Peptic Ulcer

消化性溃疡
  • 文章类型: Journal Article
    背景:质子泵抑制剂(PPI)治疗在减少内镜止血后高危消化性溃疡患者的再出血方面的有效性已得到公认。伏诺拉赞(VPZ)已证明具有达到超过4的胃pH水平的能力,与PPI相当。这项研究旨在评估静脉输注PPI与VPZ在预防高危消化性溃疡患者内镜止血后再出血方面的比较效果。方法:随机,双盲,控制,并采用了双假人设计。接受内镜下止血的消化性溃疡出血(Forrest类IA/IB或IIA/IIB)患者被随机分配到PPI组或VPZ组。3、7和30天的再出血率,需要输血的次数,住院时间,评估56天的溃疡愈合率。结果:共纳入44例符合条件的患者,包括20例患者(PPI组,n=11;VPZ组,n=9)与高风险消化性溃疡。平均年龄是66岁,70%是男性。PPI组72小时内再出血发生率为9.1%,VPZ组为0%(p=1.000)。7天和30天内再出血率无显著差异(18.2%vs.11.1%,p=1.000)。此外,两组之间的溃疡愈合率没有显着差异(87.5%vs.77.8%)。结论:这项初步研究表明,口服vonoprazan和连续PPI输注在预防内镜下成功止血后高危消化性溃疡患者的复发性出血事件方面具有相当的疗效。
    Background: Proton pump inhibitor (PPI) therapy is well-established for its effectiveness in reducing re-bleeding in high-risk peptic ulcer patients following endoscopic hemostasis. Vonoprazan (VPZ) has demonstrated the capacity to achieve gastric pH levels exceeding 4, comparable to PPIs. This study aims to evaluate the comparative efficacy of intravenous PPI infusion versus VPZ in preventing re-bleeding after endoscopic hemostasis in patients with high-risk peptic ulcers. Methods: A randomized, double-blind, controlled, and double-dummy design was employed. Patients with peptic ulcer bleeding (Forrest class IA/IB or IIA/IIB) who underwent endoscopic hemostasis were randomly assigned to either the PPI group or the VPZ group. Re-bleeding rates at 3, 7, and 30 days, the number of blood transfusions required, length of hospitalization, and ulcer healing rate at 56 days were assessed. Results: A total of 44 eligible patients were enrolled, including 20 patients (PPI group, n = 11; VPZ group, n = 9) with high-risk peptic ulcers. The mean age was 66 years, with 70% being male. Re-bleeding within 72 h occurred in 9.1% of the PPI group versus 0% in the VPZ group (p = 1.000). There was no significant difference in re-bleeding rates within 7 days and 30 days (18.2% vs. 11.1%, p = 1.000). Additionally, the ulcer healing rate did not significantly differ between the groups (87.5% vs. 77.8%). Conclusions: This pilot study demonstrates comparable efficacy between oral vonoprazan and continuous PPI infusion in preventing recurrent bleeding events among high-risk peptic ulcer patients following successful endoscopic hemostasis.
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  • 文章类型: Journal Article
    背景:为了比较急性穿孔性消化性溃疡(PPU)患者的临床结果,非手术,和手术干预,探讨OTSC封闭的有效性和安全性。
    方法:住院,抗生素使用,饮食恢复时间,并对死亡率进行回顾性分析。采用二元Logistic回归分析确定影响PPU并发脓毒症的危险因素。
    结果:患者分为三个治疗组:OTSC(n=62),非手术(n=72),和手术组(n=55)。从症状发作到入院的中位时间(IQR)为9.0(4-23)h。OTSC组中88.71%(55/62)的患者在24h内(中位[IQR]时间:14.5[7.00-30.25]h)进行了OTSC闭合。OTSC和手术组的穿孔直径分别为9.87mm±5.97mm和8.55mm±6.17mm,分别。OTSC(9.50[7.00-12.25]天)和非手术组(9.00[7.00-13.00]天)的中位住院时间(IQR)相似(p>0.05),但短于手术组(12.00[10.00-16.00]天),(p<0.05)。OTSC组(7.00[3.00-10.00])抗生素使用的中位持续时间短于非手术组(9.00[7.00-11.00])和手术组(11.00[9.00-13.00])(p<0.05);OTSC组(4.00[2.00-5.25])恢复口服喂养的时间短于非手术组(7.8.00[6.13]分别为(p<0.05)。各组间死亡率无差异(p=0.109)。入院时白蛋白水平较低,年龄较大,肌酐水平升高与脓毒症风险增加相关,OR(95CI)为0.826(0.687-0.993),1.077(1.005-1.154),和1.025(1.006-1.043),分别(均p<0.05)。
    结论:OTSC封堵术可改善无脓毒症的急性PPU患者的临床结局。年龄,低蛋白血症,基线肾功能障碍会增加败血症的风险,而死亡率与脓毒症和多器官功能障碍有关。
    BACKGROUND: To compare the clinical outcomes in patients with acute perforated peptic ulcer (PPU) treated with over-the-scope clip (OTSC), non-surgical, and surgical interventions, and to explore the effectiveness and safety of OTSC closure.
