Clinical evaluation of supplemental administration of flavoxate hydrochloride in benign prostatic hyperplasia patients with nocturia resistant to an alpha1-adrenoceptor blocker

We examined the effectiveness of supplemental administration of flavoxate hydrochloride in patients with benign prostatic hyperplasia (BPH) whose nocturia was not adequately relieved by an alpha1-adrenoceptor blocker. Fifty-two patients who had two or more nocturnal micturition after administration of tamsulosin hydrochloride or naftopidil for 4 weeks or more received 400-600 mg of flavoxate hydrochloride in addition to an alpha1-adrenoceptor blocker for another 8-12 weeks. With supplemental administration of flavoxate hydrochloride, significant improvement was observed in the number of nocturnal micturition, total International Prostate Sympton Score, quality of life score and BPH impact index. No significant change was observed in the voided volume, Qmax, voiding time and residual urine volume. Supplemental administration of flavoxate hydrochloride is therefore effective for the improvement of nocturia and QOL in BPH patients resistant to an alpha1-adrenoceptor blocker.     

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.     

Comparison of two alpha1-adrenoceptor antagonists, naftopidil and tamsulosin hydrochloride, in the treatment of lower urinary tract symptoms with benign prostatic hyperplasia: a randomized crossover study

OBJECTIVES: To compare the efficacy of two alpha(1)-adrenoceptor antagonists, alpha(1A)-adrenoceptor-selective tamsulosin hydrochloride and alpha(1D)-adrenoceptor-selective naftopidil, in the treatment of lower urinary tract symptoms (LUTS) with benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: Thirty-four patients (mean age 72.4 years, sd 4.3, range 66-79) with LUTS (International Prostate Symptom Score, IPSS >8) secondary to BPH were enrolled in a randomized crossover study. Seventeen patients were initially prescribed naftopidil 50 mg for 4 weeks, followed by tamsulosin 0.2 mg for 4 weeks (group A); another 17 were initially prescribed tamsulosin 0.2 mg, followed by naftopidil 50 mg (group B). Patients changed to the alternative treatment after a 1-week washout period. Efficacy criteria were improvement in LUTS (IPSS), quality of life (QoL), uroflowmetry, and pressure-flow study (PFS) values based on the treatment with each agent. RESULTS: At baseline there were no significant differences between the groups in IPSS, QoL, uroflowmetry values or PFS values, except for the volume at maximum desire to void. After treatment with each agent, the IPSS and QoL were significantly improved and the reduction in bladder outlet obstruction confirmed by PFS. Naftopidil was significantly more effective than tamsulosin in relieving nocturia. The increases from baseline (before treatment) to the endpoint (after treatment with each agent) in the volume at first desire and maximum desire to void were significantly higher with naftopidil than with tamsulosin. Involuntary contractions disappeared in two patients with relief of nocturia with naftopidil, but not with tamsulosin. The decrease in other symptoms of the IPSS, QoL, increase in uroflowmetry values and changes in other PFS values were similar for both agents. CONCLUSIONS: The two agents provided similar efficacy in the treatment of LUTS with BPH. However, naftopidil was better than tamsulosin for nocturia. The disappearance of involuntary contraction and the greater increase in first-desire volume with naftopidil may be associated with the relief of nocturia. The alpha(1D)-adrenoceptor antagonist is effective in alleviating both voiding and storage symptoms. The alpha(1D)-adrenoceptor antagonist may be more effective than the alpha(1A)-adrenoceptor antagonist in LUTS with BPH.     

Evaluation of supplemental administration of Eviprostat in patients with benign prostatic hyperplasia with persistent symptoms following treatment with alpha1-adrenoceptor blocker

We examined the effectiveness of supplemental administration of Eviprostat in patients with benign prostatic hyperplasia (BPH) whose lower urinary tract symptoms (LUTS) caused by BPH were not adequately relieved by an alpha1-adrenoceptor blocker. Twenty-nine patients with insufficient improvement in the International Prostate Symptom Score (IPSS) and quality of life (QOL) score after administration of 50 mg naftopidil for 4 weeks or more received 6 tablets of Eviprostat in addition to naftopidil for another 2 weeks or more. With supplemental administration of Eviprostat, significant improvement was observed in the symptoms of incomplete emptying, daytime frequency, intermittency, weak stream, total IPSS, sum of the IPSS subscores for voiding symptoms (intermittency, weak stream and straining), sum of the IPSS subscores for storage symptoms (daytime frequency, urgency and nocturia), and QOL score. Supplemental administration of Eviprostat is therefore effective for the improvement of LUTS and QOL in BPH patients resistant to an alpha1-adrenoceptor blocker.     

