路氏润燥汤联合针刺疗法治疗原发性干燥综合征106例眼干症状增效研究
本文选题:路氏润燥汤 + 原发性干燥综合征 ; 参考:《北京中医药大学》2016年硕士论文
【摘要】:原发性干燥综合征(Primary sjogren's syndrome,pSS)是一种以侵犯泪腺、唾液腺等外分泌腺体,具有淋巴细胞浸润和特异性自身抗体(抗SSA/SSB)为特征的弥漫性结缔组织病。临床上主要表现为干燥性角结膜炎、口腔干燥症、反复腮腺肿大、关节疼痛等,还可累及其他多个器官而出现肾功能不全、肺间质纤维化等复杂的临床表现。目前,现代医学对本病的发病机制尚不明确,治疗上也无特效疗法及药物,临床常用疗法有:替代治疗(人工泪液、人工唾液等)和系统治疗(糖皮质激素类、免疫抑制剂类药物),现有疗法对患者的症状缓解作用有限,且长期疗效不佳,全身性副作用大。中医治疗本病有可明显缓解症状,且副作用小、应用安全的优势特点,探索、规范本病的中医疗法十分必要。国医大师路志正教授首创"燥痹"的病名,并将原发性干燥综合征纳入其中。路志正教授结合自身多年临床经验,总结出本病"气阴两虚、瘀血阻络"的基本病机,并创立"益气养阴,润燥通络"的治疗原则,自拟"路氏润燥汤",并配合经验组穴,以治疗本病。目的:评价路氏润燥汤治疗气阴两虚、瘀血阻络型原发性干燥综合征患者眼干症状的疗效及联合针刺疗法对疗效的增加作用。同时评价路氏润燥汤及针刺疗法的临床应用价值。方法:本项研究收录符合纳入标准的原发性干燥综合征气阴两虚、瘀血阻络型患者106例,将所纳入的病例随机分为治疗组和对照组,每组53例。治疗组以路氏润燥汤为基本方随证加减并联合针刺疗法治疗受试者,对照组予路氏润燥汤为基本方随证加减汤剂治疗,两组患者总疗程均为3个月。采用随机、单盲、对照、前瞻性临床试验方法,分别于治疗0、1、2、3、4、8、12周时评价受试者的临床疗效与安全性指标,并于第0、12周评价实验室检查指标,以评价路氏润燥汤联合针刺疗法的疗效和安全性。结果:(1)路氏润燥汤联合针刺疗法治疗及路氏润燥汤单方治疗,对于受试者眼干症状均有缓解效果。且路氏润燥汤联合针刺疗法对于症状的改善更为快速、显著。且随治疗时间延长,疗效呈持续增加趋势。(2)路氏润燥汤联合针刺疗法及路氏润燥汤单方均可改善原发性干燥综合征患者吸墨试验结果,即对患者的泪腺分泌功能有改善作用。(3)路氏润燥汤联合针刺疗法治疗及路氏润燥汤单方治疗,对于受试者中医整体证候均有缓解效果。且路氏润燥汤联合针刺疗法更加快速、显著地改善了受试者的中医整体证候。且随治疗时间延长,疗效呈持续增加趋势。(4)在路氏润燥汤及针刺疗法的安全性评价方面,治疗期间无血液系统受损、肝肾功能受损等不良反应发生,表明路氏润燥汤及针刺疗法安全可靠。结论:本次研究体现了路氏润燥汤治疗原发性干燥综合征的显著临床疗效,及方药联合针刺疗法对临床疗效的增加作用。治疗可有效缓解受试者的眼干症状,改善受试者的泪腺分泌功能,并可降低受试者的病情活动度指标。治疗过程中对受试者的安全性指标无不良影响。本疗法有较大的临床推广价值。
[Abstract]:Primary sjogren's syndrome (pSS) is a diffuse connective tissue disease characterized by infiltration of the lacrimal gland, salivary glands, lymphocytic infiltration and specific autoantibodies (anti SSA/SSB). The main manifestations are dry keratoconjunctivitis, oral desiccation, repeated parotid enlargement, and joint pain. There are complicated clinical manifestations of renal insufficiency and pulmonary interstitial fibrosis in other organs. At present, the pathogenesis of the disease is not clear, there is no special treatment and drugs in the treatment of modern medicine. The common clinical treatments are replacement therapy (artificial lacrimal fluid, artificial saliva, etc.) and systematic therapy (glucocorticoids, exempts) The current therapy has limited effect on relieving the symptoms of the patients, and the long-term effect is poor and the systemic side effects are large. Traditional Chinese medicine treatment of this disease can obviously alleviate the symptoms, and the side effects are small. It is necessary to explore and standardize the traditional Chinese medicine therapy of this disease. Professor Lu Zhizheng of the Chinese medicine is the first to create a "dry arthralgia" disease. According to his years of clinical experience, Professor Lu Zhizheng summed up the basic pathogenesis of the disease "Qi Yin deficiency, blood stasis obstructing collaterals", and established the principle of "Nourishing Qi and nourishing Yin, moistening dryness dredging collaterals", drawing up "Lu Shi run dryness soup" and combining with experience group points to treat the disease. Objective: To evaluate the treatment of Lu Shi Runzao soup. The effect of the eye dry