    METHODS: Hospital stay, antibiotic use, diet resumption time, and mortality rate were analyzed retrospectively. Binary Logistic regression analysis was used to identify the risk factors influencing PPU complicated with sepsis.
    RESULTS: Patients were divided into three treatment groups: OTSC (n = 62), non-surgical (n = 72), and surgical (n = 55) groups. The median time (IQR) from symptom onset to admission was 9.0 (4-23) h. 88.71% (55/62) of the patients in In the OTSC group underwent OTSC closure within 24 h (median [IQR] time: 14.5 [7.00-30.25] h). The perforation diameters in the OTSC and surgical groups were 9.87 mm ± 5.97 mm and 8.55 mm ± 6.17 mm, respectively. The median (IQR) hospital stays in the OTSC (9.50 [7.00-12.25] days) and non-surgical group (9.00[7.00-13.00]days) were similar (p > 0.05), but shorter than that in surgical group (12.00[10.00-16.00]days), (p < 0.05). The median duration of antibiotic use was shorter in the OTSC group (7.00[3.00-10.00]) than in the non-surgical group (9.00[7.00-11.00]) and surgical group (11.00[9.00-13.00]) ( p < 0.05); and the time to resume oral feeding was shorter in the OTSC group (4.00[2.00-5.25]) than in the non-surgical group (7.00[6.13-9.00]) and surgical group (8.00[6.53-10.00]), respectively ( p < 0.05). No mortality difference among groups (p = 0.109) was found. Lower albumin level at admission, older age, and elevated creatinine levels were associated with increased sepsis risk, with OR(95%CI) of 0.826 (0.687-0.993), 1.077 (1.005-1.154), and 1.025 (1.006-1.043), respectively (all p < 0.05).
    CONCLUSIONS: OTSC closure improves clinical outcomes of acute PPU patients without sepsis. Age, hypoalbuminemia, and baseline renal dysfunction increase the risk of sepsis, while mortality was associated with sepsis and multiorgan dysfunction.
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  • 文章类型: Journal Article
    目的:比较2型糖尿病(T2DM)暴露于钠-葡萄糖协同转运蛋白2抑制剂(SGLT2I)的患者胃癌和其他胃部疾病的风险。二肽基肽酶-4抑制剂(DPP4I)或胰高血糖素样肽-1受体激动剂(GLP1a)。
    方法:这是一项以人群为基础的队列研究,对服用SGLT2I的T2DM患者进行前瞻性收集的数据,DPP4I或GLP1a于2015年1月1日至2020年12月31日从香港。结果是新发胃癌,消化性溃疡(PU),急性胃炎,非急性胃炎,胃食管反流病(GERD)。使用最近邻搜索进行倾向得分匹配(1:1),并应用多变量Cox回归。SGLT2I之间的三臂比较,DPP4I和GLP1a使用倾向评分以治疗加权的逆概率进行。
    结果:共纳入62,858例患者(中位年龄:62.2岁[SD:12.8];55.93%男性;SGLT2I:n=23,442;DPP4I:n=39,416)。在匹配的队列中,SGLT2I的胃癌发病率较低(每1000人年发病率,IR:0.32;95%置信区间,CI0.23-0.43)比DPP4I(每1000人年IR:1.22;CI1.03-1.42)用户高。多变量Cox回归发现SGLT2I的使用与较低的胃癌风险相关(HR0.30;95%CI0.19-0.48),PU,急性胃炎,非急性胃炎,和GERD(p<0.05)相比DPP4I使用。在三臂分析中,与SGLT2I相比,GLP1a的使用与更高的胃癌和GERD风险相关。
    结论:SGLT2I的使用与新发胃癌的风险降低相关,PU,急性胃炎,非急性胃炎,与GERD进行匹配和调整后相比DPP4I使用。与使用GLP1a相比,使用SGLT2I与GERD和胃癌的风险较低相关。
    OBJECTIVE: To compare the risks of gastric cancer and other gastric diseases in patients with type-2 diabetes mellitus (T2DM) exposed to sodium-glucose cotransporter 2 inhibitors (SGLT2I), dipeptidyl peptidase-4 inhibitors (DPP4I) or glucagon-like peptide-1 receptor agonists (GLP1a).
