who participated in the test in 2022, and the data on sex, education background, type of personnel, whether they passed the medical licensing examination, and practice test scores were analyzed to investigate related influencing factors. SPSS 23.0 and GraphPad Prism 8 were used for the chi-square test, the t-test, the one-way of variance, and the Fisher's exact test. A multiple linear regression analysis was used to identify influencing factors, and a Pearson correlation analysis was also performed. Results:The scores of the annual professional proficiency test for 202 residents were normally distributed with the highest number of the residents with a score of 90-99 points and the lowest number of the residents with a score of <70 points. The residents who passed the medical licensing examination had a significantly higher score of the annual professional proficiency test than those who failed the examination ( t=2.87, P=0.005), and the residents who passed the three practice tests had a significantly higher score of the annual professional proficiency test than those who failed the practice tests ( P<0.05). The score of the second practice test, the score of the third practice test, and the passing of medical licensing examination were independent influencing factors for the score of annual professional proficiency test ( R2=0.236, R2=0.201, F=6.60, P<0.05). The correlation analysis showed that the scores of the three practice tests were positively correlated with the final score ( r=0.189, 0.373, and 0.311, P<0.05). Conclusions:Improving the passing rate of medical licensing examination and strengthening pre-examination practice tests can help to improve the score of annual professional proficiency test. At the same time, it is necessary to improve the quality of training through the measures such as strengthening the homogenization management of different types of students, improving the attention and enthusiasm of all levels, and accelerating the construction of question banks.
6.Application of post competency-oriented "TECK" teaching model in clinical pathology internship teaching
Wei DOU ; Dongxu WANG ; Zhongwei AI ; Fan YANG ; Yonghong HUANG ; Dandan CUI ; Haiying DONG
Chinese Journal of Medical Education Research 2024;23(10):1384-1389
Objective:To investigate the effects of the "TECK" (theoretical class, experimental course, case discussion, and knowledge reinforcement) teaching model oriented by post competency in clinical pathology internship teaching.Methods:The intern students from 2015 to 2019 in the pathology direction of clinical medicine in the School of Pathology, Qiqihar Medical College, who were enrolled in the internship from 2019 to 2023, were selected as the research objects.We enrolled 32 medical students from grades 2017, 2018, and 2019 (research group) and 24 medical students from grades 2015 and 2016 (control group) who would participate in pathology internships. The control group adopted the traditional internship mode, while the research group adopted the competency-oriented "TECK" teaching mode. After the internship, the two groups were compared for internship assessment score and surveyed for post competency. With the use of SPSS 18.0 statistical software. Continuous data were presented as (mean±standard deviation) and t-test was used for comparison between groups. Count data were expressed in the number of cases, and chi-square test was used for comparison between groups.The significance level α was 0.05. Results:The research group showed significantly higher scores of skill assessment (82.81±4.20 vs. 79.58±5.09) and pathological diagnosis assessment (80.28±4.23 vs. 76.21±4.58) than the control group (both P<0.05), with no significant difference in the score of theoretical knowledge ( P>0.05). In terms of post competency, the research group was superior to the control group in clinical skills and medical care ability (12.38±0.94 vs. 11.35±0.76), disease prevention and health promotion ability (6.28±0.92 vs. 4.48±0.93), interpersonal communication and information management ability (19.81±1.09 vs. 17.00±1.28), and teamwork and scientific research ability (11.44±1.27 vs. 9.25±0.87; all P<0.05). There were no significant differences between the two groups in core values and professional literacy and medical knowledge and lifelong learning (both P>0.05). Conclusions:In undergraduate internships, the competency-oriented "TECK"teaching mode can significantly improve students' clinical operation and pathological diagnosis ability, and effectively cultivate their abilities of clinical skills and medical care, disease prevention and health promotion, interpersonal communication and information management, teamwork and scientific research.
