This study aimed to evaluate the effectiveness of tamsulosin monotherapy for the treatment of ureteral stent-related symptoms(SRSs)and compare it with that of solifenacin monotherapy and combined therapy of tamsulosin...This study aimed to evaluate the effectiveness of tamsulosin monotherapy for the treatment of ureteral stent-related symptoms(SRSs)and compare it with that of solifenacin monotherapy and combined therapy of tamsulosin and silifenacin.Randomized controlled trials(RCTs),which evaluated the effectiveness of tamsulosin for the treatment of SRSs,were searched from the databases PubMed,EMBASE and the Cochrane Library published up to November 2018.Eight RCTs involving 1087 participants were finally included in this meta-analysis.The results showed that tamsulosin monotherapy could significantly decrease the urinary symptoms[mean difference(MD)—7.56,95%confidence interval(CI)(-11.47,-3.65),P=0.0001]and body pain[MD-5.25,95%CI(-8.03,-2.46),P=0.0002],and improve the sexual performance[MD-1.06,95%CI(-1.89,-0.24),P=0.01]compared with the control group.Moreover,there was no significant difference between tamsulosin monotherapy and solifenacin monotherapy in all outcomes except for significantly better sexual performance in solifenacin group[MD 0.29,95%CI(0.06,0.51),P=0.01].In addition,the effectiveness of combined therapy of tamsulosin and solifenacin was not superior to that of tamsulosin monotherapy.Our study demonstrated that tamsulosin monotherapy was effective for the treatment of patients with SRSs;evident superiority could not be found for therapy of tamsulosin and solifenacin combined.展开更多
This study was undertaken to determine the impact on ejaculatory function of tamsulosin （0.2 mg） given once daily （OD） for 12 weeks and to identify risk factors for ejaculatory dysfunction in patients undergoing t...This study was undertaken to determine the impact on ejaculatory function of tamsulosin （0.2 mg） given once daily （OD） for 12 weeks and to identify risk factors for ejaculatory dysfunction in patients undergoing this treatment. Males with an International Prostatic Symptom Score （IPSS） ≥ 8 were enrolled in this study. All participants completed questionnaires, including the IPSS and the Male Sexual Health Questionnaire （MSHQ）, and serum prostate-specific antigen, transrectal ultrasound and uroflowmetry with post-void residual were measured. After initiating 0.2 mg OD tamsulosin, patients were re-evaluated on the fourth and twelfth weeks of medication. The chi-squared test, the independent t-test and one-way ANOVA were used to compare means. Binary logistic regression analysis was used to calculate the odds ratio for all risk factors. A total of 177 men constituted the study cohort. No significant difference was observed between baseline and follow-up for the erectile function, ejaculatory function, satisfaction, sexual activity and desire domains （EFD, EjFD, SDA and ADD） or for erectile or ejaculatory bother mean scores. After 12 weeks, the overall incidence of ejaculatory dysfunction （EjD） was 13.4%. Incidences of the seven different types of EjD （decreased frequency, delay, dryness, decreased strength/force, decreased volume, decreased pleasure and pain at ejaculation） were 2.4%, 3.1%, 3.9%, 3.9%, 6.3%, 7.1% and 3.1%, respectively. Baseline EjFD scores were higher for I PSS responders than for non-responders （26.09 vs. 24.06, P=0.03）. An EjFD score reduction was more frequent in IPSS responders. The incidence of EjD was small, but not negligible and was more frequent in patients with less lower urinary tract symptoms, a smaller prostate, higher baseline MSHQ totals and higher EjFD scores.展开更多
Objectives:To compare the efficacy of tamsulosin versus tamsulosin plus tadalafil in achieving clearance of fragments after shock wave lithotripsy(SWL)to treat renal calculi.Methods:Between January 2016 to December 20...Objectives:To compare the efficacy of tamsulosin versus tamsulosin plus tadalafil in achieving clearance of fragments after shock wave lithotripsy(SWL)to treat renal calculi.Methods:Between January 2016 to December 2017,140 patients with solitary,non-branched,non-lower calyceal renal calculus and measuring less than 20 mm and treated with SWL were randomized to tamsulosin(group A)or tamsulosin plus tadalafil(group B).Therapy was given for a period of 4 weeks.Stone clearance rate,analgesic requirement,occurrence of steinstrasse,need for auxiliary procedures(endoscopic treatment),and adverse effects of drugs were recorded.Results:The overall clearance rate was 72.5%(50/69)in the group A and 90.1%(64/71)in the group B(pZ0.007).For stones up to 12 mm,the difference in the clearance rate was significant(pZ0.039)while it was not so for stones larger than 12 mm(pZ0.151).There was no statistically significant difference between the two groups with regards to analgesic requirement(pZ0.94),occurrence of steinstrasse(pZ0.101),need for auxiliary procedures(pZ0.76),and adverse effects of the drugs(pZ0.148).Conclusion:Our study shows that adjunctive medical expulsive therapy with tamsulosin and tadalafil achieves better clearance rate than tadalafil alone in patients receiving SWL for renal stones.展开更多
The aim of the present study was to develop tamsulosin hydrochloride sustained-release pellets using two-layered membrane techniques.Centrifugal granulator and fluidizedbed coater were employed to prepare drug-loaded ...The aim of the present study was to develop tamsulosin hydrochloride sustained-release pellets using two-layered membrane techniques.Centrifugal granulator and fluidizedbed coater were employed to prepare drug-loaded pellets and to employ two-layered membrane coating respectively.The prepared pellets were evaluated for physicochemical characterization,subjected to differential scanning calorimetry(DSC)and in vitro release of different pH.Different release models and scanning electron microscopy(SEM)were utilized to analyze the release mechanism of Harnual■ and home-made pellets.By comparing the dissolution profiles,the ratio and coating weight gain of Eudragit■ NE30D and Eudragit■ L30D55 which constitute the inside membrane were identified as 18:1 and 10%-11%.The coating amount of outside membrane containing Eudragit■ L30D55 was determined to be 0.8%.The similarity factors(f_(2))of home-made capsule and commercially available product(Harnual■)were above 50 in different dissolution media.DSC studies confirmed that drug and excipients had good compatibility and SEM photographs showed the similarities and differences of coating surface between Harnual■ and self-made pellets before and after dissolution.According to Ritger-Peppas model,the two dosage form had different release mechanism.展开更多
