施普善治疗急性缺血性脑卒中的随机双盲对照研究.docVIP

施普善治疗急性缺血性脑卒中的随机双盲对照研究 　　作者：薛丽霞 孙晓江 作者单位：上海交通大学附属第六人民医院神经内科，上海 200233 　　【摘要】 目的 探讨施普善治疗急性缺血性脑卒中的临床疗效、安全性及其对患者血清钙、镁的影响。方法 采用随机、双盲安慰剂对照研究。40例急性缺血性脑卒中患者随机分为施普善组20例和安慰剂组20例，分别于治疗后14、21和28 d时观察疗效和不良反应，以及入院24 h和治疗10 d时血清钙、镁浓度的变化。结果 两组疗效及总有效率在治疗后28 d时比较有显著差异(分别为P=0.0207，P=0.041);施普善组用药后血清Ca2+、Mg2+浓度较治疗前显著升高(分别为P=0.006，P=0.014);而安慰剂组用药前后血清Ca2+、Mg2+含量均无明显变化(均P0.05)。结论 施普善能够使缺血性脑卒中患者血清Ca2+、Mg2+含量有所恢复，对改善患者的意识状态、肌力及语言功能方面有一定作用且具有较好的安全性。 　　【关键词】 缺血性脑卒中;施普善;随机对照研究 　　Double-blind and randomized controlled trial of cerebrolysin in the treatment of acute ischemic stroke 　　XUE Li-Xia, SUN Xiao-Jiang. 　　Department of Neurology, the 6th Peoples Hospital, Shanghai Jiaotong University, Shanghai 200233, China 　　【Abstract】 Objective To evaluate the efficacy and safety of cerebrolysin in the treatment of acute ischemic stroke and to explore its effect on serum calcium and magnesium. Methods A double-blind and randomized controlled clinical trial was conducted for treating acute ischemic stroke. Forty cases with acute ischemic stroke were randomly assigned to cerebrolysin and placebo groups. Clinical efficacy and adverse reaction were observed on day 14, 21 and 28 after treatment. The changes of serum calcium and magnesium before and after treatment were also studied. Results On day 28 after treatment, there was a statistically significant difference in therapeutic efficacy and total effective rate between the two groups (P=0.020 7，P=0.041, respectively). Serum calcium and magnesium concentration in cerebrolysin group increased significantly between before and after administration (P=0.006, P=0.014, respectively), but there was no significant difference in the placebo group (P0.05). Conclusions Cerebrolysin is efficacious and safe in the improvement of neurological function of patients with acute ischemic stroke, and can decrease the encephalic injury by increasing the concentration of serum calcium and magnesium. 　　【Key words】 Cerebrolysin; Acute ischemic stroke