Proton pump inhibitors

质子泵抑制剂
  • 文章类型: Journal Article
    背景:幽门螺杆菌(H.pylori)是与胃腺癌(AC)相关的广泛微生物。相比之下,据报道,幽门螺杆菌感染与食管癌之间存在负相关.这种所谓的保护作用的潜在机制仍然存在争议。
    目的:了解食管癌患者幽门螺杆菌感染情况。我们对在我院诊断的食管肿瘤进行了回顾性观察研究.
    方法:我们回顾性分析了一组诊断为食管癌的患者中幽门螺杆菌感染的患病率。还记录了伴随的或先前的质子泵抑制剂(PPI)的使用。
    结果:共有89例食管癌患者(男69例,77.5%),平均年龄66岁(范围,包括26-93岁)。AC是最常见的病理变异(n=47,52.8%),其次是鳞状细胞癌(n=37,41.6%)。14种AC(29.8%)起源于胃食管交界处,33种(70.2%)起源于食管体内。总的来说,54例患者(60.7%)出现在III期和IV期。以前的幽门螺杆菌感染仅发生在4例患者中(4.5%),3患有AC(占所有AC的6.3%)和1患有鳞状细胞癌(占所有鳞状细胞肿瘤的2.7%)。所有既往幽门螺杆菌感染的患者均为III-IV期。只有一名患者之前接受过幽门螺杆菌根除治疗,而86例(96.6%)曾接受过既往或同时接受过PPI治疗.
    结论:在我们的患者队列中,在对石蜡包埋的原发性肿瘤进行组织学评估后,我们发现以前幽门螺杆菌感染的患病率非常低.我们还回顾了患者的病史,结论是大多数人已经接受或正在接受PPI治疗.在该食管癌患者队列中发现的幽门螺杆菌感染的最低患病率表明其具有保护作用。
    BACKGROUND: Helicobacter pylori (H. pylori) is a widespread microorganism related to gastric adenocarcinoma (AC). In contrast, it has been reported that an inverse association exists between H. pylori infection and esophageal carcinoma. The mechanisms underlying this supposedly protective effect remain controversial.
    OBJECTIVE: To determine the prevalence of H. pylori infection in esophageal carcinoma patients, we performed a retrospective observational study of esophageal tumors diagnosed in our hospital.
    METHODS: We retrospectively reviewed the prevalence of H. pylori infection in a cohort of patients diagnosed with esophageal carcinoma. Concomitant or previous proton pump inhibitor (PPI) usage was also recorded.
    RESULTS: A total of 89 patients with esophageal carcinoma (69 males, 77.5%), with a mean age of 66 years (range, 26-93 years) were included. AC was the most frequent pathological variant (n = 47, 52.8%), followed by squamous cell carcinoma (n = 37, 41.6%). Fourteen ACs (29.8%) originated in the gastroesophageal junction and 33 (70.2%) in the esophageal body. Overall, 54 patients (60.7%) presented at stages III and IV. Previous H. pylori infection occurred only in 4 patients (4.5%), 3 with AC (6.3% of all ACs) and 1 with squamous cell carcinoma (2.7% of all squamous cell tumors). All patients with previous H. pylori infection had stage III-IV. Only one patient had received prior H. pylori eradication therapy, whereas 86 (96.6%) had received previous or concomitant PPI treatment.
    CONCLUSIONS: In our cohort of patients, and after histologic evaluation of paraffin-embedded primary tumors, we found a very low prevalence of previous H. pylori infection. We also reviewed the medical history of the patients, concluding that the majority had received or were on PPI treatment. The minimal prevalence of H. pylori infection found in this cohort of patients with esophageal carcinoma suggests a protective role.
