Tamsulosin Research Articles

Efficacy and Tolerability of 6-Month Treatment with Tamsulosin Plus the Hexanic Extract of Serenoa repens versus Tamsulosin Plus 5-Alpha-Reductase Inhibitors for Moderate-to-Severe LUTS-BPH Patients: Results of a Paired Matched Clinical Study.

The objective of this subset analysis was to evaluate and compare the efficacy and tolerability of two combination treatments for men with moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). Data were from a real-world, open-label, prospective, and multicenter study performed in outpatient urology clinics. Men with moderate-to-severe LUTS/BPH received 6-month treatment with tamsulosin (TAM) in combination with either the hexanic extract of S. repens (HESr) or a 5-alpha-reductase inhibitor (5ARI). Changes in urinary symptoms and quality of life were measured using the IPSS and BII questionnaires, respectively. Treatment tolerability was assessed by recording adverse effects (AEs). Patients in the two study groups were matched using iterative and propensity score matching approaches. After iterative matching, data were available from 136 patients (n = 68 treated with TAM + 5ARI, n = 68 with TAM + HESr). After 6 months of treatment, mean (SD) IPSS total score improved by 7.7 (6.3) and 6.7 (5.0) points in the TAM + 5ARI and TAM + HESr groups, respectively (p = 0.272); mean BII total scores improved by 3.1 (2.9) and 2.9 (2.4) points (p = 0.751), respectively. AEs were reported by 26.5% and 10.3% of patients in the same groups, mostly affecting sexual function (p < 0.027). When used in a real-world setting to treat patients with moderate-severe LUTS/BPH, 6-month treatment with TAM + HESr was as effective as TAM + 5ARI, but with better tolerability.

Green & Sensitive pH-dependent Spectrofluorimetric Assay of Tamsulosin Hydrochloride and Tadalafil in their New Combined Formulation for Benign Prostatic Hyperplasia: Application to Spiked Human Plasma

Sensitive and green spectrofluorimetric methods were utilized for Tamsulosin Hydrochloride (TAM) and Tadalafil (TDL) assessment in bulk and their newly available combined mixture for benign prostatic hyperplasia and erectile dysfunction. The technique relies on measuring native fluorescence of TAM in 0.1 N HCl at 324 nm and TDL in 0.1 N NaOH at 348 nm due to their different fluorimetric behavior in acidic and basic media where TAM has no fluorescence in basic medium and vice versa. To achieve better regression, the spectra were derivatized allowing determination of TAM at 314 nm and TDL at 320 and 380 nm (peak to peak) by applying third and first derivative, respectively. In addition, pH-dependent “constant-wavelength synchronous” spectrofluorimetry was applied where TAM and TDL were determined at 218 nm in acidic medium and at 268 nm in basic medium, respectively. Finally, derivatizing the latter emission spectra allowed determination of TAM and TDL at 232 nm and at 262 and 278 nm (peak to peak), respectively. Acidic and basic emission spectra where scanned at λexc = 225 nm (for TAM assay) and at λexc = 247 nm (for TDL assay), respectively. Fluorescence–concentration plots were linear and the proposed methods were used for analysis of TAM and TDL combined laboratory prepared formulation. These procedures are green, sensitive and of low cost which make them suitable for quality control analysis of the two drugs. In addition, the high selectivity of the proposed methods was tested by successfully applying them for TAM and TDL assay in plasma samples.

Evaluation of the anticorrosion performance of Tamsulosin as corrosion inhibitor for pipeline steel in acidic environment: experimental and theoretical study

The inhibition performance of expired Tamsulosin (TAM) was studied on St52 pipeline steel in 1 M HCl by gravimetric, electrochemical impedance spectroscopy (EIS), potentiodynamic polarization (PDP), scanning electron microscopy (SEM) and energy-dispersive X-ray (EDX) spectroscopic analysis. It was seen that the presence of the studied expired drug decreased the corrosion rate of the pipeline steel. TAM’s efficiency as an inhibitor increased as its concentration increased but decrease with temperature rise. The expired drug showed maximal inhibition efficiency of 98.1% from weight loss measurement at 2.0 × 10−3 M TAM concentration and 303 K. PDP results showed that TAM acted as a mixed-type inhibitor. The adsorption study revealed that Langmuir isotherms gave the best fit. The surface morphological study revealed that TAM formed an adsorbed protective layer on the St52 steel surface in the acid medium. The theoretical study performed using the density functional theory (DFT) allowed correlation with an experimental study.

