Saleh Mustafa, Boukhdoud Mona, Boukhdoud Hayam, Al Zein Mohammad, Salameh Pascale
Faculty of Medical Sciences, Lebanese University, Lebanon.
School of Medicine, Lebanese American University, Byblos, Lebanon.
J Clin Neuromuscul Dis. 2023 Mar 1;24(3):119-129. doi: 10.1097/CND.0000000000000441.
Guillain-Barré syndrome (GBS) is an immune-mediated polyradiculoneuropathy that remains a debilitating disease despite medical treatment. Numerous challenges still exist, including the development of disease-modifying therapies that can improve prognosis, particularly in patients with poor prognostic outcomes. In this study, we explored clinical trials related to GBS, analyzed the trial characteristics, suggested some ideas for improvement, and discussed recent advances.
On December 30, 2021, the authors searched ClinicalTrials.gov for all interventional and therapeutic clinical trials related to GBS, without any restrictions on the date or location. Trial characteristics including trial duration, location, phase, sample size, and publications were retrieved and analyzed.
Twenty-one trials fulfilled the selection criteria. Clinical trials were conducted in 11 different countries, most of them occurring in Asia. On average, the trial duration across the phases was around 2 years. About two-thirds of trials were completed, and 39% of trials were in the early phases (1 and 2). Only 24% of all trials and 60% of completed trials have publications in this study.
The study revealed a low number of trials, lack of geographic diversity, scanty enrollment of patients, and paucity of clinical trial duration and publications regarding GBS clinical trials. Optimization of GBS trials is fundamental to achieving effective therapies for this disease.
吉兰 - 巴雷综合征（GBS）是一种免疫介导的多发性神经根神经病，尽管进行了医学治疗，它仍然是一种使人衰弱的疾病。仍然存在许多挑战，包括开发能够改善预后的疾病修饰疗法，特别是对于预后不良的患者。在本研究中，我们探索了与GBS相关的临床试验，分析了试验特征，提出了一些改进建议，并讨论了最新进展。
2021年12月30日，作者在ClinicalTrials.gov上搜索了所有与GBS相关的介入性和治疗性临床试验，对日期或地点没有任何限制。检索并分析了试验特征，包括试验持续时间、地点、阶段、样本量和出版物。
21项试验符合入选标准。临床试验在11个不同国家进行，其中大部分在亚洲。各阶段的平均试验持续时间约为2年。约三分之二的试验已完成，39%的试验处于早期阶段（1期和2期）。在本研究中，所有试验中只有24%以及已完成试验中有60%有出版物。
该研究揭示了GBS临床试验数量少、缺乏地域多样性、患者入组不足以及临床试验持续时间和出版物匮乏的问题。优化GBS试验对于实现针对该疾病的有效治疗至关重要。
