| Objective:To observe the clinical curative effect of Gubenjiannao Liquid combined with zopiclone in the treatment of spleen and kidney deficiency type of primary insomnia,provide research evidence for the clinical popularization and application of Gubenjiannao Liquid in treating primary insomnia,and provide new ideas for the treatment of such diseases by traditional Chinese medicine.Methods:From the outpatient clinic of Department of traditional Chinese medicine,affiliated to the Min Da Hospital of Hubei Institute for Nationalities,the patient was diagnosed as primary insomnia and syndrome type belonging to spleen and kidney deficiency.60 eligible subjects were randomly divided into two groups,30 cases in each group.They were labeled as treatment group and control group,respectively.There were no significant differences in gender,age,severity of insomnia,Pittsburgh sleep quality index(Pittsburgh sleep quality index,PSQI),Epworth sleepiness scale(Epoworth sleepiness scale,ESS),self rating Depression Scale(Self-rating Depression),and self rating anxiety scale.It has comparability.The two groups were supplemented by psychological counseling,sleep restriction and sleep hygiene education.The control group was treated with Eszopiclone Tablets,3mg/ times,1times per day and half an hour before bedtime.The patients in the treatment group were treated with Gubenjian nao Liquid at the same time on the basis of the control group,30ml/ times,3 times per day,and in the morning,the middle and the late.The prescription of "Gubenjiannao Liquid" is a self preparation in the affiliated Min Da Hospital of Hubei Institute for Nationalities.Its essential medicines are five ingredients:Radix Codonopsis,Poria,Lycium barbarum,sour jujube kernel and hawthorn.The two groups were treated for 4 weeks,1 courses were observed.The patients in the two groups should not take drugs that affect the study during the observation period.The two groups of patients were performed routine blood routine,urine routine,stool routine+occult blood,liver function,renal function and electrocardiogram examination.After the course of treatment,the above items were reviewed.During the treatment,the patients’ adverse events were recorded and treated in time.At the end of the treatment,the scores of PSQI,ESS,SDS and SAS were evaluated in the two groups,and the efficiency was calculated.The data were statistically analyzed with SPSS17.0,and the results were P<0.5,indicating the statistical significance.Results:1.Comparison of sleep conditions After treatment,compared with before treatment,both the treatment group and the control group can improve PSQI,the PSQI(8.63±1.92)points in the treatment group and the PSQI(10.59±2.06)points in the control group.There was a very significant difference between the treatment group and the control group(P<0.01),and the treatment group improved sleep status better than the control group.2.Comparison of emotional status After treatment,compared with before treatment,bo th the treatment group and the control group can improve the patients’ depression and anxiety.The treatment group SDS(41.25 ± 3.72)points,the control group SDS(45.23± 2.85)points;treatment group SAS(41.33 ± 3.15)points,the control group SAS(44.63 ± 3.06)points.There was a difference between the treatment group and the control group(P<0.05).The treatment group improved the depression and anxiety mood of the patients better than the control group.3.Comparison of daytime sleepiness status After treatment,compared with before treatment,both the treatment group and the control group can improve daytime sleepiness,the treatment group ESS(9.67 ± 2.59)points,the control group ESS(11.47 ± 2.63)points.There was a very significant difference between the treatment group and the control group(P<0.01),and the treatment group improved daytime sleepiness better than the control group.4.Comparison of clinical curative effect,treatment group cured 9 cases(30%),markedly effective in 12 cases(40%),effective in 7 cases(23.33%),invalid in 2 cases(6.67%),effective rate 93.33%;control group cured 7 cases(23.33%),markedly effective in 10 cases(33.33%),effective in 8 cases(26.67%),invalid in 5 cases(16.66%),and effective rate(83.34%).After treatment,the total effective rate of the treatment group was higher than that of the control group,and the statistical analysis showed that there was a very significant difference in the total effective rate between the two groups(P<0.01).Conclusions:1.Gubenjiannao liquid combined with eszopiclone greatly improved the comprehensive efficacy of primary insomnia.2.Gubenjiannao liquid combined with eszopicione has a more obvious advantage in improving patients’ daytime sleepiness,shortening sleep time,improving sleep disorders,and reducing the use of hypnotic drugs.3.Gubenjiannao liquid combined with eszopiclone in the treatment of primary insomnia provides a reliable basis for the combination of traditional Chinese and Western medicine,and highlights the outstanding advantages of the combination of traditional Chinese and Western medicine.4.The safety evaluation of Gubenjiannao liquid is good,and is worthy of further clinical promotion and application. |