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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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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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=
| Item | Control(n=40) | Treatment(n=40) |
|---|
Age (year, ) | 67.49±6.52 | 67.49±6.52 |
Disease duration (years, ) | 5.80±0.59 | 5.77±0.63 |
| Degree of hyperplasia(n,%) | | |
| Grade Ⅱ | 19(47.50) | 18(45.00) |
| Grade Ⅲ | 21(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-2, ) | 23.54±1.69 | 23.44±1.53 |
SBP(mmHg, ) | 102.14±3.58 | 102.23±3.69 |
DBP(mmHg, ) | 71.19±2.58 | 71.52±2.44 |
HR(beat·min-1, ) | 81.25±4.58 | 81.54±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=
| Item | Control(n=40) | Treatment(n=40) |
|---|
Age (year, ) | 67.49±6.52 | 67.49±6.52 |
Disease duration (years, ) | 5.80±0.59 | 5.77±0.63 |
| Degree of hyperplasia(n,%) | | |
| Grade Ⅱ | 19(47.50) | 18(45.00) |
| Grade Ⅲ | 21(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-2, ) | 23.54±1.69 | 23.44±1.53 |
SBP(mmHg, ) | 102.14±3.58 | 102.23±3.69 |
DBP(mmHg, ) | 71.19±2.58 | 71.52±2.44 |
HR(beat·min-1, ) | 81.25±4.58 | 81.54±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(
)
, figureFileSmall=null, figureFileBig=null, tableContent=
| Group | IPSS score (points) | Prostate volume (mL) | QoL score (points) |
|---|
| Before treatment | After treatment | Before treatment | After treatment | Before treatment | After treatment |
|---|
| Control(n=40) | 19.37±1.40 | 13.79±1.05* | 48.46±4.40 | 40.89±3.12* | 4.66±0.32 | 2.51±0.52* |
| Treatment(n=40) | 19.16±1.77 | 10.52±0.98*△ | 47.78±4.55 | 40.46±3.06*△ | 4.71±0.29 | 2.01±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(
)
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| Group | IPSS score (points) | Prostate volume (mL) | QoL score (points) |
|---|
| Before treatment | After treatment | Before treatment | After treatment | Before treatment | After treatment |
|---|
| Control(n=40) | 19.37±1.40 | 13.79±1.05* | 48.46±4.40 | 40.89±3.12* | 4.66±0.32 | 2.51±0.52* |
| Treatment(n=40) | 19.16±1.77 | 10.52±0.98*△ | 47.78±4.55 | 40.46±3.06*△ | 4.71±0.29 | 2.01±0.77*△ |
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Comparison of urodynamic indexes between two groups(
)
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| Group | PVR(mL) | AER(mL·s-1) | Qmax(mL·s-1) |
|---|
| Before treatment | After treatment | Before treatment | After treatment | Before treatment | After treatment |
|---|
| Control(n=40) | 45.28±4.14 | 35.79±3.24* | 12.59±1.40 | 14.37±1.22* | 17.40±1.40 | 21.96±2.77* |
| Treatment(n=40) | 45.77±4.05 | 31.60±3.75*△ | 12.13±1.14 | 16.88±1.46*△ | 17.06±1.52 | 24.09±2.53*△ |
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2组患者尿动力学指标的比较(
)
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| Group | PVR(mL) | AER(mL·s-1) | Qmax(mL·s-1) |
|---|
| Before treatment | After treatment | Before treatment | After treatment | Before treatment | After treatment |
|---|
| Control(n=40) | 45.28±4.14 | 35.79±3.24* | 12.59±1.40 | 14.37±1.22* | 17.40±1.40 | 21.96±2.77* |
| Treatment(n=40) | 45.77±4.05 | 31.60±3.75*△ | 12.13±1.14 | 16.88±1.46*△ | 17.06±1.52 | 24.09±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 (
)
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| Group | PSA(ng·L-1) | Red blood cell counts in urine sediment (per HP) |
| Before treatment | After treatment | Before treatment | After treatment |
| Control(n=40) | 2.29±0.41 | 0.74±0.10* | 49.22±4.14 | 40.25±3.22* |
| Treatment(n=40) | 2.27±0.45 | 0.51±0.09*△ | 49.87±4.05 | 37.41±3.06*△ |
| Group | T(ng·mL-1) | E2(pg·mL-1) |
| Before treatment | After treatment | Before treatment | After treatment |
| Control(n=40) | 812.44±10.78 | 929.78±16.77* | 42.41±3.40 | 127.58±10.35* |
| Treatment(n=40) | 811.04±10.58 | 974.05±16.87*△ | 42.06±3.55 | 136.47±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=
| Group | PSA(ng·L-1) | Red blood cell counts in urine sediment (per HP) |
| Before treatment | After treatment | Before treatment | After treatment |
| Control(n=40) | 2.29±0.41 | 0.74±0.10* | 49.22±4.14 | 40.25±3.22* |
| Treatment(n=40) | 2.27±0.45 | 0.51±0.09*△ | 49.87±4.05 | 37.41±3.06*△ |
| Group | T(ng·mL-1) | E2(pg·mL-1) |
| Before treatment | After treatment | Before treatment | After treatment |
| Control(n=40) | 812.44±10.78 | 929.78±16.77* | 42.41±3.40 | 127.58±10.35* |
| Treatment(n=40) | 811.04±10.58 | 974.05±16.87*△ | 42.06±3.55 | 136.47±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,%)
, figureFileSmall=null, figureFileBig=null, tableContent=
| Item | Control(n=40) | Treatment(n=40) |
|---|
| Significant effect | 17(42.50) | 20(50.00) |
| Effective | 15(37.50) | 18(45.00) |
| Invalid | 8(20.00) | 2(5.00) |
| Total efficiency | 32(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=
| Item | Control(n=40) | Treatment(n=40) |
|---|
| Significant effect | 17(42.50) | 20(50.00) |
| Effective | 15(37.50) | 18(45.00) |
| Invalid | 8(20.00) | 2(5.00) |
| Total efficiency | 32(80.00) | 38(95.00)△ |
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