Solifenacin significantly improves all symptoms of overactive bladder syndrome

Overactive bladder syndrome (OAB) is a chronic condition characterised by urgency, with or without associated urge incontinence. Solifenacin succinate is a once daily, bladder selective antimuscarinic available in two doses (5 and 10 mg). The recommended dose is 5 mg once daily and can be increased to 10 mg once daily if 5 mg is well tolerated. This article presents pooled efficacy and safety data from four large, placebo-controlled, multinational phase III trials of solifenacin succinate with a total enrolment of over 2800 patients. Data from these trials show that solifenacin 5 and 10 mg once daily is significantly more effective than placebo at reducing urgency, incontinence, micturition frequency and nocturia and at increasing volume voided per micturition. Adverse events were mainly mild-to-moderate in all treatment groups. The results of these phase III trials support the use of solifenacin in the treatment of OAB.     

托特罗定治疗特发性膀胱过度活动症

目的观察新型毒蕈咸受体拮抗药托特罗定治疗特发性膀胱过度活动症的有效性和安全性。方法将托特罗定1mg呼奥昔布宁5mg及安慰剂进行对比,疗程3周。夜间入睡前2h口服。结果与安慰剂相比,托特罗定和奥昔布宁都使入睡前1h夜尿次数(P<0.01)显著减少。两种药物的副作用主要为口干。在口干(发生率和强度)方面,托特罗定要明显优于奥昔布宁(P<0.05)。结论托特罗定治疗特发性膀胱过度活动症效果明确,疗程3周即能达到疗效。尽管奥昔布宁也具有很好的疗效,但不良反应限制了它的应用。     

Efficacy and safety of solifenacin succinate 10 mg once Daily: A multicenter, phase III, randomized, double-blind, placebo-controlled, parallel-group trial in patients with overactive bladder

Background: Solifenacin succinate is an antimuscarinic drug with reported efficacy and tolerability at a recommended starting dose of 5 mg QD in patients with overactive bladder (OAB).Objective: The objective of this trial was to investigate the efficacy, safety, and tolerability of solifenacin 10 mg QD in patients with OAB.Methods: In this multicenter, Phase III, double-blind, placebo-controlled, parallel-group trial, patients aged ≥18 years with OAB were randomized at a 1:1 ratio to receive solifenacin 10 mg or placebo QD for 12 weeks. The patients were instructed to complete a micturition diary for the 3 days preceding each scheduled visit (weeks 4, 8, and 12). The primary end point was the change from baseline in the mean number of micturitions per 24 hours; secondary end points included the mean change from baseline in the number of episodes per 24 hours of urgency, incontinence, nocturnal voiding, and nocturia and the mean volume voided per micturition. Tolerability was monitored through adverse events (AEs), vital sign measurements, ECGs, laboratory assessments, and physical examination.Results: A total of 672 patients were randomized and received ≥1 dose of study drug (solifenacin, n = 340; placebo, n = 332). The mean (SE) decrease from baseline to study end in the number of micturitions per 24 hours was significantly greater in the solifenacin group compared with the placebo group (−3.0 [0.2] vs −1.5 [0.2], respectively; P < 0.001). The mean decrease in the number of episodes of incontinence was significantly greater in the solifenacin group compared with the placebo group (−2.0 [0.2] vs −1.1 [0.2]; P < 0.001), as was the mean decrease in the number of episodes of urgency (−4.1 [0.2] vs −2.1 [0.2]; P < 0.001). Of the patients with ≥1 incontinence episode per 24 hours at baseline, significantly more patients in the solifenacin group achieved complete continence at study end than did patients in the placebo group (119/225 [52.9%] vs 80/237 [33.8%]; P < 0.001). The change from baseline to study end in the mean volume voided per micturition increased significantly in the solifenacin group compared with the placebo group (47.2 vs 2.7 mL; P < 0.001). Most AEs were mild or moderate in intensity. The AEs that were most commonly reported in the solifenacin-treated group were anticholinergic in nature: dry mouth (91 [26.8%] vs 13 patients [3.9%] in the placebo group; P < 0.001); constipation (58 [17.1%] vs 11 [3.3%]; P < 0.001); and blurred vision (12 [3.5%] vs 4 [1.2%]; P < 0.05). Serious AEs (SAEs) were reported for 5 patients in the solifenacin group and 3 patients in the placebo group. In the solifenacin group, 2 patients experienced chest pain, 1 had cellulitis, 1 had dehydration, and 1 had colonic obstruction; only 1 SAE (colonic obstruction) was judged to be possibly related to the study drug. In the placebo group, 1 patient had chest pain, 1 had bacterial meningitis, and 1 had hemopericardium.Conclusions: This study found that solifenacin 10 mg QD for 12 weeks was associated with significantly reduced symptoms of OAB, including the frequency of micturition, and episodes of urgency and of incontinence. With solifenacin, the volume voided per micturition increased by 47.2 mL, and 53% of patients with ≥1 incontinence episode per 24 hours at baseline achieved complete continence. This efficacy was accompanied by a favorable safety and tolerability profile.     