Evaluation of Clinical Effect of Double Dose Tamsulosin Hydrochloride Sustained-release Tablets on Type �� Prostatitis

Evaluation of Clinical Effect of Double Dose Tamsulosin Hydrochloride Sustained-release Tablets on Type �� Prostatitis

Tamsulosin and risk of priapism: A causality assessment using Austin Bradford Hill Criteria.

Tamsulosin hydrochloride, a selective alpha‐adrenergic blocking agent has been previously associated with priapism. Priapism is a medically serious condition that, if not intervened, can cause permanent erectile dysfunction. This study was conducted to investigate whether the association of tamsulosin and priapism is causal. All currently available evidence such as experimental, biological, toxicological, published studies, and safety data mined from the WHO global pharmacovigilance database was systematically organized into the Austin Bradford Hill causality assessment framework. In the international pharmacovigilance database, a strong association between tamsulosin and priapism (IC025 = 4.1; PRR025 = 19.9; ROR025 = 20) was observed. There were 122 cases of priapism associated with tamsulosin submitted to the database from 23 countries. In 87.7% of the cases, tamsulosin was reported as a ‘sole suspect,’ and in 50.8%, it was the only drug administered. In several patients, priapism resolved following discontinuation of tamsulosin and recurred after its reintroduction. Both in the published and unpublished data, for majority of the cases, the time to onset of priapism was within few days following the first intake of tamsulosin. Cases of priapism, particularly those published, were consistent in their clinical features with patients experiencing prolonged painful erection that required aspiration of cavernosal blood, irrigation of the corpora cavernosa, and treatment with vasopressors. Other alpha‐adrenergic blocking agents that are structurally analogous with tamsulosin have also been associated with priapism. In several cases, tamsulosin was used off‐label, for the treatment of ureteral calculi expulsion. Eight patients experienced priapism that ended up with serious complications such as ejaculation disorders and erectile dysfunction. The currently available totality of evidence suggests that the association of tamsulosin and priapism is causal. Healthcare professionals are therefore recommended to cautiously prescribe tamsulosin and ensure that consumers are aware of the potential risk of priapism.

Two green chromatographic methods for the quantification of tamsulosin and solifenacin along with four of their impurities.

Modern analytical procedures often include impurity profiling to verify the potency, safety, and effectiveness of new formulations. We had to develop techniques based on green analysis since the detrimental influence of solvents and chemicals on the environment has now become a serious concern. Two selective, sensitive, and green liquid chromatography methods were established and fully validated for quantitation of tamsulosin hydrochloride and solifenacin succinate along with four of their official and/or related impurities namely; tamsulosin sulfonic acid, tamsulosin impurity H, solifenacin impurity A and solifenacin impurity C. The first used high-performance thin-layer chromatography with silica gel 60 F254 plates as the stationary phase and an elution system of ethyl acetate:butanol:glacial acetic acid (10.0:0.4:0.1, by volume) and a scanning wavelength of 225.0nm. The second method depended on HPLC with diode array detection. Chromatographic separation was accomplished on a Zorbax SB C18 (250 × 4.6 mm2 , 5 μm) column utilizing a mixture of 10.0mM sodium dihydrogen phosphate (pH 3.0, adjusted by o-phosphoric acid) and methanol, at a flow rate of 0.8mL/min in a gradient elution mode and then the separated peaks were scanned at a wavelength of 225.0nm. To assess the greenness profile, three distinct methodologies were applied.

