1.The interval of rescue treatment does not affect the efficacy and safety of Helicobacter pylori eradication: A prospective multicenter observational study.
Minjuan LIN ; Junnan HU ; Jing LIU ; Juan WANG ; Zhongxue HAN ; Xiaohong WANG ; Zhenzhen ZHAI ; Yanan YU ; Wenjie YUAN ; Wen ZHANG ; Zhi WANG ; Qingzhou KONG ; Boshen LIN ; Yuming DING ; Meng WAN ; Wenlin ZHANG ; Miao DUAN ; Shuyan ZENG ; Yueyue LI ; Xiuli ZUO ; Yanqing LI
Chinese Medical Journal 2025;138(12):1439-1446
BACKGROUND:
The effect of the interval between previous Helicobacter pylori (H. pylori) eradication and rescue treatment on therapeutic outcomes remains unknown. The aim of this study was to investigate the association between eradication rates and treatment interval durations in H. pylori infections.
METHODS:
This prospective observational study was conducted from December 2021 to February 2023 at six tertiary hospitals in Shandong, China. We recruited patients who were positive for H. pylori infection and required rescue treatment. Demographic information, previous times of eradication therapy, last eradication therapy date, and history of antibiotic use data were collected. The patients were divided into four groups based on the rescue treatment interval length: Group A, ≥4 weeks and ≤3 months; Group B, >3 and ≤6 months; Group C, >6 and ≤12 months; and Group D, >12 months. The primary outcome was the eradication rate of H. pylori . Drug compliance and adverse events (AEs) were also assessed. Pearson's χ2 test or Fisher's exact test was used to compare eradication rates between groups.
RESULTS:
A total of 670 patients were enrolled in this study. The intention-to-treat (ITT) eradication rates were 88.3% (158/179) in Group A, 89.6% (120/134) in Group B, 89.1% (123/138) in Group C, and 87.7% (192/219) in Group D. The per-protocol (PP) eradication rates were 92.9% (156/168) in Group A, 94.5% (120/127) in Group B, 94.5% (121/128) in Group C, and 93.6% (190/203) in Group D. There was no statistically significant difference in the eradication rates between groups in either the ITT ( P = 0.949) or PP analysis ( P = 0.921). No significant differences were observed in the incidence of AEs ( P = 0.934) or drug compliance ( P = 0.849) between groups.
CONCLUSION:
The interval duration of rescue treatment had no significant effect on H. pylori eradication rates or the incidence of AEs.
REGISTRATION
ClinicalTrials.gov , NCT05173493.
Humans
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Helicobacter Infections/drug therapy*
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Helicobacter pylori/pathogenicity*
;
Male
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Female
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Prospective Studies
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Middle Aged
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Anti-Bacterial Agents/adverse effects*
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Adult
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Aged
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Treatment Outcome
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Proton Pump Inhibitors/therapeutic use*
3.Plateau hypoxia improves tumor immune microenvironment and inhibits subcutaneous tumor growth of colorectal cancer
Sijie ZHAO ; Meng WANG ; Yuan GAO ; Fang YANG ; Shaofan HU ; Hongming MIAO
Journal of Army Medical University 2025;47(1):38-50
Objective To investigate the effects of plateau hypoxia on the growth and tumor microenvironment of colorectal carcinoma in vivo.Methods A total of 16 male BALB/C mice(6 weeks old,weight 18-20 g)were randomly divided into plateau hypoxic group and plain normoxic group,with 8 mice in each group,while 14 male C57BL/6 mice were grouped in same way,with 7 mice in each group.The mice in the plateau hypoxic group were housed in a low-pressure oxygen(10%)chamber to simulate an altitude of approximately 5 600 m,while the mice of the other group was maintained in SPF-grade normal atmospheric conditions(21%oxygen,at an altitude of about 300 m).Colorectal tumor MC38 cells and colon adenocarcinoma CT26 cells were subcutaneously implanted into C57BL/6 mice and BALB/C mice,respectively to construct subcutaneous tumor-bearing mouse models.Then the tumor size and weight were measured in 4 groups of mice.After the tumor tissues,spleen and blood samples were collected in the C57BL/6 mice.Flow cytometry was used to determine the percentages of macrophages,T lymphocytes,IFN-γ+T