奥昔布宁对下尿路刺激症及急迫性尿失禁病人的疗效

目的：比较国产与进口奥昔布宁对下尿路刺激症及急迫性尿失禁病人的疗效。方法：２０３例下尿路刺激症及急迫性尿失禁病人（男性１３５例，女性６８例，年龄５２±ｓ１７ａ），随机分试验组１２３例与对照组８０例，试验组与对照组分别给国产与进口奥昔布宁片５ｍｇ，ｐｏ，ｔｉｄ，７￣１４ｄ。儿童减半。结果：以总点数、尿流率及尿量评估２组皆有显疗效（Ｐ〈０．０１），２组间疗效判别不显（Ｐ〉０．０５）。不良反应轻微。     

盐酸奥昔布宁缓释片临床疗效观察

目的:评价盐酸奥昔布宁缓释片与奥昔布宁片对尿频、尿急和急迫性尿失禁病人的有效性和安全性。方法:120例尿频、尿急和急迫性尿失禁病人,(男性42例,女性78例,年龄41.90±12.51岁),随机分成试验组60例予盐酸奥昔布宁缓释片10mg,po.qd,42d,对照组60例予奥昔布宁片5mg,po,bid,42d。试验采用随机、双盲、双模拟、阳性药物平行对照方法。结果:以用药前后24 h平均排尿次数、平均每次排尿量和尿失禁次数的变化评估,各组治疗前后疗效差异有显著性(P<0.05),两组间比较疗效差异无显著性(P>0.1)。不良反应轻。结论:盐酸奥昔布宁缓释片是治疗尿频、尿急和急迫性尿失禁的有效和安全的药物。     

盐酸奥昔布宁缓释片临床疗效观察

目的:评价盐酸奥昔布宁缓释片与奥昔布宁片对尿频、尿急和急迫性尿失禁病人的有效性和安全性。方法:120例尿频、尿急和急迫性尿失禁病人,(男性42例,女性78例,年龄41.90±12.51岁),随机分成试验组60例予盐酸奥昔布宁缓释片10mg,po.qd,42d,对照组60例予奥昔布宁片5mg,po,bid,42d。试验采用随机、双盲、双模拟、阳性药物平行对照方法。结果:以用药前后24 h平均排尿次数、平均每次排尿量和尿失禁次数的变化评估,各组治疗前后疗效差异有显著性(P<0.05),两组间比较疗效差异无显著性(P>0.1)。不良反应轻。结论:盐酸奥昔布宁缓释片是治疗尿频、尿急和急迫性尿失禁的有效和安全的药物。     

曲司氯铵治疗膀胱过度活动症的多中心临床研究

目的：评价曲司氯铵治疗膀胱过度活动症的有效性和安全性。方法：以盐酸奥昔布宁为对照，采用随机双盲双模拟多中心临床试验设计，144例膀胱过度活动症患者随机均分为试验组和对照组，分别服用曲司氨铵20mg或奥昔布宁5mg,bid。结果：治疗6周后，试验组（n=69）和对照组（n=64)24h平均排尿次数头值，尿失禁患者的平均尿失禁次数减少值以及平均每次尿量增加值比较无统计学差异（P＞0．05）。试验组患者不良事件的总发生率为47．2％，其中主要不良事件口干发生率为23．6％，而奥昔布宁组不良事件总发生率为76．4％，口干发生率为68．1％，不良事件总发生率及口干发生率在两组间均有明显统计学差异（P＜0．001）。结论：曲司氨铵治疗膀胱过度活动症与奥昔布宁等效，但不良反应明显低于奥昔布宁。     

国产盐酸丙哌维林片治疗膀胱过度活动症的临床观察

目的：研究国产盐酸丙哌维林片治疗膀胱过度活动症的疗效和安全性。方法：选择膀胱过度活动症患者42例,分成试验组(22例)和对照组(20例)。试验组早、晚各给予盐酸丙哌维林片20mg 盐酸奥昔布宁模拟片5mg;对照组早、晚各给予盐酸奥昔布宁片5mg 盐酸丙哌维林模拟片20mg。两组疗程为6周。结果：丙哌维林和奥昔布宁治疗膀胱过度活动症疗效相当。前者的不良反应发生率低于后者。结论：盐酸丙哌维林是治疗膀胱过度活动症更为理想的药物。     

