索利那新与丙咪嗪联合治疗能否在去氨加压素抵抗性单症状性夜间遗尿症中发挥作用？一项前瞻性双盲随机安慰剂对照研究。
Can the combined treatment of solifenacin and imipramine has a role in desmopressin refractory monosymptomatic nocturnal enuresis? A prospective double-blind randomized placebo-controlled study.
机构信息
Department of Urology, Ain Shams University, Cairo, Egypt.
出版信息
Urologia. 2021 Nov;88(4):369-373. doi: 10.1177/0391560321993587. Epub 2021 Feb 10.
BACKGROUND
Nocturnal enuresis is a common disease of childhood. It can be classified into monosymptomatic nocturnal enuresis (MNE) or nonmonosymptomatic nocturnal enuresis (NMNE). Imipramine is a tricyclic antidepressant used to treat enuresis with initial success rates are high as 50% but some studies record a high relapse rate and it has a cardiotoxic effect when overdosed. Anticholinergics may be effective in the treatment of children with bladder storage dysfunction, including daytime incontinence. However, anticholinergics monotherapy is not effective in treating MNE. In our study, we used a low dose (25 mg) of imipramine in order to avoid its potential side effects and combined it with the synergistic anticholinergic action of solifenacin. Our objective was to evaluate the efficacy and safety of the combination of solifenacin and imipramine compared with placebo in the treatment of desmopressin refractory MNE.
METHODS
One hundred children aged 6 years or more with primary MNE unresponsive to desmopressin treatment were included. The children were randomly divided into two equal groups. Group A received imipramine 25 mg and solifenacin 5-10 mg oral tablets and group B received placebo once 1 h before bedtime for 3 months. The primary end point was to investigate the efficacy of the combined treatment of solifenacin and imipramine and the secondary end point was the safety of the drugs.
RESULTS
Our study showed that the mean post treatment wet nights per month was significantly lesser in the treatment group than placebo group ( < 0.001) and cure rate was significantly higher in treatment group than placebo group ( < 0.001). The relapse rate was statistically significantly lower in treatment group than placebo group ( = 0.032). No significant side effects related to the drugs were reported.
CONCLUSION
The combination treatment of solifenacin and imipramine is a useful and safe treatment for nocturnal enuresis after failure of everything else.
背景
遗尿症是一种常见的儿童疾病。它可以分为单纯性夜间遗尿症（MNE）或非单纯性夜间遗尿症（NMNE）。丙咪嗪是一种三环类抗抑郁药，用于治疗遗尿症，初始成功率高达 50%，但一些研究记录了较高的复发率，并且过量使用会有心脏毒性。抗胆碱能药物可能对膀胱储存功能障碍（包括日间尿失禁）的儿童有效。然而，抗胆碱能药物单药治疗对 MNE 无效。在我们的研究中，我们使用了低剂量（25mg）的丙咪嗪以避免其潜在的副作用，并将其与索利那新的协同抗胆碱能作用相结合。我们的目的是评估索利那新和丙咪嗪联合治疗与安慰剂相比在治疗去氨加压素难治性 MNE 中的疗效和安全性。
方法
我们纳入了 100 名年龄在 6 岁或以上的原发性 MNE 对去氨加压素治疗无反应的儿童。这些儿童被随机分为两组。A 组接受丙咪嗪 25mg 和索利那新 5-10mg 口服片剂，B 组在睡前 1 小时接受安慰剂治疗，持续 3 个月。主要终点是研究索利那新和丙咪嗪联合治疗的疗效，次要终点是药物的安全性。
结果
我们的研究表明，治疗组每月平均治疗后湿夜数明显少于安慰剂组（<0.001），治疗组的治愈率明显高于安慰剂组（<0.001）。治疗组的复发率明显低于安慰剂组（=0.032）。未报告与药物相关的显著不良反应。
结论
在所有其他治疗失败后，索利那新和丙咪嗪联合治疗是一种有用且安全的治疗夜间遗尿症的方法。
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