POEM

POEM
  • 文章类型: Journal Article
    目的:内镜压力研究集成系统(EPSIS)是一种用于评估食管下括约肌功能的内镜诊断系统。尽管以前的研究已经确定EPSIS作为诊断门失弛缓症的工具是有效的,尚不确定EPSIS是否可以在经口内镜肌切开术(POEM)之前和之后检测到明显的变化,这是贲门失弛缓症的首要治疗方法。本研究旨在评估EPSIS作为评估POEM临床效果的客观诊断工具的有效性。
    方法:我们对2022年1月至2023年12月接受POEM的患者进行了回顾性分析。患者术前和术后2个月接受EPSIS。胃内压力(IGP)参数,包括最大IGP,IGP差异,比较了POEM前后的波形梯度。这些参数也在两组之间进行了比较:术后胃食管反流病(GERD)组和非GERD组。
    结果:共50例患者被分析。术后平均最大IGP显著低于术前(15.0mmHgvs.19.8mmHg,P<0.001)。术后平均IGP差异和波形梯度也显著低于术前(8.0mmHgvs.12.2mmHg,P<0.001;和0.26mmHg/svs.0.43mmHg/s,分别为P<0.001)。GERD组术后平均波形梯度显著降低(17例,34%)高于非GERD组(33例,66%)(0.207mmHg与0.291mmHg,P=0.034)。
    结论:结果支持使用EPSIS作为评估POEM效果的有效诊断工具。
    OBJECTIVE: The endoscopic pressure study integrated system (EPSIS) is an endoscopic diagnostic system utilized for evaluation of lower esophageal sphincter function. Although previous studies have determined that EPSIS was effective as a tool for the diagnosis of achalasia, it remains uncertain if EPSIS can detect significant changes before and after peroral endoscopic myotomy (POEM), which is the premier treatment for achalasia. This study aimed to evaluate the effectiveness of EPSIS as an objective diagnostic tool for assessing the clinical effect of POEM.
    METHODS: We conducted a retrospective analysis of patients who underwent POEM from January 2022 to December 2023. The patients underwent EPSIS preoperatively and 2 months postoperatively. Intragastric pressure (IGP) parameters, including the maximum IGP, IGP difference, and waveform gradient were compared pre- and post-POEM. These parameters also were compared between two groups: the postoperative gastroesophageal reflux disease (GERD) group and the non-GERD group.
    RESULTS: A total of 50 patients were analyzed. The mean maximum IGP was significantly lower postoperatively than preoperatively (15.0 mmHg vs. 19.8 mmHg, P < 0.001). The mean IGP difference and waveform gradient were also significantly lower postoperatively than preoperatively (8.0 mmHg vs. 12.2 mmHg, P < 0.001; and 0.26 mmHg/s vs. 0.43 mmHg/s, P < 0.001, respectively). The mean postoperative waveform gradient was significantly lower in the GERD group (17 patients, 34%) than in the non-GERD group (33 patients, 66%) (0.207 mmHg vs. 0.291 mmHg, P = 0.034).
    CONCLUSIONS: The results supported the use of EPSIS as an effective diagnostic tool for assessing the effect of POEM.
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  • 文章类型: Journal Article
    背景:纵向切口是经口内镜下肌切开术(POEM)治疗食管运动性疾病时进入粘膜下间隙的常用切口。横向切口是另一种可供选择的方法,回顾性数据表明它的手术时间和发生气体相关事件的机会更少。
    方法:这是一个单中心,在三级保健医院进行的随机试验.将接受POEM治疗的食管运动障碍患者随机分为A组(纵向切口)和B组(横向切口)。主要目的是比较进入粘膜下空间所需的时间。次要目标是比较闭合切口所需的时间,闭合切口所需的夹子数量,以及与天然气有关的事件的发展。使用Kelsey方法计算非劣效性设计的样本量。
    结果:60例患者随机分组(每组30例)。在比较两种类型的切口时,进入时间[3(2,5)对2(1.75,5)分钟没有差异,p=0.399],闭合时间[7(4,13.5)对9(6.75,19)分钟,p=0.155],和闭合所需的夹子数量[4(4,6)和5(4,7),p=0.156]。此外,两组间与气体相关的事件具有可比性(腹膜需抽吸-5vs2,p=0.228,皮下气肿-3vs1,p=0.301).
