Efficacy and Safety of Solifenacin Plus Tamsulosin OCAS in Men with Voiding and Storage Lower Urinary Tract Symptoms: Results from a Phase 2, Dose-finding Study (SATURN)

Background

Storage symptoms are often undertreated in men with lower urinary tract symptoms (LUTS).

Objective

To evaluate the combination of an antimuscarinic (solifenacin) with an α-blocker (tamsulosin) versus tamsulosin alone in the treatment of men with LUTS.

Design, setting, and participants

A double-blind, 12-wk, phase 2 study in 937 men with LUTS (≥3 mo, total International Prostate Symptom Score [IPSS] ≥13, and maximum urinary flow rate 4.0–15.0 ml/s).

Intervention

Eight treatment groups: tamsulosin oral controlled absorption system (OCAS) 0.4 mg; solifenacin 3, 6, or 9 mg; solifenacin 3, 6 or 9 mg plus tamsulosin OCAS 0.4 mg; or placebo.

Outcome measurements and statistical analysis

The primary efficacy end point was change from baseline in total IPSS. Secondary end points included micturition diary and quality-of-life (QoL) parameters. Post hoc subgroup analyses were performed by severity of baseline storage symptoms, with statistical comparisons presented only for tamsulosin OCAS alone versus combination therapy, due to the small sample size of the solifenacin monotherapy and placebo subgroups.

Results and limitations

Combination therapy was associated with significant improvements in micturition frequency and voided volume versus tamsulosin OCAS alone in the total study population; improvements in total IPSS were not significant. Statistically significant improvements in urgency episodes, micturition frequency, total urgency score, voided volume, IPSS storage subscore, IPSS-QoL index, and Patient Perception of Bladder Condition were observed in a subpopulation of men with two or more urgency episodes per 24 h (Patient Perception of Intensity of Urgency Scale grade 3 or 4) and eight or more micturitions per 24 h at baseline (storage symptoms subgroup) with combination therapy versus tamsulosin OCAS alone (p ≤ 0.05 for the dose–response slope, all variables). Combination therapy was well tolerated, and adverse events were consistent with the safety profiles of both compounds.

Conclusions

Solifenacin plus tamsulosin OCAS did not significantly improve IPSS in the total study population but offered significant efficacy and QoL benefits over tamsulosin OCAS monotherapy in men with both voiding and storage symptoms at baseline. Combination therapy was well tolerated.

ClinicalTrials.gov identifier

NCT00510406     

癃闭舒胶囊联合盐酸坦洛新治疗盆腔术后排尿功能障碍

目的 观察癃闭舒胶囊联合盐酸坦洛新治疗盆腔术后排尿功能障碍的临床疗效.方法 选择2010年7月～2013年7月我院盆腔术后排尿功能障碍患者80例,按入院顺序随机分为对照组和治疗组各40例.对照组给予盐酸坦洛新0.2mg,每晚1次;治疗组给予盐酸坦洛新0.2 mg,每晚1次,癃闭舒胶囊3粒,每天2次,治疗8周后评定临床疗效及测定残余尿量、最大尿流率（Qmax）和平均尿流率（Qave）,同时记录不良反应.结果 治疗组治疗后总有效率优于对照组（P＜0.05）;两组治疗后膀胱残余尿量、Qmax、Qave均较治疗前明显改善（P＜0.05）,且治疗组各项指标优于对照组（P＜0.05）.两组均未见明显不良反应.结论 癃闭舒胶囊联合盐酸坦洛新治疗盆腔术后排尿功能障碍疗效满意,副作用少,值得临床推广应用.     

