Tapia-Perez H, Sanchez-Aguilar M, Torres-Corzo J G, Rodriguez-Leyva I, Gonzalez-Aguirre D, Gordillo-Moscoso A, Chalita-Williams C
Faculty of Medicine, Department of Epidemiology, Universidad Autónoma de San Luis Potosí., San Luis Potosí, Mexico.
Cent Eur Neurosurg. 2009 Feb;70(1):15-20. doi: 10.1055/s-0028-1082064. Epub 2009 Feb 5.
Spontaneous intracerebral hemorrhage (ICH) represents the most fatal kind of stroke, and there is still no treatment available that improves the outcome. Statins are cholesterol reducers, and during the last few years many additional effects have been demonstrated that might be neuroprotective. We designed a pilot clinical study in order to evaluate whether the administration of statins is associated with a better outcome.
From August to December 2006 we carried out a prospective/retrospective non-randomized clinical study. The prospective group was treated with rosuvastatin (20 mg) and the retrospective control group was taken from our clinical records with a relation of 1:3. We included patients of both sexes, aged > or =15 years with proven ICH in CT-scan. Exclusion criteria were a history of neoplasm, head injury four weeks before admission, non-hypertensive reasons, brainstem hemorrhage, steroid administration, cranial surgery, initial hydrocephalus, and NIHSS > or =30.
We analyzed 18 patients treated with rosuvastatin and 57 controls with similar basic characteristics. The mortality rate during hospitalization was 1 (5.6%) patient in the statin group and 9 (15.8%) in the control group; the hazard ratio adjusted by the initial Glasgow Coma Scale (GCS), intubation, admission in intensive care unit, disruption into the subarachnoid space was 0.20 (95% CI 0.02-1.67). The odds ratio for NIHSS > or =15 at release was 0.04 (95% CI 0.003-0.93).
The use of statins during the acute phase of ICH could be associated with a better outcome. Further clinical trials are necessary to confirm a possible therapeutic effect and evaluate the toxicity of statins.
自发性脑出血（ICH）是最致命的一种中风类型，目前仍没有能改善预后的治疗方法。他汀类药物是降胆固醇药物，在过去几年中已证实其具有许多可能具有神经保护作用的额外效应。我们设计了一项前瞻性临床研究，以评估使用他汀类药物是否与更好的预后相关。
2006年8月至12月，我们开展了一项前瞻性/回顾性非随机临床研究。前瞻性组接受瑞舒伐他汀（20毫克）治疗，回顾性对照组从我们的临床记录中选取，比例为1:3。我们纳入了年龄≥15岁、经CT扫描证实为ICH的男女患者。排除标准包括有肿瘤病史、入院前四周有头部损伤、非高血压原因、脑干出血、使用类固醇、颅脑手术、初始脑积水以及美国国立卫生研究院卒中量表（NIHSS）评分≥30。
我们分析了18例接受瑞舒伐他汀治疗的患者和57例具有相似基本特征的对照组患者。他汀类药物组住院期间死亡率为1例（5.6%），对照组为9例（15.8%）；经初始格拉斯哥昏迷量表（GCS）、插管、入住重症监护病房、蛛网膜下腔破裂情况调整后的风险比为0.20（95%可信区间0.02 - 1.67）。出院时NIHSS评分≥15的比值比为0.04（95%可信区间0.003 - 0.93）。
在ICH急性期使用他汀类药物可能与更好的预后相关。需要进一步的临床试验来证实可能的治疗效果并评估他汀类药物的毒性。
