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微灌肠剂缓解便秘的用户体验的真实世界证据。

Real World Evidence of User Experience with Microenemas for Relief of Constipation.

作者信息

Rasche Stefanie, Spegel Christer, Lundh Katarina

机构信息

Kenvue, Johnson und Johnson GmbH, Neuss, Germany.

McNeil AB, Part of Kenvue, Helsingborg, Sweden.

出版信息

Drugs Real World Outcomes. 2024 Dec;11(4):659-667. doi: 10.1007/s40801-024-00444-z. Epub 2024 Sep 8.

DOI:10.1007/s40801-024-00444-z
PMID:39244682
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11589039/
Abstract

BACKGROUND

Constipation is a commonly reported gastrointestinal complaint. Research on this widespread condition focuses mainly on clinical trials for chronic constipation with less emphasis on patient experience and nonchronic situations. Sufferers report that constipation interferes with daily activities and quality of life. It is likely that this is common among all sufferers of constipation, regardless of how often the condition is experienced.

OBJECTIVE

This work explored attitudes and perceptions of people who experience occasional constipation and self-treat with over the counter products, particularly Microlax microenemas.

METHODS

In this retrospective study, real-world data were collected from 1635 respondents from France and Russia who experienced occasional constipation. Participants completed a questionnaire about their experiences with occasional (not chronic) constipation and perceptions of over the counter treatments of oral laxatives, suppositories, and Microlax microenemas. Questions focused on comfort, quality of life, ease of use, and reliability of these treatments. Participants had used the microenema for treatment of occasional constipation within 3 months of study participation. Occasional constipation was based on the Rome IV diagnostic criteria for adults and babies. Data were analyzed across the total population of all groups, then by subgroup. Success criteria were defined as of at least 70% agreement with the statements scoring ≥ 7 on the scale of 0-10. The proportion of respondents agreeing with the individual statements was calculated using the denominator for the total sample within each group.

RESULTS

This study shows that experiencing even occasional bouts of constipation negatively affect quality of life and well-being. Participants (women aged 25-54 years, older men, and women aged 60-80 years) reported that it severely limited daily life and activities and caused negative emotions and embarrassment. Pregnant women and mothers with babies showed great concern that constipation indicated a serious and painful condition and was bad for their babies. Participants agreed that using Microlax microenema provided greater ease of use, comfort, reliability, and safety than oral laxatives and rectal suppositories.

CONCLUSIONS

Sufferers of occasional constipation report that these bouts interfere with their daily lives and reduce quality of life, similar to what is reported for those with chronic constipation based on existing literature. The microenema, Microlax, showed benefits in the relief of occasional constipation compared with oral laxatives and rectal suppositories. Trepidation about using the microenema, experienced before using it, was greatly reduced after the first and subsequent uses. Microlax microenema enabled users to regain the feeling of control and provided positive impacts on quality of life and well-being.

摘要

背景

便秘是一种常见的胃肠道疾病主诉。针对这种普遍情况的研究主要集中在慢性便秘的临床试验上,对患者体验和非慢性情况的关注较少。患者报告称,便秘会干扰日常活动和生活质量。无论便秘发作的频率如何,这种情况在所有便秘患者中可能都很常见。

目的

本研究探讨了偶尔便秘并使用非处方产品(尤其是微 lax 微灌肠剂)进行自我治疗的人群的态度和看法。

方法

在这项回顾性研究中,收集了来自法国和俄罗斯的 1635 名偶尔便秘患者的真实世界数据。参与者完成了一份关于他们偶尔(非慢性)便秘经历以及对口服泻药、栓剂和微 lax 微灌肠剂等非处方治疗方法看法的问卷。问题集中在这些治疗方法的舒适度、生活质量、易用性和可靠性上。参与者在参与研究的 3 个月内使用过微灌肠剂治疗偶尔便秘。偶尔便秘是根据罗马 IV 成人及婴儿诊断标准确定的。对所有组的总体人群进行数据分析,然后按亚组进行分析。成功标准定义为至少 70%的人同意在 0 - 10 分的量表上得分≥7 的陈述。使用每组总样本的分母计算同意各单项陈述的受访者比例。

结果

本研究表明,即使偶尔发作便秘也会对生活质量和幸福感产生负面影响。参与者(年龄在 25 - 54 岁的女性、老年男性以及年龄在 60 - 80 岁的女性)报告称,便秘严重限制了日常生活和活动,并导致负面情绪和尴尬。孕妇和有婴儿的母亲非常担心便秘表明病情严重且痛苦,对她们的宝宝不利。参与者一致认为,与口服泻药和直肠栓剂相比,使用微 lax 微灌肠剂更易于使用、更舒适、更可靠且更安全。

结论

偶尔便秘的患者报告称,这些发作会干扰他们的日常生活并降低生活质量,这与现有文献中慢性便秘患者的情况类似。与口服泻药和直肠栓剂相比,微 lax 微灌肠剂在缓解偶尔便秘方面显示出益处。在使用微灌肠剂之前所体验到的恐惧,在首次使用及后续使用后大大降低。微 lax 微灌肠剂使使用者重新获得控制感,并对生活质量和幸福感产生积极影响。

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本文引用的文献

1
A real world evaluation of a treatment for infant colic based on the experience and perceptions of 4004 parents.基于4004位家长的经验和看法对一种婴儿腹绞痛治疗方法的真实世界评估。
Br J Nurs. 2017 Mar 1;26(5 Suppl 1):S3-S10. doi: 10.12968/bjon.2017.26.Sup5.S3.
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Constipation is casting a shadow over everyday life - a systematic review on older people's experience of living with constipation.便秘正在给日常生活蒙上阴影——一项关于老年人便秘生活体验的系统综述。
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A real-world evidence study evaluating a treatment for nappy rash.一项评估尿布疹治疗方法的真实世界证据研究。
Br J Nurs. 2016;25(8):432-9. doi: 10.12968/bjon.2016.25.8.432.
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Epidemiology and burden of chronic constipation.慢性便秘的流行病学与负担
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