7.Efficacy and safety of anaprazole in the treatment of reflux esophagitis: a multicenter, randomized, double-blinded phase Ⅱ clinical study
Huiyun ZHU ; Huizhen FAN ; Zhongwei PAN ; Caibin HUANG ; Hao WU ; Jigang RUAN ; Nonghua LYU ; Zhaoshen LI ; Yiqi DU
Chinese Journal of Digestion 2024;44(9):590-597
Objective:To evaluate the efficacy and safety of anaprazole (40 mg and 60 mg) and compared with rabeprazole (20 mg) in the treatment of reflux esophagitis (RE).Methods:This multicenter, randomized, double-blinded, positive drug parallel controlled study was led by the First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital) and a total of 24 clinical trial institutions nationwide including the First Affiliated Hospital of Nanchang University, Yichun People′s Hospital, Meihekou Central Hospital, the First Affiliated Hospital of Gannan Medical University, and Jinhua Central Hospital, participated in this research. A total of 156 patients with RE (Los Angeles grade A to D) were enrolled and randomly divided into 3 groups, anaprazole 40 mg group, anaprazole 60 mg group and rabeprazole 20 mg group, using a random number table in a ratio of 1∶1∶1. Patients in the above 3 groups were treated with the appropriate trial medication once per day for 4 or 8 weeks. The endoscopic healing rates were evaluated by Blinded Independent Central Review (BICR) and investigators. In addition, the improvement in the severity of individual symptoms (daytime reflux, daytime heartburn, nighttime reflux, nighttime heartburn) and medication safety were also evaluated. The endoscopic healing rates and 95% confidence intervals (95% CI) at week-8 and -4 were calculated by groups, as well as the difference in the healing rates and their 95% CI among groups. The chi-square test was used for statistical analysis. Results:A total of 153 subjects were included in the full analysis set (FAS), 144 in the per-protocol analysis set (PPS) and 151 in the safety set (SS). In the FAS, after 8 weeks of treatment, the endoscopic healing rates of anaprazole 40 mg group, anaprazde 60 mg group and raberazole 20 mg group blindly assessed by BICR were 86.0% (43/50), 86.5% (45/52) and 86.3% (44/51), respectively, and the 95% CI were 76.4% to 95.6%, 77.3% to 95.8% and 76.8% to 95.7%, respectively.The endoscopic healing rates of anaprazole 40 mg group, anaprazde 60 mg group and raberazole 20 mg group blindly evaluated by investigators were 88.0% (44/50), 90.4% (47/52) and 86.3% (44/51), respectively, and the 95% CI were 79.0% to 97.0%, 82.4% to 98.4% and 76.8% to 95.7%, respectively. The endoscopic healing rates were similar among groups. In the FAS, the differences in healing rates(95% CI) assessed by BICR and investigators between anaprazole 40 mg, anaprazole 60 mg and rabeprazole 20 mg group were -0.3%(-13.7% to 13.2%), 0.6%(-12.3% to 13.6%), respectively and 1.7%(-11.3% to 14.8%), 3.9%(-8.5% to 16.3%), respectively. The results of the PPS were consistent with those of the FAS. After 8 weeks of treatment, the severity scores of individual symptoms (daytime reflux, daytime heartburn, nighttime reflux, nighttime heartburn) decreased in all groups. The differences between post-treatment and baseline in anaprazole 40 mg group, anaprazole 60 mg group and rabeprazole 20 mg group were -1.54±1.00, -1.91±1.00, -1.51±0.76, -1.45±0.71; -1.30±0.94, -1.59±0.96, -1.33±0.65, -1.42±0.60; and -1.74±0.85, -1.76±0.93, -1.45±0.66, -1.66±0.79, respectively. The incidence of treatment emergent adverse event of anaprazole 40 mg group, anaprazole 60 mg group and rabeprazole 20 mg group were 57.1% (28/49), 48.1% (25/52) and 60.0% (30/50), respectively, and the incidence of treatment related adverse event were 18.4% (9/24), 25.0% (13/52) and 24.0% (12/50), respectively. There were no statistically significant differences in the incidence of treatment emergent adverse event and treatment related adverse event among 3 groups (all P>0.05). Conclusion:The efficacy and safety of anaprazole 40, 60 mg/d, and rabeprazole 20 mg/d in the treatment of RE are comparable.