A novel stability-indicating RP-HPLC method was developed and validated for simultaneous determination of Solifenacin Succinate & Tamsulosin Hydrochloride and its impurities in tablet dosage form. The method was d...A novel stability-indicating RP-HPLC method was developed and validated for simultaneous determination of Solifenacin Succinate & Tamsulosin Hydrochloride and its impurities in tablet dosage form. The method was developed using L1 column with gradient using the mobile phase consist of solvent-A (pH = 6.6, phosphate buffer + 0.5% Triethylamine) and solvent-B (90% Acetonitrile). The eluted compounds were monitored at 225 nm. Solifenacin Succinate & Tamsulosin Hydrochloride was subjected to oxidative, acid, base, hydrolytic, thermal and photolytic stress conditions. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantitation, accuracy, precision and robustness. The limit of quantification results was ranged from 0.135 - 0.221 μg/mL for Solifenacin Succinate impurities and 0.043 - 0.090 μg/mL for Tamsulosin Hydrochloride impurities. This method is suitable for the estimation of impurities and assay of Solifenacin Succinate & Tamsulosin Hydrochloride in tablets dosage form.展开更多
The alpha1 adrenoreceptor antagonist tamsulosin is primarily used to treat benign prostatic hypertrophy. In this study, we intragastrically administered rats with 0.01,0.1 and 1 mg/kg tamsulosin to investigate the eff...The alpha1 adrenoreceptor antagonist tamsulosin is primarily used to treat benign prostatic hypertrophy. In this study, we intragastrically administered rats with 0.01,0.1 and 1 mg/kg tamsulosin to investigate the effects of tamsulosin on memory function, and hippocampal cell apoptosis and proliferation following intracerebral hemorrhage. Step-down avoidance task results showed that tamsulosin treatment markedly alleviated intracerebral hemorrhage- induced short-term memory impairment. Terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling results showed that tamsulosin treatment markedly suppressed intracerebral hemorrhage-induced caspase-3 expression in the hippocampal CA1 region and cell proliferation in the hippocampal dentate gyrus. Tamsulosin treatment at a dose of 0.01 mg/kg exhibited the most potent inhibitory effects on cell apoptosis and proliferation. These findings suggest that tamsulosin treatment facilitates the recovery of rat memory function by inhibiting hippocampal cell apoptosis and proliferation followincl intracerebral hemorrhaQe.展开更多
The development and validation of an isocratic high performance liquid chromatographic method is described for the determination of tamsulosin hydrochloride in sustained release tablets. The determination was performe...The development and validation of an isocratic high performance liquid chromatographic method is described for the determination of tamsulosin hydrochloride in sustained release tablets. The determination was performed on a Diamonsil BDS C18 column with a mobile phase consisting of a mixture of acetonitrile, methanol and 0 5% phosphoric acid solution (20∶30∶50, V/V/V ) at a flow rate of 1 0 mL/min. UV detection was made at 274 nm. The linear range for tamsulosin hydrochloride was 0 81-8 10 μg/mL. The mean recovery was 99 8% ( S R=0 7%, n =9), and the precision was found to be 0 45% ( n =9). The proposed method can be used for routine analysis of tamsulosin hydrochloride in sustained release tablets.展开更多
BACKGROUND Tamsulosin,a selectiveα1-adrenergic receptor antagonist,is commonly used for treating neurogenic bladder in patients with spinal cord injury(SCI).No severe adverse events have been described with such tams...BACKGROUND Tamsulosin,a selectiveα1-adrenergic receptor antagonist,is commonly used for treating neurogenic bladder in patients with spinal cord injury(SCI).No severe adverse events have been described with such tamsulosin use.To our knowledge,we report the first case of severe life-threatening hypotension as an adverse effect of tamsulosin in a person with SCI.Therefore,we report this case to inform that this severe adverse effect of tamsulosin can occur when treating patients with SCI.CASE SUMMARY A 59-year-old woman was diagnosed with cervical spinal cord myelopathy and was classified as American Spinal Injury Association Impairment Scale D,neurological level of injury C3.Because she suffered from voiding difficulty due to neurogenic bladder,we prescribed tamsulosin.Her vital signs remained stable,but occasional hypotensive symptoms followed defecation.We reduced the dose of tamsulosin,but after administering tamsulosin for 9 d,she experienced lifethreatening hypotension with no evidence of hypovolemic shock,neurogenic shock,cardiogenic shock,or septic shock.A hypotensive condition induced by tamsulosin was the suspected cause,and her symptoms could be associated with adverse effects of tamsulosin.As symptoms resolved after stopping tamsulosin,and no other reason was found,we concluded that tamsulosin was the cause of her symptoms.CONCLUSION Caution for severe hypotension is needed when administering tamsulosin for neurogenic bladder in a patient with SCI.展开更多