    METHODS: This was a population-based cohort study of prospectively collected data on patients with T2DM prescribed SGLT2I, DPP4I or GLP1a between January 1st 2015 and December 31st 2020 from Hong Kong. The outcomes were new-onset gastric cancer, peptic ulcer (PU), acute gastritis, non-acute gastritis, and gastroesophageal reflux disease (GERD). Propensity score matching (1:1) using the nearest neighbour search was performed, and multivariable Cox regression was applied. A three-arm comparison between SGLT2I, DPP4I and GLP1a was conducted using propensity scores with inverse probability of treatment weighting.
    RESULTS: A total of 62,858 patients (median age: 62.2 years old [SD: 12.8]; 55.93% males; SGLT2I: n = 23,442; DPP4I: n = 39,416) were included. In the matched cohort, the incidence of gastric cancer was lower in SGLT2I (Incidence rate per 1000 person-year, IR: 0.32; 95% confidence interval, CI 0.23-0.43) than in DPP4I (IR per 1000 person-year: 1.22; CI 1.03-1.42) users. Multivariable Cox regression found that SGLT2I use was associated with lower risks of gastric cancer (HR 0.30; 95% CI 0.19-0.48), PU, acute gastritis, non-acute gastritis, and GERD (p < 0.05) compared to DPP4I use. In the three-arm analysis, GLP1a use was associated with higher risks of gastric cancer and GERD compared to SGLT2I use.
    CONCLUSIONS: The use of SGLT2I was associated with lower risks of new-onset gastric cancer, PU, acute gastritis, non-acute gastritis, and GERD after matching and adjustments compared to DPP4I use. SGLT2I use was associated with lower risks of GERD and gastric cancer compared to GLP1a use.
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  • 文章类型: Journal Article
    幽门螺杆菌是胃十二指肠疾病的最常见原因。cagA阳性幽门螺杆菌是胃癌危险因素的概念似乎仅适用于来自西方国家的幽门螺杆菌菌株。在发病过程中,其他毒力基因可能与cagA具有协同作用。本研究旨在调查幽门螺杆菌cagA,vaca,和icea的流行,基因型,以及它们与越南患者临床结局的关联。使用PCR技术对从141例胃十二指肠疾病患者的胃活检中提取的DNA确定了cagA状态以及vacA和iceA基因型。在对cagA进行分子分析后,vaca,和一个基因,混合幽门螺杆菌菌株的样品,积极性,或者对于cagA和cagPAI空站点都是否定的,或未鉴定的基因型被排除。最后,107个样本被检查。CagA的存在,vaca,并且在77.6%中检测到了iceA基因,100%,80.4%的病例,分别。值得注意的是,带有EPIYA-ABD的cagA(+),vacAs1i1m1、vacAs1i1m2、iceA1和iceA2占73.8%,44.9%,33.6%,48.6%,31.8%的病例,分别。四种iceA2亚型(24-aa,59-aa,94-aa,和129-aa变体)被发现,59-aa变体最普遍(70.6%)。在26.2%和25.1%的病例中发现了cagA(+)/vacAs1i1m1/iceA1和cagA(+)/vacAs1i1m2/iceA1的组合,分别。进行了多变量逻辑回归分析,在调整了年龄和性别后,以胃炎组作为参考对照。在vacAs1i1m2基因型之间发现了统计学上显著的关联,iceA1变体,和cagA(+)/vacAs1i1m2/iceA1组合和胃癌;调整后的OR估计为18.02(95%CI:3.39-95.81),4.09(95%CI:1.1-15.08),和16.19(95%CI:3.42-76.66),分别。有趣的是,第一次,我们的研究发现vacAs1i1m2,而vacAs1i1m1不是胃癌的危险因素。这项研究说明了幽门螺杆菌cagA的遗传多样性,vaca,和iceA基因跨地理区域,有助于理解这些基因型对临床结果的重要性。
