| Objective:Insomnia is a common complication after stroke,which seriously affects the quality of patient life.In this study,ozone autohemotherapy was used to treat patients with post-ischemic stroke insomnia(PISI),to observe the effect of this intervention program on the sleep quality of such patients and to explore its underlying mechanism.Methods:This study was a randomized,single-blind,clinical trial.A total of 63 ischemic stroke patients who met the inclusion/exclusion criteria were selected from a tertiary hospital in Changchun and a secondary hospital in Dehui.These participants were randomly divided into two groups:patients in the control group received basic medical therapy(8 mg betahistine hydrochloride[q8h]plus 0.1 g aspirin[q24h])and routine care,while those in the experimental group received additional ozone autohemotherapy once daily for 10 days.The patients were evaluated before and after the intervention,and the assessment tools included general information questionnaire,Insomnia Severity Index(ISI)and Pittsburgh sleep quality Index(PSQI).In addition,peripheral blood samples were collected for laboratory analysis,and the measurement indicators included brain neurotrophic factor(BDNF),inflammatory factors,blood routine index,neurotransmitter,liver function index and kidney function index.Statistical analysis was performed by SPSS Statistics 26.0 and graphs were produced using Graphpad Prism5.Group differences of categorical variables were analyzed using X~2tests.Shapiro-Wilk was used to test whether the data were conformed normally distributed.Homogeneity of variance was tested using F-test.Data with normal distribution were represented as mean±SD,and were analyzed by one-way ANOVA.The data that were not normally distributed were expressed as medians and quartiles,and were analyzed using Wilcoxon rank sum test.The P value less than 0.05 was considered to indicate significance.Results:(1)Baseline:there were no significant differences in age,gender proportion,proportion of smoking and drinking,pathological type of stroke,ISI score,PSQI score,sleep duration,finger oxygen saturation and blood index content between the two groups before the intervention(P>0.05).(2)Severity of insomnia and sleep quality:compared with before intervention,the ISI and PSQI score of the experimental group after treatment were decreased,the degree of insomnia was reduced,and the duration of night sleep was prolonged.Comparison between the two groups after intervention showed that the night sleep quality and sleep duration of patients in the experimental group were significantly better than those in the control group(P<0.05).(3)The content of serum inflammatory factors:compared with before intervention,the content of serum interleukin-10(IL-10)in the control group was significantly decreased after intervention.After intervention,the content of serum C-reactive protein(CRP)in the experimental group was significantly lower than that in the control group(P<0.05).(4)Content of neurotransmitters:compared with before intervention,the serum levels of BDNF and norepinephrine(NE)in the control group decreased after intervention(P<0.05).After intervention,the serum levels of serotonin(5-HT),BDNF and NE in the experimental group were significantly higher than those in the control group(P<0.05).(5)Liver function and kidney function:before and after intervention,the serum UREA in the experimental group was significantly higher than that in the control group(P<0.05).(6)Peripheral blood parameters:there were no significant changes in blood cell count,hemoglobin,platelet count and blood lipid levels between the two groups before and after intervention.(7)Adverse events:no grade≥3 serious adverse events were observed during the intervention.A total of 8 primary adverse events were reported,including 3 cases(10%)in the control group and 5 cases(15.1%)in the experimental group.During the intervention,2 patients(3.2%)had mild nausea,4 patients(6.3%)had rash,and 2patients(3.2%)had flushing.There was no significant difference in the incidence of adverse events between the two groups.Conclusion:(1)The 10-day ozone autohemotherapy intervention can significantly improve the sleep quality of patients with PISI,increase the night sleep duration of patients,and reduce the severity of insomnia.(2)Ozone autohemotherapy intervention can maintain the levels of serum IL-10,BDNF and 5-HT in patients with PISI,and reduce the content of serum CRP.It can inhibit the development of inflammation and promote the repair of damaged nerve cells.(3)Ozone autohemotherapy is a simple,safe,reliable and economical treatment scheme,which is worthy of promotion. |
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