琥珀酸索利那新治疗前列腺电切术后膀胱过度活动症的临床观察

目的探讨琥珀酸索利那新在治疗前列腺电切术后膀胱过度活动症方面的作用。方法实验组23例,从术后出现膀胱过度活动症症状开始给予琥珀酸索利那新口服,5mg/次,1次/d,直至将导尿管拔除后停药;对照组23例,术后留置硬膜外镇痛泵,4d后拔除。结果实验组与对照组相比,疗效差异无显著性(P0.05)。结论琥珀酸索利那新治疗前列腺电切术后膀胱过度活动症的效果与术后留置硬膜外镇痛泵基本相当,但口服琥珀酸索利那新方法简便,适宜广泛临床应用,尤其是基层医院。     

Evaluating the effect of three newly approved overactive bladder syndrome treating agents on parotid and submandibular salivary glands: Modulation of CXCL10 expression

Background

Despite enormous progresses in understanding pathophysiology of the lower urinary tract, antimuscarinics remain the chief clinically well-established approach for improving symptoms of overactive bladder (OAB). Dry mouth on the other hand remains one of the most untolerated systemic side effects of these drugs that limits their uses and results in high discontinuation rate. Three novel drugs have been recently approved by US Food and Drug Administration for treatment of OAB: trospium, darifenacin, and solifenacin.

Safety and Efficacy of Mirabegron: Analysis of a Large Integrated Clinical Trial Database of Patients with Overactive Bladder Receiving Mirabegron,Antimuscarinics, or Placebo

BackgroundMirabegron, a β3-adrenoreceptor agonist, is an alternative drug to antimuscarinics for overactive bladder (OAB) symptoms.ObjectiveTo summarise safety and efficacy reporting of mirabegron treatment for OAB symptoms.Design, setting, and participantsPooled data analysed from 10 phase 2–4, double-blind, 12-wk mirabegron monotherapy studies in adults with OAB who had received one or more doses of study drug.InterventionMirabegron: 25 and 50 mg; antimuscarinics: solifenacin (2.5, 5, and 10 mg) and tolterodine extended release (4 mg).Outcome measurements and statistical analysisBaseline OAB-related characteristics, intrinsic and extrinsic factors, and analyses by age (<65 vs ≥65 yr and <75 vs ≥75 yr) and sex were assessed. Solifenacin 2.5 and 10 mg groups were not included in the efficacy analyses (small patient numbers). Safety was evaluated using the proportion of treatment-emergent adverse events. Efficacy variables were derived from bladder diaries (baseline and week 12).Results and limitationsBaseline hypertension and diabetes were more frequent across treatment groups in the older versus younger age groups and in men versus women. Within sexes, frequencies were similar between treatment groups. Some differences were observed in baseline characteristics, including type of incontinence and medical history between sexes. No previously unreported safety concerns were identified. Improvements in efficacy (mean number of incontinence episodes/24 h, micturitions/24 h, urgency episodes/24 h, volume voided/micturition, and nocturia episodes) versus placebo were observed in all treatment groups. Significant treatment-by-subgroup interactions included change from baseline in the mean number of incontinence episodes/24 h by age (<65 vs ≥65 yr), nocturia by age (<65 vs ≥65 yr and <75 vs ≥75 yr), and urgency episodes by previous OAB medication.ConclusionsData from this integrated database of 10 mirabegron studies reaffirm the safety and efficacy profiles of mirabegron, solifenacin, and tolterodine in adults of different age groups and sexes.Patient summaryOveractive bladder is a complex of symptoms including a compelling desire to pass urine that leads to increased frequency, which may lead to a degree of incontinence if you do not reach the toilet in time and may wake you from sleep. We pooled data from 10 different studies of mirabegron in patients with overactive bladder symptoms, and looked at the effect in the total number of patients who received the treatment, as well as in different age groups and between men and women. No new safety concerns were identified, and mirabegron improved the symptoms of overactive bladder.     

Solifenacin-induced delirium and hallucinations

Solifenacin-induced cognitive adverse effects have not been reported frequently, but solifenacin-induced delirium and hallucinations with successful switching to darifenacin, without additional drug, have not been reported in the literature. In this case report, we present an 80-year-old Caucasian male with insomnia and anxiety symptoms and overactive bladder who developed delirium and hallucinations when treated with solifenacin and trazodone. After solifenacin discontinuation and switching to darifenacin, symptoms significantly improved immediately. Such a case has not yet been described in literature; however, an adverse effect associated with solifenacin can occur, as this report clearly demonstrates.     

口干对应用索利那新治疗的膀胱过度活动症患者饮水量和治疗效果的影响

目的探讨口干对应用索利那新治疗的膀胱过度活动症(OAB)患者饮水量和治疗效果的影响。方法以2014年1月-2015年12月在我院门诊诊治的女性OAB患者82例为研究对象。所有患者均口服索利那新治疗4周,根据有无口干分为口干组和无口干组。治疗前后评估患者饮水量和膀胱过度活动症症状评分(OABSS)。结果 12例(14.6%)患者出现口干,70例无明显口干。两组患者间的一般情况、初始饮水量、初始OABSS评分比较,差异无统计学意义(P0.05)。与无口干组相比,口干组治疗后的饮水量改变、OABSS评分改变均较小。结论口干是削弱索利那新治疗膀胱过度活动症疗效的一个因素,进行相关的护理干预是有必要和有意义的。     

A cost-utility analysis of once daily solifenacin compared to tolterodine in the treatment of overactive bladder syndrome

ABSTRACT

Objective: To evaluate the cost-utility of solifenacin, a new generation antimuscarinic, compared with tolterodine in the treatment of overactive bladder syndrome (OAB), from the perspective of the UK National Health Service (NHS).

