Liu Zhou, Liu Lingying, Zhang Zhijian, Chen Zuhui, Zhao Bin
Department of Neurology, Affiliated Hospital of Guangdong Medical College, Zhanjiang, China.
Cochrane Database Syst Rev. 2013 Apr 30;2013(4):CD008184. doi: 10.1002/14651858.CD008184.pub2.
Cerebral vasospasm and related delayed ischaemic deficits (DIDs) occur in about 17% to 40% of patients with aneurysmal subarachnoid haemorrhage (SAH) and lead to a poor outcome. Cholesterol-reducing agents might improve unfavourable outcomes.
To assess the effects of cholesterol-reducing agents for improving outcomes in patients with aneurysmal SAH.
We searched the Cochrane Stroke Group Trials Register (May 2012), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 5), MEDLINE (1948 to May 2012) and EMBASE (1980 to May 2012). We also searched three Chinese databases: SinoMed, CNKI and VIP (May 2012). In an effort to identify further published, ongoing and unpublished trials we searched relevant clinical trials and research registers (May 2012), contacted pharmaceutical companies and investigators known to be involved in previous trials and screened the reference lists of all relevant articles identified.
We included randomised controlled trials (RCTs) that compared cholesterol-reducing agents with control or placebo treatment in participants with aneurysmal SAH.
Two review authors independently applied the inclusion criteria, reviewed the relevant trials and extracted data. We did not perform meta-analysis as we only included one RCT in the review.
We included one study in which 39 patients received either simvastatin (80 mg daily; n = 19) or placebo (n = 20) for 14 days. The incidence of DIDs (secondary outcome) was 26% (5/19) in the simvastatin group versus 60% (12/20) in the placebo group (risk ratio (RR) 0.44, 95% confidence interval (CI) 0.19 to 1.01, P = 0.05). This means that, in this study, simvastatin had no effect on DIDs. Two patients in the simvastatin group and one patient in the placebo group had elevated levels of aspartate transaminase or alanine transaminase. One patient in the simvastatin group had a raised creatine phosphokinase. There were no results from this trial for the primary outcome of death or dependency at six months.
AUTHORS' CONCLUSIONS: We cannot draw any conclusions about the effectiveness and safety of lowering cholesterol in aneurysmal SAH because of insufficient reliable evidence from only one small trial. More RCTs are needed.
脑动脉痉挛及相关的迟发性缺血性神经功能缺损（DIDs）发生于约17%至40%的动脉瘤性蛛网膜下腔出血（SAH）患者中，并导致不良预后。降胆固醇药物可能改善不良预后。
评估降胆固醇药物对改善动脉瘤性SAH患者预后的效果。
我们检索了Cochrane卒中组试验注册库（2012年5月）、Cochrane对照试验中央注册库（CENTRAL）（《Cochrane图书馆》2012年第5期）、MEDLINE（1948年至2012年5月）和EMBASE（1980年至2012年5月）。我们还检索了三个中文数据库：中国生物医学文献数据库、中国知网和维普资讯（2012年5月）。为了识别更多已发表、正在进行和未发表的试验，我们检索了相关临床试验和研究注册库（2012年5月），联系了已知参与既往试验的制药公司和研究者，并筛选了所有已识别的相关文章的参考文献列表。
我们纳入了比较降胆固醇药物与对照组或安慰剂治疗动脉瘤性SAH参与者的随机对照试验（RCT）。
两位综述作者独立应用纳入标准，审查相关试验并提取数据。由于本综述仅纳入了一项RCT，因此我们未进行Meta分析。
我们纳入了一项研究，其中39例患者接受辛伐他汀（每日80mg；n = 19）或安慰剂（n = 20）治疗14天。辛伐他汀组DIDs（次要结局）的发生率为26%（5/19），而安慰剂组为60%（12/20）（风险比（RR）0.44，95%置信区间（CI）0.19至1.01，P = 0.05）。这意味着，在本研究中，辛伐他汀对DIDs没有影响。辛伐他汀组有2例患者和安慰剂组有1例患者的天冬氨酸转氨酶或丙氨酸转氨酶水平升高。辛伐他汀组有1例患者的肌酸磷酸激酶升高。该试验未得出关于六个月时死亡或依赖这一主要结局的结果。
由于仅一项小型试验提供的可靠证据不足，我们无法就降低胆固醇在动脉瘤性SAH中的有效性和安全性得出任何结论。需要更多的RCT。
