Di Rezze Simone, Frasca Vittorio, Inghilleri Maurizio, Durastanti Valentina, Cortese Antonio, Giacomelli Elena, Millefiorini Enrico
Department of Neurological Sciences, "La Sapienza University", Rome, Italy.
Clin Neuropharmacol. 2012 Sep-Oct;35(5):231-4. doi: 10.1097/WNF.0b013e3182613dce.
Overactive bladder (OAB) syndrome represents one of the main urinary disorders associated with multiple sclerosis (MS). At present, no widely accepted effective treatment is available. Duloxetine, an antidepressant acting as a selective serotonin-norepinephrine reuptake inhibitor, has been shown to be effective in the treatment of some symptoms of stress urinary incontinence and OAB because of etiology other than MS.The present study aims at establishing the efficacy and tolerability of duloxetine in the treatment of OAB in patients affected by remitting-relapsing MS and secondary progressive MS.
Twenty-three patients with MS, 13 of which with remitting-relapsing MS and 10 with secondary progressive MS, have been treated with duloxetine and placebo for a total period of 8 weeks during a single-blinded cross-over trial. At each programmed visit, patients have been screened for the following: (1) quantitative evaluation of maximal bladder capacity and postmicturition residual volume; (2) questionnaire administration to evaluate bladder disorder--Overactive Bladder Questionnaire, quality of life--Visual Analogue Scale-Quality of life, fatigue--Fatigue Severity Scale, and depression--Beck Depression Inventory.
Three patients did not complete the study because of duloxetine-related adverse events. A statistically significant improvement in bladder disorder, as measured by OAB-Q, has been observed after duloxetine treatment compared with both basal levels and placebo with values of 21.8 ± 1.1 versus 34.2 ± 1.2 (P < 0.0001) and 21.8 ± 1.1 versus 30.1 ± 1.7 (P < 0.003), respectively.In addition, a decrease in postmicturition residual volume has also been observed compared with basal level (6.8 ± 3.2 ml vs 38.1 ± 12.2 ml, P = 0.06) together with an improvement in quality of life (7.1 ± 0.5 vs 6.3 ± 0.4, P = 0.07). Both these changes were close to being statistically significant.
It emerges from this study that duloxetine might become an effective therapeutic alternative to be investigated in a larger number of MS patients for the treatment of OAB. Duloxetine should be considered a first-choice drug in the treatment of MS patients presenting both depression and OAB; in addition, it should also be considered as a suitable alternative or as concomitant treatment in MS patients with OAB but not experiencing depression.
膀胱过度活动症（OAB）综合征是与多发性硬化症（MS）相关的主要泌尿系统疾病之一。目前，尚无广泛接受的有效治疗方法。度洛西汀是一种作为选择性5-羟色胺-去甲肾上腺素再摄取抑制剂的抗抑郁药，已被证明对治疗某些因非MS病因引起的压力性尿失禁和OAB症状有效。本研究旨在确定度洛西汀治疗复发缓解型MS和继发进展型MS患者OAB的疗效和耐受性。
23例MS患者，其中13例为复发缓解型MS，10例为继发进展型MS，在单盲交叉试验中接受度洛西汀和安慰剂治疗，为期8周。在每次预定访视时，对患者进行以下筛查：（1）最大膀胱容量和排尿后残余尿量的定量评估；（2）进行问卷调查以评估膀胱疾病——膀胱过度活动症问卷、生活质量——视觉模拟量表-生活质量、疲劳——疲劳严重程度量表和抑郁——贝克抑郁量表。
3例患者因度洛西汀相关不良事件未完成研究。与基线水平和安慰剂相比，度洛西汀治疗后，以OAB-Q测量的膀胱疾病有统计学显著改善，值分别为21.8±1.1与34.2±1.2（P<0.0001）和21.8±1.1与30.1±1.7（P<0.003）。此外，与基线水平相比，排尿后残余尿量也有所减少（6.8±3.2ml对38.1±12.2ml，P=0.06），生活质量有所改善（7.1±0.5对6.3±0.4，P=0.07）。这两个变化都接近具有统计学显著性。
本研究表明，度洛西汀可能成为一种有效的治疗选择，有待在更多MS患者中进行研究以治疗OAB。度洛西汀应被视为治疗同时患有抑郁和OAB的MS患者的首选药物；此外，对于患有OAB但未患抑郁的MS患者，它也应被视为合适的替代药物或联合治疗药物。
