Article(id=1246531409628783216, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1246531406415941821, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.16.004, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1746547200000, receivedDateStr=2025-05-07, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1775125847488, onlineDateStr=2026-04-02, pubDate=1756310400000, pubDateStr=2025-08-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1775125847488, onlineIssueDateStr=2026-04-02, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1775125847488, creator=13701087609, updateTime=1775125847488, updator=13701087609, issue=Issue{id=1246531406415941821, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='16', pageStart='2251', pageEnd='2400', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=1, specialIssue=null, createTime=1775125846723, creator=13701087609, updateTime=1775125956861, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1246531868481446285, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1246531406415941821, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1246531868481446286, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1246531406415941821, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=2269, endPage=2274, ext={EN=ArticleExt(id=1246531415806993218, articleId=1246531409628783216, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trial on the combination of urapidil and finasteride in the treatment of benign prostatic hyperplasia with lower urinary tract symptoms, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
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.

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目的

观察乌拉地尔缓释胶囊联合非那雄胺治片治疗良性前列腺增生伴下尿路症状的临床疗效和安全性。

方法

将良性前列腺增生伴下尿路症状患者随机分为试验组和对照组。2组均用非那雄胺片进行基础治疗,每次5 mg,每日1次,口服。试验组加用乌拉地尔缓释胶囊治疗,初始剂量为每天30 mg,若患者临床症状未改善,可在1~2周内逐渐增加剂量至每天60 mg,每日2次,口服,对照组不进行额外的治疗。比较2组患者临床症状改善情况、生活质量、尿动力学指标、实验室指标和临床疗效,并评价安全性。

结果

试验组与对照组各纳入45例患者,研究途中因个人因素退出研究及失访患者共10例,试验组与对照组各5例,最终共80例患者完成本次研究,试验组和对照组各40例。试验组的总有效率为95.00%(38例/40例),对照组为80.00%(32例/40例),试验组显著高于对照组(P<0.05)。治疗后,试验组和对照组的国际前列腺症状评分(IPSS)分别为(10.52±0.98)和(13.79±1.05)分;前列腺生活质量评分(QoL)分别为(2.01±0.77)和(2.51±0.52)分,试验组的上述指标均显著低于对照组(均P<0.05)。治疗后,试验组和对照组的残余尿量(PVR)分别为(31.60±3.75)和(35.79±3.24)mL;平均尿流率(AER)分别为(16.88±1.46)和(14.37±1.22)mL·s-1;最大尿流率(Qmax)分别为(24.09±2.53)和(21.96±2.77)mL·s-1,试验组的PVR水平显著低于对照组;试验组的AER和Qmax水平均显著高于对照组(均P<0.05)。治疗后,试验组和对照组的前列腺特异性抗原(PSA)分别为(0.51±0.09)和(0.74±0.10)ng·L-1;尿沉渣红细胞数分别为(37.41±3.06)和(40.25±3.22)cells·HP-1,试验组的上述指标均显著低于对照组(均P<0.05)。治疗后,试验组和对照组睾酮(T)分别为(974.05±16.87)和(929.78±16.77)ng·mL-1,雌二醇(E2)分别为(136.47±10.55)和(127.58±10.35)pg·mL-1,试验组的上述指标均显著高于对照组(均P<0.05)。试验组和对照组的主要的药物不良反均为胃肠道不适、头痛等,试验组总药物不良反应发生率为12.50%(5例/40例),对照组为5.00%(2例/40例),2组比较在统计学上差异无统计学意义(P>0.05)。

结论

与单用非那雄胺片比较,良性前列腺增生伴下尿路症状患者经乌拉地尔缓释胶囊与非那雄胺片联合治疗,尿动力学指标与临床症状均得到了显著改善,性激素水平得以恢复,治疗效果与生活质量得到了提升。

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于淼,副主任医师 MP:13055187726 E-mail:
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曾顺(1982- ),男,主治医师,主要从事中西医结合泌尿外科及男科方面的临床和科研工作

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曾顺(1982- ),男,主治医师,主要从事中西医结合泌尿外科及男科方面的临床和科研工作

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曾顺(1982- ),男,主治医师,主要从事中西医结合泌尿外科及男科方面的临床和科研工作

