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西洛他唑在亚洲人群急性和慢性缺血性卒中二级预防中的疗效与安全性——一项更新的荟萃分析

The efficacy and safety of cilostazol for the secondary prevention of ischemic stroke in acute and chronic phases in Asian population--an updated meta-analysis.

作者信息

Shi LiGen, Pu JiaLi, Xu Liang, Malaguit Jay, Zhang Jianmin, Chen Sheng

机构信息

Department of Neurosurgery, Second Affiliated Hospital, School of Medicine, Zhejiang University, 88 Jiefang Road, Hangzhou, 310009, Zhejiang, China.

Department of Neurology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.

出版信息

BMC Neurol. 2014 Dec 20;14:251. doi: 10.1186/s12883-014-0251-7.

Abstract

BACKGROUNDS

While previous meta-analysis have investigated the efficacy of cilostazol in the secondary prevention of ischemic stroke, they were criticized for their methodology, which confused the acute and chronic phases of stroke. We present a new systematic review, which differs from previous meta-analysis by distinguishing between the different phases of stroke, and includes two new randomized, controlled trials (RCTs).

METHODS

All RCTs investigating the effect of cilostazol on secondary prevention of ischemic stroke were obtained. Outcomes were analyzed by Review Manager, including recurrence of cerebral infarction (ROCI), hemorrhage stroke or subarachnoid hemorrhage (HSSH), all-cause death (ACD), and modified Rankin Scale score (mRS). The Grading of Recommendations Assessment, Development and Evaluation (GRADE) assessed the quality of the evidence.

RESULTS

5491 patients from six studies were included in the current study. In secondary prevention of ischemic stroke in chronic phase, cilostazol was associated with a 47% reduction in ROCI (relative risk [RR] 0.53, 95% confidence interval [CI] 0.34 to 0.81, p = 0.003), while no significant difference in HSSH and ACD compared with placebo; and 71% reduction in HSSH (RR 0.29, 95% CI 0.15 to 0.56, p = 0.0002) compared with aspirin, but not in ROCI and ACD. In the secondary prevention of ischemic stroke in acute phase, cilostazol did not show any effect in the ROCI, HSSH, ACD and mRS compared to placebo or aspirin. The quality of the evidence from chronic phase was high or moderate, and those from acute phase were moderate or low when analyzed by GRADE approach.

CONCLUSION

Cilostazol provided a protective effect in the secondary prevention of the chronic phase of ischemic stroke.

摘要

背景

虽然既往的荟萃分析研究了西洛他唑在缺血性卒中二级预防中的疗效,但因其方法学将卒中的急性期和慢性期混淆而受到批评。我们进行了一项新的系统评价,该评价与既往荟萃分析的不同之处在于区分了卒中的不同阶段,并且纳入了两项新的随机对照试验(RCT)。

方法

获取了所有研究西洛他唑对缺血性卒中二级预防效果的RCT。采用Review Manager对结局进行分析,包括脑梗死复发(ROCI)、出血性卒中或蛛网膜下腔出血(HSSH)、全因死亡(ACD)以及改良Rankin量表评分(mRS)。采用推荐意见分级的评估、制定与评价(GRADE)方法评估证据质量。

结果

本研究纳入了6项研究中的5491例患者。在慢性期缺血性卒中的二级预防中,西洛他唑使ROCI降低了47%(相对危险度[RR]0.53,95%置信区间[CI]0.34至0.81,p = 0.003),而与安慰剂相比,HSSH和ACD无显著差异;与阿司匹林相比,HSSH降低了71%(RR 0.29,95%CI 0.15至0.56,p = 0.0002),但ROCI和ACD无差异。在急性期缺血性卒中的二级预防中,与安慰剂或阿司匹林相比,西洛他唑在ROCI、HSSH、ACD和mRS方面均未显示出任何效果。采用GRADE方法分析时,慢性期证据质量为高或中,急性期证据质量为中或低。

结论

西洛他唑在缺血性卒中慢性期的二级预防中具有保护作用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b647/4301843/29a5d36e27a8/12883_2014_251_Fig1_HTML.jpg

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