舒脑欣滴丸改善皮层下缺血性脑小血管病患者睡眠和认知功能随机对照研究OA北大核心CSTPCD
Randomized Controlled Trial on Sleep and Cognitive Function in Patients with Subcortical Ischemic Cerebral Small Vessel Disease Treated with Shunaoxin Dropping Pills
目的 评价舒脑欣滴丸对皮层下缺血性脑小血管患者主观睡眠状况、客观睡眠参数及认知功能的影响.方法 自2020年1月-2022年9月从162例缺血性脑小血管病患者中筛选123例皮层下缺血性脑小血管病患者,随机分为常规治疗对照组(61例)和舒脑欣治疗组(62例).两组均给予常规治疗,包括抗血小板、调脂及控制脑血管病危险因素,舒脑欣治疗组在此基础上加用舒脑欣滴丸,疗程为3个月.收集两组患者匹兹堡睡眠质量指数(PSQI)、失眠严重指数(ISI)、Epworth嗜睡量表(ESS)、汉密尔顿焦虑量表(HAMA)、汉密尔顿抑郁量表(HAMD)、简易精神状态量表(MMSE)、数字广度测试(DST)、听觉词语学习测试(AVLT)、数字符号转换测试(SDMT)、连线测试(TMT)、Stroop色词测试(Stroop Test)的评分,并应用便携式睡眠监测仪(PSM)监测患者睡眠微结构相关参数.结果 治疗3个月后,与常规治疗对照组比较,舒脑欣治疗组PSQI、ESS、HAMA、HAMD评分降低程度大,PSM监测的客观总睡眠时间延长、入睡潜伏期缩短及睡眠效率提高程度大,AVLT-即刻学习、SDMT、TMT、Stroop色词测试表现改善程度较大(P＜0.05).结论 舒脑欣滴丸可改善皮层下缺血性脑小血管病患者的主观睡眠质量、日间嗜睡程度以及焦虑抑郁情绪,延长客观总睡眠时间,缩短入睡潜伏期,提高睡眠效率,并改善词语即刻学习能力、执行功能和信息处理加工速度.
Objective To evaluate the effect of Shunaoxin Dropping Pills on subjective sleep status,objective sleep parameters and cognitive function in patients with subcortical ischemic cerebral small vessel disease.Methods Totally 123 patients with subcortical ischemic cerebral small vessel disease were selected from 162 patients with ischemic cerebral small vessel disease from January,2020 to September,2022,they were randomly asigned to the control group(61 cases)and the Shunaoxin treatment group(62 cases).All patients received anti-platelet,lipid regulation and controlling risk factors of cerebrovascular disease.On this basis,Shunaoxin treatment group were treated with Shunaoxin Dropping Pills additionally,and the course of treatment was 3 months.The following scores were collected:Pittsburgh Sleep Quality Index(PSQI),Insomnia severity index(ISI),Epworth Sleepiness Scale(ESS),Hamilton's Anxiety Scale(HAMA),Hamilton's Depression Scale(HAMD),Mini-mental state exam(MMSE),Digital Span Test(DST),Auditory Verbal Learning Test(AVLT),Symbol digit modalities test(SDMT),Trail Making Test(TMT),Stroop Test and the objective sleep parameters were evaluated by the portable sleep monitor(PSM).Results After 3 months of treatment,compared to the control group,the Shunaoxin treatment group showed greater decrease in PSQI,ESS,HAMA and HAMD scores,greater increase in objective total sleep time and sleep efficiency,greater decrease in sleep latency,and greater improvements in AVLT-learning,SDMT,TMT and Stroop test with significance(P＜0.05).Conclusion Shunaoxin Dropping Pills can significantly improve the subjective sleep quality and daytime sleepiness,objective total sleep time and sleep efficiency,shorten the sleep latency,alleviate the severity of anxiety and depression,improve verbal learning and attention-executive function in the patients with subcortical ischemic cerebral small vessel disease.
冯明;张轩;王倩;薛蓉
天津市中西医结合医院神经外科(天津 300102)天津医科大学总医院空港医院神经内科(天津 300308)天津市第三中心医院分院神经内科(天津 300250)天津医科大学总医院神经内科(天津 300052)
舒脑欣滴丸皮层下缺血性脑小血管便携式睡眠监测仪睡眠认知功能中西医结合随机对照试验
Shunaoxin Dropping Pillssubcortical ischemic cerebral small vessel diseaseportable sleep monitorsleepcognitive functionintegrative medicinerandomized controlled trial
《中国中西医结合杂志》 2024 (008)
936-943 / 8
评论