    结论:这项随机试验显示了相当的进入时间,关闭时间,闭合切口所需的夹子数量,以及纵向和横向切口之间与气体相关的事件。
    背景:CTRI/2021/08/035829。
    BACKGROUND: Longitudinal incision is the commonly used incision for entry into the submucosal space during peroral endoscopic myotomy (POEM) for esophageal motility disorders. Transverse incision is another alternative for entry and retrospective data suggest it has less operative time and chance of gas-related events.
    METHODS: This was a single-center, randomized trial conducted at a tertiary care hospital. Patients undergoing POEM for esophageal motility disorders were randomized into group A (longitudinal incision) and group B (transverse incision). The primary objective was to compare the time needed for entry into the submucosal space. The secondary objectives were to compare the time needed to close the incision, number of clips required to close the incision, and development of gas-related events. The sample size was calculated as for a non-inferiority design using Kelsey method.
    RESULTS: Sixty patients were randomized (30 in each group). On comparing the 2 types of incisions, there was no difference in entry time [3 (2, 5) vs 2 (1.75, 5) min, p = 0.399], closure time [7 (4, 13.5) vs 9 (6.75, 19) min, p = 0.155], and number of clips needed for closure [4 (4, 6) vs 5 (4, 7), p = 0.156]. Additionally, the gas-related events were comparable between the 2 groups (capnoperitoneum needing aspiration-5 vs 2, p = 0.228, and development of subcutaneous emphysema-3 vs 1, p = 0.301).
    CONCLUSIONS: This randomized trial shows comparable entry time, closure time, number of clips needed to close the incision, and gas-related events between longitudinal and transverse incisions.
    BACKGROUND: CTRI/2021/08/035829.
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  • 文章类型: Journal Article
    背景:Lebrikizumab在16周和52周时在中度至重度特应性皮炎(AD)患者的皮肤清除率和患者报告结局方面与安慰剂相比显着改善。我们报告了lebrikizumab单药治疗的持续影响,在52周和两次访问之间,关于瘙痒和睡眠不足症状的频率,通过以患者为导向的湿疹测量(POEM)评估,在中度至重度AD患者中。
    方法:在ADvocate1和ADvocate2中,第16周的lebrikizumab应答者(EASI75或IGA0/1,改善≥2点,无抢救药物)每2周(Q2W)随机分配给lebrikizumab,每4周(Q4W),或安慰剂36周。该汇总分析报告了lebrikizumabQ2W和Q4W治疗组的项目1(瘙痒)和2(睡眠障碍)实现POEM反应0(无天)或1(1-2天)的患者从第16周改善至第52周。观察到(不包括治疗停止后收集的数据,抢救药物的使用,或患者转移到逃生臂)报告结果。
    结果:在第16周,对于lebrikizumabQ2W和Q4W,35.9%(n=37/103)和39.3%(n=42/107)的患者对POEM(Itch)项目1有0或1应答,12.6%(n=13/103)和12.1%(n=13/107)有0应答。共有66.0%(n=68/103)和72.6%(n=77/106)的患者对POEM(睡眠)项目2有0或1应答,37.9%(n=39/103)和44.3%(n=47/106)分别有0应答。到第52周,对于lebrikizumabQ2W和Q4W,44.6%(n=29/65)和48.0%(n=36/75)对POEM(Itch)的第1项做出0或1反应,21.5%(n=14/65)和18.7%(n=14/75)的患者应答0。共有83.1%(n=54/65)和78.4%(n=58/74)对POEM(睡眠)项目2做出0或1的反应,67.7%(n=44/65)和59.5%(n=44/74)的反应分别为0。
    结论:每周POEM对瘙痒和睡眠障碍的反应在剂量和就诊之间保持稳定,从第16周到第52周,在接受lebrikizumab治疗的患者中继续改善,证明随着时间的推移,关键AD症状持续改善。
    背景:ADvocate1(NCT04146363)和ADvocate2(NCT04178967)。
    BACKGROUND: Lebrikizumab demonstrated significant improvement versus placebo for measures of skin clearance and patient-reported outcomes at weeks 16 and 52 in patients with moderate-to-severe atopic dermatitis (AD). We report the sustained impact of lebrikizumab monotherapy, over 52 weeks and between visits, on the frequency of itch and sleep loss symptoms, as assessed by Patient-Oriented Eczema Measure (POEM), in patients with moderate-to-severe AD.