Naftopidil versus tamsulosin hydrochloride for lower urinary tract symptoms associated with benign prostatic hyperplasia with special reference to the storage symptom: A prospective randomized controlled study

Objectives: In order to compare the clinical efficacy of naftopidil (Naf) and tamsulosin hydrochloride (Tam), which differ in their selectivity to alpha receptor subtypes, we performed a multi‐center prospective randomized controlled study. Methods: Men complaining of lower urinary tract symptoms due to benign prostatic hypertrophy, were randomized into two treatment groups: one receiving 50 mg Naftopidil daily (Naf group, n = 31 pts), and one receiving 0.2 mg Tam once daily (Tam group, n = 28 pts). Baseline symptom scores were compared to those at 2 weeks and at the end of the observation period (6–8 weeks). Results: In the Naf group at 2 weeks, the score of the daytime frequency significantly improved from 3.5 to 2.2 (P = 0.03), and the score of nocturia improved significantly from 3.5 to 2.2 (P = 0.0004), respectively. In the Tam group at 2 weeks, however, no significant improvement was noted in the increased score of daytime frequency (P = 0.1) or nocturia (P = 0.2). At 2 weeks, the storage symptom score of the frequency to the combined score of daytime frequencies and the score of nocturia was better in the Naf group (improved from 7.0 to 4.4, P = 0.0017) than in the Tam group (from 6.8 to 4.9, P = 0.08) (P < 0.05). At 6–8 weeks, the effects of the two drugs on lower urinary tract symptoms were comparable. Conclusions: Naf demonstrated a significant early response to improve storage symptoms at 2 weeks, including daytime frequency and nocturia, compared with Tam.     

Clinical effects of naftopidil on nocturia associated with benign prostatic hyperplasia

We studied the efficacy of naftopidil (50 mg/day) on nocturia associated with benign prostatic hyperplasia in 35 patients (62-80 years old). The patients had BPH > 20 ml, nocturia, more than 3 times, international prostate symptom score (IPSS) > 7, quality of life score (QOL) < 1, and maximum flow rate (Qmax) < 15 ml/sec. They received naftopidil for more than 6 weeks. IPSS, QOL, Qmax, micturition volume, and side effects were analyzed. Naftopidil was effective for nocturia associated with benign prostatic hyperplasia, especially when taken at night.     

Short‐term effects of crossover treatment with silodosin and tamsulosin hydrochloride for lower urinary tract symptoms associated with benign prostatic hyperplasia

Objectives: To compare the efficacy and safety of silodosin and tamsulosin in patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) by a randomized crossover method. Methods: BPH patients with the complaint of LUTS were included in this study, and were randomly divided into two groups: a silodosin‐preceding group (4 weeks of twice‐daily administration of silodosin at 4 mg, followed by 4 weeks of once‐daily administration of tamsulosin at 0.2 mg) or a tamsulosin‐preceding group (4 weeks' administration of tamsulosin, followed by 4 weeks' administration of silodosin). No drug withdrawal period was provided when switching the drug. Results: In the first treatment period, both drugs significantly improved the International Prostate Symptom Score total score, but the improvement by silodosin was significantly superior to that by tamsulosin. After crossover treatment, significant improvement was observed only with silodosin treatment. Moreover, intergroup comparison of changes revealed that silodosin showed significant improvement of straining and nocturia with first and crossover treatments, respectively, compared with tamsulosin. Silodosin also significantly improved quality of life (QOL) score in both treatment periods, while tamsulosin significantly improved QOL score only in the first treatment period. The most frequent adverse drug reaction was ejaculatory disorder with silodosin; however, the incidence of dizziness with silodosin was similar to that with tamsulosin. Conclusions: In BPH/LUTS patients, silodosin exhibits excellent efficacy in improving subjective symptoms in both initial and crossover treatment, and it appears to improve the QOL of patients.     

The effectiveness of naftopidil in patients with benign prostatic hyperplasia evaluated by QOL index

We examined the effectiveness of naftopidil in 81 patients with lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH). We examined quality of life (QOL) and determined which symptoms improved as a result of naftopidil administration. The findings indicated that storage symptoms, voiding symptoms, total International Prostate Sympotom Score (IPSS), QOL index, Qmax and residual urine volume were significantly improved after treatment when compared to baseline. Improvement of nocturia and incomplete emptying by naftopidil contributed to improvement in QOL, odds ratio between the good response group and poor response group were 3.6 and 2.3, respectively. During naftopidil treatment, two of the 81 patients complained of adverse events. The results show that naftpidil is effective for LUTS caused by BPH, and that improvement of nocturia and incomplete emptying contributed to the improvement in QOL.     

