breath tests

呼气试验
  • 文章类型: Journal Article
    背景:在这项研究中,呼出气测试被认为是检测和监测乳腺癌(BC)的一种有前途的方法。
    方法:使用高压光子电离飞行时间质谱(HPPI-TOFMS)平台检测呼吸样品中的挥发性有机化合物(VOC)。然后,在VOCs上构建机器学习(ML)模型,用于BC的诊断及其进展监测。最终,1981年有可用呼吸样本的女性被纳入研究,其中937(47.3%)被诊断为BC。VOC面板用于ML模型构建,用于BC检测和进展监测。
    结果:在盲测试队列中,这种基于VOC的模型成功区分了有和无BC的患者,具有敏感性,特异性,受试者特征曲线下面积(AUC)值为85.9%,90.4%,0.946区分有和没有淋巴结转移(LNM)的患者或患有肿瘤淋巴结转移(TNM)0/I/II或III/IV期疾病的患者时,相应的AUC值分别为0.840和0.708。尽管开发的基于VOC的模型在尝试根据病理模式(导管原位癌(DCIS)与侵袭性BC(IBC))或分子亚型(管腔与人类表皮生长因子受体2(HER2)与三阴性BC(TNBC))区分患者时表现不佳。
    结论:总的来说,基于HPPI-TOFMS的呼吸组学方法可能为BC的检测和进展监测提供价值.需要进一步的研究来探索已识别的VOCs的基本机制。
    BACKGROUND: In this study, exhaled breath testing has been considered a promising method for the detection and monitoring of breast cancer (BC).
    METHODS: A high-pressure photon ionization time-of-flight mass spectrometry (HPPI-TOFMS) platform was used to detect volatile organic compounds (VOCs) in breath samples. Then, machine learning (ML) models were constructed on VOCs for the diagnosis of BC and its progression monitoring. Ultimately, 1981 women with useable breath samples were included in the study, of whom 937 (47.3 %) had been diagnosed with BC. VOC panels were used for ML model construction for BC detection and progression monitoring.
    RESULTS: On the blinded testing cohort, this VOC-based model successfully differentiated patients with and without BC with sensitivity, specificity, and area under receiver operator characteristic curve (AUC) values of 85.9 %, 90.4 %, and 0.946. The corresponding AUC values when differentiating between patients with and without lymph node metastasis (LNM) or between patients with tumor-node-metastasis (TNM) stage 0/I/II or III/IV disease were 0.840 and 0.708, respectively. While developed VOC-based models exhibited poor performance when attempting to differentiate between patients based on pathological patterns (Ductal carcinoma in situ (DCIS) vs Invasive BC (IBC)) or molecular subtypes (Luminal vs Human epidermal growth factor receptor 2 (HER2+) vs Triple-negative BC (TNBC)) of BC.
    CONCLUSIONS: Collectively, the HPPI-TOFMS-based breathomics approaches may offer value for the detection and progression monitoring of BC. Additional research is necessary to explore the fundamental mechanisms of the identified VOCs.
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  • 文章类型: Journal Article
    目的:本研究评估了人体测量学,生物化学,和炎症生物标志物,以及诊断为小肠细菌过度生长(SIBO)的巴西儿童的饮食摄入量,并将其与没有SIBO的儿童进行比较。
    方法:这是一项对106名7至10岁儿童的横断面研究。进行葡萄糖-氢呼气试验以诊断小肠细菌过度生长(SIBO)。评估了人体测量和饮食特征。收集血液样品并测量血清生化参数和细胞因子。
    结果:SIBO的发生率为13.2%。年龄,BMI,BMI/年龄WC,BFP,SIBO阳性和SIBO阴性儿童的性别和生化指标相似(p>0.05)。与SIBO阴性儿童相比,SIBO阳性儿童的超加工食品的高消费量往往更高(47.8±8.2vs.42.6±9.5,p=0.06)。SIBO阳性儿童的血清IL-17水平高于SIBO阴性儿童[69.5(5.4-125.7)与53.4(2.3-157.7),p=0.03],而SIBO阳性儿童的血清IL-10水平低于SIBO阴性儿童[2.3(0.6-7.2)vs.5.7(0.5-30.8),p=0.04]。最后,在根据性别调整的逻辑回归中,BMI和年龄,超加工食品的消费(p=0.03)和IL-6水平(p=0.003)被发现有助于SIBO的发生。
    结论:这项研究首次发现生活在巴西东北部地区的儿童中发生了13%的SIBO,并表明食用超加工食品和血清IL-6水平可能会影响儿科人群中SIBO的发生。
    OBJECTIVE: This study evaluated anthropometric, biochemical, and inflammatory biomarkers, as well as dietary intake in Brazilian children diagnosed with small intestinal bacterial overgrowth (SIBO) and compared them with their counterparts without SIBO.