    METHODS: In ADvocate1 and ADvocate2, Week-16 lebrikizumab responders (EASI75 or IGA 0/1 with ≥ 2-point improvement and without rescue medication) were randomized to lebrikizumab every 2 weeks (Q2W), every 4 weeks (Q4W), or placebo for 36 weeks. This pooled analysis reports improvement from Week 16 to 52 in patients achieving POEM response 0 (no days) or 1 (1-2 days) for Items 1 (itch) and 2 (sleep disturbance) for the lebrikizumab Q2W and Q4W treatment arms. Observed (excluding data collected after treatment discontinuation, rescue medication use, or patient transfer to escape arm) results were reported.
    RESULTS: At Week 16, for lebrikizumab Q2W and Q4W, 35.9% (n = 37/103) and 39.3% (n = 42/107) of patients responded 0 or 1 to Item 1 of POEM (Itch) and 12.6% (n = 13/103) and 12.1% (n = 13/107) responded 0. A total of 66.0% (n = 68/103) and 72.6% (n = 77/106) of patients responded 0 or 1 to Item 2 of POEM (Sleep) and 37.9% (n = 39/103) and 44.3% (n = 47/106) responded 0, respectively. By Week 52, for lebrikizumab Q2W and Q4W, 44.6% (n = 29/65) and 48.0% (n = 36/75) responded 0 or 1 to Item 1 of POEM (Itch), and 21.5% (n = 14/65) and 18.7% (n = 14/75) of patients responded 0. A total of 83.1% (n = 54/65) and 78.4% (n = 58/74) responded 0 or 1 to Item 2 of POEM (Sleep), and 67.7% (n = 44/65) and 59.5% (n = 44/74) responded 0, respectively.
    CONCLUSIONS: Weekly POEM responses for itch and sleep disturbance remained stable between doses and visits, and continued to improve from Week 16 through 52, in lebrikizumab-treated patients, demonstrating consistent improvement over time for key AD symptoms.
    BACKGROUND: ADvocate1 (NCT04146363) and ADvocate2 (NCT04178967).
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  • 文章类型: Editorial
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  • 文章类型: Journal Article
    翻译和验证希腊版本的患者导向湿疹措施(POEM)是我们的目标。使用并行反向翻译过程来翻译POEM。总共招募了59名成人特应性皮炎患者来评估有效性和可靠性。通过与医生的患者访谈,包含人口统计信息的问卷,POEM,填写皮肤病学生活质量指数(DLQI)。第一次访问后的3-7天,进行了第二次POEM完成。与研究参与者一起进行的POEM项目表现出良好的内部一致性(Cronbach的α=0.88),并没有发现整体的地板和天花板的影响。DLQI和POEM评分之间存在显著相关性(Spearmanrho=0.71;p<0.001)。访谈之间的POEM得分显示平均组内相关系数(95%置信区间)为0.89(0.80,0.94),表明良好的重测可靠性。患者报告的结果指标在希腊变得越来越普遍,因此,访问文献中经常使用的经过验证的仪器的希腊语翻译是至关重要的。
    Translating and validating the Greek version of the Patient Oriented Eczema Measure (POEM) was our goal. A parallel backtranslation process was used to translate POEM. A total of fifty-nine adult atopic dermatitis patients were enlisted to assess validity and reliability. Through patient interviews with physicians, a questionnaire comprising demographics, POEM, and the dermatology life quality index (DLQI) was filled out. 3-7 days after the first visit, a second POEM completion was conducted. The POEM items conducted with study participants demonstrated a good level of internal consistency (Cronbach\'s alpha = 0.88), and no overall floor and ceiling effects were found. There was a significant correlation between the DLQI and POEM scores (Spearman rho =0.71; p<0.001). The POEM score between interviews showed an average intraclass correlation coefficient (95% confidence interval) of 0.89 (0.80, 0.94), indicating good to excellent test-retest reliability. Patient-reported outcome measures are becoming more and more common in Greece, so it\'s critical to have access to Greek translations of validated instruments that are frequently used in literature.