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journalName=现代药物与临床, refType=null, unstructuredReference=范月霞,王雅慧,蔡建红,. 前列舒乐颗粒联合非那雄胺治疗良性前列腺增生症的临床研究[J]. 现代药物与临床,2023,38(10):2568-2572., articleTitle=前列舒乐颗粒联合非那雄胺治疗良性前列腺增生症的临床研究, refAbstract=null), Reference(id=1246531426687017344, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1246531409628783216, doi=null, pmid=null, pmcid=null, year=2023, volume=20, issue=22, pageStart=3279, pageEnd=3281,3286, url=null, language=null, rfNumber=[12], rfOrder=11, authorNames=王忠军, 冯驰, 殷雍, journalName=检验医学与临床, refType=null, unstructuredReference=王忠军,冯驰,殷雍,. 非那雄胺对前列腺增生患者经尿道前列腺钬激光剜除术后尿动力学指标及IPSS评分的影响[J]. 检验医学与临床,2023,20(22):3279-3281,3286., articleTitle=非那雄胺对前列腺增生患者经尿道前列腺钬激光剜除术后尿动力学指标及IPSS评分的影响, refAbstract=null), Reference(id=1246531426745737601, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1246531409628783216, doi=null, pmid=null, pmcid=null, year=2023, volume=29, issue=6, pageStart=538, pageEnd=542, url=null, language=null, rfNumber=[13], rfOrder=12, authorNames=崔岩康, 商学军, journalName=中华男科学杂志, refType=null, unstructuredReference=崔岩康,商学军. 乌拉地尔改善良性前列腺增生患者下尿路症状的有效性评估:系统评价及meta分析[J]. 中华男科学杂志,2023,29(6):538-542., articleTitle=乌拉地尔改善良性前列腺增生患者下尿路症状的有效性评估:系统评价及meta分析, refAbstract=null), Reference(id=1246531426800263556, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1246531409628783216, doi=null, pmid=null, pmcid=null, year=2025, volume=42, issue=6, pageStart=1011, pageEnd=1014,1018, url=null, language=null, rfNumber=[14], rfOrder=13, authorNames=魏超, 丁玉峰, journalName=医学临床研究, refType=null, unstructuredReference=魏超,丁玉峰.非那雄胺对大鼠良性前列腺增生致下尿路症状的影响及作用机制[J].医学临床研究,2025,42(6): 1011-1014,1018., articleTitle=非那雄胺对大鼠良性前列腺增生致下尿路症状的影响及作用机制, refAbstract=null), Reference(id=1246531426875761031, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1246531409628783216, doi=null, pmid=null, pmcid=null, year=2024, volume=26, issue=11, pageStart=1704, pageEnd=1707, url=null, language=null, rfNumber=[15], rfOrder=14, authorNames=董玉, 王语嫣, journalName=中国医师杂志, refType=null, unstructuredReference=董玉,王语嫣. 乌拉地尔注射液联合神经节苷脂对高血压基底节区脑出血开颅患者预后的影响[J]. 中国医师杂志,2024,26(11):1704-1707., articleTitle=乌拉地尔注射液联合神经节苷脂对高血压基底节区脑出血开颅患者预后的影响, refAbstract=null), Reference(id=1246531426934481289, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1246531409628783216, doi=null, pmid=null, pmcid=null, year=2020, volume=91, issue=4, pageStart=205, pageEnd=210, url=null, language=null, rfNumber=[16], rfOrder=15, authorNames=BUSETTO G M, DEL GIUDICE F, D′AGOSTINO D, journalName=Arch Ital Urol Androl, refType=null, unstructuredReference=BUSETTO G M, DEL GIUDICE F, D′AGOSTINO D, et al. Efficacy and safety of finasteride (5 alpha-reductase inhibitor) monotherapy in patients with benign prostatic hyperplasia: A critical review of the literature [J]. Arch Ital Urol Androl, 2020,91(4):205-210., articleTitle=Efficacy and safety of finasteride (5 alpha-reductase inhibitor) monotherapy in patients with benign prostatic hyperplasia: A critical review of the literature, refAbstract=null), Reference(id=1246531426993201547, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1246531409628783216, doi=null, pmid=null, pmcid=null, year=2023, volume=13, issue=1, pageStart=5308, pageEnd=null, url=null, language=null, rfNumber=[17], rfOrder=16, authorNames=LAANANI M, WEILL A, JOLLANT F, journalName=Sci Rep, refType=null, unstructuredReference=LAANANI M, WEILL A, JOLLANT F, et al. Suicidal risk associated with finasteride versus dutasteride among men treated for benign prostatic hyperplasia: Nationwide cohort study [J]. Sci Rep, 2023,13(1):5308., articleTitle=Suicidal risk associated with finasteride versus dutasteride among men treated for benign prostatic hyperplasia: Nationwide cohort study, refAbstract=null)], funds=[Fund(id=1246531425617469790, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1246531409628783216, awardId=B2024096, language=CN, fundingSource=湖南中医药管理局一般课题基金资助项目(B2024096), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1246531420508807286, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1246531409628783216, xref=1a., ext=[AuthorCompanyExt(id=1246531420517195895, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1246531409628783216, companyId=1246531420508807286, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1a.Department of Urology, Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Changsha 410005, Hunan Province, China), AuthorCompanyExt(id=1246531420521390200, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1246531409628783216, companyId=1246531420508807286, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1a.湖南中医药大学 第二附属医院泌尿外科,湖南 长沙 410005)]), AuthorCompany(id=1246531420605276287, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1246531409628783216, xref=1b., ext=[AuthorCompanyExt(id=1246531420613664896, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1246531409628783216, companyId=1246531420605276287, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1b.Department of Andrology, Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Changsha 410005, Hunan Province, China), AuthorCompanyExt(id=1246531420622053505, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1246531409628783216, companyId=1246531420605276287, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1b.湖南中医药大学 第二附属医院男科,湖南 长沙 410005)])], figs=[ArticleFig(id=1246531424652779816, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1246531409628783216, language=EN, label=Table 1, caption=

