盐酸丙哌维林在先前抗胆碱能药物反应不佳者中的疗效评估。

Evaluation of Usefulness of Propiverine Hydrochloride in Poor Responders to Previous Anticholinergics.

作者信息

Masumori Naoya, Funato Yuya, Yamaguchi Yasunobu, Itoh Kunio

机构信息

Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan.

Pharmacovigilance Department, Taiho Pharmaceutical Co., Ltd., Tokyo, Japan.

出版信息

Low Urin Tract Symptoms. 2018 May;10(2):116-121. doi: 10.1111/luts.12145. Epub 2016 Nov 5.

DOI:10.1111/luts.12145

PMID:29664239

Abstract

OBJECTIVES

In recent years, some patients have been unresponsive to anticholinergics used in the treatment of pollakisuria/urinary incontinence. It has been suggested that propiverine hydrochloride, which has not only anticholinergic activity, but also calcium antagonistic activity, may be useful in poor responders to other anticholinergics. In this study, a specific drug use-results survey was conducted in poor responders to other anticholinergics to evaluate the usefulness of propiverine hydrochloride.

METHODS

In this survey, propiverine hydrochloride was administered for 12 weeks to poor responders to previous anticholinergics, and its usefulness was evaluated by the overactive bladder symptom score (OABSS).

RESULTS

A total of 3851 subjects at 680 institutions were enrolled in the survey. Of the 3624 subjects included in the safety evaluation (male 1899, female 1725, mean age 73.4 years), 2932 were included in the efficacy evaluation (male 1610, female 1322, mean age 73.8 years). Propiverine hydrochloride significantly improved the OABSS without any safety concerns in poor responders to previous anticholinergics (OABSS, 8.22 at baseline, 6.50 at Week 4, 5.87 at Week 8, and 5.57 at Week 12, P < 0.001).

CONCLUSIONS

The present findings indicate that propiverine hydrochloride may be a useful therapeutic option for poor responders to previous anticholinergics.

摘要

目的

近年来，一些患者对用于治疗尿频/尿失禁的抗胆碱能药物无反应。有人提出，盐酸丙哌维林不仅具有抗胆碱能活性，还具有钙拮抗活性，可能对其他抗胆碱能药物治疗效果不佳的患者有用。在本研究中，对其他抗胆碱能药物治疗效果不佳的患者进行了一项特定的药物使用结果调查，以评估盐酸丙哌维林的有效性。

方法

在本次调查中，对先前使用抗胆碱能药物治疗效果不佳的患者给予盐酸丙哌维林治疗12周，并通过膀胱过度活动症症状评分（OABSS）评估其有效性。

结果

共有680家机构的3851名受试者参与了调查。在纳入安全性评估的3624名受试者中（男性1899名，女性1725名，平均年龄73.4岁），2932名纳入了疗效评估（男性1610名，女性1322名，平均年龄73.8岁）。盐酸丙哌维林显著改善了OABSS，且对先前抗胆碱能药物治疗效果不佳的患者没有任何安全性问题（OABSS，基线时为8.22，第4周时为6.50，第8周时为5.87，第12周时为5.57，P<0.001）。