【作者】 徐世钊；

【导师】 李万瑶；

【作者基本信息】 广州中医药大学 ， 针灸推拿学， 2010， 博士

【摘要】 本研究拟采用针药结合疗法治疗慢性前列腺增生患者,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随机对照研究,观察温针灸结合中药治疗中医辩证属湿热挟瘀证的慢性前列腺增生症,与单纯中药组为对照,以期证实温针灸治疗前列腺增生症虚症的确切疗效。方法采用随机对照方法,将入选的72例慢性前列腺增生症患者,按1：1对照原则分为试验组、对照组各36例,试验组采用温针灸+中药(前列康片)口服,操作方法：主穴：肾俞,大肠俞、秩边；配穴：中极,关元,水道,三阴交。主穴为每次必取穴位,其余穴位随症加减。主穴行温针灸,其余配穴只行针刺得气后留针。先取背俞穴位常规消毒后,手持直径0.35mm×40mm毫针,快速直刺进针,施以平补平泻的手法得气后,于针柄加上1.5cm艾柱,温针灸1～3壮,并依每个患者不同症状给予随症配穴；当所有艾柱烧尽清除灰烬后出针,再取腹部俞穴位常规方法操作。口服中药(前列康片)：前列康片(普乐安片)为片剂：0.5g／片,60片／瓶,口服,5片／次,3次／日。病人在服药期间不得服用对主症主病起治疗作用的其他药物。一周为一个疗程,连续四个疗程后观察疗效。对照组采用口服中药(前列康片)治疗。疗效指标观测：(1)临床症状、体征、舌象、脉象等；(2)IPSS：排尿通畅情况,排尿时间,夜尿数等；(3)排尿症状对生活质量的影响(L)；(4)肛门指检情况；(5)肾、膀胱、前列腺B超检查；(6)尿流动力学检查；(7)血清前列腺特异性抗原(PSA)测定(必要时做)；观察时间：以上各项实验室指标均在纳入病例前及试验结束时进行,其余各项每周观察记录一次。结果本研究共有合格受试者72例,治疗组36例,对照组36例；均为门诊病人。西医诊断为前列腺增生症,中医辨证为湿热挟瘀证。合格病例随机分为温针灸结合中药治疗组(简称试验组)和中药治疗组(简称对照组),各36例。患者基线特征的可比性分析：治疗前,两组性别、年龄、病程构成情况、I-PSS前列腺症状评分、生活质量、排尿状况、小腹症状、最大尿流率、残余尿量、排尿时间、前列腺直肠指诊分级、尿频、尿急、排尿费力等临床症状以及舌象、脉象等比较,差异均无统计学意义。提示影响两组资料组间均衡性较好,具有可比性。中医症状疗效比较：治疗组临床控制率为22.22%,显效率为25.0%,有效率为41.67%,总有效率为88.89%；对照组临床控制率为8.33%,显效率为13.89%,有效率为63.89%,总有效率为86.11%。两组总疗效等级差异比较(Ridit分析,z=1.99,P<0.05),差别有统计学意义。提示治疗组疗效优于对照组。两组总显效率(临床控制率+显效率)比较,差异有统计学意义(χ2=4.96,P=0.025<0.05)。提示治疗组的总显效率(47.22%)高于对照组(22.22%)。国际咨询委员会推荐标准疗效比较,治疗组显效率为37.4%,有效率为48.7%,总有效率为86.1%；对照组显效率为26.0%,有效率为50.0%,总有效率为76.0%。两组比较,差异有统计学意义。两组治疗后病情程度改善情况比较,差异有统计学意义(Z=1.99,P=0.045)。两组治疗后I-PSS前列腺症状评分改善程度比较,差异有统计学意义(Z=2.04,P=0.040)。两组治疗后生活质量改善程度比较,差异有统计学意义(Z=1.97,P=0.04)。两组治疗后排尿状况改善程度比较,差异有统计学意义(Z=2.03,P=0.04)。两组治疗后小腹症状改善程度比较,差异有统计学意义(Z=1.99,P=0.04)。两组治疗后最大尿流率改善程度比较,差异无统计学意义。两组治疗后残留尿量减少程度比较,差异有统计学意义(Z=2.24,P=0.02)。两组治疗后前列腺体积缩小程度(优：前列腺体积治疗后前比值460%；良：前列腺体积治疗后前比值≤80%；中：前列腺体积治疗后前比值≤90%；劣：前列腺体积治疗后前比值>90%)比较,差异无统计学意义。两组治疗后排尿时间缩短程度比较,差异有统计学意义(Z=1.97,P=0.04)。两组治疗后小腹症状、尿频比较,差异有统计学意义。两组治疗后排尿状况、口苦、口粘、口渴不欲饮、尿急、排尿费力、夜尿多比较,差异无统计学意义。两组治疗前后最大尿流率差值比较(组间比较),差异无统计学意义。治疗组治疗前后最大尿流率比较,差异有统计学意义(t=2.10,P=0.03)。对照组治疗前后最大尿流率比较,差异有统计学意义(t=2.85,P=0.00)。两组治疗前后平均尿流率差值比较(组间比较),差异无统计学意义。治疗组治疗前后平均尿流率比较,差异有统计学意义(t=2.56,P=0.01)。对照组治疗前后平均尿流率比较,差异有统计学意义(t=1.99,P=0.04)。两组治疗前后排尿时间差值比较(组间比较),差异无统计学意义。治疗组治疗前后排尿时间比较,差异有统计学意义(t=3.36,P=0.00)。对照组治疗前后排尿时间比较,差异有统计学意义(t=2.11,P=0.03)。两组治疗前后残余尿量差值比较(组间比较),差异有统计学意义(t=3.22,P=0.00)。治疗组治疗前后残余尿量比较,差异有统计学意义(t=2.08,P=0.04)。对照组治疗前后残余尿量比较,差异无统计学意义。安全性检测：两组治疗前检测了血常规,大便常规,尿常规,肝功能(GPT),肾功能(BUN),(均在正常范围内),治疗后复查,均未见异常。用药后未观察到不良反应症状。结论治疗组临床控制率为22.22%,显效率为25.0%,有效率为41.67%,总有效率为88.89%；对照组临床控制率为8.33%,显效率为13.89%,有效率为63.89%,总有效率为86.11%。两组总疗效等级差异比较(Ridit分析,z=1.99,P<0.05),差别有统计学意义。提示治疗组疗效优于对照组。两组总显效率(临床控制率+显效率)比较,差异有统计学意义(χ2=4.96,P=0.025<0.05)。提示治疗组的总显效率(47.22%)高于对照组(22.22%)。临床症状、体征、尿流动力学检查疗效结果表明,两组治疗后病情程度、I-PSS前列腺症状评分、生活质量、排尿状况、小腹症状、最大尿流率、残余尿量、排尿时间、平均尿流率等,均有明显改善。治疗组治疗后前列腺增生患者病情程度、生活质量、排尿状况、小腹症状、残余尿量、排尿时间、平均尿流率等改善程度均明显高于对照组(P<0.05),而治疗组治疗后I-PSS前列腺症状评分、前列腺体积、最大尿流率等改善程度均与对照组相似(P>0.05)。提示针药结合治疗前列腺增生症,能明显改善患者的主要临床症状、体征及尿流动力学检查结果,其作用优于对照组。安全性检测结果表明,部分病人治疗前后血、尿、大便常规、肝功能(GPT)、肾功能(BUN)、心电图检测结果,未能提示针药结合治疗后对血液系统及心、肝、肾功能有损害。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。研究结果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。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(湿热挟瘀证)可有效提高其临床疗效,值得推广。更多还原