lymphocytes,and myeloid-derived suppressor cells(MDSC).The differences in these immune cells were compared between the cells from the plateau hypoxic group and those from the plain normoxic group.Results The weight of subcutaneous tumor mass was significantly inhibited in both C57BL/6 and BALB/C mice from the plateau hypoxic group than those from the 2 plain normoxic groups(0.17 vs 0.09 g,1.38 vs 0.51 g,P<0.01).When compared with the immune cells from the tumor mass of the plain normoxic C57BL/6 mice,the percentage of M2-type macrophages was reduced in the tumor tissue from the plateau hypoxic mice(22.13%vs 15.90%,P<0.05),so was that of MDSC(2.06%vs 1.05%,P<0.01),particularly in the monocytic(M)-MDSC subgroup(60.97%vs 41.13%,P<0.01).While,no significant change was observed in the proportion of the polymorphonuclear(PMN)-MDSC subgroup(10.97%vs 9.70%,P>0.05).Additionally,the percentage of CD4+T cells was significantly reduced(48.70%vs 41.93%,P<0.05),whereas that of CD8+T cells was obviously increased(41.25%vs 51.18%,P<0.05),along with a notable rise in the proportions of IFN-γ+T,IFN-γ+CD4+T and IFN-γ+CD8+T cells(28.58%vs 59.65%,23.33%vs 53.65%,36.9%vs 66.48%,P<0.01).However,between the peripheral blood samples of the 2 groups of C57BL/6 mice,the proportions of M1-type macrophages and CD4+T cells were reduced(84.98%vs 78.43%,5.86%vs 4.01%,P<0.01),and those of MDSC and PMN-MDC were increased(4.47%vs 16.43%,36.56%vs 62.97%,P<0.01).In the spleen tissues,notable decreases were observed in the proportions of CD8+T cells and IFN-γ+CD8+T cells between the 2 groups(33.05%vs 27.68%,5.13%vs 1.58%,P<0.01).Conclusion Plateau hypoxia improves the immune response within the tumor microenvironment,and inhibits subcutaneous tumor growth of colorectal cancer,but suppresses systemic immune response.
6.Construction and application of the early rehabilitation management model for patients with kinesiophobia after total knee arthroplasty based on a topic-oriented quality control circle
Libai CAI ; Miaoran CUI ; Jiping MENG ; Yangyang LIU ; Yang LYU ; Wenjing HUANG ; Jinhong MIAO ; Cong YUAN
Chinese Journal of Modern Nursing 2025;31(3):368-374
Objective:To construct an early rehabilitation management model for postoperative kinesiophobia patients after total knee arthroplasty (TKA) based on a topic-oriented quality control circle method, aiming to improve the quality of early rehabilitation management.Methods:Using a convenience sampling method, 120 TKA patients with kinesiophobia treated in the Department of Orthopedics at the First Affiliated Hospital of Zhengzhou University from January to April 2022 and September to December 2022 were selected. The patients from January to April 2022 were set as the control group, and those from September to December 2022 were set as the observation group, with 60 patients in each group. The control group received routine rehabilitation management after TKA surgery, while the observation group received the early rehabilitation management model based on the 10 steps of the topic-oriented quality control circle (topic selection, activity planning, clarification of the topic, goal setting, countermeasure formulation, pursuit of optimal strategies, etc.) in addition to the routine management. The differences between the two groups were compared in terms of kinesiophobia score, knee function score, pain score, early rehabilitation assessment rate, effective analgesia rate, and 24-hour ambulation rate.Results:After the intervention, the observation group showed significantly lower knee pain scores (2.89±0.66) and kinesiophobia scores (23.27±4.87) compared to the control group, with a significantly higher knee function score (74.47±7.40), all differences were statistically significant (all P<0.01). Additionally, the observation group had a significantly higher early rehabilitation assessment rate, effective analgesia rate, 24-hour ambulation rate, early rehabilitation compliance rate, earlier time for the first ambulation, shorter hospital stay, and reduced costs compared to the control group, with all differences showing statistical significance (all P<0.01) . Conclusions:The application of the topic-oriented quality control circle to construct and implement an early rehabilitation management model for postoperative kinesiophobia patients after TKA can effectively improve the quality of early rehabilitation management, reduce kinesiophobia levels, enhance knee joint function, and alleviate the economic burden.
