萘哌地尔联合托特罗定治疗前列腺增生合并膀胱过度活动症的疗效分析

目的 探讨萘哌地尔联合托特罗定治疗前列腺增生（BPH）合并膀胱过度活动症的疗效.方法 49例BPH前列腺增生合并膀胱过度活动症患者,按随机表法分为2组,分别给予萘哌地尔＋托特罗定和单独服用萘哌地尔,于用药前和用药6周后观察患者前列腺症状评分、最大尿流率、平均尿流率和尿急相关症状评分.结果 49例中共47例患者完成了实验评估.入选患者用药后均无尿潴留的发生.联合治疗组治疗前、后国际前列腺症状评分（IPSS）（21.2±2.7和16.1±1.7）、生活质量评分（QOL）（5.4±1.9和2.1±0.6）,差异均具有统计学意义（P=0.000）.单独用药组治疗前后的IPSS分别为23.1±1.7和17.2±1.9,QOL评分分别为5.5±0.8和3.1±0.9,（P=0.000）;治疗后二组间IPSS评分、QOL评分均有显著性差异 （P=0.01和P=0.02）.治疗6周后2组患者最大尿流率（Qmax）和平均尿流率（Qave）明显提高（联合治疗组治疗前后Qmav分别为10±2.1,14±4.2;Qave分别为6.7±2.1,9.5±2.5,均P=0.000;单独用药组治疗前后Qmax分别为9±4.2,15±5.3,Qave分别6.1±3.1,9.7±2.7,均P=0.000）;2组治疗前后残余尿量均无显著性差异（P=0.26,P=0.14）.结论 萘哌地尔联合托特罗定治疗BPH合并膀胱过度活动症是一种安全而有效的方法.     

萘哌地尔治疗良性前列腺增生伴膀胱过度活动症的临床观察

目的:探讨α1A、α1D肾上腺素能受体阻滞剂萘哌地尔治疗良性前列腺增生(BPH)伴膀胱过度活动症(OAB)的有效性及安全性。方法:采用自身对照的临床试验方法,萘哌地尔25mg,每日1次口服,对50例BPH伴OAB患者进行了为期6周的治疗。于治疗前后,以国际前列腺症状评分(IPSS)、生活质量评估(QOL)及最大尿流率(Qmax)、平均尿流率(Qave)、尿量(VV),以及血压和心率为评估指标,观察其有效性及安全性。结果:服药6周后,可评价病例46例。IPSS平均降低9.75分(P<0.01),其中,排尿症状评分平均降低3.97分(P<0.01),储尿症状评分平均降低5.78分(P<0.01);QOL平均降低1.95分(P<0.01),Qmax平均增加4.29ml/s(P<0.01),Qave平均增加3.75ml/s(P<0.01),VV平均增加55.12ml(P<0.05)。血压及心律无明显变化(P>0.05)。治疗过程中不良事件发生率4.35%(1例患者出现头晕)。结论:萘哌地尔治疗BPH伴OAB有效,安全。     

索利那新联合坦索罗辛对良性前列腺增生合并膀胱过动症的疗效及神经阻滞机制研究

目的分析索利那新联合坦索罗辛对良性前列腺增生(BPH)合并膀胱过动症的疗效及神经阻滞机制。方法随机将郑州大学第二附属医院2017-07—2018-07间收治的80例BPH合并膀胱过动症的患者分为2组,各40例。对照组给予坦索罗辛治疗,观察组给予索利那新联合坦索罗辛治疗。观察2组患者的国际前列腺症状(IPSS)评分、膀胱过度活动症自我评价量表(OABSS)评分、排尿期症状(VSS)评分、后储尿期症状(USPSS)评分、最大尿流率(Qmax)、尿量(VV)、平均尿流率(Qave)、残余尿量及不良反应。结果治疗前,2组患者的IPSS、OABSS、VSS、USPSS、Qmax、VV、Qave及残余尿量指标差异均无统计学意义(P0.05)。治疗后,2组患者的上述指标均明显改善,但观察组的改善效果显著优于对照组,差异均有统计学意义(P0.05)。而且观察组不良反应率低于对照组,差异有统计学意义(P0.05)。结论索利那新联合坦索罗辛治疗BPH合并膀胱过动症,可明显改善患者症状,不良反应少,安全有效。     