Giardiasis

Although giardiasis is a common cause of diarrheal disease, the diagnosis often is missed. The infection can be benign or the cause of severe, fulminant, and worrisome diarrhea with malabsorption, particularly in patients with altered immune status. Once diagnosis is made, however, treatment is simple and response very rewarding.     

The Use of Respiratory Function Tests in Clinical Medicine

Abstract

Background: Antimuscarinics have proven efficacy as first-line therapy in overactive bladder (OAB); however, data on their use in older adults are needed. Objective: To assess the efficacy and tolerability of solifenacin in patients aged ≥ 65 years, we conducted post-hoc analyses of data from VESIcare® Open-Label Trial (VOLT) and VESIcare® Efficacy and Research Study US (VERSUS). Methods: In both of these 12-week, open-label, flexible-dosing studies involving 2645 patients with OAB for ≥ 3 months, patients received 5 mg solifenacin daily for 4 weeks, with an option to increase to 10 mg at week 4 (both studies) and week 8 (VOLT). VERSUS patients had received tolterodine extended release 4 mg for ≥ 4 weeks without sufficient subjective improvement in urgency (mean ≥ 3 urgency episodes/24 h). Baseline values 14 days after tolterodine washout were used for comparison with VOLT. Common study endpoints were the Patient Perception of Bladder Condition (PPBC) scale and the Overactive Bladder Questionnaire (OAB-q). VOLT used a horizontal visual analog scale (VAS), and diary-recorded symptom data were captured in VERSUS. Results: In the full analysis sets (FAS), 40% of VOLT and 44% of VERSUS patients were aged ≥ 65 years. After 12 weeks of solifenacin, older patients experienced decreases in OAB symptoms, and improvements from baseline on the PPBC, OAB-q, and VAS. In total, 59% of older VOLT and 62% of older VERSUS patients reported ≥ 1 treatment-emergent adverse event (AE); the AEs were mostly anticholinergic and of mild-to-moderate severity. Results were consistent with younger patients and the FAS. Conclusions: In this large group of older patients, flexibly dosed solifenacin was associated with reductions in diary-documented OAB symptoms (VERSUS). In both studies, solifenacin was associated with improvements in measures assessing patients' perception of their bladder problems, symptom bother, and aspects of health-related quality of life. Adverse event rates in older patients were comparable to those in younger patients and the FAS.     

Resection and Primary Anastomosis for Lesions of the Left Portion of the Colon

Injury to surrounding tissues during radiotherapy for oral cancer can have devastating physical and psychologic consequences for the patient. Oral complications include xerostomia, dental decay, mucositis, taste loss, osteoradionecrosis, infection, and trismus. In many instances, these problems can be eradicated or controlled with appropriate treatment.     

Persistence with antimuscarinic therapy in patients with overactive bladder

Overactive bladder (OAB) is a chronic condition, which impacts patients' health and quality of life. The primary symptoms of OAB are distressing and may interfere with work, psychosocial and sexual functioning. OAB also is associated with increased risk of urinary tract infections, fractures from falls, skin infections and depression. Patient's concerns about the effects of incontinence on lifestyle highlight the need to restore continence. The mainstay of treatment is antimuscarinic drug therapy, which may often produce only modest reductions in OAB symptoms and may be accompanied by bothersome adverse effects, leading to poor adherence to prescribed medications. Successful treatment of OAB depends on persistence with the prescribed medication, and efficacy and tolerability are key influencers of persistence. New antimuscarinic agents are now available for treating OAB that significantly improve symptoms of incontinence, urgency and frequency with few adverse effects. An improved efficacy and tolerability profile should result in greater patient satisfaction and persistence with therapy during long-term therapy.     

