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补脾温肾方治疗脾虚腹泻型肠易激综合征的临床研究

Study of the Clinical Observation on treating Diarrhea Type Irritable Bowel Syndrome with formula of Invigorating Spleen and Warming Kidney

【作者】 罗裕兴

【导师】 黄穗平;

【作者基本信息】 广州中医药大学 , 中医内科学, 2012, 博士

【摘要】 肠易激综合征(irritable bowel syndrome, IBS)作为一种功能性疾病,虽然不对人类的生命构成威胁,但其病情缠绵、反复发作,对人们的工作和生活造成严重影响,造成医疗资源的巨大损耗,现已引起医学界的广泛重视,而中医运用辨证论治理论体系辨证施治,大大提高了治愈率,减少了复发,逐步体现出中医药的优势。一、理论研究目的:透过检索文献,对肠易激综合征(Irritable Bowel Syndrome, IBS)的中西医研究状况,进行分析综合和整理,以及分析现存的问题。方法:通过CNKI、万方、PUbMed检索系统对近年来中医药和现代医学对肠易激综合征的研究进行了总结。结果:1.对近年来中国传统医学与现代医学对肠易激综合征(IBS)作出研究性的总结。这不仅介绍了现代医学对IBS的病因和发病机制、流行病学、临床诊断标准和治疗进展。2.介绍了中医对本病的病名、病因病机的认识,以及对本病临床辨证分型的各种中药治疗、针灸、推拿以及中、西医结合治疗等数方面研究进展,并分析其临床疗效。结论:总括而言,指出了目前存在的问题和该疾病的未来前景,为研究中医药学对IBS-D的治疗提供临床根据,奠定临床理论基础。二、临床研究目的:1.以中医的“辨证论治”,并结合“治未病”的思想,观察运用补脾温肾方(参苓白术散合四神丸加减)治疗脾虚腹泻型肠易激综合征(IBS-D)的临床疗效并深入探讨其作用,以明确补脾温肾方的疗效。2.通过总结目前的研究成果,明确目前存在的问题,并展望本病的研究前景,为研究补脾温肾方对IBS-D的治疗提供临床依据、理论思路、以及循证研究的材料。方法:1.对2010年11月至2011年10月广州中医药大学附属广东省中医院二沙岛医院门诊及香港博爱医院中医门诊就诊,符合罗马Ⅲ诊断标准,且中医辨证为脾虚证的患者83例,采用随机分组的方法,将其分为治疗组43例和对照组40例。两组患者在年龄、性别、病程、治疗前中医症状积分上无明显差异,具有可比性(P>0.05)。治疗组以补脾温肾方治疗,水煎,150ml/次,早、晚温服;对照组予参苓白术散加减,水煎,150ml/次,早、晚温服;两组疗程均为4周,疗程完结后均随访1月。2.分别对腹泻、腹胀、腹痛、神疲乏力、纳呆食少及排便不尽感等症状和体征进行疗效观察。另外,亦对用药的安全性进行观察,包括血、尿常规、大便常规、心电图、肝功能(ALT)、肾功能(BUN、 Cr),血糖(Glu)、心电图等。最后,将建立统计数据库,对临床资料进行收集,并进行数据统计学处理,计数资料采用X2检验,计量数据使用t检验,各组之间采用独立样本t检验。结果:1.治疗组以补脾温肾方(参苓白术散合四神丸加减)治疗脾虚泄泻型IBS,总有效率为95.35%。对照组单纯治以补脾,方用参苓白术散,总有效率95.0%,经统计学处理(P>0.05),表明两组药物在治疗脾虚泄泻型IBS时无显著差别,同样有效。但在改善腹泻、腹痛、神疲乏力方面两组比较,经统计学处理,P<0.05,有显著性差异,说明补脾温肾方在改善腹泻、腹痛、神疲乏力方面明显优于对照组。2.治疗组患者在临床试验中没有发现到不良反应,证明药物安全有效。同时,在中医证侯总积分和单项症状积分方面分别与对照组比较,治疗组的结果也明显优于对照组。对于一个月后复发率的观察,治疗组的复发率为9.3%,而对照组为15.00%,但两组复发率的差异经统计学处理,没有统计学意义(P>0.05)。3.两组患者治疗前后血常规、肝功能(ALT、 AST)、肾功能(BUN、 Cr)、血糖(Glu)、治疗前后比较,经统计学分析,无统计学意义(差异)(P>0.05)。尿、便常规+OB、心电图与治疗前比较没有变化。结论:以中医的“辨证论治”,并结合“治未病”的思想,运用补脾温肾方治疗脾虚腹泻型肠易激综合征(IBS-D)疗效显著,能显著改善患者的主要临床症状、中医证侯表现。于临床治疗上,补脾温肾方亦甚具安全性。

