摘要：

目的 探讨奥拉西坦联合银杏叶提取物治疗急性脑出血的有效性和安全性，以及对血清炎性因子表达变化的影响。方法 纳入2016年6月至2018年1月诊断明确的急性脑出血病例210例， 采用随机区组设计法分为单纯奥拉西坦治疗组（奥拉西坦治疗组）和奥拉西坦联合银杏叶提取物治疗组 （联合治疗组），分别评价两种治疗方案疗效，定量分析治疗前后脑水肿量和脑血肿量变化，并通过美国国立卫生研究院卒中量表（NIHSS）评价治疗前后神经功能、蒙特利尔认知评价量表（MoCA）和日常生活活动能力量表（ADL）评价治疗前后认知功能和日常生活活动能力，监测治疗前后氧化应激指标和血清炎性因子表达变化，记录药物不良反应。结果 经两种方案治疗后，脑水肿量和脑血肿量减少（均P= 0.000），NIHSS评分减少、MoCA和ADL评分增加（均P=0.000），氧化应激指标超氧化物歧化酶水平升高、丙二醛和一氧化氮水平降低（均P=0.000），血清炎性因子白细胞介素-8和细胞间黏附分子-1水平降 低、脑钠肽水平升高（均 P=0.000）；两种治疗方案比较，联合治疗组优于奥拉西坦治疗组（均 P= 0.000）。联合治疗组总有效率高于奥拉西坦治疗组［92.38%（97/105）对80.95%（85/105）； χ2=5.934， P= 0.015］、药物不良反应发生率低于奥拉西坦治疗组［8.57%（9/105）对19.05%（20/105）； χ2=4.841， P= 0.028］。结论 奥拉西坦联合银杏叶提取物可有效减少急性脑出血患者脑水肿量和脑血肿量，从而改善神经功能、提高认知功能和日常生活活动能力，且疗效和安全性良好，具有临床应用价值。

关键词: 脑出血, 吡咯烷类, 银杏, 植物提取物, 氧化性应激, 细胞因子类

Abstract:

Objective To investigate the efficacy and safety of oxiracetam combined with Ginkgo biloba leaf extract in the treatment of acute cerebral hemorrhage and the effect of oxiracetam on the expression of serum inflammatory factors. Methods A total of 210 cases of acute cerebral hemorrhage diagnosed definitely from June 2016 to January 2018 were included. Patients were divided into two groups by randomized block design method: simple oxiracetam treatment group (oxiracetam treatment group) and oxiracetam combined with Ginkgo biloba leaf extract treatment group (combined treatment group). The curative effect of the two treatment schemes were evaluated, and quantitative analysis was made on the changes of brain edema and cerebral hematoma. National Institutes of Health Stroke Scale (NIHSS), Montreal Cognitive Rating Scale (MoCA), and Activity of Daily Living Capacity Scale (ADL) were used to evaluate neurological function, cognitive function, and activities of daily living of patients. The changes of oxidative stress index and serum inflammatory factor expression before and after treatment were monitored, and adverse drug reactions were recorded. Results After treatment with the two regimens, brain edema and hematoma were decreased (all P =0.000), NIHSS score was decreased, MoCA and ADL score were increased (all P =0.000), superoxide dismutase (SOD) level was increased, malondialdehyde (MDA) and nitric oxide (NO) level were decreased (all P=0.000), serum inflammatory factors interleukin-8 (IL-8) and intercellular adhesion molecular-1 (ICAM-1) level were decreased, and B-type natriuretic peptide (BNP) level was increased (all P=0.000). The total effective rate of the combined treatment group was higher than that of the oxiracetam treatment group [92.38% (97/105) vs.80.95%(85/105); χ2=5.934, P=0.015]. The incidence of adverse drug reactions of the combined treatment group was lower than that of the oxiracetam treatment group [8.57% (9/105) vs. 19.05% (20/105); χ2 =4.841, P =0.028]. Conclusions Oxiracetam combined with Ginkgo biloba leaf extract can effectively reduce the amount of brain edema and cerebral hemorrhage in patients with acute cerebral hemorrhage, thereby improving nerve function, cognitive function and activities of daily living. It has good efficacy and safety. Therefore, it is valuable for clinical application.

Key words: Cerebral hemorrhage, Pyrrolidines, Ginkgo biloba, Plant extracts, Oxidative stress, Cytokines