Objective: To review the evidence for tamsulosin as medical expulsive therapy in enhancing the effectiveness of distal ureteral stone clearance rate. Methods: We searched Pubmed/Medline, Embase, CBM and the Cochrane L...Objective: To review the evidence for tamsulosin as medical expulsive therapy in enhancing the effectiveness of distal ureteral stone clearance rate. Methods: We searched Pubmed/Medline, Embase, CBM and the Cochrane Library up to October 2011. All randomized controlled trials in which tamsulosin was evaluated with distal ureterolithiasis were eligible for the analysis. Outcome measure assessed was stone clearance rate. Two authors independently assessed study quality and extracted data. All data were analyzed using RevMan 5.1. Results: Thirteen studies involving 1067 participants met the inclusion criteria. Study duration ranged from 7 to 42 d. The pooled analysis showed an improvement of 41% in stone clearance rate of tamsulosin as medical expulsive therapy for distal ureteral calculi (RR=1.41, 95% CI=1.18 to 1.70). According to stone size (6 mm<size<10 mm, 5 mm<size<6 mm, size <5 mm), the pooling effects of tamsulosin were analyzed, with a higher stone expulsion rate obtained than control (RR=1.52, 1.75, 1.05, 95% CI=1.30 to 1.77, 1.25 to 2.45, 0.95 to 1.16, respectively). Adverse effects of tamsulosin, mainly retrograde ejaculation, dizziness and hypotension, were reported in 7 included trials. Conclusion: Treatment with tamsulosin appears to be a safe and effective medical expulsion therapy for distal ureterolithiasis. To make a definite clinical recommendation to use tamsulosin as medical expulsive treatment for distal ureteral calculi, high quality multicentric, randomized, double blinded, controlled trials are necessary to prove its efficacy.展开更多
Objectives: In 2010, tamsulosin 0.2 mg (OD) was withdrawn from Thailand and replaced with tamsulosin 0.4 mg (OD). Therefore, we assessed the impact of this change on the patients, at a men’s health clinic, with lower...Objectives: In 2010, tamsulosin 0.2 mg (OD) was withdrawn from Thailand and replaced with tamsulosin 0.4 mg (OD). Therefore, we assessed the impact of this change on the patients, at a men’s health clinic, with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH). Material and Methods: Subjects were 100 men with BPH who had been taking tamsulosin 0.2 mg as needed for at least 3 months. The outcome measures were IPSS, AMS and IEFF5 scores and uroflowmetry. Tolerability was evaluated on by adverse events. Changes from baseline were assessed using the paired t-test. SPSS version 12.0 was used for statistical analysis, with p 0.05 considered significant. Results: The mean follow up of tamsulosin 0.2 and 0.4 mg were 20.23 and 10.56 months respectively. On switching from tamsulosin 0.2 to 0.4 mg, mean IPSS score improved from 15.54 ± SD 1.25 to 14.13 ± SD 1.09 (p = 0.034), Q max 15.91 cm3/sec ± SD 1.36 to 16.69 cm3/sec ± SD 1.52 (p = 0.128), and nocturia 3.15 ± SD 0.32 to 2.68 ± SD 0.39 (p = 0.015), respectively. However IEFF-5 score and AMS score increased from14.78 ± SD 1.38 to 15.79 ± SD 1.03 (p = 0.0055) and 34.76 ± SD 2.76 to 33.21 ± SD 2.62 (p = 0.0853), respectively. Treatment-related adverse events of Tamsulosin 0.2 mg included dizziness (4%), postural hypotension (3%) and retrograde ejaculation (3%). Interestingly, no withdrawals resulted from adverse events during Tamsulosin 0.4 mg assessment. Conclusions: Switching to tamsulosin 0.4 mg improves LUTS. The change was well tolerated by the majority of patients. Increased symptoms scores of erectile dysfunction and aging male during the study may be due to increased age.展开更多
Background: Stone disease is a wide health problem;certain drugs have been used as supplement with ESWL for the treatment of symptomatic uncomplicated lower ureteric stone like Nefidipine, Alfuzosin and Tamsulosin. Th...Background: Stone disease is a wide health problem;certain drugs have been used as supplement with ESWL for the treatment of symptomatic uncomplicated lower ureteric stone like Nefidipine, Alfuzosin and Tamsulosin. The purpose of this study is to evaluate the efficacy of Tamsulosin for the treatment of lower ureteric stone of 5 - 10 mm diameter after ESWL. Methods: A total of 105 patients with lower ureteric stone of less than 10 mm diameters were divided into two groups. Group 1 including 48 patients received 0.4 mg Tamsulosin and diclofenac sodium analgesia as needed immediately after ESWL and continued until stone expulsion was confirmed up to maximum of 30 days. Group 2 including 47 patients was given diclofenac sodium only as needed after ESWL. Result: 46 of 49 patients in group 1 and 44 of 48 patients in group 2 ultimately passed stones. The number of ESWL sessions was 1.4 ± 0.6 in group 1 & 1.42 ± 0.75 in group 2. There were 10 patients who needed analgesia after ESWL in group 1 and 17 patients in group 2. Visual analogue scale pain severity score was 5.32 ± 1.23 and 6.41 ± 1.26 in group 1 and 2, respectively. The time to stone expulsion in group 1 and 2 was 8 ± 5.4 days and 12 ± 10.3 days, respectively. No significant complications or side effects occurred. Conclusion: The use of Tamsulosin in combination with ESWL in patients with lower ureteric stone of 5 - 10 mm was effective for reducing the time to stone expulsion, decreasing need for analgesia, and facilitating stone passage without significant improvement in stone free rate.展开更多
Objective: To evaluate and compare the safety and efficacy of Solifenacin, Tamsulosin, and Tadalafil in treating ureteral stent related symptoms (SRS) in patients with indwelling Double-J ureteral stents. Materials an...Objective: To evaluate and compare the safety and efficacy of Solifenacin, Tamsulosin, and Tadalafil in treating ureteral stent related symptoms (SRS) in patients with indwelling Double-J ureteral stents. Materials and Methods: A prospective randomized controlled study was conducted on 146 consecutive patients in the department of urology, Government Stanley Medical College & Hospital, Chennai, Tamilnadu, India between Sept 2017-March 2019, with SRS after taking informed consent and confirming DJ Stent position by X-ray KUB post-operatively. Patients were randomized into 4 groups: Group A (Placebo), Group B (Solifenacin 5 mg), and Group B (Tamsulosin 0.4 mg) and group D (Tadalafil 5 mg) at end of 1st week till the removal of DJ stent at end of 3 weeks. All patients were assessed for bothersome lower urinary tract symptoms (LUTS) using