【作者】 邱斌；

【导师】 王旭；

【作者基本信息】 南京中医药大学 ， 中西结合临床， 2010， 博士

【摘要】 目的：观察温肾通阳法结合西药治疗妇女糖尿病神经源性膀胱证属中医肾阳亏虚证患者的临床表现、体征、排尿症状评分、排尿症状生活质量评分、尿动力学参数、糖化血红蛋白、血脂等指标的变化情况,对其临床疗效及安全性进行评价。方法：通过文献研究,回顾中医学与西医学对糖尿病神经源性膀胱的认识,结合导师经验,探讨糖尿病神经源性膀胱的中医病因病机和治疗方法,提出肾阳亏虚是糖尿病神经源性膀胱的重要病理机制,确定以温肾通阳为其治法,并拟结合西医α肾上腺能受体阻滞剂及乌拉胆碱两种药物联合治疗。采用随机平行对照的研究方法将60例糖尿病神经源性膀胱肾阳亏虚证患者随机分为两组,治疗组(中西医结合治疗组)29例,对照组(对照组)31例。在基础治疗(饮食控制、药物控制血糖血脂)的基础上,治疗组服用桂附地黄丸散剂(每次12g,每日3次)及西药盐酸坦索罗辛口服常释剂型(Tamsulosin Hydrochloride,0.2mg)(每次0.2mg,每日1次)和乌拉胆碱(Urecholine,25mg)(每次25mg,每日3次)。对照组不服用中药,两组均以12周为1疗程,治疗前后完善相关检查。观察患者治疗前后临床症状、体征、排尿症状评分、排尿症状生活质量评分、尿动力学参数、糖化血红蛋白、血脂(甘油三酯、总胆固醇)等指标的变化。全部数据以SPSS15.0统计软件进行统计学分析。结果：确诊并最后纳入的糖尿病神经源性膀胱肾阳虚证患者60例(治疗组29例,对照组31例),治疗前两组的年龄、病程、临床症状体征、排尿症状评分、排尿症状生活质量评分、尿动力学参数、糖化血红蛋白、血脂(甘油三酯、总胆固醇)等基线数据经统计学处理无显着性差异,有可比性(P<0.05)。研究结果：①疗效比较：对照组总有效率25.80%,其中显效2例(6.45%),有效6例(19.35%),无效23例(74.19%)。治疗组,总有效率89.66%,其中显效14例(48.27%),有效12例(41.37%),无效3例(10.34%)。②中医肾阳虚证候：治疗组患者治疗后症状有明显改善,提示治疗组对中医肾阳虚症状的改善作用明显优于对照组(P<0.05)。③改善下尿路症状,排尿生活质量：治疗组排尿症状指数(AUA-SI),排尿症状生活质量评分的改善程度与治疗前比较有明显改善(P<0.05),同时优于对照组(P<0.05),提示桂附地黄丸具有改善下尿路症状及排尿生活质量的作用。④尿动力学参数影响：治疗组患者治疗后最大尿流速、膀胱灌注初始感觉、残留尿、膀胱排空率均明显改善,与治疗前比较均有显着性差异(P＜0.05),但膀胱容积、逼尿肌压力治疗后没有统计学意义(P>0.05)。两组间治疗后比较,治疗组最大尿流速、膀胱灌注初始感觉、残留尿、膀胱排空率均改善较对照组有显着差异(P<0.05),提示桂附地黄丸具有改善尿动力学参数的作用。⑤降糖效果：治疗组治疗后糖化血红蛋白有明显下降(P<0.05),与对照组比较有统计学意义(P<0.05),提示桂附地黄丸具有一定的降糖作用。⑥调节血脂：治疗组治疗后甘油三脂及总胆固醇均较治疗前下降(P<0.05)；对照组治疗后甘油三脂及总胆固醇水平治疗前后相比均无明显改变(P>0.05)。两组间治疗后比较,治疗组较对照组的甘油三脂及总胆固醇改善有统计学意义(P<0.05),提示桂附地黄丸具有调节血脂的作用。结论：该研究表明,温肾通阳法结合西药治疗糖尿病神经源性膀胱肾阳虚证优于单纯西药治疗,具有改善排尿症状、提高排尿生活质量作用。尿动力学测定显示桂附地黄丸能提高糖尿病神经源性膀胱肾阳虚证患者的最大尿流速及膀胱排空率,减少其残留尿,但对于膀胱容积及逼尿肌压力的影响不明显。同时本研究也表明桂附地黄丸能明显改善糖尿病神经源性膀胱肾阳虚证患者血糖、血脂,并且无毒副作用,证实该方药安全有效,临床应用于糖尿病神经源性膀胱具有广泛的前景。但因本研究周期较短,临床数据样本偏小,确切疗效仍需进一步大样本、长周期、多中心观察。更多还原