    METHODS: This was a cross-sectional study with 106 children aged 7 to 10 years. A glucose-hydrogen breath test was performed to diagnose small intestinal bacterial overgrowth (SIBO). Anthropometric and dietary characteristics were assessed. Blood samples were collected and serum biochemical parameters and cytokines were measured.
    RESULTS: The occurrence of SIBO was 13.2%. Age, BMI, BMI/age WC, BFP, sex and biochemical markers were similar between SIBO-positive and SIBO-negative children (p > 0.05). High consumption of ultra-processed foods tended to be higher in SIBO-positive compared to SIBO-negative children (47.8 ± 8.2 vs. 42.6 ± 9.5, p = 0.06). Serum levels of IL-17 were higher in SIBO-positive than in SIBO-negative children [69.5 (5.4-125.7) vs. 53.4 (2.3-157.7), p = 0.03], while serum levels of IL-10 were lower in SIBO-positive than in SIBO-negative children [2.3 (0.6-7.2) vs. 5.7 (0.5-30.8), p = 0.04]. Finally, in a logistic regression adjusted for sex, BMI and age, consumption of ultra-processed foods (p = 0.03) and IL-6 levels (p = 0.003) were found to contribute to the occurrence of SIBO.
    CONCLUSIONS: this study identified for the first time an occurrence of 13% of SIBO in children living in the northeastern region of Brazil and showed that consumption of ultra-processed foods and serum levels of IL-6 may influence the occurrence of the SIBO in the pediatrics population.
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  • 文章类型: Journal Article
    背景:理论上,使用胃壁拭子(Swab-RUT)对幽门螺杆菌(H.幽门螺杆菌)是安全的。然而,Swab-RUT的有效性和实用性尚不清楚。因此,我们使用胃壁粘膜钳(Forceps-RUT)和13C-尿素呼气试验(UBT)评估了Swab-RUT与RUT的有效性和实用性。
    方法:本研究为多中心前瞻性观察性研究。当受检者在食管胃十二指肠镜检查期间怀疑幽门螺杆菌感染时,我们连续进行拭子-RUT和镊子-RUT。当受检者没有怀疑幽门螺杆菌感染时,我们单独表演了Swab-RUT。我们使用UBT验证了幽门螺杆菌感染的状态。
    结果:在2016年5月至2020年12月期间,来自四个机构的94名考生被录取(平均年龄[范围],56.5[26-88]年)。在这项研究中,灵敏度,特异性,Swab-RUT对UBT的准确性为0.933(95%置信区间:0.779-0.992),0.922(0.827-0.974),和0.926(0.853-0.970),分别。拭子-RUT对UBT的Kappa系数为0.833,拭子-RUT对镊子-RUT的Kappa系数为0.936。在这项研究中没有观察到并发症。
    结论:与常规Forceps-RUT相比,Swarb-RUT是幽门螺杆菌感染状态的有效检查方法。
    BACKGROUND: Theoretically, a rapid urease test (RUT) using a swab of the gastric wall (Swab-RUT) for Helicobacter pylori (H. pylori) is safe. However, the validity and utility of Swab-RUT remain unclear. Therefore, we assessed the validity and utility of Swab-RUT compared to RUT using mucosal forceps of the gastric wall (Forceps-RUT) and 13C-urea breath test (UBT).