the validated Ureteral Stent Symptom Questionnaire (USSQ) at 1st week and 3 weeks after the starting of medications. Appropriate statistical analysis as carried out and the level of significance was set at P Results: LUTS, general health, and work performance improved with Solifenacin, Tamsulosin and Tadalafil and all the three were comparable in relieving urinary symptoms. Tadalafil was better at relieving body pain, additional problems and sexual problems better than Tamsulosin. Tadalafil showed comparable improvement in LUTS, better sexual health and decreased body pain compared to solifenacin, whereas the latter had better general health, additional problems & work performance scores. Conclusion: Solifenacin is more effective than Tamsulosin in alleviating LUTS associated with SRS and both show a distinctive advantage over placebo. PDE inhibitor Tadalafil can also be tried for SRS and is as effective as antimuscarinics and α-blockers in relieving urinary symptoms and is more efficacious in relieving sexual symptoms and body pain.展开更多
Objective To evaluate the efficacy and safety of combination therapy of tamsulosin and solifenacin for benign prostatic hyperplasia ( BPH) with overactive bladder ( OAB) . Methods 82 patients with OAB and coexisting B...Objective To evaluate the efficacy and safety of combination therapy of tamsulosin and solifenacin for benign prostatic hyperplasia ( BPH) with overactive bladder ( OAB) . Methods 82 patients with OAB and coexisting BPH were randomly divided into tamsulosin group ( n展开更多
Objective To evaluate the efficacy of sollfenacin with or without tamsulosin in patients with overactive bladder ( OAB ) . Methods Fifty-three patients with OAB were randomly divided into two groups ( group
Background Tamsulosin, an alpha-1 receptor antagonist, has been demonstrated effective in promoting distal ureteral stone passage and in reducing pain associated with stone expulsion. This study aimed to evaluate the ...Background Tamsulosin, an alpha-1 receptor antagonist, has been demonstrated effective in promoting distal ureteral stone passage and in reducing pain associated with stone expulsion. This study aimed to evaluate the effect of tamsulosin in comparison with nifedipine and extracorporeal shock wave lithotripsy （ESWL） on the expulsion rate of distal ureteral stones at different sizes. Methods We assigned 314 patients to three categories： Ⅰ, the stone with maximal diameter of 4.0-5.9 mm; Ⅱ, 6.0-7.9 mm, and Ⅲ, 8.0-9.9 mm. Patients in each category were randomly subdivided into three treatment subgroups： group A （nifedipine group）, group B （tamsulosin group）, and group C （ESWL group）. Stone-free rate and the dose of analgesics were recorded weekly during the 4-week follow-up period. Results Three hundred and three patients completed the study. The results showed that nifedipine and tamsulosin treatments promoted a small （4-8 mm, categories Ⅰ and Ⅱ） stone expulsive rate that was comparable with ESWL treatment. Nonetheless, when the stone diameter was 8.0-9.9 mm, ESWL showed a greater stone free rate than nifedipine and tamsulosin treatments; no significant difference existed between the latter two therapies. Although the ESWL treatment group required the least analgesics, tamsulosin treatments required less pain medication than nifedipine （P 〈0.05）. Conclusions Tamsulosin treatment is recommended for patients with the stone diameter smaller than 8 mm because of its feasibility, effectiveness and safety. ESWL is more appropriate than tamsulosin therapy for the patients whose stones are larger than 8 mm.展开更多
Background Tamsulosin hydrochloride can significantly improve benign prostatic hyperplasia （BPH） symptoms after the first dose and achieve long-term efficacy in European and American populations; however, the coresp...Background Tamsulosin hydrochloride can significantly improve benign prostatic hyperplasia （BPH） symptoms after the first dose and achieve long-term efficacy in European and American populations; however, the coresponding studies from China are rarely seen. The purpose of this study was to evaluate the long-term efficacy and safety of tamsulosin hydrochloride 0.2 mg once daily in patients with lower urinary tract symptoms （LUTS） suggestive of BPH in China. Methods Chinese patients with LUTS suggestive of BPH were enrolled in a 4-week placebo run-in period and subsequent 60-week open-label study. Tamsulosin hydrochloride 0.2 mg was administered daily during the period of the study. The efficacy and safety parameters were evaluated at the end of treatment period I （0-12 weeks） and period II （13-60 weeks）. The BPH patients were divided into tamsulosin monotherapy group and combination therapy group which received concomitant medication of finasteride 5 mg once daily after the evaluation at the end of treatment period I. Results A total of 113 patients were recruited to the study. Eighty-two patients received tamsulosin monotherapy and twenty-nine received combination therapy during the treatment period I1. Tamsulosin hydrochloride produced a great improvement in mean maximum urinary flow rate （Qmax） （1.7 ml/s, 3 ml/s） and a significant decrease in mean international prostate symptom score （IPSS） （4.1,6.4） after 12-week and 60-week treatments, respectively. At the end of treatment period II, there were significant improvement in IPSS, quality of life （QOL） score, Qmax and average flow rate （eave） for combination therapy group compared with the treatment period I （all P 〈0.05）. No serious adverse events （SAE） were recorded during the study. Conclusion Long-term tamsulosin hydrochloride therapy is a safe, effective and well-tolerated method for the treatment for LUTS suggestive of BPH in China.展开更多
