改良脾腔静脉分流联合断流术治疗食管胃底静脉曲张破裂出血

目的 探讨改良脾腔静脉分流联合贲门周围断流术治疗门静脉高压症食管胃底静脉曲张破裂出血的临床疗效.方法 回顾性分析1997年至2007年陕西省人民医院采用改良脾腔静脉分流联合贲门周围血管断流术(90例,联合组)及贲门周围血管断流术(78例,断流组)治疗门静脉高压症食管胃底静脉曲张破裂出血患者的临床资料,应用彩色多普勒超声、术中门静脉压力监测等观察开腹后和术后门静脉系统血流动力学变化.采用方差分析及配对t检验和x2检验分析相关数据.结果 联合组和断流组患者手术死亡率分别为3%(3/90)和5%(4/78),其差异无统计学意义(x2=0.038,P＞0.05);术后远期出血率分别为6%(5/79)和13%(8/60),其差异有统计学意义(x2=4.824,P<0.05);肝性脑病发生率分别为6%(5/79)和7%(4/60),其差异无统计学意义(x2=0.072,P＞0.05);术后1、3、5、10年生存率分别为97%(77/79)、92%(55/60)、80%(16/20)、60%(3/5)和97%(58/60)、83%(40/48)、73%(22/30)、53%(8/15),其差异无统计学意义(x2=0.731,P＞0.05).联合组开腹后和术后门静脉压力分别为(38.8±4.2)、(33.1±1.5)cm H2O(1 cm H2O=0.098 kPa),其差异有统计学意义(t=8.574,P<0.05);断流组开腹后和术后门静脉压力分别为(38.9±2.5)、(34.6±2.6)cm H2O,其差异有统计学意义(t=6.530,P<0.05);两组患者术后门静脉压力比较差异有统计学意义(t=2.859,P<0.05).联合组开腹后和术后门静脉直径分别为(1.40±0.41)、(1.22±0.15)cm,其差异有统计学意义(t=2.608,P<0.05);血流量分别为(1280±350)、(830±360)ml/min,其差异有统计学意义(t=5.668,P<0.05).断流组开腹后和术后门静脉直径分别为(1.41±0.32)、(1.27±0.32)cm,其差异无统计学意义(t=1.637,P＞0.05);血流量分别为(1350±380)、(980±290)ml/min,其差异有统计学意义(t=4.096,P<0.05).两组患者术后门静脉血流量比较差异无统计学意义(t=1.871,P＞0.05).结论 改良脾腔静脉分流联合断流术止血效果确切、再出血率低,血流动力学变化合理,临床疗效满意,是治疗门静脉高压症食管胃底静脉曲张破裂出血的较佳术式.     

肝移植后采用巴利昔单抗进行免疫诱导治疗

目的 探讨肝移植后采用巴利昔单抗进行免疫诱导治疗预防急性排斥反应的有效性和安全性.方法 160例肝移植患者中,47例术后给予两剂巴利昔单抗(20 mg/剂)进行免疫诱导治疗(研究组),另外113例为对照组,不使用巴利昔单抗.所有患者术后均采用他克莫司、霉酚酸酯和糖皮质激素预防排斥反应.结果 术后1年内,研究组的急性排斥反应发生率为8.5%(4/47),对照组为22.1%(25/113),二者间的差异有统计学意义(P＜0.05);研究组排斥反应活动指数平均为4,对照组为6,两组间的差异无统计学意义(P＞0.05).研究组术后感染发生率为31.9 %(15/47),对照组为26.5%(30/113),两组间的差异无统计学意义(P＞0.05).研究组患者及移植肝1年存活率分别为95.7%和95.7%,对照组分别为96.5%和94.7%,两组间的差异均无统计学意义(P＞0.05).两组间其它不良反应发生率的差异也无统计学意义.结论 在以他克莫司为基础的免疫抑制治疗方案中,采用巴利昔单抗进行诱导治疗可明显降低肝移植后急性排斥反应发生率,且不增加感染和其它不良反应发生率.     

