| Objective:To evaluated the effectiveness and safety of xiaochaihu decoction combined with mirtazapine in treating chronic insomnia.Methods:Select Navy General Hospital outpatient service 76 cases of patients with chronic insomnia, using randomized controlled principle,It can be divided into two groups, treatment group (38 cases) shall be xiaochaihu decoction combined mirtazapine treatment, control group (38 cases) which can be xiaochaihu decoction, the intervention took 8 weeks.Before and after treatment, respectively,2,4,6, and 8 weekend with Pittsburgh sleep quality index (PSQI) scale, TCM symptom scale for the evaluation of curative effect, and to evaluate the adverse event symptoms scale (TESS).Result:1. The study included 76 patients, treatment group fell off 2 cases, control group fell off 6 cases, finally 36 cases were included in the treatment group, and 32 cases in the control group.2. After 8 weeks treatment,19 cases has cured in the treatment group (52.78%),3 cases were markedly improved (8.33%), the total effective rate was 88.89%; Control group has 6 cases (18.75%),1 case (3.13%) had marked effect, the total effective rate was 68.76%, after statistics processing, the clinical total effective rate in treatment group (p< 0.05), the cure rate (p<0.01) were better than that in control group.3. During 8 weeks, two groups of curative effect are the extension of treatment and improve, in the treatment group work faster, better curative effect. Two groups before treatment was no statistically significant difference PSQI scale score (p> 0.05), after 4 and 8 weekend the PSQI scores were significantly lower than control group (p< 0.05). Two group markedly effective rate also started showing 4 weekend (30.56%vs9.38%) (p< 0.05), treatment (44.44%vs12.50%),86 weekend weekend (61.11% vs21.88) significant difference (P<0.01).4. After 8 weeks treatment, two groups of patients with total sleep time, sleep efficiency has increased,sleep latency, awakening times are reduced, but the index in treatment group improved better, compared two groups was statistically significant difference (p< 0.05), the treatment group total sleep time increase for 152 min, sleep efficiency increased by 29%, shorten sleep time 46 min, awakening times reduced to 0 and 1.5. After 8 weeks treatment, two groups of patients with TCM syndrome scale score was decreased, the difference was statistically significant (p< 0.05).8 week latet, the treatment group was (9.31+2.75) points vs control group(10.84+2.88), there was no statistically significant difference (p> 0.05).6. After 8 weeks treatment, the treatment group dry mouth(mouth bitter) (26/4), dizziness (17/2), loss of appetite (23/0), stool irregularities (20/1), irritability (30/0), and other symptoms improved significantly, which compared with the control group before and after treatment in defecate (95%vs31.58%), loss of appetite (100%vs43.75%), emotional (100%vs74.07%), and other aspects of the improvement is obvious (p< 0.01).7. Two groups of patients before and after treatment the blood routine, urine routine, liver function, renal function, the results are normal, the treatment group TESS scale score (4.07 ± 1.14), the control group (3.55±0.87) points, according to the t-test, the two groups has no statistical significance (p> 0.05).Conclusion:Xiaochaihu decoction combined with mirtazapine can be the good choice to treat the adults chronic insomnia, and also the simultaneous phenomenon. It reliable curative effect, high safety, also with the value of clinical promotion. |
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