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乌司奴单抗在炎症性肠病中的应用综述:来自ClinicalTrials.gov注册库的见解

Comprehensive Review of Ustekinumab Utilization in Inflammatory Bowel Diseases: Insights from the ClinicalTrials.gov Registry.

作者信息

Alorfi Nasser M, Alourfi Mansour M, Bokhari Ghfran Abdulrahman, Alkhattabi Abdullah, Ibrahim Nihal Abdalla, Alsabban Abdulmalik Mohammed, Almatrafi Mohammad J, Zakri Yaser Abdulaziz, Almahmoud Abdullah Jasem, Al-Ghamdi Khalid Mohammed A, Alsharif Saeed Nasser

机构信息

Department of Pharmacology and Toxicology, College of Pharmacy, Umm Al-Qura University, Makkah, Saudi Arabia.

Internal Medicine Department, King Faisal Medical City for Southern Region, Abha, Saudi Arabia.

出版信息

Int J Gen Med. 2023 Sep 20;16:4283-4294. doi: 10.2147/IJGM.S433636. eCollection 2023.

Abstract

BACKGROUND

Inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis, are chronic inflammatory conditions affecting the gastrointestinal tract. To achieve and sustain remission, effective treatment strategies are necessary. Ustekinumab, a biologic agent targeting interleukin-12 and interleukin-23, has emerged as a significant therapeutic option for moderate to severe IBD.

AIM

To gain insights into the utilization of Ustekinumab for IBD, we conducted a comprehensive review of the ClinicalTrials.gov registry.

METHODS

A comprehensive search of the ClinicalTrials.gov was conducted to find all clinical trials involving the use of Ustekinumab in IBD patients. As of December 30th, 2022, 69 clinical trials were identified that included IBD and Ustekinumab. The study list was saved, and those clinical trials that fitted the definition of targeted therapy were included in the review.

RESULTS

The results showed that Ustekinumab was associated with significant improvements in the clinical response and remission rates, in both Crohn's disease and ulcerative colitis patients. Additionally, the safety profile of Ustekinumab was generally favourable, with low rates of adverse events reported. In terms of study design, most of the relevant studies found in the database were interventional studies. The investigation focused on completed studies and found that there were a limited number of clinical trials with interventional measures.

CONCLUSION

Ustekinumab appears to be a promising treatment option for patients with IBD, with the potential to provide significant clinical benefits and a favourable safety profile. Further research is warranted to confirm these findings and explore optimal dosing and treatment regimens.

摘要

背景

炎症性肠病(IBD),包括克罗恩病和溃疡性结肠炎,是影响胃肠道的慢性炎症性疾病。为了实现并维持病情缓解,有效的治疗策略必不可少。乌司奴单抗是一种靶向白细胞介素-12和白细胞介素-23的生物制剂,已成为中重度IBD的重要治疗选择。

目的

为深入了解乌司奴单抗在IBD中的应用情况,我们对ClinicalTrials.gov注册库进行了全面综述。

方法

对ClinicalTrials.gov进行全面检索,以查找所有涉及在IBD患者中使用乌司奴单抗的临床试验。截至2022年12月30日,共识别出69项包括IBD和乌司奴单抗的临床试验。保存研究列表,并将符合靶向治疗定义的临床试验纳入综述。

结果

结果显示,乌司奴单抗在克罗恩病和溃疡性结肠炎患者中均与临床反应和缓解率的显著改善相关。此外,乌司奴单抗的安全性总体良好,不良事件报告率较低。在研究设计方面,数据库中发现的大多数相关研究为干预性研究。该调查聚焦于已完成的研究,发现采用干预措施的临床试验数量有限。

结论

乌司奴单抗似乎是IBD患者的一种有前景的治疗选择,有可能带来显著的临床益处且安全性良好。有必要进行进一步研究以证实这些发现,并探索最佳剂量和治疗方案。

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