小剂量肉毒杆菌毒素A治疗难治特发性膀胱过动症的疗效与安全性：一项多中心、双盲、随机、安慰剂对照的剂量范围研究

Background:

In the treatment of patients with idiopathic overactive bladder (iOAB), high doses of botulinum toxin type A (BoNTA) were often associated with complications resulting from high postvoid residuals (PVR), leading to clean intermittent catheterisation (CIC) and urinary tract infections (UTI).

Objective:

Evaluate the efficacy and tolerability of low doses of onabotulinumtoxinA compared to placebo in patients with iOAB.

Design, Setting, and Participants:

Between 2005 and 2009, adults with persistent iOAB were included in a prospective, randomised, double-blind, placebo-controlled comparative trial.

Intervention:

Patients were randomised to undergo a single intradetrusor injection procedure of either placebo or onabotulinumtoxinA (50U, 100U or 150U).

Measurements:

The initial evaluations (ie, clinical and urodynamic variables as well as quality of life [QoL]) were repeated at day 8 and months 1, 3, 5, and 6.

Results and Limitations:

Ninety-nine patients were included in the efficacy analysis. Three months after the procedure, we observed >50% improvement versus baseline in urgency and urge urinary incontinence (UUI) in 65% and 56% of patients who respectively received 100U (p=0.086) and 150U (p=0.261) BoNTA injections and >75% improvement in 40% of patients of both groups (100U [p=0.058] and 150U [p=0.022]). Complete continence was observed in 55% and 50% patients after 100U and 150U BoNTA treatment, respectively, at month 3. Frequency symptoms and QoL improved up to the 6-mo visit. We observed only three patients with a PVR >200ml in the 150U group and a few UTIs.

Conclusions:

100U and 150U BoNTA injections were well tolerated and have both shown to improve symptoms and QoL in patients with iOAB. Nevertheless, 100U injections showed a reasonable efficacy, with a lower risk of high PVR.

Trial Registration:

ClinicalTrials.gov NCT00231491.