酒石酸托特罗定与奥昔布宁双盲双模拟随机对照治疗膀胱过度活动症多中心临床研究

目的评价国产酒石酸托特罗定治疗膀胱过度活动症的有效性和安全性.方法以盐酸奥昔布宁为对照,采用随机双盲双模拟多中心临床试验设计,对237例(托特罗定组114例,奥昔布宁组123例)膀胱过度活动症患者进行研究,服药方法每日2次,每次托特罗定2mg或奥昔布宁5mg.结果治疗6周后,试验组(n=109)和对照组(n=108)24h平均排尿次数减少、尿失禁患者的平均尿失禁次数减少以及平均每次尿量增加比较无统计学差异(P＞0.05).试验组患者不良事件的总发生率48.2%,其中主要不良事件口干发生率为32.5%;而奥昔布宁组不良事件的总发生率为65.0%,口干发生率为55.3%,不良事件总发生率及口干发生率在两组间均有统计学差异(P＜0.05).结论托特罗定是治疗膀胱过度活动症的有效药物,其疗效与奥昔布宁等效,但其药物不良反应明显低于奥昔布宁.     

大视野

新药研发美食品药监局批准奥昔布宁凝用于膀胱过度活动症美FDA已经批准局部外用的3%奥昔布宁凝胶制剂(剂型为84 mg,约为3 ml)用于治疗膀胱过度活动症(OAB),其中涉及尿急、尿频及急迫性尿失禁等症状。奥昔布宁是一种兼     

1,6-二磷酸果糖治疗冠心病97例

目的：比较国产与进口１，６－二磷酸果糖（ＦＤＰ）对冠心病心绞痛的作用。方法：冠心病心绞痛病人１０７例，以单盲、对比法分为国产ＦＤＰ组（６６例，年龄６１±ｓ７ａ）；进口ＦＤＰ组（３１例，年龄６２±１０ａ）；对照组（２０例，年龄５９±８ａ）。国产或进口ＦＤＰ组均以１０ｇ溶于注射用水１００ｍＬ中，对照组用５％葡萄糖１００ｍＬ，３组均作静脉滴注，１０～１４ｍｉｎ内滴完，ｂｉｄ，共７ｄ。结果：国产与进口ＦＤＰ及对照组抗心绞痛症状疗效依次为８３％，８１％及２５％；心电图改善率依次为６７％，６２％及１２％；国产与进口ＦＤＰ组组间比较均Ｐ＞０．０５，２组均优于对照组（Ｐ＜０．０１）。且２组不良反应相似，均较轻微。结论：国产与进口ＦＤＰ治疗冠心病心绞痛疗效均有效。     

治疗膀胱过度活动症的新药托特罗定

托特罗定是新型竞争性毒蕈碱受体拮抗剂，对膀胱的选择性远大于唾液腺的选择性，在临床上用于治疗由膀胱过度活动引起的尿频、尿急和急迫性尿失禁。疗效与奥昔布宁相当，耐受性却明显优于奥昔布宁。主要代谢物为5－羟甲基衍生物，也具有相似的药学活性。     

04110 急迫性尿失禁该用什么口服药

据比利时及威尔士研究人员说，速释(IR)奥昔布宁(oxybutynin)(Ⅰ)、缓释(XR)奥昔布宁(Ⅱ)和托特罗定(Ⅲ)都是治疗急迫性尿失禁价效比好的选择。药物的选择取决于决策者是否愿意为每增加无尿失禁一周而付款。     

60例氯胺酮滥用伴有泌尿系统损害患者的临床观察与分析

目的:介绍氯胺酮(俗称K粉)滥用引发泌尿系损害的临床症状和可能的生理机制。方法:对60例氯胺酮滥用者进行临床症状观察,以及血尿常规、血生化检查和B超检查。结果:滥用人群以青少年为主,鼻吸是主要使用方式。60例氯胺酮滥用者中合并重症泌尿系症状者52例,主要临床表现为尿痛、尿急、尿频、血尿和尿失禁等下尿路刺激症状。临床症状与滥用时间和滥用剂量有关。停止氯胺酮滥用和积极的治疗,尿路刺激症状和尿失禁症状逐渐缓解或消失。但症状持续时间较长。结论:氯胺酮滥用可以导致严重的泌尿系功能损害,临床表现以下尿路刺激症状为主。停止滥用以及对症治疗可以缓解症状。B超、CT等影像学检查有助于临床诊断。     

