前列腺增生症围手术期中医证型与症状评分、病理基础的相关性研究
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摘要
目的
     良性前列腺增生(benign prostatic hyperplasia,BPH)是引起中老年男性排尿障碍原因中最为常见的一种良性疾病,其发病率随着年龄的增长而增加。欧美等泌尿外科学会制定的BPH诊疗指南结合主观症状以及客观因素的结果,如国际前列腺症状评分(International Prostate Symptom Score,IPSS)、前列腺体积、最大尿流率、残余尿量的结果对患者病情的轻重程度进行综合判断。IPSS评分标准是目前国际公认的判断BPH患者症状严重程度的最佳手段,而中医证型的核心因素就是患者的主观症状,因此两者之间可能存在某种内在联系,进而对两者的相关性进行必要的研究。
     BPH是一种进展性疾病,部分患者最终需要外科治疗来解除下尿路症状及其对生活质量所致的影响和并发症。完善的围手术期处理则是提高手术效果和术后生活质量的重要保证。中医药在围手术期处理上存在独特的优势(缓解患者术后的下尿路症状,防治术后并发症,保持患者较高的生活质量)。
     本研究将中医证型与患者主观症状和客观指标、术后病理类型结合起来,解决BPH围手术期中医证型与IPSS、最大尿流率、病理类型的关系,将有助于提高前列腺增生症中医辨证的准确性,同时还为辨病与辨证相结合的中医证型的量化和客观化做出有益的探索,为以后中西医结合学会推出前列腺增生症中医诊断治疗指南提供基础数据。
     方法
     Ⅰ:回顾性研究
     1.系统整理BPH中医证型文献资料,研究广州中医药大学第一附属医院及广西中医学院第一附属医院2005、2006年符合纳入标准的病例
     (1)年龄介于50岁至85岁之间。
     (2)符合《中国泌尿外科疾病诊断治疗指南2006版》良性前列腺增生诊断治疗标准。
     (3)符合卫生部《中药新药临床研究指导原则评分标准》(1997)。中医证型为(肺热失宣证、膀胱湿热证、中气下陷证、肾阴亏虚证、肾阳虚损证、血瘀下焦证六个证型)的前列腺增生症的辨证标准。
     2.研究指标
     系统整理BPH中医证型文献资料,总结历史病例资料,我院课题组最后确立BPH围手术期中医证型。
     Ⅱ前瞻性研究
     1.纳入病例标准
     (1)年龄介于50岁至85岁之间。
     (2)符合《中国泌尿外科疾病诊断治疗指南2006版》良性前列腺增生诊断治疗标准。
     (3)符合卫生部《中药新药临床研究指导原则评分标准》(1997)。中医证型为(肾气亏虚、血瘀下焦、膀胱湿热3种证型)的前列腺增生症的辨证标准。
     (4)行TURP或前列腺摘除术,术后标本作病理检查诊断为前列腺增生。
     2.观察指标:
     2.1入选病例术前观察
     (1)术前IPSS
     (2)中医证型
     (3)尿流率测定
     (4)血清前列腺特异抗原(PSA)
     (5)超声测定前列腺体积
     (6)超声测定膀胱残余尿
     2.2术后1周病例观察
     (1)术后1周IPSS
     (2)中医证型
     (3)尿流率测定
     (4)病理分型
     结果
     1.回顾性研究结果
     我们根据BPH围手术期的这一特定阶段的病因病机特点:肾虚血瘀湿热,膀胱决渎失司是本病的基本病机;大多数医家在BPH的围手术期中医治疗中,基本治法是以补益肾气、活血化瘀、清热利湿为主。回顾性分析广州中医药大学第一附属医院及广西中医学院第一附属医院2005,2006年BHP病例资料324例,其中肾阴亏虚证60例、肾阳虚损证36例、中气下陷证40例共136例占总的中医证型约42%,充分说明了肾虚是BPH的主要因素:血瘀下焦证76例占总的中医证型约23.5%,充分说明了血瘀下焦证是BPH的常见证型;膀胱湿热证96例占总的中医证型约29.6%,充分说明了膀胱湿热证是BPH的常见证型。我们最后认为BPH围手术期中医证型按虚实分类,虚证主要为肾气亏虚证,实证常见为血瘀下焦证、膀胱湿热证3种证型最为常见,基本反映了前列腺增生症中医病因及主要的病理变化。
     2.前瞻性研究结果
     符合入选标准的病例资料138例,其中膀胱湿热证42例、血瘀下焦证39例、肾气亏虚证57例,其中术后病理诊断为前列腺癌患者6例不进入统计分析,术后1周6例患者仍留置尿管未能作IPSS研究和尿流率检测,经统计学处理纳入结果分析。入选病例BPH围手术期中医证型与PSA、前列腺体积、残余尿、最大尿流率研究结果:PSA均值最大的为肾气亏虚证,膀胱湿热证PSA异常均值相对较低;肾气亏虚证前列体积偏大,血瘀下焦证、膀胱湿热证前列腺体积偏小:膀胱湿热证者残余尿相对较多,最大尿流率血瘀下焦证最高。
     3.前瞻性BPH围手术期中医证型与IPSS、病理分型的研究结果
     BPH围手术期中医证型与IPSS评分进行logistic回归分析的CATMOD过程计算结果汇总显示(SE:标准回归系数,OR:优势比值) P<0.05,OR>1,具有统计学意义,即BPH围手术期中医证型结果为肾气亏虚证、血瘀下焦证、膀胱湿热证3种证型与IPSS评分密切相关。