Clinical observation on Tongdu Tiaoqi acupuncture combined with warming acupuncture for postoperative urinary retention

To compare the therapeutic effect of Tongdu Tiaoqi acupuncture (acupuncture for unblocking governor vessel and regulating qi ) combined with warming acupuncture, Tongdu Tiaoqi acupuncture, abdominal moxibustion and oral tamsulosin hydrochloride sustained release capsule on postoperative urinary retention. A total of 120 patients with postoperative urinary retention were randomized into an acupuncture-moxibustion group, an acupuncture group, a moxibustion group and a medication group, 30 cases in each group. Tongdu Tiaoqi acupuncture combined with warming acupuncture were applied in the acupuncture-moxibustion group. Tongdu Tiaoqi acupuncture was applied at Baihui (GV 20), Shuigou (CV 26) etc. in the acupuncture group. Moxibustion was applied at Qihai (CV 6), Guanyuan (CV 4), Shuidao (ST 28) and Sanyinjiao (SP 6) in the moxibustion group. Tamsulosin hydrochloride sustained release capsule was given orally in the medication group. The treatment was once a day, and 5-day treatment was required in each group. Before and after treatment, the residual urine volume of bladder, the visual analogue scale (VAS) score and the time of first urethral catheter removal were observed, and the clinical efficacy was compared in the 4 groups. After treatment, the residual urine volume of bladder was decreased compared before treatment in the 4 groups (P<0.05), and that in the acupuncture-moxibustion group was less than the other 3 groups (P<0.05). After treatment, the VAS scores were decreased compared before treatment in the acupuncture-moxibustion group, the acupuncture group and the moxibustion group (P<0.05), and those in the 3 groups were lower than the medication group (P<0.05). The time of first urethral catheter removal in the acupuncture-moxibustion group was earlier than the other 3 groups (P<0.05). The total effective rate was 93.3% (28/30) in the acupuncture-moxibustion group, which was superior to 63.3% (19/30) in the acupuncture group, 60.0% (18/30) in the moxibustion group and 66.7% (20/30) in the medication group (P<0.05). The therapeutic effect of Tongdu Tiaoqi acupuncture combined with warming acupuncture on postoperative urinary retention is superior to simple acupuncture, abdominal moxibustion and tamsulosin hydrochloride sustained release capsule.

Identification and Determination of Related Substances in Tamsulosin Hydrochloride Sustained-Release Capsules

Tamsulosin hydrochloride sustained-release capsules contained core-shell structure based pellets with tamsulosin hydrochloride as middle layer and the weight of excipients was 800 times more than tamsulosin hydrochloride. Therefore, the extraction should release the related substances of tamsulosin hydrochloride from the pellets and minimize the degradation of tamsulosin hydrochloride during the extraction. And the chromatographic methods should be specific to separate the excipients and their degradation products with the main related substances of tamsulosin hydrochloride. In present study, tamsulosin hydrochloride and its related substances were extracted with sonication after incubated at 50° for 10 min in methanolic sodium hydroxide solution and the dissolved excipients was then precipitate with acetonitrile. The extraction was further separated on a C18 column with gradient elution. Forced degradation proved that 5 possible related substances (retinoschisin 1 to retinoschisin 5) from tamsulosin hydrochloride capsules could be separated with the degradation products from excipients. These related substances were identified with electrospray ionization mass spectrometry/mass spectrometry. The method was also validated and results showed the resolution of main related substances of tamsulosin hydrochloride and the degradation products of excipients was above 1.5. The limit of detection of retinoschisin 4 and retinoschisin 5 equals to 0.1 % of tamsulosin hydrochloride in capsules. The inter-day precisions and recovery were 1.14 %-2.18 % (n=12), 100.0 %-100.8 % (n=9), respectively. With the established method, related substances in tamsulosin hydrochloride sustained-release capsules proved <0.1 % to 0.28 %, with retinoschisin 4 as main related substance. This method could be used for the evaluation of related substances in tamsulosin hydrochloride sustained-release capsules and for its routine quality control and the extraction could be applied to other core-shell structure pellets contained capsules.