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.     

Comparison of tamsulosin and naftopidil for efficacy and safety in the treatment of benign prostatic hyperplasia: a randomized controlled trial

OBJECTIVES: To compare the efficacy and safety of two alpha1a/alpha1d adrenoceptor (AR) antagonists with different affinity for the alpha1AR subtypes, tamsulosin and naftopidil, in the treatment of benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: Patients with BPH were randomized to receive either tamsulosin or naftopidil. The primary efficacy variables were the changes in the total International Prostate Symptom Score (IPSS), maximum flow rate on free uroflowmetry, and residual urine volume. The secondary efficacy variables were average flow rate, changes in the IPSS storage score, IPSS voiding score, and quality-of-life (QoL) Index score, from baseline to endpoint (12 weeks). Data on all randomized patients were included in the safety analyses for adverse effects and changes in blood pressure. RESULTS: Of the 185 patients enrolled data for 144 who were eligible for inclusion in the efficacy analysis were analysed (75 from the tamsulosin and 69 from the naftopidil group). There was no significant difference in any variable at baseline between the groups. There were statistically significant improvements for all primary and secondary variables in both groups, except for residual urine in the tamsulosin group. However, there was no significant intergroup difference in the improvement of any efficacy variable between the groups. The adverse effects were comparable, with no significant differences in systolic and diastolic blood pressure after treatment in both groups. CONCLUSIONS: This study suggests that naftopidil is as effective and safe as tamsulosin. Both drugs were effective in improving storage and voiding symptoms. However, there was no difference in clinical efficacy or adverse effects between the alpha1 AR antagonists with different affinity to alpha1 subtypes, alpha1a and alpha1d.     

Clinical efficacy of naftopidil on lower urinary tract symptoms after radical prostatectomy

Objective:   The management of lower urinary tract symptoms that persist after radical prostatectomy remains to be established. We investigated whether an α1-blocker, naftopidil, improves LUTS in patients ≥1 year after radical prostatectomy.
Methods:   A total of 29 male patients received 25 mg/day of naftopidil for the first week, then 75 mg/day for 4 weeks. The frequency-volume chart, international prostate symptom score and quality of life index (QOL) were examined before and at the end of the 5-week administration in all subjects.
Results:   Total international prostate symptom score (I-PSS) and I-PSS subtotals associated with voiding symptoms and storage symptoms were significantly decreased at 5 weeks compared with baseline ( P  < 0.001 each). QOL index was significantly improved with naftopidil for 5 weeks ( P  < 0.001). From analyses of the frequency-volume chart, mean and maximum volume/void were significantly increased ( P  < 0.05 each).
Conclusion:   Lower urinary tract symptoms detected in patients ≥1 year after radical prostatectomy were markedly improved with administration of naftopidil at 75 mg/day. These symptoms could represent a novel target for medical treatment by improved understanding of the symptom pathology in the near future.     

Clinical efficacy of an α1A/D-adrenoceptor blocker (naftopidil) on overactive bladder symptoms in patients with benign prostatic hyperplasia

AIM: We evaluated the efficacy of an alpha1a/d blocker, naftopidil, on storage symptoms in patients with benign prostatic hyperplasia (BPH), using frequency/volume charts (FVC). METHODS: A total of 81 patients with BPH (52-91 years, mean age 69.0 years) were studied. The inclusion criteria were: (i) one or more episode(s) of urinary urgency/day; (ii) a score of eight or more points on the International Prostate Symptom Score (I-PSS); and (iii) three or more points in any of the scores for three items (frequency, nocturia, and urgency) of the I-PSS. The patients received 50-75 mg/day of naftopidil for 6 weeks. All the patients were examined for 2-day FVC before and after the administration of naftopidil. I-PSS, quality of life index, and uroflowmetry were also evaluated. RESULTS: Total I-PSS decreased from 19.1 to 10.5 points (P < 0.0001), with significant improvement of both storage and voiding symptom scores (P < 0.0001, both). The score for urgency decreased from 3.1 to 1.4 (P < 0.0001). Daytime and night-time frequency decreased from 9.3 to 8.0 (P < 0.0001) and from 2.7 to 2.0 (P = 0.0009), respectively. Mean volume/void increased from 174.0 to 188.6 mL (P = 0.0453). Nocturia decreased from 3.2 to 2.3 (P < 0.0001) in 40 patients who suffered from nocturia two times or more. Notably, significant improvement of nocturia was observed in the patients both with and without nocturnal polyuria (P = 0.0006 and 0.0135, respectively). CONCLUSION: The alpha1a/d blocker naftopidil improves not only voiding symptoms but also storage symptoms, and is effective for nocturia in patients with BPH regardless of the existence of nocturnal polyuria.     

