【作者】 陈震刚；

【导师】 赖新生；

【作者基本信息】 广州中医药大学 ， 针灸推拿学， 2010， 博士

【摘要】 前列腺增生症是中老年男性常见疾病。随着人口老龄化进程,其发病率将进一步增加,严重影响老年男性的生活质量,甚至出现各种并发症,威胁病人的生命,成为影响我国老年男性健康的最重要的疾病之一,是二十一世纪面临的严峻课题。温针疗法是将针刺和艾灸结合的中医特色疗法,在治疗许多疾病中,尤其是对中医辨证虚证的病症发挥其独特疗效。本研究拟采用温针疗法治疗慢性前列腺增生虚证患者,期望借此研究能开拓该病治疗的有效途径,为目前在人群中发病率较高的慢性前列腺增生提供一种新的安全有效的治疗方案。目的本课题采用临床流行病学、临床科研方法学及数理统计分析方法,进行临床随机对照研究,观察温针灸结合中药治疗中医辨证属虚症(肾阳不足、肝肾亏虚)的慢性前列腺增生症,以期证实温针灸治疗前列腺增生症虚症的确切疗效。方法根据《中药新药临床研究指导原则》关于癃闭的诊断标准,收集2008年2月至2009年2月期间在台湾贺安中医诊所就诊的符合病例筛选标准的50例慢性前列腺增生症患者。采用单盲随机化方法,按1：1对照原则分为试验组、对照组,试验组采用温针灸结合中药治疗,对照组采用单纯中药治疗。一周为一个疗程,连续二个疗程后观察治疗前后前列腺体积、残余尿量及其临床疗效。用EPIDATA3.1软件建立数据库,用SPSS15.0软件进行统计分析。计量资料用均数±标准差(x±S)表示,计数资料用构成比(%)表示。计量资料组间比较采用t检验(方差不齐采用t’检验或秩和检验),自身前后比较用配对t检验或Wilcoxon配对秩和检验。分类资料组间比较采用χ2检验,等级资料组间比较采用Wilcoxon秩和检验。统计图形的制作采用软件Graph Pad Prism 4.03完成。结果临床共收集合格病例50例,均为50岁以上的老年人。温针灸结合中药治疗组(简称试验组)25例,年龄最小50岁,最大73岁,平均年龄61.34±5.32岁,病程最短者3年,最长者15年,平均8.34±2.78年；中药治疗组(简称对照组)25例,年龄最小51岁,最大66岁,平均年龄58.92±4.96岁。病程最短者1年,最长者12年,平均6.89±2.63年。患者基线特征的可比性分析中,试验组与对照组年龄、病程、病情程度、治疗前前列腺体积、残余尿量比较,差异均无统计学意义,两组患者基线特征具有可比性。主要研究指标疗效,在改善前列腺体积方面,试验组与对照组治疗后差异无统计学意义。各组治疗前与治疗后比较,两组均无统计学意义。提示：提示温针灸结合中药治疗组和单纯中药组对前列腺体积无明显影响。在改善残余尿量方面,治疗后两组差异有统计学意义。各组治疗前与治疗后比较,两组均有统计学意义。提示：两组治疗方法都能改善尿路的梗阻状态,试验组残余尿量改变量较对照组大,提示温针灸结合中药治疗组解除尿路梗阻的疗效优于对照组。在临床疗效方面,试验组25例患者,显效5例,有效17例,总有效率88.0%；单纯中药组25例患者,显效0例,有效16例,总有效率64.0%。两组临床疗效与总有效率的比较,差异均有统计学意义。且试验组的总有效率较对照组高。提示：经温针灸结合中药治疗后,前列腺增生患者的临床症状明显改善,效果显著。结论结合临床,温针灸结合中药治疗组能解除尿路梗阻症状,疗效肯定,初步证明了采用温针灸结合中药的方法治疗慢性前列腺增生虚证可有效提高其临床疗效,值得推广。更多还原

