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索利那新治疗特发性正常压力脑积水患者膀胱过度活动症症状的疗效和安全性:一项开放标签、多中心、前瞻性研究。

Efficacy and safety of solifenacin to treat overactive bladder symptoms in patients with idiopathic normal pressure hydrocephalus: an open-label, multicenter, prospective study.

机构信息

Department of Urology, Hanyang University College of Medicine, Seoul, Korea.

出版信息

Neurourol Urodyn. 2012 Sep;31(7):1175-80. doi: 10.1002/nau.22234. Epub 2012 Jun 6.

DOI:10.1002/nau.22234
PMID:22674356
Abstract

AIMS

To evaluate the efficacy and safety of solifenacin 5 mg to treat voiding symptoms caused by idiopathic normal pressure hydrocephalus (iNPH) after a ventriculoperitoneal (V-P) shunt operation.

METHODS

A total of 53 patients diagnosed with iNPH and complaining of voiding symptoms were enrolled. Before treatment with solifenacin (V1), 4 (V2) and 12 (V3) weeks after starting solifenacin overactive bladder symptom score (OABSS), the International Prostate Symptom Score (IPSS), Quality of Life (QoL) score, maximal urine flow rate (Q(max) ), voided volume, and post-voiding residual urine volume (PVR) were measured. An urodynamic study (UDS) was performed at V1 and V3, and the safety of solifenacin was assessed at V1, V2, and V3.

RESULTS

Of the 53 patients, 38 patients (71.70%) completed the 12-week clinical trial. The mean patient age was 52.24 ± 10.08 years. OABSS and IPSS were significantly improved. The mean voided volume was 147.18 ± 61.84 ml at V1 and 160.03 ± 62.59 ml at V3 (P < 0.001), and PVR was 64.87 ± 41.11 ml at V1 and 69.05 ± 39.54 ml at V3 (P = 0.009). Of the 31 patients who underwent UDS, 26 patients (83.87%) had detrusor overactivity (DO) at V1, with a mean value of 107.67 ± 18.13 ml. Of the 26 with DO at V1, 22 (84.62%) still had DO at V3. A mean DO of 131.66 ± 15.27 ml was observed at V3 (P < 0.001). The most common adverse effects was dry mouths.

CONCLUSIONS

Solifenacin is effective in the treatment of OABS in iNPH patients who underwent the V-P shunt operation. Solifenacin increases bladder capacity causing of DO at UDS.

摘要

目的

评估索利那新 5 毫克治疗脑室腹腔(V-P)分流术后特发性正常压力脑积水(iNPH)引起的排尿症状的疗效和安全性。

方法

共纳入 53 例诊断为 iNPH 并伴有排尿症状的患者。在开始使用索利那新前(V1)、4 周(V2)和 12 周(V3)时,分别评估膀胱过度活动症症状评分(OABSS)、国际前列腺症状评分(IPSS)、生活质量(QoL)评分、最大尿流率(Qmax)、排尿量和残余尿量(PVR)。在 V1 和 V3 时进行尿动力学检查(UDS),并在 V1、V2 和 V3 时评估索利那新的安全性。

结果

53 例患者中,38 例(71.70%)完成了 12 周的临床试验。患者平均年龄为 52.24 ± 10.08 岁。OABSS 和 IPSS 均显著改善。V1 时平均排尿量为 147.18 ± 61.84ml,V3 时为 160.03 ± 62.59ml(P<0.001),V1 时 PVR 为 64.87 ± 41.11ml,V3 时为 69.05 ± 39.54ml(P=0.009)。在 31 例行 UDS 的患者中,26 例(83.87%)在 V1 时存在逼尿肌过度活动(DO),平均为 107.67 ± 18.13ml。26 例 V1 时存在 DO 的患者中,22 例(84.62%)在 V3 时仍存在 DO。V3 时观察到 DO 的平均平均值为 131.66 ± 15.27ml(P<0.001)。最常见的不良反应是口干。

结论

索利那新可有效治疗 V-P 分流术后 iNPH 患者的膀胱过度活动症。索利那新增加膀胱容量,导致 UDS 时 DO。

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