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[米帕明150,000单位(40毫克)与安慰剂治疗良性前列腺增生的双盲评估]

[Double-blind evaluation of mepartricin 150.000 U (40 mg) compared with placebo in benign prostatic hypertrophy].

作者信息

Prezioso D, Mirone V, Fabrizio F, Lotti T

机构信息

Cattedra di Urologia, II Facoltà di Medicina, Università degli Studi, Napoli.

出版信息

Minerva Urol Nefrol. 1996 Dec;48(4):207-11.

PMID:9005590
Abstract

The therapeutic efficacy and tolerance of a new 150,000 U (40 mg) formulation of mepartricin (to be administered once-a-day in the evening) were evaluated during a double-blind study against placebo in 2 groups of uncomplicated BPH patients treated for 60 days. The data obtained disclosed a positive pharmaco-therapeutic effect of this new formulation coupled with excellent local and systemic tolerance. At the end of trial the various objective and subjective parameters considered showed marked improvement in the group treated with mepartricin, with statistically significant differences from the placebo-treated group. The treatment efficacy was judged positive in 74-78% of cases by patients and physicians in the mepartricin group and in 36.4% of cases in the placebo group.

摘要

在一项双盲研究中,对两组未并发其他疾病的良性前列腺增生(BPH)患者进行了为期60天的治疗,评估了新的15万单位(40毫克)甲帕霉素制剂(每晚给药一次)相对于安慰剂的治疗效果和耐受性。所获得的数据表明,这种新制剂具有积极的药物治疗效果,且局部和全身耐受性良好。试验结束时,所考虑的各种客观和主观参数显示,接受甲帕霉素治疗的组有显著改善,与安慰剂治疗组相比有统计学意义上的显著差异。甲帕霉素组中,患者和医生判定治疗有效的病例分别为74%-78%,而安慰剂组为36.4%。

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