AbstractGastroesophageal reflux disease (GERD) presents a general health problem with a variety of symptoms and an impairment of life quality. Conservative therapies do not offer sufficient symptom relief in up to 30% of patients. Patients who suffer from ineffective esophageal motility (IEM) and also GERD may exhibit symptoms ranging from mild to severe.

摘要胃食管反流病（GERD）是一种常见的健康问题，具有多种症状和生活质量受损。保守疗法不能为多达30%的患者提供足够的症状缓解。患有无效食管动力（IEM）和GERD的患者可能表现出轻度至重度的症状。

In cases where surgical intervention becomes necessary for this diverse group of patients, it is important to consider the potential occurrence of postoperative dysphagia. RefluxStop is a new alternative anti-reflux surgery potentially reducing postoperative dysphagia rates. In this bicentric tertiary hospital observational study consecutive patients diagnosed with PPI refractory GERD and IEM that received RefluxStop implantation were included.

如果这一多样化的患者需要手术干预，重要的是要考虑术后吞咽困难的潜在发生。RefluxStop是一种新的替代抗反流手术，可能会降低术后吞咽困难率。在这项双中心三级医院观察性研究中，包括连续接受回流停止植入的PPI难治性GERD和IEM患者。

A first safety and efficacy evaluation including clinical examination and GERD-HRQL questionnaire was conducted. 40 patients (25 male and 15 female) were included. 31 patients (77.5%) were on PPI at time of surgery, with mean acid exposure time of 8.14% ± 2.53. The median hospital stay was 3 days. Postoperative QoL improved significantly measured by GERD HRQL total score from 32.83 ± 5.08 to 6.6 ± 3.71 (p < 0.001).

进行了第一次安全性和有效性评估，包括临床检查和GERD-HRQL问卷。纳入40例患者（男25例，女15例）。31名患者（77.5%）在手术时接受PPI治疗，平均酸暴露时间为8.14%±2.53。中位住院时间为3天。GERD HRQL总分从32.83±5.08降至6.6±3.71（p<0.001），术后生活质量显着改善。

A 84% reduction of PPI usage (p < 0.001) was noted. 36 patients (90%) showed gone or improved symptoms and were satisfied at first follow-up. Two severe adverse events need mentioning: one postoperative slipping of the RefluxStop with need of immediate revisional operation on the first postoperative day (Clavien–Dindo Score 3b) and one device migration with no necessary further intervention.

注意到PPI使用减少了84%（p<0.001）。36名患者（90%）表现出消失或改善的症状，并在首次随访时感到满意。有两个严重的不良事件需要提及：一个是术后第一天需要立即修复手术（Clavien-Dindo评分3b）的反流停止术后滑倒，另一个是无需进一步干预的器械迁移。

RefluxStop device implantation is safe and efficient in the short term follow up in patients with GERD and IEM. Further studies and longer follow-up are necessary to prove long-la.

在GERD和IEM患者的短期随访中，回流停止装置植入是安全有效的。需要进一步的研究和更长的随访时间来证明长期la。

IntroductionGastroesophageal reflux disease (GERD) is one of the most common diseases worldwide with prevalence rates up to 33%1. Around 1 billion people throughout all continents are currently suffering from GERD2.Up to 30% of these patients suffer from PPI therapy refractory GERD, meaning that no symptom relief is achieved by lifestyle modifications and medication3.

简介胃食管反流病（GERD）是全球最常见的疾病之一，患病率高达33%1。目前，各大洲约有10亿人患有GERD2。这些患者中高达30%患有PPI治疗难治性GERD，这意味着通过改变生活方式和药物治疗无法缓解症状3。

If conservative therapy has been exhausted, the next step is considered to be anti-reflux surgery4. Much has been improved since the beginning of Nissen fundoplication over 60 years ago: nowadays, surgeons may choose between total and partial fundoplication, magnetic sphincter augmentation, and anti-reflux mucosectomy, just to name a few procedures4.Patients with long time GERD are reported to have a higher likelihood to suffer from esophageal motility disorder, such as ineffective esophageal motility (IEM)5.

