| Objective: To explore the the clinical efficacy and safety of Jiawei Jiaotai Wan in treating Insomnia of Incoordination between Heart and Kidney,basing on the Theory of Relative Equilibrium of Yin-Yang,so as to provide more clinical evidence for the treatment of Insomnia of Incoordination between Heart and Kidney by integrated traditional Chinese medicine(TCM)and western medicine.Methods: A total of 60 patients who diagnosed with Insomnia of Incoordination between Heart and Kidney,who admitted to the encephalology department of the First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine from February 2020 to December 2020 and met the standard were selected.According to the random number table method,60 patients were divided to treatment group(Jiawei Jiaotai Wan combine with diazepam group)and control group(diazepam group),with 30 patients in each group.The control group oral diazepam and receive appropriate health education of sleep,and control group oral Jiawei Jiaotai Wan on the basis of the treatment in the control group.The period of treatment for both groups was 2 weeks,instructing patients bland diet,and fast foods such as spicy stimulation were banned during the treatment.TCM syndrome score,the total score Pittsburgh Sleep quality Index(PSQI)and the each factor of integral were detailed recorded before and after treatment in the two groups,which patients were diagnosed with Insomnia of Incoordination between Heart and Kidney.The improvement of syndromes and the total clinical curative effect of the two groups were evaluated respectively after the results were calculated by points rate formula.During the same time,the safety indexes of the patients such as urine routine,liver and kidney function,electrocardiogram(ecg)were monitored in the before and after treatment.To evaluate the safety of the drug treatment,possible adverse against such as nausea,headache,diarrhea were recorded detailed and divided into different grades.Using SPSS 20.0 software for statistical data analysis and evaluating the efficacy and safety of Insomnia of Incoordination between Heart and Kidney treated by Jiawei Jiaotai Wan.Result:1.Basic situation: the basic situation of a total of 60 patients who diagnosed with Insomnia of Incoordination between Heart and Kidney,such as gender,age,course of the disease,TCM syndrome score,PSQI score were statistics analysis before the treatment,and there were no statistically significant difference.2.Total clinical efficacy: the total clinical effective rate in the treatment group was 90.00%,and the total clinical effective rate of the control group was 76.67%.The total clinical effective rate of the treatment group was better than that of the control group,and the difference was statistically significant(P<0.05).3.TCM syndrome score: after treatment,the TCM syndrome score of both groups was significantly lower than that before treatment(P<0.01),and the score of the treatment group was lower than that of the control group,the difference was statistically significant(P<0.05).After treatment,the each factor of integral(include vexation and sleeplessness,palpitation and dreaminess,dizziness and tinnitus,soreness and weakness of waist and knees,tidal fever and night sweating,five upset hot,tianjin less dry throat)of the treatment group was significantly lower than before except amnesia,irregular menstruation or men’s night emission.The rest of integral of the control group was not improved obvious except include vexation and sleeplessness and palpitation and dreaminess,showing that the treatment group has more advantages in improving TCM syndrome when compared with the control group.4.Pittsburgh Sleep quality Index(PSQI)score: after treatment,the integral of 7 factor of the two groups were reduced,and the treatment group has more advantages in improving sleep quality,sleep Latency,sleep disorder,medicine hypnotize,daytime dysfunction and Pittsburgh Sleep quality Index(PSQI)score when compared with the control group,while it is no more differences in sleep time and sleep efficiency.Showing that the treatment group was more advantages than the control group in improving the patient’s sleeping.5.Safety evaluation: before and after treatment,the safety indexes of 60 patients,such as urine routine,liver and kidney function and electrocardiogram is no obvious anomalous change.Mild adverse reactions were found in 1 patient in the treatment group and 2 patients in the control group,and there was no statistically significant difference between the two groups in the cases of adverse reactions(P>0.05).Conclusion: 1.Based on the TCM theory of yin and yang in equilibrium,adding Jiawei Jiaotai Wan to treat Insomnia of Incoordination between Heart and Kidney to oral western medicine treatment which can further improve the quality of sleep of patient,reduce a variety of TCM syndrome caused by Incoordination between Heart and Kidney and improve the clinical efficacy.2.The drug safety of Jiawei Jiaotai Wan is well,which is worthy of clinical research and promotion. |
PDF Full Text Request