[Cerebrolysin as an early add-on to reperfusion therapy: heterogeneous treatment effect analysis in ischemic stroke patients with varying risk of hemorrhagic transformation].
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引用次数: 0
Abstract
Objective: The study goal was the assessment of heterogeneous treatment effects of Cerebrolysin as an early add-on to reperfusion therapy in stroke patients with varying risk of hemorrhagic transformation (HT).
Material and methods: It was post hoc analysis of the CEREHETIS trial (ISRCTN87656744). Patients with middle cerebral artery infarction (n=238) were stratified by HT risk with the HTI score. The study outcomes were symptomatic and any HT, and functional outcome measured with the modified Rankin Scale (mRS) on day 90. Favorable outcome was defined as an mRS score of ≤2. Heterogeneous treatment effect analysis was performed using techniques of meta-analysis and the matching-smoothing method.
Results: Heterogeneity of Cerebrolysin treatment effects was moderate (I2=36.98-69.3%, H2=1.59-3.26) and mild (I2=18.33-32.39%, H2=1.22-1.48) for symptomatic and any HT, respectively. A positive impact of the Cerebrolysin treatment on HT and functional outcome was observed in patients with moderate (HTI=1) and high (HTI≥2) HT risk. However, the effect was neutral in those with low risk (HTI=0). In high HT risk patients, there was a steady decline in the rate of symptomatic (HTI=0 vs. HTI≥2: by 3.8%, p=0.120 vs. 14.3%, p<0.001) and any HT (HTI=0 vs. HTI≥2: by 0.6%, p=0.864 vs. 19.5%, p<0.001). Likewise, Cerebrolysin treatment resulted in an overall decrease in the mRS scores (HTI=0 vs. HTI≥2: by 2.1%, p=0.893 vs. 63%, p<0.001) with a reciprocal increase of the fraction with favorable outcome (HTI=0 vs. HTI≥2: by 2% p=0.634 vs. 19.2%, p<0.001).
Conclusion: Clinically meaningful heterogeneity of Cerebrolysin treatment effects on HT and functional outcome was established in stroke patients. The Cerebrolysin positive impact was significant in those whose estimated on-admission HT risk was either moderate or high.
研究目的研究目标是评估脑复康作为再灌注疗法的早期附加疗法,对具有不同出血转化(HT)风险的脑卒中患者的不同治疗效果:这是对CEREHETIS试验(ISRCTN87656744)的事后分析。根据 HTI 评分对大脑中动脉梗死患者(238 人)进行出血性转化风险分层。研究结果为无症状和任何 HT,以及第 90 天用改良兰金量表(mRS)测量的功能结果。良好的疗效定义为 mRS 评分≤2。采用荟萃分析技术和匹配平滑法进行了异质性治疗效果分析:脑复康治疗效果的异质性在无症状和任何HT中分别为中度(I2=36.98-69.3%,H2=1.59-3.26)和轻度(I2=18.33-32.39%,H2=1.22-1.48)。在中度(HTI=1)和高度(HTI≥2)高血压风险患者中,观察到脑活素治疗对高血压和功能预后的积极影响。然而,对低风险(HTI=0)患者的影响是中性的。在高血压风险患者中,无症状率稳步下降(HTI=0 vs. HTI≥2:下降 3.8%,p=0.120 vs. 14.3%,pp=0.864 vs. 19.5%,pp=0.893 vs. 63%,pp=0.634 vs. 19.2%,pConclusion):脑活素治疗对脑卒中患者高血压和功能预后的影响具有临床意义的异质性。脑复康对入院时高血压风险估计为中度或高度的患者具有显著的积极影响。
期刊介绍:
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