肉毒杆菌毒素获准用于治疗膀胱过动症

圣路易斯(MD Consult)——2013年1月18日，美国食品药品管理局(FDA)和Allergan宣布，Botox(A型肉毒杆菌毒素)已获准用于治疗有急迫性尿失禁、尿急和尿频症状，并且对抗胆碱能药物应答不佳或不耐受的成人膀胱过动症(OAB)。Botox含有微量的高纯度肉毒杆菌毒素蛋白。Botox的配方中含有辅助性蛋白以使核心毒素维持稳定而不降解。据称，该产品可通过阻断神经冲动向膀胱肌肉的传递而暂时舒缓收缩的肌肉，从而缓解OAB症状。

Botox用于这一新适应证的安全性和有效性，已在2项双盲、随机、多中心、安慰剂对照、为期24周的试验中得到了验证。这2项试验共招募了1,105例有膀胱过动症症状的患者，后者随机分组后注射100单位Botox(每次注射5单位，共注射20次)或安慰剂。结果显示，治疗12周后，Botox组患者每日发生尿失禁的次数平均比安慰剂组患者减少了1.6~1.9次，每日小便次数平均比安慰剂组患者减少了1.0~1.7次，排尿量平均比安慰剂组患者增加了30 ml。在这2项试验中，Botox减少尿漏和其他OAB症状的疗效持续中位时间分别为135天和168天，而安慰剂组分别为88天和92天。

在这些临床研究中，在Botox治疗12周内最常报告的不良反应包括尿路感染(18% vs. 安慰剂组6%)、排尿困难(9% vs. 7%)和尿潴留(6.5% vs. 0.4%)。

如果之前Botox治疗的效果减弱，可在至少间隔12周的前提下再次使用该药治疗。

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ST LOUIS (MD Consult) - On January 18, 2013, the US Food and Drug Administration (FDA) and Allergan announced the approval of Botox (onabotulinumtoxinA) for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency in adults who have shown an inadequate response to or are intolerant of an anticholinergic medication. Botox contains minute amounts of a highly purified botulinum toxin protein refined from the bacterium, Clostridium botulinum. The Botox formula contains auxiliary proteins that stabilize the core toxin in Botox from degradation. The product is believed to relieve OAB symptoms by temporarily calming muscle contractions by blocking the transmission of nerve impulses to the bladder muscle.

The safety and effectiveness of Botox for this new indication were established in 2 double-blind, randomized, multicenter, placebo-controlled, 24-week trials of 1105 patients with symptoms of overactive bladder. Patients were randomly assigned to receive injections of 100 units of Botox (20 injections of 5 units each) or placebo. Results after 12 weeks showed that patients treated with Botox experienced urinary incontinence an average of 1.6 to 1.9 times less per day than patients treated with placebo. Botox-treated patients also needed to urinate on average 1.0 to 1.7 times less per day and expelled an average of about 30 mL more urine than patients treated with placebo. The median duration for efficacy with Botox at reducing urinary leakage and other symptoms of OAB in the 2 studies was 135 to 168 days, compared with 88 to 92 days with placebo.

In the clinical studies, the most frequently reported adverse reactions reported within 12 weeks of receiving Botox injections included urinary tract infection (18% vs 6% with placebo), dysuria (9% vs 7% with placebo), and urinary retention (6.5% vs 0.4% with placebo).

Treatment with Botox can be repeated when the benefits from the previous treatment have decreased, and after at least 12 weeks have passed since the last treatment.

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