Comparison of general information in two groups

, figureFileSmall=null, figureFileBig=null, tableContent=
ItemControl(n=40)Treatment(n=40)
Age (year,67.49±6.5267.49±6.52
Disease duration (years,)5.80±0.595.77±0.63
Degree of hyperplasia(n,%)
Grade Ⅱ19(47.50)18(45.00)
Grade Ⅲ21(52.50)22(55.00)
Hyperglycemia(n,%)21(52.50)22(55.00)
Hypertension(n,%)23(57.50)22(55.00)
Hyperlipidemia(n,%)18(45.00)16(40.00)
BMI(kg·m-223.54±1.6923.44±1.53
SBP(mmHg,102.14±3.58102.23±3.69
DBP(mmHg,71.19±2.5871.52±2.44
HR(beat·min-181.25±4.5881.54±4.05
), ArticleFig(id=1246531424736665903, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1246531409628783216, language=CN, label=表1, caption=

2组患者一般资料的比较

, figureFileSmall=null, figureFileBig=null, tableContent=
ItemControl(n=40)Treatment(n=40)
Age (year,67.49±6.5267.49±6.52
Disease duration (years,)5.80±0.595.77±0.63
Degree of hyperplasia(n,%)
Grade Ⅱ19(47.50)18(45.00)
Grade Ⅲ21(52.50)22(55.00)
Hyperglycemia(n,%)21(52.50)22(55.00)
Hypertension(n,%)23(57.50)22(55.00)
Hyperlipidemia(n,%)18(45.00)16(40.00)
BMI(kg·m-223.54±1.6923.44±1.53
SBP(mmHg,102.14±3.58102.23±3.69
DBP(mmHg,71.19±2.5871.52±2.44
HR(beat·min-181.25±4.5881.54±4.05
), ArticleFig(id=1246531424845717811, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1246531409628783216, language=EN, label=Table 2, caption=

Comparison of international prostate symptom score(IPSS), prostate volume and quality of life between two groups(

