Effects of 100 and 300 units of onabotulinum toxin A on lower urinary tract symptoms of benign prostatic hyperplasia: a phase II randomized clinical trial.
Effects of 100 and 300 units of onabotulinum toxin A on lower urinary tract symptoms of benign prostatic hyperplasia: a phase II randomized clinical trial.
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DOI：
10.1016/j.juro.2011.04.062
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发表时间：
2011-09
期刊：
影响因子：
--
通讯作者：
Bruskewitz R
中科院分区：
文献类型：
--
作者：
Crawford ED;Hirst K;Kusek JW;Donnell RF;Kaplan SA;McVary KT;Mynderse LA;Roehrborn CG;Smith CP;Bruskewitz R
我们进行了一项2阶段、多中心、双盲、随机、II期临床试验，使用100和300单位剂量的onabotetransitoxin A治疗良性前列腺增生的下尿路症状。临床诊断为良性前列腺增生、美国泌尿外科协会症状指数≥ 8、最大尿流率≤ 15 ml/s、排尿量≥ 125 ml、排尿后残余尿量≤ 350 ml的50岁或以上男性患者随机接受前列腺经直肠注射100或300单位的奥那巴毒素A。主要结局是美国泌尿外科协会症状指数和/或最大尿流率和安全性从基线到3个月至少改善30%。这些人被跟踪了12个月。共有134名男性接受随机化和治疗（68名接受100单位治疗，66名接受300单位治疗），131名在3个月时接受评估，108名在12个月时接受评估。每次给药均符合3个月主要结局标准。在100单位组中，平均基线美国泌尿外科协会症状指数为18.8，在3个月和12个月时分别下降了7.1和6.9。在300单位组中，基线19.5分别降低了8.9和7.1。在100单位组中，平均基线最大尿流率10.0 ml/s分别增加了2.5和2.2，在300单位组中，基线最大尿流率9.6分别增加了2.6和2.3。前列腺内注射100或300单位的onabotetrabotrabotoxin A通过了预定的治疗有效性和安全性标准，并且需要进行随机试验。100单位剂量可能是优选的，因为具有降低的成本和副作用的类似功效。
We conducted a 2-stage, multicenter, double-blind, randomized phase II clinical trial of 100 and 300 unit doses of onabotulinum toxin A to treat the lower urinary tract symptoms of benign prostatic hyperplasia. Men 50 years old or older with clinically diagnosed benign prostatic hyperplasia, American Urological Association symptom index 8 or greater, maximum urinary flow rate less than 15 ml per second, voided volume 125 ml or greater, and post-void residual 350 ml or less were randomized to prostatic transrectal injection of 100 or 300 units of onabotulinum toxin A. The primary outcome was at least 30% improvement from baseline to 3 months in American Urological Association symptom index and/or maximum urinary flow rate and safety. The men were followed for 12 months. A total of 134 men were randomized and treated (68 with 100 units, 66 with 300 units), with 131 assessed at 3 months and 108 assessed at 12 months. Each dose met the 3-month primary outcome criteria. In the 100 unit arm the mean baseline American Urological Association symptom index of 18.8 decreased by 7.1 and 6.9 at 3 and 12 months, respectively. In the 300 unit arm the baseline of 19.5 decreased by 8.9 and 7.1, respectively. In the 100 unit arm the mean baseline maximum urinary flow rate of 10.0 ml per second increased by 2.5 and 2.2, respectively, and in the 300 unit arm the baseline of 9.6 increased by 2.6 and 2.3, respectively. The intraprostatic injection of 100 or 300 units of onabotulinum toxin A passed predetermined criteria for treatment efficacy and safety, and a randomized trial with either dose is warranted. The 100 unit dose may be preferable due to similar efficacy with reduced costs and adverse effects.
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