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窄带成像技术用于非糜烂性反流病的诊断:一项国际、多中心、随机对照试验。

Narrow-band imaging for the diagnosis of nonerosive reflux disease: an international, multicenter, randomized controlled trial.

机构信息

Department of Gastroenterology, Kansas City VA Medical Center, Kansas City, Missouri, USA.

Department of Pathology, Kansas City VA Medical Center, Kansas City, Missouri, USA.

出版信息

Gastrointest Endosc. 2022 Sep;96(3):457-466.e3. doi: 10.1016/j.gie.2022.04.020. Epub 2022 Apr 26.

Abstract

BACKGROUND AND AIMS

We examined the accuracy of narrow-band imaging (NBI) findings in nonerosive reflux disease (NERD) patients compared with control subjects and the impact of proton pump inhibitor (PPI) therapy on these mucosal changes in a multicenter, double-blind, randomized controlled trial.

METHODS

NERD patients (typical symptoms using a validated GERD questionnaire, absence of erosive esophagitis, and abnormal 48-hour pH study) and control subjects underwent high-definition white-light endoscopy followed by NBI and biopsy sampling of the distal esophagus. Then, NERD patients were randomized to esomeprazole 40 mg/day or placebo for 8 weeks, followed by repeat endoscopy. The presence of distal esophageal mucosal changes on NBI were recorded at baseline and after treatment: intrapapillary capillary loops (IPCLs; number, dilation, and tortuosity), microerosions, increased vascularity, columnar islands, and ridge/villous pattern (RVP) above the squamocolumnar junction.

RESULTS

Of 122 screened, 21 NERD and 21 control subjects were identified (mean age, 49.5 ± 14.6 years; 62% men; and 85% white). The combination of IPCL tortuosity, RVP, and microerosions (62% vs 19%, P < .05) had a high specificity (86%) and moderate sensitivity (60%) for NERD with an area under the curve of .74. In 10 NERD patients treated with PPIs, resolution of microerosions was most significant (P = .047) compared with placebo (n = 11). RVP resolved in all NERD patients after therapy (P = .02) and correlated with acid exposure time (P = .004). Papillary length (P = .02) and basal cell thickness (P = .02) significantly correlated with a combination of IPCL tortuosity, RVP, and microerosions.

CONCLUSIONS

In this randomized controlled trial, RVP on NBI demonstrated a high specificity, correlated with acid exposure time, and improved with PPI therapy, suggesting that it could be used as a surrogate marker for diagnosis of NERD. (Clinical trial registration number: NCT02081404.).

摘要

背景和目的

我们在一项多中心、双盲、随机对照试验中,比较了窄带成像(NBI)在非糜烂性反流病(NERD)患者中的准确性,并比较了质子泵抑制剂(PPI)治疗对这些黏膜变化的影响。

方法

NERD 患者(使用经过验证的 GERD 问卷有典型症状、无糜烂性食管炎和异常 48 小时 pH 研究)和对照组接受高清白光内镜检查,然后进行 NBI 和远端食管活检采样。然后,NERD 患者被随机分配到埃索美拉唑 40 mg/天或安慰剂治疗 8 周,然后重复内镜检查。记录基线和治疗后 NBI 远端食管黏膜变化的存在情况:黏膜下毛细血管袢(IPCL;数量、扩张和扭曲)、微糜烂、血管增多、柱状岛和鳞柱状交界处上方的脊/绒毛状模式(RVP)。

结果

在 122 名筛查者中,确定了 21 名 NERD 和 21 名对照组患者(平均年龄 49.5±14.6 岁;62%为男性;85%为白人)。IPCL 扭曲、RVP 和微糜烂的组合(62%比 19%,P<.05)对 NERD 具有高特异性(86%)和中等敏感性(60%),曲线下面积为 0.74。在接受 PPI 治疗的 10 名 NERD 患者中,与安慰剂(n=11)相比,微糜烂的缓解最为显著(P=0.047)。所有 NERD 患者在治疗后 RVP 均得到缓解(P=0.02),并与酸暴露时间相关(P=0.004)。乳头长度(P=0.02)和基底细胞厚度(P=0.02)与 IPCL 扭曲、RVP 和微糜烂的组合显著相关。

结论

在这项随机对照试验中,NBI 上的 RVP 表现出高特异性,与酸暴露时间相关,且用 PPI 治疗可改善,提示其可作为 NERD 诊断的替代标志物。(临床试验注册号:NCT02081404.)

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