如果保守治疗已经耗尽，下一步被认为是抗反流手术4。自60多年前尼森胃底折叠术开始以来，情况已有了很大改善：如今，外科医生可以在全胃底折叠术和部分胃底折叠术，磁性括约肌增强术和抗反流性粘液切除术之间进行选择，仅举几个程序4。据报道，长期GERD患者患食管动力障碍的可能性更高，例如无效食管动力（IEM）5。

This disorder is defined by the Chicago classification v4.0 as more than 70% ineffective swallows or at least 50% failed peristalsis with a normal integrated relaxation pressure (IRP)6. This patient group consisting of up to 36% of GERD patients is heterogenous in clinical presentation7,8,9,10. It is suggested, that IEM might subsequently lead to worse abnormal acid burden, heartburn, regurgitation and to a certain degree dysphagia5,11.

芝加哥分类v4.0将这种疾病定义为超过70%的无效吞咽或至少50%的蠕动失败，具有正常的综合松弛压力（IRP）6。该患者组由高达36%的GERD患者组成，在临床表现上是异质的7,8,9,10。有人提出，IEM可能随后导致更严重的异常酸负荷，胃灼热，反流和一定程度的吞咽困难5,11。

The inconsistency in symptoms, especially in regard to dysphagia, makes this patient group quite difficult to treat adequately. Even though various studies could show similar adverse events with different surgical techniques, the problem of postoperative dysphagia is still under debate in IEM patients undergoing anti-reflux surgery12,13,14.

症状的不一致，特别是在吞咽困难方面，使得该患者组很难得到充分治疗。尽管各种研究可能会显示不同手术技术的类似不良事件，但在接受抗反流手术的IEM患者中，术后吞咽困难的问题仍在争论中[12,13,14]。

A new anti-reflux surgical technique is intended to prevent dysphagia postoperatively: the implantation of the RefluxStop™, a sili.

一种新的抗反流手术技术旨在预防术后吞咽困难：植入RefluxStop™sili。

ReferencesCollaborators GBDG-oRD. The global, regional, and national burden of gastro–oesophageal reflux disease in 195 countries and territories, 1990–2017: A systematic analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol. Hepatol. 5(6), 561–581 (2020).Article

参考文献合作者GBDG oRD。1990-2017年195个国家和地区胃食管反流病的全球，区域和国家负担：2017年全球疾病负担研究的系统分析。柳叶刀肠胃病。肝病。5（6），561-581（2020）。文章

Google Scholar

谷歌学者

Nirwan, J. S. et al. Global prevalence and risk factors of gastro–oesophageal reflux disease (GORD): Systematic review with meta-analysis. Sci. Rep. 10(1), 5814 (2020).Article

Nirwan，J.S.等人，《胃食管反流病（GORD）的全球患病率和危险因素：荟萃分析的系统评价》。科学。代表10（1），5814（2020）。文章

ADS

广告

CAS

中科院

PubMed

PubMed

PubMed Central

公共医学中心

Google Scholar

谷歌学者

Yadlapati, R. & DeLay, K. Proton pump inhibitor-refractory gastroesophageal reflux disease. Med. Clin. N. Am. 103(1), 15–27 (2019).Article

Yadlapati，R。＆DeLay，K。质子泵抑制剂难治性胃食管反流病。医学临床。N、 上午103（1），15-27（2019）。文章

PubMed

PubMed

Google Scholar

谷歌学者

Callahan, Z. M. et al. Outcomes after anti-reflux procedures: Nissen, Toupet, magnetic sphincter augmentation or anti-reflux mucosectomy?. Surg. Endosc. 37, 3944–3951 (2022).Article

Callahan，Z.M.等人。抗反流手术后的结果：Nissen，Toupet，磁性括约肌增强术或抗反流粘液切除术？。外科医师。373944-3951（2022）。文章

PubMed

PubMed

Google Scholar

谷歌学者

Gyawali, C. P. et al. Ineffective esophageal motility: Concepts, future directions, and conclusions from the Stanford 2018 symposium. Neurogastroenterol. Motil. 31(9), e13584 (2019).Article