盆底脏器脱垂患者与下尿路功能障碍关系的探讨

目的探讨盆底脏器脱垂患者与下尿路功能障碍之间的关系。方法于2009年7月-2010年11月对54例诊断为盆腔脏器脱垂的住院患者进行病史采集、妇科检查、POP—Q评分及尿动力学检查,探讨盆腔脏器脱垂与下尿路功能障碍的关系。结果54例POP患者中,出现下尿路主观症状44例,其中尿失禁症状27例（压力性24例,急迫性1例,混合性2例）,尿急和／或尿频27例,排尿功能障碍16例。尿动力学检查结果显示：压力性尿失禁28例,急迫性尿失禁2例,混合性尿失禁2例,伴膀胱顺应性降低1例,腹压排尿3例。腹部漏尿点压力（ALPP）〈60cmH2O有10例,60～90cmH2O13例,〉90cmH2O7例。与尿失禁主观症状的符合率为70％（19／27）;隐匿性尿失禁的发生率为41％（11／27）,均为重度阴道前壁脱垂的患者。结论POP患者术前在减轻脱垂程度情况下行尿动力学检查可更客观地评价下尿路功能障碍,POP患者术前应了解膀胱及尿道括约肌功能,注意排除隐匿性尿失禁。     

甲氯芬酯治疗急性脑梗死后尿失禁

目的 :观察甲氯芬酯对急性脑梗死后尿失禁的疗效。方法 :急性脑梗死后合并尿失禁病人 80例分为 2组。治疗组在对照组治疗方案 (复方丹参注射液等 )的基础上加用甲氯芬酯 0 .3g ,po ,tid ,共观察 1mo。结果 :治疗组中伴有和不伴失语及认知障碍的病人症状改善均较对照组有显著差异 (分别为P <0 .0 5 ,P <0 .0 1)。精神状态简易速评量表(MMSE)评分及日常生活能力量表 (ADL)评分均显著提高 (P <0 .0 1)。结论 :甲氯芬酯改善了病人的认知能力及日常生活能力 ,对急性脑梗死后尿失禁有一定的治疗作用 ,且安全性好 ,不良反应少。     

Preliminary evaluation of a new controlled-release oxybutynin in urinary incontinence

OBJECTIVE: To conduct a preliminary evaluation of a new oral formulation of controlled-release (CR) oxybutynin tablet taken once-daily in patients with urinary urge incontinence. RESEARCH DESIGN AND METHODS: A single-centre, open-label, 8-week study was conducted. Patients with urodynamically-confirmed detrusor instability, micturition frequency (>/= 8 voids/day) and/or urinary incontinence (>/= 2 incontinence periods/day) were enrolled. The study duration was 8 weeks: patients received IR oxybutynin (2.5-5 mg bid) for 2 weeks, followed by a 2-week washout/baseline period to avoid carryover effects, and oral CR oxybutynin (15 mg OD) for 4 weeks. Daily void frequency, fluid intake, urinary incontinence episodes, and spontaneously reported adverse events were recorded in a daily diary for five consecutive days in each treatment period. RESULTS: Of 12 enrolled patients, 9 patients efficacy; all patients were evaluable for safety. completed the study and were evaluable for Compared to baseline/washout, CR oxybutynin reduced UI episodes/day by 45% (p = 0.13) and micturitions/day by 15% (p = 0.07). Treatment with IR oxybutynin (mean dose: 6.7 +/- 2.5 mg/day) reduced UI episodes/day from baseline by 7% (p = 0.58) and voids/day by 6% (p = 0.29). Fluid intake remained consistent at approximately 2 litres/day during all study periods. The most common adverse event was dry mouth. CONCLUSIONS: Based on the reductions in daily frequency of incontinence and micturition following 4-weeks treatment, CR oxybutynin (15 mg OD) was at least as effective as the patients' previous dose of IR oxybutynin (mean dose: 6.7 +/- 2.5 mg/day). These improvements were achieved without restriction of fluid intake. Initial 15 mg doses of CR oxybutynin appear to be well tolerated.     

妊娠末期女性下尿路症状调查分析

目的调查妊娠妇女最末1个月下尿路症状发病情况。方法采用女性下尿路症状国际尿失禁标准问卷(ICIQ-FLUTS),于产后3d详细询问产妇的一般情况和孕前、孕期尿失禁发病情况和妊娠期最末1个月的下尿路症状。结果456名正常怀孕妇女参加这项研究。其中最常见的下尿路症状是夜尿(79.2%)和压力性尿失禁(30.5%),其次是尿急(27.4%),尿频(25.0%),排尿中断(16.2%),排尿延迟(11.0%),排尿时需要用力(4.2%),混合型尿失禁(4.1%),排尿疼痛(2.2%),急迫性尿失禁(0.9%)。结论夜尿、压力性尿失禁是最常见下尿路症状,夜尿对孕妇的生活质量影响最大。     

Preliminary evaluation of a new controlled-release oxybutynin in urinary incontinence

SUMMARY

Objective: To conduct a preliminary evaluation of a new oral formulation of controlled-release (CR) oxybutynin tablet taken once-daily in patients with urinary urge incontinence.