精准肝切除治疗原发性肝癌的疗效评价

目的 初步探讨精准肝切除治疗原发性肝癌的疗效.方法 将2007年7月至2009年10月南京大学医学院附属鼓楼医院103例原发性肝癌患者根据不同肝切除方式分为精准组(54例)和常规组(49例).比较两组患者的术中、术后和随访情况.计量资料采用t检验,方差不齐采用t'检验,计数资料采用Fisher确切概率法进行分析.结果 两组患者均无围手术期死亡.精准组和常规组术中失血量分别为(635±608)ml和(929±1044)ml,两组比较差异无统计学意义(t=1.722,P>0.05);术中输血量分别为(222±381)ml和(542±785)ml,两组比较筹异有统计学意义(t=2.590,P<0.05);术后AST分别为(158±121)U/L和(292±347)U/L,两组比较差异有统计学意义(t=2.558,P<0.05);肿瘤标本切缘阳性率分别为2%(1/54)和18%(9/49),两组比较差异有统计学意义(P<0.05);术后并发症发生率分别为7%(4/54)和24%(12/49),两组比较差异有统计学意义(P<0.05);术后1年肿瘤复发率分别为24%(8/33)和42%(20/48);术后1年生存率分别为85%(28/33)和77%(37/48),两组预后比较差异无统计学意义(P>0.05).结论 肝癌患者在准确的术前评估后采用精准肝切除,手术打击较小,术后恢复更快,具有较好的疗效.     

胆囊腺鳞癌和鳞癌与胆囊腺癌的临床对比研究

目的 探讨胆囊腺鳞癌和鳞癌的临床特点.方法 回顾性分析112例胆囊癌患者的临床资料,将其中11例胆囊腺鳞癌和鳞癌的临床特点和预后与同期收治的101例胆囊腺癌进行比较.结果 腺鳞癌/鳞癌组与腺癌组的肿瘤浸润分期为13或T4的比例分别为100%和53%,两组的差异有统计学意义(X2=7.013,P=0.008).腺鳞癌/鳞癌与进展期腺癌(T3或T4期)的远处转移发生率分别为0和35%,差异有统计学意义(X2=3.900,P=0.048),两组的淋巴结转移率为82%和87%(X2=0.000,P=1.000).腺鳞癌/鳞癌组和进展期的腺癌组的胃肠道侵犯发生率分别为45%和15%,差异无统计学意义(X2=3.618,P=0.054).两组的中位生存期分别为5个月和4个月,生存差异无统计学意义(X2=0.359,P=0.549).结论 胆囊腺鳞癌和鳞癌的局部侵袭性强,而远处转移率低.淋巴结转移情况与腺癌相似.     

爱普列特治疗良性前列腺增生临床疗效观察

目的:研究观察爱普列特治疗BPH的疗效和安全性.方法:60例患者分为两组,试验组30例,服用爱普列特每天两次,每次5 mg,对照组30例,服用保列治每天一次,每次5 mg,疗程6个月.结果:给药3个月后,爱普列特和保列治有效率分别为56.7%和60.0%,6个月后有效率分别为86.7%和90.0%,两组相比均差异无统计学意义(P＞0.05).不良反应发生率爱普列特组为10.0%(3/30),保列治组为13.3%(4/30),两者相比差异无统计学意义(P＞0.05).结论:爱普列特可明显改善BPH患者临床症状,不良反应发生率低,疗效和耐受性与保列治类似,是一种安全有效的治疗BPH的药物.     

