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Received:May 05, 2022 Published Online:November 20, 2022
Received:May 05, 2022 Published Online:November 20, 2022
中文摘要: 目的 应用多模态MRI评估脑络通颗粒治疗脑小血管病（CSVD）的临床疗效。方法采用随机对照的研究方法，选择2020年1月至2021年12月南京中医药大学附属医院80例符合标准的CSVD患者，按照随机数字表法分为试验组与对照组，各40例，试验组给予口服脑络通颗粒+阿司匹林；对照组只给予口服阿司匹林。两组均连续治疗180 d。治疗0 d、90 d、180 d测评患者的认知功能，包括简易智力状态检查量表（MMSE）、蒙特利尔认知评估量表（MoCA）、日常生活活动能力［Barthel指数量表（BI）］。治疗0 d、180 d，利用多模态MRI扫描（包含T1、T2、DWI、FLAIR、SWI等序列），评估影像学指标（MRI总负荷）；检测两组血清同型半胱氨酸（Hcy）、超敏C反应蛋白（hs-CRP）水平。结果 治疗0 d,两组患者MRI总负荷、MMSE、MoCA和BI评分、血清Hcy和hs-CRP水平比较差异无统计学意义（P＞0.05）。治疗90 d、180 d，试验组MMSE、MoCA和BI评分较治疗0 d明显提高,且均高于对照组（P＜0.05，P＜0.01）。治疗180 d，试验组血清Hcy和hs-CRP水平较治疗0 d明显降低,且均低于对照组（P＜0.05，P＜0.01）；MRI总负荷较治疗0d和对照组有所降低，但差异无统计学意义（P＞0.05）。结论 脑络通颗粒可以改善CSVD患者的认知功能及日常生活活动能力，但是对MRI影像学改变并不明显。这种治疗作用可能与降低血清Hcy、减轻炎性反应以保护血管内皮的机制有关。
Abstract:Objective To evaluate the clinical efficacy of Naoluotong granule in the treatment of cerebral small vascular disease(CSVD) by multimodal MRI. Methods A randomized controlled study was performed in 80 patients with CSVD treated from January 2019 to December 2020, who met the inclusion criteria and were divided into experimental group and control group( n=40, each). Naoluotong granule plus aspirin was given in experimental group, and aspirin alone was given in control group, with continuous oral administration for 180 days in both groups. On day 0 of treatment, day 90 and day 180 of treatment, the cognitive functions of the patients were assessed, including the mini-mental state examination(MMSE), Montreal cognitive assessment(MoCA) and Barthel activity of daily living scale ［Barthel index（BI）］. Multi-modal MRI scans (including T1, T2, DWI, FLAIR, SWI etc.) were performed to evaluate the imaging indicators(total MRI load) at day 0 and day 180 after treatment. The levels of serum homocysteine(Hcy) and hypersensitive C-reactive protein(hs-CRP) were detected. Results On day 0 of treatment, there was no significant difference in MRI total load, MMSE, MoCA and BI scores, serum Hcy and hs-CRP levels between two groups(P>0.05). On day 90 and day 180 of treatment, the scores of MMSE, MoCA and BI in experimental group were significantly improved compared with day 0 of treatment, and all were higher than those in control group (P＜0.05, P＜0.01). On day 180 of treatment, the levels of serum Hcy and hs-CRP in experimental group were significantly lower than those on day 0 of treatment, and both were lower than those in control group (P＜0.05, P＜0.01); the total MRI load was lower than that on day 0 and in control group, but the difference was not statistically significant (P＞0.05). Conclusions Naoluotong granule can improve the cognitive function and activities of daily living of patients with CSVD, which may be related to the mechanism of reducing serum Hcy level and alleviating inflammatory reaction to protect vascular endothelium function. However, it has no obvious impacts on MRI indicators.
keywords: Naoluotong granule Cerebral small vascular disease Cognitive function Total magnetic resonance load
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基金项目:江苏省中医药管理局课题（YB201908）
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