萘哌地尔与盐酸特拉唑嗪治疗良性前列腺增生的疗效与安全性评估

目的 评估蔡哌地尔（浦畅）治疗良性前列腺增生症的有效性和安全性。方法 根据随机、双盲、双模拟、多中心阳性药物平行对照法，240例BPH患者随机分为试验组120例和对照组120例，试验组给予每晚口服萘哌地尔片50mg；对照组给予每晚口服盐酸特拦唑嗪片2mg，两组疗程均为2个月。以国际前列腺症状评分（IPSS）、最大尿流率（Qmax）和临床疗效评价作为主要疗效指标，以平均尿流率（Qave）、生活质量评分（QOL）和残余尿量的变化作为次要疗效指标。结果 治疗8周后，共有236例进入统计分析。IPSS、Qmax、Qave、QOL、残余尿量治疗前后两组组内比较差异有统计学意义（P〈0.01），治疗前后两组组间比较差异无统计学意义（P〉0.05）；不良反应率两组间比较差异无统计学意义（P〉0.05），总的不良事件较少，但对照组有3例患者出现直立性低血压，试验组没有出现。结论蔡哌地尔（浦畅）是治疗良性前列腺增生有效且安全的药物。     

福施乐治疗良性前列腺增生的临床研究

目的:观察福施乐治疗BPH的有效性和安全性。方法:采用多中心、开放性、自身前后对照的临床研究方法,对60例BPH患者采用福施乐治疗12周。以国际前列腺症状评分(IPSS)、最大尿流率(Qmax)、膀胱残余尿(PVR)和前列腺体积为主要疗效指标,以生活质量评分(QOL)和平均尿流率(Qave)为次要疗效指标,来评价福施乐治疗BPH的效果。结果:治疗12周后,患者IPSS评分、Qmax、PVR、QOL评分、Qave均比治疗前明显改善(P<0.01),而前列腺体积治疗前后无显著性差异(P>0.05)。结论:福施乐可明显改善BPH患者的排尿症状,增加尿流率,减少残余尿,无明显不良反应,治疗BPH安全、有效。     

舍尼亭联合α受体阻滞剂治疗BPH伴逼尿肌过度活动的临床研究

目的:评价舍尼亭联合α受体阻滞剂治疗良性前列腺增生伴逼尿肌过度活动的有效性及安全性。方法:将113例良性前列腺增生伴逼尿肌过度活动患者随机分为A、B两组,A组联合应用舍尼亭(4 mg,1次/d)及可多华(4 mg,1次/d);B组单独使用可多华,治疗时间为12周,记录并比较治疗前后两组患者平均24 h排尿次数、IPSS及QOL评分、最大尿流率、残余尿量及尿潴留次数。结果:治疗后A组平均24 h排尿次数、IPSS及QOL评分改善较B组明显[(3.9±1.25vs2.6±1.37)、(4.4±1.27vs2.2±0.91)、(1.8±1.04)vs(0.5±0.26),P均<0.05];最大尿流率、残余尿量变化两组没有明显差异,两组病例均未发生尿潴留。结论:舍尼亭联合α受体阻滞剂能有效缓解良性前列腺增生伴逼尿肌过度活动患者的排尿困难及尿频、尿急等症状,联合用药后未发现舍尼亭对患者最大尿流率、残余尿量的影响,不增加急性尿潴留的发生率。     