【Abstract】 ObjectiveThis randomized controlled clinical research adopts the clinical epidemiological methods, clinical research methods and statistical methods. It takes pure Chinese herbs therapy as comparison and observes the clinical curative effect of applying acupuncture and Chinese herbs to cure hyperplasia of prostate (moist heat and blood stasis). It discusses the difference of the clinical effect and provides the basis for the clinical treatment of hyperplasia of prostate.MethodsThe research has 70 patients of hyperplasia of prostate (moist heat and blood stasis), who were treated in Chinese Medicine clinic in Taiwan from February 2008 to February 2009 and who met the case selection standards.All the patients were divided into two groups (the warm needle acupuncture added Chinese herbs group, and pure Chinese herbs group), with 35 in each group at the rate of 1:1. The pure Chinese herbs group were treated with the QIANLIE KANG TABLETS, taking 2.5g a time, tid, P.O. The warm needle acupuncture added Chinese herbs group were treated with warm needle acupuncture and taking the QIANLIE KANG TABLETS the same way as the pure Chinese herbs group. A week was a course. All the patients were treated for four weeks. After every week, patients’clinical symptom, IPSS, PSA, quality of life, and urodynamic study, etc. were measured. Before and after the treatment, check the safety indexes.Use software EPIDATA 3.1 to set up the database and use software SPSS 15.0 for statistics and analysis. The measurement material is expressed by x±S and the numeration material by constituent percentage. For the interclass comparison of the measurement material, take F test (for heterogeneity, take Kruskal-Wallis H rank sum test); for the interclass multiple comparison, take q test (Newman-Keuls); for self circa comparison, take the t pair test or pair rank sum test. For the interclass comparison of the classified material, take x2 test. For the interclass comparison of the ranked material, use Kruskal-Wallis H rank sum test. Draw the statistics graphs with software Graph Pad Prism 4.03.ResultsThis research collects 70 cases with no difference in two groups in age, course of disease, clinical symptom, IPSS, PSA, quality of life, and urodynamic study, etc.The warm needle acupuncture added Chinese herbs group has significant curative effect for hyperplasia of prostate (moist heat and blood stasis) treatment. The control rate is 22.2%; the efficient rate is 25.0%; the effective rate is 41.6%,;the total effective rate is 88.9%.According to the standard of international advisory council, the warm needle acupuncture added Chinese herbs group has more significant curative effect for hyperplasia of prostate (moist heat and blood stasis) treatment. The control rate is 37.4%; the efficient rate is 48.7%; the total effective rate is 86.1%.After the treatment, the patients’clinical symptom, IPSS, PSA, quality of life, and urodynamic study changes a lot. The therapy of warm needle acupuncture added Chinese herbs can effectively improve the patients’ clinical symptom, urine condition, and quality of life, and lower the patients’residual urine volume and urine time. In a word, the therapy of warm needle acupuncture added Chinese herbs, has better effect than the therapy of pure Chinese herbs, and it is safe without side effect.ConclusionBased on the clinical results, the warm needle acupuncture added Chinese herbs therapy can cure the hyperplasia of prostate (moist heat and blood stasis) noticeably. It can adjust the patients’clinical symptom, urine condition, and quality of life, lower the patients’residual urine volume, and shorten the urine time. It is safe and has no side effect. It is an effective method for hyperplasia of prostate (moist heat and blood stasis) and deserves being popularized.更多还原