    METHODS: This study was a multicenter prospective observational study. When the examinees were suspected of H. pylori infection during esophagogastroduodenoscopy, we performed Swab-RUT and Forceps-RUT continuously. When the examinees were not suspected of H. pylori infection, we performed Swab-RUT alone. We validated the status of H. pylori infection using UBT.
    RESULTS: Ninety-four examinees were enrolled from four institutions between May 2016 and December 2020 (median age [range], 56.5 [26-88] years). In this study, the sensitivity, specificity, and accuracy of Swab-RUT to UBT were 0.933 (95% confidence interval: 0.779-0.992), 0.922 (0.827-0.974), and 0.926 (0.853-0.970), respectively. The Kappa coefficient of Swab-RUT to UBT was 0.833, and that of Swab-RUT to forceps-RUT was 0.936. No complications were observed in this study.
    CONCLUSIONS: Swab-RUT is a valid examination for the status of H. pylori infection compared to the conventional Forceps-RUT.
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  • 文章类型: Letter
    暂无摘要。
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  • 文章类型: Journal Article
    背景:尚未研究呼出气冷凝液(EBC)中美托洛尔的浓度。在这里,我们的目标是确定EBC中的美托洛尔水平,等离子体,还有尿液样本.
    方法:从39名接受美托洛尔的患者中收集生物样本。使用液相色谱质谱测定美托洛尔。研究了生物流体中获得的美托洛尔水平的可能相互关系。
    结果:EBC的决定系数等于0.9998、0.9941和0.9963,获得了可接受的线性,等离子体,还有尿液样本,分别。关于EBC,校准曲线在0.6-500、0.4-500和0.7-10,000µg·L-1的范围内呈线性关系,等离子体,还有尿液样本,分别。EBC的检测和定量限分别为(0.18、0.12和0.21µg·L-1)和(0.60、0.40和0.70µg·L-1),等离子体,还有尿液样本,分别。日内和日间重复的相对标准偏差在5.2和6.1和3.3-4.6%之间获得,分别。EBC中获得的美托洛尔平均水平,等离子体,39例患者的尿液样本分别为5.35、70.76和1943.1µg·L-1。研究样品中美托洛尔的日剂量与血浆和尿浓度之间存在相关性,而每日剂量和EBC水平没有观察到显著的相关性。血浆-尿液水平之间的相关性是显著的,然而,血浆和EBC浓度之间无显著相关性.
    结论:美托洛尔水平因阿塞拜疆人群的代谢模式而变化很大,患者接受的不同剂量,配方效应,年龄,性别,以及与共同给药的药物的相互作用。观察到EBC-血浆浓度的相关性较差,血浆-尿液浓度的相关性显着。需要进一步调查才能为个性化医疗部门提供最新服务。
    BACKGROUND: Concentrations of metoprolol in exhaled breath condensate (EBC) have not been investigated. Herein, we aim to determine the metoprolol levels in EBC, plasma, and urine samples.
    METHODS: Biological samples were collected from 39 patients receiving metoprolol. Metoprolol was determined using liquid chromatography mass spectrometery. The obtained metoprolol levels in biological fluids were investigated for possible inter-correlations.
    RESULTS: Acceptable linearity was obtained with coefficient of determinations equal to 0.9998, 0.9941, and 0.9963 for EBC, plasma, and urine samples, respectively. The calibration curves were linear in the ranges of 0.6-500, 0.4-500, and 0.7-10,000 µg·L- 1 regarding EBC, plasma, and urine samples, respectively. The detection and quantification limits were (0.18, 0.12, and 0.21 µg·L- 1) and (0.60, 0.40, and 0.70 µg·L- 1) for EBC, plasma, and urine samples, respectively. The relative standard deviations for the intra- and inter-day replications were obtained between 5.2 and 6.1 and 3.3-4.6%, respectively. The obtained mean metoprolol levels in EBC, plasma, and urine samples of 39 patients were 5.35, 70.76, and 1943.1 µg·L- 1. There were correlations between daily dose and plasma and urinary concentrations of metoprolol in the investigated samples, whereas no significant correlation was observed for daily dose and EBC levels. The correlation among plasma-urine levels was significant, however, the non-significant correlation was obtained between plasma and EBC concentrations.