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  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    背景和研究目的内镜下夹(TTSC)用于止血和闭合。我们记录了带有锚叉的新TTSC的性能。患者和方法我们在美国和加拿大的三家医院对50名具有内窥镜夹闭适应症的患者进行了新的TTSC的前瞻性病例系列。在索引程序后对患者进行30天的随访。结果包括与装置或手术相关的缺陷闭合和严重不良事件(SAE)的发生率。结果50例患者共进行了56次夹闭手术。在结肠(33)或胃(1)的内镜粘膜切除术(EMR)后,进行了34次手术,16息肉切除术后,两个用于活动性出血的止血,每个一个用于瘘管闭合,经口内镜肌切开术粘膜闭合术,或锚定饲管。在33个结肠EMR缺损中的32个和22个其他缺损中的21个中实现了完全缺损闭合。所有夹子都按照标记的使用方向放置。41例患者(82.0%),据报道,预防延迟性出血是内镜下夹闭的适应症.有三例延迟出血。没有与设备相关的严重不良事件。唯一的技术困难是过早部署剪辑的一个实例。结论一种新型的带有锚叉的TTSC在一系列缺损闭合中显示出成功的效果。可接受的安全概况,技术难题发生率低。
    Background and study aims Endoscopic through-the-scope clips (TTSC) are used for hemostasis and closure. We documented the performance of a new TTSC with anchor prongs. Patients and methods We conducted a prospective case series of the new TTSC in 50 patients with an indication for endoscopic clipping at three hospitals in the United States and Canada. Patients were followed for 30 days after the index procedure. Outcomes included defect closure and rate of serious adverse events (SAEs) related to the device or procedure. Results Fifty patients had 56 clipping procedures. Thirty-four procedures were clipping after endoscopic mucosal resection (EMR) in the colon (33) or stomach (1), 16 after polypectomy, two for hemostasis of active bleeding, and one each for fistula closure, per-oral endoscopic myotomy mucosal closure, or anchoring a feeding tube. Complete defect closure was achieved in 32 of 33 colon EMR defects and 21 of 22 other defects. All clips were placed per labeled directions for use. In 41 patients (82.0%), prophylaxis of delayed bleeding was reported as an indication for endoscopic clipping. There were three instances of delayed bleeding. There were no device-related SAEs. The only technical difficulty was one instance of premature clip deployment. Conclusions A novel TTSC with anchor prongs showed success in a range of defect closures, an acceptable safety profile, and low incidence of technical difficulties.
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  • 文章类型: Journal Article
    背景:本研究的目的是比较肌切开术深度的影响(选择性内层肌切开术(SIM)与全层肌切开术(FTM))对POEM治疗贲门失弛缓症患者的预后。
    方法:这是一个回顾性研究,观察,2018年10月至2022年9月在两个三级中心进行。患者分为两组:SIM和FTM。主要终点是6个月时的临床疗效,而次要终点是术后标准(如疼痛,住院时间,并发症)和胃食管反流病(GERD)(6个月时的食管炎,胃灼热,和pH测定)。
    结果:158例患者纳入研究(FTM组33例,SIM组125例)。两组6个月和12个月的成功率相似,SIM组为84%和70%,FTM组为90%和80%,分别(p=0.57和p=0.74)。然而,与SIM组相比,FTM组消耗了更多的阿片类镇痛药(41%vs21%,p<0.01)。FTM组的住院时间长于SIM组(2.17±2.62vs2.94±2.33,p<0.001)。6个月时食管炎的发生率相当(SIM组为16%,FTM组为12%,p=0.73)。SIM组和FTM组在6个月或12个月时的胃灼热没有显着差异(18.5%vs3.8%,p=0.07和27%vs12.5%,p分别=0.35)。
    结论:FTM和SIM在临床疗效和GERD发生方面无显著差异。然而,全层肌切开术与更多的术后疼痛和更长的住院时间相关.因此,选择性内部肌切开术应优于全层肌切开术。
    BACKGROUND: The aim of this study was to compare the impact of the depth of myotomy (selective inner layer myotomy (SIM) vs. full-thickness myotomy (FTM)) on the outcome of patients treated with POEM for achalasia.
