| Objective:To observe the clinical efficacy and safety of Shangxia Liangji decoction in the treatment of insomnia(disharmony between heart and kidney).Methods:In this study,66 patients with insomnia(disharmony between heart and kidney)from January 2022 to December 2022 were selected from the internal medicine outpatient department of HEILONGJIANG ZHONGYIYAODAXUE FUSHU DIER YIYUAN.According to the random number table method,all patients were divided into the traditional Chinese medicine group and the control group according to the principle of 1:1,with 33 cases in each group.Both groups treatment lasted for 28 days.The traditional Chinese medicine group was treated with Shangxia Liangji Decoction,one dose a day.The control group was treated with eszopiclone tablet orally,3mg daily.By observing and comparing the Pittsburgh Sleep Quality Index(PSQI)scale score,Insomnia Severity Index(ISI)scale score,The 36-item Short Form Health Survey(SF-36)score,TCM Symptom Scale scale score changes of the two groups on day 0 and day 28 of treatment and the effective rate after treatment.All data were processed using the statistical analysis software SPSS 26.0,and the clinical efficacy and safety of Shangxia Liangji decoction in the treatment of insomnia(disharmony between heart and kidney)patients were discussed.Results:1.Before treatment,there were no significant differences in age,gender and disease course scores between the two groups(P > 0.05).2.PSQI scale analysis: Before treatment,there was no significant difference in total PSQI scores and scores of each factor between the two groups(P > 0.05).After treatment,the total score of PSQI and the scores of all factors in both groups were decreased compared with those before treatment(P < 0.05).The two groups were compared between groups,there were no significant differences between the two groups in PSQI total scores and scores of each factor(P > 0.05).3.TCM syndrome score scale analysis: Before treatment,there was no statistical significance in the total TCM syndrome score and single syndrome score between the two groups(P > 0.05).After treatment,the total scores of TCM syndromes and the scores of single syndromes in the TCM group were decreased compared with before treatment(P < 0.05);in the control group,the total scores of TCM syndroms were all decreased,and the scores of 7single syndroms,including insomnia,intermittent awakening,zygomatic fever,male wet dream impotence,female irregular menstruation,oral and tongue pain,tongue image and pulse image,were all decreased compared with those before treatment(P < 0.05).By comparison between the two groups,the total scores of TCM syndroms between the two groups were statistically significant,and the scores of 7 single syndroms,including palpitation,dry throat less body fluid,waist and knee soreness,vertigo tinnitus,night sweats,vexing heat in the chest,dry stools,were statistically significant(P < 0.05).4.Analysis of ISI scale and SF-36 scale: Before treatment,there were no significant differences in ISI scores and SF-36 scores of each dimension between the two groups(P > 0.05).After treatment,ISI scores in both groups were lower than before treatment(P < 0.05).There was no significant difference in ISI scores between the two groups(P > 0.05),but there were statistically significant differences in SF-36 scores of energy,emotional function,mental health and health changes(P < 0.05).5.Clinical effect analysis:Efficacy criteria of PSQI scale: The total effective rate of the Chinese medicine group was 83.87%,and that of the control group was 87.50%.There was no significant difference in the effective rate of the two groups in the treatment of insomnia(disharmony between heart and kidney)(P > 0.05).Conclusion:1.Shangxia Liangji decoction can improve the overall sleeping status of patients with good safety;2.Shangxia Liangji decoction can significantly relieve insomnia(disharmony between heart and kidney)patients with a series of symptoms of traditional Chinese medicine,such as palpitation,dry throat less body fluid,waist and knee soreness,vertigo tinnitus,night sweats,vexing heat in the chest,dry stools and other accompanying symptoms;3.Shangxia Liangji decoction can significantly improve the quality of life of patients with insomnia(disharmony between heart and kidney). |
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