Effect of Qianlietongyu Capsule Combined with Tamsulosin Hydrochloride in the Treatment of Prostatitis Complicated with Premature Ejaculation

To discuss the clinical effect of Qianlietongyu capsule combined with tamsulosin hydrochloride in the treatment of prostatitis complicated with premature ejaculation and its impact on the sexual life of patients. We selected 70 patients with prostatitis complicated with premature ejaculation untreated in our hospital from July 2020 to July 2021 and divided them into control group (35 cases) and observation group (35 cases). Treated control group with compound lidocaine cream, after receiving the same treatment as control group, treated observation group with tamsulosin hydrochloride and Qianlietongyu capsule. After 1 mo treatment, observation group possessed lower National Institutes of Health chronic prostatitis symptom index score than control group, but it possessed higher intravaginal ejaculation latency time than control group (p<0.05); after treatment, observation group possessed lower interleukin 8 and tumor necrosis factor alpha levels, higher maximum urinary flow rate and lower bladder residual urine volume than control group (p<0.05). After treatment, the total clinical effective rate and sexual life satisfaction of observation group were 94.29 % (33/35) and 88.57 % (31/35) respectively, those in control group were 77.1 % (27/35) and 68.57 % (24/35) respectively, the differences possessed statistical significance (p<0.05). In clinical treatment of patients with prostatitis complicated with premature ejaculation, tamsulosin hydrochloride combined with Qianlietongyu capsule can significantly improve the effect of patients’ clinical symptoms and related biochemical indicators, improve the overall clinical treatment effect and promote patients to obtain more ideal sexual life satisfaction after treatment.

The effectiveness of tamsulosin hydrochloride with terazosin combination therapy for chronic prostatitis Type-III b.

Objectives:To study the therapeutic effects of combined tamsulosin hydrochloride and terazosin treatment for patients with chronic prostatitis Type-III b.Methods:This study involved 180 patients with chronic prostatitis Type-III b treated between January 2018 and December 2020 conducted at Nanhua Hospital Affiliated to Nanhua University. Patients were randomly divided into two equal groups: one receiving oral terazosin hydrochloride tablets only (control group), and one orally receiving both tamsulosin hydrochloride sustained-release tablets and terazosin hydrochloride tablets (observation group). Outcome measurements included symptom scoring, inflammatory cytokine levels, as well as white blood cell and lecithin body counts in the prostatic fluid.Results:After 30 days of treatment, the observation group showed greater treatment effectiveness (86.67% vs. 73.33%, P<0.05). QLS, USS, PS, and NIH-CPSI symptom scores were lower in the observation group than the control group (P<0.05). No differences in adverse event distribution and incidence were noted. EPS IL-2 increased more in the observation group, while PGE-2, MIP-1α, and MIP-2 decreased more in the observation group. WBC levels decreased more in the observation group, while lecithin body levels increased more in the observation group.Conclusion:The combination of tamsulosin hydrochloride and terazosin for the treatment of patients with chronic prostatitis Type-III b has a significant effect. This approach reduced patient symptoms, lowered inflammatory biomarkers, and generally improved quality of life. This approach appears to have clinical value worthy of future investigation.

Innovative electrochemical electrode modified with Al2O3 nanoparticle decorated MWCNTs for ultra-trace determination of tamsulosin and solifenacin in human plasma and urine samples and their pharmaceutical dosage form.

A simple, cheap, sensitive, and time-saving square wave voltammetric (SWV) procedure using a carbon paste electrode modified with aluminum oxide nanoparticle decorated multi-walled carbon nanoparticles (Al2O3-NPs/MWCNTs/CPE) is presented for the ultra-sensitive determination of tamsulosin (TAM) and solifenacin (SOL), one of the most prescribed pharmaceutical combinations in urology. Characterization of the developed electrode was performed using scanning electron microscopy (SEM), X-ray diffraction (XRD) patterns, energy dispersive X-ray analysis (EDX), transmission electron microscopy (TEM) and FT-IR spectrophotometry. The voltammetric behavior of TAM/SOL was evaluated using Al2O3-NPs in different content and electrode compositions. The use of Al2O3 functionalized MWCNTs as a CPE modifier increased the process of electron transfer as well as improved the electrode active surface area therefore, ultra-sensitive results were acquired with a linear range of 10–100 and 12–125 ng ml−1 for TAM and SOL respectively, and a limit of the detection value of 2.69 and 3.25 ng ml−1 for TAM and SOL, respectively. Interestingly, the proposed method succeeded in quantifying TAM and SOL with acceptable percentage recoveries in dosage forms having diverged concentration ranges and in the biological fluids with very low peak plasma concentration (Cmax). Furthermore, the proposed method was validated, according to the ICH criteria, and shown to be accurate and reproducible.