Background Pharmacological therapy has been considered as the first-line treatment for patients with uncomplicated benign prostatic hyperplasia （BPH）. The aim of this study was to evaluate the efficacy and safety of...Background Pharmacological therapy has been considered as the first-line treatment for patients with uncomplicated benign prostatic hyperplasia （BPH）. The aim of this study was to evaluate the efficacy and safety of tamsulosin compared with a placebo for treating BPH. Methods The randomized placebo-controlled trials （RCT） of tamsulosin for the treatment of BPH from all over the world were searched. PubMed, Ovid, ScienceDirect, EBSCO, CBM, and CNKI were searched, as well as a manual search of four Chinese journals： Chinese Journal of Andrology, National Journal of Andrology, Chinese Journal of Urology, and Journal of Clinical Urologywas also performed. Two reviewers independently screened the studies for eligibility, evaluated the quality and extracted the data from the eligible studies, with confirmation by cross-checking. Divergences of opinions were settled by discussion. Meta-analysis was processed by Rev Man 5.0 software, fail-safe number was performed by SASS.0 software. Results Seven RCTs involving 2455 men met the inclusion criteria. The basic characteristics of patients were comparable in all the studies. Comparing three common criteria： international prostate symptom score （IPSS）/Boyarsky symptom score, maximum flow rate （MFR）, quality of life （QOL）, tamsulosin was better than placebo at improving IPSS and MFR, with no significant difference in the QOL. Adverse events of tamsulosin also showed no significant difference from the placebo group （Z=1.62, P=0.10, OR=1.22, 95% Cl 0.96-1.54）. Conclusions Tamsulosin is better than placebo at improving IPSS and MFR. Adverse events of tamsuloisn show no significant difference compared with placebo. More high quality trials with larger samples and longer follow-up are proposed.展开更多
文摘This study aimed to evaluate the effectiveness of tamsulosin monotherapy for the treatment of ureteral stent-related symptoms(SRSs)and compare it with that of solifenacin monotherapy and combined therapy of tamsulosin and silifenacin.Randomized controlled trials(RCTs),which evaluated the effectiveness of tamsulosin for the treatment of SRSs,were searched from the databases PubMed,EMBASE and the Cochrane Library published up to November 2018.Eight RCTs involving 1087 participants were finally included in this meta-analysis.The results showed that tamsulosin monotherapy could significantly decrease the urinary symptoms[mean difference(MD)—7.56,95%confidence interval(CI)(-11.47,-3.65),P=0.0001]and body pain[MD-5.25,95%CI(-8.03,-2.46),P=0.0002],and improve the sexual performance[MD-1.06,95%CI(-1.89,-0.24),P=0.01]compared with the control group.Moreover,there was no significant difference between tamsulosin monotherapy and solifenacin monotherapy in all outcomes except for significantly better sexual performance in solifenacin group[MD 0.29,95%CI(0.06,0.51),P=0.01].In addition,the effectiveness of combined therapy of tamsulosin and solifenacin was not superior to that of tamsulosin monotherapy.Our study demonstrated that tamsulosin monotherapy was effective for the treatment of patients with SRSs;evident superiority could not be found for therapy of tamsulosin and solifenacin combined.
文摘This study was undertaken to determine the impact on ejaculatory function of tamsulosin （0.2 mg） given once daily （OD） for 12 weeks and to identify risk factors for ejaculatory dysfunction in patients undergoing this treatment. Males with an International Prostatic Symptom Score （IPSS） ≥ 8 were enrolled in this study. All participants completed questionnaires, including the IPSS and the Male Sexual Health Questionnaire （MSHQ）, and serum prostate-specific antigen, transrectal ultrasound and uroflowmetry with post-void residual were measured. After initiating 0.2 mg OD tamsulosin, patients were re-evaluated on the fourth and twelfth weeks of medication. The chi-squared test, the independent t-test and one-way ANOVA were used to compare means. Binary logistic regression analysis was used to calculate the odds ratio for all risk factors. A total of 177 men constituted the study cohort. No significant difference was observed between baseline and follow-up for the erectile function, ejaculatory function, satisfaction, sexual activity and desire domains （EFD, EjFD, SDA and ADD） or for erectile or ejaculatory bother mean scores. After 12 weeks, the overall incidence of ejaculatory dysfunction （EjD） was 13.4%. Incidences of the seven different types of EjD （decreased frequency, delay, dryness, decreased strength/force, decreased volume, decreased pleasure and pain at ejaculation） were 2.4%, 3.1%, 3.9%, 3.9%, 6.3%, 7.1% and 3.1%, respectively. Baseline EjFD scores were higher for I PSS responders than for non-responders （26.09 vs. 24.06, P=0.03）. An EjFD score reduction was more frequent in IPSS responders. The incidence of EjD was small, but not negligible and was more frequent in patients with less lower urinary tract symptoms, a smaller prostate, higher baseline MSHQ totals and higher EjFD scores.
文摘Objectives:To compare the efficacy of tamsulosin versus tamsulosin plus tadalafil in achieving clearance of fragments after shock wave lithotripsy(SWL)to treat renal calculi.Methods:Between January 2016 to December 2017,140 patients with solitary,non-branched,non-lower calyceal renal calculus and measuring less than 20 mm and treated with SWL were randomized to tamsulosin(group A)or tamsulosin plus tadalafil(group B).Therapy was given for a period of 4 weeks.Stone clearance rate,analgesic requirement,occurrence of steinstrasse,need for auxiliary procedures(endoscopic treatment),and adverse effects of drugs were recorded.Results:The overall clearance rate was 72.5%(50/69)in the group A and 90.1%(64/71)in the group B(pZ0.007).For stones up to 12 mm,the difference in the clearance rate was significant(pZ0.039)while it was not so for stones larger than 12 mm(pZ0.151).There was no statistically significant difference between the two groups with regards to analgesic requirement(pZ0.94),occurrence of steinstrasse(pZ0.101),need for auxiliary procedures(pZ0.76),and adverse effects of the drugs(pZ0.148).Conclusion:Our study shows that adjunctive medical expulsive therapy with tamsulosin and tadalafil achieves better clearance rate than tadalafil alone in patients receiving SWL for renal stones.