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  • 文章类型: Journal Article
    背景:同时使用氯吡格雷和质子泵抑制剂(PPI)很常见,但PPI可能降低经皮冠状动脉介入治疗(PCI)患者氯吡格雷的抗血小板作用.我们评估了PPI使用对PCI术后患者临床结局的影响,通过纳入P2Y12反应单元(PRU)和CYP2C19基因分型结果。
    方法:来自接受PCI联合药物洗脱支架植入术并接受氯吡格雷双联抗血小板治疗(DAPT)的患者的多中心登记,在PCI时接受PPI治疗的患者(PPI使用者)与未接受PPI治疗的患者(非使用者)进行比较.主要结果包括全因死亡,心肌梗塞,支架内血栓形成,或12个月的脑血管意外。大出血(出血学术研究联盟[BARC]类型3-5)和胃肠道(GI)出血(BARC类型3-5)是重要的次要结果。使用1:1倾向评分(PS)匹配和竞争风险分析比较调整后的结果。
    结果:在13,160名患者中,2235(17.0%)是处方PPI,平均年龄为65.4岁。PPI使用者的治疗中PRU水平高于非使用者。PS匹配后,主要结局发生在PPI使用者的51例患者中(累积发生率,4.7%)和41例非使用者患者(累积发生率,3.7%;对数秩p=0.27)。在两个CYP2C19功能丧失等位基因的携带者中,PPI的使用与主要结局的风险增加有关(风险比,3.22;95%置信区间,1.18-8.78)。PS匹配队列中PPI使用者和非使用者的大出血和消化道出血(BARC3-5型)发生率相当。
    结论:在接受基于氯吡格雷的DAPT的PCI术后患者中,PPI使用与不良心脑血管事件的风险增加无关。但治疗中PRU有少量但显著的增加.使用更个性化方法的未来研究将进一步阐明这些相互作用并指导循证临床实践。
    BACKGROUND: Concomitant use of clopidogrel and proton pump inhibitor (PPI) is common, but PPI may reduce the antiplatelet effects of clopidogrel in patients undergoing percutaneous coronary intervention (PCI). We evaluated the impact of PPI use on clinical outcomes in post-PCI patients, by incorporating P2Y12 reaction unit (PRU) and CYP2C19 genotyping results.
    METHODS: From a multicenter registry of patients who underwent PCI with drug-eluting stent implantation and received clopidogrel-based dual antiplatelet therapy (DAPT), patients who were prescribed a PPI at the time of PCI (PPI users) were compared to those who were not (non-users). The primary outcome included all-cause death, myocardial infarction, stent thrombosis, or cerebrovascular accident at 12 months. Major bleeding (Bleeding Academic Research Consortium [BARC] types 3-5) and gastrointestinal (GI) bleeding (BARC types 3-5) were important secondary outcomes. The adjusted outcomes were compared using a 1:1 propensity-score (PS) matching and competing risk analysis.
    RESULTS: Of 13,160 patients, 2,235 (17.0%) were prescribed PPI, with an average age of 65.4 years. PPI users had higher on-treatment PRU levels than non-users. After PS matching, the primary outcome occurred in 51 patients who were PPI users (cumulative incidence, 4.7%) and 41 patients who were non-users (cumulative incidence, 3.7%; log-rank p = 0.27). In carriers of both CYP2C19 loss-of-function alleles, PPI use was linked to an increased risk of the primary outcome (hazard ratio, 3.22; 95% confidence interval, 1.18-8.78). The incidence of major bleeding and GI bleeding (BARC types 3-5) was comparable between PPI users and non-users in the PS-matched cohort.
    CONCLUSIONS: In post-PCI patients receiving clopidogrel-based DAPT, PPI use was not linked to an increased risk of adverse cardiac and cerebrovascular events, but there was a small but significant increase in on-treatment PRU. Future research using a more individualized approach would further elucidate these interactions and guide evidence-based clinical practices.
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  • 文章类型: Journal Article
    顺铂是鼻咽癌(NPC)最常用的基于铂的治疗方法。然而,由于其肾毒性和胃肠道反应,其临床应用受到限制。在先前的研究中已经报道了质子泵抑制剂(PPIs)增加肾毒性风险。我们旨在评估PPI是否增加顺铂诱导的NPC患者的肾毒性。总的来说,295名患者被纳入这项前瞻性队列研究:145名患者在PPI组,150名非PPI组。所有患者均接受顺铂为主的诱导化疗,其次是基于顺铂的同步放化疗。PPI组在每个化疗周期内接受40mg静脉注射埃索美拉唑钠,持续7天。卡方检验和具有比值比和95%置信区间的逻辑回归分析用于评估PPI与急性肾损伤(AKI)风险之间的关联。PPIs组AKI发生率明显高于非PPIs组(P=0.005)。在调整了包括人口统计特征在内的各种混杂因素后,临床特征,和肾功能指标,使用PPI与较高的AKI风险显著相关(比值比:2.775;95%置信区间1.280-6.020;P=0.010)。两组急慢性肾脏病的发生率相似(P>0.05),PPIs组的恶心发生率低于非PPIs组(P=0.029).这项研究表明,使用PPI可能会增加顺铂引起的NPC患者急性肾毒性的风险。
    Cisplatin is the most commonly used platinum-based treatment for nasopharyngeal carcinoma (NPC). However, its clinical application is limited owing to its nephrotoxicity and gastrointestinal reactions. Proton pump inhibitors (PPIs) have been reported to increase nephrotoxicity risk in previous studies. We aimed to evaluate whether PPIs increase cisplatin-induced nephrotoxicity in patients with NPC. In total, 295 patients were included in this prospective cohort study: 145 in the PPIs group and 150 in the non-PPIs group. All patients underwent cisplatin-based induction chemotherapy, followed by cisplatin-based concurrent chemoradiotherapy. The PPIs group received 40 mg of intravenous esomeprazole sodium for 7 days in each chemotherapy cycle. Chi-squared test and logistic regression analyses with odds ratios and 95% confidence intervals were applied to assess the association between PPIs and the risk of acute kidney injury (AKI). AKI incidence in the PPIs group was significantly higher than that in the non-PPIs group (P = 0.005). After adjusting for various confounders including demographic features, clinical features, and renal function indices, PPIs use was significantly associated with a higher AKI risk (odds ratio: 2.775; 95% confidence interval 1.280-6.020; P = 0.010). The incidences of acute and chronic kidney diseases were similar between both groups (P > 0.05), whereas the incidence of nausea was lower in the PPIs group than in the non-PPIs group (P = 0.029). This study has shown that PPIs use may increase the risk of cisplatin-induced acute nephrotoxicity in patients with NPC.