    METHODS: This was a retrospective, observational, conducted in two tertiary centers between October 2018 and September 2022. Patients were divided into two groups: SIM and FTM. The primary endpoint was clinical efficacy at 6 months, while secondary endpoints were postoperative criteria (such as pain, length of hospital stay, complications) and occurrence of gastroesophageal reflux disease (GERD) (esophagitis at 6 months, heartburn, and pH-metry).
    RESULTS: 158 patients were included in the study (33 in the FTM group and 125 in the SIM group). The success rates at 6 and 12 months were similar in both groups, with 84 % and 70 % in the SIM group versus 90 % and 80 % in the FTM group, respectively (p = 0.57 and p = 0.74). However, more opioid analgesics were consumed in the FTM group compared to the SIM group (41% vs 21 %, p < 0.01). The length of hospitalization was longer in the FTM group than in the SIM group (2.17 ± 2.62 vs 2.94 ± 2.33, p < 0.001). The rate of esophagitis at 6 months was comparable (16 % in the SIM group vs 12 % in the FTM group, p = 0.73). There was no significant difference in terms of heartburn at 6 or 12 months between the SIM and FTM groups (18.5% vs 3.8 %, p = 0.07 and 27% vs 12.5 %, p = 0.35, respectively).
    CONCLUSIONS: There was no significant difference in terms of clinical efficacy and GERD occurrence between FTM and SIM. However, full-thickness myotomy was associated with more postoperative pain and a longer length of hospital stay. Therefore, selective internal myotomy should be preferred over full-thickness myotomy.
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  • 文章类型: Systematic Review
    背景:经口内镜下肌切开术(POEM)是一种新兴的有效治疗贲门失弛缓症的方法。然而,相当比例的患者对治疗反应不佳.经过十多年的临床实践,已确定与POEM故障相关的潜在风险因素。本荟萃分析旨在总结POEM失败危险因素的证据。
    方法:在PubMed上进行了系统的文献检索,Embase,WebofScience,和Cochrane图书馆从成立到6月10日,2022年。我们纳入了英国研究,这些研究报告了门失弛缓症患者的POEM结局,并确定了POEM失败的危险因素。使用固定或随机效应模型提取和分析相关信息以汇集效应大小。
    结果:本综述共纳入27项研究,包括9371例贲门失弛缓症患者。合并失败率为8%(90%CI7%-10%)。我们确定了乙状结肠食管(OR1.90,95%CI1.45-2.47),I型贲门失弛缓症(OR1.30,95%CI1.04-1.63),和III型贲门失弛缓症(OR1.26,95%CI0.89-1.78)与较差的临床反应相关。相反,II型贲门失弛缓症与较好的反应相关(OR0.59,95%CI0.47-0.75).先前使用Heller肌切开术(OR5.75,95%CI3.97-8.34)和先前的球囊扩张(OR1.18,95%CI1.07-1.29)的治疗也与更高的临床失败风险相关。
    结论:我们的荟萃分析结果表明,乙状结肠食管,测压弛缓症亚型,和以前的治疗与POEM失败有关。这些信息可用于指导治疗决策并提高POEM在门失弛缓症患者中的成功率。
    BACKGROUND: Peroral endoscopic myotomy (POEM) is an emerging effective treatment for achalasia. However, a significant proportion of patients do not respond well to the treatment. After over a decade of clinical practice, potential risk factors associated with POEM failure have been identified. This meta-analysis aimed to summarize the evidence of risk factors for POEM failure.
