【摘要】：目的：通過(guò)使用“解郁安神湯”治療肝火擾心型失眠的隨機(jī)對(duì)照研究,觀察“解郁安神湯”的相關(guān)療效。方法：本研究按照非劣性檢驗(yàn)公式計(jì)算,共需要60例有效病例,考慮到隨訪過(guò)程中可能出現(xiàn)病例脫落,故將樣本量擴(kuò)大10%,按照納入標(biāo)準(zhǔn)篩選66例患者作為受試對(duì)象。試驗(yàn)采用完全隨機(jī)分組,應(yīng)用DPS2.0軟件指定試驗(yàn)樣本數(shù)66,分組數(shù)2,得到治療組和對(duì)照組相關(guān)的對(duì)應(yīng)編號(hào)。按照就診順序依次將符合納入標(biāo)準(zhǔn)的66例肝火擾心型失眠患者編號(hào),并依照軟件預(yù)先設(shè)計(jì)的分組結(jié)果納入到治療組和對(duì)照組中,每組33人。其中治療組服用“解郁安神湯”；對(duì)照組服用右佐匹克隆片,4周為一個(gè)療程,統(tǒng)計(jì)并觀察治療前后兩組PSQI評(píng)分和中醫(yī)癥候評(píng)分變化。結(jié)果：經(jīng)治療后兩組組內(nèi)在PSQI各成分及總分上較前對(duì)比均有顯著性差異(P0.01)。PSQI減分率方面,治療組有效率為83.3%,對(duì)照組有效率為93.3%,治療后兩組對(duì)比無(wú)統(tǒng)計(jì)學(xué)差異(P0.05)。治療組和對(duì)照組治療后PSQI各成分、總分組間對(duì)比無(wú)顯著性差異(P0.05)。在治療后的中醫(yī)證候總分評(píng)定中,兩組比較有顯著統(tǒng)計(jì)學(xué)差異(P0.01),治療組優(yōu)于對(duì)照組。在中醫(yī)證候的單癥狀評(píng)定中,治療組在多夢(mèng)、急躁易怒、胸脅疼痛、口干、小便黃赤的癥狀改善方面優(yōu)于對(duì)照組,結(jié)果具有統(tǒng)計(jì)學(xué)意義(P0.05),其中,在多夢(mèng)、急躁易怒、胸脅疼痛、小便黃赤的改善方面具有顯著統(tǒng)計(jì)學(xué)意義(P0.01),而在失眠的單項(xiàng)比較中兩組無(wú)統(tǒng)計(jì)學(xué)差異(P0.05)結(jié)論：解郁安神湯可以提高肝火擾心型失眠患者的睡眠質(zhì)量,縮短入睡時(shí)間,增加肝火擾心型失眠患者的睡眠時(shí)間,改善其睡眠效率、睡眠障礙及日間功能障礙,與右佐匹克隆有相近的療效。解郁安神湯在多夢(mèng)、急躁易怒、胸脅疼痛、口干、小便黃赤的中醫(yī)癥狀改善方面優(yōu)于右佐匹克隆。
[Abstract]:Objective: to observe the effect of Jieyu Anshen decoction on insomnia caused by liver fire. Methods: according to the formula of non-inferiority test, 60 effective cases were needed. Taking into account the possibility of cases falling off during the follow-up, the sample size was expanded by 10% and 66 patients were selected as subjects according to the inclusive criteria. The experiment was divided into complete random groups, 66 samples and 2 groups were assigned by DPS2.0 software. The corresponding numbers of the treatment group and the control group were obtained. According to the order of seeing a doctor, 66 cases of insomniacs with liver fire and heart disturbance were enrolled into the treatment group and the control group according to the pre-designed results of the software, with 33 patients in each group. The treatment group took "Jiayu Anshen decoction" and the control group took right zopicone tablet for a course of 4 weeks. The changes of PSQI score and TCM symptom score before and after treatment were statistically observed. Results: after treatment, there were significant differences in the components and total scores of PSQI between the two groups (P0.01). PSQI score reduction rate, the effective rate was 83.3% in the treatment group and 93.3% in the control group). There was no statistical difference between the two groups after treatment (P0.05). There was no significant difference in the components and total scores of PSQI between the treatment group and the control group (P0.05). In the total score of TCM syndromes after treatment, there was significant difference between the two groups (P0.01), the treatment group was better than the control group. In the single symptom evaluation of TCM syndromes, the treatment group was superior to the control group in the improvement of the symptoms of multiple dreams, irritability and irritability, chest and flank pain, dry mouth, and yellow red urine. The results were statistically significant (P0.05), among which, in many dreams, irritability and irritability, The improvement of chest and flank pain and urine yellow red were statistically significant (P0.01). There was no statistical difference between the two groups in the single comparison of insomnia (P0.05) conclusion: Jieyu Anshen decoction can improve the sleep quality of patients with insomnia caused by liver fire, shorten the time to sleep, increase the sleep time of patients with insomnia caused by liver fire. The improvement of sleep efficiency, sleep disorder and daytime dysfunction is similar to that of right zopicron. Jieyu Anshen decoction is superior to right Zopicron in improving TCM symptoms of dreamy, irritable, chest and flank pain, dry mouth and yellow red urine.
【學(xué)位授予單位】：成都中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2016
【分類號(hào)】：R256.23

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