Formulation Development and Evaluation of Multiple Unit Pellet System of Tamsulosin Hydrochloride

The aim of current work was to grow extended release multiple unit pellets of Tamsulosin Hydrochloride, is an alpha-blocker, used for the healing of the symptoms of a prostate gland condition called BPH (benign prostatic hyperplasia) by extrusion- spheronization (E/S) and solution/suspension layering (S/S) method. In the Extrusion-Spheronization, A ratio of 75:25, 67:33, 64:36 Tamsulosin Hydrochloride and Microcrystalline cellulose were mixed for making drug pellets and extended release (ER) coating was performed in fluidized bed processor (FBP) by solution/suspension layering with Ethyl cellulose (aqueous. dispersion, 4 cps and 7 cps) and Hypromellose (5cps) with different ratios % weight buildups accordingly. In the Solution/suspension layering (S/S) method, Tamsulosin Hydrochloride drug pellets were prepared by layering onto MCC spheres in FBP. These drug pellets were further coated for extended release with HPMC, 5cps and EC, 7cps. In drug coating stage, drug and different binder (Hypromellose, 5 cps) concentrations 8, 10, 12, 14 mg/unit were coated onto the cores for optimization of binder concentration. The weight of MCC spheres were optimized for further formulations. For all the drug coated pellets, ER coating was given with EC, 7cps and HPMC, 5 cps at a coating level of 8% weight by weight. In the extrusion- spheronization (E/S) Optimization of Drug pellets: Among the trials TD3 (Tamsulosin HCl and MCC) showed good mechanical strength with better yield due to increased MCC concentration. Optimization of Extended Release Coating: Optimized TD3 drug pellets were coated with ER coating using water insoluble polymer (Aq.EC 25% dispersion/ EC, 4cps/ EC, 7cps) and water soluble polymer (HPMC, 5cps). Among these polymers, extended release coating was optimized (TD3E14) with the combination of EC, 7cps and HPMC, 5cps at 8% weight build up. In the Solution/Suspension layering: Optimization of binder concentration in drug coating stage: HPMC, 5cps with 12 mg/unit for TF7 was optimized based on %yield. Optimization of MCC spheres in drug coating stage in formulation of ER pellets with different weight drug pellets: The weight of MCC spheres (160, 170, 180, 190 mg/unit) used in the drug coating stage with binder HPMC, 5cps (12 mg/unit). These drug pellets were given with ER coating at 8% weight buildup by using EC, 7cps and HPMC, 5cps. Among these trials, TF7E7 was optimized. Based on the investigations of the present study, conclusions was. formulating low dose, high soluble, BCS class I drug- Tamsulosin Hydrochloride ER formulation by extrusion-spheronization showed flexibility for batch processing and cost effectiveness while solution/suspension layering was process feasible but time consuming due to high drug loading.

Sensitive detection of tamsulosin hydrochloride based on dual-emission ratiometric fluorescence probe consisting of amine-carbon quantum dots and rhodamine B

In this work, amine-carbon quantum dots (CQDs)/rhodamine B (RhB) ratiometric fluorescent (RF) sensor was employed for effective and selective determination of tamsulosin hydrochloride (TMS) based on a dual-emission fluorescence system. Although the function of amine-CQDs is to transfer the specific interaction between TMS and sensor into detectable fluorescence (FL) signals, RhB as a reference unit has been employed to omit internal and external effects. The FL signal was quenched by adding the TMS at 442 nm; nevertheless, it did not change at 569 nm. The material characterization and investigation of the sensing mechanism were done. The optimization of pH, the volumetric ratio of CQDs to RhB, and interaction time parameters were carried out by the one-variable-at-a-time (OVAT) method. The quantitative analysis of the concentration of TMS for this RF sensor in a linear range of 0.446–7.083 μg mL−1 (1.091–17.338 μM) was obtained (R2 = 0.9969, n = 3) under optimum conditions. The limit of detection and quantitation values were estimated to be 0.033 μg mL−1 (0.081 μM) and 0.109 μg mL−1 (0.267 μM), respectively. The repeatability of intra-day and inter-day were less than one percent. This inexpensive RF probe was well applied to determine TMS in biological fluids, and acceptable achievements were obtained.