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  • 文章类型: Journal Article
    急性肾损伤(AKI)是接受大手术的患者的严重术后并发症。质子泵抑制剂(PPI)在术前用于预防术后胃肠道出血。术前使用PPI是否与术后AKI风险增加相关仍不确定。
    这项回顾性队列研究使用北京大学第一医院临床数据仓库的电子病历,对2018年1月1日至2020年12月31日期间所有接受大手术的成人住院患者进行筛查。暴露是术前使用PPI,定义为大手术前7天内使用PPI。主要结果是术后AKI,定义为大手术后7天内发生AKI;次要结局包括院内AKI和院内死亡率.
    总共21,533名患者被纳入研究(平均[SD]年龄,57.8[15.0]岁;51.2%男性),其中944人(4.4%)在大手术前7天内服用PPI(PPI使用者)。总的来说,72例PPI使用者(7.6%)和356例非使用者(1.7%)发生术后AKI。调整后,术前使用PPI与术后AKI风险增加相关(调整后的OR,1.47;95%CI,1.04-2.07)和院内AKI(调整后OR,1.41;95%CI,1.03-1.94)。此外,亚组分析显示,同时使用非甾体类抗炎药或利尿剂会增加术后AKI发生PPI的风险.在完全校正模型中,术前PPI使用和院内死亡率之间没有显着差异(校正OR1.63;95%CI,0.55-4.85)。
    术前使用PPI与大手术患者AKI风险增加相关。伴随使用其他肾毒性药物可能会增加这种风险。临床医生在开始PPI预防之前应权衡利弊。
    UNASSIGNED: Acute kidney injury (AKI) is a severe postoperative complication in patients undergoing major surgery. Proton pump inhibitors (PPIs) are used preoperatively as prophylaxis for postoperative gastrointestinal bleeding. Whether preoperative PPI use is associated with an increased risk of postoperative AKI remains uncertain.
    UNASSIGNED: This retrospective cohort study used electronic medical records from the clinical data warehouse of Peking University First Hospital to screen all adult hospitalizations undergoing major surgery between 1 January 2018 and 31 December 2020. Exposure was preoperative PPI use, defined as PPI use within 7 days before major surgery. The primary outcome was postoperative AKI, defined as AKI occurring within 7 days after major surgery; secondary outcomes included in-hospital AKI and in-hospital mortality.
    UNASSIGNED: A total of 21,533 patients were included in the study (mean [SD] age, 57.8 [15.0] years; 51.2% male), of which 944 (4.4%) were prescribed PPI within 7 days before major surgery (PPI users). Overall, 72 PPI users (7.6%) and 356 non-users (1.7%) developed postoperative AKI. After adjustment, preoperative PPI use was associated with an increased risk of postoperative AKI (adjusted OR, 1.47; 95% CI, 1.04-2.07) and in-hospital AKI (adjusted OR, 1.41; 95% CI, 1.03-1.94). Moreover, subgroup analyses showed that the risk of PPI on postoperative AKI was amplified by the concomitant use of non-steroidal anti-inflammatory drugs or diuretics. No significant difference was observed between preoperative PPI use and in-hospital mortality in the fully adjusted model (adjusted OR 1.63; 95% CI, 0.55-4.85).
    UNASSIGNED: Preoperative PPI use was associated with an increased risk of AKI in patients undergoing major surgery. This risk may be enhanced by the concomitant use of other nephrotoxic drugs. Clinicians should weigh the pros and cons before initiating PPI prophylaxis.
