阿托伐他汀联合地塞米松治疗慢性硬脑膜下血肿（ATOCH II）：一项随机对照试验的研究方案。
Atorvastatin combined with dexamethasone in chronic subdural haematoma (ATOCH II): study protocol for a randomized controlled trial.
机构信息
Department of Neurosurgery, Tianjin Medical University General Hospital, Key Laboratory of Post-trauma Neuro-repair and Regeneration in Central Nervous System, Ministry of Education, Tianjin Key Laboratory of Injuries, Variations and Regeneration of Nervous System, Tianjin Neurological Institute, No. 154 Anshan Road, Tianjin, 300052, People's Republic of China.
Department of Neurosurgery, The First Affiliated Hospital of Harbin Medical University, No. 23 Youzheng Street, Nangang District, Harbin, Heilongjiang Province, 150001, People's Republic of China.
出版信息
Trials. 2021 Dec 11;22(1):905. doi: 10.1186/s13063-021-05871-9.
BACKGROUND
Chronic subdural haematoma (CSDH) is a common condition in the elderly that often requires neurosurgical management. For small CSDH, evidence has emerged that statins may reduce haematoma volume and improve outcomes, presumably by reducing local inflammation and promoting vascular repair. We wish to extend this evidence in a study that aims to determine the efficacy and safety of atorvastatin combined with low-dose dexamethasone in patients with CSDH.
METHODS
The second ATorvastatin On Chronic subdural Hematoma (ATOCH-II) study is a multi-centre, randomized, placebo-controlled, double-blind trial which aims to enrol 240 adult patients with a conservative therapeutic indication for CSDH, randomly allocated to standard treatment with atorvastatin 20 mg combined with low-dose dexamethasone (or matching placebos) daily for 28 days, and with 152 days of follow-up. The primary outcome is a composite good outcome defined by any reduction from baseline in haematoma volume and survival free of surgery at 28 days. Secondary outcomes include functional outcome on the modified Rankin scale (mRS) and modified Barthel Index at 28 days, surgical transition and reduction in haematoma volumes at 14, 28 and 90 days.
DISCUSSION
This multi-centre clinical trial aims to provide high-quality evidence on the efficacy and safety of the combined treatment of atorvastatin and low-dose dexamethasone to reduce inflammation and enhance angiogenesis in CSDH.
TRIAL REGISTRATION
ChiCTR, ChiCTR1900021659 . Registered on 3 March 2019, http://www.chictr.org.cn/showproj.aspx?proj=36157 .
背景
慢性硬脑膜下血肿（CSDH）是老年人的一种常见疾病，通常需要神经外科治疗。对于小的 CSDH，有证据表明他汀类药物可能通过减少局部炎症和促进血管修复来减少血肿体积并改善预后。我们希望在一项旨在确定阿托伐他汀联合小剂量地塞米松治疗 CSDH 患者的疗效和安全性的研究中扩展这一证据。
方法
第二项阿托伐他汀治疗慢性硬脑膜下血肿（ATOCH-II）研究是一项多中心、随机、安慰剂对照、双盲试验，旨在招募 240 名具有 CSDH 保守治疗指征的成年患者，随机分配接受阿托伐他汀 20mg 联合小剂量地塞米松（或匹配安慰剂）每日治疗 28 天，并进行 152 天随访。主要结局是血肿体积从基线减少的复合良好结局，以及 28 天无手术生存。次要结局包括改良Rankin 量表（mRS）和改良Barthel 指数在 28 天的功能结局、手术转换和血肿体积在 14、28 和 90 天的减少。
讨论
这项多中心临床试验旨在提供阿托伐他汀联合小剂量地塞米松治疗 CSDH 减少炎症和增强血管生成的疗效和安全性的高质量证据。
试验注册
ChiCTR，ChiCTR1900021659。于 2019 年 3 月 3 日注册，网址为：http://www.chictr.org.cn/showproj.aspx?proj=36157。
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