7.Construction and application of the early rehabilitation management model for patients with kinesiophobia after total knee arthroplasty based on a topic-oriented quality control circle
Libai CAI ; Miaoran CUI ; Jiping MENG ; Yangyang LIU ; Yang LYU ; Wenjing HUANG ; Jinhong MIAO ; Cong YUAN
Chinese Journal of Modern Nursing 2025;31(3):368-374
Objective:To construct an early rehabilitation management model for postoperative kinesiophobia patients after total knee arthroplasty (TKA) based on a topic-oriented quality control circle method, aiming to improve the quality of early rehabilitation management.Methods:Using a convenience sampling method, 120 TKA patients with kinesiophobia treated in the Department of Orthopedics at the First Affiliated Hospital of Zhengzhou University from January to April 2022 and September to December 2022 were selected. The patients from January to April 2022 were set as the control group, and those from September to December 2022 were set as the observation group, with 60 patients in each group. The control group received routine rehabilitation management after TKA surgery, while the observation group received the early rehabilitation management model based on the 10 steps of the topic-oriented quality control circle (topic selection, activity planning, clarification of the topic, goal setting, countermeasure formulation, pursuit of optimal strategies, etc.) in addition to the routine management. The differences between the two groups were compared in terms of kinesiophobia score, knee function score, pain score, early rehabilitation assessment rate, effective analgesia rate, and 24-hour ambulation rate.Results:After the intervention, the observation group showed significantly lower knee pain scores (2.89±0.66) and kinesiophobia scores (23.27±4.87) compared to the control group, with a significantly higher knee function score (74.47±7.40), all differences were statistically significant (all P<0.01). Additionally, the observation group had a significantly higher early rehabilitation assessment rate, effective analgesia rate, 24-hour ambulation rate, early rehabilitation compliance rate, earlier time for the first ambulation, shorter hospital stay, and reduced costs compared to the control group, with all differences showing statistical significance (all P<0.01) . Conclusions:The application of the topic-oriented quality control circle to construct and implement an early rehabilitation management model for postoperative kinesiophobia patients after TKA can effectively improve the quality of early rehabilitation management, reduce kinesiophobia levels, enhance knee joint function, and alleviate the economic burden.
8.Safety of high-carbohydrate fluid diet 2 h versus overnight fasting before non-emergency endoscopic retrograde cholangiopancreatography: A single-blind, multicenter, randomized controlled trial
Wenbo MENG ; W. Joseph LEUNG ; Zhenyu WANG ; Qiyong LI ; Leida ZHANG ; Kai ZHANG ; Xuefeng WANG ; Meng WANG ; Qi WANG ; Yingmei SHAO ; Jijun ZHANG ; Ping YUE ; Lei ZHANG ; Kexiang ZHU ; Xiaoliang ZHU ; Hui ZHANG ; Senlin HOU ; Kailin CAI ; Hao SUN ; Ping XUE ; Wei LIU ; Haiping WANG ; Li ZHANG ; Songming DING ; Zhiqing YANG ; Ming ZHANG ; Hao WENG ; Qingyuan WU ; Bendong CHEN ; Tiemin JIANG ; Yingkai WANG ; Lichao ZHANG ; Ke WU ; Xue YANG ; Zilong WEN ; Chun LIU ; Long MIAO ; Zhengfeng WANG ; Jiajia LI ; Xiaowen YAN ; Fangzhao WANG ; Lingen ZHANG ; Mingzhen BAI ; Ningning MI ; Xianzhuo ZHANG ; Wence ZHOU ; Jinqiu YUAN ; Azumi SUZUKI ; Kiyohito TANAKA ; Jiankang LIU ; Ula NUR ; Elisabete WEIDERPASS ; Xun LI
Chinese Medical Journal 2024;137(12):1437-1446
Background::Although overnight fasting is recommended prior to endoscopic retrograde cholangiopancreatography (ERCP), the benefits and safety of high-carbohydrate fluid diet (CFD) intake 2 h before ERCP remain unclear. This study aimed to analyze whether high-CFD intake 2 h before ERCP can be safe and accelerate patients’ recovery.Methods::This prospective, multicenter, randomized controlled trial involved 15 tertiary ERCP centers. A total of 1330 patients were randomized into CFD group ( n = 665) and fasting group ( n = 665). The CFD group received 400 mL of maltodextrin orally 2 h before ERCP, while the control group abstained from food/water overnight (>6 h) before ERCP. All ERCP procedures were performed using deep sedation with intravenous propofol. The investigators were blinded but not the patients. The primary outcomes included postoperative fatigue and abdominal pain score, and the secondary outcomes included complications and changes in metabolic indicators. The outcomes were analyzed according to a modified intention-to-treat principle. Results::The post-ERCP fatigue scores were significantly lower at 4 h (4.1 ± 2.6 vs. 4.8 ± 2.8, t = 4.23, P <0.001) and 20 h (2.4 ± 2.1 vs. 3.4 ± 2.4, t= 7.94, P <0.001) in the CFD group, with least-squares mean differences of 0.48 (95% confidence interval [CI]: 0.26–0.71, P <0.001) and 0.76 (95% CI: 0.57–0.95, P <0.001), respectively. The 4-h pain scores (2.1 ± 1.7 vs. 2.2 ± 1.7, t = 2.60, P = 0.009, with a least-squares mean difference of 0.21 [95% CI: 0.05–0.37]) and positive urine ketone levels (7.7% [39/509] vs. 15.4% [82/533], χ2 = 15.13, P <0.001) were lower in the CFD group. The CFD group had significantly less cholangitis (2.1% [13/634] vs. 4.0% [26/658], χ2 = 3.99, P = 0.046) but not pancreatitis (5.5% [35/634] vs. 6.5% [43/658], χ2 = 0.59, P = 0.444). Subgroup analysis revealed that CFD reduced the incidence of complications in patients with native papilla (odds ratio [OR]: 0.61, 95% CI: 0.39–0.95, P = 0.028) in the multivariable models. Conclusion::Ingesting 400 mL of CFD 2 h before ERCP is safe, with a reduction in post-ERCP fatigue, abdominal pain, and cholangitis during recovery.Trail Registration::ClinicalTrials.gov, No. NCT03075280.