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  • 文章类型: Journal Article
    背景:嗜酸细胞性食管炎是一种慢性食道炎症性疾病。这项真实世界的研究使用患者和医生调查来描述嗜酸性粒细胞性食管炎的临床特征和疾病负担-总体上以及尽管接受了治疗但仍存在吞咽困难的患者亚组。
    方法:本研究中分析的数据来自2020年美国和欧盟的嗜酸性粒细胞性食管炎患者。符合条件的患者年龄≥12岁,诊断为嗜酸性粒细胞性食管炎,诊断时食管嗜酸性粒细胞计数≥15/高倍视野,目前正在治疗嗜酸性粒细胞性食管炎。
    结果:总体而言,包括1001名患者,尽管接受了治疗,但其中356人(36%)有吞咽困难。两个人群的人口统计学和临床特征相似。尽管接受了治疗,但总体上更多患者(69%)的嗜酸性食管炎严重程度较轻(48%)。两个人群的患者病史相似,除了一些例外:常见的患者报告的症状是吞咽困难(70%和86%)和胃灼热/酸反流(55%和49%),医生报告的常见症状包括吞咽困难(75%和91%)和食物嵌塞(46%和52%).两个人群的治疗史相似;总体而言,最常见的治疗是质子泵抑制剂(83%)和外用糖皮质激素(51%).患者报告有症状的天数略多,对日常生活活动的影响更大,尽管接受治疗,但吞咽困难人群的焦虑或抑郁水平略高于总人口。
    结论:嗜酸细胞性食管炎表现出严重的症状和合并症,严重影响患者的健康和生活质量。需要提高对嗜酸性粒细胞性食管炎的认识和新的治疗方法。
    BACKGROUND: Eosinophilic esophagitis is a chronic inflammatory disorder of the esophagus. This real-world study used patient and physician surveys to describe the clinical characteristics and disease burden of eosinophilic esophagitis-overall and in a subgroup of patients with dysphagia despite treatment.
    METHODS: Data analyzed in this study were collected in 2020 from US and EU patients with eosinophilic esophagitis. Eligible patients were aged ≥ 12 years with a diagnosis of eosinophilic esophagitis, had an esophageal count of ≥ 15 eosinophils/high-power field at diagnosis, and were currently prescribed treatment for eosinophilic esophagitis.
    RESULTS: Overall, 1001 patients were included, of whom 356 (36%) had dysphagia despite treatment. Demographics and clinical characteristics were similar in both populations. The severity of eosinophilic esophagitis was mild in more patients overall (69%) versus those with dysphagia despite treatment (48%). Patient disease history was similar in both populations, with some exceptions: common patient-reported symptoms were dysphagia (70% and 86%) and heartburn/acid reflux (55% and 49%), and common physician-reported symptoms were dysphagia (75% and 91%) and food impaction (46% and 52%). Treatment history was similar in both populations; overall, the most common treatments were proton pump inhibitors (83%) and topical corticosteroids (51%). Patients reported slightly more days with symptoms, higher impacts on activities of daily living, and slightly higher anxiety or depression in the dysphagia-despite-treatment population versus the overall population.
    CONCLUSIONS: Eosinophilic esophagitis presents severe symptoms and comorbidities that substantially impact patients\' well-being and quality of life. Greater awareness of and novel treatments for eosinophilic esophagitis are needed.
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  • 文章类型: Journal Article
    长期或过度使用酸抑制剂可能会通过改变肠道微生态系统而增加艰难梭菌感染(CDI)的风险。沃诺拉赞,一种新型的钾竞争性酸阻断剂,比质子泵抑制剂(PPI)表现出更快,更持续的酸抑制作用。因此,vonoprazan可能对肠道微生物群产生更大的影响,可能导致CDI。
    本研究旨在通过日本不良药物事件报告(JADER)和FDA不良事件报告系统(FAERS)数据库探索酸抑制剂与CDI之间的潜在关系。
    通过不成比例分析对JADER和FAERS数据库进行回顾性分析。
    我们使用JADER和FAERS数据库对vonoprazan和PPI诱导的CDI进行了信号检测分析。使用报告比值比(ROR)和相应的95%置信区间(95%CI)计算酸抑制剂与CDI之间的关联。当95%CI的下限超过1时,认为该关联具有统计学意义。
    在JADER数据库中,基于可疑药物报告的沃诺拉赞和PPI的ROR(95%CI)为15.84(12.23-20.50)和2.51(1.92-3.28),分别。在FAERS数据库中,基于主要和次要可疑药物报告的沃诺拉赞和PPI的ROR(95%CI)为11.50(6.36-20.82)和1.42(1.34-1.51),分别。亚组分析显示,60岁及以上的老年患者与CDI的相关性更强。在JADER数据库中,60岁及以上患者的vonoprazan和PPI的ROR(95%CI)为15.35(11.59-20.33)和1.65(1.14-2.39),分别。同样,FAERS数据库中vonoprazan和PPI的ROR(95%CI)为12.56(6.26-25.20)和1.43(1.31-1.57),分别。排除幽门螺杆菌(H.幽门螺杆菌)感染,抑酸剂的使用仍与CDI相关.