免疫调控营养对重症急性胰腺炎的治疗作用

目的 探讨免疫调控营养对重症急性胰腺炎(SAP)患者的治疗作用.方法 前瞻性分析2008年2月至2009年10月华中科技大学同济医学院附属协和医院收治的80例SAP患者的临床资料.将80例SAP患者按照配对的方法分为常规营养组(CN组)和免疫调控营养组(IRN组),每组40例.CN组接受分阶段营养支持,而IRN组则在常规营养治疗基础上联合应用ω-3多不饱和脂肪酸(ω-3 PUFA)和谷氨酰胺.评估两组患者在治疗第1、4、7、10、14天的APACHEⅡ评分,比较两组患者住院期间肺部感染、腹腔感染、脓毒血症发生率,手术干预率,ICU时间,住院时间和病死率的差异.采用t检验和χ2检验分析检测数据.结果 IRN组患者APACHEⅡ评分在治疗的第4、7天分别为(15.3±1.8)、(9.0±1.8)分,明显低于CN组的(20.0±2.7)、(13.3±2.4)分,两组比较,差异有统计学意义(t=3.3,2.8,P<0.05),IRN组在第10、14天仍低于CN组,但两组比较,差异无统计学意义(t=0.7,0.6,P>0.05).IRN组肺部感染、腹腔感染发生率和手术干预率分别为18%(7/40)、13%(5/40)和5%(2/40),显著低于CN组的38%(15/40)、33%(13/40)和20%(8/40),两组比较,差异有统计学意义(χ2=4.0,4.6,4.1,P<0.05).IRN组脓毒血症发生率为5%(2/40),低于CN组的8%(3/40),但两组比较,差异无统计学意义(χ2=0.0,P>0.05).IRN组的ICU时间和住院时间分别为(5.4±1.6)、(38.6±9.3)d,而CN组分别为(7.8±2.8)、(43.1±11.6)d,两组比较,差异有统计学意义(t=2.7,3.7,P<0.05).IRN组和CN组病死率分别为5%(2/40)和8%(3/40),两组比较,差异无统计学意义(χ2=0.0,P>0.05).结论 在SAP患者营养支持中添加ω-3PUFA及谷氨酰胺可调控SAP早期过度炎症反应,有效减少严重感染的发生,降低手术率,缩短ICU时间及住院时间,对SAP具有积极的治疗作用.     

支气管动脉灌注化疗栓塞联合125I粒子植入治疗局部晚期非小细胞肺癌

目的前瞻性研究支气管动脉灌注化疗栓塞(BACE)联合放射性~(125)I粒子组织间植入治疗局部晚期非小细胞肺癌(LANSCLC)的临床疗效。方法将入选的90例患者随机分为两组:对研究组45例患者采用联合BACE(经支气管动脉GP方案局部化疗+微球栓塞)+~(125)I粒子植入,对照组45例患者采用静脉GP方案化疗+三维适形放疗。比较两组患者的近期疗效、生存率及不良反应等。结果治疗后3、6、12个月,研究组瘤体大小较对照组显著缩小,Karnofsky评分显著提高(P均0.05);治疗后3、6、12个月的研究组的总有效率分别为73.33%(44/60)、78.18%(43/55)和83.33%(40/48),而对照组分别为38.46%(20/52)、53.19%(25/47)和65.85%(27/41),差异均有统计学意义(P均0.05)。研究组和对照组1年生存率分别为84.44%(38/45)和55.56%(25/45),差异有统计学意义(χ~2=6.57,P0.05)。两组骨髓抑制和放射性肺炎发生率差异有统计学意义(P均0.05),胃肠道反应发生率差异无统计学意义(P0.05)。结论 BACE联合~(125)I粒子组织间植入治疗LANSCLC有一定的疗效,且不良反应少,值得进一步推广。     

