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Clinical trial on the combination of urapidil and finasteride in the treatment of benign prostatic hyperplasia with lower urinary tract symptoms
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Shun ZENG1a, Yi-tao LIN1b, Hao ZHOU1a, Ying PAN1a, Miao YU1a
Chinese Journal of Clinical Pharmacology | 2025, 41(16) : 2269 - 2274
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Chinese Journal of Clinical Pharmacology | 2025, 41(16): 2269-2274
Clinical and Basic Bridging Research
Clinical trial on the combination of urapidil and finasteride in the treatment of benign prostatic hyperplasia with lower urinary tract symptoms
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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
Published: 2025-08-28 doi: 10.13699/j.cnki.1001-6821.2025.16.004
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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
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
Year 2025 volume 41 Issue 16
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doi: 10.13699/j.cnki.1001-6821.2025.16.004
  • Receive Date:2025-05-07
  • Online Date:2026-04-02
  • Published:2025-08-28
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  • Received:2025-05-07
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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
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表12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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