良性前列腺增生症规范化治疗方案的多中心临床研究

目的 比较不同种类药物治疗良性前列腺增生（BPH）的疗效与差异,确定不同药物对不同患者的最佳适应证。方法 采用随机平行对照、多中心临床研究方法,对2002年9月至2003年12月906例BPH患者,随机进入选择性α-受体阻滞剂特拉唑嗪、多沙唑嗪、坦索罗辛与萘哌地尔;50α-还原酶抑制剂非那雄胺与爱普列特以及植物制剂舍尼通等7种治疗药物组。每3个月随访一次,国际前列腺症状评分（IPSS）与生活质量评分（QOL）,最大尿流率（Qmax）与平均尿流率（Qave）,前列腺总体积（TPV）与前列腺移行带体积以及残余尿量为观察指标进行疗效评价。根据不同指标基线水平将患者进行分层,比较各治疗组患者主观指标IPSS和客观指标Qmax的改善情况。结果 基线指标分析显示,全组主观指标IPSS评分和客观指标Qmax水平与TPV以及移行带体积呈明显相关性（P〈0．01）。至随访6个月时各类药物均使BPH患者的主观指标IPSS与QOL评分及客观指标Qmax与残余尿量有明显改善。各种药物对主客观指标的影响程度的组间比较显示,对IPSS的改善无显著差异;5α-还原酶抑制剂类药物爱普列特与非那雄胺可以使TPV和移行带体积均明显缩小（P〈0．05）。将患者以前列腺体积〈35．5cm^3和≥35．5cm^3分为两层,在非那雄胺治疗的患者中Qmax平均增加5．7ml／s和2．2ml／s（P〈0．01）,在舍尼通、萘哌地尔及多沙唑嗪治疗组,≥35．5cm^3者症状改善更为明显（P〈0．05）。以IPSS〈20分和≥20分进行分层,各种药物的疗效均在≥20分时更为明显（P〈0．01）。结论 各种药物均可明显改善BPH患者的主、客观症状,各种药物的疗效均对基线IPSS评分较高的患者疗效更为明显。5α-还原酶抑制剂能明显减小前列腺体积,对于前列腺体积≥35．5cm^2者有更为明显的主客观疗效。     

经尿道电气化术治疗女性膀胱颈部梗阻

目的：探讨经尿道电气化术应用于女性膀胱颈部梗阻的疗效。方法：采用经尿道电气术治疗女性膀胱颈部梗阻13例,并同时气化和处理膀胱、尿道伴有的其他病灶。随访15－48个月。结果 ：术后排尿症 状评分、生活质量指数、最大尿流率（Qmax）、平均尿流率（AFR）、尿量均得到显著改善,无严重并发症。随访期间疗效稳定,上述指标无显著改变,膀胱镜复查未见异常。结论 ：经尿道电气化术治疗女性膀胱颈部梗阻,疗效确 切、稳定、损伤轻微,若同时清除伴有病灶可减少复发。     

盐酸坦索罗辛治疗BPH24例临床疗效观察

目的：观察盐酸坦索罗辛治疗BPH的临床疗效。方法：对22例患者均予盐酸坦索罗辛0．2mg，口服，QN，连服6周。观察治疗前、后的国际前列腺症状评分（IPSS）、生活质量评分（QOL）、膀胱剩余尿（RV）及最大尿流率（Qmax）等指标。结果：与治疗前相比，患者的IPSS评分明显下降（12．4±3．5VS22．4±6．8），QOL、Qmax、RV等亦得以明显改善。结论：对于前列腺体积中、轻度增大者，单用哈乐即可达到理想疗效，从而降低患者经济负担，提高长期用药的依从性。     

良性前列腺增生患者术前压力-流率测定的局限性

目的评估良性前列腺增生(BPH)患者术前行压力一流率测定的应用价值。方法BPH患者69例,根据尿动力学检查直线被动尿道阻力关系(PURR)图结果分为膀胱出口梗阻(BOO)组50例,无或可疑BOO组19例,术前行剩余尿、尿流率、膀胱有效容量和压力-流率测定,国际前列腺症状评分(IPSS)、生活质量评分(QOL)。术后3个月复查比较尿动力学指标变化。结果无或可疑BOO组和有BOO组平均Qmax分别为12.8 ml/s和7.6 ml/s,差异有统计学意义(P<0.01),2组年龄、膀胱最大容量、剩余尿、膀胱有效容量、IPSS和QOL等参数差异无统计学意义(P>0.05)。术后2组平均Qmax分别提高了7.2 ml/s和10.8 ml/s,BOO组Qmax提高幅度与无或可疑BOO组比较差异有统计学意义(P<0.05);2组IPSS和QOL与术前比较差异有统计学意义(P<0.05),IPSS和QOL的改善幅度2组间差异无统计学意义(P>0.05)。BOO组术前逼尿肌活动过度21例(42%),无或可疑BOO例组逼尿肌活动过度7例(37%)。BOO组和无或可疑BOO组术后3个月IPSS和QOL等参数改善不明显分别有15例(30%)和6例(32%)。结论压力-流率测定有无BOO,对大部分BPH患者仍有预测疗效的作用;但术前膀胱有效容量大小以及逼尿肌活动过度等因素影响了手术疗效。部分伴严重下尿路症状(LUTS)的BPH患者无BOO,手术疗效满意。术前BPH患者压力-流率测定应有选择应用,结果分析个体化。     

