【摘要】：目的：采用單盲隨機(jī)對(duì)照實(shí)驗(yàn)的方法,把納入病例分為穴位組(穴位針刺+艾司唑侖)和非穴位組(非穴位針刺+艾司唑侖),評(píng)估針刺結(jié)合艾司唑侖治療肝火擾心型原發(fā)性失眠的療效同時(shí)找出針刺穴位對(duì)比非穴位的療效差異為針刺臨床研究中安慰療法的設(shè)計(jì)提供參考依據(jù)。并探討這種療效的產(chǎn)生與心理指標(biāo)SAS、SDS評(píng)分改善的相關(guān)性。方法：1本次研究共納入68例患者,來(lái)自廣東省中醫(yī)院大德路總院傳統(tǒng)療法科均符合納入標(biāo)準(zhǔn)。運(yùn)用SAS統(tǒng)計(jì)軟件采用分層、區(qū)組隨機(jī)的方法,按病例分配數(shù)及兩組1：1的隨機(jī)比例生成隨機(jī)數(shù)字分組表進(jìn)行隨機(jī)分組。采用單盲隨機(jī)對(duì)照試驗(yàn)的方法把病例分為穴位組(穴位針刺+艾司唑侖)、非穴位組(非穴位針刺十艾司唑侖)。2、治療方法：穴位組(穴位針刺+艾司唑侖)：每日針刺穴位一次同時(shí)睡前給予1粒艾司唑侖；非穴位組(非穴位針刺+艾司唑侖)：每日針刺非穴位一次同時(shí)睡前給予1粒艾司唑侖。兩組治療時(shí)間均為4周。3、療效判定標(biāo)準(zhǔn)：治療前后均進(jìn)行主要指標(biāo)PSQI(匹茲堡睡眠質(zhì)量)量表,次要指標(biāo)SAS(焦慮自評(píng))量表、SDS(抑郁自評(píng))量表評(píng)價(jià)。4、復(fù)發(fā)率評(píng)價(jià)：治療結(jié)束后第2周、第4周進(jìn)行隨訪,若隨訪時(shí)點(diǎn)的PSQI量表總評(píng)分〉療程結(jié)束時(shí)的分值,視為復(fù)發(fā),并進(jìn)行X2檢驗(yàn)及Kaplan-Meier生存曲線分析。5、PSQI和相關(guān)心理指標(biāo)相關(guān)性分析：應(yīng)用Spearman相關(guān)計(jì)算分析心理指標(biāo)SDS、SAS量表和PSQI評(píng)分及其治療前后差值間的相關(guān)性。6、安全性比較：記錄每組治療期間出現(xiàn)的白天嗜睡、頭暈、頭痛等不適現(xiàn)象。結(jié)果：1 療效比較：1.1 總有效率穴位組總有效率95.2%,非穴位組總有效率90.0%。穴位組優(yōu)于非穴位組,經(jīng)X2檢驗(yàn)穴位組和非穴位組相比差異有統(tǒng)計(jì)學(xué)意義。1.2 PSQI量表1.2.1 組內(nèi)比較：治療4周后穴位組、非穴位組PSQI總評(píng)分與治療前相比均有顯著改善。治療4周后穴位組PSQI評(píng)分中日間功能評(píng)分較治療前有顯著改善。非穴位組日間功能評(píng)分較治療前雖有降低但差異無(wú)統(tǒng)計(jì)學(xué)意義(P＞0.05)。1.2.2 組間比較：治療4周后PSQI量表總評(píng)分穴位組顯著低于非穴位組。治療4周后PSQI量表中日間功能評(píng)分穴位組顯著低于非穴位組。1.2.3 組間差值比較治療4周前后PSQI總評(píng)分差值穴位組和非穴位組相比較高,且差異具有統(tǒng)計(jì)學(xué)意義。治療4周前后日間功能評(píng)分差值穴位組和非穴位組相比較高,且差異具有統(tǒng)計(jì)學(xué)意義。1.3 心理指標(biāo)(SAS量表、SDS量表)：1.3.1 組內(nèi)對(duì)比治療4周后,穴位組SAS評(píng)分較治療前顯著降低,非穴位組較治療前雖降低但差異無(wú)統(tǒng)計(jì)學(xué)意義(P0.05)。兩組SDS總評(píng)分與治療前相比均無(wú)顯著改善(P0.05)。1.3.2 組間對(duì)比治療4周后兩組SDS、SAS總評(píng)分兩兩比較差異無(wú)統(tǒng)計(jì)學(xué)意義。2 復(fù)發(fā)情況比較：經(jīng)X2分析及Kaplan-Meier檢驗(yàn),治療結(jié)束后第2周隨訪兩組相比差異無(wú)統(tǒng)計(jì)學(xué)意義(P＞0.05)。治療結(jié)束后第4周隨訪穴位組和非穴位組相比復(fù)發(fā)風(fēng)險(xiǎn)較低且差異有統(tǒng)計(jì)學(xué)意義。3心理指標(biāo)和PSQI量表及其療效相關(guān)性分析治療前抑郁自評(píng)量表(SDS)、焦慮自評(píng)量表(SAS)和睡眠質(zhì)量量表(PSQI)之間呈顯著正相關(guān)性,抑郁自評(píng)量表(SDS)和PSQI評(píng)分無(wú)顯著相關(guān)性(P0.05)。PSQI總分的改善和SAS評(píng)分的改善呈顯著正相關(guān)。4 安全性比較：治療期間穴位組1例患者出現(xiàn)輕度頭暈、嗜睡；非穴位組2例患者出現(xiàn)治療后服藥后輕度頭暈、嗜睡伴胃腸道不適,兩組比較差異無(wú)統(tǒng)計(jì)學(xué)意義。對(duì)上述患者進(jìn)行肝腎常規(guī)、血分析等檢查后無(wú)明顯異常,未發(fā)現(xiàn)與藥物有關(guān)和可能有關(guān)的嚴(yán)重不良反應(yīng),病人全身和局部耐受性好。結(jié)論：1 穴位組在改善睡眠質(zhì)量及日間功能障礙方面優(yōu)于非穴位組；在減少?gòu)?fù)發(fā)率方面也優(yōu)于非穴位組。2 睡眠質(zhì)量的改善與患者心理狀況密切相關(guān),兩組睡眠質(zhì)量的改善和焦慮傾程度的減輕有顯著相關(guān)性,和抑郁程度的改善無(wú)顯著相關(guān)性。
[Abstract]:Objective: The method of single-blind randomized controlled trial was used to divide the cases into the acupuncture point group (the acupuncture points of the acupuncture points of the acupuncture points) and the non-acupuncture point group (the non-acupuncture point acupuncture + eisphalan). To evaluate the effect of acupuncture on the treatment of primary insomnia of the heart-fire-disturbed heart-type primary insomnia, it is found that the difference of the curative effect of the acupuncture points on the non-acupuncture points is the reference for the design of the comfort therapy in the clinical study of acupuncture. The correlation between the results of this effect and the improvement of the psychological index SAS and SDS score was also discussed. Methods: A total of 68 patients were included in this study, from the traditional therapy section of the Dade Road General Hospital in the middle hospital of Guangdong Province. Using SAS statistical software, the random data packet table was randomly divided according to the number of cases and the random proportion of 1: 1 of the two groups. A single-blind randomized controlled trial was used to divide the cases into the acupuncture point group (the acupuncture points of the acupuncture points of the acupuncture points), and the non-acupuncture point group (the non-acupuncture point acupuncture + eisphalan). 2. The treatment method: the acupuncture point group (the acupuncture point acupuncture at the acupuncture point + elisphalan): The acupuncture points of each day and the acupuncture point of the acupuncture point were given 1 eesecilun in the same time, and the non-acupuncture point group (non-acupuncture point acupuncture + eisphalan): once daily acupuncture and non-acupuncture points, the acupuncture points were given 1 eesecilun before and after the same time. The treatment time of the two groups was 4 weeks. 