    METHODS: A systematic literature search was conducted on PubMed, Embase, Web of Science, and Cochrane Library from inception to June 10th, 2022. We included English studies that reported POEM outcomes in achalasia patients and identified risk factors for POEM failure. Relevant information was extracted and analyzed using fixed- or randomized-effect models to pool the effect size.
    RESULTS: A total of 27 studies comprising 9371 patients with achalasia were included in this review. The pooled failure rate was 8% (90% CI 7%-10%). We identified sigmoid esophagus (OR 1.90, 95% CI 1.45-2.47), type I achalasia (OR 1.30, 95% CI 1.04-1.63), and type III achalasia (OR 1.26, 95% CI 0.89-1.78) were associated with a worse clinical response. Conversely, type II achalasia was associated with a better response (OR 0.59, 95% CI 0.47-0.75). Prior treatment with Heller myotomy (OR 5.75, 95% CI 3.97-8.34) and prior balloon dilation (OR 1.18, 95% CI 1.07-1.29) were also associated with a higher risk of clinical failure.
    CONCLUSIONS: Our meta-analysis results demonstrated that sigmoid esophagus, manometric achalasia subtype, and prior treatment were associated with POEM failure. This information could be used to guide treatment decisions and improve the success rate of POEM in achalasia patients.
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  • 文章类型: Journal Article
    贲门失弛缓症有多种治疗选择。然而,经口内镜肌切开术(POEM)和腹腔镜Heller肌切开术合并胃底折叠术(LHM)具有疗效和并发症发生率低的特点。比较POEM和LHM对贲门失弛缓症患者的几种结局。本系统评价是根据系统评价和荟萃分析(PRISMA)指南的首选报告项目进行的。使用PubMed进行了详尽的文献检索,WebofScience,和Cochrane图书馆数据库。包括比较POEM和LHM在贲门失弛缓症患者中的几种结果的研究。关于临床成功的数据,手术时间,术中并发症,逗留时间,再干预率,术后疼痛,整体并发症,出现GERD症状,使用质子弹抑制剂和食管炎进行提取。使用MINORS量表对纳入研究进行质量评估。我们纳入了20项回顾性观察研究,总共5139名参与者。结果表明,术中并发症没有统计学上的显着差异,术后并发症,再干预率,出现GERD症状,GERDHRQL,使用质子泵抑制剂,POEM组和LHM组之间的食管炎。相反,POEM与更高的临床成功率和更短的手术时间相关。逗留时间,和术后疼痛。这项荟萃分析得出的结论是,POEM和LHM,是贲门失弛缓症的有效和安全的治疗方法。然而,POEM在临床成功方面表现出更好的结果,手术时间,逗留时间,术后疼痛,和低复发率的趋势。
    There are various therapeutic options for achalasia. Nevertheless, peroral endoscopic myotomy (POEM) and laparoscopic Heller myotomy with fundoplication (LHM) are distinguished by their efficacy and low incidence of complications. Compare POEM and LHM regarding several outcomes in patients with achalasia. This systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. An exhaustive literature search was performed using PubMed, Web of Science, and Cochrane Library databases. Studies comparing several outcomes between POEM and LHM in patients with achalasia were included. Data on clinical success, operative time, intraoperative complications, length of stay, reintervention rates, postoperative pain, overall complications, occurrence of GERD symptoms, use of proton bomb inhibitors and esophagitis were extracted. Quality assessment of the included studies was performed using the MINORS scale. We included 20 retrospective observational studies with a combined total of 5139 participants. The results demonstrated that there was no statistically significant difference in terms of intraoperative complications, postoperative complications, reintervention rate, occurrence of GERD symptoms, GERD HRQL, use of proton pump inhibitors, and esophagitis between POEM and LHM groups. Conversely, POEM was associated with higher clinical success and shorter operative time, length of stay, and postoperative pain. This meta-analysis concludes that both POEM and LHM, are effective and safe treatments for achalasia. However, POEM demonstrates better results regarding clinical success, operative time, length of stay, postoperative pain, and a tendency towards lower recurrence.
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