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GroupIPSS score (points)Prostate volume (mL)QoL score (points)
Before treatmentAfter treatmentBefore treatmentAfter treatmentBefore treatmentAfter treatment
Control(n=40)19.37±1.4013.79±1.05*48.46±4.4040.89±3.12*4.66±0.322.51±0.52*
Treatment(n=40)19.16±1.7710.52±0.98*△47.78±4.5540.46±3.06*△4.71±0.292.01±0.77*△
), ArticleFig(id=1246531424942186806, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1246531409628783216, language=CN, label=表2, caption=

2组患者国际前列腺症状评分(IPSS)、前列腺体积和生活质量的比较(

, figureFileSmall=null, figureFileBig=null, tableContent=
GroupIPSS score (points)Prostate volume (mL)QoL score (points)
Before treatmentAfter treatmentBefore treatmentAfter treatmentBefore treatmentAfter treatment
Control(n=40)19.37±1.4013.79±1.05*48.46±4.4040.89±3.12*4.66±0.322.51±0.52*
Treatment(n=40)19.16±1.7710.52±0.98*△47.78±4.5540.46±3.06*△4.71±0.292.01±0.77*△
), ArticleFig(id=1246531425047044411, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1246531409628783216, language=EN, label=Table 3, caption=

Comparison of urodynamic indexes between two groups(

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GroupPVR(mL)AER(mL·s-1Qmax(mL·s-1
Before treatmentAfter treatmentBefore treatmentAfter treatmentBefore treatmentAfter treatment
Control(n=40)45.28±4.1435.79±3.24*12.59±1.4014.37±1.22*17.40±1.4021.96±2.77*
Treatment(n=40)45.77±4.0531.60±3.75*△12.13±1.1416.88±1.46*△17.06±1.5224.09±2.53*△
), ArticleFig(id=1246531425118347584, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1246531409628783216, language=CN, label=表3, caption=

2组患者尿动力学指标的比较(

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GroupPVR(mL)AER(mL·s-1Qmax(mL·s-1
Before treatmentAfter treatmentBefore treatmentAfter treatmentBefore treatmentAfter treatment
Control(n=40)45.28±4.1435.79±3.24*12.59±1.4014.37±1.22*17.40±1.4021.96±2.77*
Treatment(n=40)45.77±4.0531.60±3.75*△12.13±1.1416.88±1.46*△17.06±1.5224.09±2.53*△
), ArticleFig(id=1246531425223205190, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1246531409628783216, language=EN, label=Table 4, caption=

Comparison of laboratory indexes between the two groups (

, figureFileSmall=null, figureFileBig=null, tableContent=
GroupPSA(ng·L-1Red blood cell counts in urine sediment (per HP)
Before treatmentAfter treatmentBefore treatmentAfter treatment
Control(n=40)2.29±0.410.74±0.10*49.22±4.1440.25±3.22*
Treatment(n=40)2.27±0.450.51±0.09*△49.87±4.0537.41±3.06*△
GroupT(ng·mL-1E2(pg·mL-1
Before treatmentAfter treatmentBefore treatmentAfter treatment
Control(n=40)812.44±10.78929.78±16.77*42.41±3.40127.58±10.35*
Treatment(n=40)811.04±10.58974.05±16.87*△42.06±3.55136.47±10.55*△
), ArticleFig(id=1246531425328062795, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1246531409628783216, language=CN, label=表4, caption=

2组患者实验室指标的比较(

, figureFileSmall=null, figureFileBig=null, tableContent=
GroupPSA(ng·L-1Red blood cell counts in urine sediment (per HP)
Before treatmentAfter treatmentBefore treatmentAfter treatment
Control(n=40)2.29±0.410.74±0.10*49.22±4.1440.25±3.22*
Treatment(n=40)2.27±0.450.51±0.09*△49.87±4.0537.41±3.06*△
GroupT(ng·mL-1E2(pg·mL-1
Before treatmentAfter treatmentBefore treatmentAfter treatment
Control(n=40)812.44±10.78929.78±16.77*42.41±3.40127.58±10.35*
Treatment(n=40)811.04±10.58974.05±16.87*△42.06±3.55136.47±10.55*△
), ArticleFig(id=1246531425437114705, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1246531409628783216, language=EN, label=Table 5, caption=

Comparison of clinical effects between the two groups(n,%)