    Helicobacter pylori is the most common cause of gastroduodenal diseases. The concept that cagA-positive H. pylori is a risk factor for gastric cancer appears to be true only for H. pylori strains from Western countries. Other virulent genes may have a synergistic interaction with cagA during pathogenesis. This study aims to investigate H. pylori cagA, vacA, and iceA prevalence, genotypes, and their association to clinical outcomes in Vietnamese patients. The cagA status and vacA and iceA genotypes were determined using the PCR technique on DNA extracted from gastric biopsies of 141 patients with gastroduodenal diseases. After performing molecular analysis for cagA, vacA, and iceA genes, samples with mixed H. pylori strains, positivity, or negativity for both cagA and cagPAI-empty site, or unidentified genotypes were excluded. Finally, 107 samples were examined. The presence of the cagA, vacA, and iceA genes were detected in 77.6%, 100%, and 80.4% of cases, respectively. Notably, cagA( +) with EPIYA-ABD, vacA s1i1m1, vacA s1i1m2, iceA1, and iceA2 accounted for 73.8%, 44.9%, 33.6%, 48.6%, and 31.8% of cases, respectively. Four iceA2 subtypes (24-aa, 59-aa, 94-aa, and 129-aa variants) were found, with the 59-aa variant the most prevalent (70.6%). The cagA( +)/vacAs1i1m1/iceA1 and cagA( +)/vacAs1i1m2/iceA1 combinations were found in 26.2% and 25.1% of cases, respectively. A multivariable logistic regression analysis was performed, after adjusting for age and gender, with the gastritis group was used as a reference control. Statistically significant associations were found between the vacA s1i1m2 genotype, the iceA1 variant, and the cagA( +)/vacAs1i1m2/iceA1 combination and gastric cancer; the adjusted ORs were estimated as 18.02 (95% CI: 3.39-95.81), 4.09 (95% CI: 1.1-15.08), and 16.19 (95% CI: 3.42-76.66), respectively. Interestingly, for the first time, our study found that vacA s1i1m2, but not vacA s1i1m1, was a risk factor for gastric cancer. This study illustrates the genetic diversity of the H. pylori cagA, vacA, and iceA genes across geographical regions and contributes to understanding the importance of these genotypes for clinical outcomes.
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  • 文章类型: Journal Article
    目的:高剂量质子泵抑制剂(PPI)治疗已被推荐用于预防高危消化性溃疡(PU)止血后再出血。Vonoprazan已被证明在各种酸相关疾病中不劣于PPI。本研究旨在比较vonoprazan与PPI预防高危PU止血后再出血的疗效。
    方法:多中心,随机化,在6个中心进行了非劣效性研究.根据标准方案进行内镜前和内镜治疗。止血成功后,高危PU出血患者(ForrestIa/Ib级,IIa/IIb)随机分为1:1接受vonoprazan(20mgBID,持续3天,然后20-mgOD,持续28天)或高剂量PPI(泮托拉唑静脉输注8mg/小时,持续3天,然后奥美拉唑20mgBID28天)。主要结果是30天再出血率。次要结果包括3天和7天再出血率,全因和出血相关死亡率,抢救治疗率,输血,住院时间,和安全。
    结果:在194名患者中,基线特征,出血的严重程度,两组溃疡分期相当。vonoprazan和PPI组的30天再出血率分别为7.1%(7/98)和10.4%(10/96),分别确认了vonoprazan对PPI的非劣效性(在10%范围内)(%风险差异=-3.3;95%置信区间=-11.2,4.7;P<0.001)。vonoprazan组的3天和7天再出血率仍然不劣于PPI(通过Farrington和Manning检验P<0.001)。两组之间的所有次要结局也具有可比性。
    结论:高危PU出血患者,vonoprazan预防30日再出血的疗效不劣于静脉PPI.
    OBJECTIVE: High-dose proton pump inhibitor (PPI) therapy has been recommended to prevent rebleeding of high-risk peptic ulcer (PU) after hemostasis. Vonoprazan has been proven to be noninferior to PPIs in various acid-related diseases. This study aimed to compare the efficacy of vonoprazan vs PPI for preventing high-risk PU rebleeding after hemostasis.
