曲克蘆丁腦蛋白水解物注射液治療急性腦梗死的隨機、單盲和安慰劑對照研究
發(fā)布時間:2018-06-15 14:55
本文選題:曲克蘆丁腦蛋白水解物 + 急性腦梗死。 參考:《中國神經(jīng)免疫學和神經(jīng)病學雜志》2016年04期
【摘要】:目的探討曲克蘆丁腦蛋白水解物注射液治療急性腦梗死的療效及安全性。方法選取符合入組條件的急性腦梗死患者456例,按1∶3比例隨機分為對照組和治療組,其中治療組共342例給予曲克蘆丁腦蛋白水解物注射液治療14d,對照組共114例給予滅菌注射用水,兩組基礎治療一致。主要療效觀察指標為兩組患者發(fā)病90d時的改良Rankin量表評價分析無明顯殘障(0~2級)患者的比例,次要療效指標為治療7d、14d后美國國立衛(wèi)生院神經(jīng)功能缺損評分(NIHSS)評分較基線降低≥7分者所占百分比和治療14d、發(fā)病后90d Barthel指數(shù)評價≥75分者所占百分比。結(jié)果治療組發(fā)病90d后無明顯殘障病例(改良Rankin量表評分0~2級)百分比明顯高于對照組(83.92%νs.69.3%,P0.01);用藥14d時治療組NIHSS評分降低≥7分者所占百分比明顯高于對照組(31.37%νs.4.08%,P0.01);治療組發(fā)病90d后Barthel指數(shù)≥75者所占百分比高于對照組(85.38%νs.76.32%,P0.05)。治療組和對照組分別發(fā)生26例(7.28%)、11例(9.17%)不良反應(一般不良事件),組間比較差異無統(tǒng)計學意義(P0.05)。結(jié)論曲克蘆丁腦蛋白水解物注射液可改善急性腦梗死患者的神經(jīng)功能缺損程度,促進功能恢復,且不良反應少,安全性較好,值得臨床推廣。
[Abstract]:Objective to investigate the efficacy and safety of troxerutin brain protein hydrolysate injection in the treatment of acute cerebral infarction. Methods 456 patients with acute cerebral infarction were randomly divided into control group and treatment group according to 1:3 ratio. 342 cases in the treatment group were treated with troxorutin brain protein hydrolysate injection for 14 days, and 114 cases in the control group were treated with sterilizing water. The main outcome index was the proportion of patients in the two groups who were evaluated by modified Rankin scale at 90 days after onset of the disease. The secondary outcome measures were the percentage of patients with neurological impairment score (NIHSS) of the National Institutes of Health (NIH) reduced 鈮,
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