Research design and methods: A 1-year Markov model was constructed using data from a 12-week, randomised, double-blind study that compared flexible dosing with solifenacin (5?mg and 10?mg) with tolterodine (IR 2?mg bd/ER 4?mg) in adults with OAB. The model incorporated five discrete health states that were based on disease severity (micturitions/day and incontinence episodes/day). A ‘drop out’ state was also used in the model to account for patients that discontinued treatment in the first year. UK-specific costs for drug treatment and pad use as well as utilities were assigned to each health state.

Results: Solifenacin was a less costly and more effective treatment strategy compared with tolterodine. During the course of 1 year, the estimated cost per patient was £509 for patients treated with solifenacin and £526 for those given tolterodine, a cost saving of £17 per patient. Treatment with solifenacin was also associated with a small incremental gain of 0.004 quality-adjusted-life-years (QALYs) over tolterodine. Sensitivity analysis suggests that the incremental cost effectiveness of solifenacin relative to tolterodine does not appear to exceed £30?000/QALY with even large variations in key model parameters.

Conclusion: Flexible dosing with solifenacin is likely to be cost-effective versus tolterodine in the treatment of OAB. Further studies are needed to confirm these results.     

Beneficio terapéutico tras cambiar tolterodina por otros nuevos antimuscarínicos

ObjectivesTo explore in the daily clinical practice setting that antimuscarinic, Fesoterodine or Solifenacin, provides a greater clinical benefit after changing their prior Overactive Bladder (OAB) therapy with tolterodine extended-release (ER) to other novel antimuscarinic agents.Material and methodsA post-hoc analysis of data from an observational multicenter, cross-sectional, retrospective study. Adult patients of both sexes, with OAB and OAB-V8 score ≥ 8, who switched to fesoterodine or solifenacin within the 3-4 months before study visit from their prior tolterodine-ER-based therapy due to poor response were included. 92 patients were selected for each treatment group, matched (1:1) according to conditioned probability using the propensity score. Benefit of treatment change perceived by the physician and patient was evaluated by means of the Clinical Global Impression of Improvement subscale (CGI-I) and Treatment Benefit Scale (TBS), respectively. Degree of worry, bother and interference with daily living activities due to urinary symptoms, level of satisfaction, and preference for current treatment were also assessed.ResultsFesoterodine provided a significantly greater improvement than solifenacina in terms of therapeutic benefit perceived by the physician according to ICG-I. 96.7% of the patients on fesoterodine treatment vs. 81.6% of the solifenacin group showed a score of improvement in TBS (P < .05). Fesoterodine was also better rated than solifenacin with regard to satisfaction and preference for the new treatment (93.4 vs. 78.2% P < .05).ConclusionsIn daily clinical practice the switch from tolterodine LP to fesoterodine seems to provide greater benefits both from the physician's and the patient's point of view compared with those provided by solifenacin.     

索利那新防治经尿道前列腺电切术后膀胱痉挛的疗效观察

目的 评估经尿道前列腺电切（TURP）围手术期使用索利那新对术后膀胱痉挛的防治疗效.方法 BPH患者150例.随机分为3组,每组50例.索利那新组（A组）：术前1 d起口服索利那新1次/d,5 mg/次,至拔除导尿管后3 d;托特罗定组（B组）：术前1 d起口服托特罗定2次/d,2 mg/次,至拔除导尿管后3 d;吲哚美辛组（C组）：疼痛时予肛纳吲哚美辛栓25 mg.观察比较3组患者经尿道前列腺电切术后膀胱痉挛发生次数、持续时间以及膀胱冲洗、冲洗液转清、留置导尿管时间等.结果 A组术后24、24~48、48~72 h膀胱痉挛次数（0.86±0.08,1.80±0.14,1.06±0.13）均少于B组（1.02±0.08,2.02±0.12,1.24±0.12）和C组（1.88±0.12,2.68±0.18,2.24±0.19）,且与C组相比,差异有统计学意义（P＜0.05）.A 组术后24、24~48、48~72 h膀胱痉挛平均持续时间[（0.74±0.25）、（0.17±0.03）、（0.18±0.04）h]均少于B组[（0.61±0.25）、（0.16±0.34）、（0.17±0.32）h]和C组[（0.43±0.22）、（0.13±0.04）、（0.14±0.04）h],且与C组相比,差异有统计学意义（P＜0.05）.术后A组膀胱冲洗时间、冲洗液转清时间、留置导尿管时间[（2.2±0.6）、（1.6±0.6）、（5.0±0.7）d]也均早于B组[（2.3±0.6）、（1.8±0.5）、（5.2±0.8）d]和C组[（2.6±0.7）、（2.1±0.7）、（5.4±0.6）d],且与C组相比,差异有统计学意义（P＜0.05）.A组总的不良反应率和口干的发生率（10.0%,6.0%）均较B组（26.0%,20.0%）低,且差异有统计学意义（P＜0.05）.结论 TURP患者围手术期应用索利那新可有效防治膀胱痉挛,临床效果满意、安全.