精准肝切除治疗原发性肝癌的效果分析

目的探讨精准肝切除技术在原发性肝癌切除中的应用价值。方法回顾性分析我院2011年1月至2012年6月收治的75例原发性肝癌行肝切除患者的临床资料,其中精准肝切除42例(精准组),非规则性肝切除33例(常规组),比较两组术后和围手术期情况,包括术中失血量和输血量,术后谷丙转氨酶(ALT)、谷草转氨酶(AST)、总胆红素(TBil)水平,术后恢复时间,并发症发生率,术后肿瘤标本切缘阳性率,术后1年复发率和生存率。结果两组患者均无围手术期死亡。精准组和常规组术中失血量分别为(612±435)ml和(1325±557)ml,两组比较差异有统计学意义(t=2.578,P0.05);术中输血量分别为(325±157)ml和(856±375)ml,两组比较差异有统计学意义(t=2.25,P0.05);术后第3天:ALT分别为(385±296)U/L和(442±403)U/L,两组比较差异无统计学意义(t=1.132,P0.05),AST分别为(132±115)U/L和(306±352)U/L,两组比较差异有统计学意义(t=2.41,P0.05),TBil分别为(28±12)mmol/L和(32±18)mmol/L,两组比较差异无统计学意义(t=0.233,P0.05);术后恢复时间分别为(9.3±3.5)d和(14.2±5.4)d,两组比较差异有统计学意义(t=2.15,P0.05)。肿瘤标本切缘阳性率分别为7.1%(3/42)和21.2%(7/33),两组间差异有统计学意义(P0.05);术后并发症发生率分别为9.5%(4/42)和27.3%(9/33),两组比较差异有统计学意义(P0.05);术后1年肿瘤复发率分别为28.6%(12/42)和42.4%(14/33),术后1年生存率分别为88.1%(37/42)和78.8%(26/33),两组预后比较差异无统计学意义(P0.05)。结论肝癌患者在准确的术前评估后采用精准肝切除,手术创伤小,术中出血少,术后恢复快,具有较好的疗效。     

人精子中芳香化酶表达与精子运动能力

目的 研究精子芳香化酶表达与精子运动能力的关系.方法 分别采用RT-PCR和流式细胞术检测精子中芳香化酶的mRNA和蛋白质水平,采用CASA分析系统评价精子的运动能力.结果 精子P450arom/GAPDH比值和P450arom阳性率都与活动率有一定相关性,相关系数分别为0.6512(P<0.05)和0.6726(P<0.05).正常男性(n=46)与弱精子症患者(n=42)精子的P450arom/GAPDH比值分别为(0.63±0.24)和(0.34±0.14),P450arom阳性率分别为(48.73±19.92)%和(22.83±9.59)%,差异都有统计学意义(P<0.001).结论 芳香化酶可能与精子运动能力的获得有一定关系,芳香化酶表达异常可能与弱精子症的发生有关.     

腹腔镜根治性全胃切除治疗胃底贲门癌的临床研究

目的 探讨腹腔镜根治性全胃切除治疗胃底贲门癌的临床疗效和可行性.方法 回顾性分析2007年4月至2009年4月福建医科大学附属协和医院收治的176例胃底贲门癌行根治性全胃切除患者的临床资料,其中腹腔镜全胃切除81例(LATG组),开腹全胃切除95例(OTG组).比较两组患者术中及术后、淋巴结清扫、并发症发生率及病死率情况.计量资料采用t检验,计数资料采用x2检验.结果 两组患者均成功完成手术.LATG组和OTG组患者术中出血量分别为(98±84)ml和(339±245)ml,术中输血例数分别为3例和19例,术后肛门排气时间分别为(3.9±1.1)d和(5.0±1.6)d,术后住院时间分别为(13±5)d和(15±5)d,其差异有统计学意义(t=4.16,x2=6.82,t=4.57,2.83,P<0.05).LATG组和OTG组患者平均淋巴结清扫数目分别为(28±12)枚和(29±11)枚,其差异无统计学意义(t=0.42,P＞0.05);按肿瘤浸润深度进行分层分析,LATG组和OTG组患者T1、T2、T3期平均淋巴结清扫数目分别为(21±8)、(25±7)、(29±11)枚和(29±12)、(31±9)、(28±11)枚,其差异无统计学意义(t=1.53,1.90,0.65,P＞0.05).LATG组和OTG组患者术后并发症发生率和病死率分别为11%(9/81)、0和19%(18/95)、1%(1/95),其差异无统计学意义(x2=2.07,1.18,P＞0.05).结论 腹腔镜根治性全胃切除能达到与开腹手术相同的根治效果,且具有安全、术后恢复快等优点.     

