指压腕带对GLP-1药物相关恶心的止吐作用

Florencia Ziemke , Soufiane Belarj , Jem Esguerra , Anita Reyes , Nawfal Istfan
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引用次数: 0

摘要

恶心是GLP-1受体激动剂(GLP-1a)报道最多的副作用之一。目前的建议不足以控制症状,包括止吐药物,行为改变,GLP-1a剂量调整,并经常导致治疗中断。Sea-Band®是一种无药物,fda批准的II类医疗器械,用于缓解晕车、孕吐、化疗和麻醉引起的恶心。该设备是一套柔软,弹性,可重复使用的指压腕带(ACW),在手腕折痕下方佩戴一个面向皮肤的塑料按钮,在心包穴位施加压力。我们假设ACW是GLP-1a相关恶心的有效工具。这是一项单臂、开放标签、非随机、前瞻性介入研究,评估ACW对非怀孕成人glp -1伴恶心的止吐效果。GLP-1a为西马鲁肽或替西帕肽。排除标准为服用GLP-1a且无恶心、近期使用止吐药物、其他恶心相关疾病、胃轻瘫史和未控制的胃食管反流疾病的患者。患者被告知如何在恶心开始时正确放置和使用ACW,并每周随访4周。随访评估恶心的频率,ACW的使用频率和持续时间,以及恶心的变化。结果在4周的时间里,31名成人参与者中有359次恶心发作。成年人,平均年龄55岁,平均BMI 34,平均HbA1c 5.9%,每周有超过80%的时间报告恶心。ACW用于所有记录的恶心发作。在整个研究期间,药物剂量保持稳定。三分之一的发作在5分钟内缓解恶心,其余发作在5分钟以上但不到20分钟。采用logistic回归模型评估恶心缓解的可能性。在研究期间,观察到恶心缓解率超过80%,调整了恶心发作减少和发作减少之间的相关性。结论:虽然不是对照试验,但这项试点、概念验证和实用研究表明,ACW可能为治疗GLP-1a相关的恶心提供了一种安全、自我给药、可重复使用和无药物的选择。ACW减轻恶心的效果在80%以上的发作中可见,并在整个研究期间保持一致。三分之一的参与者在头三周佩戴ACW后5分钟内感到缓解。考虑到人口的样本量相对较小,进一步的大规模调查是合理的。恶心在日常使用GLP-1a中很常见,我们的研究结果表明,使用ACW可能提供一线治疗干预,可以随意使用,以抑制破坏性症状,改善日常幸福感,并对患者的GLP-1a治疗过程产生积极影响。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Antiemetic effect of acupressure wristbands for GLP-1 medication associated nausea

Antiemetic effect of acupressure wristbands for GLP-1 medication associated nausea

Background

Nausea is one of the most reported side effect of GLP-1 receptor agonists (GLP-1a). Current recommendations fall short in taming the symptoms, include antiemetic medication, behavior changes, GLP-1a dose adjustment, and often cause a disruption to treatment. Sea-Band® is a drug-free, class II FDA-cleared medical device for relief of nausea in motion sickness, morning sickness, chemotherapy and anesthesia induced nausea. The device is a set of soft, elastic, reusable acupressure wristbands (ACW) with a skin-facing plastic button worn below the wrist crease applying pressure at acupoint pericardium 6. We hypothesized that ACW was an effective tool for GLP-1a associated nausea.

Methods

This was a one-arm, open-label, non-randomized, prospective interventional study evaluating the antiemetic effect of ACW in non-pregnant adults on GLP-1as with nausea. GLP-1a were semaglutide or tirzepatide. Exclusion criteria were patients on GLP-1a without nausea, recent use of antiemetic medications, other nausea-related conditions, history of gastroparesis, and uncontrolled gastroesophageal reflux disease. Patients were shown how to properly place and use ACW at the onset of nausea and were followed weekly for 4 weeks. Follow-ups assessed frequency of nausea, ACW use frequency and duration, and change in nausea.

Results

359 episodes of nausea were recorded amongst 31 adult participants over 4 weeks. Adults, mean age 55, mean BMI 34, mean HbA1c 5.9 %, reported nausea over 80 % of the time on a weekly basis. ACW were used in all recorded episodes of nausea. Medication doses were kept stable throughout the duration of this study. Nausea relief was achieved within 5 min in one third of episodes, and in over 5 min but under 20 min in the remainder of the episodes. A logistic regression model was used to evaluate the likelihood of nausea relief. A consistent rate of nausea relief over 80 % was observed during the study period, adjusting for the correlation between reduced nausea episodes and reduced episodes.

Conclusion

Although not a controlled trial, this pilot, proof of concept, pragmatic study suggests that ACW may offer a safe, self-administered, reusable, and drug-free option for managing GLP-1a associated nausea.ACW’s nausea reducing effect was seen in over 80 % of episodes, and remained consistent throughout the study period. One third of participants experienced relief within 5 min of wearing ACW in the first three weeks. Given the relatively small sample size of the population, further large-scale investigations are justified. Nausea is common in day-to-day real-world use of GLP-1as, and our results suggest that using ACW may provide a first-line therapeutic intervention used ad libitum to tame a disruptive symptom, improve day-to-day well-being, and positively impact a person’s treatment journey on GLP-1a.
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