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目的考察小牛血清去蛋白肠溶胶囊对改善由脑部血液循环障碍(缺血性损害)所引起的神经功能缺损的临床有效性和安全性。方法采用随机双盲多中心试验设计,将入选病例随机分成试验组与对照组,试验组给予小牛血清去蛋白肠溶胶囊,对照组给小牛血清去蛋白肠溶胶囊安慰剂,在治疗前和治疗后7、14、28 d 采用 NIHSS、BT、mRS 量表评价,90 d 使用 BI、mRS 量表评价,考察治疗前后的分值改变,并进行安全性分析。结果治疗前治疗组与试验组的 NIHSS、BI、mRS 量表评分经统计学分析差异无统计学意义;对照组与试验组 NIHSS 评分治疗后14、28 d 分别为7.70±3.36,6.17±3.02;5.89±3.76,3.63±2.49,治疗组与试验组相比差异有统计学意义(P<0.01);治疗90d,BI 和 mRS 量表评价,治疗组与试验组相比差异有统计学意义(P<0.01),不良反应事件发生较少。结论小牛血清去蛋白肠溶胶囊可以有效地改善急性缺血性脑损害患者的神经功能缺损,提高生活能力,改善生活质量,安全性较好。
Objective To investigate the clinical efficacy and safety of bovine serum albumin-removing enteric-coated capsules in improving neurological deficits caused by cerebral blood circulation disorders (ischemic damage). Methods A randomized, double-blind, multi-center trial was designed. The selected cases were randomly divided into experimental group and control group. The experimental group received bovine serum albumin-enteric-coated capsules. The control group received placebo of bovine serum albumin- At 7, 14 and 28 days after treatment, NIHSS, BT and mRS were used to evaluate the changes. After 90 days, BI and mRS were used to evaluate the changes of scores before and after treatment, and safety analysis was performed. Results There was no significant difference in NIHSS, BI and mRS scores between the treatment group and the experimental group before the treatment. The NIHSS scores of the control group and the experimental group were 7.70 ± 3.36 and 6. 17 ± 3.02 respectively 14 and 28 d after treatment. 5.89 ± 3.76,3.63 ± 2.49, the difference between the treatment group and the experimental group was statistically significant (P <0.01); After 90 days of treatment, BI and mRS scale evaluation, the treatment group compared with the experimental group, the difference was statistically significant (P <0.01), fewer adverse reaction events occurred. Conclusion The bovine serum albumin-removing enteric-coated capsules can effectively improve the neurological deficit in patients with acute ischemic brain damage, improve the living ability, improve the quality of life, and have better safety.