Effect of Chinese herbal medicine on overactive bladder

Gosha-jinki-gan (GJG), a traditional Chinese medicine, is known to be potentially effective for urinary disturbance. For the clinical evaluation of Gosha-jinki-gan, we administered GJG for 6 weeks to elderly male patients with overactive bladder (OAB) and assessed its efficacy and tolerability. In this study, 30 male patients with over 6 months of OAB symptoms had received 2.5 g GJG mixture x 3/day. After 6 weeks of treatment, the efficacy, safety, and tolerability were assessed. We evaluated International Prostate Symptom Score (I-PSS), Overactive Bladder Symptom Score (OABSS), quality of life (QOL), maximal urinary flow rate (Qmax), average urinary flow rate (Qave), incidence of urinary incontinence, and post-void residual before and after treatment. We observed significant improvements in I-PSS (15.2 +/- 1.0 vs. 12.0 +/- 0.9, p < 0.0001), OABSS (7.5 +/- 0.6 vs. 4.9 +/- 0.5, p < 0.0001), and QOL score (4.4 +/- 1.0 vs. 3.3 +/- 1.1, p < 0.0001, Wilcoxon rank sum test). GJG was significantly effective in improving urgency, micturition frequency, nocturia, and urinary incontinence (p < 0.05). However, Qmax, Qave, and post void residual did not significantly change. Mild adverse effects were observed in 3 cases. The symptoms were diarrhea, nausea, and urinary frequency. These data suggest that Gosha-jinki-gan may be a new potential therapeutic agent for OAB without deterioration of voiding function in men with benign prostatic obstruction (BPO).     

生物反馈／电刺激联合托特罗定治疗女性膀胱过度活动症

目的：评价生物反馈／电刺激联合托特罗定治疗女性膀胱过度活动症（OAB）的疗效。方法：60例女性OAB患者采用生物反馈／电刺激（20天）联合口服托特罗定（4周）进行治疗,结束后3个月评价疗效并追踪观察。结果：60例女性OAB患者中,治愈32例（53．3％）,有效22例（36．7％）,无效6例（10．0％）,总有效率达90％。54例获6个月追踪观察,无复发。结论：生物反馈／电刺激联合托特罗定是治疗女性OAB的一种有效方法。     

A comparative study assessing clinical effects of naftopidil and tamsulosin hydrochloride on benign prostatic hyperplasia with overactive bladder

PURPOSE: We compared the efficacy of naftopidil with that of tamsulosin hydrochloride for 154 symptomatic benign prostatic hyperplasia (BPH) patients who also suffered from overactive bladder (OAB) symptoms. MATERIALS AND METHODS: Naftopidil and tamsulosin hydrochloride were administered for eight weeks. The international prostate symptom score (IPSS), QOL index, maximum flow rate (Q(max)), residual urine volume (RUV) and side effect profile were determined before the administration and after eight weeks of treatment. RESULTS: In the naftopidil group, seven parameters of IPSS and QOL index were improved significantly at the endpoint compared to the baseline. In the tamsulosin group, all parameters except frequency and straining were also improved. Both drugs improved the Q(max) at the endpoint, too. The RUV did not change in both groups. Naftopidil was also superior to tamsulosin hydrochloride regarding general treatment outcome by the Japanese clinical guideline of urinary disturbance. CONCLUSIONS: This study demonstrated that naftopidil was clinically efficacious in the treatment of BPH patients with OAB.     