    METHODS: A multicenter, randomized, noninferiority study was conducted in 6 centers. Pre-endoscopic and endoscopic therapy were performed according to standard protocol. After successful hemostasis, patients with high-risk PU bleeding (Forrest class Ia/Ib, IIa/IIb) were randomized into 1:1 to receive vonoprazan (20 mg twice a day for 3 days, then 20 mg once a day for 28 days) or high-dose PPI (pantoprazole intravenous infusion 8 mg/h for 3 days, then omeprazole 20 mg twice a day for 28 days). The primary outcome was a 30-day rebleeding rate. Secondary outcomes included 3- and 7-day rebleeding rate, all-cause and bleeding-related mortality, rate of rescue therapy, blood transfusion, length of hospital stay, and safety.
    RESULTS: Of 194 patients, baseline characteristics, severity of bleeding, and stage of ulcers were comparable between the 2 groups. The 30-day rebleeding rates in vonoprazan and PPI groups were 7.1% (7 of 98) and 10.4% (10 of 96), respectively; noninferiority (within 10% margin) of vonoprazan to PPI was confirmed (%risk difference, -3.3; 95% confidence interval, -11.2 to 4.7; P < .001). The 3-day and 7-day rebleeding rates in the vonoprazan group remained noninferior to PPI (P < .001 by Farrington and Manning test). All secondary outcomes were also comparable between the 2 groups.
    CONCLUSIONS: In patients with high-risk PU bleeding, the efficacy of vonoprazan in preventing 30-day rebleeding was noninferior to intravenous PPI. (ClinicalTrials.gov, Number: NCT05005910).
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  • 文章类型: Journal Article
    背景:穿孔性消化性溃疡是一种与高发病率和死亡率相关的危及生命的并发症。有几种治疗方法可用。此网络荟萃分析(NMA)的目的是比较手术和替代方法治疗穿孔性消化性溃疡的死亡率和其他患者相关结局。
    方法:系统文献检索PubMed/MEDLINE,科克伦图书馆,Embase,CINAHL,ClinicalTrials.gov试验注册和ICTRP将使用预定义的搜索词进行。为了解决最有效的治疗方法的问题,将对上述每个结果进行NMA。预计将有一个封闭的干预网络。其95%CI的标准化平均差将用作连续结果的效果度量,并且将为二元结果计算具有95%CI的OR。
    背景:根据本荟萃分析中使用的数据的性质,这涉及来自先前发表的研究的汇总信息,道德批准被认为是不必要的。结果将直接传播给决策者(例如,外科医生,胃肠病学家)通过在同行评审的期刊上发表和在会议上的介绍。
    CRD42023482932。
    BACKGROUND: Perforated peptic ulcers are a life-threatening complication associated with high morbidity and mortality. Several treatment approaches are available. The aim of this network meta-analysis (NMA) is to compare surgical and alternative approaches for the treatment of perforated peptic ulcers regarding mortality and other patient-relevant outcomes.
    METHODS: A systematic literature search of PubMed/MEDLINE, Cochrane Library, Embase, CINAHL, ClinicalTrials.gov trial registry and ICTRP will be conducted with predefined search terms.To address the question of the most effective treatment approach, an NMA will be performed for each of the outcomes mentioned above. A closed network of interventions is expected. The standardised mean difference with its 95% CI will be used as the effect measure for the continuous outcomes, and the ORs with 95% CI will be calculated for the binary outcomes.
    BACKGROUND: In accordance with the nature of the data used in this meta-analysis, which involves aggregate information from previously published studies ethical approval is deemed unnecessary. Results will be disseminated directly to decision-makers (eg, surgeons, gastroenterologists) through publication in peer-reviewed journals and presentation at conferences.
    UNASSIGNED: CRD42023482932.