【Abstract】 Hyperplasia of prostate is a common disease in older men. With the population aging process, the incidence rate will further increase, seriously affecting quality of life of older men, or even complications, threatening the patients’life. It has been one of the most important diseases that infects the health of old men and become a very topic in the 21st century.Warm needling moxibustion is a therapy combined with needling and moxibustion, which has the Chinese characteristics in the treatment of many diseases, especially diseases with deficency syndrome by TCM differentiation of symptoms and signs. This therapy can play an unique effect. In this study, We intend to apply warm needling moxibustion therapy in patients with chronic hyperplasia of prostate of deficency syndrome, and hope that this study will explore an effective way to treat this disease and provid a new safe and effective treatment program for it has a higher disease incidence in present population.ObjectiveThis study use clinical epidemiology and clinical scientific research, mathematical statistics and analytical method, by randomized controlled study, the objective of this reseach is to observe the clinical effect of warm needling moxibustion conbined with Chinese herbs in treating chronic hyperplasia of prostate of deficency syndrome (deficency of kidney or deficency of liver and kidney) and to confirm the therapy of Warm needling moxibustion has an exact effect n the exact effect in treating this disease.MethodsAccording to the diagnostic criteria of retention of urine/uroschesis in guiding principles of new drugs in Chinese medicine clinical research, we collected 50 cases of patients with chronic hyperplasia of prostate who met the criteria from Taiwan Chenzhengang’TCM Clinical during February 2008 and February 2009. Applying randomized single-blind method, we diveded the reseach objects into test group and control group in the ratio of 1:1. The patients in test group were treated with warm needling moxibustion conbined with Chinese herbs, and the other ones treated with pure Chinese herbs. One week for a course of treatment.After two course, observing the changes on prostate volume, residual urine volume and its clinical effect before and after treatment.Using EpiData 3.1 software to establish database and statistical software SPSS15.0 to complete statistical analysis.Measurement data with means±tandard deviation (x±S), numeration data with composition ratio (%), measurement data between groups with T-test (heterogeneity of variance with t’test or rank sum test), before and after itself with paired-samples T-test or Wilcoxon paired rank sum test, Categorical data between groups with Chi-Square test, ranked data between groups with Wilcoxon rank sum test. Making use of statistical graphics software Graph Pad Prism 4.03 to complete statistical graph.Results5o qualified clinical cases were collected and the patients were all over 50 years old. Warm needling moxibustion conbined with Chinese herbs group(simplely called test group) 25 cases, the youngest 50 years old, the oldest 73 years old, mean age 61.34±5.32, the shortest disease duration 3 years, the longest 15 years, mean disease duration 8.34±2.78 years; Chinese herbs goup(control group) 25 cases, the youngest 51 years old, the oldest 66 years old, mean age 58.92±4.96, the shortest disease duration 1 years, the longest 12 years, mean 6.89±2.63 years.Comparability of baseline characteristics of patients in the test group and control group in age, duration, severity, prostate volume and residual urine volume before treatment, the difference had no statistical significance,meaning the baseline characteristics of the two groups were comparable.The effect of main study indicators:the difference was not statistically significant (P> 0.05) in improving prostate volume in the two group. Comparing the difference of each group on this aspect before and after treatment, the results showed no statistically significant difference in both groups, indicating that these two therapies had no impact on Prostate volume. The difference was statistically significant (P<0.05) in improving residual urine volume in the two group. Comparing the difference of each group on this aspect before and after treatment, the results showed statistically significant difference in both groups, indicating that both therapies had effect on improving urinary tract obstruction and the test group was larger in changing the amount of residual urine volume than the control group. It means that the effect of warm needling moxibustion combined with Chinese medicine group was more effective than the control group in relieving urinary tract obstruction.About clinical efficacy:25 patients in the test group,5 remarkably effective cases,17 effective cases, total effective rate was 88.0%; 25 patients in pure Chinese herbs group,0 remarkably effective cases,16 effective cases, total effective rate was 64.0%. Comparing therapeutic effect and the total effective rate of the two groups,the differences were statistically significant and the total effective rate of the test group was higer than that of control group. After received the treatment of warm moxibustion combined with Chinese medicine, the patients’clinical symptoms were evidently improved, showing that this therapy has an remarkable effect.ConlcusionThe therapy of warm needling moxibustion conbined with Chinese herbs can relieve the synptoms of urinary tract obstruction and has a remarkable effect. This study has initially proved that this therapy can significantly raise the clinical effet on treating chronic hyperplasia of prostate of deficency syndrome and is worthy of promotion.更多还原