Chen Junhui, Li Mingchang, Chen Lei, Xu Qinyi, Yan Tengfeng, Zhang Chunlei, Hu Ping, He Jianqing, Zhu Xun, Zhu Xingen, Wang Yuhai
Department of Neurosurgery, 904th Hospital of Joint Logistic Support Force of PLA, Wuxi Clinical College of Anhui Medical University, Wuxi, China.
Department of Neurosurgery, Renmin Hospital of Wuhan University, Wuhan, China.
Front Pharmacol. 2024 Jan 5;14:1323292. doi: 10.3389/fphar.2023.1323292. eCollection 2023.
Spontaneous subarachnoid hemorrhage (SAH), is a disorder that may be fatal and is primarily caused by a ruptured brain aneurysm. Despite significant leaps forward in the methods to produce aneurysms, the long-term outcomes did not much improve. Pioglitazone is a medication that has been authorized by the FDA as an agonist for the peroxisome proliferator-activated receptor-gamma (PPARγ). Pioglitazone or PPARγ has neuroprotective benefits in animal experiments both during and after traumatic brain injury (TBI) and SAH. Nevertheless, the treatment impact of Pioglitazone on humans is still unknown at this time. As a result, we will conduct a randomized, double-blind, placebo-controlled trial to explore the impact of pioglitazone on SAH. This trial will recruit 400 patients with SAH from four Chinese hospitals. These patients will be equally and randomly assigned to Pioglitazone and placebo control groups for up to 30 days. Scores on the modified Rankin scale (mRS) are the primary outcomes. The secondary outcomes are a 30-day all-cause mortality rate, 6 months of Montreal cognitive assessment (Mo-CA), delayed cerebral ischemia, the requirement for intensive care, the incidence of sepsis, . All serious adverse events (SAEs) were recorded during the hospital. Every primary and safety analysis was conducted based on the intention-to-treat technique. The participants were given either a matching placebo or 15 mg of pioglitazone, with dose titrated to a target of 45 mg daily. Data on the therapeutic use of pioglitazone after SAH will be provided as a consequence of the findings of this experiment. In addition, this pilot trial is the first to prospectively investigate the effectiveness and safety of pioglitazone in patients with SAH. Ethics approval was obtained from the Medical Ethics Committee of 904th Hospital of Joint Logistic Support Force of PLA (Wuxi Taihu Hospital, approval No. 20220701). The findings of the trial will be presented at conferences, discussed in relevant patient groups, and published in peer-reviewed journals. clinicaltrials.gov, identifier ChiCTR2200062954.
自发性蛛网膜下腔出血（SAH）是一种可能致命的疾病，主要由脑动脉瘤破裂引起。尽管在制造动脉瘤的方法上取得了重大进展，但长期预后并没有太大改善。吡格列酮是一种已被美国食品药品监督管理局（FDA）批准为过氧化物酶体增殖物激活受体γ（PPARγ）激动剂的药物。在动物实验中，吡格列酮或PPARγ在创伤性脑损伤（TBI）和SAH期间及之后均具有神经保护作用。然而，目前吡格列酮对人类的治疗效果仍不清楚。因此，我们将进行一项随机、双盲、安慰剂对照试验，以探讨吡格列酮对SAH的影响。 该试验将从四家中国医院招募400例SAH患者。这些患者将被平等随机分配到吡格列酮组和安慰剂对照组，为期30天。改良Rankin量表（mRS）评分是主要结局指标。次要结局指标包括30天全因死亡率、蒙特利尔认知评估（Mo-CA）6个月评分、迟发性脑缺血、重症监护需求、脓毒症发生率。住院期间记录所有严重不良事件（SAE）。每项主要分析和安全性分析均基于意向性分析技术进行。参与者分别给予匹配的安慰剂或15毫克吡格列酮，剂量滴定至每日45毫克的目标剂量。本实验结果将提供SAH后吡格列酮治疗用途的数据。此外，这项初步试验是首次前瞻性研究吡格列酮在SAH患者中的有效性和安全性。 已获得中国人民解放军联勤保障部队第904医院医学伦理委员会（无锡太湖医院，批准号20220701）的伦理批准。试验结果将在会议上展示，在相关患者群体中进行讨论，并发表在同行评审期刊上。 临床试验注册号：ChiCTR2200062954。