Clinical impact of tamsulosin on generic and symptom-specific quality of life for benign prostatic hyperplasia patients: Using international prostate symptom score and Rand Medical Outcomes Study 36-item Health Survey

AIM: To examine the efficiency of alpha1-blocker treatment on disease-specific and generic quality of life (QOL) in men with clinically diagnosed benign prostatic hyperplasia (BPH), the improvement of QOL scores with International prostate symptom score (I-PSS) and Rand Medical Outcomes Study 36-item Health Survey (SF-36) was prospectively analyzed. METHODS: A total of 68 newly diagnosed patients with symptomatic BPH that satisfied all inclusion and none of the exclusion criteria were prospectively recruited. All patients received 0.2 mg/day of tamsulosin for 12 weeks. All patients underwent pretreatment documentation of lower urinary tract symptoms (LUTS) and assessment of symptom-specific QOL. Symptoms and general health-related QOL (HRQOL) were assessed using the I-PSS and SF-36, respectively. Also, other objective variables, such as prostate volume, maximal urinary flow and postvoid residual urine volume, were evaluated. RESULTS: After 12 weeks, decrease in I-PSS was 27% compared with baseline (from 16.4 +/- 7.18 to 11.9 +/- 7.56). All questionnaires in the I-PSS showed improvement after tamsulosin treatment and the I-PSS QOL score was improved from 4.51 +/- 1.14 to 3.17 +/- 1.38 (P < 0.0001) at 12 weeks after tamsulosin administration. In intragroup comparisons of HRQOL scores with age-gender adjusted SF-36 Japanese national norms, three SF-36 subscales (bodily pain, BP; social function, SF; and mental health, MH) were worse in the BPH group aged over 70 years, while younger BPH groups aged <70 had better mean SF-36 physical function (PF) scores compared with age-gender adjusted Japanese national norms. In the BPH group with a prostatic volume > or =20 mL, three mean SF-36 scales (BP, SF and MH) were significantly improved after tamsulosin treatment. It is noteworthy that these SF-36 subscales were identical to those observed to worsen in the older BPH group compared to Japanese national norms. CONCLUSIONS: Treatment with tamsulosin for symptomatic BPH patients is associated with significant improvement in the generic HRQOL, in addition to disease-specific QOL and symptoms, at 3 months after drug administration. In particularly, for generic HRQOL with SF-36, tamsulosin treatment can efficiently improve three mean SF-36 subscales (BP, SF and MH) that are decreased in older BPH patients.     

Naftopidil monotherapy vs naftopidil and an anticholinergic agent combined therapy for storage symptoms associated with benign prostatic hyperplasia: A prospective randomized controlled study

AIM: The aim of this study was to compare the efficacy and safety of alpha1-adrenoceptor (alpha1-AR) antagonist monotherapy with combination therapy using alpha1-AR antagonist and anticholinergic agent for benign prostatic hyperplasia (BPH) with storage symptoms as the chief complaint. METHODS: In this prospective comparative study, either 25-75 mg/day of naftopidil monotherapy (monotherapy group) or combination therapy using 25-75 mg/day of naftopidil and an anticholinergic agent (10-20 mg/day of propiverine hydrochloride or 2-6 mg/day of oxybutynin hydrochloride; cotherapy group) were administered for 12 weeks to 101 BPH patients with storage symptoms. RESULTS: International prostate symptom score (IPSS) and quality of life (QOL) index improved significantly in both groups, with no marked differences between groups. Maximum flow rate (Qmax) and residual urine volume (RUV) tended to improve in both groups, again with no marked differences between groups. However, median post-therapeutic RUV was significantly worse for the cotherapy group (45.0 mL) than for the monotherapy group (13.5 mL; P = 0.0210). Ratio of patients with increased RUV was also significantly worse for cotherapy (22.9%) than for monotherapy (5.0%; P = 0.038). CONCLUSIONS: Although the anticholinergic dosage was low, the present results suggest that naftopidil monotherapy was as useful as combination therapy of naftopidil and an anticholinergic agent. Therefore, naftopidil is a useful agent as the first choice in BPH patients with storage symptoms.     

