滋养肝肾法加针灸治疗围绝经期妇女失眠症的临床对照研究

【作者】 赵云安；

【导师】 王小云；

【作者基本信息】 广州中医药大学 ， 中医妇科学， 2010， 博士

【摘要】 研究背景围绝经期是妇女由中年向老年过渡时期,由于卵巢功能衰退,雌激素分泌减少,使神经系统功能和精神稳定性减退,对外环境的适应性能力降低,对各种精神因素和躯体疾病较敏感,耐受力很差,出现自主神经和性腺内分泌功能失调的一系列症状,病初多表现为失眠多梦、头晕头痛、烘热汗出、月经紊乱、周身不适、乏力等,以后逐渐发展可出现忧郁、焦虑、猜疑等。在疾病发展的过程中,「失眠」往往是患者最为关注的病证,而且往往是诸多症状伴发失眠,失眠又加重诸多症状,给患者造成极大的躯体不适和精神痛苦。所以围绝经期诸症中,失眠症的治疗尤为重要。因此围绝经期失眠的治疗愈发显得重要。现代医学治疗失眠采用睡眠诱导剂或镇静催眠药,虽然起效快,作用强,但存在一定的副作用,潜在的成瘾性和反弹性,影响患者正常的工作和学习；心理治疗亦是常见方法方一,但因个性化的不同原因,疗效稳定性不高,推广亦难。为此很多患者现常求助于中医中药的治疗,以达到改善失眠的症状,提高睡眠质量失眠症属于中医“不寐”的范畴,中医通过总体医疗、辩证论治,确切的发挥了中医药的优势,且疗效稳定,不易复发,无成瘾性,患者较易接受。本研究就是论证比较中药更年安神散加针灸治疗此病的确切疗效和安全性。研究目的本研究采用中药「更年安神散」加针灸治疗围绝经期妇女失眠症,观察「更年安神散」治疗围绝经期妇女失眠症的临床有效性和安全性,望能提高临床治疗效果便于临床推广应用；另加针刺组比较其治疗效果,探讨「更年安神散」加针刺治疗围绝经期妇女失眠症的可能作用机理；观察PSQI量表作为围绝经期妇女失眠症的临床疗效评价指标之可能性。研究方法本研究采用随机对照的临床试验设计,选择2009年8日至2010年2月香港赵云安中医诊所门诊就诊符合纳入标准之围绝经期失眠症妇女90人,利用简单化随机分组的方法分为A、B、C三组,A組爲针灸組(补「阴足乔」泻「阳足乔」方法)。B組爲中药組(口服更年安神散组)。C組爲中药加针灸组,共觀察90例,每組30例。A、B组各自口服更年安神散治疗8周,其中C组针药并用,各分别在治疗前、治疗后8周后进行观察中医症候记分、匹兹堡睡眠质量量表(PSQI)评分：并在治疗前后检测患者的心率、血压、血、尿、便常规和肝肾功能等一般安全性项目,填写观察表,记录不良反应。研究結論结果显示：治疗C組(中药加针灸组)的中医证候、PSQI量表、表评分均优于A、B对照组。中药(更年安神散组)加针灸组不仅具有良好的镇静安神作用,而且能改善围绝经期妇女失眠患者伴发的各种失眠多梦、头晕头痛、烘热汗出、心烦易怒、心悸不安、月经紊乱、耳鸣、健忘等症状本论文旨在通过探讨中药及灸刺或联合疗法,在临床上治疗围绝经期妇女失眠症的疗效差异,为防治围绝经期妇女的失眠症提供新的思路和更有效的方法更多还原

【Abstract】 BackgroundPerimenopause is a period of transition that women of middle-aged go into the elderly. Due to the functional decline of ovarian and low estrogen levels, the function of nervous system and mental stability decrease and adaptive capacity to external environment decline; patients will be more sensitive to psychological factors and physical diseases with poor tolerance, series of symptoms of endocrine disorders of autonomic nervous and gonads.The first symptoms are often insomnia accompanied by frequent dream, dizziness and headache, hot flashes and sweating, menstrual disorders, the whole body discomfort, fatigue, etc., and which can develop into depression, anxiety, suspicion and so on. In the course of development of the disease, insomnia is often the most concerned for patients, and other symptoms are usually accompanied by insomnia which in turn, can aggravate other symptoms even further. These cause significant physical discomfort and mental anguish to patients. Therefore, the treatment of insomnia becomes especially important. In modern medicine, sleep inducer and sedative-hypnotic drugs are often used in treatment of insomnia which have quick and strong effect but also with certain side effects, potential addiction and rebound which will affect patients’ normal work and study. Psychotherapy is also a common method, but because of the different reasons of personalization, the efficacy is not so stable and the method is difficult to promote. So now, many patients turn to ask help from Chinese medicine to relieve insomnia and improve sleep quality. TCM brings its superiority into full play through concept of wholism and syndrome differentiation, and it has stable curative effect with hard recurrence, no addiction and it is more acceptable to patients. This research is to demonstrate and compare the exact curative effect and safety of Chinese herbs Gengniananshensan combined with acupuncture in treating this disease.PurposeThis research uses Chinese herbs Gengniananshensan combined with acupuncture to treat women’s insomnia in perimenopause and observe its clinical effectiveness and safety, and hope to improve the clinical results and make the application and extension in clinic be more convenient. Otherwise, acupuncture group was added to compare the therapeutic effect and probable mechanism. At last, it observed the possibility for PSQI Scale as evaluation index of clinical effect to the insomnia in perimenopause.MethodsThis research use clinical trial design of randomized control. Ninety women with insomnia in perimenopause who were accorded with the inclusive criteria from August, 2009 to February,2010 in doctor Zhao Yunan’s clinic were randomly divided into three groups, and every group had 30 patients. Group A use acupuncture (supplying Yinzuqiao and reducing Yangzuqiao); Group B use Chinese herbs (Gengniananshensan); Group C use Gengniananshensan combined with acupuncture. The treatments all sustained 8 weeks. TCM symptoms score, PSQI score were observed, and the patients’general safety test such as HR, BP, blood routine test, urine routine, stool routine, liver and kidney function, etc. and adverse reactions were recorded respectively before and after the treatments..ResultsThe results showed that TCM symptoms score, PSQI score in group C is better than those in other two groups. Treatment of Chinese herbs combined with acupuncture had not only good effect on sedation and tranquilization, but also on improving varieties of symptoms such as fantod and inquietude, insomnia accompanied with frequent dream, dizziness, headache, hot flushes and sweating, vexation and irritable, palpitations and anxiety, menstrual disorders, tinnitus, forgetfulness, and so on.This article aims to provide new ideas and more effective ways for preventing and treating insomnia of women in perimenopause through discovering and discussing the differences in curative effect among Chinese herbs, acupuncture, or combination therapies in clinic.更多还原