Efficacy and safety of finasteride therapy for benign prostatic hyperplasia: results of a 2-year randomized controlled trial (the PROSPECT study). PROscar Safety Plus Efficacy Canadian Two year Study.
💡 한 문장 핵심
양성 전립선비대증에 대한 finasteride 치료의 효능과 안전성: 2년 무작위 대조 시험 결과 (PROSPECT study). PROscar Safety Plus Efficacy Canadian Two year Study.
🦱 탈모
🔵 RCT
무작위 임상시험
5/5 보강
TL;DR
Finasteride is a well-tolerated and effective alternative to watchful waiting in the treatment of moderate BPH and the incidence of adverse events related to sexual dysfunction were significantly higher in the finasteride group than in the placebo group.
📑 코퍼스 인용 관계
· 인용됨 17 · 인용함 13
→ 이 논문이 인용한 논문 (4) ▾
- Maintenance of clinical efficacy with finasteride therapy for 24 months in patients with b… Archives of internal medicine · 1994
- Three-year safety and efficacy data on the use of finasteride in the treatment of benign p… Urology · 1994
- Scandinavian clinical study of finasteride in the treatment of benign prostatic hyperplasi… European urology · 1992
- The effect of finasteride in men with benign prostatic hyperplasia. The Finasteride Study … The New England journal of medicine · 1992
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연도별 인용 (2012–2024) · 합계 88
OpenAlex 토픽 ·
Urinary Bladder and Prostate Research
Prostate Cancer Diagnosis and Treatment
Pelvic floor disorders treatments
🇰🇷 한글 요약 🌐 Abstract
【연구 목적】
중등도 양성 전립선비대증(benign prostatic hyperplasia, BPH) 환자에서 finasteride(피나스테리드) 5 mg/일을 2년간 투여했을 때의 유효성과 안전성을 평가하기 위한 연구입니다.
【방법】
캐나다 28개 기관에서 진행된 이중맹검·위약대조·무작위 전향적 다기관 연구로, 45~80세 남성 613명을 1개월 위약 도입기 후 finasteride군과 위약군으로 배정해 2년간 추적(472명 완료)했으며, BPH 증상점수·최대요속·전립선 용적 변화와 이상반응을 측정했습니다.
【주요 결과】
finasteride군은 위약군 대비 증상점수(−2.1 vs −0.7점), 최대요속(+1.4 vs +0.3 mL/s), 전립선 용적(−21% vs +8.4%) 모두 유의하게 개선되었습니다(모두 p≤0.01). 전체 이상반응 빈도는 양군이 유사(약 81%)했으나, 성기능 관련 이상반응은 finasteride군에서 유의하게 높았습니다(사정장애 7.7% vs 1.7%, 발기부전 15.8% vs 6.3%).
【임상적 시사점 (성형외과 의사 관점)】
이 약물은 5α-환원효소 억제제(5-alpha reductase inhibitor)로, 성형외과에서는 남성형 탈모(androgenetic alopecia) 치료에 1 mg 용량으로 활용되는 동일 계열 약물입니다. 본 연구처럼 고용량(5 mg)뿐 아니라 저용량에서도 발기부전·사정장애·성욕감퇴 등 성기능 이상반응 가능성을 환자에게 사전 고지하고 동의를 받는 것이 중요하며, 가임기 남성·임부 접촉 주의(기형 유발 위험)도 함께 상담해야 합니다.
[OBJECTIVE] To evaluate the efficacy and safety of 2 years' treatment of moderate benign prostatic hyperplasia (BPH) with finasteride.
[DESIGN] Double-blind, parallel-group, placebo-controlled, multicentre, prospective randomized study.
[SETTING] Outpatient care in 28 centres across Canada.
[PARTICIPANTS] Men aged 45 to 80, in good health, with moderate BPH and no evidence of prostate cancer. A total of 613 men were entered into the study; 472 completed the 2 years of treatment.
[INTERVENTION] After 1 month of receiving a placebo (run-in period), patients were given either finasteride (5 mg/d) or a placebo for 2 years.
[EFFICACY] changes from baseline in BPH symptom scores, maximum urinary flow rates and prostate volume.
[SAFETY] onset, course and resolution of all adverse events during the treatment period.