文摘The aim of the present study was to develop tamsulosin hydrochloride sustained-release pellets using two-layered membrane techniques.Centrifugal granulator and fluidizedbed coater were employed to prepare drug-loaded pellets and to employ two-layered membrane coating respectively.The prepared pellets were evaluated for physicochemical characterization,subjected to differential scanning calorimetry(DSC)and in vitro release of different pH.Different release models and scanning electron microscopy(SEM)were utilized to analyze the release mechanism of Harnual■ and home-made pellets.By comparing the dissolution profiles,the ratio and coating weight gain of Eudragit■ NE30D and Eudragit■ L30D55 which constitute the inside membrane were identified as 18:1 and 10%-11%.The coating amount of outside membrane containing Eudragit■ L30D55 was determined to be 0.8%.The similarity factors(f_(2))of home-made capsule and commercially available product(Harnual■)were above 50 in different dissolution media.DSC studies confirmed that drug and excipients had good compatibility and SEM photographs showed the similarities and differences of coating surface between Harnual■ and self-made pellets before and after dissolution.According to Ritger-Peppas model,the two dosage form had different release mechanism.
文摘A novel stability-indicating RP-HPLC method was developed and validated for simultaneous determination of Solifenacin Succinate & Tamsulosin Hydrochloride and its impurities in tablet dosage form. The method was developed using L1 column with gradient using the mobile phase consist of solvent-A (pH = 6.6, phosphate buffer + 0.5% Triethylamine) and solvent-B (90% Acetonitrile). The eluted compounds were monitored at 225 nm. Solifenacin Succinate & Tamsulosin Hydrochloride was subjected to oxidative, acid, base, hydrolytic, thermal and photolytic stress conditions. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantitation, accuracy, precision and robustness. The limit of quantification results was ranged from 0.135 - 0.221 μg/mL for Solifenacin Succinate impurities and 0.043 - 0.090 μg/mL for Tamsulosin Hydrochloride impurities. This method is suitable for the estimation of impurities and assay of Solifenacin Succinate & Tamsulosin Hydrochloride in tablets dosage form.
基金the National Research Foundation of Korea Grant funded by the Korean Government, No. 2010-0003794the Research Fund, 2010 of Gachon University Gil Hospital
文摘The alpha1 adrenoreceptor antagonist tamsulosin is primarily used to treat benign prostatic hypertrophy. In this study, we intragastrically administered rats with 0.01,0.1 and 1 mg/kg tamsulosin to investigate the effects of tamsulosin on memory function, and hippocampal cell apoptosis and proliferation following intracerebral hemorrhage. Step-down avoidance task results showed that tamsulosin treatment markedly alleviated intracerebral hemorrhage- induced short-term memory impairment. Terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling results showed that tamsulosin treatment markedly suppressed intracerebral hemorrhage-induced caspase-3 expression in the hippocampal CA1 region and cell proliferation in the hippocampal dentate gyrus. Tamsulosin treatment at a dose of 0.01 mg/kg exhibited the most potent inhibitory effects on cell apoptosis and proliferation. These findings suggest that tamsulosin treatment facilitates the recovery of rat memory function by inhibiting hippocampal cell apoptosis and proliferation followincl intracerebral hemorrhaQe.
文摘The development and validation of an isocratic high performance liquid chromatographic method is described for the determination of tamsulosin hydrochloride in sustained release tablets. The determination was performed on a Diamonsil BDS C18 column with a mobile phase consisting of a mixture of acetonitrile, methanol and 0 5% phosphoric acid solution (20∶30∶50, V/V/V ) at a flow rate of 1 0 mL/min. UV detection was made at 274 nm. The linear range for tamsulosin hydrochloride was 0 81-8 10 μg/mL. The mean recovery was 99 8% ( S R=0 7%, n =9), and the precision was found to be 0 45% ( n =9). The proposed method can be used for routine analysis of tamsulosin hydrochloride in sustained release tablets.
文摘BACKGROUND Tamsulosin,a selectiveα1-adrenergic receptor antagonist,is commonly used for treating neurogenic bladder in patients with spinal cord injury(SCI).No severe adverse events have been described with such tamsulosin use.To our knowledge,we report the first case of severe life-threatening hypotension as an adverse effect of tamsulosin in a person with SCI.Therefore,we report this case to inform that this severe adverse effect of tamsulosin can occur when treating patients with SCI.CASE SUMMARY A 59-year-old woman was diagnosed with cervical spinal cord myelopathy and was classified as American Spinal Injury Association Impairment Scale D,neurological level of injury C3.Because she suffered from voiding difficulty due to neurogenic bladder,we prescribed tamsulosin.Her vital signs remained stable,but occasional hypotensive symptoms followed defecation.We reduced the dose of tamsulosin,but after administering tamsulosin for 9 d,she experienced lifethreatening hypotension with no evidence of hypovolemic shock,neurogenic shock,cardiogenic shock,or septic shock.A hypotensive condition induced by tamsulosin was the suspected cause,and her symptoms could be associated with adverse effects of tamsulosin.As symptoms resolved after stopping tamsulosin,and no other reason was found,we concluded that tamsulosin was the cause of her symptoms.CONCLUSION Caution for severe hypotension is needed when administering tamsulosin for neurogenic bladder in a patient with SCI.