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ItemControl(n=40)Treatment(n=40)
Significant effect17(42.50)20(50.00)
Effective15(37.50)18(45.00)
Invalid8(20.00)2(5.00)
Total efficiency32(80.00)38(95.00)
), ArticleFig(id=1246531425529389398, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1246531409628783216, language=CN, label=表5, caption=

2组患者临床疗效的比较(n,%)

, figureFileSmall=null, figureFileBig=null, tableContent=
ItemControl(n=40)Treatment(n=40)
Significant effect17(42.50)20(50.00)
Effective15(37.50)18(45.00)
Invalid8(20.00)2(5.00)
Total efficiency32(80.00)38(95.00)
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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
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曾顺 1a , 林奕涛 1b , 周浩 1a , 潘滢 1a , 于淼 1a
中国临床药理学杂志 | 临床与基础桥接研究 2025,41(16): 2269-2274
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中国临床药理学杂志 | 临床与基础桥接研究 2025, 41(16): 2269-2274
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
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曾顺1a, 林奕涛1b, 周浩1a, 潘滢1a, 于淼1a
作者信息
  • 1a.湖南中医药大学 第二附属医院泌尿外科,湖南 长沙 410005
  • 1b.湖南中医药大学 第二附属医院男科,湖南 长沙 410005
  • 曾顺(1982- ),男,主治医师,主要从事中西医结合泌尿外科及男科方面的临床和科研工作

通讯作者:

于淼,副主任医师 MP:13055187726 E-mail:
Clinical trial on the combination of urapidil and finasteride in the treatment of benign prostatic hyperplasia with lower urinary tract symptoms
Shun ZENG1a, Yi-tao LIN1b, Hao ZHOU1a, Ying PAN1a, Miao YU1a
Affiliations
  • 1a.Department of Urology, Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Changsha 410005, Hunan Province, China
  • 1b.Department of Andrology, Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Changsha 410005, Hunan Province, China
出版时间: 2025-08-28 doi: 10.13699/j.cnki.1001-6821.2025.16.004
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目的

观察乌拉地尔缓释胶囊联合非那雄胺治片治疗良性前列腺增生伴下尿路症状的临床疗效和安全性。

方法

将良性前列腺增生伴下尿路症状患者随机分为试验组和对照组。2组均用非那雄胺片进行基础治疗,每次5 mg,每日1次,口服。试验组加用乌拉地尔缓释胶囊治疗,初始剂量为每天30 mg,若患者临床症状未改善,可在1~2周内逐渐增加剂量至每天60 mg,每日2次,口服,对照组不进行额外的治疗。比较2组患者临床症状改善情况、生活质量、尿动力学指标、实验室指标和临床疗效,并评价安全性。

结果

试验组与对照组各纳入45例患者,研究途中因个人因素退出研究及失访患者共10例,试验组与对照组各5例,最终共80例患者完成本次研究,试验组和对照组各40例。试验组的总有效率为95.00%(38例/40例),对照组为80.00%(32例/40例),试验组显著高于对照组(P<0.05)。治疗后,试验组和对照组的国际前列腺症状评分(IPSS)分别为(10.52±0.98)和(13.79±1.05)分;前列腺生活质量评分(QoL)分别为(2.01±0.77)和(2.51±0.52)分,试验组的上述指标均显著低于对照组(均P<0.05)。治疗后,试验组和对照组的残余尿量(PVR)分别为(31.60±3.75)和(35.79±3.24)mL;平均尿流率(AER)分别为(16.88±1.46)和(14.37±1.22)mL·s-1;最大尿流率(Qmax)分别为(24.09±2.53)和(21.96±2.77)mL·s-1,试验组的PVR水平显著低于对照组;试验组的AER和Qmax水平均显著高于对照组(均P<0.05)。治疗后,试验组和对照组的前列腺特异性抗原(PSA)分别为(0.51±0.09)和(0.74±0.10)ng·L-1;尿沉渣红细胞数分别为(37.41±3.06)和(40.25±3.22)cells·HP-1,试验组的上述指标均显著低于对照组(均P<0.05)。治疗后,试验组和对照组睾酮(T)分别为(974.05±16.87)和(929.78±16.77)ng·mL-1,雌二醇(E2)分别为(136.47±10.55)和(127.58±10.35)pg·mL-1,试验组的上述指标均显著高于对照组(均P<0.05)。试验组和对照组的主要的药物不良反均为胃肠道不适、头痛等,试验组总药物不良反应发生率为12.50%(5例/40例),对照组为5.00%(2例/40例),2组比较在统计学上差异无统计学意义(P>0.05)。

