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1、美国胃肠病学会精选2015主办单位：艾斯维尔（ELSEVIER）赞助单位：阿斯利康（AstraZeneca）会议时间：2015 年 6 月 28 日会议地点：中国科技会堂 B205 会议室论坛主席：杨云生教授消化疾病周（DDW）是全球规模最大和最富盛名的消化疾病领域学术会议，每年吸引了全球最多的胃肠病学、肝病学、内镜学和消化道相关领域的医生、研究者和学者参与。DDW 2015 于 5 月 16 日19 日在美国华盛顿召开，为了在第一时间把 DDW 的最新资讯带入中国，让更多的中国医生能同步获取 DDW 的精华内容，于 2015 年 6 月 28 日在北京开展 DDW 中国行。09 : 00 -
2、 09：30DDW 2015 - AGA HighlightsSheila E. Crowe加州大学圣地亚哥分校医学教授DDW2015 IN CHINADigestive Disease Week开场消化盛举，中外同行DDW 2015 - AGA 精选胃食管反流病、Barrett 食管、EoE 与幽门螺杆菌Sheila E. Crowe, MD, FRCPC, FACP, FACG加拿大圣地亚哥分校医学教授论坛主题论坛主题胃食管反流（胃食管反流（GERD）GERD 管理GERD 食管外表现Barrett 食管（食管（BE）BE 的历史根除 BE 的长期随访嗜酸性食管炎（嗜酸性食管炎（EoE）E
3、oE 管理幽门螺杆菌幽门螺杆菌与胃粘膜菌群相关进行性成为胃癌与包括 GERD 在内的疾病相关对根除治疗的耐药性# 688 Long-Term Results Confirm Safety and Efficacy of a Magnetic Esophageal Device for GERD RobertA. et al食管磁性装置治疗食管磁性装置治疗 GERD 的长期疗效：的长期疗效：安全性和有效性安全性和有效性BACKGROUND: Based on 2-year results of a planned 5-year pivotal trial, the U.S. Food and D
4、rug Administration granted approval of a magnetic device to augment the lower esophageal sphincter for GERD (LINX Reflux Management System, Torax Medical, Inc.). The magnetic device is the only antireflux procedure to mechanically restore competency to the antireflux barrier without using the gastri
5、c fundus. Interim results have shown significant reduction in acid exposure, control of reflux-related symptoms, and elimination of acid suppression therapy, without causing bothersome side effects. The final results of a 5-year study are now reported.背景基于美国 FDA 批准的用磁性装置加固食管下括约肌的 5 年试验性研究截止至 2 年时的结果
6、。该装置是唯一具有如下特点的抗返流手术，可以机械性的恢复食管 下括约肌的抗返流屏障的能力，同时保留了胃底部的解剖结构。中期结果表明， 食管酸暴露显著降低，反流相关症状得以控制，无需抑酸治疗，且并未引起严重 的不良反应。本文报道 5 年后最终的疗效。METHODS: We prospectively assessed 100 patients using predefined endpoints.At the 1-year interval, pH scores were assessed and were significantly improved. At the 1, 2, 3, 4 an
7、d 5-year visits, quality of life, reflux control, proton-pump inhibitor (PPI) use, side effects and adverse events were evaluated. The net clinical effect of the magnetic device was assessed by comparing each individuals specific symptom complex before and after treatment along with the side-effect
8、profile.方法我们用事先定义的有效标准前瞻性的评估了 100 名患者的疗效。随访间期为 1 年，给予患者 pH 评分，发现患者的 pH 评分显著改善。在第 1、2、3、4、5 年 随访时，对患者的生活质量，反流症状的控制，PPI 的用量，副反应及严重的不 良反应发生率进行评估。 该磁性装置的整体疗效通过治疗前后患者个体的特异症 状及不良反应来评估。RESULTS: 100 patients were implanted with the LINX device and 85 were followedat 5 years. Early withdrawals included those