索利那新联合坦索罗辛治疗经尿道前列腺电切术术后膀胱过度活动症

目的探讨索利那新联合盐酸坦索罗辛预防性治疗经尿道前列腺电切术（TURP）后膀胱过度活动症的疗效。方法收集84例良性前列腺增生症患者的基本资料,发病年龄52～0（72．34-6．4）岁,随机分为4组：联合药物组、索利那新组、坦索罗辛组及对照组各21例。比较各组TuRP术后3d内膀胱区阵发性痉挛性疼痛的次数、膀胱痉挛持续时间及拔管后第1天和第3天尿频、尿急的情况。结果各组在术后3d内膀胱痉挛次数、膀胱痉挛平均持续时间均少于对照组（P〈O．05）;索利那新组术后第2、第3天膀胱痉挛次数分别为（1．64±0．42）次和（1．28±o．65）次,膀胱痉挛平均持续时间分别为（0.1±0．18）h和（0．20±0．07）h,少于盐酸坦索罗辛组（3．03±0．28）次和（2．18±0．58）次、（O．28±0．15）h和（0．23±0．11）h。联合药物组膀胱痉挛次数（1．334±0．31）次和（0.88±0.21）次,其持续时间为（0.184±0．11）h和（0．15±0．10）h,少于索利那新组（P〈0．05）。拔管后第1、3天,索利那新联合坦索罗辛组患者的尿频、尿急次数明显低于索利那新组和盐酸坦索罗辛组（P〈O．05）。结论早期预防性联合应用索利那新与坦索罗辛可能是一种安全有效的缓解患者TuRP术后膀胱过度活动症的方法,有助于患者的术后恢复和生活质量的提高。     

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。     

高选择性M受体阻滞剂治疗高龄BPH患者膀胱过度活动症的疗效及安全性

目的探讨高选择性M受体阻滞剂索利那新治疗高龄BPH患者膀胱过度活动症（OAB）的疗效及安全性。方法选取2010年7月至2011年5月于我院泌尿外科门诊就诊、年龄≥75岁、确诊为OAB的BPH患者30例,给予索利那新治疗,每日1次,每次5mg,治疗周期3个月。治疗前后以排尿日记、国际前列腺症状评分（IPSS）、膀胱过度活动症状评分（OABSS）、患者感知膀胱症状情况分级量表（PPBC）、生活质量评分（QOL）为主要疗效指标,对疗效及服药安全性进行评价。结果治疗后的24h平均尿急次数、24h平均排尿次数、夜尿次数及每周尿失禁次数均较治疗前好转;IPSS、OABSS、PPBC、QOL评分均低于治疗前,差异具有统计学意义（均P〈0.05）。9例患者出现轻度口干、便秘等不良反应,均能耐受,对症治疗后缓解。2例患者出现排尿困难情况,停药1周并加用α受体阻滞剂后缓解。结论高选择性M受体阻滞剂索利那新治疗高龄BPH患者的膀胱过度活动症疗效较好,不良反应轻,是一种相对安全有效的药物治疗方法。     

Nocturnal polyuria and nocturia relief in patients treated with solifenacin for overactive bladder symptoms

The objectives of this study are to determine whether patients with overactive bladder (OAB) and nocturia achieved relief of their nighttime voiding symptoms when treated with solifenacin and whether having nocturnal polyuria (NP) affected that response. The patients pooled from four phase III clinical trials were evaluated for reductions in nocturia episodes after treatment with solifenacin (5 or 10 mg) or placebo. A second analysis was performed in patients with and without NP. The patients treated with solifenacin experienced statistically significant reductions in nocturia episodes; median reductions were −35.5% for 5 mg of solifenacin and −36.4% for 10 mg of solifenacin compared with −25.0% for placebo, and significantly more patients treated with solifenacin vs placebo achieved a mean nocturic frequency of ≤1 episode/night. Solifenacin significantly reduced nocturia episodes only in patients without NP (mean change was −0.61 episodes/night for both doses compared with −0.43 episodes for placebo). Solifenacin significantly improved nocturia symptoms only in OAB patients without NP.     

