| Objective:This study aims to further verify the clinical effectiveness and safety of treating insomnia of Parkinson’s disease with Yin deficiency and fire syndrome by collecting clinical cases related to insomnia of Parkinson’s disease and using small sample randomized controlled trial,so as to provide a new treatment idea for insomnia of Parkinson’s disease with traditional Chinese medicine.Methods:In this study,64 subjects who were diagnosed with PD insomnia in the outpatient department and ward of the Department of Encephalopathy of Wuhan Hospital of Traditional Chinese Medicine from November 2018 to November 2020 were included.According to the small sample randomized controlled trial,the patients were divided into observation group and control group,with 32 cases in each group,and 3 cases were excluded.Finally,30 patients in the control group were given basic anti-Parkinson’s disease therapy(oral anti-Parkinson’s drug)and dexzopiclone tablet.Observation group(n=31)was treated with Jiji water and fire combined basic treatment for 8 weeks.Prior to treatment,age,sex,duration of insomnia,and H-Y grade were analyzed for comparability.Before and after treatment,scales(Parkinson’s Disease Sleep Assessment Scale-2,PDSS-2;Insomnia Severity Index Scale,ISI;Pittsburgh Sleep Quality Index Scale,PSQI;Self-Rating Sleep Status Scale,SRSS;Hamilton Anxiety Scale(HAMA)score recording and evaluation.SPSS26.0statistical software was used to analyze and compare the results,combined with the efficacy indicators of traditional Chinese medicine,in order to verify the clinical effectiveness and safety of both water and fire therapy in the treatment of Yin deficiency and fire flaming insomnia.Results:1.Before treatment,gender,age,duration of insomnia and H-Y grading were statistically analyzed for the subjects in the two groups,and there was no statistical significance in the above four factors between the two groups(P>0.05),and the data of the two groups were comparable in the analysis of corresponding scale scores.2.Intra-group and inter-group comparison of PDSS-2 scores between the two groups: after 2 weeks of treatment,scores in the observation group were significantly higher than those before treatment(P<0.05);The scores of the control group were significantly higher than those before treatment(P<0.01).There was significant difference between the two groups(P<0.01).After8 weeks of treatment,the scores of observation group were significantly higher than those before treatment,the difference was significant(P<0.01);The scores of the control group were higher than those before treatment,and the overall difference was significant(P<0.05).The score of the observation group was significantly higher than that of the control group,the difference was significant(P<0.01).3.Comparison of ISI scale scores between the two groups: 1 week after treatment,the scores of the observation group were not significantly different from those before treatment(P<0.05);The scores of control group were significantly different from those before treatment(P<0.01).There were significant differences in scores between the two groups(P<0.01).At 8 weeks after treatment,the scores of the observation group were significantly lower than those before treatment(P<0.01).The scores of the control group were significantly lower than those before treatment(P<0.05).At this time,the scores of the observation group were significantly lower than those of the control group,and the scores were significantly different between the two groups(P<0.01).4.Comparison of PSQI scores between the two groups: after 8weeks of treatment,the score of the observation group was significantly lower than that before treatment,the difference was significant(P<0.01);The scores of the control group showed statistically significant difference between the two groups before and after treatment(P>0.05).After treatment,the scores in the observation group were significantly lower than those in the control group(P<0.01).Comparison of SRSS scores between the two groups: after 8 weeks of treatment,the scores of the observation group were significantly different before and after treatment(P<0.01);In the control group,there was a statistically significant difference in scores before and after treatment(P>0.05).The treatment group was significantly lower than the control group between the two groups(P<0.01).Comparison of HAMA scale scores between the two groups: the scores of the observation group were significantly lower after treatment than before treatment(P<0.01);The scores of the control group after treatment were significantly different from those before treatment(P>0.05).After treatment,the score of observation group was lower than that of control group,and the difference was statistically significant(P<0.01).5.The intra-group and inter-group comparison of TCM syndrome scores between the two groups: 8 weeks after treatment,the observation group was significantly lower than before treatment,the difference was significant(P<0.01);There was no significant difference in the scores of control group compared with those before treatment(P>0.05).The scores of the observation group were significantly lower than that of the control group(P<0.01).6.Comparison of the effective rate of TCM treatment of insomnia:after treatment,the total effective rate of the observation group was 80.6%,the total effective rate of the control group was 40%,the rate of the observation group was significantly higher than the control group,the difference was statistically significant(P<0.01).7.During the whole clinical study,no obvious adverse reactions occurred to the subjects in the two groups.Before and after treatment,the vital signs and laboratory examinations of the subjects in the two groups were within the normal range.Conclusion:1.The combination of Jiji Water and Fire Prestige and basic treatment of Parkinson’s disease can significantly improve the insomnia symptoms of Parkinson’s disease patients with Yin deficiency and Huo wang syndrome.2.Dexzopicron tablets combined with basic anti-Parkinson’s disease treatment can improve the sleep quality of PD insomnia patients in a short period of time,and the effect is clear;However,the combination of the combination of water and fire method and the basic treatment of anti-Parkinson’s disease has a better long-term effect on improving the insomnia symptoms of Parkinson’s patients with Yin deficiency and fire swelling syndrome than the single use of dexzopiclone tablet,and the clinical effect is more stable.3.The combination of water and fire method has certain advantages in improving the anxiety state of PD insomnia patients with Yin deficiency and fire swelling syndrome,while dexzopiclonum tablet has an uncertain clinical effect on the anxiety state of PD insomnia patients.4.During the treatment of PD insomnia,no adverse events occurred and the safety was good... |
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