信:卢比前列酮治疗masld -性别失衡和致盲考虑

IF 6.6 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY
Jiru Li, Qi-En Shen
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引用次数: 0

摘要

我们怀着极大的兴趣阅读了El-Kassas及其同事b[1]的研究。该研究提供了有价值的见解,表明Lubiprostone耐受性良好,可有效降低MASLD患者的肝脏脂肪含量。然而,我们希望强调几个关键的考虑因素,以加强对研究结果的解释,并为未来的研究提出途径。首先,我们想强调的是,在研究的患者群体中存在显著的性别失衡。患者组中女性比例高得不成比例,对照组为83%,干预组为91%。此外,干预组女性患者的平均年龄(43.3±9.1岁)低于对照组(47.0±10.2岁)。这种年龄差异与更年期过渡相一致,增加了绝经前和围绝经期妇女之间雌激素水平的差异。雌激素在脂肪肝疾病b[2]的进展中起关键作用。由于雌激素水平下降,绝经后妇女脂肪肝的临床病程往往会恶化[2,3]。考虑到本研究中两组患者的年龄差异,雌激素水平在干预组和对照组之间可能存在显著差异,这可能夸大了lubiprostone的实际效果。一种更精细的方法可能包括监测雌激素水平,作为这些激素如何影响MASLD病程和治疗结果的更广泛分析的一部分。其次,虽然我们赞扬作者采用随机双盲设计,但我们注意到与药物机制相关的潜在限制。众所周知,卢比前列石作为一种泻药,对肠道运动有直接影响。在临床实践中,服用泻药的患者往往能够根据胃肠道功能的变化来推断他们的治疗组,这可能会影响他们对药物疗效的看法。尽管研究报告参与者和护理人员对治疗分配都是盲目的,但对卢比前列石的生理反应可能会引入心理偏差。因此,在类似的研究设计中,可以在研究中引入一种虚拟泻药(一种没有生理作用的药物)作为对照组,以确保参与者不能通过他们的生理反应来判断他们的组。最后,重要的是要承认研究纳入标准的局限性。所有试验参与者的肝酶均低于40,这表明该研究的重点是轻度肝脂肪变性和无明显脂肪性肝炎的个体。MASLD是一种进行性慢性疾病,其管理需要长期的方法。润滑油前列石的长期安全性和耐受性仍不确定,特别是在合并代谢疾病的患者中。因此,我们建议未来的研究应考虑更多不同程度肝损伤和代谢功能障碍的人群。此外,有必要延长随访时间来评估鲁比前列素的长期影响,包括潜在的不良反应、耐药性以及与MASLD治疗中常用的其他疗法的相互作用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Letter: Lubiprostone Treatment for MASLD—Gender Imbalance and Blinding Considerations

We read with great interest the studies by El-Kassas and their colleagues [1]. This study provides valuable insights, demonstrating that Lubiprostone is well tolerated and effectively reduces liver fat content in patients with MASLD. However, we wish to highlight a few key considerations to enhance the interpretation of the findings and propose avenues for future research.

Firstly, we would like to highlight the significant gender imbalance in the study's patient population. The patient group included a disproportionately high percentage of women, with 83% in the control group and 91% in the intervention group. Additionally, the mean age of the female patients in the intervention group (43.3 ± 9.1 years) was younger than that in the control group (47.0 ± 10.2 years). This age difference aligns with the menopausal transition, increasing oestrogen level variations between pre-menopausal and peri-menopausal women. Oestrogen plays a critical role in the progression of fatty liver disease [2]. Postmenopausal women often experience a worsened clinical course of fatty liver due to the decline in oestrogen levels [2, 3]. Given the age difference between the two groups of patients in this study, oestrogen levels may have differed significantly between the intervention and control groups, which may have exaggerated the actual effects of lubiprostone. A more refined approach might include monitoring oestrogen levels as part of a broader analysis of how these hormones influence the course of MASLD and treatment outcomes.

Secondly, while we commend the authors for employing a randomised, double-blind design, we note a potential limitation related to the drug's mechanism. Lubiprostone, as a laxative, is known to have a direct effect on bowel movements [4]. In clinical practice, patients receiving laxatives are often able to infer their treatment group based on changes in gastrointestinal function, which may affect their perceptions of the drug's efficacy. Although the study reports that both the participants and caregivers were blinded to treatment allocation, the physiological response to lubiprostone may introduce a psychological bias. Therefore, in similar study designs, a dummy laxative (a drug with no physiological effect) could be introduced as a control group in the study to ensure that participants are not able to judge their group by their physiological response.

Finally, it is important to acknowledge the limitations in the study's inclusion criteria. All trial participants had liver enzymes under 40, which suggests that the study focused on individuals with mild liver steatosis and without overt steatohepatitis. MASLD is a progressive, chronic disease, and its management requires a long-term approach. The safety and tolerability of lubiprostone over extended periods remain uncertain, particularly in patients with co-morbid metabolic conditions [5]. As such, we recommend that future research should consider a more diverse population with varying degrees of liver injury and metabolic dysfunction. Furthermore, extended follow-up periods are necessary to evaluate the long-term effects of lubiprostone, including potential adverse effects, drug resistance, and interactions with other therapies commonly used in the management of MASLD.

Jiru Li: conceptualization, methodology, writing – original draft. Qi-En Shen: supervision, conceptualization, writing – review and editing.

The authors have nothing to report.

The authors declare no conflicts of interest.

This article is linked to El-Kassas et al papers. To view these articles, visit https://doi.org/10.1111/apt.18478 and https://doi.org/10.1111/apt.70132.

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来源期刊
CiteScore
15.60
自引率
7.90%
发文量
527
审稿时长
3-6 weeks
期刊介绍: Alimentary Pharmacology & Therapeutics is a global pharmacology journal focused on the impact of drugs on the human gastrointestinal and hepato-biliary systems. It covers a diverse range of topics, often with immediate clinical relevance to its readership.
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