前列癃闭通片联合坦洛新胶囊治疗肾虚血瘀型BPH的临床研究

发布时间：2018-09-04 07:45

【摘要】：背景：良性前列腺增生症(Benign Prostatic Hyperplasia, BPH)是中老年男性的多发病、常见病,其发病率随人口寿命的延长、生活水平的提高而逐年增加。50-60岁男性一般有50%出现病理上前列腺肥大,80岁时可高达90%以上。前列腺肥大可以压迫尿道,使尿道狭窄,出现排尿困难、尿不尽,严重者出现尿潴留,如梗阻时间过长可导致肾功能损害,甚至危及生命；BPH已成为国际上关注的重大疾病。前列腺增生属于中医学上的“癃闭”、“精癃”的范畴。本研究小组立足于临床结合理论,采用前列癃闭通片联合坦洛新胶囊治疗肾虚血瘀型良性前列腺增生症,在改善患者排尿症状、提高生活质量等方面取得了显著的疗效。目的：研究前列癃闭通片联合坦洛新胶囊治疗肾虚血瘀型BPH的临床疗效及安全性。方法：采用随机、对照的临床研究方法,选取良性前列腺增生症(肾虚血瘀型)患者87例,分为2组,即治疗组和对照组,治疗组44例,对照组43例。治疗组服用前列癃闭通片联合坦洛新胶囊,对照组服用坦洛新胶囊。1个月为一个疗程,共观察3个疗程。3个疗程结束后,观察两组治疗前后患者国际前列腺症状评分(I-PSS)、排尿症状对生活质量(QOL)的影响、中医症状评分、最大尿流率(MFR)、前列腺体积及残余尿的变化。所有的结果均采用SPSS19.0统计分析软件进行统计分析,P0.05表示差异有统计学意义。结果：治疗组42例病人中,治愈率21.88%、显效率53.13%、有效率21.88%、无效率3.13%,总有效率96.87%；相比对照组42例病人,(治愈率6.25%、显效率25%、有效率46.88%、无效率21.88%,总有效率78.12%),总有效率差异有统计学意义(P0.05)。两组在国际前列腺症状评分(I-PSS)、排尿症状对生活质量(QOL)的影响、中医证状评分、最大尿流率(MFR)、残余尿量(RUV)均较治疗前有明显改善,优于对照组,差异有统计学意义(P0.05)。治疗后前列腺体积相比,治疗组对缩小前列腺体积有一定的作用(P0.05),而对照组对前列腺体积无明显改变,差异无统计学意义(P0.05)。结论：前列癃闭通片联合坦洛新胶囊治疗肾虚血瘀型良性前列腺增生症临床安全有效,能提高药物治疗的总有效率,减少IPSS积分,改善排尿症状对生活质量的影响,提高患者的生活质量,减少中医症状评分,缩小前列腺体积,增加最大尿流率,减少残余尿量,特别是能明显改善患者的排尿症状；故可以作为治疗该病的一种良好选择。
[Abstract]:Background: benign prostatic hyperplasia (Benign Prostatic Hyperplasia, BPH) is a common disease in middle-aged and elderly men. 50% of males aged 50 to 60 years have pathological prostatic hypertrophy, which can reach more than 90% by the age of 80 years. Prostatic hypertrophy can compress urethra, make urethral stricture, dysuria, urine retention in severe cases, such as too long time of obstruction can lead to damage of renal function, even life-threatening BPH has become a major disease of international concern. Prostatic hyperplasia belongs to the traditional Chinese medicine "Longlongong", "Longlong" category. Based on the theory of clinical combination, the study group treated benign prostatic hyperplasia of kidney deficiency and blood stasis type with Qianlie Longboutong tablet and Tanluoxin capsule, and achieved remarkable curative effect in improving the urination symptoms and improving the quality of life of the patients. Objective: to study the clinical efficacy and safety of Qianlie Longboutong tablet combined with Tanluoxin capsule in the treatment of kidney deficiency and blood stasis type BPH. Methods: 87 patients with benign prostatic hyperplasia (kidney deficiency and blood stasis) were randomly divided into two groups: treatment group (n = 44) and control group (n = 43). The treatment group was treated with Qianlie Longboutong tablet combined with Tanluoxin capsule, and the control group was treated with tanluoxin capsule. One month was a course of treatment and three courses of treatment were observed. The changes of international prostate symptom score (I-PSS), the influence of urination symptoms on quality of life (QOL), traditional Chinese medicine (TCM) symptom score, maximum urinary flow rate (MFR),) and residual urine were observed before and after treatment. All the results were statistically significant using SPSS19.0 statistical analysis software. Results: in the treatment group, the cure rate was 21.88, the effective rate was 53.13, the effective rate was 21.88, the inefficiency was 3.13, the total effective rate was 96.87. Compared with 42 patients in the control group, the total effective rate was 78.12% and the total effective rate was 78.12%. The total effective rate was significantly higher than that of the control group (cure rate 6.25%, effective rate 256.88%, effective rate 46.88%, total effective rate 78.12%) (P0.05). The international prostatic symptom score (I-PSS), the effect of urination symptom on (QOL), TCM syndrome score and (RUV) of (MFR), residual urine volume in both groups were significantly improved compared with those before treatment, and the difference was statistically significant (P0.05). Compared with the prostate volume after treatment, the treatment group had a certain effect on reducing the prostate volume (P0.05), while the control group had no significant change in prostate volume, the difference was not statistically significant (P0.05). Conclusion: Qianlie Longboutong tablet combined with Tanluoxin capsule is safe and effective in the treatment of benign prostatic hyperplasia with kidney deficiency and blood stasis. It can improve the total effective rate of drug therapy, reduce the IPSS score, and improve the effect of urination symptoms on the quality of life. It can improve the quality of life of patients, reduce the score of TCM symptoms, reduce the volume of prostate, increase the maximum urine flow rate, reduce the residual urine volume, especially can obviously improve the urination symptoms of the patients, so it can be used as a good choice for the treatment of the disease.
【学位授予单位】：北京中医药大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R697.3

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