| Objectives:This research through compare between curative effect of Fu-Fang-Zao-Ren-An-Shen Capsule and Dexzopiclone on the therapy of insomnia with Xin Gan Xue Xu, preliminary observe the clinic efficiency of Fu-Fang-Zao-Ren-An-Shen Capsule. It makes full use of the advantages of The first affiliated hospital of anhui university of Traditional Chinese Medicine's preparations. explores a better therapy method, at the same time provide some theoretical basises for clinical application and further promotion of Fu-Fang-Zao-Ren-An-Shen capsule.Methods:According to the visiting time, we randomly divided 60 patients who meet the standards into Fu-Fang-Zao-Ren-An-Shen Capsule therapy group and Dexzopiclone control group,30 patients in each group. The therapy group was treated with Fu-Fang-Zao-Ren-An-Shen Capsule and the control group was treated with Dexzopiclone. Adopting the international PSQI, TCM syndrome, the relevant psychological observation index HAMA, HAMD and laboratory observation index 5-HT as observational indexes, we make comparisons of the self-control before and after therapy, and also between the two groups after therapy, then evaluate the improvements of sleeping for both groups.Results:(1) Clinical Assessment:? Clinical Efficacy:The total effective rate of the therapy group was 86.67%and the control group was 76.67%, there was no statistically significant difference(.P>0.05), comparing the two groups, which suggested that the efficacy of two groups are almost the same.? Efficacy of TCM Syndrome:The total efficiency rate of the therapy group was 90%.It was higher than the control group 53.33%,and therapeutic effect of the therapy group was significantly superior to that of the control group (P?0.01), which suggested that Fu-Fang-Zao-Ren-An-Shen Capsule is better than Dexzopiclone in improving aspects of TCM syndrome.(2) Therapeutic index evaluation:? The total score of PSQI and scores of each elements:There were no significant difference between the two groups of PSQI score and total score on pretherapy (P>0.05). After therapy, there were significant difference between the two groups of PSQI score and total score (P?0.05), the Sleep quality?sleep efficiency?time of initiating? maintaining sleep and the total score of PSQI had extremely difference among them (P?0.01). Before and after therapy, the therapy group has different degrees advance on the total score of PSQI and scores of each elements (P?0.05 or P?0.01). Before and after therapy, the control group has different degrees advance on the total score of PSQI and scores of each elements only except daytime function element (P?0.05 or.P?0.01).? Evaluation of relevant psychological index:Before therapy, two groups of patients with HAMA, HAMD scores showed no significant difference (P>0.05); after therapy, two groups of patients with HAMA total score difference is very significant (P?0.01), there is statistical significance; two groups of patients with HAMD total score difference is very significant (P?0.01), there is statistical significance; before and after therapy in treatment group, the score of HAMA has significant difference (P?0.01) and was statistically significant; HAMD total score was statistically significant (P?0.01), was statistically significant; contrast group before and after therapy, the score of HAMA has significant difference (P?0.01), with statistical significance; there were significant differences in the scores of HAMD (P?0.01), statistical significance.? TCM Syndrome Score:Before treatment, two groups of patients with traditional Chinese medicine symptom scores and total scores showed no significant difference (P> 0.05); after therapy, two groups of TCM syndromes in patients with each factor score and total score were statistically significant (P?0.05 or P?0.01); treatment group before and after therapy, TCM syndromes of each factor score and total score were significantly improved (P?0.01); contrast group before and after therapy, only in difficulty falling asleep, easy to wake up, palpitations forgetful, hot, look ghastly pale and total score were improved in different degrees (P?0.05 or P?0.01); The therapy group had superior improvement on TCM syndrome score than the control group (P?0.01).? Observation of Laboratory Index:There was no obvious difference between the two groups of 5-HT pretherapy (P>0.05). After therapy, there had extremely difference between the two groups of 5-HT (P?0.01). Before and after therapy, the therapy group had extremely difference on 5-HT (P?0.01). Before and after therapy, the control group had extremely difference on 5-HT also(P<0.01). It proved that after therapy, with the improvement of sleep quality, the 5-HT was increased for both control group and therapy group. To some extent,5-HT had relations with sleep quality.Conclusion:Fu-Fang-Zao-Ren-An-Shen Capsule can effectively improve sleep status, and the clinical efficiency was almost the same with Dexzopiclone. On improvement of TCM syndrome and sleep quality, it was better than Dexzopiclone. Fu-Fang-Zao-Ren-An-Shen Capsule doesn't have obvious toxicity and side effects, therefore, it's worthy of clinical application. |
PDF Full Text Request