9、 lost to follow-up (n=6), device explant (n=6), patient declined re-consent for extended follow-up (n=2), and unrelated, terminal cancer (n=1). No device erosions, migrations or malfunctions occurred.结果植入了该装置的 100 名患者，在第 5 年时，随访到了 85 人。有 15 名患者第 5 年时没有随访到，包括 6 名患者失访，6 名患者移除了装置，2 名患者拒绝延长 随访时间，1 名患者发生
10、了与 GERD 无关的癌症。没有装置的腐烂、移位及功能 不良发生。The 5-year median total GERD-HRQL scores improved from 27 off PPIs and 11 on PPIs at baseline to 4 after magnetic sphincter augmentation. Grade Aand B esophagitis decreased from 40% of patients at baseline to 16% at 5 years. Daily PPI use was 100% of patients at base
11、line and decreased to 15.3% at 5 years.5 年平均 GERD-HRQL 评分显著改善，从不服药（PPI）时的 27 分及服药（PPI） 时的 11 分的基线水平，降到应用磁性装置加固食管下括约肌时的 4 分。洛杉矶 分级为 A 级 和 B 级食管炎的发生率从基线时的 40%，5 年后降到 16%。从基 线时 100%的患者需要服用 PPI，降到 5 年后的 15.3%。Patients reporting moderate or severe regurgitation decreased from 57% at baseline to 1.2% at 5
12、 years. All patients reported the ability to belch and vomit if needed. Daily, bothersome dysphagia was reported by 5% of patients at baseline and was not significantly increased 5-years after implant at 6%. Daily, bothersome gas/bloat decreased from 52% of patients at baseline to 8.3% at 5 years.中重
13、度反流的发生率从基线时的 57%降到了 5 年后的 1.2%。所有患者需要时均 可以打嗝及呕吐。5 年后吞咽困难的发生率（6%）较基线水平（5%）并没有显 著的提升。烦人的嗳气/腹胀的发生率从治疗前的 52%降到了 8.3%。CONCLUSIONS: Sphincter augmentation with a magnetic device provides significant and durable reflux control with minimal side effects. No new safety risks emerged in the 5-year follow-up p
14、eriod. Long-term safety and efficacy have been established.结论用磁性装置加固食管下括约肌可以显著而持久的控制反流， 其不良反应的发生率 极低。在为期 5 年的随访期内，并没有出现新的安全隐患，长期的安全性及有效 性得以证实。5 年年 FDA 上市前批准临床试验上市前批准临床试验试验设计试验设计前瞻性多中心受试者自行控制预定义成功标准试验终点试验终点pH 控制（1 年）PPI 使用（1-5 年）GERD 症状量表评分（1-5 年）成功定义为成功定义为60%的患者在以下终点有 50%改善pH 值（4.0 12 months after I
15、ND diagnosis).研究方法疗效衡量疗效衡量已有肿瘤形成IND 诊断后 12 个月，发生 LGD 或 HGD/EAC新发肿瘤形成新发肿瘤形成：IND 诊断后超过 12 个月，发生 LGD 或 HGD/EACResults: 354 IND patients were identified with 106 patients eligible for analysis.Of 87 patients with follow-up endoscopy + biopsies within 1 year of IND diagnosis, 7(8%) had prevalent disease
16、(2 LGD, 4 HGD 1 EAC). The prevalence of LGD was2.3%, HGD was 4.6%, and EAC was 1.1%. Importantly, 4 of the 7 prevalent(2 LGD, 2 HGD) cases were found to have dysplasia within 6 months of INDdiagnosis. No demographic or endoscopic characteristics studied were associated withprevalent disease. Of the 106 IND patients, there were 66 patients withoutprevalent dysplasia with 1-year follow-up. 3 (4.5%) progressed (1 to LGD after 12months, 2 to HGD after 16.5 and 52 months), yielding an
