原络配穴为主针药结合治疗心肾不交型失眠症的临床研究
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摘要
保证充足的睡眠是国际社会公认的三项健康标准之一,睡眠是机体自身保护性抑制过程,神经细胞长期处于活跃状态可因能量过度消耗而出现功能衰竭,充足的睡眠则可以避免这一情况的发生,且能够恢复疲劳的神经细胞的正常生理功能。7至8小时的正常睡眠时间,是正常成年人所必须的。然而随着日益激烈的社会竞争,工作和生活压力不断增大,失眠的发病率与日俱增。在传统医学中,失眠称之为“不寐”,也被称为“不得卧”、“目不瞑”、“不得眠”、“卧不安”、“卧不得安”、“夜不瞑”等。失眠不仅影响个人日常生活,也导致社会工作效率下降,同时也加剧医疗费用负担。当今社会,失眠症已成为许多国家广泛关注的公共卫生问题。
     目的:
     本课题采用随机对照研究,观察原络配穴疗法为主针药结合治疗心肾不交型失眠症的临床疗效,旨在评价以原络配穴法为指导,辅以中药六味地黄丸合交泰丸内服,针药结合疗法治疗心肾不交型失眠症的临床疗效及探讨其作用机理,为临床治疗心肾不交型失眠症提供依据保证充足的睡眠是国际社会公认的三项健康标准之一,睡眠是一种保护性抑制过程,避免神经细胞过度消耗而导致功能衰竭,使疲劳的神经细胞恢复正常的生理功能。成人每天正常的睡眠时间为7-8小时,但随着社会竞争日益激烈,工作和生活节奏加快,失眠的发病率呈现不断增加的趋势。在传统医学中,失眠称之为“不寐”,也被称为“不得卧”、“目不瞑”、“不得眠”、“卧不安”、“卧不得安”、“夜不瞑”等。失眠不仅影响个人日常生活,也导致社会工作效率下降,同时也加剧医疗费用负担。当今社会,失眠症已成为许多国家广泛关注的公共卫生问题。
     本课题采用随机对照研究,观察原络配穴疗法为主针药结合治疗心肾不交型失眠症的临床疗效,旨在评价以原络配穴法为指导,辅以中药六味地黄丸合交泰丸内服,针药结合疗法治疗心肾不交型失眠症的临床疗效及探讨其作用机理,为临床治疗心肾型失眠提供依据。方法:
     研究对象选取2011年2月至2012年3月期间在台湾土城市易元堂中医诊所接受治疗的门诊病人为研究的目标人群,将其中符合病例筛选标准的90例心肾不交型失眠症患者,按1:1:1的比例随机分配至综合疗法组(A组)、原络配穴疗法组(B组)中药组(C组),每组各有30例。综合疗法组选用原络配穴为主的针刺疗法结合六味地黄丸合交泰丸科学中药方剂内服,并与原络配穴疗法组和中药组对照,4周为一疗程,共治疗一个疗程。治疗后统计患者PSQI评分及SF-36评分,以及睡眠质量分级情况,并统计临床疗效。
     结果:
     本研究采用随机对照试验方法进行临床试验,共有合格受试者90例。随机分为ABC三组,每组各30例患者。三组可比性比较:年龄、性别、病程、及治疗前PSQI和SF-36评分,以及睡眠质量分级情况,差异均无显著性意义(P>0.05),三组间的一般资料具有可比性。
     1.PSQI评分比较:治疗前三组患者PSQI评分比较差异无统计学意义(P>0.05),具有可比性。经一个疗程治疗后,三组患者PSQI较治疗前均有明显下降,经统计学分析,三组评分差异有统计学意义(P<0.01)。进一步进行两两比较,A组与B组评分差异具有统计学意义(P<0.01);A组与C组评分差异具有统计学意义(P<0.01);B组与C组评分差异不具有统计学意义(P>0.05)。上述结果提示,经不同治疗方案后,综合疗法相较于单纯原络配穴疗法组和中药组更能显著降低失眠患者PSQI评分,综合疗法在降低患者PSQI评分方面具有更好疗效。
     2.SF-36评分比较:治疗前三组患者SF-36评分比较,差异无统计学意义(P>0.05),具有可比性。经一个疗程治疗后,三组患者SF-36较治疗前均有明显提高,经统计学分析,三组评分差异有统计学意义(P<0.01)。进一步进行两两比较,A组与B组评分差异具有统计学意义(P<0.01);A组与C组评分差异具有统计学意义(P<0.01);B组与C组评分差异不具有统计学意义(P>0.05)。上述结果提示,经不同治疗方案后,综合疗法相较于单纯原络配穴疗法组和中药组更能显著提高失眠患者SF-36评分,综合疗法在提高患者SF-36评分方面具有更好疗效。
     3.睡眠质量分级比较:三组患者治疗前睡眠质量分级比较,差异无统计学意义(P>0.05),具有可比性。经一个疗程治疗后,三组患者睡眠质量分级情况明显改善,A组Ⅰ-Ⅱ级17人,Ⅲ级2人,Ⅳ-Ⅴ级1人;B组Ⅰ-Ⅱ级15人,Ⅲ级4人,Ⅲ-Ⅴ级1人;C组Ⅰ-Ⅱ级10人,Ⅲ级8人,Ⅲ-Ⅴ级2人。经Ridit分析,差异有统计学意义(P<0.05)。结果提示综合疗法能显著改善患者睡眠质量。
     4.临床疗效上:A组临床痊愈10例,显效10例,有效7例,无效3例;B组临床痊愈8例,显效10例,有效7例,无效5例;C组临床痊愈6例,显效8例,有效9例,无效7例;A组总有效率90.0%,B组总有效率83.4%,C组总有效率76.6%,经Ridit分析,差异有统计学意义(P<0.05)。
     结论:
     本研究提示,综合疗法组即原络配穴疗法为主结合中药疗法,可以显著降低患者PSQI评分,提高SF-36评分,改善睡眠质量分级,与单纯原络配穴疗法及中药方剂内服疗法相比,具有良好的临床疗效。
The international community has acknowledged that sufficient sleep is one of key element for three health standards. Sleep is an important protection mechanism for nerve cell. It can avoid high consumption of energy which will contribute to cell dysfunction and failure. Enough sleep is helpful for the recovery of physiological function. The normal morpheus of the adult is7to8hours. With the increasingly competitive of society, the living rhythm guicken, the disease incidence rate of insomnia has been on the rise. In the traditional Chinese, insomnia is also called sleeplessness. Insomnia is not only influencing the daily life, depression work efficiency, but also increasing the medical burden. In modern society, insomnia has been the focus of the world's public health problem.
     Objective
     this study adapted randomly compared researching method. To observe the therapeutic effect, we applied the needle medicine combination therapy for the insomnia patients which diagnosed with the TCM syndrome (imbalance between heart-yang and kidney-yin) study the mechanism of this method and Provide theoretical basis for its clinical application.