行为疗法联合托特罗定治疗女性膀胱过度活动症伴急迫性尿失禁的疗效观察

目的探讨行为疗法联合托特罗定治疗女性膀胱过度活动症(OAB)伴急迫性尿失禁(UUI)的临床疗效。方法选取北京市清河社区卫生服务中心就诊的女性OAB伴UUI患者91例,按就诊时间随机分为2组,A组45例,给予口服托特罗定8周;B组46例,给予行为疗法联合口服托特罗定联合治疗8周。比较2组治疗后患者的排尿日记、生活质量评分和尿流动力学检查结果。结果治疗后2组患者24h排尿次数、24h尿失禁次数均明显减少,每次排尿量、膀胱测压容积均明显增加,生活质量评分均改善,B组较A组效果更明显,差异有统计学意义(P0.05)。结论行为疗法联合托特罗定比单用托特罗定治疗女性OAB伴UUI更有效。     

Comparisons of the therapeutic safety of seven oral antimuscarinic drugs in patients with overactive bladder: a network meta-analysis

ObjectivesThis network meta-analysis aimed to assess the safety profiles of seven commonly used oral antimuscarinic drugs (darifenacin, fesoterodine, imidafenacin, oxybutynin, propiverine, solifenacin, and tolterodine) in patients with overactive bladder (OAB).MethodsPubMed, Cochrane Library, EMBASE, CNKI, and Wanfang databases were searched for randomized controlled trials (RCTs). Studies comparing one or more antimuscarinic drugs for treating OAB with reported adverse effects (AEs) were eligible. Data were extracted, and a network meta-analysis was performed by two authors independently.ResultsForty-five RCTs and 124,587 patients were included. The results demonstrated that tolterodine had better safety outcomes for 7 out of 12 major AEs, including dry mouth, constipation, urinary retention, dizziness, urinary tract infection, dry eyes, and dry skin. Darifenacin, fesoterodine, imidafenacin, oxybutynin, and solifenacin presented comparable safety profiles.ConclusionsTolterodine may be preferable as it showed a reduced association with important AEs. Darifenacin, fesoterodine, imidafenacin, oxybutynin, and solifenacin have similar safety profiles in treating patients with OAB. Taken together, this analysis provides a valuable overview of the therapeutic safety for oral antimuscarinic drugs and is useful for personalized medicine in patients with OAB.Trial registration: This trial was retrospectively registered at INPLASY (https://inplasy.com/) with the registration number 202170095.     

胃十二指肠溃疡穿孔的CT表现

目的：探讨胃十二指肠溃疡穿孔的CT表现及其诊断价值。材料与方法：回顾性分析5例经手术病理证实的胃十二指肠溃疡穿孔者的CT表现。结果：本组5例中，急、亚急性穿孔4例，慢性穿孔1例。穿孔部位包括：胃窦小弯侧1例，胃体大弯侧1例，十二指肠球部上壁及前壁各1例，十二指肠球后部后壁1例。溃疡穿孔的CT表现；定性征象有腹腔内游离气体；定位片像有局部管壁增厚，不规则，周围脂肪层模糊；同时能全面地显示穿孔后腹腔内的继发改变。本组5例中有3例未能确定穿孔部位。结论：CT对诊断胃十二指肠溃疡穿孔很有价值，优于其它影像学检查，但对部分急性穿孔的定应诊断、慢性穿孔的定性诊断有一定限度。     

感觉相关的排尿日记在社区女性膀胱过度活动症中的应用研究

目的 应用感觉相关的排尿日记评价40岁及以上的社区女性的膀胱过度活动症(OAB)发病情况.方法 620例女性(平均58岁)完成了3 d的感觉相关的排尿日记.膀胱感觉的定义:0级=膀胱没有感觉,1级=膀胱有涨满的感觉,但没有排尿的愿望,2级=有排尿愿望,3级=有强烈的排尿愿望,4级=有非常紧迫的排尿愿望,但没有急迫性尿失禁,5级=出现因尿急引起的漏尿.结果 96例(15.5%)有OAB症状,包括74例(11.9%)没有急迫性尿失禁(即干性OAB)和22例(3.5%)伴有急迫性尿失禁(即湿性OAB).在全部的11 418次排尿中,随着膀胱感觉等级的增加,排尿量显著增加.干性OAB受试者的24 h排尿量显著高于正常受试者.湿性OAB受试者的平均排尿量显著低于干性OAB受试者和正常受试者.无尿急感觉的正常组的膀胱感觉3级时平均排尿量显著高于其他各组.湿性OAB组的膀胱感觉4级和5级时排尿量显著低于正常组和干性OAB组.结论 感觉相关的排尿日记能有效地评价排尿感觉、尿失禁和排尿模式.正常组、干性OAB组和湿性OAB组中引起诸如尿急或尿频等症状的原因可能不同.     