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  • 文章类型: Journal Article
    背景:探讨高危消化性溃疡出血患者预防性经动脉栓塞术后再出血风险和30天死亡率的相关因素。
    方法:我们回顾性回顾了医疗记录,包括所有在Rigshospitalet进行了胃十二指肠动脉预防性栓塞的患者,丹麦,在内窥镜检查证实和治疗的消化性硫化物出血后,从2016年到2021年。数据是从电子健康记录和栓塞程序的成像中收集的。主要结果是再出血和30天死亡率。我们对两种可能的危险因素的结果进行了后勤回归分析。危险因素包括:活动性出血;可见的血唇;Rockall评分;解剖学变异;标准化栓塞程序;以及栓塞前的内窥镜检查次数。
    结果:我们纳入了176例患者。栓塞后再出血发生率为25%,30天死亡率为15%。未进行标准化栓塞手术的再出血几率(比值比3.029,95%置信区间(CI)1.395-6.579)和30天总死亡率增加了3.262(1.252-8.497)。一次以上的内窥镜检查与再出血几率增加相关(比值比2.369,95%CI1.088-5.158)。高Rockall评分增加了30天死亡率的几率(比值比2.587,95%CI1.243-5.386)。活动性出血,可见的hemoclips,解剖变异不影响再出血风险或30日死亡率.偏离标准栓塞程序的原因是解剖变异,不栓塞胃十二指肠动脉的靶向治疗,技术故障。
    结论:偏离标准栓塞程序会增加再出血和30天死亡率的风险,栓塞前一次以上的内镜检查与更高的再出血几率相关,高Rockall评分会增加30天死亡率的风险.我们建议在栓塞后密切监测具有这些危险因素的患者。早期发现再出血可以允许适当和早期的再干预。
    BACKGROUND: To investigate factors associated with risk for rebleeding and 30-day mortality following prophylactic transarterial embolization in patients with high-risk peptic ulcer bleeding.
    METHODS: We retrospectively reviewed medical records and included all patients who had undergone prophylactic embolization of the gastroduodenal artery at Rigshospitalet, Denmark, following an endoscopy-verified and treated peptic Sulcer bleeding, from 2016 to 2021. Data were collected from electronic health records and imaging from the embolization procedures. Primary outcomes were rebleeding and 30-day mortality. We performed logistical regression analyses for both outcomes with possible risk factors. Risk factors included: active bleeding; visible hemoclips; Rockall-score; anatomical variants; standardized embolization procedure; and number of endoscopies prior to embolization.
    RESULTS: We included 176 patients. Rebleeding occurred in 25% following embolization and 30-day mortality was 15%. Not undergoing a standardized embolization procedure increased the odds of both rebleeding (odds ratio 3.029, 95% confidence interval (CI) 1.395-6.579) and 30-day overall mortality by 3.262 (1.252-8.497). More than one endoscopy was associated with increased odds of rebleeding (odds ratio 2.369, 95% CI 1.088-5.158). High Rockall-score increased the odds of 30-day mortality (odds ratio 2.587, 95% CI 1.243-5.386). Active bleeding, visible hemoclips, and anatomical variants did not affect risk of rebleeding or 30-day mortality. Reasons for deviation from standard embolization procedure were anatomical variations, targeted treatment without embolizing the gastroduodenal artery, and technical failure.
    CONCLUSIONS: Deviation from the standard embolization procedure increased the risk of rebleeding and 30-day mortality, more than one endoscopy prior to embolization was associated with higher odds of rebleeding, and a high Rockall-score increased the risk of 30-day mortality. We suggest that patients with these risk factors are monitored closely following embolization. Early detection of rebleeding may allow for proper and early re-intervention.
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  • 文章类型: Journal Article
    UNASSIGNED: Peptic ulcer disease (PUD) is common worldwide. Its incidence and prevalence have been declining in recent years in developed countries, and a similar trend has been observed in many parts of Africa including Nigeria.
    UNASSIGNED: This study aimed to provide an endoscopic update on PUD in the Northern Savannah of Nigeria and compare with past reports from the region and recent reports from Nigeria, Africa, and the rest of the world.
    UNASSIGNED: Upper gastrointestinal endoscopy records of consecutive patients diagnosed with PUD between January 2014 and September 2022 at an endoscopy unit of a tertiary institution in North-West Nigeria were retrieved and demographic data, types of peptic ulcer, and their characteristics were extracted and analyzed.
    UNASSIGNED: Over a 9-year period, 171/1958 (8.7%) patients were diagnosed with PUD: mean age 48.8 years (range 14-85), 68.4% male, and 70% >40 years. 59.6% were gastric ulcers (GU), 31.6% duodenal ulcers (DU), and 8.8% were both. The mean age of patients with GU was slightly higher than those with DU (49.9 years vs. 46.6 years, P = 0.29); patients aged <40 years were significantly more likely to be diagnosed with DU than GU (54.7% vs. 33.9%, P = 0.016) while those >40 years significantly more GU than DU (74.6% vs. 54.7%, P = 0.016). There were no significant gender differences between GU and DU.
    UNASSIGNED: The prevalence and pattern of PUD in Northern Savannah of Nigeria have changed - patients were predominantly male and older, and GU predominated.