3. The criteria for efficacy determination: the primary indexes PSQI (Pittsburgh sleep quality) scale, the secondary index SAS (anxiety self-evaluation) scale, the SDS (depression self-evaluation) scale and the recurrence rate evaluation were performed before and after the treatment. 4. The recurrence rate evaluation: the second week after the end of the treatment, Follow-up at week 4, if the score of the PSQI scale at the time of follow-up> the score at the end of the course of treatment is considered to be a recurrence, and the X2 test and the Kaplan-Meier survival curve analysis are performed. 5, PSQI and related psychometric correlation analysis: Spearman-related calculation and analysis of the psychological index SDS, The correlation between the SAS scale and the PSQI score and the difference between the pre-and post-treatment differences. 6. Comparison of safety: Record daytime sleepiness, dizziness, headache and other discomfort during each group of treatment. Results: 1. The total effective rate of the 1. 1 total effective acupoint group was 95.2%, and the total effective rate of the non-acupuncture point group was 90.0%. Compared with the non-acupuncture point group, the point group was better than that of the non-acupuncture point group. Compared with the non-acupuncture point group, the group of the acupoint group and the non-acupuncture point group had a statistically significant difference compared with that of the non-acupuncture point group. The score of the day function in the PSQI score of the acupoint group after 4 weeks of treatment was significantly improved before the treatment. The scores of the day function of the non-acupuncture point group were lower than that before treatment (P> 0.05). The comparison between the two groups: The total score of the PSQI scale after 4 weeks of treatment was significantly lower than that of the non-acupuncture point group. in that PSQI scale, the mean score of the day function score in the PSQI scale was significantly lower than that of the non-acupuncture point group. The results showed that after 4 weeks, the SAS score of the acupuncture point group was significantly lower than that before the treatment for 4 weeks after the treatment for 4 weeks after the treatment for 4 weeks. The non-acupuncture point group was lower than that before treatment (P0.05). There was no significant improvement in the total scores of SDS in the two groups (P0.05). There was no significant difference between the two groups after the end of treatment (P> 0.05). in that follow-up of the 4-week follow-up group and the non-acupuncture point group, the risk of recurrence was low and the difference was statistically significant. There was a significant positive correlation between the anxiety self-rating scale (SAS) and the sleep quality scale (PSQI), and there was no significant correlation between the self-rating scale (SDS) and the PSQI score (P0.05). The improvement of the total score of PSQI and the improvement of the SAS score were positively correlated. There were mild dizziness and somnolence in one patient in the acupuncture point group during the treatment period, and 2 patients with non-acupuncture point group had mild dizziness, lethargy and gastrointestinal discomfort after treatment, and the difference between the two groups was not statistically significant. The above-mentioned patients had no obvious abnormality after the examination of the liver and kidney, blood analysis, etc., and no serious adverse reactions related to the drug and possibly related were found, and the whole body and the local tolerance of the patient were good. Conclusion: 1 point group is superior to non-acupuncture point group in improving sleep quality and day function, and it is also superior to non-acupuncture point group in reducing the recurrence rate. The improvement of sleep quality is closely related to the psychological condition of the patient, and the improvement of the sleep quality and the reduction of the degree of anxiety of the two groups have a significant correlation. and there was no significant correlation between the degree of depression and the degree of depression.
【學(xué)位授予單位】：廣州中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2016
【分類(lèi)號(hào)】：R246.6

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