中国临床药理学杂志2025，Vol.41Issue(16)：2269-2274,6.DOI:10.13699/j.cnki.1001-6821.2025.16.004
乌拉地尔联合非那雄胺治疗良性前列腺增生伴下尿路症状的临床研究
Clinical trial on the combination of urapidil and finasteride in the treatment of benign prostatic hyperplasia with lower urinary tract symptoms
摘要
Abstract
Objective To analyze the effect of urapidil sustained release capsules combined with finasteride tablet in the treatment of benign prostatic hyperplasia with lower urinary tract symptoms.Methods Patients with benign prostatic hyperplasia accompanied by lower urinary tract symptoms were included and randomly divided into treatment group and control group.Both groups received basic treatment with finasteride tablets,5 mg each time,once daily,orally.The treatment group was treated with urapidil sustained release capsules,with an initial dose of 30 mg per day.If the patient's clinical symptoms did not improve within 1-2 weeks,the dose could be gradually increased to 60 mg per day,with a maximum dose not exceeding 60 mg per day,twice a day,orally.Control group did not receive additional treatment.Compare the improvement of symptoms,quality of life,urodynamic indicators,laboratory indicators,clinical efficacy and evaluate safety between two groups.Results A total of 45 patients in treatment group and control group were included respectively.Ten patients withdrew from the study due to lost to follow-up or personal factors during the study,5 patients in each groups.Finally,a total of 80 patients completed the study,40 patients in treatment group and 40 patients in control group.The total effective rate of treatment group was 95.00％(38 cases/40 cases),while that of control group was 80.00％(32 cases/40 cases),which was statistically significantly higher in treatment group than in control group(P＜0.05).After treatment,the international prostate symptom score(IPSS)of treatment group and control group were(10.52±0.98)and(13.79±1.05)points;the prostate quality of life score(QoL)were(2.01±0.77)and(2.51±0.52)points,above indicators in treatment group were statistically significantly lower than those in control group(all P＜0.05).After treatment,post-void residual urine volume(PVR)levels of treatment group and control group were(31.60±3.75)and(35.79±3.24)mL,respectively;the average urinary flow rates(AER)were(16.88±1.46)and(14.37±1.22)mL·s-1,respectively;the maximum urinary flow rates(Qmax)were(24.09±2.03)and(21.96±2.77)mL·s-1,respectively.The PVR level in treatment group was statistically significantly lower than that in control group,while the AER and Qmax levels were statistically significantly higher than those in the control group(all P＜0.05).After treatment,the prostate-specific antigen(PSA)levels in treatment group and control group were(0.51±0.09)and(0.74±0.10)ng·L-1,respectively;the numbers of red blood cells in urine sediment were(37.41±3.06)and(40.25±3.22)cells per HP,respectively,and the above indicators in treatment group were statistically significantly lower than those in control group(all P＜0.05).After treatment,the testosterone(T)levels in treatment group and control group were(974.05±16.87)and(929.78±16.77)ng·mL-1,respectively;the estradiol(E2)levels were(136.47±10.55)and(127.58±10.35)pg·mL-1,respectively.The above indicators in treatment group were significantly higher than those in control group(all P＜0.05).The main adverse drug reactions in both groups were gastrointestinal discomfort,headache,etc.The incidence of adverse drug reactions in treatment group was 12.50％(5 cases/40 cases),while in control group was 5.00％(2 cases/40 cases).There was no statistically significant difference between the two groups(P＞0.05).Conclusion Patients with benign prostatic hyperplasia accompanied by lower urinary tract symptoms were treated with combination therapy of urapidil sustained-release capsules and finasteride tablet,which improved their urodynamic indicators and clinical symptoms,restored their sex hormone levels,improved their treatment efficacy and quality of life.关键词
乌拉地尔缓释胶囊/非那雄胺片/良性前列腺增生/下尿路症状Key words
urapidil sustained release capsule/finasteride tablet/benign prostatic hyperplasia/lower urinary tract symptoms分类
医药卫生引用本文复制引用
曾顺,林奕涛,周浩,潘滢,于淼..乌拉地尔联合非那雄胺治疗良性前列腺增生伴下尿路症状的临床研究[J].中国临床药理学杂志,2025,41(16):2269-2274,6.基金项目
湖南中医药管理局一般课题基金资助项目(B2024096) （B2024096）