Gyawali，C.P.等人，《无效食管动力：斯坦福2018年研讨会的概念，未来方向和结论》。。运动型。31（9），e13584（2019）。文章

PubMed

PubMed

PubMed Central

公共医学中心

Google Scholar

谷歌学者

Yadlapati, R. et al. Esophageal motility disorders on high-resolution manometry: Chicago classification version 4.0((c)). Neurogastroenterol. Motil. 33(1), 14058 (2021).Article

Yadlapati，R。等。高分辨率测压的食管动力障碍：芝加哥分类4.0版（（c））。。运动型。33（1），14058（2021）。文章

Google Scholar

谷歌学者

Abdel Jalil, A. A. & Castell, D. O. Ineffective esophageal motility (IEM): The old–new frontier in esophagology. Curr. Gastroenterol. Rep. 18(1), 1 (2016).Article

Abdel Jalil，A.A.＆Castell，D.O。无效食管动力（IEM）：食管学的新旧前沿。货币。胃肠道。代表18（1），1（2016）。文章

PubMed

PubMed

Google Scholar

谷歌学者

Ho, S. C., Chang, C. S., Wu, C. Y. & Chen, G. H. Ineffective esophageal motility is a primary motility disorder in gastroesophageal reflux disease. Dig. Dis. Sci. 47(3), 652–656 (2002).Article

Ho，S.C.，Chang，C.S.，Wu，C.Y。＆Chen，G.H。无效的食管动力是胃食管反流病的主要动力障碍。挖掘。Dis。科学。47（3），652-656（2002）。文章

PubMed

PubMed

Google Scholar

谷歌学者

Lee, K. J., Kim, J. H. & Cho, S. W. Prevalence of ineffective esophageal motility and its relevance to symptoms and esophageal acid exposure in Korean patients referred for foregut symptoms. Digestion 73, 171–177 (2006).Article

Lee，K.J.，Kim，J.H。＆Cho，S.W。韩国前肠症状患者无效食管动力的患病率及其与症状和食管酸暴露的相关性。消化73171-177（2006）。文章

PubMed

PubMed

Google Scholar

谷歌学者

Triadafilopoulos, G., Tandon, A., Shetler, K. P. & Clarke, J. Clinical and pH study characteristics in reflux patients with and without ineffective oesophageal motility (IEM). BMJ Open Gastroenterol. 3(1), e000126 (2016).Article

Triadafilopoulos，G.，Tandon，A.，Shetler，K.P。＆Clarke，J。有和没有无效食管动力（IEM）的反流患者的临床和pH研究特征。BMJ开放胃肠道。3（1），e000126（2016）。文章

PubMed

PubMed

PubMed Central

公共医学中心

Google Scholar

谷歌学者

Rangan, V. et al. Dysphagia worsens with increasing ineffective swallows among patients with ineffective esophageal motility. J. Clin. Gastroenterol. 57, 694–699 (2022).Article

Rangan，V。等人。在食管动力无效的患者中，吞咽困难随着无效吞咽的增加而恶化。J、 临床。胃肠道。57694-699（2022）。文章

Google Scholar

谷歌学者

Asti, E. et al. Removal of the magnetic sphincter augmentation device: Surgical technique and results of a single-center cohort study. Ann. Surg. 265(5), 941–945 (2017).Article

Asti，E.等人。磁性括约肌增强装置的切除：手术技术和单中心队列研究的结果。《安·外科杂志》265（5），941-945（2017）。文章

PubMed

PubMed

Google Scholar

谷歌学者

Skubleny, D. et al. LINX((R)) magnetic esophageal sphincter augmentation versus Nissen fundoplication for gastroesophageal reflux disease: A systematic review and meta-analysis. Surg. Endosc. 31(8), 3078–3084 (2017).Article

Skubleny，D。等人LINX（（R））磁性食管括约肌增强术与Nissen胃底折叠术治疗胃食管反流病：系统评价和荟萃分析。外科医师。31（8），3078-3084（2017）。文章

PubMed

PubMed

Google Scholar

谷歌学者

Reynolds, J. L. et al. Laparoscopic magnetic sphincter augmentation vs laparoscopic Nissen fundoplication: A matched-pair analysis of 100 patients. J. Am. Coll. Surg. 221(1), 123–128 (2015).Article