Additional effect of propiverine for naftopidil-resistant nocturia in the patient with benign prostate hypertrophy

The efficacy and safety of additional administration of propiverine were prospectively studied for naftopidil-resistant nocturia in patients with benign prostatic hypertrophy (BPH). Patients of 50 years and over with BPH who experienced nocturia twice a night or more and an overall International Prostate Symptom Score (IPSS) of 8 or more were first administered naftopidil (50 or 75 mg/day) for 4 weeks. Thirty subjects who did not show improvement in nocturia and requested further treatment were enrolled in the present study. Propiverine was then administered concomitantly 10 mg/day for 8 weeks. Significant improvement was observed with additional propiverine in the frequency of nocturia on voiding diary, total IPSS, voiding symptom, storage symptom and nocturnal voiding scores. No significant change was observed in the peak urinary flow rate (Qmax), mean urinary flow rate (Qave), voided urine volume, or residual urine volume. Adverse events were dysuria (2 cases), increased residual urine (6 cases), weak urine flow (1 case), thirsty (2 cases), angular cheilitis (1 case). Administration of propiverine was suspended in 7 subjects, 1 following dysuria and 6 following increased residual urine volume. The suspension of propiverine following increased residual urine volume was significantly more prevalent in subjects with pretreatment Qmax values of less than 10 ml/second or in subjects whose prostate specific antigen (PSA) levels were 2 ng/ml or more. In conclusion, the results indicate that additional administration of propiverine may be useful for the patients with BPH who have naftopidil-resistant nocturia. However, caution must be exercised regarding Qmax and PSA levels.     

��1-Adrenoceptor blocker naftopidil improves sleep disturbance with reduction in nocturnal urine volume

Objectives

To examine the mechanism underlying improvements in nocturia by ??₁-blockers, we investigated whether the ??₁-blocker naftopidil acts on nocturia with sleep disturbance using a frequency/volume chart (FVC).

Methods

A total of 56 male patients with lower urinary tract symptoms were enrolled. The inclusion criteria were as follows: eight or more points on the I-PSS; three or more points on the I-PSS score for nocturia; and prostate volume larger than 20?ml. Patients received 50?mg of naftopidil once daily for 4?weeks, and non-responders received 75?mg for another 4?weeks. All patients were examined, and their data entered into FVC for 2?days before and after administration of naftopidil. Quality of sleep was also evaluated using modified Pittsburgh sleep quality index (PSQI).

Results

Patients with sleep quality scores of three or four were assigned to sleep disturbance group (n?=?33), while those with scores of less than three were assigned to non-disturbance group (n?=?23). After administration of naftopidil, total I-PSS decreased and nocturia score decreased from 3.5 to 2.6 (P?<?0.01). Total mean score of modified PSQI in sleep disturbance group became significantly lower after administration of naftopidil (from 16.9 to 14.0; P?<?0.01). Naftopidil significantly decreased nocturnal urine volume, resulting in a decrease in the nocturnal polyuria index in both sleep disturbance and non-disturbance groups.

Conclusion

These results suggest that ??₁-blockers have the ability to normalize sleep disorders. Naftopidil improved nocturnal polyuria regardless of the presence of sleep disturbance, meaning that it might directly reduce nocturnal urine production.     

良性前列腺增生患者经尿道前列腺切除术后排尿症状改变及分析

目的 研究良性前列腺增生患者经尿道前列腺切除术后排尿症状的变化及其与术前临床参数的关系。方法 对281例良性前列腺增生手术患者进行随访,对其手术前、后排尿症状评分和术前临床资料进行分析。患者年龄（70±6）岁。术前前列腺体积（75±39）ml,血清总前列腺特异性抗原（T—PSA）（5±5）ng／ml,最大尿流率（8±3）ml／s,切除前列腺重量（32±19）g。术前国际前列腺症状评分（IPSS）（24±7）分,生活质量评分（QOL）（4．6±1．0）分,平均梗阻症状（3．6±1．2）分,平均刺激症状（3．5±1．0）分。结果 术后IPSS（7±7）分,生活质量评分（1．2±1．1）分,与术前相比,均明显改善。不同排尿症状改善的幅度不同,平均梗阻症状的改善幅度大于平均刺激症状的改善。术后夜尿和尿频分别为（2．2±1．1）分和（1．2±1．4）分。结论 经尿道前列腺切除患者术后排尿症状明显改善,症状的改善程度与术前IPSS和QOL相关,而与患者年龄、术前前列腺体积、T-PSA、最大尿流率、切除前列腺重量无相关性。梗阻症状的改善优于刺激症状的改善,而夜尿是改善幅度最小的症状。     