     BPH围手术期中医证型与病理分型进行logistic回归分析的CATMOD过程计算结果汇总显示(SE:标准回归系数,OR:优势比值) P<0.05,OR>1,具有统计学意义,即BPH围手术期中医证型结果为肾气亏虚证、血瘀下焦证、膀胱湿热证3种证型与病理分型密切相关。
     BPH围手术期中医证型为肾气亏虚证患者病理学表现以腺体成分增生为主,临床表现前列腺体积较大,IPSS评分较低,中药则以补益肾气为主治疗更有效。研究发现BPH围手术期中医证型为血瘀下焦证患者病理学表现以间质增生为主,平均最大尿流率最高,中药则以活血祛瘀治疗能较快改善尿道刺激症状。研究发现BPH围手术期中医证型为膀胱湿热证患者病理学表现以前列腺增生并慢性炎症,临床IPSS评分最高,较易发生急性尿潴留,膀胱残余尿量最大。
     结论
     1.根据BPH围手术期的这一特定阶段的病因病机特点,回顾性分析、前瞻性研究证实BPH围手术期中医证型按虚实分类,虚证主要为肾气亏虚证,实证常见为血瘀下焦证、膀胱湿热证3种证型最为常见,是促使患者住院手术的主要证型,基本反映了前列腺增生症中医病因及主要的病理变化。
     2.研究发现BPH围手术期中医证型为血瘀下焦证患者组织病理学表现以间质增生为主,西药治疗上以应用抑制平滑肌收缩的α1受体阻滞剂治疗的效果好,中药则以活血祛瘀治疗能较快改善尿道刺激症状、提高尿流率。
     3.BPH围手术期常见中医证型肾气亏虚证、血瘀下焦证、膀胱湿热证3种证型与IPSS、病理类型的密切相关,将有助于提高BPH中医辨证的准确性,为辨病与辨证相结合的中医证型的量化和客观化做出有益的探索,从而发挥中医药在围手术期处理上存在独特的优势,防治术后并发症、提高生活质量及疾病的进展。
Objective
     It is widely accepted that International Prostate Symptom Score(IPSS) is the best method to detect the severity of clinical symptoms of benign prostatic hyperplasia(BPH).Furthermore,there were positive correlation between subjective symptoms and TCM Syndrome Type.BPH is a progressive disease,some patients demand Surgical Treatment,in order to lower urinary tract symptoms (LUTS),which cause complication and influence the quality of life.To guarantee the surgical operation effect and to improve the quality of postoperative life,we have to give the proper peri-operative management round the surgical operation period.TCM has the special advantage in peri-operative management,it can relieve LUTS of BPH patients,and prenvent the postoperative complications,also keep the quality of life after operation. In this research,in order to explore the relationship between TCM Syndrome Type(including kidney qi deficiency,blood stasis in low energize,bladder Damp-heat Pattern) and therapeutic efficacy objective index for Maximum flow rate (Qmax)、pathological types(Proliferation is mainly occurred in interstitial tissue,or glandular organ,inflammatory exudation).It has been proved that BPH had different significance when it occurred in interstitial substance or glandular organ,it may be have different significance TCM Syndrome Type.This research may be helpful to explore the objective indexes of Chinese Medical Syndrome Differentiation of BPH and instruct clinical medication.