。J、 美国科罗拉多州。Surg.221（1），123-128（2015）。文章

PubMed

PubMed

Google Scholar

谷歌学者

Bjelovic, M. et al. Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1 year results : RefluxStopTM device; a new method in acid reflux surgery obtaining CE mark. BMC Surg. 20(1), 159 (2020).Article

Bjelovic，M。等人。用新的动态治疗方法治疗酸反流的非活性植入式装置：1年结果‡：RefluxStopTM装置；酸反流手术中获得CE标志的新方法。BMC Surg。20（1），159（2020）。文章

PubMed

PubMed

PubMed Central

公共医学中心

Google Scholar

谷歌学者

Velanovich, V. The development of the GERD-HRQL symptom severity instrument. Dis. Esophagus 20(2), 130–134 (2007).Article

Velanovich，V。GERD-HRQL症状严重程度仪器的开发。Dis。食道20（2），130-134（2007）。文章

CAS

中科院

PubMed

PubMed

Google Scholar

谷歌学者

Stephan, D., Borbely, Y. & Schoppmann, S. F. RefluxStopTM therapy—A new minimally invasive technology in anti-reflux surgery. Surg. Technol. Int. https://doi.org/10.52198/22.STI.41.GS1622 (2022).Article

Stephan，D.，Borbely，Y。＆Schoppmann，S.F。RefluxStopTM疗法-一种抗反流手术中的新型微创技术。外科技术。。https://doi.org/10.52198/22.STI.41.GS1622（2022年）。文章

PubMed

PubMed

Google Scholar

谷歌学者

Armstrong, D. et al. The endoscopic assessment of esophagitis: A progress report on observer agreement. Gastroenterology 111(1), 85–92 (1996).Article

Armstrong，D.等人，《内镜下食管炎评估：观察者协议进展报告》。胃肠病学111（1），85-92（1996）。文章

CAS

中科院

PubMed

PubMed

Google Scholar

谷歌学者

Gyawali, C. P. et al. Modern diagnosis of GERD: The Lyon consensus. Gut 67(7), 1351–1362 (2018).Article

Gyawali，C.P.等人。GERD的现代诊断：里昂共识。肠道67（7），1351-1362（2018）。文章

PubMed

PubMed

Google Scholar

谷歌学者

Zhang, R. et al. Effect of laparoscopic angle of His reconstruction in the treatment of patients with gastroesophageal reflux disease and hiatal hernia. Chin. Med. J. 135(14), 1750–1752 (2022).Article

Zhang，R。等。腹腔镜下His重建角治疗胃食管反流病和食管裂孔疝的效果。下巴。《医学杂志》135（14），1750-1752（2022）。文章

PubMed

PubMed

PubMed Central

公共医学中心

Google Scholar

谷歌学者

Fuchs, K. H. et al. Severity of GERD and disease progression. Dis. Esophagus https://doi.org/10.1093/dote/doab006 (2021).Article

Fuchs，K.H.等人，《GERD的严重程度和疾病进展》。Dis。食道https://doi.org/10.1093/dote/doab006（2021年）。文章

PubMed

PubMed

Google Scholar

谷歌学者

Herbella, F. A. & Del Grande, J. C. Human cadavers as an experimental model for esophageal surgery. Dis. Esophagus 14(3–4), 218–222 (2001).Article

。Dis。食道14（3-4），218-222（2001）。文章

CAS

中科院

PubMed

PubMed

Google Scholar

谷歌学者

Nissen, R. Gastropexy as the lone procedure in the surgical repair of hiatus hernia. Am. J. Surg. 92(3), 389–392 (1956).Article

Nissen，R。Gastropexy是手术修复裂孔疝的唯一手术。《美国外科杂志》92（3），389-392（1956）。文章

CAS

中科院

PubMed

PubMed

Google Scholar

谷歌学者

Herbella, F. A., Oliveira, D. R. & Del Grande, J. C. Eponyms in esophageal surgery. Dis. Esophagus 17(1), 1–9 (2004).Article