Solifenacin

Pharacologic therapy has been the mainstay of treatment for patients who have overactive bladder. In recent years, a number of new antimuscarinic agents have been introduced. Solifenacin succinate is a new once-daily antimuscarinic agent that is an effective and well-tolerated treatment option for patients who have overactive bladder. Solifenacin increases functional bladder capacity and decreases urgency, frequency, and incontinence. In pharmacokinetic studies, solifenacin demonstrated selectivity for the bladder over the salivary gland; thus, it is likely that the bladder selectivity of this agent is responsible for the low incidence of dry mouth and constipation reported in the clinical trials.     

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

目的比较索利那新及托特罗定治疗经尿道前列腺电切术（TURP）术后患者膀胱过度活动症（OAB）的有效性与安全性。方法选取126例TURP后出现OAB症状的患者,随机分为4组：A组（索利那新5mg,1次/d）,B组（索利那新10mg,1次/d）,C组（托特罗定2mg,2次/d）,D组（安慰剂组）。术后6h开始服药,观察治疗前及拔管后7d日间排尿次数、夜间排尿次数、尿急、急迫性尿失禁以及对日常生活造成的影响。进一步进行OAB症状评分表（OABSS）评分和感知膀胱症状量表（PPBC）评分;观察各组口干、便秘、视力模糊症状等不良反应的发生率以及肝功能、肾功能指标变化。结果拔管后7d,A、B、C组与D组OABSS及PPBC评分有显著性差异（P〈0.05）,A、B组,B、C组,A、C组之间无显著性差异（P〉0.05）。A组2例出现口干,1例便秘;B组5例口干,3例便秘,2例视力模糊;C组有4例口干,2例便秘,1例视力模糊;D组仅1例便秘。各组第7d复查的肝功能、肾功能与术前相比无统计学差异（P〉0.05）。结论索利那新治疗TURP术后OAB症状比托特罗定更安全,5mg足以发挥疗效,副作用更少。     

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.     

Randomized, double-blind placebo- and tolterodine-controlled trial of the once-daily antimuscarinic agent solifenacin in patients with symptomatic overactive bladder

OBJECTIVE: To assess in a phase 3a trial the efficacy of solifenacin succinate, a once-daily oral antimuscarinic agent in development at 5-mg and 10-mg dosage strengths, for the treatment of overactive bladder (OAB) (Yamanouchi Pharmaceutical Co. Ltd, Tokyo, Japan) compared with placebo in patients with symptoms of OAB, i.e. urgency, incontinence, and frequency, with additional objectives being to assess the safety and tolerability of solifenacin and to compare the efficacy and safety of solifenacin with tolterodine 2 mg twice daily. PATIENTS AND METHODS: The study was an international, multicentre, randomized, double-blind, tolterodine- and placebo-controlled trial conducted at 98 centres. Adult patients with symptomatic OAB for > or = 3 months were eligible; after a single-blind 2-week placebo run-in period patients were randomized equally to a 12-week double-blind treatment with either tolterodine 2 mg twice daily, placebo, solifenacin 5 mg or 10 mg once daily. Efficacy variables included change from baseline in the mean number of urgency, incontinence and urge incontinence episodes, and change from baseline in voids/24 h and mean volume voided/void. RESULTS: In all, 1281 patients were enrolled, 1081 randomized and 1077 treated; 1033 were evaluated for efficacy. Compared with placebo, the change from baseline (-1.41, -32.7%) in the mean number of urgency episodes per 24 h was statistically significantly lower with solifenacin 5 mg (-2.85, -51.9%) and 10 mg (-3.07, -54.7%; both P < 0.001), but not with tolterodine (-2.05, -37.9%; P = 0.0511). There was a statistically insignificant decrease in episodes of incontinence with tolterodine (-1.14; P = 0.1122) but a significant decrease in patients treated with solifenacin 5 (-1.42; P = 0.008) and 10 mg (-1.45; P = 0.0038). Compared with placebo (-1.20, -8.1%) the mean number of voids/24 h was significantly lower in patients receiving tolterodine (-1.88, -15%; P = 0.0145), solifenacin 5 (-2.19, -17%) and 10 mg (-2.61, -20%; both P < 0.001). The mean volume voided/void was also significantly higher with all three active treatments (P < 0.001). Solifenacin was well tolerated; compared with placebo (4.9%), dry mouth (the most common side-effect), mostly mild, was reported in 18.6% of patients receiving tolterodine, 14.0% receiving 5 mg and 21.3% receiving 10 mg solifenacin. CONCLUSION: Solifenacin 5 and 10 mg once daily improved urgency and other symptoms of OAB, and was associated with an acceptable level of anticholinergic side-effects. Solifenacin demonstrated significantly favourable efficacy to side-effect ratio in treating symptomatic OAB.     

