Randomized Controlled Trial on Sleep and Cognitive Function in Patients with Subcortical Ischemic Cerebral Small Vessel Disease Treated with Shunaoxin Dropping Pills
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.
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