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α1受体阻滞剂YM617在良性前列腺增生治疗中的应用。YM617临床研究组。

Use of an alpha 1-blocker, YM617, in the treatment of benign prostatic hypertrophy. YM617 Clinical Study Group.

作者信息

Kawabe K, Ueno A, Takimoto Y, Aso Y, Kato H

机构信息

Department of Urology, Hamamatsu University School of Medicine, Japan.

出版信息

J Urol. 1990 Oct;144(4):908-11; discussion 911-2. doi: 10.1016/s0022-5347(17)39620-9.

DOI:10.1016/s0022-5347(17)39620-9
PMID:1697914
Abstract

A recently synthesized alpha 1-blocker, (R)(-)-5-[2-[[2-(o-ethoxyphenoxy)ethyl]amino]propyl]-2- methoxybenzenesulfonamide hydrochloride (YM617), was evaluated in 270 patients with benign prostatic hypertrophy in a double-blind study. After 2 weeks on placebo the patients were assigned at random to 4 groups: group P--placebo, group L--0.1 mg., group M--0.2 mg. and group H--0.4 mg. of YM617. Comparing the placebo to the treatment period, subjective symptoms, such as nocturia and urgency, were significantly decreased in group H (p less than 0.01). The sensation of incomplete voiding was significantly improved in groups M and H (p less than 0.01). However, the differences among the groups were statistically insignificant. Residual urine volume was significantly decreased in groups L, M and H after instillation of saline into the bladder (p less than 0.01) but not in group P. The maximum and average flow rates were significantly increased in groups L, M and H (p less than 0.01) but not in group P. Average flow rate showed significant differences between groups M or H versus group P. Neither orthostatic hypotension nor a decrease in blood pressure was noted. Adverse side effects and changes in laboratory data were all slight and disappeared when the second tests were performed. In summary, the irritative and obstructive symptoms caused by benign prostatic hypertrophy were decreased and urodynamic studies were markedly improved by the alpha 1-blocker, YM617. The drug seems to be useful in the treatment of patients with benign prostatic hypertrophy.

摘要

一种最近合成的α1受体阻滞剂,(R)(-)-5-[2-[[2-(邻乙氧基苯氧基)乙基]氨基]丙基]-2-甲氧基苯磺酰胺盐酸盐(YM617),在一项双盲研究中对270例良性前列腺增生患者进行了评估。在服用安慰剂2周后,患者被随机分为4组:P组——安慰剂组,L组——0.1毫克YM617组,M组——0.2毫克YM617组,H组——0.4毫克YM617组。与安慰剂期相比,治疗期时,H组的主观症状,如夜尿症和尿急,显著减轻(p<0.01)。M组和H组的排尿不尽感显著改善(p<0.01)。然而,各组之间的差异无统计学意义。向膀胱内注入生理盐水后,L组、M组和H组的残余尿量显著减少(p<0.01),而P组未减少。L组、M组和H组的最大尿流率和平均尿流率显著增加(p<0.01),而P组未增加。M组或H组与P组之间的平均尿流率存在显著差异。未观察到体位性低血压或血压下降。不良副作用和实验室数据变化均轻微,在进行第二次检测时消失。总之,α1受体阻滞剂YM617可减轻良性前列腺增生引起的刺激性和梗阻性症状,并显著改善尿动力学研究。该药物似乎对良性前列腺增生患者的治疗有用。

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