【Abstract】 Purpose:To study the efficacy of traditional Chinese medicine of warming the kidney and activating yang method for diabetic neurogenic bladder in female with type 2 diabetes mellitus. The clinical symptoms of insufficiency of kidney-YANG, America urological association lower urinary symptom score index, impact of urinary symptoms against quality of life was evaluate. The urodynamic study data including maximum flow rate, residual urine, and first sensation in filling phase, post-voiding residual urine volume, urinary bladder capacity, maximum detrusor pressure and voiding efficacy was collected. The level of serum glycated hemoglobin Alc, total cholesterol and triglycerol were also determined for the difference between control group(western medicine group) and study group(Chinese medicine and western medicine combine treatment group) was compared.Methods:A randomized, controlled trial was conducted in 60 patients with type 2 diabetes mellitus associated with insufficiency of kidney-YANG. The patients were randomly classified into two groups. Based on ordinary treatment and diet control, the control group (n=31) was treated by tamsulosin orally (0.2mg daily) and urecholine (75 mg daily, divided in three doses).The control group (n=29) was treated by tamsulosin orally (0.2mg daily) and urecholine (75 mg daily, divided in three doses) and Bawei Di Huang Wan (12 gm daily, divided in three doses). The treatment course was 12 weeks. The symptom of insufficiency of kidney-YANG, lower urinary tract symptoms, impact of quality of life by lower urinary tract symptoms was evaluated with questionnaires. The standard videourodynamic study was performed and parameters were recorded. The serum levels of glycated hemoglobin A1C, total cholesterol, triglycerol were also recorded before and after trial. All the data was managed by the SPSS 15.0 statistics software for statistically significance between groups.Results:Before trial, age, disease course, clinical symptoms of insufficiency of kidney-YANG, lower urinary tract symptom score, impact of quality of life, parameters of urodynamic study, serum level of glycated hemoglobin, total cholesterol, triglycerol showed no statistical differences(P<0.05). The total effective rate in clinical symptoms of insufficiency of kidney-YANG of study group was 89.66%, while the control group was 25.80%. The study group had an advantage than the control group (P<0.05). In terms of lower urinary tract symptoms (AUA-SI) and quality of life, there was improvement in the study group (P<0.05). The study group had significant advantage on the lower urinary tract symptoms (AUA-SI) and quality of life over control group (P<0.05). The urodynamic parameters including maximum urinary flow rate, post-voiding residual volume, first sensation of cystometry, voiding efficacy improved significantly in study group. But bladder capacity, maximum detrusor pressure have no difference after trial (P>0.05). The study group also gained advantage in improvement of maximum urinary flow rate, post-voiding residual volume, first sensation of cystometry, voiding efficacy in comparison with control group (P<0.05). It showed Bawei Di Huang Wan is effective in treating the diabetic nurogenic bladder. The serum level of glycated hemoglobin A1C, total cholesterol, triglycerol lowered after treatment in study group (P<0.05) but not in control group (P>0.05). We concluded that Bawei Di Huang Wan may have advantage in blood sugar and better hyperlipidemia control in diabetic neurogenic bladder patients.Conclusion:This randomized control study showed that the method of warming the kidney and activating yang of traditional Chinese medicine combine with alpha blockers and cholinergic agents may have synergic effect in treating diabetic neurogenic bladder patients. However, the case number and period of present study is limited, further large scale, long term, multiple centers clinical trial is necessary to clarify the effectiveness and mechanism of Bawei Di Huang Wan for treating lower urinary tract dysfunction in diabetic patients.更多还原