结论

与单用非那雄胺片比较,良性前列腺增生伴下尿路症状患者经乌拉地尔缓释胶囊与非那雄胺片联合治疗,尿动力学指标与临床症状均得到了显著改善,性激素水平得以恢复,治疗效果与生活质量得到了提升。

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
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.

urapidil sustained release capsule  /  finasteride tablet  /  benign prostatic hyperplasia  /  lower urinary tract symptoms
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. 中国临床药理学杂志, 2025 , 41 (16) : 2269 -2274 . DOI: 10.13699/j.cnki.1001-6821.2025.16.004
Shun ZENG, Yi-tao LIN, Hao ZHOU, Ying PAN, Miao YU. Clinical trial on the combination of urapidil and finasteride in the treatment of benign prostatic hyperplasia with lower urinary tract symptoms[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (16) : 2269 -2274 . DOI: 10.13699/j.cnki.1001-6821.2025.16.004
良性前列腺增生多见于中老年男性,常伴有尿路症状,以尿频、尿急、夜尿增多、排尿分叉等症状为主,部分患者可能并发血尿、尿路感染、膀胱结石、肾积水等症状,需要及时治疗[1-2]。目前,对于良性前列腺增生伴下尿路症状的患者主要用非那雄胺等药物进行治,其作为5α-还原酶抑制剂,能参与睾酮与双氢睾酮之间的转变,促使患者的前列腺体积缩小,下尿路症状得到改善,但单独使用临床效果不佳[3]。研究表明,乌拉地尔可用于良性前列腺增生的治疗,其在日本老年下尿路症状治疗中取得了良好的临床疗效[4]。为进一步提升良性前列腺增生伴下尿路症状的治疗效果,本研究用乌拉地尔联合非那雄胺治疗的方案进行治疗,旨在分析联合用药治疗良性前列腺增生伴下尿路症状的临床疗效和安全性,以期为临床良性前列腺增生治疗方案的完善提供临床数据参考。
本研究按前瞻性、单中心、随机、对照、开放、临床研究方法设计。
2024年1月至2024年12月以本院就诊的良性前列腺增生伴下尿路症状患者入选为研究对象,本研究经湖南中医药大学第二附属医院医学伦理委员会批准(伦理批号:2023-KY-033)。所有患者均签署知情同意书。
诊断与入选标准 符合《中国良性前列腺增生诊治指南》[5]中良性前列腺增生疾病诊断标准,且为Ⅱ或Ⅲ度增生者;近30 d内未接受良性前列腺增生相关治疗者;预计生存期>6个月者;对研究所用的乌拉地尔和非那雄胺等药品无过敏症状者;了解研究内容,自愿加入者。
排除标准 合并尿路感染者,存在尿道缩窄现象者,有前列腺手术史者,合并精神类疾病者,存在语言功能、听觉功能障碍,不能与旁人正常沟通者,依从性差者。
非那雄胺片,规格:每片5 mg,批号:240813,批准文号:国药准字H20070146,湖北舒邦药业有限公司生产;乌拉地尔缓释胶囊,规格:每片30 mg,批号:240708,批准文号:国药准字H20070161,西安远大德天药业股份有限公司生产。
UF5000尿沉渣分析仪,日本Sysmex公司产品;YG 0014-0101酶联免疫检测仪,德国欧蒙医学实验诊断股份公司产品。
将入组的患者用随机抽签法分为试验组和对照组。2组均使用非那雄胺片作为基础治疗,每次5 mg,每日1次,口服,可与或不与食物同服。试验组在此基础上给予乌拉地尔缓释胶囊治疗,初始剂量为每天30 mg,每日2次,口服,若患者临床症状未改善,可在1~2周内逐渐增加剂量至每天60 mg,最大剂量不超过每天60 mg,每日2次,口服,并可根据年龄、症状做适当增减。以上2组患者均连续治疗8周。