     Method
     Ⅰ:Literature Review and the clinical data of BPH patients,cases of The First Affiliated Hospital of Guangzhou TCM University and The First Affiliated Hospital of Guangxi TCM College from 2005 to 2006 were analyzed retrospectively. The target establishment of this investigation is to find out TCM Syndrome Type of BPH on Peri-operative.
     Using the methods of literature data,BPH patients aged 50-85 years, diagnosis criteria of BPH was according to《Clinical Practice Guidelines for patients with urologic diseases》(Na Yan Quan as the Chief Compiler). The diagnostic criteria referred to the classification and diagnostic standard of《Guiding Principles for Clinical Study of New Chinese Medicines》(Chinese Ministry of Health,1997 Edition3),TCM Syndrome Type including Lung-heat syndrome,syndrome of downward flow of damp-heat,Kidney-Yang Deficiency, kidney-yin deficiency,Qi stagnation and blood stasis syndrome,Zhong Qi deficiency
     ⅡProspective Study of BPH patients preoperative investigative according to TCM Syndrome Type of on Peri-operative.Using the methods of prospective survey.BPH patients aged 50-85 years,diagnosis criteria of BPH was according to Clinical Practice Guidelines for patients with urologic diseases(Na Yan Quan as the Chief Compiler).The diagnostic criteria referred to the classification and diagnostic standard of《Guiding Principles for Clinical Study of New Chinese Medicines》(Chinese Ministry of Health,1997 Edition3),TCM Syndrome Type including kidney qi deficiency syndrome,blood stasis in low energize,bladder Damp-heat Pattern.BPH was definitely diagnosed by postoperative pathological examination in all of patients under went TURP or prostatectomy in The First Affiliated Hospital of Guangzhou TCM University.Investigation content including IPSS,TCM Syndrome Type,Qmax,PSA,the prostatevolume measured and residual urine by transrectal ultrasound.
     ⅢProspective Study of BPH patients post-operative investigative according to TCM Syndrome Type of on one week after operation.Investigation content including IPSS,TCM Syndrome Type,Qmax,pathological types.
     Result
     Literature Review and the clinical data of BPH patients,324 cases of The First Affiliated Hospital of Guangzhou TCM University and The First Affiliated Hospital of Guangxi TCM College from 2005 to 2006 were analyzed retrospectively.Among them,60 cases of kidney-yin deficiency,36 cases of Kidney-Yang Deficiency,40 cases of Zhong Qi deficiency,and these 3 kinds of TCM Syndrome Type can be concluded kidney-qi deficiency,and then total 136 cases account for 42%.76 cases of Qi stagnation and blood stasis syndrome account for 23.5%,96 cases of syndrome of downward flow of damp-heat account for 29.6%.The numerical results show that kidney-qi deficiency,Qi stagnation and blood stasis syndrome,syndrome of downward flow of damp-heat were the most common type.The investigation result showed that,TCM Syndrome Type of BPH on Peri-operative is closely related to IPSS,Qmax,PSA,the prostatevolume measured and residual urine by transrectal ultrasound,pathological types.
     Conclusion
     By discussing the etiology,pathogenesis,syndrome differentiation according to TCM Syndrome Type of BPH on Peri-operative,the article puts forward that kidney-qi deficiency,Qi stagnation and blood stasis syndrome,syndrome of downward flow of damp-heat were the most common type,which means BPH outpatients turn into inpatients and receiving operation.To guarantee the surgical operation result and to improve the postoperative life quality, we have to give the proper peri-operative management round the surgical operation period processing.The closely relation between TCM Syndrome Type of BPH on Peri-operative and several clinical factors(IPSS,Qmax,PSA, the prostatevolume measured and residual urine by transrectal ultrasound, pathological types),it may be helpful to explore the objective indexes of Chinese Medical Syndrome Differentiation of BPH.Exert the Advantages of TCM to management in peri-operative and to prevent postoperative complications, and guarantee the quality of life after operation.In the future, multi-center,large sampled and prospective random comparison therapeutic study based on evaluative criteria constituted by Traditional Chinese Medicine-Western Medicine Integrating Institute provide basic information and evidences.
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