文摘Objective: To review the evidence for tamsulosin as medical expulsive therapy in enhancing the effectiveness of distal ureteral stone clearance rate. Methods: We searched Pubmed/Medline, Embase, CBM and the Cochrane Library up to October 2011. All randomized controlled trials in which tamsulosin was evaluated with distal ureterolithiasis were eligible for the analysis. Outcome measure assessed was stone clearance rate. Two authors independently assessed study quality and extracted data. All data were analyzed using RevMan 5.1. Results: Thirteen studies involving 1067 participants met the inclusion criteria. Study duration ranged from 7 to 42 d. The pooled analysis showed an improvement of 41% in stone clearance rate of tamsulosin as medical expulsive therapy for distal ureteral calculi (RR=1.41, 95% CI=1.18 to 1.70). According to stone size (6 mm<size<10 mm, 5 mm<size<6 mm, size <5 mm), the pooling effects of tamsulosin were analyzed, with a higher stone expulsion rate obtained than control (RR=1.52, 1.75, 1.05, 95% CI=1.30 to 1.77, 1.25 to 2.45, 0.95 to 1.16, respectively). Adverse effects of tamsulosin, mainly retrograde ejaculation, dizziness and hypotension, were reported in 7 included trials. Conclusion: Treatment with tamsulosin appears to be a safe and effective medical expulsion therapy for distal ureterolithiasis. To make a definite clinical recommendation to use tamsulosin as medical expulsive treatment for distal ureteral calculi, high quality multicentric, randomized, double blinded, controlled trials are necessary to prove its efficacy.
文摘Objectives: In 2010, tamsulosin 0.2 mg (OD) was withdrawn from Thailand and replaced with tamsulosin 0.4 mg (OD). Therefore, we assessed the impact of this change on the patients, at a men’s health clinic, with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH). Material and Methods: Subjects were 100 men with BPH who had been taking tamsulosin 0.2 mg as needed for at least 3 months. The outcome measures were IPSS, AMS and IEFF5 scores and uroflowmetry. Tolerability was evaluated on by adverse events. Changes from baseline were assessed using the paired t-test. SPSS version 12.0 was used for statistical analysis, with p 0.05 considered significant. Results: The mean follow up of tamsulosin 0.2 and 0.4 mg were 20.23 and 10.56 months respectively. On switching from tamsulosin 0.2 to 0.4 mg, mean IPSS score improved from 15.54 ± SD 1.25 to 14.13 ± SD 1.09 (p = 0.034), Q max 15.91 cm3/sec ± SD 1.36 to 16.69 cm3/sec ± SD 1.52 (p = 0.128), and nocturia 3.15 ± SD 0.32 to 2.68 ± SD 0.39 (p = 0.015), respectively. However IEFF-5 score and AMS score increased from14.78 ± SD 1.38 to 15.79 ± SD 1.03 (p = 0.0055) and 34.76 ± SD 2.76 to 33.21 ± SD 2.62 (p = 0.0853), respectively. Treatment-related adverse events of Tamsulosin 0.2 mg included dizziness (4%), postural hypotension (3%) and retrograde ejaculation (3%). Interestingly, no withdrawals resulted from adverse events during Tamsulosin 0.4 mg assessment. Conclusions: Switching to tamsulosin 0.4 mg improves LUTS. The change was well tolerated by the majority of patients. Increased symptoms scores of erectile dysfunction and aging male during the study may be due to increased age.
文摘Background: Stone disease is a wide health problem;certain drugs have been used as supplement with ESWL for the treatment of symptomatic uncomplicated lower ureteric stone like Nefidipine, Alfuzosin and Tamsulosin. The purpose of this study is to evaluate the efficacy of Tamsulosin for the treatment of lower ureteric stone of 5 - 10 mm diameter after ESWL. Methods: A total of 105 patients with lower ureteric stone of less than 10 mm diameters were divided into two groups. Group 1 including 48 patients received 0.4 mg Tamsulosin and diclofenac sodium analgesia as needed immediately after ESWL and continued until stone expulsion was confirmed up to maximum of 30 days. Group 2 including 47 patients was given diclofenac sodium only as needed after ESWL. Result: 46 of 49 patients in group 1 and 44 of 48 patients in group 2 ultimately passed stones. The number of ESWL sessions was 1.4 ± 0.6 in group 1 & 1.42 ± 0.75 in group 2. There were 10 patients who needed analgesia after ESWL in group 1 and 17 patients in group 2. Visual analogue scale pain severity score was 5.32 ± 1.23 and 6.41 ± 1.26 in group 1 and 2, respectively. The time to stone expulsion in group 1 and 2 was 8 ± 5.4 days and 12 ± 10.3 days, respectively. No significant complications or side effects occurred. Conclusion: The use of Tamsulosin in combination with ESWL in patients with lower ureteric stone of 5 - 10 mm was effective for reducing the time to stone expulsion, decreasing need for analgesia, and facilitating stone passage without significant improvement in stone free rate.
文摘Objective: To evaluate and compare the safety and efficacy of Solifenacin, Tamsulosin, and Tadalafil in treating ureteral stent related symptoms (SRS) in patients with indwelling Double-J ureteral stents. Materials and Methods: A prospective randomized controlled study was conducted on 146 consecutive patients in the department of urology, Government Stanley Medical College & Hospital, Chennai, Tamilnadu, India between Sept 2017-March 2019, with SRS after taking informed consent and confirming DJ Stent position by X-ray KUB post-operatively. Patients were randomized into 4 groups: Group A (Placebo), Group B (Solifenacin 5 mg), and Group B (Tamsulosin 0.4 mg) and group D (Tadalafil 5 mg) at end of 1st week till the removal of DJ stent at end of 3 weeks. All patients were assessed for bothersome lower urinary tract symptoms (LUTS) using the validated Ureteral Stent Symptom Questionnaire (USSQ) at 1st week and 3 weeks after the starting of medications. Appropriate statistical analysis as carried out and the level of significance was set at P Results: LUTS, general health, and work performance improved with Solifenacin, Tamsulosin and Tadalafil and all the three were comparable in relieving urinary symptoms. Tadalafil was better at relieving body pain, additional problems and sexual problems better than Tamsulosin. Tadalafil showed comparable improvement in LUTS, better sexual health and decreased body pain compared to solifenacin, whereas the latter had better general health, additional problems & work performance scores. Conclusion: Solifenacin is more effective than Tamsulosin in alleviating LUTS associated with SRS and both show a distinctive advantage over placebo. PDE inhibitor Tadalafil can also be tried for SRS and is as effective as antimuscarinics and α-blockers in relieving urinary symptoms and is more efficacious in relieving sexual symptoms and body pain.