Clinical evaluation of the effect of tamsulosin hydrochloride and cernitin pollen extract on urinary disturbance associated with benign prostatic hyperplasia in a multicentered study

We evaluated the clinical efficacy and safety of tamsulosin hydrochloride and cernitin pollen extract in 243 patients with urinary disturbance associated with benign prostatic hyperplasia. They were assigned randomly to 3 groups, oral tamsulosin hydrochloride, cernitin pollen extract and their combination were administered for 12 weeks. The international prostate symptom score, post-voided residual urine and uroflowmetrogram were obtained before and after treatment. The international prostate symptom score improved in each group and then the maximum flow rate and average flow rate also increased significantly in the tamsulosin hydrochloride-administered groups. In conclusion, the administration of only tamsulosin hydrochloride and the combination of tamsulosin hydrochloride and cernitin pollen extract seemed more effective then the administration of only cernitin pollen extract in the treatment of urinary disturbance associated with benign prostatic hyperplasia.     

盐酸坦索罗辛治疗伴有下尿路症状的BPH有效性和安全性研究

目的 评价长期服用盐酸坦索罗辛治疗伴有下尿路症状(LUTS)的BPH的有效性和安全性.方法 2005-2007年LUTS/BPH患者113例,经4周安慰剂导入期,进入60周开放性研究,每天早餐前口服盐酸坦索罗辛0.2 mg.Ⅰ期治疗(0～12周)结束时对盐酸坦索罗辛的有效性和安全性进行评价,IPSS改善≥25%者行Ⅱ期(13～60周)治疗;IPSS改善＜25%者Ⅱ期联合使用非那雄胺治疗.Ⅱ期治疗结束时行有效性和安全性评价.受试者随访期间监测症状、体征、实验室检查和不良事件.IPSS和Qmax为主要有效性评价参数.结果 113例患者完成Ⅰ期治疗111例,IPSS由治疗前19.5降为15.4,平均改善率21.2%;平均Qmax由治疗前11.2 ml/s提高1.7 ml/s,平均改善率16.5%,治疗前后比较差异均有统计学意义(P＜0.05).完成Ⅱ期治疗95例,其中联合使用非那雄胺25例、未联合使用非那雄胺者70例(P＞0.05),IPSS由治疗前19.0±4.7降为12.6±3.2,改善率30.3%; Qmax由治疗前(11.6±2.3)ml/s提高3.0 ml/s;生活质量评分(QOL)由4.3±0.8降为2.6±0.7,治疗前后比较差异均有统计学意义(P＜0.05).治疗前后IIEF-5评分、前列腺体积和血压差异无统计学意义(P＞0.05).治疗期间共发生13例24次不良事件,其中头晕5例8次、腹泻2例2次、乏力2例5次、口干1例6次,头痛、恶心及皮肤瘙痒各1例1次.无严重不良事件.结果 盐酸坦索罗辛治疗伴有LUTS的BPH患者安全有效,疗效持久,耐受性好,可以作为有效的常规治疗药物.     

A randomized controlled study comparing clinical effects of naftopidil and tamsulosin on benign prostatic hyperplasia

A prospective randomized controlled study was performed to compare the clinical effects of naftopidil and tamsulosin. Men complaining of lower urinary tract symptoms due to benign prostatic hyperplasia were randomized into two groups : one receiving 50mg naftopidil once daily (Naf group, n=36 patients), and the other receiving 0.2 mg tamsulosin once daily (Tam group, n=32 patients). In the Naf group at 12 weeks, 7 items of the International Prostate Symptom Score (IPSS), storage and voiding symptoms, total IPSS, quality of life (QOL) index (QOLI) and Qmax were improved significantly. In the Tam group at 12 weeks, 6 items of IPSS except urgency, storage and voiding symptoms, total IPSS, QOLI and Qmax were improved significantly. Improvement of residual urine volume (PVR) was insignificant in both groups. In intergroup comparison between the Naf and the Tam groups, variations of 7 items of IPSS, storage and voiding symptoms, total IPSS, QOLI, Qmax and PVR at 4 and 12 weeks after treatment were not statistically significant. There was almost no difference in clinical efficacy between Naf and Tam.