萘哌地尔治疗老年前列腺增生临床疗效的随机对照研究被引量：2

Randomized controlled studies on clinical curative effect of naftopidil on elderly patients with prostatic hyperplasia

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摘要目的探讨肾上腺素能受体阻滞剂萘哌地尔治疗老年前列腺增生的有效性和安全性。方法选取2013年2—12月在我院泌尿外科收治并确诊的68例老年前列腺增生患者,将其随机分为观察组和对照组,每组34例。本实验按随机、双盲双模、阳性药物平行对照实验。观察组服用萘哌地尔25 mg,1次/d,睡前服用,同时加服1粒外观与盐酸坦索罗辛相同的安慰剂;对照组服用盐酸坦索罗辛0.2 mg,1次/d,睡前服用,同时加服1片外观与萘哌地尔相同的安慰剂。所有患者均用药8周。评估患者治疗前后的国际前列腺症状评分(IPSS)、生活质量评分(QOL)、尿急症状评分使用尿路敏感度量表(USS)、平均尿流速(Qave)、最大尿流速(Qmax);利用彩超测定患者膀胱残留尿量,治疗后检查血、尿常规,观察前列腺体积、心率、血压、心电图及各项实验室指标的变化。结果两组内治疗前、后的IPSS及QOL评分比较,均有显著统计学差异(P<0.01),USS评分比较,差异有统计学意义(P<0.05);两组患者的IPSS、QOL、USS评分治疗前后比较,则均无统计学差异(P>0.05)。两组内治疗前、后Qmax与Qave比较,差异均有显著统计学意义(P<0.01),两组患者的残留尿量组内治疗前、后差异无统计学意义(P>0.05);治疗后两组间Qmax比较,差异有统计学意义(P<0.05),治疗前Qmax、Qave、残余尿量及治疗后Qave、残余尿量两组间比较差异无统计学意义(P>0.05)。治疗前后两组患者的前列腺体积、血常规、尿常规、心率、血压、心电图及各项实验室指标均无明显变化,两组间比较差异均无统计学意义(P>0.05)。观察组有1例头晕,1例恶心,不良反应均不严重,继续服用后无加重现象,没有因不良反应而停药者。对照组中出现1例头晕,1例便秘,1例胸闷,1例口干,1例尿潴留退出试验。两组患者的不良反应发生率比较,差异有统计学意义(P<0.05)。结论萘哌地尔与坦索罗辛治疗老年前列腺增生的临床效果相当,萘哌地尔能明显改善患者的临床症状及尿急症状,提高患者生活质量,增加最大尿流速和平均尿流速,减少残余尿量,不良反应少于坦索罗辛,是一种安全有效的治疗前列腺增生的药物。 Objective To explore the efficacy of adrenergic receptor blocker naflopidil in the treatment of senile hyperplasia of pros- tate and its safety. Methods Sixty-eight elderly patients with prostatic hyperplasia admitted to our department from February 2013 through December 2013 were enrolled in the randomized, double-blinded, dual mode, positive drug parallel contrast study, and divided into trial group and control group at random （ n = 34/group）. The trial group took 25 mg of naftopidil plus a pill of pla- cebo with the same look as hydrochloric acid tamsulosin before sleeping; the ontrol group took 0.2 mg of hydrochloric acid tam- sulosin plus a pill of placebo with the same look as naftopidil before sleeping. A1 the patients took the medication for 8 weeks. We assessed their international prostate symptom score （IPSS） , quality of life （QOL） scale, urinary urgency symptom via uri- nary sensation scale （USS） , and Qave （ average flow rate） and Qmax （ maximal flow rate） before and after treatment. We also measured their bladder residual urine volume by means of color ultrasonography. Results There were significant differences in IPSS and QOL scale （P 〈0.01 ） and USS （P 〈 0.05 ） in both the two groups between before and after treatment; between the two groups, there were no significant differences in IPSS, QOL scale and USS （ P 〉 0.05 ） either before or after treatment. In both the two groups, there were significant differences in Qave and Qmax （ P 〈 0.01 ） and there was no significant difference in residual urine volume （ P 〉 0.05 ） between before and after treatment ; between the two groups, there was significant difference in Qmax （ P 〉 0.05 ） after treatment, and there were no significant differences in Qmax, Qave and residual urine wflume before treat- ment and in Qave and residual urine volume after treatment （P 〉 0.05）. As for adverse reaction, in trial group there was 1 case of dizziness and 1 case of nausea without aggravation under the condition of continued medication. In the control group there was 1 case of dizziness, 1 case of constipation, 1 case of chest tightness, 1 case of dry mouth and 1 case of urinary retention resuhing in withdrawal from the trial. The difference in adverse reac- tion was statistically significant （P 〈 0.05 ）. Conclusion Although naftopidil and tamsulosin is of the same clinical effect of treat- ment on elderly patients with hyperplasia, naftopidil has the advantage of obvious improvements in symptoms, QOL, maximal and average urinary flow rate, and residual urine volume. It leads to less adverse reaction.