Research design and methods: A single-centre, open-label, 8-week study was conducted. Patients with urodynamically-confirmed detrusor instability, micturition frequency (> 8 voids/day) and/or urinary incontinence (> 2 incontinence periods/day) were enrolled. The study duration was 8 weeks: patients received IR oxybutynin (2.5-5?mg bid) for 2 weeks, followed by a 2-week washout/baseline period to avoid carryover effects, and oral CR oxybutynin (15?mg OD) for 4 weeks. Daily void frequency, fluid intake, urinary incontinence episodes, and spontaneously reported adverse events were recorded in a daily diary for five consecutive days in each treatment period.

Results: Of 12 enrolled patients, 9 patients completed the study and were evaluable for efficacy; all patients were evaluable for safety. Compared to baseline/washout, CR oxybutynin reduced UI episodes/day by 45% (p?=?0.13) and micturitions/day by 15% (p?=?0.07). Treatment with IR oxybutynin (mean dose: 6.7?±?2.5mg/day) reduced UI episodes/day from baseline by 7% (p?=?0.58) and voids/day by 6% (p?=?0.29). Fluid intake remained consistent at approximately 2 litres/day during all study periods. The most common adverse event was dry mouth.

Conclusion: Based on the reductions in daily frequency of incontinence and micturition following 4-weeks treatment, CR oxybutynin (15?mg OD) was at least as effective as the patients' previous dose of IR oxybutynin (mean dose: 6.7?±?2.5?mg/day). These improvements were achieved without restriction of fluid intake. Initial 15mg doses of CR oxybutynin appear to be well tolerated.     

Transdermal oxybutynin: a new treatment for overactive bladder

Overactive bladder has been successfully treated with oral anticholinergic drugs such as oxybutynin chloride. Although oral oxybutynin has been effective in controlling urinary urge incontinence and in decreasing incontinence episodes, adverse events, particularly dry mouth, often cause patients to discontinue oral therapy and to endure incontinence. Transdermal oxybutynin (Oxytrol^®, Watson Pharmaceuticals) is applied twice-weekly to maintain the efficacy of oral oxybutynin while significantly minimising side effects (e.g., dry mouth) that complicate therapy. By avoiding hepatic and gastrointestinal metabolism of oxybutynin, less N-desethyloxybutynin (N-DEO), the compound thought to be responsible for anticholinergic side effects, such as dry mouth, is produced. The new transdermal oxybutynin formulation offers patients with urinary incontinence an effective, safe and well-tolerated option for managing the symptoms of overactive bladder.     

国产酒石酸托特罗定片治疗膀胱过度活动症的临床研究

目的 :研究国产酒石酸托特罗定片治疗膀胱过度活动症的疗效和安全性。方法 :选择膀胱过度活动症56例 ,随机分为托特罗定组和奥昔布宁组各28例 ,疗程6周。结果 :托特罗定片和奥昔布宁片治疗膀胱过度活动症疗效相当 ,前者的不良反应发生率低于后者。结论 :托特罗定片是治疗膀胱过度活动症更为理想的药物     

西替利嗪治疗慢性荨麻疹113例

目的：比较国产与进口西替利嗪片对慢性荨麻疹的疗效及不良反应。方法：选择慢性荨麻疹病人１１３例,采用随机对照双盲法给予国产或进口西替利嗪片。其中国产组５４例（男性１８例,女性３６例,年龄 ３４ ａ ± ｓ１２ａ）给予国产西替利嗪片,进口组 ５９例（男性 ３０例,女性 ２９例,年龄 ３２ ａ±１１ａ）给予进口西替利嗪片,均为 １０ ｍｐ,ｐｏ, ｑｄ× ２ ｗｋ。结果：国产组与进口组的总有效率分别为 ９１％和８８％（Ｐ＞０．０５）。２组的不良反应均较轻微。结论：国产与进口西替利嗪片治疗慢性荨麻疹均安全有效。     

国产与进口头孢吡肟治疗泌尿系感染随机单盲对照临床研究

目的　评价国产与进口头孢吡肟治疗急性中重度泌尿系统感染的有效性和安全性。方法　用区组随机平行对照、多中心单盲试验设计,用进口头孢吡肟作对照药。共入组127例病例,剔除5例,进入疗效分析病例数为122例,其中试验组61例,对照组61例。国产和进口头孢吡肟均为每次给药2g, 30~60min内静脉点滴,bid,疗程7~14天。结果　治疗结束后,临床有效率分别为试验组98. 36%,对照组96. 72%;试验组与对照组致病菌清除率均为100%。2组药物不良反应发生率分别为6. 45%和10. 77%。2组对比差异均无统计学意义(P>0. 05)。结论　国产与进口头孢吡肟对急性泌尿系统感染均安全、有效。