    虽然基于JADER和FAERS数据库的信号检测分析无法确定因果关系,我们的研究表明,vonoprazan和PPI均与CDI显著相关.在两个数据库中,Vonoprazan与CDI的相关性更强。
    沃诺拉赞和艰难梭菌感染风险。
    沃诺拉赞是一种新型的抑酸剂,与传统的质子泵抑制剂(PPI)相比,它对酸的抑制作用更强。沃诺拉赞可能对肠道微生物群产生更大的影响,这可能会增加艰难梭菌感染(CDI)的风险。FDA创建了FDA不良事件报告系统(FAERS)数据库以支持上市后监测计划。PMDA创建了日本药品不良反应事件报告(JADER)数据库,专门收集日本的不良反应报告。为了进一步了解抑酸剂与CDI之间的潜在关系,本研究使用JADER和FAERS数据库进行分析.
    本研究分析了在JADER和FAERS数据库中使用酸抑制剂后报告的CDI案例。
    分析显示,在两个数据库中,vonoprazan和PPI均与CDI显着相关。值得注意的是,与PPI相比,vonoprazan表现出更强的关联。亚组分析表明,这种关联在60岁及以上的老年患者中更为明显。此外,排除幽门螺杆菌的影响(H.pylori)并未减少酸抑制剂与CDI之间的关联。
    尽管基于JADER和FAERS数据库的信号检测分析无法确定因果关系,结果显示,vonoprazan和PPI均与CDI显著相关.沃诺拉赞与CDI的相关性也比PPI更强,这可能是一个潜在的安全问题,需要进一步的临床研究来证实这一发现。
    UNASSIGNED: Prolonged or excessive use of acid suppressants may increase the risk of Clostridioides difficile infection (CDI) by altering the intestinal microecosystem. Vonoprazan, a novel potassium-competitive acid blocker, exhibits a faster and more sustained acid-suppressive effect than proton pump inhibitors (PPIs). Therefore, vonoprazan may have a greater impact on the gut microbiota, potentially resulting in CDI.
    UNASSIGNED: This study aimed to explore the potential relationship between acid suppressants and CDI by the Japan Adverse Drug Event Report (JADER) and the FDA Adverse Event Reporting System (FAERS) databases.
    UNASSIGNED: A retrospective analysis of the JADER and FAERS databases was examined by disproportionality analysis.
    UNASSIGNED: We performed signal detection analyses of CDI induced by vonoprazan and PPIs using the JADER and FAERS databases. The association between acid suppressants and CDI was calculated using the reporting odds ratio (ROR) and corresponding 95% confidence interval (95% CI). When the lower limit of the 95% CI is exceeded by 1, the association is considered statistically significant.
    UNASSIGNED: In the JADER database, the ROR (95% CI) for vonoprazan and PPIs based on suspect drug reports was 15.84 (12.23-20.50) and 2.51 (1.92-3.28), respectively. In the FAERS database, the ROR (95% CI) for vonoprazan and PPIs based on primary and secondary suspect drug reports was 11.50 (6.36-20.82) and 1.42 (1.34-1.51), respectively. Subgroup analysis showed that elderly patients aged 60 years and older were more strongly associated with CDI. The ROR (95% CI) for vonoprazan and PPIs in patients aged 60 years and older in the JADER database was 15.35 (11.59-20.33) and 1.65 (1.14-2.39), respectively. Similarly, the ROR (95% CI) for vonoprazan and PPIs in the FAERS database was 12.56 (6.26-25.20) and 1.43 (1.31-1.57), respectively. Excluding the effect of Helicobacter pylori (H. pylori) infection, the use of acid suppressants was still associated with CDI.
    UNASSIGNED: While signal detection analysis based on the JADER and FAERS databases could not establish causality, our study demonstrated that both vonoprazan and PPIs were significantly associated with CDI. Vonoprazan showed a stronger association with CDI in both databases.
    Vonoprazan and Clostridioides difficile infection risk.
    UNASSIGNED: Vonoprazan is a new type of acid suppressant, which has a stronger effect on acid inhibition than traditional proton pump inhibitors (PPIs). Vonoprazan may have a greater impact on the gut microbiota, which may increase the risk of Clostridioides difficile infection (CDI). The FDA created the FDA Adverse Event Reporting System (FAERS) database to support the post-market surveillance program. The PMDA created the Japan Adverse Drug Reaction Event Report (JADER) database to specifically collect adverse reaction reports in Japan. To further understand the potential relationship between acid suppressants and CDI, this study was analyzed using the JADER and FAERS databases.
    UNASSIGNED: This study analyzed cases of CDI reported after the use of acid suppressants in the JADER and FAERS databases.