9.Clinical and literature analysis of amphotericin B-associated nephrogenic diabetes insipidus
Jie YU ; Nan XU ; Miao YANG ; Meng LI ; Gaoshuang LAN ; Zhengxiang LI ; Hengjie YUAN
Adverse Drug Reactions Journal 2024;26(8):467-473
Objective:To investigate the clinical features, management, and prognosis of amphotericin B (AmB)-associated nephrogenic diabetes insipidus (NDI).Methods:The diagnosis and treatment process of a patient with AmB-related NDI who was admitted to the General Hospital of Tianjin Medical University was reported, and the main clinical data of the patient and related cases such as gender, age, primary disease, medication, NDI occurrence, treatment and outcome collected from CNKI, Wanfang Medical, and VIP databases, PubMed, Web of Science, and ScienceDirect (up to August 22, 2023) were analyzed descriptively.Results:A total of 11 patients were included in the analysis, including 7 males and 4 females, with an average age of 41 years, ranging from 12 to 66 years. The correlation between AmB and NDI was probable in 7 cases and possible in 4 cases. The time from the beginning of medication to the occurrence of NDI was 3 days to 3 weeks, and the urine volume was 3.8-10.8 L/d. Among the 11 patients, 6 patients had hypokalemia and 5 patients had elevated serum creatinine; 9 patients did not stop using AmB due to their conditions, the intervention plans were described in details in 4 patients and AmB treatments were completed after symptomatic treatments, 7 patients were cured or improved, and 2 patients died. Among the 2 patients who stopped taking the medication, 1 patient showed significant improvement in symptoms and resumed using AmB without recurrence; the other case was improved after stopping the medication, but relapsed after resuming use without stopping the medication, and the patient died from the primary disease.Conclusions:During the use of AmB, close attention should be paid to the occurrence of NDI. After occurrence of NDI, most patients can continue taking the AmB and have a good prognosis after symptomatic treatments.
10.Clinical and literature analysis of amphotericin B-associated nephrogenic diabetes insipidus
Jie YU ; Nan XU ; Miao YANG ; Meng LI ; Gaoshuang LAN ; Zhengxiang LI ; Hengjie YUAN
Adverse Drug Reactions Journal 2024;26(8):467-473
Objective:To investigate the clinical features, management, and prognosis of amphotericin B (AmB)-associated nephrogenic diabetes insipidus (NDI).Methods:The diagnosis and treatment process of a patient with AmB-related NDI who was admitted to the General Hospital of Tianjin Medical University was reported, and the main clinical data of the patient and related cases such as gender, age, primary disease, medication, NDI occurrence, treatment and outcome collected from CNKI, Wanfang Medical, and VIP databases, PubMed, Web of Science, and ScienceDirect (up to August 22, 2023) were analyzed descriptively.Results:A total of 11 patients were included in the analysis, including 7 males and 4 females, with an average age of 41 years, ranging from 12 to 66 years. The correlation between AmB and NDI was probable in 7 cases and possible in 4 cases. The time from the beginning of medication to the occurrence of NDI was 3 days to 3 weeks, and the urine volume was 3.8-10.8 L/d. Among the 11 patients, 6 patients had hypokalemia and 5 patients had elevated serum creatinine; 9 patients did not stop using AmB due to their conditions, the intervention plans were described in details in 4 patients and AmB treatments were completed after symptomatic treatments, 7 patients were cured or improved, and 2 patients died. Among the 2 patients who stopped taking the medication, 1 patient showed significant improvement in symptoms and resumed using AmB without recurrence; the other case was improved after stopping the medication, but relapsed after resuming use without stopping the medication, and the patient died from the primary disease.Conclusions:During the use of AmB, close attention should be paid to the occurrence of NDI. After occurrence of NDI, most patients can continue taking the AmB and have a good prognosis after symptomatic treatments.

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