坦洛新缓释胶囊联合全雄激素阻断治疗晚期前列腺癌伴膀胱出口梗阻的疗效

目的：探讨坦洛新缓释胶囊与全雄激素阻断联合用于晚期前列腺癌伴膀胱出口梗阻的疗效。方法将68例晚期前列腺癌伴膀胱出口梗阻患者随机分为观察组与对照组。两组均接受全雄激素阻断治疗,观察组在此基础上口服坦洛新缓释胶囊0.2 mg,1次/d,疗程均为4个月。结果治疗4个月后,两组QOL及Qmax较治疗前明显上升,IPSS评分、RU和TPSA较治疗前明显减少（P〈0.05或P〈0.01）,且观察组IPSS、QOL、Qmax、RU改善幅度明显优于对照组（P〈0.05）。对照组未发生明显药物不良反应,观察组出现体位性头晕1例,症状较轻。结论坦洛新缓释胶囊联合雄激素阻断能迅速有效地改善晚期前列腺癌患者LUTS症状,提高患者的生活质量,安全、经济。     

利尿排石汤联合坦洛新对体外碎石后排石效果的影响

正输尿管结石多为肾结石下降过程中停留在输尿管狭窄处所致,占泌尿系结石的33%～54%~([1])。结石易停留或嵌顿在输尿管的上段,约占全部输尿管结石的58%,而下段输尿管结石仅占33%,中段最少~([1])。冲击波碎石(extracorporeal shock wave lidmtfipsy,ESWL)属非器械侵入性微创方法,是治疗输尿管结     

坦索罗辛联合五淋化石丸在输尿管下段结石体外震波碎石术后辅助排石效果观察

目的探讨体外震波碎石术(ESWL)治疗输尿管下段结石后应用坦索罗辛联合五淋化石丸辅助排石的效果。方法对120例输尿管下段结石患者随机分为对照组(60例)和治疗组(60例),对照组ES-WL后应用五淋化石丸,1.25g/次,3次/d,未应用输尿管平滑肌松弛剂;治疗组ESWL后在对照组治疗方案的基础上予以口服α_1肾上腺索能受体阻滞剂坦索罗辛,0.4 mg/次,1次/d。观察两组的结石排出率、结石排出时间、并发症(肾绞痛、发热、血尿)发生率及药物的副作用并比较。每例患者观察时间不超过2周。结果治疗组排石率为88.3%,对照组为46.7%,治疗组高于对照组(P0.01)。肾绞痛、发热、血尿的发生率对照组分别为35.0%、20.0%、23.3%,治疗组分别为10.0%、6.7%、8.3%,治疗组低于对照组(P0.05)。治疗组除2例发生头晕外,无其他不良反应发生。结论坦索罗辛联合五淋化石丸能够发挥两者的协同作用,提高输尿管下段结石ESWL后的排石率,降低肾绞痛、发热、血尿及药物副作用的发生率,且安全有效,值得临床推广应用。     

清淋方联合坦索罗辛治疗前列腺增生电切术后膀胱过度活动症的临床效果

目的 探讨清淋方联合坦索罗辛治疗前列腺增生电切术后膀胱过度活动症的效果。方法 回顾性选取本院2017年1月至2019年12月收治的前列腺增生行电切术后膀胱过度活动症患者97例,根据其用药的不同分为常规组(n=46,坦索罗辛)与联合组(n=51,坦索罗辛+清淋方),疗程为12周。比较两组患者治疗前后症状的变化,记录用药期间出现的不良反应,治疗前后对两组患者进行各项症状评分:国际前列腺症状评分(IPSS)、膀胱过度活动症状评分(OABSS)、储尿期症状评分(USPSS)、排尿期症状评分(VSS),评价两组治疗的总有效率。结果 治疗后两组症状均有一定程度改善,治疗后联合组最大尿流量多于常规组,且膀胱痉挛次数及持续时间均少于常规组,差异均有统计学意义(P0.05);经治疗后两组各症状评分均有所降低(P0.05),治疗后联合组IPSS、OABSS、USPSS低于常规组(P0.05);两组不良反应发生率比较,差异无统计学意义(P0.05);联合组临床总有效率高于常规组(P0.05)。结论 与单用坦索罗辛相比,清淋方联合坦索罗辛治疗前列腺增生电切术后膀胱过度活动症,能进一步改善患者症状,提高临床疗效。     

Urinary retention in early urinary catheter removal after colorectal surgery

Background

High urinary infection (UTI) rate (12%) for our rectal surgery prompted practice change to early catheter removal (postoperative day 2) and prophylactic tamsulosin. Here we report urinary retention (UR) and UTI after this change.

