腦蛋白水解物輔助治療急性腦梗死療效與安全性的系統(tǒng)評(píng)價(jià)
發(fā)布時(shí)間:2018-01-25 16:46
本文關(guān)鍵詞: 腦蛋白水解物 急性腦梗死 隨機(jī)對(duì)照試驗(yàn) 系統(tǒng)評(píng)價(jià) 療效 安全性 出處:《中國(guó)藥房》2017年30期 論文類型:期刊論文
【摘要】:目的:系統(tǒng)評(píng)價(jià)腦蛋白水解物輔助治療急性腦梗死的療效與安全性,為臨床提供循證參考。方法:計(jì)算機(jī)檢索SCI、Cochrane圖書館、EMBase、Pub Med、相關(guān)期刊論文(CJFD)、中文科技期刊數(shù)據(jù)庫(kù)(VIP)、萬(wàn)方數(shù)據(jù)庫(kù),收集腦蛋白水解物聯(lián)合常規(guī)方案(試驗(yàn)組)對(duì)比單純常規(guī)方案或聯(lián)合安慰劑(對(duì)照組)治療急性腦梗死的隨機(jī)對(duì)照試驗(yàn)(RCT),提取資料并按照Cochrane系統(tǒng)評(píng)價(jià)員手冊(cè)5.1.0評(píng)價(jià)質(zhì)量后,采用Rev Man 5.2統(tǒng)計(jì)軟件對(duì)數(shù)據(jù)進(jìn)行Meta分析。結(jié)果:最終納入20項(xiàng)RCT,包括3 313例患者。Meta分析結(jié)果顯示,試驗(yàn)組患者美國(guó)國(guó)立衛(wèi)生研究院卒中量表(NIHSS)評(píng)分[MD=-1.77,95%CI(-2.33,-1.21),P0.001]、有效率[OR=2.85,95%CI(1.75,4.63),P0.001]、Barthel指數(shù)(BI)評(píng)分[MD=7.30,95%CI(3.48,11.13),P0.001]顯著高于對(duì)照組,差異均有統(tǒng)計(jì)學(xué)意義;兩組患者致殘率[OR=0.46,95%CI(0.20,1.03),P=0.06]、死亡率[OR=0.79,95%CI(0.52,1.19),P=0.25]、不良反應(yīng)發(fā)生率[OR=1.04,95%CI(0.85,1.27),P=0.72]和嚴(yán)重不良反應(yīng)發(fā)生率[OR=0.01,95%CI(-0.02,0.04),P=0.51]比較,差異均無(wú)統(tǒng)計(jì)學(xué)意義。結(jié)論:腦蛋白水解物輔助治療急性腦梗死療效較好,可以顯著改善患者神經(jīng)功能缺損狀態(tài)和生活質(zhì)量,且不增加不良反應(yīng)的發(fā)生。
[Abstract]:Objective: to evaluate the efficacy and safety of cerebral protein hydrolysates in the treatment of acute cerebral infarction (ACI) and to provide evidence based reference for clinical application. Methods: the SCI Cochrane library was searched by computer. EmBase / Pub Med. Chinese Journal Full-text Database CJFDN, Chinese Sci-tech Journals Database VIPN, Wanfang Database. A randomized controlled trial of brain protein hydrolysate combined with routine regimen (trial group) for the treatment of acute cerebral infarction was conducted compared with conventional regimen or placebo (control group). The data were extracted and the quality was evaluated according to the Cochrane system evaluator's manual 5.1.0. Rev Man 5.2 statistical software was used to analyze the data by Meta. Results: 20 RCTs were included, including 3 313 patients. Meta-analysis results showed. NIHSS score of the National Institutes of Health Stroke scale in the trial Group. [MD-1.77 / 95 CIQ -2.33 ~ 1.21 / P0.001, effective rate. [The score of Barthel Index (BI) was 1.75 / 4.63 / P0.001. [The incidence of disability in the two groups was significantly higher than that in the control group (P 0.001). [Orr 0.46 95 CI 0.20 0. 03 P0.06, mortality rate: 0. 20%, 0. 06%, 0. 06%, 0. 06%, 0. 06%. [The incidence of adverse reactions was 0.72% 1.19% (P < 0.05), and the incidence of adverse reactions was 0.79% (P < 0.05) and 0.52% (P < 0.05). [The incidence of severe adverse reactions and the incidence of severe adverse reactions were 0.85% and 1.27% (P = 0.72) respectively. [There was no significant difference between the two groups. Conclusion: the therapeutic effect of cerebral protein hydrolysate in the treatment of acute cerebral infarction is better. It can significantly improve the state of neurological deficit and quality of life, and does not increase the occurrence of adverse reactions.
【作者單位】: 四川大學(xué)華西公共衛(wèi)生學(xué)院;四川大學(xué)華西醫(yī)院神經(jīng)內(nèi)科;四川大學(xué)華西醫(yī)院國(guó)家藥物臨床試驗(yàn)機(jī)構(gòu);
【基金】:四川省科技支撐計(jì)劃項(xiàng)目(No.2013SZ0003)
【分類號(hào)】:R743.33
【正文快照】: 610041)急性腦梗死是指因腦部血液循環(huán)障礙,缺血、缺氧所致的局限性腦組織缺血性壞死或軟化,是成人最常見的致殘性疾病。有資料顯示,急性腦梗死后3個(gè)月的死亡/殘疾率約為34.5%~37.1%[1]。目前,急性腦梗死的常規(guī)治療為在一般處理的基礎(chǔ)上,改善患者腦循環(huán)、保護(hù)腦神經(jīng)(稱為特異
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