穴位与非穴位对比治疗肝火扰心型原发性失眠的临床研究

发布时间：2018-11-11 01:34

【摘要】：目的：采用单盲随机对照实验的方法,把纳入病例分为穴位组(穴位针刺+艾司唑仑)和非穴位组(非穴位针刺+艾司唑仑),评估针刺结合艾司唑仑治疗肝火扰心型原发性失眠的疗效同时找出针刺穴位对比非穴位的疗效差异为针刺临床研究中安慰疗法的设计提供参考依据。并探讨这种疗效的产生与心理指标SAS、SDS评分改善的相关性。方法：1本次研究共纳入68例患者,来自广东省中医院大德路总院传统疗法科均符合纳入标准。运用SAS统计软件采用分层、区组随机的方法,按病例分配数及两组1：1的随机比例生成随机数字分组表进行随机分组。采用单盲随机对照试验的方法把病例分为穴位组(穴位针刺+艾司唑仑)、非穴位组(非穴位针刺十艾司唑仑)。2、治疗方法：穴位组(穴位针刺+艾司唑仑)：每日针刺穴位一次同时睡前给予1粒艾司唑仑；非穴位组(非穴位针刺+艾司唑仑)：每日针刺非穴位一次同时睡前给予1粒艾司唑仑。两组治疗时间均为4周。3、疗效判定标准：治疗前后均进行主要指标PSQI(匹兹堡睡眠质量)量表,次要指标SAS(焦虑自评)量表、SDS(抑郁自评)量表评价。4、复发率评价：治疗结束后第2周、第4周进行随访,若随访时点的PSQI量表总评分〉疗程结束时的分值,视为复发,并进行X2检验及Kaplan-Meier生存曲线分析。5、PSQI和相关心理指标相关性分析：应用Spearman相关计算分析心理指标SDS、SAS量表和PSQI评分及其治疗前后差值间的相关性。6、安全性比较：记录每组治疗期间出现的白天嗜睡、头晕、头痛等不适现象。结果：1 疗效比较：1.1 总有效率穴位组总有效率95.2%,非穴位组总有效率90.0%。穴位组优于非穴位组,经X2检验穴位组和非穴位组相比差异有统计学意义。1.2 PSQI量表1.2.1 组内比较：治疗4周后穴位组、非穴位组PSQI总评分与治疗前相比均有显著改善。治疗4周后穴位组PSQI评分中日间功能评分较治疗前有显著改善。非穴位组日间功能评分较治疗前虽有降低但差异无统计学意义(P＞0.05)。1.2.2 组间比较：治疗4周后PSQI量表总评分穴位组显著低于非穴位组。治疗4周后PSQI量表中日间功能评分穴位组显著低于非穴位组。1.2.3 组间差值比较治疗4周前后PSQI总评分差值穴位组和非穴位组相比较高,且差异具有统计学意义。治疗4周前后日间功能评分差值穴位组和非穴位组相比较高,且差异具有统计学意义。1.3 心理指标(SAS量表、SDS量表)：1.3.1 组内对比治疗4周后,穴位组SAS评分较治疗前显著降低,非穴位组较治疗前虽降低但差异无统计学意义(P0.05)。两组SDS总评分与治疗前相比均无显著改善(P0.05)。1.3.2 组间对比治疗4周后两组SDS、SAS总评分两两比较差异无统计学意义。2 复发情况比较：经X2分析及Kaplan-Meier检验,治疗结束后第2周随访两组相比差异无统计学意义(P＞0.05)。治疗结束后第4周随访穴位组和非穴位组相比复发风险较低且差异有统计学意义。3心理指标和PSQI量表及其疗效相关性分析治疗前抑郁自评量表(SDS)、焦虑自评量表(SAS)和睡眠质量量表(PSQI)之间呈显著正相关性,抑郁自评量表(SDS)和PSQI评分无显著相关性(P0.05)。PSQI总分的改善和SAS评分的改善呈显著正相关。4 安全性比较：治疗期间穴位组1例患者出现轻度头晕、嗜睡；非穴位组2例患者出现治疗后服药后轻度头晕、嗜睡伴胃肠道不适,两组比较差异无统计学意义。对上述患者进行肝肾常规、血分析等检查后无明显异常,未发现与药物有关和可能有关的严重不良反应,病人全身和局部耐受性好。结论：1 穴位组在改善睡眠质量及日间功能障碍方面优于非穴位组；在减少复发率方面也优于非穴位组。2 睡眠质量的改善与患者心理状况密切相关,两组睡眠质量的改善和焦虑倾程度的减轻有显著相关性,和抑郁程度的改善无显著相关性。
[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.
【学位授予单位】：广州中医药大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R246.6

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