symptoms of the patients with Qi and yin deficiency, blood stasis type primary Sjogren syndrome and the effect of combined acupuncture therapy on the curative effect. At the same time, the clinical application value of Lu's moistening dryness soup and acupuncture therapy was evaluated. Methods: This study included 106 cases of primary Sjogren syndrome, Qi and yin deficiency, and blood stasis obstructing collaterals. The cases were randomly divided into the treatment group and the control group, with 53 cases in each group. The treatment group was treated with Lu Shi Runzao soup as the basic prescription and combined with acupuncture therapy. The control group was treated with Lu Shi Runzao soup as the basic prescription, and the two group of patients had a total course of 3 months. The treatment was randomized, single blind, control, prospective clinical. The test method was used to evaluate the clinical efficacy and safety indexes of the subjects at 0,1,2,3,4,8,12 week, and to evaluate the laboratory test indexes at week 0,12 to evaluate the efficacy and safety of Lu Shi Runzao decoction combined with acupuncture. Results: (1) Lu Zao Runzao decoction combined with acupuncture therapy and Lu Shi Runzao Decoction single prescription treatment, for subjects. The effect of Lu's moistening dryness soup combined with acupuncture on symptoms was more rapid and significant. And with the prolonged treatment time, the curative effect continued to increase. (2) Lu's moistening decoction combined with acupuncture and Lu's moistening dryness decoction could improve the results of ink absorption test in patients with primary Sjogren syndrome, that is, to the patients. The secretion function of lacrimal gland has improved effect. (3) Lu Shi Runzao decoction combined with acupuncture therapy and Lu Shi Runzao Decoction single prescription treatment, the subjects have relieved effect on the whole syndrome of Chinese medicine. And Lu Shi run dryness soup combined acupuncture therapy is more rapid, significantly improved the whole syndrome of the subjects of Chinese medicine. (4) in the safety evaluation of Lu Shi Runzao Decoction and acupuncture therapy, there was no damage of blood system and impaired liver and kidney function during the treatment, which showed that Lu Shi Runzao soup and acupuncture therapy were safe and reliable. Conclusion: This study shows the significant clinical effect of Lu's moistening dryness soup in the treatment of primary Sjogren syndrome. The effect of acupuncture combined with acupuncture on clinical efficacy. The treatment can effectively relieve the symptoms of the eyes of the subjects, improve the secretory function of the lacrimal gland, and reduce the index of the degree of activity of the subjects. There is no adverse effect on the safety index of the subjects during the treatment. This therapy has great clinical value.
【学位授予单位】:北京中医药大学
【学位级别】:硕士
【学位授予年份】:2016
【分类号】:R259
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