【Abstract】 Irritable bowel syndrome,(IBS) is a functional diseases, which is not a threat to the life, but its long course and relapse have influence on the work and life of people and results in the huge waste in medical and health resources. So IBS has aroused the attention of international medical community, the traditional Chinese Medicine raise the cure rate and reduce recurs in TCM syndrome differentiation, and the TCM gradually has superiority in IBS.1. Literature reviewObject iveThis part outlined the recent progresses in the TCM and western medicine researches on IBS-D.MethodsThrough summarizing these documents from the system of CNKI> mengfung^PubMed.ResultFirst, it introduces the western medicine progresses in epidemiology, pathogenesis, clinical diagnostic standard and various treatments. And meanwhile it introduces the TCM understanding to the disease name, etiology, and pathogenesis of IBS, and the progresses in syndrome differentiation, all kinds of treatments in herbal medicine, acupuncture, Tui Na massage, and integrated Chinese and western medicine and analyses the curative effect of these treatments.ConclusionsThe literature review says the existing problems and research foreground of IBS-D. Above all, these theories provide basis for the TCM research in IBS-D.2. Clinic Study Object i veTo explore the therapeutic effect and mechanism of bu pi yi shen in treating Spleen Yang-deficiency syndrome of irritable bowel syndrome-diarrhea(IBSHD) and show the safety of bu pi yi shen Soup.Methods1. This research was based on83cases of outpatients from Subsidiary of the Guangdong Provincial Hospital of Guangzhou University of Traditional Chinese Medicine Ershadao hospital outpatient and Hong Kong Pok Oi Hospital Chinese Medicine Clinic during November2010-october2011who meet Rome III diagnostic criteria and Spleen Yang-deficiency syndrome of TCM. They were divided into two groups randomly. The first group is the treatment group,43patients of which were treated with bu pi yi shen, Shen Ling Atractylodes Powder and Sishen Pill,150ml, two times a day. The other group is the control group, with40patients being treated with Shen Ling Atractylodes Powder,150ml, two times a day. The cases of both groups are treated4weeks and followed up1month. There was no statistical difference between two groups in age, sex, course, and scores of traditional Chinese medical symptoms(P>0.05).2. This part make a safety observation (Blood, urine, stool routine, ECG, liver function (ALT), renal function (BUN, Cr), glucose (Glu), electrocardiogram) and clinical observation. Finally, after collection of clinical data, establish a database, according to the requirements for statistical analysis, counting data using the X2test, measurement data using the t test, comparison between two groups using independent t testResult1. Treatment group total effectiveness is95.35%. Control group total effectiveness is95.00%. Treatment group total effectiveness surpasses the control group total effectiveness is not obviously (P>0.05)2. Two groups of patient’s symptom total integral has the obvious difference before the treatment and the latter (P<0.05). The treatment group Chinese medicine symptom total integral’s improvement is as good as the control groups.3.There is no statistically difference in safty indicators such as WBC, RBC, Hb, PLT, ALT, AST, BUN, Cr, Glu AND ESR between the treatment group and control group (P<0.05).Cone Iusions 1. Above all, bu pi yi shen appears to have the significant effect in the treatment of Spleen Yang-deficiency syndrome of IBS-D. It has improve the clinic syptoms, TCM syndrome and the quality of life of IBS-D patients. In this study, treatment group used bu pi yi shen, achieved good clinical efficacy, further evidence that Spleen Yang-deficiency syndrome is the basic pathogenesis of traditional Chinese medicine of irritable bowel syndrome-diarrhea(IBS-D).2. The trial shows the clinic safety of Shen Ling Atractylodes Powder and Sishen Pill.

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