Dataset Information

Efficacy and Safety of Cerebrolysin for Acute Ischemic Stroke: A Meta-Analysis of Randomized Controlled Trials.

ABSTRACT: Cerebrolysin was reported to be effective in the neurological improvement of patients with acute ischemic stroke (AIS) in experimental models, while data from clinical trials were inconsistent. We performed a meta-analysis to explore the efficacy and safety of cerebrolysin for AIS. PubMed, EMBASE, and Cochrane Library were searched for randomized controlled trials, which intervened within 72 hours after the stroke onset. We investigated the efficacy and safety outcomes, respectively. Risk ratios and mean differences were pooled with fixed-effects model or random-effects model. Seven studies were identified, involving 1779 patients with AIS. The summary results failed to demonstrate significant superiority of cerebrolysin in the assessment of efficacy outcomes of mRS and BI. Similarly, administration of cerebrolysin had neutral effects on safety outcomes compared with placebo, including mortality and SAE. However, the number of included studies was small, especially in the analysis of efficacy outcomes, which might cause publication bias and inaccurate between-studies variance in the meta-analysis. Conclusively, although it seemed to be safe, routine use of cerebrolysin to improve the long-term rehabilitation after stroke could not be supported by available evidence.

SUBMITTER: Zhang D

PROVIDER: S-EPMC5474547 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Efficacy and Safety of Cerebrolysin for Acute Ischemic Stroke: A Meta-Analysis of Randomized Controlled Trials.

Zhang Danfeng D Dong Yan Y Li Ya Y Chen Jigang J Wang Junyu J Hou Lijun L

BioMed research international 20170605

Cerebrolysin was reported to be effective in the neurological improvement of patients with acute ischemic stroke (AIS) in experimental models, while data from clinical trials were inconsistent. We performed a meta-analysis to explore the efficacy and safety of cerebrolysin for AIS. PubMed, EMBASE, and Cochrane Library were searched for randomized controlled trials, which intervened within 72 hours after the stroke onset. We investigated the efficacy and safety outcomes, respectively. Risk ratios ...[more]

PMID: 28656143

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Project description:ObjectiveTo assess the efficacy and safety of PNS on antiplatelet therapy in the treatment of AIS.MethodsWe searched 7 literature databases and 2 clinical studies databases for randomized controlled studies (RCTs) evaluating PNS as an adjuvant therapy for AIS. Relevant studies were retrieved and screened, and data were extracted independently by two reviewers. The quality of the included studies was assessed using the Cochrane Risk Assessment Tool. Meta-analysis was carried out with the Rev Man 5.4 software.ResultsOf 8267 records identified, 43 RCTs met our inclusion criteria (n = 4170 patients). Patients assigned to PNS with conventional treatments (CTs) had improved functional independence at 90 days compared with those assigned to CTs alone (RR = 1.87, 95% CI = 1.37, to 2.55, P < 0.0001). Patients who received PNS combined with CTs showed significantly high improvements in neurological function among individuals with AIS on the neurologic deficit score (NDS) (MD CSS = -5.71, 95% CI = -9.55 to -1.87, P=0.004; MD NIHSS = -3.94, 95% CI = -5.65 to -2.23, P < 0.00001). The results also showed PNS contributed to a betterment in activities of daily living (ADL) on the Barthel index (MD day 10 BI = 4.86, 95% CI = 2.18, to 7.54, P < 0.00001; MD day 14 BI = 13.92, 95% CI = 11.46 to 16.38, P < 0.00001; MD day 28 BI = 7.16, 95% CI = 0.60, to 13.72, P < 0.00001). In addition, PNS, compared with CTs alone, could significantly improve overall response rate (ORR) (RR NIHSS = 1.20, 95% CI = 1.16, to 1.24, P < 0.00001; RR CSS = 1.15, 95% CI = 1.08, to 1.24, P < 0.0001), hemorheological parameters, maximum platelet aggregation rate (MPAR) (MD = -6.82, 95% CI = -9.62 to -4.02, P < 0.00001), platelet parameters (MD PLT = 4.85, 95% CI = 1.82 to 7.84, P=0.002; MD MPV = -0.79, 95% CI = -1.09 to -0.48, P < 0.00001), and serum CD62P (MD = -0.21, 95% CI = -0.29 to -0.13, P < 0.00001). The incidence of adverse reactions in PNS was lower than that in the control group (RR = 0.62, 95% CI = 0.39 to 0.97, P=0.04). Adverse reactions in the PNS were mild adverse reactions.ConclusionPNS may be effective and safe in treating AIS on ameliorating neurological deficit, improving activities of daily living function, and enhancing antiplatelet effects. However, more high-quality evidence is needed before it can be recommended for routine antiplatelet therapy in patients with AIS.

Project description:BackgroundMany of these therapies have been compared against placebos, but have not been directly compared against each other. To evaluate the efficacy and safety of several commonly used drugs for AIS directly or indirectly.MethodsA systematic literature review was performed to identify randomized controlled trials (RCTs) published prior to April 2013 for AIS therapies. The primary outcome measures were the National Institutes of Health Stroke Scale (NIHSS) scores and the clinical effective rate. A fixed-effects meta-analysis and meta-regression are performed; lastly, performed a mixed treatment comparison was performed through the Bayesian methods.ResultsOutcome of efficacy of therapies for acute ischemic stroke are as followed: All of the therapies mentioned above yielded results a more effective result than placebo, Sodium ozagrel (RR 3.86, 95%CI 3.18-4.61); Sodium ozagrel + edaravone (RR 9.60, 95%CI 7.04-13.06); Edaravone (RR 4.07, 95%CI 3.30-5.01); Edaravone + Kininogenase (RR 15.33, 95%CI 10.03-23.05). The significant difference in efficacy between edaravone monotherapy and Sodium ozagrel + edaravone was evident (RR 0.43, 95%CI 0.08-0.61) and was also significant between efficacy of edaravone + Kininogenase and Sodium ozagrel (RR 4.00, 95%CI 2.47-6.24). The differences between the risk and benefit were not significant when comparing Sodium ozagrel and edaravone or edaravone + Kininogenase and Sodium ozagrel + Edaravone for AIS. Outcome of the defect of neurological function: Placebo served a significant difference in treating the defects of neurological function compared with Sodium ozagrel (WMD = -3.11, 95%CI -4.43 to -1.79), Sodium ozagrel + edaravone (WMD = -6.25, 95%CI -7.96 to -4.54) and Edaravone + Kininogenase (WMD = -3.47, 95%CI -5.73 to -1.21).ConclusionsIt provides that the efficacy of edaravone monotherapy in treatment was not more effective than Sodium ozagrel + edaravone.The efficacy of edaravone + Kininogenase monotherapy in treatment was more effective than Sodium ozagrel. Edaravone + Kininogenase and Sodium ozagrel + Edaravone appeared the most effective treatments. And Sodium ozagrel, Sodium ozagrel + edaravone, Edaravone + Kininogenase can improve the nerve dysfunction.

Dataset Information

Efficacy and Safety of Cerebrolysin for Acute Ischemic Stroke: A Meta-Analysis of Randomized Controlled Trials.

Publications

Efficacy and Safety of Cerebrolysin for Acute Ischemic Stroke: A Meta-Analysis of Randomized Controlled Trials.

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