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在一项随机、双盲的索利那新(SUNRISE)试验中评估膀胱过度活动症症状的严重程度和剂量递增反应。

Severity of overactive bladder symptoms and response to dose escalation in a randomized, double-blind trial of solifenacin (SUNRISE).

机构信息

Department of Urogynaecology, King's College Hospital, London, UK.

出版信息

BJU Int. 2013 May;111(5):804-10. doi: 10.1111/j.1464-410X.2012.11654.x. Epub 2013 Jan 7.

DOI:10.1111/j.1464-410X.2012.11654.x
PMID:23294801
Abstract

UNLABELLED

WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: Antimuscarinics are effective and well tolerated for treatment of OAB. Studies have found that a flexible dosing strategy can be effective in improving OAB symptoms with minimal impact on tolerability. This study confirms these findings with two doses of solifenacin, and shows that improved outcomes can be achieved by increasing solifenacin dose (from 5 to 10 mg) in patients with more severe symptoms.

OBJECTIVE

To determine the relationship between severity of baseline overactive bladder (OAB) symptoms and requests for solifenacin dose increases, and the efficacy of 5 and 10 mg solifenacin doses in relieving OAB symptoms in patients who requested a dose increase.

PATIENTS AND METHODS

In a 16-week clinical study, patients with OAB were randomized to double-blind treatment with solifenacin or placebo once daily. At week 8, all patients could request a dose increase; these patients entered a second phase of 8 weeks in which those in the solifenacin group were randomized to either 5 or 10 mg doses. The primary efficacy variable was mean change in the number of urgency episodes with or without incontinence per 24 h, measured using the Patient Perception of Intensity of Urgency Scale (PPIUS; grades 3 and 4).

RESULTS

Of 591 patients receiving solifenacin at 8 weeks, 275 (46.5%) requested a dose increase to 10 mg, and were further randomized to receive 10 mg (n = 140) or to remain on 5 mg (n = 135). Patients who requested a dose increase at week 8 generally had more severe OAB symptoms at baseline and a smaller response at week 8 to the initial solifenacin 5 mg dosage than those who did not. Greater reductions in the mean number of severe urgency episodes (PPIUS grades 3 and 4) were observed from week 8 to the end of treatment for patients requesting a dose increase and randomized to 10 mg solifenacin compared with those randomized to remain on 5 mg (mean reductions -0.9 vs -0.4, respectively), although these did not reach statistical significance. Statistically significant reductions were observed in mean total urgency score (TUS; -2.7 vs -0.6; P = 0.010), mean maximum PPIUS urgency rating (-0.3 vs -0.1; P = 0.034) and mean micturition frequency (-0.8 vs -0.1; P = 0.037). For all other OAB variables, greater changes were observed in the solifenacin 10 mg group but these did not reach statistical significance. Of those who requested a dose increase, eight (5.7%) patients randomized to receive 10 mg and one (0.7%) patient randomized to remain on 5 mg reported new or worsening cases of dry mouth.

CONCLUSIONS

Increasing the solifenacin dose to 10 mg further improved OAB symptoms in patients who requested a dose increase after 8 weeks' treatment with 5 mg solifenacin. The present study supports the view that patients with severe OAB symptoms benefit from a higher antimuscarinic dose.

摘要

背景:抗毒蕈碱药物治疗 OAB 有效且耐受性良好。研究发现,灵活的剂量策略可以在最小影响耐受性的情况下有效改善 OAB 症状。本研究使用两种索利那新剂量证实了这一发现,并表明在症状更严重的患者中增加索利那新剂量(从 5 毫克增加到 10 毫克)可以获得更好的疗效。

目的:确定基线 OAB 症状严重程度与索利那新剂量增加请求之间的关系,以及在请求增加剂量的患者中,5 毫克和 10 毫克索利那新剂量缓解 OAB 症状的疗效。

患者和方法:在一项为期 16 周的临床研究中,OAB 患者被随机分配接受索利那新或安慰剂每日一次的双盲治疗。在第 8 周时,所有患者均可请求增加剂量;这些患者进入第二阶段 8 周,其中索利那新组患者被随机分配至 5 毫克或 10 毫克剂量。主要疗效变量是使用尿急严重程度量表(PPIUS;等级 3 和 4)测量的 24 小时内尿急次数的平均变化,包括有或无尿失禁。

结果:在接受索利那新治疗的 591 例患者中,有 275 例(46.5%)在第 8 周时请求增加剂量至 10 毫克,并进一步随机分为接受 10 毫克(n = 140)或继续接受 5 毫克(n = 135)。与未请求增加剂量的患者相比,在第 8 周请求增加剂量的患者基线时 OAB 症状通常更严重,对初始索利那新 5 毫克剂量的反应也更小。与继续接受 5 毫克治疗的患者相比,请求增加剂量并随机接受 10 毫克索利那新治疗的患者从第 8 周开始到治疗结束时,严重尿急发作次数(PPIUS 等级 3 和 4)的平均减少幅度更大(分别为-0.9 与-0.4,P=0.010),尽管这些差异没有达到统计学意义。在总尿急评分(TUS;-2.7 与-0.6,P=0.010)、最大 PPIUS 尿急评分(-0.3 与-0.1,P=0.034)和平均排尿频率(-0.8 与-0.1,P=0.037)方面,观察到统计学显著的减少。对于所有其他 OAB 变量,在索利那新 10 毫克组中观察到更大的变化,但这些变化没有达到统计学意义。在请求增加剂量的患者中,有 8 例(5.7%)随机接受 10 毫克治疗的患者和 1 例(0.7%)继续接受 5 毫克治疗的患者报告出现新的或恶化的口干病例。

结论:在接受 5 毫克索利那新治疗 8 周后,增加索利那新剂量至 10 毫克进一步改善了请求增加剂量的患者的 OAB 症状。本研究支持这样一种观点,即严重 OAB 症状的患者受益于更高的抗毒蕈碱药物剂量。

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