Herbella，F.A.，Oliveira，D.R。＆Del Grande，J.C。食管手术中的同名词。Dis。食道17（1），1-9（2004）。文章

CAS

中科院

PubMed

PubMed

Google Scholar

谷歌学者

Stylopoulos, N. & Rattner, D. W. The history of hiatal hernia surgery: From Bowditch to laparoscopy. Ann. Surg. 241(1), 185–193 (2005).Article

Stylopoulos，N。＆Rattner，D.W。食管裂孔疝手术的历史：从Bowditch到腹腔镜检查。《外科杂志》241（1），185-193（2005）。文章

PubMed

PubMed

PubMed Central

公共医学中心

Google Scholar

谷歌学者

Nguyen, N. T. T. N. et al. The American Foregut Society white paper on the endoscopic classification of esophagogastric junction integrity. Foregut 2(4), 339–348 (2022).Article

Nguyen，N.T.T.N.等人，《美国前肠学会关于食管胃连接完整性内镜分类的白皮书》。前肠2（4），339-348（2022）。文章

Google Scholar

谷歌学者

Hasak, S., Brunt, L. M., Wang, D. & Gyawali, C. P. Clinical characteristics and outcomes of patients with postfundoplication dysphagia. Clin. Gastroenterol. Hepatol. 17(10), 1982–1990 (2019).Article

Hasak，S.，Brunt，L.M.，Wang，D。和Gyawali，C.P。胃底折叠术后吞咽困难患者的临床特征和结果。临床。胃肠道。肝病。17（10），1982-1990（2019）。文章

PubMed

PubMed

Google Scholar

谷歌学者

Fringeli, Y., Linas, I., Kessler, U. & Zehetner, J. Short-term results of laparoscopic anti-reflux surgery with the RefluxStop device in patients with gastro-esophageal reflux disease and ineffective esophageal motility. Langenbecks Arch. Surg. 409(1), 78 (2024).Article

Fringeli，Y.，Linas，I.，Kessler，U。＆Zehetner，J。使用RefluxStop装置对胃食管反流病和无效食管动力患者进行腹腔镜抗反流手术的短期结果。Langenbecks拱门。Surg.409（1），78（2024）。文章

PubMed

PubMed

PubMed Central

公共医学中心

Google Scholar

谷歌学者

Download referencesFundingS.F.S. received travel grants and speaker honoraria, and J.F. received travel grants.Author informationAuthors and AffiliationsDepartment of Surgery, Division of General Surgery, Comprehensive Cancer Center, Upper-GI Unit, Medical University of Vienna, Spitalgasse 23, Waehringer Guertel 18-20, 1090, Vienna, AustriaJ.

下载referencesFundingS。F、 美国获得了旅行补助金和演讲者酬金，J.F.获得了旅行补助金。作者信息作者和附属机构维也纳医科大学上消化道综合癌症中心普通外科外科，斯皮塔加塞23号，Waehringer Guertel 18-201090，维也纳，澳大利亚。

Feka, M. Saad, M. Paireder, I. Kristo, E. Rieder, R. Asari & S. F. SchoppmannDepartment of Surgery, King Edward VII’s Hospital, London, UKN. BoyleAuthorsJ. FekaView author publicationsYou can also search for this author in.

费卡，M。萨阿德，M。佩雷德，I。克里斯托，E。里德，R。Asari公司。F、 肖普曼英国伦敦爱德华七世国王医院外科。BoyleAuthorsJ。FekaView作者出版物您也可以在中搜索此作者。

PubMed Google ScholarM. SaadView author publicationsYou can also search for this author in

PubMed谷歌学术出版社。SaadView作者出版物您也可以在

PubMed Google ScholarN. BoyleView author publicationsYou can also search for this author in

PubMed谷歌学术评论。BoyleView作者出版物您也可以在

PubMed Google ScholarM. PairederView author publicationsYou can also search for this author in

PubMed谷歌学术评论。PairederView作者出版物您也可以在

PubMed Google ScholarI. KristoView author publicationsYou can also search for this author in

PubMed Google ScholarI.KristoView作者出版物您也可以在

PubMed Google ScholarE. RiederView author publicationsYou can also search for this author in

PubMed谷歌ScholarE。RiederView作者出版物您也可以在

PubMed Google ScholarR. AsariView author publicationsYou can also search for this author in

PubMed Google ScholarS. F. SchoppmannView author publicationsYou can also search for this author in

PubMed谷歌学者。F.SchoppmannView作者出版物您也可以在

PubMed Google ScholarContributionsF.J.: conception and design of the work, acquisition of data, wrote the manuscript. M.S., N.B.: acquisition of data, drafting, critical revision of the article. M.P, I.K., E.R., R.A.: drafting and critical revision of the article. S.S.: conception of the work, final approval of the version to be published.