[RESULTS] In the efficacy analyses the mean BPH symptom scores decreased 2.1 points (from 15.8 to 13.7) in the finasteride group, as compared with a decrease of 0.7 points (from 16.6 to 15.9) in the placebo group (P < or = 0.01). The maximum urinary flow rate increased by a mean of 1.4 mL/s (from 11.1 to 12.5 mL/s) in the finasteride group, as compared with an increase of 0.3 mL/s (from 10.9 to 11.2 mL/s) in the placebo group (p < or = 0.01). The mean prostate volume decreased by 21% (from a mean volume of 44.1 cm3 at baseline) in the treatment group; it increased by 8.4% (from a mean volume of 45.8 cm3 at baseline) in the placebo group (p < or = 0.01). In the safety analysis, the proportion of patients who experienced any adverse event was similar in the two groups (81.0% in the treatment group and 81.2% in the placebo group). However, the incidence of adverse events related to sexual dysfunction were significantly higher in the finasteride group than in the placebo group (ejaculation disorder 7.7% v. 1.7% and impotence 15.8% v. 6.3%; p < or = 0.01 for both parameters).
[CONCLUSION] Finasteride is a well-tolerated and effective alternative to watchful waiting in the treatment of moderate BPH.
[DESIGN] Double-blind, parallel-group, placebo-controlled, multicentre, prospective randomized study.
[SETTING] Outpatient care in 28 centres across Canada.
[PARTICIPANTS] Men aged 45 to 80, in good health, with moderate BPH and no evidence of prostate cancer. A total of 613 men were entered into the study; 472 completed the 2 years of treatment.
[INTERVENTION] After 1 month of receiving a placebo (run-in period), patients were given either finasteride (5 mg/d) or a placebo for 2 years.
[EFFICACY] changes from baseline in BPH symptom scores, maximum urinary flow rates and prostate volume.
[SAFETY] onset, course and resolution of all adverse events during the treatment period.
[RESULTS] In the efficacy analyses the mean BPH symptom scores decreased 2.1 points (from 15.8 to 13.7) in the finasteride group, as compared with a decrease of 0.7 points (from 16.6 to 15.9) in the placebo group (P < or = 0.01). The maximum urinary flow rate increased by a mean of 1.4 mL/s (from 11.1 to 12.5 mL/s) in the finasteride group, as compared with an increase of 0.3 mL/s (from 10.9 to 11.2 mL/s) in the placebo group (p < or = 0.01). The mean prostate volume decreased by 21% (from a mean volume of 44.1 cm3 at baseline) in the treatment group; it increased by 8.4% (from a mean volume of 45.8 cm3 at baseline) in the placebo group (p < or = 0.01). In the safety analysis, the proportion of patients who experienced any adverse event was similar in the two groups (81.0% in the treatment group and 81.2% in the placebo group). However, the incidence of adverse events related to sexual dysfunction were significantly higher in the finasteride group than in the placebo group (ejaculation disorder 7.7% v. 1.7% and impotence 15.8% v. 6.3%; p < or = 0.01 for both parameters).
[CONCLUSION] Finasteride is a well-tolerated and effective alternative to watchful waiting in the treatment of moderate BPH.
- OR 0.01
【연구 목적】 중등도 양성 전립선비대증(benign prostatic hyperplasia, BPH) 환자에서 finasteride(피나스테리드) 5 mg/일을 2년간 투여했을 때의 유효성과 안전성을 평가하기 위한 연구입니다.
APA 7
Nickel, J. C., Fradet, Y., Boake, R. C., Pommerville, P. J., Perreault, J. P., Afridi, S. K., & Elhilali, M. M. (1996). Efficacy and safety of finasteride therapy for benign prostatic hyperplasia: Results of a 2-year randomized controlled trial (the prospect study). Proscar safety plus efficacy canadian two year study.. CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, 155(9), 1251-9.
Vancouver
Nickel JC, Fradet Y, Boake RC, Pommerville PJ, Perreault JP, Afridi SK, et al. Efficacy and safety of finasteride therapy for benign prostatic hyperplasia: results of a 2-year randomized controlled trial (the PROSPECT study). PROscar Safety Plus Efficacy Canadian Two year Study. CMAJ : Cana. Medi. Asso. jour. = jour. de l'As. medi. cana.. 1996;155(9):1251-9.
