The Clinical Research On Insomnia Of Xin Pi Liang Xu Xing With An-shen-ke-li

Objectives: This topic focus on the An-Shen-Ke-Li, which is formed by changing the traditional medicine-Guipi Tang, through the comparison between curative effect of An-Shen-Ke-Li and Zao-Ren-An-Shen Capsule on the therapy of insomnia with Xin Pi Liang Xu, preliminary observe the clinic efficiency of An-Shen-Ke-Li. It makes full use of the advantages of the Chinese drug granule, explores a better therapy method, at the same time to provide reliable theory and clinical evidence for the development of An-Shen-Ke-Li.Methods: According to the visiting time, we randomly divided 60 patients who meet the standards into An-Shen-Ke-Li therapy group and Zao-Ren-An-Shen Capsule control group, 30 patients in each group. The therapy group was treated with An-Shen-Ke-Li and the control group was treated with Zao-Ren-An-Shen Capsule. Adopting the international PSQI, TCM syndrome, the relevant psychological observation index HAMA, HAMD and laboratory observation index CORT and ACTH 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:① Clinical Efficacy: The total effective rate of the therapy group was 85.71% and the control group is 74.07%, there was no statistically significant difference(p>0.05),comparing the two groups, which suggested that the efficacy of two drugs are almost the same.② Efficacy of TCM Syndrome: The total efficiency rate of the therapy group was89.29%,and therapeutic effect of the therapy group was significantly superior to that ofthe control group(p<0.01), which suggested that Traditional Chinese Medicine of An-Shen-Ke-Li is better than Zao-Ren-An-Shen Capsule in improving aspects of TCM syndrome.(2) Therapeutic index evaluation:① 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 time of initiating and maintaining sleep, 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 sleep disorders element(P<0.05 or P<0.01).② Evaluation of relevant psychological index: Before therapy, there were no significant difference between the two groups of HAMA and HAMD pretherapy(P>0.05). After therapy, there were significant difference between the two groups of scores for factors of HAMA and total score(P<0.05), among this, there were significant differences between somato-factor score and total score among them(P<0.01). There were significant difference among the anxiety factor score, cognition factor score, tissue factor score, sleep factor score, hopelessness factor score and the total score except weight factor and circadian factor(P<0.05), the anxiety factor score and the total score had extremely difference among them(P<0.01). Before and after therapy, the therapy group had extremely difference among the factors of HAMA score and the total score except circadian factor score(P<0.01). About the HAMD, the total score of HAMD and each elements score had extremely difference with each other(P<0.01). Before and after therapy, the control group had extremely difference among the factors of HAMA score and the total score(P<0.01). About the HAMD, there had significant difference among the anxiety factor score, sleep factor score and the total score(P<0.01).③ TCM Syndrome Score: There was no obvious difference between the two groups of TCM syndrome factor score and total score pretherapy(P>0.05). After therapy, there were significant differences between the two groups of TCM syndrome factor score and total score(P<0.05). Before and after therapy, the therapy group had extremely difference among the factors of TCM syndrome score and the total score(P<0.01).Before and after therapy, the control group had very obvious improvement on dreaminess and festless sleep, cardiopalmus and amnesia, fatigued spirit and malaise 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<0.05).④ Observation of Laboratory Index: There was no obvious difference between the two groups of CORT and ACTH pretherapy(P>0.05). After therapy, there had extremely difference between the two groups of CORT and ACTH(P<0.01). Before and after therapy, the therapy group had extremely difference on CORT and ACTH(P<0.01). It proved that after therapy, with the improvement of sleep quality, the CORT and ACTH decreased for both control group the therapy group. To some extent, CORT and ACTH had relations with sleep quality.Conclusion: An-Shen-Ke-Li can improve the patients’ sleeping situation effectively,and the clinical efficiency was almost the same with Zao-Ren-An-Shen Capsule. On improvement of TCM syndrome and sleep quality, it was better than Zao-Ren-An-Shen Capsul. An-Shen-Ke-Li doesn’t have obvious toxicity and side effects, therefore, it’s worthy of clinical application.