缬沙坦和非那雄胺联合治疗高血压合并良性前列腺增生

Combination therapy of valsartan and finasteride on hypertension with benign prostatic hyperplasia

目的联合应用缬沙坦、非那雄胺治疗高血压合并良性前列腺增生(BPH)患者,观察降压及BPH临床症状改善效果。方法采用随机平行对照的临床实验方法,入选2008-09-2010-12河南大学淮河医院门诊或住院的高血压合并BPH患者372例,分成3组:A组(口服缬沙坦80mg/d,n=138)、B组(口服缬纱坦80mg/d+非那雄胺组5mg/d,n=128)和C组(口服多沙唑嗪4mg/d+非那雄胺组5mg/d,n=106)。进行为期12月的观察,每3月随访1次。观察患者的血压水平、国际前列腺症状评分(IPSS)、最大尿流率(Qmax)、前列腺总体积以及残余尿量,评价各组患者的临床治疗情况。结果治疗6月后,3组患者前列腺总体积均较治疗前缩小(P<0.05)。C组前列腺体积缩小幅度大于A、B两组[治疗前后差值为(11.7±6.2)比(8.2±2.1)、(7.7±4.6)mL,均P<0.01]。治疗12月后,3组患者的IPSS和残余尿量均较治疗前减少,Qmax均较治疗前增加。B、C两组IPSS、Qmax及残余尿量的改善幅度大于A组[分别为IPSS:(6.8±2.6)、(7.9±2.3)比(2.6±2.2);Qmax:(3.2±1.4)、(5.3±1.2)比(1.5±1.1)mL/s;残余尿量:(15.3±21.4)、(16.8±5.9)比(8.1±9.2)mL;均P<0.01]。总的不良反应发生率为3.2%,其中A组2例(1.4%),B组4例(3.1%),C组6例(5.7%)。结论缬沙坦联合非那雄胺可改善高血压合并BPH患者的IPSS、Qmax和残余尿量水平。

Objective To observe the clinical efficacy of combination of valsartan and finasteride on hypertensive pa-tients with benign prostatic hyperplasia（BPH）. Methods Randomized and parallel-controlled clinical trial methods were adopted in the study. From September 2008 to December 2010, a total of 372 inpatients and outpatients with essential hypertension and BPH from Huaihe Hospital of Henan University were enrolled and divided into three groups： group A （receiving 80 mg/d of valsartan, n=138） , group B （receiving 80 mg/d of valsartan and 5 mg/d of finasteride, n=128） , and group C （4 mg/d of doxazosin and 5 mg/d of finasteride, n= 106）. All subjects were observed for 12 months and had a follow-up every 3 months. Their blood pressure levels, international prostate symptom score（IPSS）, maximum flow rate （Qmax）, total prostate volume （TPV） and residual urine volume（RUV） were measured, and the clinical efficacy of all groups were evaluated. Results After six months, the TPVs of three groups were obviously decreased （ P〈0.05 ）. The improvements in TPV of group C were superior to those of the group A and group B[difference values： （11.7±6.2） vs （8.2±2.1）, （7.7±4.6）mL, all P〈0.01]. The IPSS and RUV of all groups were decreased and Qmax increased. The improvements in IPSS, Qmax and RUV of group B and group C were superior to those of the group A [difference values： IPSS （6.8±2.6） , （7.9±2.3） vs （2.6±2.2）; Qmax（3.2±1.4）, （5.3±1.2） vs （1.5±1. 1）mL/s;RUV （15.3±21.4）, （16.8±5.9） vs （8.1±9.2）mL; all P±0. 01]. The overall incidence rate of adverse reactions was 3. 2 %, and there were 2（1.4 %）, 4（3.1%） and 6（5.7 % ） cases in A,B,C group respectively. Conclusions Valsartan combined with finasteride may be effec-tive to improve the IPSS, Qmax, RUV of hypertensive patients with BPH.