Clinical Effect of alpha 1D/A adrenoceptor inhibitor naftopidil on Benign Prostatic Hyperplasia: An International Prostate Symptom Score and King's Health Questionnaire assessment

Objectives:   To examine the effect of alpha 1D/A adrenoceptor inhibitor naftopidil on health-related quality of life (QOL) in men with benign prostatic hyperplasia (BPH).
Methods:   A total of 56 newly diagnosed patients with symptomatic BPH were prospectively enrolled and treated with 50 mg naftopidil daily for more than 12 weeks. All underwent pre-treatment documentation of lower urinary tract symptoms, QOL assessment using the international prostate symptom score (IPSS) and King's Health Questionnaire (KHQ), and uroflowmetry. A post-treatment assessment was performed at 12 weeks.
Results:   IPSS scores as well as QOL index showed a significant improvement after naftopidil administration. Similarly, all seven domains except general health perceptions and social limitations in the KHQ questionnaire were significantly improved. When dividing the patients into overactive bladder (OAB) and non-OAB groups, only the OAB group showed significant improvement in almost all the domains of KHQ. Change ratios of the IPSS were not associated with those of KHQ domain scores in the OAB group. On the other hand, in the non-OAB group more domains presented improvements, which were associated with those of IPSS scores.
Conclusions:   Twelve-week treatment with naftopidil for symptomatic BPH patients is associated with significant improvement in the IPSS, QOL index, maximum urinary flow rate, post-void residual urine volume (PVR) and almost all domains in KHQ. KHQ is useful for the evaluation of clinical response in BPH patients, particularly in those with associated OAB.     

钬激光前列腺剜除术治疗良性前列腺增生合并膀胱过度活动症的临床观察

目的 探讨钬激光前列腺剜除术治疗良性前列腺增生(BPH)合并膀胱过度活动症(OAB)的临床效果.方法 2007年5月至2010年5月,应用钬激光前列腺剜除术治疗BPH合并OAB患者37例,年龄52～89岁,平均(76±3)岁.术后3～6个月之内复查尿流率和残余尿量,术后平均随访4.9个月,通过国际前列腺症状评分(IPSS评分)、生活质量(QOL)评分、最大尿流率(Qmax)、残余尿量、影像尿动力学评价疗效.结果 本组患者术前平均IPSS评分29.6±5.2,术后下降到4.6±1.2.术前平均QOL评分4.3±0.9,术后下降到1.2±1.0.术前平均Qmax为(6±3)ml/s,术后升高到(21±5)ml/s.术前残余尿量平均(167±11)ml,术后下降到(41±18)ml.随访期间86.5%的患者OAB症状及生活质量改善,但仍有13.5%的患者术后OAB症状持续存在.结论 合并OAB的BPH患者存在明确膀胱出口梗阻时,可以首先解除膀胱出口梗阻,但术后仍有部分患者残留有OAB症状.     

Comparison of fesoterodine and tolterodine in patients with overactive bladder

OBJECTIVE

To compare, in a post hoc analysis of a phase III trial, the maximum recommended doses of fesoterodine (8 mg) and tolterodine (4 mg) for improving overactive bladder (OAB) symptoms and health‐related quality of life (HRQoL), as fesoterodine effectively reduces OAB symptoms vs placebo.

PATIENTS AND METHODS

Eligible patients with frequency (≥eight voids/24 h) and either urgency (≥six episodes over 3 days) or urgency urinary incontinence (UUI; ≥three episodes over 3 days) were randomized to placebo, fesoterodine 4 or 8 mg, or tolterodine extended‐release (ER) 4 mg for 12 weeks; fesoterodine 4 mg data were published elsewhere. Patients completed a 3‐day bladder diary in which they recorded the time of each void, voided volume (VV), and the severity of urgency. A post hoc inferential analysis was conducted on the primary endpoint (voids/24 h), the two co‐primary endpoints (UUI episodes/24 h and treatment response), several secondary endpoints (severe urgency plus UUI per 24 h, mean VV (MVV)/void, and continent days/week), HRQoL, using the King’s Health Questionnaire (KHQ) and the International Consultation on Incontinence Questionnaire‐Short Form (ICIQ‐SF), and self‐reported bladder‐related problems. A subanalysis also assessed all endpoints for patients who were incontinent at baseline. Tolerability and safety were assessed by evaluating adverse events, residual urine volume, laboratory variables and treatment withdrawals.

