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전립선 비대증에서의 TERAZOSIN의 임상효과에 관한 연구: 위약을 대조로 한 무작위 이중맹검법에 의한 시도

The Efficacy of Terazosin in the Treatment of Benign Prostatic Hyperplasia: A Randomized, Placebo-controlled Double Blind Study

대한비뇨기과학회지 1995년 36권 4호 p.406 ~ 416
이상은
손환철/이진행/김현희/이종욱

Abstract


Since it has shown that the smooth muscle is the dominant cellular constituent of the hyperplastic prostate and outlet obstruction in benign prostatic hyperplasia (BPH0 is mediated by sympathetic nerve system via prostatic smooth muscle alpha 1
receptor, various kinds of alpha blocker have been tried in the treatment of BPH with moderate effectiveness. From May 1994 to December, 1994, a randomized placebo-controlled double blind study of long-acting selective alpha 1 blocker terazosin
was
undertaken to evaluate short-term effects of pharmacotherapy for BPH. Of 80 patients with symptomatic BPH who were randomized to receive placebo or terazosin, 42 completed the study. At baseline, the irritative. obstructive and total symptom
score
(mean±SD) were 8.4±3.3, 11.8±4.9, 20.2±7.6 in placebo group and 8.3±4.3, 12.1±4.6, 20.4±7.3 in terazosin group and the peak and mean urinary flow rate 9ml/sec) were 10.7±2.6 and 5.5±2.0 in placebo group and 9.8±3.6 and 5.1±2.1 in
terazosin
group. After 28 days trial, the irritative, obstructive and total symptom score (mean±SD) were 7.4±3.8, 9.3±5.6, 16.8±9.2 in placebo group and 5.2±3.6, 6.2±4.0, 11.4±6.6 in terazosin group (p<0.05, p<0.05 and p<0.01) and the peak and mean
urinary
flow rate (ml/sec0 were 11.1±5.1 and 5.8±3.1 in placebo groupo and 14.7±6.4, 8.0±3.9 in terazosin group. (p<0.01 and p<0.01) At least 30% improvement in total symptom score and peak flow rate were observed in 67% (14.21) and 76% (16/21) of
patients
respectively in terazosin group The common side effects were mild dizziness in 5 (22%) in terazosin group and 1(5%) in placebo group but premature termination was observed in only 2(9%) patients in terazosin group and 1(5%) in placebo group. The
mean
change in baseline systolic pressure was 2mmHg for normotensive group and 19mmHg for hypertensive group. In conclusion, this study showed beneficial short term result for the safety and efficacy of long acting selective alpha 1 blocker terazosin
in
the
management of symptoms of BPH. However, the durability of the safety and efficacy of terazosin needs to be evaluated for longer periods.

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