Park Junsoo, Chun Ji-Youn, Kim Jang Hwan, Cheon Si-Yeol, Song Miho, Choo Myung-Soo, Lee Kyu-Sung, Oh Seung-June, Kim Joon Chul, Choi Jong Bo, Seo Ju Tae, Cho Sung Yong
Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro, 43-Gil, Songpa-gu, Seoul, 138-736, Korea.
Int Urol Nephrol. 2015 Feb;47(2):235-42. doi: 10.1007/s11255-014-0892-x. Epub 2014 Dec 11.
Dry mouth is among the most common side effects of antimuscarinic therapy. This study evaluated the drug-related change in dry mouth after the solifenacin treatment and the impact of dry mouth on the drug efficacy against overactive bladder syndrome (OAB).
OAB patients (n = 331) were enrolled in a prospective, multicenter, 8-week observational study of solifenacin treatment. Participants were >20 years of age and presented with OAB symptoms for ≥3 months, a total overactive bladder symptom score (OABSS) of ≥3, and an urgency score of ≥2. Primary endpoints were changes in dry mouth according to baseline dry mouth status using Xerostomia Inventory (XI) and the effect of dry mouth to the drug efficacy according to improvements in the OABSS.
Three hundred and thirty-three patients were initially screened for the study, with 331 actually enrolled. One hundred and ninety-four patients completed the study. Mean total XI scores increased by 2.8 points in the entire patient population, with larger increases for patients stratified into the non-dry mouth group (NDG) versus the dry mouth group (DG) (4.0 vs. 1.9, p = 0.015) at study baseline. Mean total OABSSs decreased by 3.2 points, with no significant differences between the NDG and the DG (-3.4 vs. -3.0 points, p = 0.578). The dry mouth aggravated in 71 patients (29.2 %) (NDG 30.1 % and DG 27.1 %), but only 10/331 individuals (3.0 %) stopped medication due to xerostomia. Dry mouth progressed in approximately 30 % of the OAB patients, regardless of its presence before solifenacin treatment. However, OAB symptoms were well relieved by solifenacin, and the adverse influence of dry mouth on drug persistence was low.
口干是抗毒蕈碱疗法最常见的副作用之一。本研究评估了索利那新治疗后口干的药物相关性变化以及口干对治疗膀胱过度活动症（OAB）药物疗效的影响。
OAB患者（n = 331）纳入一项关于索利那新治疗的前瞻性、多中心、8周观察性研究。参与者年龄>20岁，出现OAB症状≥3个月，膀胱过度活动症总症状评分（OABSS）≥3，且急迫性评分≥2。主要终点是使用口干量表（XI）根据基线口干状态评估的口干变化，以及根据OABSS改善情况评估的口干对药物疗效的影响。
最初筛选了333例患者进行研究，实际纳入331例。194例患者完成研究。在整个患者群体中，XI总评分平均增加2.8分，在研究基线时，非口干组（NDG）患者的增加幅度大于口干组（DG）患者（4.0对1.9，p = 0.015）。OABSS总评分平均下降3.2分，NDG和DG之间无显著差异（-3.4对-3.0分，p = 0.578）。71例患者（29.2%）口干加重（NDG为30.1%，DG为27.1%），但仅10/331例个体（3.0%）因口干而停药。无论索利那新治疗前是否存在口干，约30%的OAB患者口干情况加重。然而，索利那新能很好地缓解OAB症状，且口干对药物持续性的不良影响较低。