    Résumé Fond: L\'ulcère gastro-duodénal (UIP) est courant dans le monde entier. Son incidence et sa prévalence ont diminué ces dernières années dans les pays développés et une tendance similaire a été observée dans de nombreuses régions d\'Afrique, y compris au Nigeria. Avoir pour but: Fournir une mise à jour endoscopique sur l\'ulcère peptique dans la savane du nord du Nigéria et comparer avec les rapports antérieurs de la région et les rapports récents du Nigéria, d\'Afrique et du reste du monde. Méthodes: Les dossiers d\'endoscopie gastro-intestinale supérieure de patients consécutifs diagnostiqués avec PUD entre janvier 2014 et septembre 2022 dans une unité d\'endoscopie d\'un établissement tertiaire du nord-ouest du Nigeria ont été récupérés et les données démographiques, les types d\'ulcère peptique et leurs caractéristiques ont été extraits et analysés. Résultats: Sur une période de neuf ans, 171/1 958 (8,7 %) des patients ont reçu un diagnostic de PUD : âge moyen 48,8 ans (extrêmes 14 – 85), 68,4 % hommes, 70 % > 40 ans. 59,6 % étaient des ulcères gastriques (UG), 31,6 % des ulcères duodénaux (UD) et 8,8 % étaient les deux. L\'âge moyen des patients avec GU était légèrement plus élevé que ceux avec DU (49,9 ans contre 46,6 ans, P = 0,29) ; les patients âgés de < 40 ans étaient significativement plus susceptibles d\'être diagnostiqués avec DU que GU (54,7 % contre 33,9 %, P = 0,016) tandis que ceux de > 40 ans étaient significativement plus GU que DU (74,6 % contre 54,7 %, P = 0,016) . Il n\'y avait pas de différences significatives entre les sexes entre GU et DU. Conclusion: La prévalence et le schéma du PUD dans la savane du nord du Nigéria ont changé - les patients étaient principalement des hommes et plus âgés, et les GU prédominaient. Mots-clés: Ulcère peptique, épidémiologie, Kaduna-Nigeria, Ulcère gastrique, Ulcère duodénal.
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  • 文章类型: Clinical Trial, Phase III
    目的:Fexuprazan是一种新型的钾竞争性酸阻滞剂(P-CAB)。本研究旨在探讨非克苏普拉康对埃索美拉唑治疗糜烂性食管炎(EE)的疗效和安全性。
    方法:这是第三阶段,随机化,双盲多中心研究。经内窥镜检查确诊为EE的患者随机接受40mg非克苏普拉坦或40mg埃索美拉唑,每天一次,共4-8周。EE的治愈率,症状反应,GERD-健康相关生活质量(GERD-HRQL),我们比较了非索普拉康组和埃索美拉唑组的治疗引起的不良事件(TEAE).
    结果:总共332名受试者被纳入完整分析集(FAS),311名受试者被纳入符合方案集(PPS)。非索普拉康组和埃索美拉唑组8周时的治愈率分别为88.5%(146/165)和89.0%(145/163),分别,在FAS中,97.3%(145/149)和97.9%(143/146),分别,在PPS。在FAS和PPS分析中,根据8周时的EE治愈率,与埃索美拉唑相比,非索普拉坦的非劣效性均得到证实。在4周时,各组之间的EE治愈率没有显着差异。症状反应,GERD-HRQL的变化。药物相关AE的发生率在非索普拉康组为19.4%(32/165),在埃索美拉唑组为19.6%(32/163)。
    结论:本研究证明非索普拉坦治疗EE的疗效不亚于埃索美拉唑。非索普拉赞和埃索美拉唑的TEAE发生率相似。试验注册号NCT05813561。
    OBJECTIVE: Fexuprazan is a novel potassium-competitive acid blocker (P-CAB). This study aimed to explore the noninferior efficacy and safety of fexuprazan to esomeprazole in treating erosive esophagitis (EE).
    METHODS: This was a phase III, randomized, double-blind multicenter study. Patients with endoscopically confirmed EE were randomized to receive fexuprazan 40 mg or esomeprazole 40 mg once a daily for 4-8 weeks. The healing rates of EE, symptom response, GERD-health-related quality life (GERD-HRQL), and treatment-emergent adverse events (TEAEs) were compared between fexuprazan group and esomeprazole group.