A comparison of the efficacy and tolerability of solifenacin succinate and extended release tolterodine at treating overactive bladder syndrome: results of the STAR trial

OBJECTIVE: To compare two new generation antimuscarinics at their recommended doses for treatment of overactive bladder syndrome (OAB). METHODS: A prospective, double blind, double-dummy, two-arm, parallel-group, 12-week study was conducted to compare the efficacy and safety of solifenacin 5 or 10 mg and tolterodine extended release (ER) 4 mg once daily in OAB patients. After 4 weeks of treatment patients had the option to request a dose increase but were dummied throughout as approved product labelling only allowed an increase for those on solifenacin. RESULTS: Solifenacin, with a flexible dosing regimen, showed greater efficacy to tolterodine in decreasing urgency episodes, incontinence, urge incontinence and pad usage and increasing the volume voided per micturition. More solifenacin treated patients became continent and reported improvements in perception of bladder condition assessments. The majority of side effects were mild to moderate in nature, and discontinuations were comparable and low in both groups. CONCLUSIONS: Solifenacin, with a flexible dosing regimen, was found to be superior to tolterodine ER with respect to the majority of the efficacy variables.     

Solifenacin appears effective and well tolerated in patients with symptomatic idiopathic detrusor overactivity in a placebo- and tolterodine-controlled phase 2 dose-finding study

OBJECTIVES: To evaluate the dose-response relationship and safety/tolerability of solifenacin succinate (YM905) in the treatment of overactive bladder (OAB), and to compare its efficacy and safety/tolerability with tolterodine 2 mg twice daily. PATIENTS AND METHODS: This multicentre study included a 2-week single-blind placebo run-in, a 4-week double-blind placebo-controlled active treatment phase, and a 2-week follow-up. Men and women with an OAB and urodynamic evidence of detrusor overactivity were randomized to placebo or solifenacin 2.5, 5, 10 or 20 mg once daily, or tolterodine 2 mg twice daily. RESULTS: Of 265 patients enrolled, 225 were randomized and 192 completed the study. Solifenacin 5, 10 and 20 mg produced statistically significant (P < 0.05) improvements in voids/24 h vs placebo, whereas tolterodine did not; the mean change with tolterodine was between those with solifenacin 2.5 and 5 mg. The outcome was similar for the mean change from baseline to endpoint in mean volume voided/void. For incontinence and urgency episodes/24 h the solifenacin dose groups showed numerically superior changes vs placebo; the mean effects with tolterodine were generally smaller than with solifenacin. Most of the efficacy effect of solifenacin was evident at 2 weeks. Quality-of-life outcomes supported the efficacy results. Solifenacin 5 and 10 mg were well tolerated; there were no serious treatment-related adverse events. The incidence of dry mouth was 14% for solifenacin 5 and 10 mg, 2.6% for placebo and 24% for tolterodine. CONCLUSION: In this study, the 5- and 10-mg doses of solifenacin appeared to be the most clinically effective for treating OAB, considering the balance between efficacy, quality of life and tolerability. From the results of this study solifenacin 5 and 10 mg were selected for further evaluation in large-scale phase 3 studies.