    UNASSIGNED: The analysis revealed that vonoprazan and PPIs are significantly associated with CDI in both databases. Notably, vonoprazan exhibited a stronger association compared to PPIs. Subgroup analysis indicated that this association was more pronounced in elderly patients aged 60 years and older. Additionally, excluding the influence of Helicobacter pylori (H. pylori) did not diminish the association between acid suppressants and CDI.
    UNASSIGNED: Although signal detection analysis based on the JADER and FAERS databases could not establish causality, the results showed that both vonoprazan and PPIs were significantly associated with CDI. Vonoprazan was also more strongly associated with CDI than PPIs, which could be a potential safety concern, and further clinical studies are needed to confirm this finding.
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  • 文章类型: Journal Article
    背景:沃诺拉赞-阿莫西林双重疗法(VAT)治疗幽门螺杆菌的疗效(H。幽门螺杆菌)是有争议的。
    目的:评估增值税在中国人群中的疗效。
    方法:这种前瞻性,多中心,随机化,开放标签,在福建的23个中心进行了两阶段的研究,中国(2021年5月-2022年4月)。幽门螺杆菌感染患者随机接受铋四联疗法(BQT),BQT-Vonoprazan(BQT-V),七天增值税(VAT-7),十天增值税(VAT-10),和14天增值税(VAT-14)组。主要终点是幽门螺杆菌根除率。次要终点是不良事件的频率。本研究在中国临床试验注册中心注册,ChiCTR2100045778。
    结果:在第一阶段,选择VAT-7和BQT-V组进行提前终止,因为28例病例中不到23例被根除。在第二阶段,BQT的根除率,VAT-10和VA-14分别为80.2%[95%置信区间(95CI):71.4%-86.8%],93.2%(86.6%-96.7%),意向治疗(ITT)分析为92.2%(85.3%-96.0%),和80.9%(95CI:71.7%-87.5%),94.0%(87.5%-97.2%),在符合方案分析中占93.9%(87.4%-97.2%)。ITT分析显示,VAT-10和VAT-14组的根除率高于BQT组(分别为P=0.022和P=0.046)。VAT-10和VAT-14组的不良事件发生率低于BQT组(25.27%和13.73%vs37.62%,分别;P<0.001)。
    结论:持续时间为10或14天的增值税比BQT获得更高的根除率,在福建幽门螺杆菌感染患者中具有更高的耐受性安全性。
    BACKGROUND: The efficacy of Vonoprazan-amoxicillin dual therapy (VAT) in the treatment of Helicobacter pylori (H. pylori) is controversial.
    OBJECTIVE: To evaluate the efficacy of VAT in the Chinese population.
    METHODS: This prospective, multicenter, randomized, open-label, and two-stage study was conducted at 23 centers in Fujian, China (May 2021-April 2022). H. pylori-infected patients were randomized to bismuth quadruple therapy (BQT), BQT-Vonoprazan (BQT-V), seven-day VAT (VAT-7), ten-day VAT (VAT-10), and fourteen-day VAT (VAT-14) groups. The primary endpoint was the H. pylori eradication rate. The secondary endpoint was the frequency of adverse events. This study was registered with the Chinese Clinical Trial Registry, ChiCTR2100045778.
    RESULTS: In the first stage, VAT-7 and BQT-V groups were selected for early termination because less than 23 among 28 cases were eradicated. In the second stage, the eradication rates for BQT, VAT-10, and VA-14 were 80.2% [95% confidence interval (95%CI): 71.4%-86.8%], 93.2% (86.6%-96.7%), 92.2% (85.3%-96.0%) in the intention-to-treat (ITT) analysis, and 80.9% (95%CI: 71.7%-87.5%), 94.0% (87.5%-97.2%), and 93.9% (87.4%-97.2%) in the per-protocol analysis. The ITT analysis showed a higher eradication rate in the VAT-10 and VAT-14 groups than in the BQT group (P = 0.022 and P = 0.046, respectively). The incidence of adverse events in the VAT-10 and VAT-14 groups was lower than in the BQT group (25.27% and 13.73% vs 37.62%, respectively; P < 0.001).
    CONCLUSIONS: VAT with a duration of 10 or 14 days achieves a higher eradication rate than the BQT, with a more tolerable safety profile in H. pylori-infected patients in Fujian.