    RESULTS: A total of 332 subjects were included in full analysis set (FAS) and 311 in per-protocol set (PPS). The healing rates of fexuprazan and esomeprazole groups at 8 weeks were 88.5% (146/165) and 89.0% (145/163), respectively, in FAS and 97.3% (145/149) and 97.9% (143/146), respectively, in PPS. Noninferiority of fexuprazan compared with esomeprazole according to EE healing rates at 8 weeks was demonstrated in both FAS and PPS analysis. No significant difference was found between groups in EE healing rates at 4 weeks, symptom responses, and changes of GERD-HRQL. The incidence of drug-related AEs was 19.4% (32/165) in fexuprazan arm and 19.6% (32/163) in esomeprazole arm.
    CONCLUSIONS: This study demonstrated noninferior efficacy of fexuprazan to esomeprazole in treating EE. The incidence of TEAEs was similar between fexuprazan and esomeprazole. Trial registration number NCT05813561.
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  • 文章类型: Journal Article
    目的:心脏ICU(CICU)中先天性心脏病(CHD)婴儿的应激性溃疡预防(SUP)的常规使用存在争议。我们旨在进行一项初步研究,以探索进行后续更大试验以评估该人群中预扣SUP的安全性和有效性的可行性(NCT03667703)。
    方法:单中心,prospective,双盲,平行组(SUPvs.安慰剂),在接受CICU并预期需要呼吸支持超过24小时的CHD婴儿中进行的前瞻性随机对照试验(RCT)。
    方法:患者以1:1(按年龄和入院类型分层)随机接受组胺-2受体拮抗剂或安慰剂,直至停止呼吸支持。长达14天,或从CICU转移,如果更早。
    结果:可行性是由筛查率的阈值预先定义的,同意率,及时配药,和协议的遵守。安全性结果是临床上消化道(UGI)出血的发生率。我们从2019年2月至2022年3月筛查了1,426例患者;在132例符合条件的患者中,我们在70例(53%)中获得了知情同意.两名患者在获得同意后不需要接受CU,其余68例患者随机接受SUP(n=34)或安慰剂(n=34).10名患者提前退出,由于资格(n=3)或开放标签SUP使用(n=7,10%)的变化。58例患者完成了研究程序(89%的方案依从性)。符合所有可行性标准。在飞行员RCT期间,没有临床上明显的UGI出血发作。其他非严重不良事件患者的百分比在组间没有差异。
    结论:在接受CICU的CHD患儿中保留SUP是可行的。更大的多中心RCT旨在确认这种干预的安全性及其对UGI出血发生率的影响,胃肠道微生物组,和其他临床结果是必要的。
    OBJECTIVE: The routine use of stress ulcer prophylaxis (SUP) in infants with congenital heart disease (CHD) in the cardiac ICU (CICU) is controversial. We aimed to conduct a pilot study to explore the feasibility of performing a subsequent larger trial to assess the safety and efficacy of withholding SUP in this population (NCT03667703).
    METHODS: Single-center, prospective, double-blinded, parallel group (SUP vs. placebo), pilot randomized controlled pilot trial (RCT) in infants with CHD admitted to the CICU and anticipated to require respiratory support for greater than 24 hours.
    METHODS: Patients were randomized 1:1 (stratified by age and admission type) to receive a histamine-2 receptor antagonist or placebo until respiratory support was discontinued, up to 14 days, or transfer from the CICU, if earlier.
    RESULTS: Feasibility was defined a priori by thresholds of screening rate, consent rate, timely drug allocation, and protocol adherence. The safety outcome was the rate of clinically significant upper gastrointestinal (UGI) bleeding. We screened 1,426 patients from February 2019 to March 2022; of 132 eligible patients, we gained informed consent in 70 (53%). Two patients did not require CICU admission after obtaining consent, and the remaining 68 patients were randomized to SUP (n = 34) or placebo (n = 34). Ten patients were withdrawn early, because of a change in eligibility (n = 3) or open-label SUP use (n = 7, 10%). Study procedures were completed in 58 patients (89% protocol adherence). All feasibility criteria were met. There were no clinically significant episodes of UGI bleeding during the pilot RCT. The percentage of patients with other nonserious adverse events did not differ between groups.
    CONCLUSIONS: Withholding of SUP in infants with CHD admitted to the CICU was feasible. A larger multicenter RCT designed to confirm the safety of this intervention and its impact on incidence of UGI bleeding, gastrointestinal microbiome, and other clinical outcomes is warranted.
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