生活质量评估 评估时间分别为治疗前和治疗完全结束后,应用前列腺生活质量评分(quality of life score,QoL)[6]评价,包括心理状态、社会关系和个体生理3个维度,总分0~6,分值越高,生活质量越差。
前列腺体积 分别于治疗前和治疗完全结束后,经超声检查患者前列腺体积,前列腺体积(mL)=0.52×左右径(cm)×前后径(cm)×上下径(cm)。
尿动力学指标 评估时间同上,应用尿动力学检测仪测定残余尿量(post-void residual urine volume,PVR)、平均尿流率(average urinary flow rate,AER)和最大尿流率(maximum urinaryflow rate,Qmax)。
实验室指标 评估时间同上,在患者空腹状态下抽取静脉血,应用酶联免疫吸附法(enzyme-linked immunosorbent assay,ELISA)测定前列腺特异性抗原(prostate-specificantigen,PSA)、睾酮(testosterone,T)和雌二醇(estradiol ,E2)水平,尿沉渣分析仪测定尿沉渣红细胞数。
临床症状评分 评估时间同上,通过国际前列腺症状评分(international prostate symptom score,IPSS)[7]判断,包括尿等待、尿急、尿中断等7个症状,各症状均采用0~5分进行评价,最高35分,分值越高,症状越严重。
临床疗效 参考《中国良性前列腺增生诊治指南》[5]评价患者的临床疗效,显效:患者的尿频、尿急、夜尿增多等症状基本消失;有效:患者上述症状得到了明显改善;无效:上述症状未得到改善或出现加重现象,临床有效率=(显效例数+有效例数)/总例数×100%。
安全性评价 记录2组患者胃肠道不适、头痛、恶心等药物不良反应发生情况。
用SPSS 22.0软件进行统计学分析。计数资料用率(%)表示,组间比较行χ2检验;计量资料用表示,组间比较用独立样本t检验,组内比较用配对t检验。
试验组与对照组各纳入45例患者,研究途中因个人因素退出研究及失访患者共10例,试验组与对照组各5例,其中试验组患者4例因个人因素退出研究、1例失访;对照组患者2例因个人因素退出研究,3例失访。最终本研究纳入80例,其中试验组40例、对照组40例。2组患者的年龄、病史、体质量指数、血压、心率等临床资料比较,在统计学上差异均无统计学意义(均P>0.05),组间具有可比性,见表1
治疗前,2组患者的尿等待、尿急和尿中断等评估量表IPSS评分、列腺体积及QoL评分在统计学上差异均无统计学意义(均P>0.05);治疗后,试验组的IPSS评分、前列腺体积和QoL评分相比于对照组均显著降低(均P<0.05),见表2
治疗前,2组患者的尿动力学指标水平比较,在统计学上差异均无统计学意义(均P>0.05);治疗后,试验组的PVR水平与对照组比较显著降低;AER和Qmax水平与对照组比较均显著升高,在统计学上差异均有统计学意义(均P<0.05),见表3
治疗前,2组的实验室指标水平比较,在统计学上差异均无统计学意义(均P>0.05);治疗后,与对照组比较,试验组的PSA和尿沉渣红细胞数均显著降低,T和E2水平均显著升高,在统计学上差异均有统计学意义(均P<0.05),见表4
试验组的总有效率显著高于对照组(P<0.05),见表5
对照组患者发生头晕1例、胃肠道不适1例,总药物不良反应发生率为5.00%(2例/40例);试验组发生头晕2例、头痛1例、胃肠道不适1例、恶心1例,总药物不良反应发生率为12.50%(5例/40例),2组对比在统计学上差异无统计学意义(P>0.05)。
良性前列腺增生伴下尿路症状的发生主要与激素的刺激、间质上皮相互作用紊乱、前列腺细胞增殖与凋亡失衡等因素有关[8-9]。非那雄胺能阻断睾酮转化为双氢睾酮的过程,降低体内双氢睾酮的表达,减小前列腺体积,达到治疗良性前列腺增生伴下尿路症状的效果[10-11]。王忠军等[12]研究提出,前列腺增生患者经尿道前列腺钬激光剜除术后,经非那雄胺治疗,尿动力学指标及IPSS评分均得到改善,与本研究观点相似。但非那雄胺治疗良性前列腺增生伴下尿路症状时,疗程相对较长,易增加药物不良反应的发生率,影响整体临床疗效。