     Methods
     duiring the period of2011/2to2012/3. we selected90insomnia patients who accepted treatment in Taiwan Tucheng city Yi-Yuan Hall Traditional Chinese medicine clinic, randomly divided the cases into a intergration therapeutics group、a Yuan-Luo point compatibility group and a Chinese medicine group.30cases in each group. The intergration therapeutics group treated with acupuncture method which based on Yuan-Luo point compatibility, combined with TCM prescription Liuwei Dihuan JiaoTai TCM Prescription. A4weeks course of treatment, and then recorded the PSQI scores and SF-36scores、morpheus quality grading. We assessed the difference of the treatment effect of the three groups by SPSS software statistics.
     Results
     This study designed a randomized, controlled trial. There were90el igible subjects. And each group30cases. three groups of patients in sex, age and so on basic situation aspect comparison, difference non-statistics significance, P>0.05.
     1according to the PSQI scores, the three groups before treatmen was no significant difference (P>0.05). After the treatment, the PSQI score of the three groups were decreased. And the difference was significant (P<0.05). the multiple comparisons showed that, there was significant difference between A and B group, A and C groups (P<0.05). But B and C groups had no statistical significance (P>0.05). therefore the intergration therapeutics group was more effective than the other two groups in decreasing the PSQI scores.
     2according to the SF-36scores, the three groups before treatmen was no significant difference (P>0.05). After the treatment, the SF-36score of the three groups were increased. And the difference was significant (P<0.05). the multiple comparisons showed that, there was significant difference between A and B group, A and C groups (P<0.01). But B and C groups had no statistical significance (P>0.05). therefore the intergration therapeutics group was more effective than the other two groups in decreasing the SF-36scores.
     3according to morpheus quality grading, the three groups before treatmen was no significant difference (P>0.05). After the treatment, the morpheus quality grading changed. And there's remarkable significance of three groups (P<0.05), therefore the intergration therapeutics was more effective in the sleep quality improvements.
     4the clinical effect of the three groups werevcompared, in intergration therapeutics group, the effective rate was90.0%, whi le83.4%of Yuan-Luo group point compatibility group, normal acupuncture group was76.60%, the curative effect of the intergration therapeutics group was better than others (P<0.05).
     Conclusion
     In the study, the comprehensive treatment methods can remarkable decrease the PSQI scores, increase the SF-36scores, improve the morpheus quality, and the comparison proved the curative effect in the intergration therapeutics group was better than the other two group. The conclusion show that this therapy has a good curative effect and a very good application foreground.
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