AMA 11
Nickel JC, Fradet Y, Boake RC, Pommerville PJ, Perreault JP, Afridi SK, et al. Efficacy and safety of finasteride therapy for benign prostatic hyperplasia: results of a 2-year randomized controlled trial (the PROSPECT study). PROscar Safety Plus Efficacy Canadian Two year Study. CMAJ : Cana. Medi. Asso. jour. = jour. de l'As. medi. cana.. 1996;155(9):1251-9.
Chicago
Nickel, J. C., Fradet, Y., Boake, R. C., Pommerville, P. J., Perreault, J. P., Afridi, S. K., and Elhilali, M. M.. 1996. "Efficacy and safety of finasteride therapy for benign prostatic hyperplasia: results of a 2-year randomized controlled trial (the PROSPECT study). PROscar Safety Plus Efficacy Canadian Two year Study." CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne 155 (9): 1251-9.
MLA 9
Nickel, J. C., et al. "Efficacy and safety of finasteride therapy for benign prostatic hyperplasia: results of a 2-year randomized controlled trial (the PROSPECT study). PROscar Safety Plus Efficacy Canadian Two year Study." CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, vol. 155, no. 9, 1996, pp. 1251-9.
PMID
8911291 ↗
🏷️ 키워드 / MeSH 📖 같은 키워드 OA만
인용 관계
그래프 OA 노드: 7/12 (58%)
· 참조 1편 · 후속 6편
이 논문이 참조한 문헌 13
- The effect of finasteride in men with benign prostatic hyperplasia. The Finasteride Study Group.
- Three-year safety and efficacy data on the use of finasteride in the treatment of benign prostatic h…
- Scandinavian clinical study of finasteride in the treatment of benign prostatic hyperplasia.
- Maintenance of clinical efficacy with finasteride therapy for 24 months in patients with benign pros…
이 논문을 인용한 후속 연구 17
- Adverse Effects and Safety of 5-alpha Reductase Inhibitors (Finasteride, Dutasteride): A Systematic …
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- Immunohistochemical evaluation of androgen receptor and nerve structure density in human prepuce fro…
- Post-finasteride syndrome: An emerging clinical problem.
- Post-finasteride syndrome and post-SSRI sexual dysfunction: two sides of the same coin?
- Annurca Apple Nutraceutical Formulation Enhances Keratin Expression in a Human Model of Skin and Pro…
- The Impact of 5α-Reductase Inhibitor Use for Male Pattern Hair Loss on Men's Health.
- Finasteride for benign prostatic hyperplasia.
- Suicidal risk associated with finasteride versus dutasteride among men treated for benign prostatic …
- Persistent sexual dysfunction and depression in finasteride users for male pattern hair loss: a seri…
- Finasteride and Male Breast Cancer: Does the MHRA Report Show a Link?
- Finasteride in the treatment of clinical benign prostatic hyperplasia: a systematic review of random…
- Finasteride-its impact on sexual function and prostate cancer.
- Altered methylation pattern of the SRD5A2 gene in the cerebrospinal fluid of post-finasteride patien…
- Finasteride: an update of its use in the management of symptomatic benign prostatic hyperplasia.
- A risk-benefit assessment of treatment with finasteride in benign prostatic hyperplasia.
- Androgenetic alopecia: effects of oral finasteride on hormone profile, reproduction and sexual funct…
같은 제1저자의 인용 많은 논문 (5)
- Comparison of dutasteride and finasteride for treating benign prostatic hyperplasia: the Enlarged Prostate International Comparator Study (EPICS).
- Comparison of clinical trials with finasteride and dutasteride.
- A randomized placebo-controlled multicentre study to evaluate the safety and efficacy of finasteride for male chronic pelvic pain syndrome (category IIIA chronic nonbacterial prostatitis).
- Finasteride monotherapy maintains stable lower urinary tract symptoms in men with benign prostatic hyperplasia following cessation of alpha blockers.
- Placebo therapy of benign prostatic hyperplasia: a 25-month study. Canadian PROSPECT Study Group.
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