Features of the Course of Lower Urinary Tract Symptoms in Men with Benign Prostate Hyperplasia and COVID-19

Nowadays men’s health remains in priority. It is given no less attention than to the cardiovascular disorders and cancer. Low urinary tract symptoms (LUTS) accompany most urological diseases and thus are among the most significant syndromes in urology. The medico-social significance of the syndrome puts the development of protocols for its effective detection and drug treatment with long-term efficacy in a number of priority tasks, stimulating the pharmaceutical industry to search for promising candidates.. Restrictions of COVID-19 Pandemic prevent routine procedures by urologists, prompting them to provide online counseling. Under these circumstances, recommendations were made on the strategy and tactics of treatment of urological diseases during a pandemic, as well as strategic directions in the urology of the future were identified. There is a worldwide consensus among experts on minimizing invasive treatments for benign prostatic hyperplasia (BPH) to maximize the protection of medical personnel from the potential risk of COVID-19 infection, while direct contact with patients is not always possible to avoid. It is known from scientific sources that, in contrast to 2019, in 2020 there was a tendency of increase the share of hospitalizations for emergency urological conditions as well as the share of critical conditions, requiring the strengthening of anti-epidemic measures. Over the past year the ability of the SARS-CoV-2 virus to increase the severity of LUTS in men with urological pathology was reported. Furthermore the development of severe urogenital symptoms (COVID-19-associated cystitis) with a high content of proinflammatory cytokines not only in blood plasma but also in urine was registered. This allows to include LUTS «de novo» in the complex of symptoms of COVID-19. Physicians should be aware of urogenital manifestations COVID-19 and include verification of bladder dysfunction to diagnostic program. Strict adherence to WHO and EAU anti-epidemic recommendations and algorithms is extremely important, so we provide online counseling to patients with symptomatic BPH, ensuring the continuity of the specialized treatment process and minimizing direct contact. The proposed method of treatment of moderate to severe BPH associated LUTS involves tamsulosin monotherapy or in combination with finasteride. The results of the use of tamsulosin hydrochloride in cases of LUTS in BPH indicate that the percentage of acute urinary retention in patients receiving monotherapy is almost similar to that when using combination therapy (tamsulosin + finasteride) and is about 7.0% per year. The obtained data suggest that the observation of patients at a distance can be justified only temporarily, but requires strict adherence to an individually designed treatment plan, which should be based on the guidelines of the Ministry of Health of Ukraine and WHO standards. The problem of BPH is a very important issue in modern medicine and requires clear treatment algorithms, with different contexts of modern realities, such as the latest data on certain links in the pathogenesis of urinary tract obstruction caused by BPH on the background of COVID-19.

Separation and Simultaneous Quantitation of Tolterodine Tartrate and Tamsulosin Hydrochloride in Capsule Formulation by using Stability-Indicating RP-HPLC-DAD Method