Intradetrusor onabotulinumtoxinA for overactive bladder

Introduction: Overactive bladder is a life-compromising disease that affects approximately 11.8% of all men and women, with increasing rates in the elderly. The mainstay of pharmacotherapy for this disease, anticholinergics, has up to a 71% discontinuation rate at 6 months. The emerging data of intradetrusor onabotulinumtoxinA (onabotA) use for treatment of idiopathic overactive bladder is showing to be an efficacious and well-tolerated alternative to the mainstay of therapy.

Areas covered: This study covers the use of onabotA and its use for idiopathic overactive bladder, stemming from its use in neurogenic detrusor overactivity, by evaluating the conclusions of current studies. A literature search and review was carried out for onabotA in treatment of overactive bladder using PubMed.

Expert opinion: Multiple randomized clinical trials have shown that intradetrusor injection with onabotA is effective in treating non-neurogenic bladder with promising efficacy in patients who have failed traditional pharmacotherapy. This treatment may be superior in certain patients due to its higher rate of compliance and higher rates of complete symptom resolution. Long-term studies are needed.     

膀胱过度活动症症状评分表评估膀胱过度活动症的临床研究

目的 确定膀胱过度活动症症状评分表(OABSS)在评价膀胱过度活动症(OAB)中的临床应用价值.方法 初发的OAB患者接受抗毒蕈碱药物托特罗定治疗.在基线期及12周治疗后完成3 d排尿日记和OABSS,通过对比分析治疗前后相关指标的变化、变量的一致性和变化的相关性.结果 本次研究包括59例患者,男22例,女37例,年龄(31.1±9.6)岁,OABSS和相应的3 d排尿日记均显示有统计学意义的疗效改善变化.OABSS中尿急评分的效应值最大(2.10),总评分效应值1.55,排尿日记中尿急评分效应值0.92.OABSS中除白天排尿次数外,其余效应值均大于相应排尿日记的效应值,标准反应均数的变化与效应值的变化相同.OABSS中项目评分和相应排尿日记的变量在基线期及12周治疗后有良好的一致性.急迫性尿失禁及夜尿在OABSS和相应排尿日记的变量有高度相关性.结论 OABSS对治疗相关OAB症候群变化有高度敏感性,在日常临床实践中,OABSS借其简易性及可靠性,可成为排尿日记之外的一种可供选择的评估症状和疗效的工具.     

腹腔镜胃十二指肠溃疡穿孔修补术26例临床分析

目的 探讨腹腔镜胃十二指肠溃疡穿孔修补术的方法及临床应用价值.方法 回顾性分析2002年6月～2007年12月26例腹腔镜胃十二指肠溃疡穿孔修补术的临床资料.结果 26例腹腔镜手术均获成功,无中转开腹,手术时间30～90min,平均45min.术后住院时间4～8d,平均6d.其中有1例脐部穿刺孔感染,经换药后愈合;出院后均内科正规系统治疗,随访 6～24个月,经过胃镜证实溃疡均已愈合.结论 经腹腔镜下行胃十二指肠溃疡穿孔修补术具有独特优势,创伤小,恢复快,临床疗效满意.     

Validation of a simple patient questionnaire to assist self-detection of overactive bladder A study in general practice

Objective – To develop and validate a simple patient questionnaire for the detection of overactive bladder (OAB).

Design – An open, non-randomized multicentre study.

Setting – A pilot study (n=133) was conducted to bring forward five questions from initially 14 questions, for detection of OAB. These five questions were subject to further validation in the main study (n=520).

Subjects – 531 adults responding to a newspaper advertisement regarding symptoms of OAB and patients seeing a physician for other reasons were attending 28 general practitioners.

Main outcome measures – Agreement rate, sensitivity, and specificity.

Results – The agreement rate between the patients’ own diagnosis based on the patient questionnaire, and the physicians’ diagnosis based on medical history, urine analysis, and micturition chart, was 0.78 (κ=0.89). Sensitivity and specificity were 0.98 and 0.90, respectively.

Conclusion – The validated questionnaire may become a useful tool to decide whether a patient has overactive bladder. The questionnaire corresponds well with the physicians’ diagnosis.     