文摘Objective To evaluate the efficacy and safety of combination therapy of tamsulosin and solifenacin for benign prostatic hyperplasia ( BPH) with overactive bladder ( OAB) . Methods 82 patients with OAB and coexisting BPH were randomly divided into tamsulosin group ( n
文摘Objective To evaluate the efficacy of sollfenacin with or without tamsulosin in patients with overactive bladder ( OAB ) . Methods Fifty-three patients with OAB were randomly divided into two groups ( group
文摘Background Tamsulosin, an alpha-1 receptor antagonist, has been demonstrated effective in promoting distal ureteral stone passage and in reducing pain associated with stone expulsion. This study aimed to evaluate the effect of tamsulosin in comparison with nifedipine and extracorporeal shock wave lithotripsy （ESWL） on the expulsion rate of distal ureteral stones at different sizes. Methods We assigned 314 patients to three categories： Ⅰ, the stone with maximal diameter of 4.0-5.9 mm; Ⅱ, 6.0-7.9 mm, and Ⅲ, 8.0-9.9 mm. Patients in each category were randomly subdivided into three treatment subgroups： group A （nifedipine group）, group B （tamsulosin group）, and group C （ESWL group）. Stone-free rate and the dose of analgesics were recorded weekly during the 4-week follow-up period. Results Three hundred and three patients completed the study. The results showed that nifedipine and tamsulosin treatments promoted a small （4-8 mm, categories Ⅰ and Ⅱ） stone expulsive rate that was comparable with ESWL treatment. Nonetheless, when the stone diameter was 8.0-9.9 mm, ESWL showed a greater stone free rate than nifedipine and tamsulosin treatments; no significant difference existed between the latter two therapies. Although the ESWL treatment group required the least analgesics, tamsulosin treatments required less pain medication than nifedipine （P 〈0.05）. Conclusions Tamsulosin treatment is recommended for patients with the stone diameter smaller than 8 mm because of its feasibility, effectiveness and safety. ESWL is more appropriate than tamsulosin therapy for the patients whose stones are larger than 8 mm.
文摘Background Tamsulosin hydrochloride can significantly improve benign prostatic hyperplasia （BPH） symptoms after the first dose and achieve long-term efficacy in European and American populations; however, the coresponding studies from China are rarely seen. The purpose of this study was to evaluate the long-term efficacy and safety of tamsulosin hydrochloride 0.2 mg once daily in patients with lower urinary tract symptoms （LUTS） suggestive of BPH in China. Methods Chinese patients with LUTS suggestive of BPH were enrolled in a 4-week placebo run-in period and subsequent 60-week open-label study. Tamsulosin hydrochloride 0.2 mg was administered daily during the period of the study. The efficacy and safety parameters were evaluated at the end of treatment period I （0-12 weeks） and period II （13-60 weeks）. The BPH patients were divided into tamsulosin monotherapy group and combination therapy group which received concomitant medication of finasteride 5 mg once daily after the evaluation at the end of treatment period I. Results A total of 113 patients were recruited to the study. Eighty-two patients received tamsulosin monotherapy and twenty-nine received combination therapy during the treatment period I1. Tamsulosin hydrochloride produced a great improvement in mean maximum urinary flow rate （Qmax） （1.7 ml/s, 3 ml/s） and a significant decrease in mean international prostate symptom score （IPSS） （4.1,6.4） after 12-week and 60-week treatments, respectively. At the end of treatment period II, there were significant improvement in IPSS, quality of life （QOL） score, Qmax and average flow rate （eave） for combination therapy group compared with the treatment period I （all P 〈0.05）. No serious adverse events （SAE） were recorded during the study. Conclusion Long-term tamsulosin hydrochloride therapy is a safe, effective and well-tolerated method for the treatment for LUTS suggestive of BPH in China.
文摘Background Pharmacological therapy has been considered as the first-line treatment for patients with uncomplicated benign prostatic hyperplasia （BPH）. The aim of this study was to evaluate the efficacy and safety of tamsulosin compared with a placebo for treating BPH. Methods The randomized placebo-controlled trials （RCT） of tamsulosin for the treatment of BPH from all over the world were searched. PubMed, Ovid, ScienceDirect, EBSCO, CBM, and CNKI were searched, as well as a manual search of four Chinese journals： Chinese Journal of Andrology, National Journal of Andrology, Chinese Journal of Urology, and Journal of Clinical Urologywas also performed. Two reviewers independently screened the studies for eligibility, evaluated the quality and extracted the data from the eligible studies, with confirmation by cross-checking. Divergences of opinions were settled by discussion. Meta-analysis was processed by Rev Man 5.0 software, fail-safe number was performed by SASS.0 software. Results Seven RCTs involving 2455 men met the inclusion criteria. The basic characteristics of patients were comparable in all the studies. Comparing three common criteria： international prostate symptom score （IPSS）/Boyarsky symptom score, maximum flow rate （MFR）, quality of life （QOL）, tamsulosin was better than placebo at improving IPSS and MFR, with no significant difference in the QOL. Adverse events of tamsulosin also showed no significant difference from the placebo group （Z=1.62, P=0.10, OR=1.22, 95% Cl 0.96-1.54）. Conclusions Tamsulosin is better than placebo at improving IPSS and MFR. Adverse events of tamsuloisn show no significant difference compared with placebo. More high quality trials with larger samples and longer follow-up are proposed.