8.Efficacy and safety of anaprazole in the treatment of reflux esophagitis: a multicenter, randomized, double-blinded phase Ⅱ clinical study
Huiyun ZHU ; Huizhen FAN ; Zhongwei PAN ; Caibin HUANG ; Hao WU ; Jigang RUAN ; Nonghua LYU ; Zhaoshen LI ; Yiqi DU
Chinese Journal of Digestion 2024;44(9):590-597
Objective:To evaluate the efficacy and safety of anaprazole (40 mg and 60 mg) and compared with rabeprazole (20 mg) in the treatment of reflux esophagitis (RE).Methods:This multicenter, randomized, double-blinded, positive drug parallel controlled study was led by the First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital) and a total of 24 clinical trial institutions nationwide including the First Affiliated Hospital of Nanchang University, Yichun People′s Hospital, Meihekou Central Hospital, the First Affiliated Hospital of Gannan Medical University, and Jinhua Central Hospital, participated in this research. A total of 156 patients with RE (Los Angeles grade A to D) were enrolled and randomly divided into 3 groups, anaprazole 40 mg group, anaprazole 60 mg group and rabeprazole 20 mg group, using a random number table in a ratio of 1∶1∶1. Patients in the above 3 groups were treated with the appropriate trial medication once per day for 4 or 8 weeks. The endoscopic healing rates were evaluated by Blinded Independent Central Review (BICR) and investigators. In addition, the improvement in the severity of individual symptoms (daytime reflux, daytime heartburn, nighttime reflux, nighttime heartburn) and medication safety were also evaluated. The endoscopic healing rates and 95% confidence intervals (95% CI) at week-8 and -4 were calculated by groups, as well as the difference in the healing rates and their 95% CI among groups. The chi-square test was used for statistical analysis. Results:A total of 153 subjects were included in the full analysis set (FAS), 144 in the per-protocol analysis set (PPS) and 151 in the safety set (SS). In the FAS, after 8 weeks of treatment, the endoscopic healing rates of anaprazole 40 mg group, anaprazde 60 mg group and raberazole 20 mg group blindly assessed by BICR were 86.0% (43/50), 86.5% (45/52) and 86.3% (44/51), respectively, and the 95% CI were 76.4% to 95.6%, 77.3% to 95.8% and 76.8% to 95.7%, respectively.The endoscopic healing rates of anaprazole 40 mg group, anaprazde 60 mg group and raberazole 20 mg group blindly evaluated by investigators were 88.0% (44/50), 90.4% (47/52) and 86.3% (44/51), respectively, and the 95% CI were 79.0% to 97.0%, 82.4% to 98.4% and 76.8% to 95.7%, respectively. The endoscopic healing rates were similar among groups. In the FAS, the differences in healing rates(95% CI) assessed by BICR and investigators between anaprazole 40 mg, anaprazole 60 mg and rabeprazole 20 mg group were -0.3%(-13.7% to 13.2%), 0.6%(-12.3% to 13.6%), respectively and 1.7%(-11.3% to 14.8%), 3.9%(-8.5% to 16.3%), respectively. The results of the PPS were consistent with those of the FAS. After 8 weeks of treatment, the severity scores of individual symptoms (daytime reflux, daytime heartburn, nighttime reflux, nighttime heartburn) decreased in all groups. The differences between post-treatment and baseline in anaprazole 40 mg group, anaprazole 60 mg group and rabeprazole 20 mg group were -1.54±1.00, -1.91±1.00, -1.51±0.76, -1.45±0.71; -1.30±0.94, -1.59±0.96, -1.33±0.65, -1.42±0.60; and -1.74±0.85, -1.76±0.93, -1.45±0.66, -1.66±0.79, respectively. The incidence of treatment emergent adverse event of anaprazole 40 mg group, anaprazole 60 mg group and rabeprazole 20 mg group were 57.1% (28/49), 48.1% (25/52) and 60.0% (30/50), respectively, and the incidence of treatment related adverse event were 18.4% (9/24), 25.0% (13/52) and 24.0% (12/50), respectively. There were no statistically significant differences in the incidence of treatment emergent adverse event and treatment related adverse event among 3 groups (all P>0.05). Conclusion:The efficacy and safety of anaprazole 40, 60 mg/d, and rabeprazole 20 mg/d in the treatment of RE are comparable.
9.Effect and safety of anaprazole in the treatment of duodenal ulcers: a randomized, rabeprazole-controlled, phase III non-inferiority study
Huiyun ZHU ; Xue PAN ; Li ZHANG ; Hongxin SUN ; Huizhen FAN ; Zhongwei PAN ; Caibin HUANG ; Zhenwang SHI ; Jin DING ; Qi WANG ; Yiqi DU ; Nonghua LYU ; Zhaoshen LI
Chinese Medical Journal 2022;135(24):2941-2949
Background::The pharmacokinetic and clinical behaviors of many proton pump inhibitors (PPIs) in peptic ulcer treatment are altered by CYP2C19 genetic polymorphisms. This non-inferiority study evaluated the efficacy and safety of the novel PPI anaprazole compared with rabeprazole. We also explored the influence of Helicobacter pylori ( H. pylori) infection status and CYP2C19 polymorphism on anaprazole. Methods::In this multicenter, randomized, double-blind, double-dummy, positive-drug parallel-controlled, phase III study, Chinese patients with duodenal ulcers were randomized 1:1 to receive rabeprazole 10 mg + anaprazole placebo or rabeprazole placebo + anaprazole 20 mg once daily for 4 weeks. The primary efficacy endpoint was the 4-week ulcer healing rate assessed by blinded independent review. Secondary endpoints were the proportion of patients with improved overall and individual duodenal ulcer symptoms at 4 weeks. Furthermore, exploratory subgroup analysis of the primary endpoint by H. pylori status and CYP2C19 polymorphism was conducted. Adverse events were monitored for safety. Non-inferiority analysis was conducted for the primary endpoint. Results::The study enrolled 448 patients (anaprazole, n = 225; rabeprazole, n = 223). The 4-week healing rates were 90.9% and 93.7% for anaprazole and rabeprazole, respectively (difference, -2.8% [95% confidence interval, -7.7%, 2.2%]), demonstrating non-inferiority of anaprazole to rabeprazole. Overall duodenal ulcer symptoms improved in 90.9% and 92.5% of patients, respectively. Improvement rates of individual symptoms were similar between the groups. Healing rates did not significantly differ by H. pylori status or CYP2C19 genotype for either treatment group. The incidence of treatment-emergent adverse events was similar for anaprazole (72/220, 32.7%) and rabeprazole (84/219, 38.4%). Conclusions::The efficacy of anaprazole is non-inferior to that of rabeprazole in Chinese patients with duodenal ulcers.Registration::ClinicalTrials.gov, NCT04215653.
