| ObjectiveThis study mainly observed the clinical efficacy and safety of Huanglian Ejiao Decoction in the treatment of sleep disturbance caused by cerebral small vascular disease,as well as the degree of improvement in syndromes of traditional Chinese medicine and cognitive psychological state,to explore the advantages and clinical value of TCM in the treatment of sleep disturbance caused by cerebral small vascular disease.In the hope of providing feasible individualized TCM diagnosis and treatment plan and clinical evidence for the clinical treatment of sleep disturbance caused by cerebral small vascular disease with heart-kidney disharmony.MethodThis study screened and collected a total of 60 patients with sleep disturbance caused by cerebral small vascular disease with heart-kidney disharmony who met the inclusion criteria and were admitted to the Department of Neurology of Wuhan No.1 Hospital from September 2020 to January 2022,and patients were divided into observation group and control group through the method of grouping measure of random number table,with 30 patients in each group.The control group was treated with conventional western medicine（dexzopiclone 2mg once before bed every night + Trazodone hydrochloride 50 mg once an hour before bed every night）,observation group was treated with conventional western medicine（dexzopiclone 2mg once before bed every night + Trazodone hydrochloride 50 mg once an hour before bed every night）and traditional Chinese medicine decoction（Huanglian Ejiao decoction1 dose per day,200 ml each time,once after breakfast and dinner,warm to take）,and both groups were totally treated for 21 days.The Huanglian Ejiao decoction came from the Chinese medicine pharmacy of Wuhan First Hospital in bulk and was decocted for patients by the pharmacy of our hospital.Collecting the general information and clinical information of the enrolled patients after into the group,recording the Pittsburgh Sleep Quality Index（PSQI）,TCM syndrome scores evaluation,Hamilton Anxiety Scale（HAMA）and mini-mental state examination（MMSE）before and after treatment in2 groups,evaluated the clinical efficacy by self-control and intergroup control.At the same time,patients’ vital signs and medication safety indexes were routinely monitored during treatment,such as liver function,kidney function,electrolyte analysis,electrocardiogram,etc.,and recorded adverse events.After the end of the study,SPSS 25.0 statistical software was used for data collation and analysis of the observation results.Result1.Baseline comparison: before treatment,there was no significant difference in age,gender,body mass index（BMI）,course of disease and other general conditions between 2 groups;there was no significant difference in PSQI scale,HAMA scale,MMSE scale and TCM syndrome scale between 2 groups（P > 0.05）,the baseline conditions were comparable.2.Clinical efficacy evaluation（1）Comparison of PSQI scores between the two groupsAfter 21 days of treatment,the PSQI scale scores of the observation group and the control group before and after treatment were compared within the group,and the results showed that the PSQI scale scores of the two groups after treatment were significantly different from those before treatment（P<0.05）.But there was no significant difference in PSQI scale scores between the two groups after treatment（P>0.05）.It was suggested that the PSQI scale scores of the observation group and the control group were improved to some extent,but the overall improvement degree of the two groups was similar.（2）Comparison of TCM Syndrome Scale scores between two groupsAfter 21 days of treatment,the scores of TCM syndromes in the observation group and the control group before and after treatment were compared within the group,and the results showed that the scores of TCM syndromes in both groups decreased after treatment,with statistical significance（P < 0.05）.The inter-group comparison of TCM syndrome score between the two groups after treatment showed that the improvement in the observation group was significantly better than that in the control group,with statistical significance（P<0.05）.The finding revealed that the improvement of TCM syndrome score in the observation group was better than that in the control group.（3）Comparison of HAMA scores between the two groupsAfter 21 days of treatment,the HAMA scale scores of the observation group and the control group before and after treatment were compared within the group,and the results showed that the HAMA scale scores of the two groups after treatment were significantly different from those before treatment（P<0.05）.The inter-group comparison of HAMA scale scores between the two groups after treatment showed that the observation group was superior to the control group,with statistical significance（P < 0.05）.The finding revealed that the observation group was superior to the control group in improving HAMA scale scores.（4）Comparison of MMSE scores between the two groupsAfter 21 days of treatment,the MMSE scale scores of the observation group and the control group before and after treatment were compared within the group,and the results showed that the MMSE scale scores of the two groups after treatment were significantly different from those before treatment（P < 0.05）.And the inter-group comparison of MMSE scale scores between the two groups after treatment showed that the observation group was superior to the control group,with statistical significance（P<0.05）.The finding revealed that the observation group was superior to the control group in improving MMSE scale scores.（5）Comparison of curative effect between two groupsWestern medicine clinical curative effect comparison: after treatment,statistics found that in the control group there were4 cases of clinical recovery,11 cases of marked effective,11 cases of effective and 4 cases of invalid,calculated to the western medical total effective rate of the control group is 86.7%;in the observation group there were 9 cases of clinical recovery,12 cases of marked effective,7 cases of effective and 2 cases of invalid,calculated to the western medical total effective rate of the observation group is 93.3%;and between the western medical total effective rates of the two groups,there was no statistically significant difference（P>0.05）.Traditional Chinese medicine（TCM）clinical curative effect comparison: after treatment,statistics found that in the control group there were 0 case of clinical recovery,8 cases of marked effective,11 cases of effective and 11 cases of invalid,calculated to the TCM total effective rate of the control group is 63.3%;in the observation group there were 5 cases of clinical recovery,12 cases of marked effective,10 cases of effective and 3 cases of invalid,calculated to the TCM total effective rate of the observation group is 90.0%;and between the TCM total effective rates of the two groups,there was a statistically significant difference（P<0.05）,which meant the TCM clinical effect of the observation group was better than the control group.3.Safety evaluationDuring the whole process of the experiment,no significant abnormalities were found in vital signs,liver function,kidney function and other examination results of all subjects before and after treatment.One patient in the observation group appeared mild discomfort after taking the medicine,presenting as diarrhea;in the control group,2 patients showed mild discomfort after taking the medicine,including 1 case of dizziness and 1 case of fatigue.The symptoms improved after symptomatic treatment,and no treatment such as drug withdrawal or drug reduction occurred during the treatment.There was no statistical significance in the number of adverse reactions cases reported between the two groups（P>0.05）.Conclusion1.Compared with conventional western medicine alone,the Huanglian Ejiao decoction combined with conventional western medicine in the treatment of sleep disturbance caused by cerebral small vascular disease with heart-kidney disharmony can not only effectively shorten sleep latency,improve sleep quality and prolong sleep time,but also improve anxiety and cognitive function of patients.2.Compared with conventional western medicine alone,the Huanglian Ejiao decoction combined with conventional western medicine in the treatment of sleep disturbance caused by cerebral small vascular disease with heart-kidney disharmony can not only improve sleep,but also effectively relieve the symptoms such as palpitations and dreaminess,vertigo and tinnitus,waist and knee soreness,hot flashes and sweating,five upset fever,dry throat and less body fluid,the benefit of the patients was better than that of the conventional western medicine treatment group.3.Huanglian Ejiao Decoction has good safety in the treatment of sleep disturbance caused by cerebral small vascular disease with heart-kidney disharmony,without serious adverse reactions and toxic side effects,which is worthy of further clinical application. |
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