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  • 文章类型: Journal Article
    质子泵抑制剂(PPI)用于预防接受双重抗血小板治疗(DAPT)的冠状动脉治疗患者的胃肠道出血。
    对急性冠脉综合征(ACS)患者或经皮冠状动脉介入治疗(PCI)伴冠状动脉支架植入术(PCI)患者的DAPT和DAPT+PPI结果进行了系统评价,并估计,第一次,通过试验序贯分析(TSA)得出可靠结果所需的样本量.PubMed,EMBASE,本研究在Cochrane图书馆和WebofScience数据库中搜索了从发病至2022年11月1日发表的文章,用于比较接受DAPT或DAPT+PPI的ACS或PCI患者结局的随机对照试验(RCT).主要结果是胃肠道事件和主要不良心血管事件(MACEs)的发生率。
    最初的网络搜索检索了786篇参考文献。最终,2009年至2020年发表的8篇文章被纳入系统评价和荟萃分析.综合结果确定了DAPT组和DAPTPPI组之间的MACE发生率无显著差异[风险比(RR)=0.93,95%置信区间(CI)=0.81-1.06,p=0.27,I2=0%];相反,与DAPT组相比,DAPT+PPI组的胃肠道事件发生率显著降低(RR=0.33,95%CI=0.24~0.45,p<0.00001,I2=0%).MACE和胃肠道事件的TSA显示,荟萃分析包括足够的试验(所需样本量=6874),以达到80%的研究能力。
    根据我们的结果,与DAPT相比,DAPT+PPI可以显著降低PCI和ACS患者的胃肠道结局而不影响心血管结局。
    UNASSIGNED: Proton pump inhibitors (PPIs) are used to prevent gastrointestinal hemorrhage in patients with coronary treatment undergoing dual antiplatelet therapy (DAPT).
    UNASSIGNED: A systematic review was performed to compare the outcomes between DAPT and DAPT + PPI in acute coronary syndrome (ACS) patients or patients who took percutaneous coronary intervention (PCI) with coronary stent implantation (PCI patients), and to estimate, for the first time, the sample size needed for reliable results via trial sequential analysis (TSA). The PubMed, EMBASE, the Cochrane Library and Web of Science databases were searched for articles authored from the onset until November 1, 2022, for randomized controlled trials (RCTs) comparing outcomes in ACS or PCI patients who undertook DAPT or DAPT + PPI. The primary outcomes were the incidence rate of gastrointestinal events and major adverse cardiovascular events (MACEs).
    UNASSIGNED: The initial web search retrieved 786 literature references. Eventually, eight articles published between 2009 and 2020 were incorporated into the systematic review and meta-analysis. The combined results established a non-significant variation in MACEs incidences between the DAPT group and DAPT + PPI group [risk ratio (RR) = 0.93, 95% confidence interval (CI) = 0.81-1.06, p = 0.27, I 2 = 0%]; conversely, the incidence of gastrointestinal events was significantly decreased in the DAPT + PPI group in comparison with the DAPT group (RR = 0.33, 95% CI = 0.24-0.45, p < 0.00001, I 2 = 0%). TSA of MACEs and gastrointestinal events revealed that meta-analysis included adequate trials (required sample size = 6874) in the pool to achieve 80% study power.
    UNASSIGNED: Based on our results, DAPT + PPI can significantly reduce gastrointestinal outcomes without affecting cardiovascular outcomes in PCI and ACS patients compared to DAPT.
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  • 文章类型: Journal Article
    在本研究中,作者研究了胃细菌感染与幽门螺杆菌胃镜检查结果之间的关联(H.幽门螺杆菌)阴性患者。受试者为105名幽门螺杆菌阴性患者。平均年龄为72.8±9.1岁。进行内窥镜检查和胃液培养。根据胃炎的京都分类检查是否存在内窥镜检查结果。69例患者(65.7%)培养阳性,以溶血性链球菌α最为常见(51例),其次是奈瑟氏菌。(43名患者)。根据单变量分析,使用胃抗分泌药物的培养结果和背景因素之间以及萎缩性胃炎的培养结果和各种内镜检查结果之间存在显着差异,肠上皮化生,定期安排收集小静脉,粘膜肿胀,粘稠的粘液,增生性息肉,血红素,和胃的鹅卵石样病变.此外,多变量分析显示,仅在粘膜肿胀患者中,诸如使用胃抗分泌药物和内镜检查结果等背景因素存在显着差异。非H.幽门螺杆菌细菌阳性胃炎在几个方面与幽门螺杆菌感染胃炎的内镜检查结果不同。总之,我们的结果表明非H.幽门螺杆菌可能会感染胃并引起胃部炎症,尤其是长期使用胃抗分泌药物的患者。
    In the present study, the authors examined the association between gastric bacterial infection and gastric endoscopic findings in Helicobacter pylori (H. pylori)-negative patients. The subjects were 105 H. pylori-negative patients. The mean age was 72.8 ± 9.1 years. Endoscopy and gastric juice culture were performed. The presence or absence of endoscopic findings was checked according to the Kyoto classification of gastritis. Culture was positive in 69 patients (65.7%), with Streptococcus α-hemolytic being the most common (51 patients), followed by Neisseria sp. (43 patients). According to the univariate analysis, there was a significant difference between the results of culture and background factors in the use of gastric antisecretory drugs and between the results of culture and various endoscopic findings in atrophic gastritis, intestinal metaplasia, regular arrangement of collecting venule, mucosal swelling, sticky mucus, hyperplastic polyps, hematin, and gastric cobblestone-like lesions. Furthermore, multivariate analysis revealed significant differences in background factors such as the use of gastric antisecretory drugs and endoscopic findings only in patients with mucosal swelling. Endoscopic findings of non-H. pylori bacteria-positive gastritis differed from endoscopic findings of H. pylori-infected gastritis in several respects. In conclusion, our results suggest that non-H. pylori bacteria may infect the stomach and cause gastric inflammation, especially in patients who long term use gastric antisecretory drugs.