特拉唑嗪、非那司提和坦素罗辛治疗良性前列腺增生症的有效性评价

目的评价和比较特拉唑嗪、非那司提和坦素罗辛,以及其中任意两药联用与单药治疗良性前列腺增生症(benign prostatic hyperplasia,BPH)的有效性.方法计算机检索MEDLINE(1966～2004.12)、EMBASE(1984～2004.12)、Cochrane图书馆(2004年第4期)、美国<生物学文摘>光盘数据库(1990～2004.12)和中国生物医学文献光盘数据库(1978～2004.12)等,手检10种相关杂志.纳入与有效性有关的随机对照试验(RCT)和半随机对照试验(CCT),并追索已纳入文献的参考文献.由至少两位系统评价员独立进行文献筛查、质量评价和资料提取,并交叉核对,不同意见请第三者裁决.采用RevMan 4.2软件进行Meta分析.结果共初检出656篇文献,经筛选后最后纳入12篇原始研究(2 471例)进行分析,包括11篇RCT,1篇CCT.Meta分析结果显示:与特拉唑嗪比较,坦素罗辛改善国际前列腺症状评分(international prostatic symptom score, IPSS)更明显[WMD＝0.75,95%CI (0.03,1.46),P=0.04],差异有统计学意义,但在平均尿流率(average rate of urine flow, AFR)改善程度 [WMD=0.23,95%CI (-0.39,0.85),P=0.46]、残余尿量改善程度 [WMD=0.82,95%CI (-2.92,4.57),P=0.67] 以及减小前列腺体积的效果 [WMD=2.20,95%CI (-3.99,8.39),P=0.49] 方面,两者差异均无统计学意义.非那司提与坦素罗辛比较,两者在改善IPSS [WMD=0.65,95%CI (-0.45,1.75),P=0.25] 和最大尿流率方面 [WMD=0.39,95%CI (-0.72,1.51),P=0.49],其差异均无统计学意义.仅有两个研究比较了非那司提与特拉唑嗪对最大尿流率的影响,且结论各异.仅有1个研究(538例)比较了单用非那司提、特拉唑嗪与联用非那司提和特拉唑嗪治疗良性前列腺增生症的有效率,结果显示两药联用的有效率明显优于单用非那司提,但与单用特拉唑嗪无明显差异.结论非那司提、特拉唑嗪和坦素罗辛治疗良性前列腺增生症的效果差别不大.在改善IPSS和生活质量方面,坦素罗辛似乎优于特拉唑嗪;非那司提与特拉唑嗪联用比单用非那司提有效率高,但不比单用特拉唑嗪效果好.结合安全性和经济性考虑,推荐临床短期单用坦素罗辛治疗良性前列腺增生症.长期治疗方案目前尚无足够的证据支持,有待进一步研究;在新证据产生之前不推荐联合用药.鉴于有关临床研究现状,呼吁提高国内外原始研究质量,增大样本量,开展高质量临床研究.     

坦索罗辛与阿呋唑嗪治疗输尿管结石的疗效比较

目的:比较坦索罗辛与阿呋唑嗪治疗输尿管结石的疗效。方法:将156例确诊为输尿管结石的患者随机分为试验组与对照组(各78例),分别给予阿呋唑嗪10 mg、坦索罗辛0.2mg,均为qd,服药2⁴周;患者均每日饮水>2 L,适量运动。比较两组患者的排石率、结石排出时间和药品不良反应发生情况。结果:试验组与对照组的排石率分别为61.5%、83.3%(P<0.05),两组患者的结石排出时间和药品不良反应发生率差异无统计学意义(P>0.05)。结论:坦索罗辛治疗输尿管结石比阿呋唑嗪疗效更好。