    CONCLUSIONS: Metoprolol levels varied widely due to the metabolic pattern of the Azeri population, different dosages received by the patients, formulation effects, age, sex, and interactions with the co-administered drugs. A poor correlation of EBC-plasma concentrations and a significant correlation of plasma-urine concentrations were observed. Further investigations are required to provide the updated services to personalized medicine departments.
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  • 文章类型: Journal Article
    背景:当前呼吸生物标志物的敏感性和特异性通常不足以进行有效的癌症筛查,尤其是结直肠癌(CRC)。虽然CRC中的一些呼出生物标志物表现出高特异性,它们缺乏早期检测所需的灵敏度,从而限制了患者生存率的提高。方法:在本研究中,我们开发了一个先进的基于质谱的挥发物组学平台,辅以增强的呼吸采样器。该平台集成了人工智能(AI)辅助算法,以检测人体呼吸中的多种挥发性有机化合物(VOC)生物标志物。随后,我们应用该平台分析了364例临床CRC和正常呼出气样本.结果:诊断特征,包括2-甲基,辛烷值,和丁酸,该平台生成的CRC患者与正常对照具有较高的敏感性(89.7%),特异性(86.8%),和准确性(AUC=0.91)。此外,转移特征正确识别了超过50%的癌胚抗原(CEA)检测阴性的转移患者.粪便验证表明,呼吸生物标志物升高与CRC中脆弱拟杆菌引导的炎症反应相关。结论:这项研究引入了一个复杂的AI辅助质谱平台,能够识别新的和可行的呼吸生物标志物早期CRC检测。有希望的结果将该平台定位为临床应用的有效无创筛查测试,为早期发现提供了潜在的进步,并提高了CRC患者的生存率。
    Background: The sensitivity and specificity of current breath biomarkers are often inadequate for effective cancer screening, particularly in colorectal cancer (CRC). While a few exhaled biomarkers in CRC exhibit high specificity, they lack the requisite sensitivity for early-stage detection, thereby limiting improvements in patient survival rates. Methods: In this study, we developed an advanced Mass Spectrometry-based volatilomics platform, complemented by an enhanced breath sampler. The platform integrates artificial intelligence (AI)-assisted algorithms to detect multiple volatile organic compounds (VOCs) biomarkers in human breath. Subsequently, we applied this platform to analyze 364 clinical CRC and normal exhaled samples. Results: The diagnostic signatures, including 2-methyl, octane, and butyric acid, generated by the platform effectively discriminated CRC patients from normal controls with high sensitivity (89.7%), specificity (86.8%), and accuracy (AUC = 0.91). Furthermore, the metastatic signature correctly identified over 50% of metastatic patients who tested negative for carcinoembryonic antigen (CEA). Fecal validation indicated that elevated breath biomarkers correlated with an inflammatory response guided by Bacteroides fragilis in CRC. Conclusion: This study introduces a sophisticated AI-aided Mass Spectrometry-based platform capable of identifying novel and feasible breath biomarkers for early-stage CRC detection. The promising results position the platform as an efficient noninvasive screening test for clinical applications, offering potential advancements in early detection and improved survival rates for CRC patients.
