Brubaker Linda, Gousse Angelo, Sand Peter, Thompson Catherine, Patel Vaishali, Zhou Jihao, Jenkins Brenda, Sievert Karl-Dietrich
Department of Obstetrics and Gynecology, Stritch School of Medicine, Loyola University Chicago, 2160 S. First Avenue, Chicago, IL 60153, USA.
Int Urogynecol J. 2012 Aug;23(8):1017-25. doi: 10.1007/s00192-011-1655-1. Epub 2012 Jan 25.
Clinically meaningful overactive bladder syndrome (OAB) symptom relief is associated with patient satisfaction. This study evaluated the effects of onabotulinumtoxinA on patient satisfaction and goal attainment.
In a 36-week, multicenter, double-blind study, 313 participants with idiopathic OAB and urinary urgency incontinence inadequately managed with anticholinergics were randomized to placebo or one of five onabotulinumtoxinA doses. Assessment included a modified OAB-Patient Satisfaction with Treatment Questionnaire (PSTQ) and four Patient Global Assessment questions assessed changes in symptoms, quality of life, activity limitations, and emotions.
Mean changes from baseline in OAB-PSTQ scores for the main module (Q2-Q13) at week 12 were greater for each onabotulinumtoxinA group (range, -31.5% to -48.9%) versus placebo (-17.6%). Greater proportions of patients in onabotulinumtoxinA groups attained their primary goal (range, 34.5% to 65.3%) versus placebo (23.7%).
Patients with OAB are more likely to be satisfied and/or achieve their primary treatment goal with onabotulinumtoxinA treatment than with placebo, consistent with symptom improvements.
临床上有意义的膀胱过度活动症（OAB）症状缓解与患者满意度相关。本研究评估了A型肉毒毒素对患者满意度和目标达成情况的影响。
在一项为期36周的多中心双盲研究中，313名患有特发性OAB且使用抗胆碱能药物治疗效果不佳的尿急失禁患者被随机分为安慰剂组或五种A型肉毒毒素剂量组之一。评估包括一份改良的OAB-治疗患者满意度问卷（PSTQ）以及四个患者总体评估问题，这些问题评估了症状、生活质量、活动受限和情绪方面的变化。
在第12周时，各A型肉毒毒素组主要模块（Q2-Q13）的OAB-PSTQ评分相对于基线的平均变化幅度更大（范围为-31.5%至-48.9%），而安慰剂组为-17.6%。与安慰剂组（23.7%）相比，A型肉毒毒素组中达到其主要目标的患者比例更高（范围为34.5%至65.3%）。
与安慰剂相比，OAB患者接受A型肉毒毒素治疗更有可能感到满意和/或实现其主要治疗目标，这与症状改善情况一致。