RESULTS

By week 12, patients with OAB in both active‐treatment groups showed significant improvements in most bladder diary variables and treatment response rates compared with placebo. Fesoterodine 8 mg was statistically significantly better than tolterodine ER 4 mg for improving UUI episodes, severe urgency plus UUI, mean VV, and number of continent days/week. In addition, the fesoterodine and tolterodine ER groups showed significantly greater improvements in HRQoL than the placebo group, with positive changes in most domains of the KHQ and an improvement in ICIQ‐SF score. The fesoterodine 8‐mg group had statistically significant improvements over placebo in eight of nine KHQ domains. A major improvement in the severity of bladder‐related problems was reported by 39% of the fesoterodine 8 mg and 34% of the tolterodine ER groups vs 25% of those on placebo (P ≤ 0.01). Results for the subgroup of incontinent patients at baseline were similar to the overall results. Adverse events reported most commonly with active treatment included dry mouth, constipation, dry eye, dry throat, and nausea.

CONCLUSIONS

Both fesoterodine and tolterodine ER significantly improved OAB symptoms and HRQoL, with statistically significant advantages for fesoterodine 8 mg compared with tolterodine ER on several important endpoints.     

爱活尿通治疗良性前列腺增生的临床研究

目的:探讨爱活尿通(Eviprostat)治疗良性前列腺增生(BPH)的安全性及有效性。方法:采用开放、多中心的临床试验方法,对100例BPH患者进行了为期12周的观察。患者服用爱活尿通每次2片,每天3次,共12周。主要疗效指标为国际前列腺症状评分(IPSS),最大尿流率(Qm ax),膀胱残余尿量(Ru)和前列腺体积(V);次要指标为生活质量评分(QOL)和平均尿流率(Qave)。结果:服药12周后,IPSS评分较治疗前平均降低5.67分(P<0.001),QOL评分平均降低1.44分(P<0.001),Qm ax较治疗前平均增加1.70 m l/s(P<0.001),Qave平均增加1.15 m l/s(P<0.001),膀胱残余尿量(Ru)平均减少5.07 m l(P=0.046),PSA平均下降0.129μg/L(P<0.017)。临床不良反应发生率为1%。结论:爱活尿通可明显改善BPH患者的排尿症状、增加尿流率、减少残余尿量,不良反应发生率低,是一种安全、有效的治疗BPH的药物。     

社区中老年男性膀胱过度活动症患病率的调查研究

目的 探讨社区中老年男性膀胱过度活动症(OAB)的患病状况以及与年龄、下尿路症状的相关性.方法 2007年5月至2008年6月,随机选择50岁以上北京多个社区男性人群作为研究对象.下尿路症状的评估包括国际前列腺症状评分(IPSS)、生活质量(QOL)评分、腹部B超前列腺体积、残余尿量测定及最大尿流率测定.OAB的评估主要依据患者尿急的状况确定,将IPSS评分表中第4项得分≥2定义为OAB.结果 本研究共调查社区中老年男性人群1656人,符合本研究要求的共计1639人.年龄50～89岁,平均(64±10)岁.OAB的患病率为26.3%(431/1639).OAB的患病率与社区中老年男性的年龄、IPSS评分、QOL评分、前列腺体积、残余尿量以及最大尿流率均具有显著相关性(均P＜0.01).对年龄以及IPSS评分的分层研究发现,OAB的患病率随着年龄的增加以及下尿路症状的加重明显升高(P＜0.01).结论 社区中老年男性OAB的患病率随年龄增长逐渐增加,同时OAB明显影响中老年男性的生活质量.