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  • 文章类型: Journal Article
    呼吸中挥发性有机化合物(VOCs)的检测已成为早期癌症筛查的潜在方法。尽管这种方法引起了科学界和医学界越来越多的关注,它在临床上没有受到明显的牵引。有两个主要障碍。一种方法涉及特别是在早期癌症中鉴定特异性生物标志物或其组合。另一个是缺乏具有适当灵敏度和特异性的用于呼吸分析的专用设备。利用代谢组学,本章研究涉及癌症患者呼吸气体生物标志物的研究策略,癌细胞气体代谢物和合成生物标志物。我们简要探讨了七种癌症的气体生物标志物,并介绍了检测原理和临床应用。重点介绍了大型分析仪器和小型传感器技术。提出了VOC分析的挑战,包括临床使用,提取和检测,小型化努力和代谢VOC途径的检查。最后,本文对肿瘤和呼气中的VOCs检测技术进行了总结和展望。
    The detection of volatile organic compounds (VOCs) in breath has become a potential method for early cancer screening. Although this approach has attracted increasing attention from the both scientific and medical communities, it has not received appreciable traction in the clinical setting. There are two main obstacles. One involves the identification of specific biomarkers or combinations thereof especially in early cancer. The other is the lack the specialized equipment for breath analysis having the appropriate sensitivity and specificity. Using metabolomics, this chapter examines the research strategies involving gas biomarkers in cancer patient breath, cancer cell gas metabolites and synthetic biomarkers. We briefly explore gas biomarkers of seven cancers and introduce principles of detection and clinical application. Large analytical instruments and small sensor technology are highlighted. Challenges to VOC analysis are presented including clinical use, extraction and detection, miniaturization efforts and examination of metabolic VOC pathways. Finally, VOCs in cancer and in exhaled breath detection technology are summarized and future prospects explored.
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  • 文章类型: Journal Article
    背景:当前指南建议对新诊断为幽门螺杆菌的患者使用含铋的四联疗法(H.幽门螺杆菌)感染。我们的目的是比较含铋剂的四联疗法用于幽门螺杆菌感染一线治疗的四环素每日三次和每日四次的疗效和安全性。
    方法:这个多中心,非自卑,随机对照研究,在中国进行,招募治疗-幽门螺杆菌感染的初治成人,1:1随机分为两个治疗组,分别接受以下含铋的四联疗法:艾司奥美拉唑20mg,每日2次;铋220mg,每日2次;阿莫西林1000mg,每日2次;四环素500mg,每日3次(TET-T)和500mg,每日4次(TET-F).治疗后至少6周,我们进行了13C-尿素呼气试验以评估幽门螺杆菌根除情况.
    结果:总计,406例患者被随机分配到两个治疗组。意向治疗根除率分别为91.63%(186/203;95%置信区间[CI]87.82%-95.44%)和90.15%(183/203;95%CI86.05%-94.25%)(p=0.0005),按方案根除率分别为95.34%(184/193;95%CI92.36%-98.31%,TCI为9179-2.62)和95.72%(TF=91872.62)分别。TET-T治疗的患者的不良反应发生率低于TET-F治疗的患者(21.61%vs.31.63%,p=0.024),两组之间对治疗的依从性没有显着差异。
    结论:作为幽门螺杆菌感染的一线治疗,TET-T治疗的根除率不劣于TET-F治疗,同时显著降低了不良反应的发生率.
    背景:ClinicalTrials.gov标识符:NCT05431075。
    BACKGROUND: Current guidelines recommend bismuth-containing quadruple therapy for patients newly diagnosed with Helicobacter pylori (H. pylori) infection. We aimed to compare the efficacy and safety of tetracycline administered three times daily versus four times daily in bismuth-containing quadruple therapy for first-line treatment of H. pylori infection.
    METHODS: This multicenter, noninferiority, randomized controlled study, conducted in China, recruited treatment-naïve adults with H. pylori infection, randomized 1:1 into two treatment groups to receive either of the following bismuth-containing quadruple therapies: esomeprazole 20 mg twice-daily; bismuth 220 mg twice-daily; amoxicillin 1000 mg twice-daily; and tetracycline 500 mg three times daily (TET-T) versus 500 mg four times daily (TET-F). At least 6 weeks post-treatment, a 13C-urea breath test was performed to evaluate H. pylori eradication.
