Teoh Ru Jian Jonathan, Huang Chi-Jung, Chan Chi Peng, Chien Li-Yin, Chung Chih-Ping, Sung Shih-Hsien, Chen Chen-Huan, Chiang Chern-En, Cheng Hao-Min
International Health Program, National Yang-Ming University, Taipei.
Center for Evidence-based Medicine, Taipei Veterans General Hospital, Taipei.
Ther Adv Neurol Disord. 2019 Jul 24;12:1756286419864830. doi: 10.1177/1756286419864830. eCollection 2019.
It remains debatable whether statin increases the risk of intracerebral hemorrhage (ICH) in poststroke patients.
We systematically searched PubMed, EMBASE, and CENTRAL for randomized controlled trials. Trial sequential analysis (TSA) was conducted to assess the reliability and conclusiveness of the available evidence in the meta-analysis. To evaluate the overall effectiveness, the net composite endpoints were derived by totaling ischemic stroke, hemorrhagic stroke, transient ischemic attack (TIA), myocardial infarction, and cardiovascular mortality.
A total of 17 trials with 11,576 subjects with previous ischemic stroke, TIA, or ICH were included, in which statin therapy increased the risk of hemorrhagic stroke (risk ratio [RR], 1.42; 95% confidence interval [CI], 1.07-1.87), but reduced the risk of ischemic stroke (RR, 0.85; 95% CI, 0.75-0.95). For the net composite endpoints, statin therapy was associated with a 17% risk reduction (95% CI, 12-21%; number needed to treat = 6). With a control event rate 2% and RR increase 40%, the TSA suggested a conclusive signal of an increased risk of hemorrhagic stroke in stroke survivors taking statin. However, with the sensitivity analysis by changing assumptions, the conclusions about hemorrhagic stroke risk were less robust.
Statin therapy in poststroke patients increased the risk of hemorrhagic stroke but effectively reduced ischemic stroke risk. Weighing the benefits and potential harms, statin has an overall beneficial effect in patients with previous stroke or TIA. However, more studies are required to investigate the conclusiveness of the increased hemorrhagic stroke risk revealed in our study.
他汀类药物是否会增加卒中后患者脑出血（ICH）的风险仍存在争议。
我们系统检索了PubMed、EMBASE和CENTRAL中的随机对照试验。进行了试验序贯分析（TSA）以评估荟萃分析中现有证据的可靠性和决定性。为评估总体有效性，通过将缺血性卒中、出血性卒中、短暂性脑缺血发作（TIA）、心肌梗死和心血管死亡率相加得出净复合终点。
共纳入17项试验，涉及11576名既往有缺血性卒中、TIA或ICH的受试者，其中他汀类药物治疗增加了出血性卒中的风险（风险比[RR]，1.42；95%置信区间[CI]，1.07 - 1.87），但降低了缺血性卒中的风险（RR，0.85；95% CI，0.75 - 0.95）。对于净复合终点，他汀类药物治疗使风险降低了17%（95% CI，12 - 21%；需治疗人数 = 6）。在对照事件发生率为2%且RR增加40%的情况下，TSA表明服用他汀类药物的卒中幸存者出血性卒中风险增加有确凿信号。然而，通过改变假设进行敏感性分析，关于出血性卒中风险的结论不太稳健。
卒中后患者使用他汀类药物治疗增加了出血性卒中的风险，但有效降低了缺血性卒中风险。权衡利弊，他汀类药物对既往有卒中或TIA的患者总体有益。然而，需要更多研究来调查我们研究中揭示的出血性卒中风险增加的确定性。
