【摘要】：目的探討強(qiáng)化他汀治療急性腦梗死(ACI)的療效和安全性。方法發(fā)病6 h內(nèi)不符合溶栓治療的ACI患者,隨機(jī)分為對(duì)照組和強(qiáng)化組,并進(jìn)一步依據(jù)入院時(shí)美國(guó)國(guó)立衛(wèi)生院卒中量表(NIHSS)評(píng)分將各組分為3個(gè)亞組:輕度組(NIHSS≤5分),中度組(NIHSS評(píng)分6~13分),重度組(NIHSS評(píng)分≥14分)。強(qiáng)化組入院后即刻予負(fù)荷劑量阿托伐他汀80 mg,此后按40 mg/d劑量繼續(xù)服用阿托伐他汀治療90 d;對(duì)照組發(fā)病后1 w開始服用阿托伐他汀(商品名立普妥,輝瑞制藥公司,每粒10 mg,下同)10 mg,按10 mg/d劑量繼續(xù)服用阿托伐他汀治療90 d。隨訪兩組90 d主要終點(diǎn)指標(biāo)是發(fā)病后3個(gè)月臨床預(yù)后(改良Rankin量表modified Rankin Scale,m RS)評(píng)分及嚴(yán)重不良反應(yīng)發(fā)生情況;次要終點(diǎn)指標(biāo)是發(fā)病1 w時(shí)神經(jīng)功能惡化發(fā)生率和梗死體積。結(jié)果強(qiáng)化組臨床預(yù)后不良(m RS≥4分)者較對(duì)照組減少(7.3%,14.6%,χ~2=0.029,P0.05);強(qiáng)化組臨床預(yù)后良好(m RS2分)者較對(duì)照組增加(63.4%,46.3%),有好轉(zhuǎn)趨勢(shì),但差異無(wú)統(tǒng)計(jì)學(xué)意義(χ~2=1.824,P0.05);亞組分析提示輕、中度腦卒中強(qiáng)化他汀治療可分別改善臨床良好預(yù)后比率23.1%和18.1%(P0.05)。強(qiáng)化組早期神經(jīng)功能惡化發(fā)生率較對(duì)照組明顯降低(14.6%,34.1%,χ~2=4.325,P0.05)。治療1 w時(shí),強(qiáng)化組梗死體積與對(duì)照組相比,梗死體積有減少趨勢(shì)〔37.4(12~101.8),54.1(13~113.3)〕,但差異無(wú)統(tǒng)計(jì)學(xué)意義(Z=-4.324,P0.05)。至隨訪結(jié)束兩組不良反應(yīng)發(fā)生情況相似,沒有因他汀類藥物的不良反應(yīng)而需停藥者,且兩組顱內(nèi)出血的風(fēng)險(xiǎn)相比無(wú)明顯增加。結(jié)論早期強(qiáng)化他汀治療可減少ACI早期神經(jīng)功能惡化的發(fā)生,改善3個(gè)月時(shí)ACI患者不良預(yù)后,改善輕、中度腦卒中臨床良好預(yù)后比率,隨訪期間未發(fā)生嚴(yán)重不良反應(yīng)。
[Abstract]:Objective to evaluate the efficacy and safety of statin in the treatment of acute cerebral infarction (ACI). Methods ACI patients who did not conform to thrombolytic therapy within 6 hours were randomly divided into two groups: control group and intensive group. Each group was further divided into three subgroups according to the (NIHSS) score of stroke scale at admission: mild group (NIHSS 鈮，

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