    RESULTS: In total, 406 patients were randomly assigned to the two treatment groups. Intention-to-treat eradication rates were 91.63% (186/203; 95% confidence interval [CI] 87.82%-95.44%) versus 90.15% (183/203; 95% CI 86.05%-94.25%) (p = 0.0005) and per-protocol eradication rates were 95.34% (184/193; 95% CI 92.36%-98.31%) versus 95.72% (179/187; 95% CI 92.82%-98.62%) (p = 0.0002) for the TET-T and TET-F group, respectively. TET-T-treated patients had a lower incidence of adverse effects than TET-F-treated patients (21.61% vs. 31.63%, p = 0.024), with no significant differences in compliance to treatment between the groups.
    CONCLUSIONS: As a first-line therapy for H. pylori infection, the eradication rate of the TET-T therapy was noninferior to that of the TET-F therapy while significantly reducing the incidence of adverse reactions.
    BACKGROUND: ClinicalTrials.gov identifier: NCT05431075.
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  • 文章类型: Journal Article
    聚合物袋是一种应用广泛的,简单,以及用于气态样品的存储和离线分析的经济有效的方法。各种材料已被用作取样袋,所有已知的都含有杂质,成本不同,耐用性,和存储能力。在这里,我们对几种著名的袋子材料进行了比较研究,Tedlar(PVF),Kynar(PVDF),聚四氟乙烯(PTFE),和纳洛芬(PET),以及一种新材料,乙烯-乙烯基共聚物(EVOH),通常用于储存食物。我们调查了储存条件的影响,湿度,湿度袋子清洁,和光照对挥发性有机化合物浓度(丙酮,乙酸,异戊二烯,苯,柠檬烯,除其他外)在袋子中储存长达48小时的呼出人体呼吸样本中。具体来说,我们在所有材料的袋子中显示出短链脂肪酸(SCFA)的高损失(对于大多数SCFA,储存8小时后低于50%)。我们发现特德拉的样本,纳洛芬,和EVOH袋在暴露于UV辐射48小时的时间段时经历组成的变化。我们报告了所有袋中的高初始杂质水平,并且在48小时后加倍。我们将二次电喷雾电离(SESI)和质子转移反应(PTR)质谱在采样袋中储存后进行离线分析。通过呈现所有重要的m/z特征的强度变化,我们提供了对袋子内容物的时间演变的分析观点。我们还提出了一个简单的,自动化,和具有成本效益的离线样品引入系统,这使得能够将从聚合物袋收集的气体样品控制递送到质谱仪中。总的来说,我们的研究结果表明,取样袋表现出高水平的杂质,对几个环境因素敏感(例如,曝光),并为某些类别的化合物提供低回收率,例如,短链脂肪酸。
    Polymeric bags are a widely applied, simple, and cost-effective method for the storage and offline analysis of gaseous samples. Various materials have been used as sampling bags, all known to contain impurities and differing in their cost, durability, and storage capabilities. Herein, we present a comparative study of several well-known bag materials, Tedlar (PVF), Kynar (PVDF), Teflon (PTFE), and Nalophan (PET), as well as a new material, ethylene vinyl copolymer (EVOH), commonly used for storing food. We investigated the influences of storage conditions, humidity, bag cleaning, and light exposure on volatile organic compound concentration (acetone, acetic acid, isoprene, benzene, limonene, among others) in samples of exhaled human breath stored in bags for up to 48 h. Specifically, we show high losses of short-chain fatty acids (SCFAs) in bags of all materials (for most SCFAs, less than 50% after 8 h of storage). We found that samples in Tedlar, Nalophan, and EVOH bags undergo changes in composition when exposed to UV radiation over a period of 48 h. We report high initial impurity levels in all the bags and their doubling after a period of 48 h. We compare secondary electrospray ionization and proton transfer reaction mass spectrometry in the context of offline analysis after storage in sampling bags. We provide an analytical perspective on the temporal evolution of bag contents by presenting the intensity changes of all significantm/zfeatures. We also present a simple, automated, and cost-effective offline sample introduction system, which enables controlled delivery of collected gaseous samples from polymeric bags into the mass spectrometer. Overall, our findings suggest that sampling bags exhibit high levels of impurities, are sensitive to several environmental factors (e.g. light exposure), and provide low recoveries for some classes of compounds, e.g. SCFAs.
