Effect of ATorvastatin On Chronic subdural Hematoma (ATOCH): a study protocol for a randomized controlled trial.
Effect of ATorvastatin On Chronic subdural Hematoma (ATOCH): a study protocol for a randomized controlled trial.
复制标题
阿托伐他汀对慢性硬膜下血肿 (ATOCH) 的影响：随机对照试验的研究方案
DOI：
10.1186/s13063-015-1045-y
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发表时间：
2015-11-18
期刊：
影响因子：
2.5
通讯作者：
Zhang JN
中科院分区：
文献类型：
--
作者：
Jiang R;Wang D;Poon WS;Lu YC;Li XG;Zhao SG;Wang RZ;You C;Yuan XR;Zhang JM;Feng H;Fei Z;Yu XG;Zhao YL;Hu J;Kang DZ;Yu RT;Gao GD;Zhu XD;Sun T;Hao JH;Liu XZ;Su N;Yue SY;Zhang JN
背景慢性硬膜下血肿（CSDH）是一种常见病，多见于老年人。手术干预是一种安全的治疗选择。然而，复发率相对较高，手术治疗的患者的结果并不总是令人满意的。目前认为异常的血管生成和囊内炎症是CSDH发生发展的重要因素。据报道，阿托伐他汀可促进血管生成并抑制炎症。我们最近的研究表明，阿托伐他汀是有效的非手术减少和消除CSDH的副作用最小。在这里，我们报告的临床研究试验方案，旨在评估阿托伐他汀对CSDH的治疗效果。方法/设计我们设计了一个多中心，随机，安慰剂对照，双盲临床试验，以评估口服阿托伐他汀在减少CSDH的疗效。到目前为止，我们已经从中国的16个医疗中心招募了96名CT或MRI证实的CSDH患者。这些患者最初是为东方神经外科循证研究小组（ONET）研究招募的。在提供知情同意后，患者随机接受阿托伐他汀（口服20 mg/夜，持续8周）或安慰剂（糊精，持续8周）;并在治疗后随访16周。主要结局是8周治疗结束时血肿体积的变化。次要结局包括：观察4、12、24周血肿体积、Markwalder评分和格拉斯哥昏迷评分（MGS-GCS）、格拉斯哥预后评分（GOS）和日常生活活动能力-Barthel指数评分（ADL-BI）的变化。安全性将在研究期间通过监测不良事件、实验室检查、心电图（ECG）、生命体征（体温、脉搏和血压）和体重的测量进行评估。讨论本试验的结果将提供关于阿托伐他汀是否是CSDH手术治疗的有效和安全替代方案的关键信息。试验registrationClinicalTrials.gov标识符- NCT 02024373试验注册日期：2013年8月7日
BackgroundChronic subdural hematoma (CSDH) is a common disease that is more prevalent in older people. Surgical intervention is a safe treatment of choice. However, the recurrence rate is relatively high and the outcome is not always satisfactory among surgically treated patients. It is believed that aberrant angiogenesis and intracapsular inflammation contribute to the development of CSDH. Atorvastatin is reported to promote angiogenesis and suppress inflammation. We have recently shown that atorvastatin is effective to non-surgically reduce and eliminate CSDH with minimal side effects. Here, we report a clinical research trial protocol that is designed to evaluate the therapeutic effects of atorvastatin on CSDH.Methods/DesignWe have designed a multi-center, randomized, placebo-controlled, double blind clinical trial for evaluating the efficacy of oral atorvastatin in reducing CSDH. We have so far recruited 96 patients with CT-confirmed or MRI-confirmed CSDHs from 16 medical centers in China. These patients were originally recruited for the Oriental Neurosurgical Evidence-based Study Team (ONET) study. After informed consent is provided, patients are randomized to receive either atorvastatin (oral 20 mg/night for 8 weeks) or placebo (dextrin for 8 weeks); and followed for 16 weeks after the treatment. The primary outcome is the change in hematoma volume at the end of 8-week treatment. Secondary outcomes include: changes in 1) the hematoma volume at the 4th, 12th, and 24thweeks; 2) Markwalder’s Grading Scale and Glasgow Coma Scale (MGS-GCS); 3) Glasgow Outcome Score (GOS) and 4) Activities of Daily Life – the Barthel Index scale (ADL-BI). Safety will be assessed during the study by monitoring adverse events, laboratory tests, electrocardiography (ECG), measurements of vital signs (temperature, pulse, and blood pressure) and body weight.DiscussionResults of this trial will provide critical information regarding whether atorvastatin is an effective and safe alternative to surgical treatment of CSDH.Trial registrationClinicalTrials.gov Identifier – NCT02024373The date of trial registration: 7 August 2013