Effect of ATorvastatin On Chronic subdural Hematoma (ATOCH): a study protocol for a randomized controlled trial

被引：17

作者：

Jiang, Rongcai ^{[1
,2
,3
,4
,5
]}

Wang, Dong ^{[1
,2
,3
,4
,5
]}

Poon, Wai Sang ^{[6
]}

Lu, Yi Cheng ^{[7
]}

Li, Xin Gang ^{[8
]}

Zhao, Shi Guang ^{[9
]}

Wang, Ren Zhi ^{[10
]}

You, Chao ^{[11
]}

Yuan, Xian Rui ^{[12
]}

Zhang, Jian Min ^{[13
]}

Feng, Hua ^{[14
]}

Fei, Zhou ^{[15
]}

Yu, Xin Guang ^{[16
]}

Zhao, Yuan Li ^{[17
]}

Hu, Jin ^{[18
]}

Kang, De Zhi ^{[19
]}

Yu, Ru Tong ^{[20
]}

Gao, Guo Dong ^{[21
]}

Zhu, Xi De ^{[22
]}

Sun, Tao ^{[23
]}

Hao, Jie He ^{[24
]}

Liu, Xian Zhi ^{[25
]}

Su, Ning ^{[26
]}

Yue, Shu Yuan ^{[1
,2
,3
,4
,5
]}

Zhang, Jian Ning ^{[1
,2
,3
,4
,5
]}

机构：

[1] Tianjin Med Univ, Gen Hosp, Dept Neurosurg, Tianjin 300052, Peoples R China

[2] Minist Educ, Key Lab Posttrauma Neurorepair & Regenerat Cent N, Tianjin 300052, Peoples R China

[3] Tianjin Key Lab Injuries Variat & Regenerat Nervo, Tianjin 300052, Peoples R China

[4] Tianjin Neurol Inst, Tianjin 300052, Peoples R China

[5] Oriental Neurosurg Evidence Based Study Team ONET, Tianjin 300052, Peoples R China

[6] Chinese Univ Hong Kong, Prince Wales Hosp, Dept Surg, Div Neurosurg, Shatin, Hong Kong, Peoples R China

[7] Shanghai Changzheng Hosp, Dept Neurosurg, Shanghai 200003, Peoples R China

[8] Shandong Univ, Qilu Hosp, Dept Neurosurg, Jinan 250012, Shandong, Peoples R China

[9] Harbin Med Univ, Affiliated Hosp 1, Dept Neurosurg, Harbin 150001, Heilongjiang Pr, Peoples R China

[10] Peking Union Med Coll Hosp, Dept Neurosurg, Beijing 100032, Peoples R China

[11] Sichuan Univ, West China Hosp, Dept Neurosurg, Chengdu 610041, Sichuan Provinc, Peoples R China

[12] Cent South Univ, Xiangya Hosp, Dept Neurosurg, Changsha 410008, Hunan, Peoples R China

[13] Zhejiang Univ, Sch Med, Affiliated Hosp 2, Dept Neurosurg, Hangzhou 310009, Zhejiang, Peoples R China

[14] Southwest Hosp, Dept Neurosurg, Chongqing 400038, Sichuan Provinc, Peoples R China

[15] Xijing Hosp, Dept Neurosurg, Xian 710032, Shanxi Province, Peoples R China

[16] Chinese Peoples Liberat Army, Gen Hosp, Dept Neurosurg, Beijing 100853, Peoples R China

[17] Capital Med Univ, Beijing Tian Tan Hosp, Dept Neurosurg, Beijing 100050, Peoples R China

[18] Fudan Univ, Huashan Hosp, Dept Neurosurg, Shanghai 200040, Peoples R China

[19] Fujian Med Univ, Affiliated Hosp 1, Dept Neurosurg, Fuzhou 350005, Fujian Province, Peoples R China

[20] Xuzhou Med Coll, Affiliated Hosp, Dept Neurosurg, Hohhot 221006, Jiangsu, Peoples R China

[21] Fourth Mil Med Univ, Affiliated Hosp 2, Tangdu Hosp, Dept Neurosurg, Xian 710038, Shanxi Province, Peoples R China

[22] Linyi Peoples Hosp, Dept Neurosurg, Linyi 276003, Shandong, Peoples R China

[23] Ningxia Med Univ, Gen Hosp, Dept Neurosurg, Yinchuan 750004, Ningxia Provinc, Peoples R China

[24] Shanxi Med Univ, Affiliated Hosp 1, Dept Neurosurg, Taiyuan 030001, Shanxi Province, Peoples R China

[25] Zhengzhou Univ, Affiliated Hosp 1, Dept Neurosurg, Zhengzhou 450052, Henan Province, Peoples R China

[26] Inner Mongolia Peoples Hosp, Dept Neurosurg, Hohhot 010017, Inner Mongolia, Peoples R China

来源：

TRIALS | 2015年 / 16卷

基金：

中国国家自然科学基金;

关键词：

Chronic; Subdural hematoma; Atorvastatin; Conservative therapy; Absorption; ENDOTHELIAL PROGENITOR CELLS; REDUCTASE INHIBITORS STATINS; SPONTANEOUS RESOLUTION; DEXAMETHASONE; INFLAMMATION; PHYSIOPATHOGENESIS; SIMVASTATIN; RECURRENCE; RISK; VEGF;

D O I：

10.1186/s13063-015-1045-y

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

Background: Chronic 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/Design: We 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 24th weeks; 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. Discussion: Results of this trial will provide critical information regarding whether atorvastatin is an effective and safe alternative to surgical treatment of CSDH.

引用

页数：9

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