10.Endoplasmic reticulum stress and NOD-like receptor protein 3 involves in intestinal mucosal injury induced by severe heat stroke
Yan CAO ; Yanfang PEI ; Maiying FAN ; Zhongwei ZHANG ; Zhenyuan LI ; Xiaotong HAN
Chinese Journal of Emergency Medicine 2021;30(9):1088-1094
Objective:To observe whether endoplasmic reticulum stress and NOD-like receptor protein 3 (NLRP3) inflammasome activation were involved in severe heat stroke induced intestinal mucosal injury and to investigate the potential protective effect of the endoplasmic reticulum stress inhibitor 4-phenylbutyric acid (4-PBA).Methods:Thirty male BALB/c mice were randomly (random number) assigned to 3 groups: the control group, heat stroke group (HS), and 4-PBA pretreatment group (4-PBA+HS, 4-PBA 120 mg/kg, intraperitoneal injection). Mice in the control group were placed at room temperature, while mice in the HS group and 4-PBA+HS group were placed in a prewarmed chamber [temperature (35.5±0.5) °C, humidity (60.0±5.0)%]. A rectal temperature (Tc) that reached 42 °C was considered to indicate severe heat stroke. The concentrations of malondialdehyde (MDA) and superoxide dismutase (SOD) in intestinal homogenate were analyzed by a colorimetric method, serum interleukin-1β (IL-1β) and interleukin-18 (IL-18) were assessed by ELISA, intestinal histopathology was evaluated by hematoxylin and eosin (HE) staining, intestinal ultrastructure was observed by electron microscopy, and the protein expression of GRP78, CHOP, NLRP3 and cleaved caspase-1 were analyzed by Western blot. Data were statistically analyzed by ANOVA test and LSD- t multiple comparison test if homogeneous variance, or analyzed by Welch test and Dunnett's T3 multiple comparison test if heterogeneous variance. Results:The concentration of MDA in the HS group was increased ( t=14.243, P<0.01), while SOD was decreased compared with that in the control group ( t=7.781, P<0.01), and the concentrations of serum IL-1β and IL-18 were significantly elevated ( t=12.664, P<0.01; t=16.240, P<0.01). Under light microscopy, extensive destruction of small intestinal villi and inflammatory cell infiltration were observed in the intestines of mice with severe heat stroke. Transmission electron microscopy showed that endoplasmic reticulum structures were significantly expanded, and mitochondria were vacuolated in the intestines of mice with severe heat stroke. Compared with those in the control group, the protein expression levels of GRP78, CHOP, NLRP3 and cleaved caspase-1 in the small intestine were elevated in the HS group ( t=14.824, P <0.01; t=12.667, P<0.01; t=9.298, P<0.01; and t=6.588, P=0.001). Compared with those in the HS group, mice in the 4-PBA pretreatment group exhibited reduced concentrations of MDA ( t=9.167, P<0.01), increased SOD ( t=6.077, P<0.01) , and reduced serum IL-1β and IL-18 levels ( t=4.889, P= 0.001; t=5.693, P<0.01). In addition, 4-PBA pretreatment significantly alleviated the pathological disruption and ultrastructural damage to small intestine tissues. Moreover, 4-PBA pretreatment reduced GRP78, CHOP , NLRP3 and cleaved caspase-1 protein expression ( t=9.080, P<0.01; t=7.152, P<0.01; t=4.249, P=0.005; t=3.650, P=0.011). Conclusions:Endoplasmic reticulum stress and NLRP3 inflammasome are involved in intestinal mucosal injury induced by severe heat stroke. 4-PBA plays a protective role by alleviating endoplasmic reticulum stress and NLRP3 inflammasome activation.

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