腹腔镜胃十二指肠溃疡穿孔修补术与传统开腹手术的比较研究

目的：比较腹腔镜胃十二指肠溃疡穿孔修补术和传统开腹手术的临床效果。方法：回顾分析手术治疗的81例胃十二指肠溃疡穿孔患者的临床资料。其中28例行腹腔镜胃十二指肠溃疡穿孔修补术（腹腔镜组）,53例行开腹胃十二指肠溃疡穿孔修补术（开腹组）,比较两组患者的手术时间、术中出血量、并发症发生率、术后肠道功能恢复时间、住院时间及住院费用。结果：与开腹组比较,腹腔镜组手术时间较长（P〈0.05）、住院费用较高（P〈0.01）,但术中出血量较少、胃肠道功能恢复较早及住院时间较短（P〈0.05）,两组的并发症发生率无显著差异（P〉0.05）。结论：腹腔镜胃十二指肠溃疡穿孔修补术安全可靠,与传统开腹手术比较创伤小、恢复快,但住院费用较高。     

Fesoterodine for overactive bladder: A review of the literature

Background: Overactive bladder (OAB) is a chronic condition affecting both men and women, with prevalence increasing with age. Antimuscarinics form the cornerstone of treatment of OAB. Fesoterodine, a nonselective muscarinic-receptor antagonist, was approved by the US Food and Drug Administration in late 2008 for once daily, oral administration in the treatment of OAB to relieve the symptoms of urinary urge incontinence, urgency, and frequency.Objective: The aim of this review was to provide an overview of the mechanism of action of and clinical trial data for fesoterodine, and to discuss the present status of fesoterodine in the management of OAB.Methods: The MEDLINE and Google Scholar databases were searched (June 1, 1999-December 1, 2009) using the terms fesoterodine, overactive bladder, and muscarinic antagonists. Full-text articles in English were selected for reference, and articles presenting the mechanism of action, pharmacokinetics, and data from clinical trials were included. The parameters measured were tolerability, efficacy, and health-related quality of life (HRQoL). Trials involving animals and Phase I studies were excluded.Results: The initial literature search yielded 48 papers. A total of 20 articles fulfilled the inclusion criteria. In two 12-week, randomized, multicenter, Phase III clinical trials involving patients with increased micturition frequency and urgency and/or urinary urge incontinence (n = 836 and 1132 in each trial), both fesoterodine 4 and 8 mg were associated with significantly improved symptoms of OAB (frequency of micturition, urgency, and urge incontinence) compared with placebo (P < 0.05). In a post hoc analysis of pooled data of the Phase III trials, HRQoL improved significantly with both doses. In a 12-week, Phase Illb trial, fesoterodine 4 and 8 mg led to treatment satisfaction in ∼80% of patients (of 516 enrolled) who were initially unsatisfied with their previous treatment.Conclusion: A review of the literature suggests that fesoterodine is an efficacious and well-tolerated treatment option for patients with OAB.     

十二指肠溃疡患者自我管理水平的影响因素

目的了解十二指肠溃疡患者自我管理水平的现状,并探讨其影响因素。方法便利抽样选择2012年1月至2014年3月期间在南方医科大学南方医院消化科就诊的十二指肠溃疡患者200例,采用《慢性病自我管理研究测量表》中的自我管理行为量表及自我效能量表,对其进行自我管理水平的调查,并分析其影响因素。结果十二指肠溃疡患者总体自我管理行为得分为(12.26±1.90)分,自我管理水平中等偏低。主要影响因素为自我效能、文化程度和工作压力,3个因素共同解释自我管理水平变异的20.4%。结论通过对十二指肠溃疡患者自我管理水平及其影响因素分析,进行有针对性的健康教育和护理干预,有助于使患者从被动管理疾病到主动参与疾病管理,提高患者自我管理水平,减少复发率,有效提高治愈率及患者的生活质量。     

Pelvic Floor Muscle Training to Manage Overactive Bladder and Urinary Incontinence

Overactive bladder (OAB) and urinary incontinence (UI) are common chronic conditions that can negatively affect women’s quality of life. Pelvic floor muscle training is the first-line treatment. Two recent Cochrane Reviews examining pelvic floor muscle training for the treatment of UI and OAB are summarized here to provide women’s health nurses with current recommendations for UI and OAB management. This column also identifies practice improvement education in the area of pelvic floor muscle training and treatment for OAB and UI.     

综合护理干预在女性膀胱过度活动症病人中的应用

[目的]探讨综合护理干预在女性膀胱过度活动症病人治疗过程中的效果。[方法]将80例成年女性膀胱过度活动症病人随机分为对照组和观察组各40例。对照组采用药物治疗及行为疗法,观察组在对照组治疗的基础上加强心理干预、健康教育、强化行为疗法,出院后定期进行系统的电话随访,干预2周、4周、8周后观察记录两组病人排尿症状、排尿间隔时间和储尿期的单次尿量。[结果]干预4周、8周后观察组病人尿频、尿急、夜尿和尿失禁发生率均低于对照组(P<0.05);观察组病人排尿间隔时间和储尿期的单次尿量比对照组延长或增加(P<0.05)。[结论]综合护理干预治疗成年女性膀胱过度活动症能有效改善排尿症状。