PubMed谷歌学术贡献。J、 ：手稿撰写了作品的概念和设计，数据的获取。M、 S.，N.B.：获取数据，起草，对文章进行批判性修订。M、 。S、 S.：作品的构思，即将出版的版本的最终批准。

All authors listed above contributed substantially to the conception or design of the work and the acquisition, analysis, or interpretation of data for the work; and all authors contributed to the drafting of the work or revising it critically for important intellectual content and the final approval of the version to be published; and all authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.Corresponding authorCorrespondence to.

上面列出的所有作者都为作品的概念或设计以及作品数据的获取，分析或解释做出了重大贡献；所有作者都为这部作品的起草或重要知识内容的批判性修改做出了贡献，并最终批准了即将出版的版本；所有作者都同意对工作的各个方面负责，以确保与工作任何部分的准确性或完整性有关的问题得到适当的调查和解决。对应作者对应。

S. F. Schoppmann.Ethics declarations

S、 F.肖普曼。道德宣言

Competing interests

相互竞争的利益

The authors declare no competing interests.

作者声明没有利益冲突。

Additional informationPublisher's noteSpringer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.Rights and permissions

Additional informationPublisher的noteSpringer Nature在已发布地图和机构隶属关系中的管辖权主张方面保持中立。权限和权限

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made.

开放获取本文是根据知识共享署名4.0国际许可证授权的，该许可证允许以任何媒体或格式使用，共享，改编，分发和复制，只要您对原始作者和来源给予适当的信任，提供知识共享许可证的链接，并指出是否进行了更改。

The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder.

本文中的图像或其他第三方材料包含在文章的知识共享许可中，除非在材料的信用额度中另有说明。如果材料未包含在文章的知识共享许可中，并且您的预期用途不受法律法规的许可或超出许可用途，则您需要直接获得版权所有者的许可。

To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/..

http://creativecommons.org/licenses/by/4.0/..

Reprints and permissionsAbout this articleCite this articleFeka, J., Saad, M., Boyle, N. et al. Multicentric short term and safety study of ineffective esophageal motility patients treated with RefluxStop device.

转载和许可本文引用本文Feka，J.，Saad，M.，Boyle，N。等人。用回流停止装置治疗无效食管动力患者的多中心短期和安全性研究。

Sci Rep 14, 15425 (2024). https://doi.org/10.1038/s41598-024-65751-5Download citationReceived: 14 September 2023Accepted: 24 June 2024Published: 04 July 2024DOI: https://doi.org/10.1038/s41598-024-65751-5Share this articleAnyone you share the following link with will be able to read this content:Get shareable linkSorry, a shareable link is not currently available for this article.Copy to clipboard.

Sci Rep 1415425（2024）。https://doi.org/10.1038/s41598-024-65751-5Download引文接收日期：2023年9月14日接收日期：2024年6月24日发布日期：2024年7月4日OI：https://doi.org/10.1038/s41598-024-65751-5Share本文与您共享以下链接的任何人都可以阅读此内容：获取可共享链接对不起，本文目前没有可共享的链接。复制到剪贴板。

Provided by the Springer Nature SharedIt content-sharing initiative

由Springer Nature SharedIt内容共享计划提供

KeywordsGERDDysphagiaRefluxStopHis angle reconstruction

关键词gerddysphagiarefluxstophis角重建

CommentsBy submitting a comment you agree to abide by our Terms and Community Guidelines. If you find something abusive or that does not comply with our terms or guidelines please flag it as inappropriate.

评论通过提交评论，您同意遵守我们的条款和社区指南。如果您发现有虐待行为或不符合我们的条款或准则，请将其标记为不合适。