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  • 文章类型: Journal Article
    根除幽门螺杆菌对治疗幽门螺杆菌感染引起的消化性溃疡至关重要。一种在亚洲非常普遍的疾病。我们提出了两个随机的汇总分析,双盲,双假人,3期研究评估含铋剂的伏诺拉赞四联疗法根除幽门螺杆菌的疗效和安全性.年龄≥18岁的经内镜证实的十二指肠或胃溃疡的患者被随机分为1:1,每天一次接受vonoprazan20mg或兰索拉唑30mg,最多6周(十二指肠溃疡)或8周(胃溃疡)。幽门螺杆菌阳性患者在前2周接受基于vonoprazan或兰索拉唑的含铋四联疗法。在治疗后4周的随访中使用碳13尿素呼气试验确定幽门螺杆菌根除。vonoprazan对幽门螺杆菌的根除率为90.6%。兰索拉唑治疗占85.2%(差异:5.4%;95%置信区间(CI):-0.1,10.8)。在年龄<65岁和目前吸烟者的患者中,幽门螺杆菌根除率分别高出7.1%(95%CI:1.4,12.8)和12.6%(95%CI:3.9,22.0)。分别,vonoprazanvs.兰索拉唑.在中国亚群中,vonoprazan的幽门螺杆菌根除率为92.0%。兰索拉唑占86.0%(差异:6.1%;95%CI:0.5,11.7)。治疗引起的不良事件发生在72.7vs.在vonoprazan和基线时,62.6%的幽门螺杆菌阳性患者兰索拉唑手臂。使用基于vonoprazan的四联疗法根除幽门螺杆菌不劣于基于兰索拉唑的四联疗法,并且超过90%,确定幽门螺杆菌根除方案疗效的临床相关阈值(ClinicalTrials.gov标识符:NCT03050359;NCT03050307).
    Helicobacter pylori eradication is crucial in the treatment of peptic ulcers caused by H. pylori infection, a disease highly prevalent in Asia. We present a pooled analysis of two randomized, double-blind, double-dummy, phase 3 studies evaluating the efficacy and safety of vonoprazan-based bismuth-containing quadruple therapy for H. pylori eradication. Patients aged ≥18 years with endoscopically confirmed duodenal or gastric ulcers were randomized 1 : 1 to receive vonoprazan 20 mg or lansoprazole 30 mg once daily for up to 6 (duodenal ulcers) or 8 weeks (gastric ulcers). H. pylori-positive patients received vonoprazan- or lansoprazole-based bismuth-containing quadruple therapy for the first 2 weeks. H. pylori eradication was determined using the carbon-13 urea breath test at a follow-up visit 4 weeks post-treatment. The H. pylori eradication rate was 90.6% with vonoprazan vs. 85.2% with lansoprazole (difference: 5.4%; 95% confidence interval (CI): -0.1, 10.8). H. pylori eradication rates were 7.1% (95% CI: 1.4, 12.8) and 12.6% (95% CI: 3.9, 22.0) higher in patients aged <65 years and current smokers, respectively, with vonoprazan vs. lansoprazole. In the Chinese subpopulation, the H. pylori eradication rate was 92.0% with vonoprazan vs. 86.0% with lansoprazole (difference: 6.1%; 95% CI: 0.5, 11.7). Treatment-emergent adverse events occurred in 72.7 vs. 62.6% of H. pylori-positive patients at baseline in the vonoprazan vs. lansoprazole arm. H. pylori eradication with vonoprazan-based quadruple therapy was noninferior to lansoprazole-based quadruple therapy and exceeded 90%, a clinically relevant threshold for determining the efficacy of H. pylori eradication regimens (ClinicalTrials.gov identifier: NCT03050359; NCT03050307).
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