本研究发现,治疗后,试验组的总有效率与对照组相比显著升高,IPSS评分显著降低,提示与单用非那雄胺治疗比较,乌拉地尔联合非那雄胺更有助于改善患者的尿等待、尿急和尿中断等临床症状,提升临床疗效。治疗后,2组前列腺体积变化在统计学上差异无统计学意义,主要因为乌拉地尔可阻断突触后α1受体,降低外周阻力,并能激活5-羟色胺-1α受体,降低心脑血管调节总数的交感反馈作用,扩张血管,调节血液循环,减轻良性前列腺增生伴下尿路症状患者的充血肿胀现象,其主要改善良性前列腺增生患者的下尿路症状,而非缩小前列腺腺体。崔岩康等[13]研究表明,乌拉地尔是一种有效的缓解男性良性前列腺增生下尿路症状的药物,与本研究一致。
尿动力检查是评估前列腺增生患者排尿功能的重要手段,PVR、AER和Qmax等指标反映患者的排尿障碍情况。本研究发现,与治疗前对比,治疗后,2组患者的PVR水平显著下降,AER和Qmax水平均显著升高,反映了联合治疗相比于单药治疗有助于改善患者的尿动力学指标。非那雄胺能抑制前列腺组织的生长速度,缓解排尿困难等症状,从而使患者的尿动力学指标得到改善[14]。乌拉地尔可阻断尿道和膀胱平滑肌上的α1受体,松弛该部位肌肉,降低排尿阻力,从而进一步改善机体的尿动力学指标水平。同时乌拉地尔还能抑制前列腺包膜与腺体组织中的α1受体,降低前列腺张力,缓解机械性梗阻,有助于改善患者的尿动力学情况[15]
在本研究中,治疗后试验组PSA和尿沉渣红细胞数均显著降低,T和E2水平均显著升高。乌拉地尔中含有蔗糖苷酶,可分解尿液中的蔗糖与其他糖类,促使尿液中的糖含量降低,抑制细菌在尿液中的生长,抑制尿路感染,从而改善PSA和尿沉渣红细胞数水平。本研究发现,联合治疗有助于改善良性前列腺增生伴下尿路症状患者的性激素水平。非那雄胺与乌拉地尔联合治疗可缓解前列腺增生引起的排尿功能障碍症状,抑制前列腺增生的发生,从而降低前列腺增生对患者性激素的影响,有助于提升患者的生活质量[16-17]
本研究中试验组和对照组的总药物不良反应比较,在统计学上差异无统计学意义,但可观察到试验组患者的头晕、恶心等药物不良反应发生率有增加的趋势,分析其原因可能与乌拉地尔降低血压的作用有关。因此,在利用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患者时,需监测血压变化情况,及时调整治疗方案,以降低头晕恶心等药物不良反应的发生率。
本研究提示:乌拉地尔缓释胶囊联合非那雄胺片与单用非那雄胺片相比,可以更好地改善尿动力学指标与临床症状,更好地控制患者病情,提升患者生活质量,且安全性较好。但本研究的样本量相对较少,可能会对研究结果有一定影响,需开展进一步的研究以获得更全面的临床数据。
  • 湖南中医药管理局一般课题基金资助项目(B2024096)
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2025年第41卷第16期
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doi: 10.13699/j.cnki.1001-6821.2025.16.004
  • 接收时间:2025-05-07
  • 首发时间:2026-04-02
  • 出版时间:2025-08-28
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  • 收稿日期:2025-05-07
基金
湖南中医药管理局一般课题基金资助项目(B2024096)
作者信息
    1a.湖南中医药大学 第二附属医院泌尿外科,湖南 长沙 410005
    1b.湖南中医药大学 第二附属医院男科,湖南 长沙 410005

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于淼,副主任医师 MP:13055187726 E-mail:
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https://castjournals.cast.org.cn/joweb/zglcylxzz/CN/10.13699/j.cnki.1001-6821.2025.16.004
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2种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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