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  • 文章类型: Journal Article
    背景:目前越南儿童中基于抗菌药物敏感性的幽门螺杆菌根除治疗效率较低。有治疗失败的原因,在宿主遗传因素中,MDR1C3435T和CYP2C19会影响质子泵抑制剂的吸收和代谢-这是根除治疗的关键组成部分。本研究旨在探讨MDR1C3435T和CYP2C19基因多态性对治愈率的影响。
    方法:207例感染幽门螺杆菌的胃炎和消化性溃疡的儿科患者完成了基于质子泵抑制剂埃索美拉唑对抗菌药物敏感性的根除治疗。至少4周后通过脲酶呼气试验评估根除功效。使用基于Sanger原理的测序方法确定MDR1C3435T遗传多态性和CYP2C19基因型。
    结果:在这项研究中招募的207名儿童中,CYP2C19EM的比值,IM,PM表型为40.1%,46.4%,和16.9%,分别。MDR13435C/C多态性患者占43.0%,MDR13435C/T为40.1%,MDR13435T/T为16.9%。CYP2C19EM基因型患者幽门螺杆菌感染的治愈率为78.3%;IM基因型为83.3%,PM基因型为96,4%(p=0.07)。根除幽门螺杆菌的成功率为85.4%,86.7%,MDR13435C/C的患者为68.6%,C/T,和T/T,分别(p=0.02)。多因素logistic回归分析发现MDR1C3435T基因多态性是患者治疗失败的独立危险因素,CYP2C19基因型不影响幽门螺杆菌根除。
    结论:基于抗生素敏感性和埃索美拉唑的治疗方案根除幽门螺杆菌的率在CYP2C19表型之间无显著差异。MDR1C3435T多态性是影响儿童幽门螺杆菌根除结果的因素之一。
    BACKGROUND: Helicobacter pylori eradication therapy based on antimicrobial susceptibility in Vietnamese children currently get low efficiency. There are causes of treatment failure, among host genetic factors namely MDR1 C3435T and CYP2C19 affect the absorption and metabolism of proton pump inhibitors - a crucial component of eradication therapy. The study aimed to investigate the effect of MDR1 C3435T and CYP2C19 genetic polymorphisms on the cure rate.
    METHODS: 207 pediatric patients with gastritis and peptic ulcer infecting Helicobacter pylori completed the eradication therapy based on antimicrobial susceptibility with proton pump inhibitor esomeprazole. Eradication efficacy was assessed after at least 4 weeks by the urease breath test. MDR1 C3435T genetic polymorphism and CYP2C19 genotype were determined using a sequencing method based on Sanger\'s principle.
    RESULTS: Among 207 children recruited in this study, the ratio of CYP2C19 EM, IM, and PM phenotypes was 40.1%, 46.4%, and 16.9%, respectively. The patient with MDR1 3435 C/C polymorphism accounted for 43.0%, MDR1 3435 C/T was 40.1%, and MDR1 3435T/T was 16.9%. The cure rate of Helicobacter pylori infection in patients with CYP2C19 EM genotype was 78.3%; 83.3% of those with the IM genotype, and PM genotype was 96,4% (p = 0.07). Successful eradication rates for Helicobacter pylori were 85.4%, 86.7%, and 68.6% in patients with the MDR1 3435 C/C, C/T, and T/T, respectively (p = 0.02). Multiple logistic regression analysis found that MDR1 C3435T genetic polymorphisms of patients were significant independent risk factors for treatment failure, and CYP2C19 genotype did not affect Helicobacter pylori eradication.
    CONCLUSIONS: The Helicobacter pylori eradication rates by regimens based on antibiotic susceptibility and esomeprazole were not significantly different between the CYP2C19 phenotypes. The MDR1 C3435T polymorphism is one of the factors impacting Helicobacter pylori eradication results in children.
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