In the present work, a precise, accurate and selective stability-indicating RP-HPLC method has been developed and validated according to International Conference on Harmonization guidelines Q2-(R1) for the simultaneous quantitative determination of Tolterodine tartrate and Tamsulosin hydrochloride in bulk and its capsule formulation. The chromatographic separation was achieved on Hypersil octadecyl silane C18 (250 x 4.6mm, 5 μm) column at room temperature and mobile phase comprised of methanol: 0.05 M phosphate buffer, pH 7.0 in the ratio of 90:10 V/V. The flow rate of mobile phase was set at 1.0mL/min and compounds were monitored at 255nm using photodiode array detector. Tamsulosin hydrochloride and Tolterodine tartrate retention time were found to be 4.15±0.2 min and 8.42±0.2 min, respectively. The drug substances and products were subjected to acid hydrolysis, alkali hydrolysis, oxidative hydrolysis, photolytic and thermal degradation. The percent degradation of drugs was calculated in all stressed conditions. The analytical method validation parameters such as linearity, accuracy, precision, detection limits, quantitation limits and robustness indicate that drug substances and products were efficiently separated in present of their degradants and successfully applied for the routine analysis of Tolterodine tartrate and Tamsulosin hydrochloride in bulk and its capsule formulation in the quality control laboratory.

Comparison of effects of tamsulosin and silodosin on subfoveal choroidal thickness and pupil size diameters in patients with prostatic hyperplasia

To compare the effects of selective α-1 adrenoceptor antagonists on subfoveal choroidal thickness (SFCT) and pupil diameter size (PDS). This prospective study included 87 patients diagnosed with benign prostatic hyperplasia who were treated with tamsulosin hydrochloride (n = 41) or silodosin (n = 46). SFCT measurements were obtained using spectral domain optic coherence tomography (SD-OCT), and PDS measurements were obtained under mesopic, photopic and scotopic conditions using a photography-based topography system. SFCT and PDS were evaluated at baseline and 3-, 6- and 12-mo follow-ups. The initial mean SFCT was 270.53 ± 21.48µm in tamsulosin group and 271.95 ± 24. 73 in silodosin group (P = 0.078). There was no statistically significant change in SFCT at the 3-mo visit. At the 6-mo follow-up, the mean SFCT was 281.34 ± 22.09µm in tamsulosin group and 272.5 ± 22.4µm in silodosin group. At the 12th month, the mean SFCT in tamsulosin group was 290.80 ± 17.27µm, and it was 270.80 ± 13.14µm in silodosin group. There was statistically significant difference in at 6th and 12-mo visits (P = 0.014 and P = 0.00). During the follow-up, both drugs induced a similar significant decrease in PDS under all conditions. Tamsulosin hydrochloride caused a significant increase in SFCT. In contrast, SFCT did not increase in silodosin group. The decreases in PDS achieved using both drugs were similar. This should be kept in mind when choroidal disease and its response to treatment are followed by CT imaging.

Clinical efficacy evaluation and prevention of adverse reactions in a randomized trial of a combination of three drugs in the treatment of cancerous pudendal neuralgia.

To explore the clinical efficacy, safety, and prevention of major adverse reactions of the non-steroidal anti-inflammatory drug celecoxib combined with OxyContin and Pregabalin in the treatment of cancerous pudendal neuralgia. A total of 51 patients presenting with pelvic malignancies with cancerous pudendal neuralgia were selected, and random number table method was used to allocate them to either the experimental group (n=27) or control group (n=24). The control group was treated with OxyContin combined with Pregabalin, and the experimental group was treated with Celecoxib on the basis of the control group. At 24 hours after treatment, the clinical effective rate of the experimental group was 92.6%, which was significantly higher than the 66.7% of the control group (P<0.05). The numerical rating scale (NRS) scores of the 2 groups of participants on the 7th and 14th days after treatment were lower than before treatment (P<0.05), and the NRS scores of the participants in the experimental group had decreased more significantly. At the same time, the average daily consumption of OxyContin on the 7th and 14th day of the experimental group was lower than that of the control group (P<0.05). Compared with the control group, the incidence of constipation and dysuria in the experimental group was significantly reduced (P<0.05). Co-occurring in both groups during treatment, 10 participants with urinary dysfunction were treated with tamsulosin hydrochloride sustained-release capsules, no urinary retention occurred, catheterization was avoided, tamsulosin hydrochloride sustained-release capsules could be stopped after 1 week, and urination was smooth (P<0.05). After treatment, the quality of life of the 2 groups of participants had improved compared to before treatment, and the improvement was more significant in the experimental group. When treating patients with cancerous pudendal neuralgia with OxyContin and Pregabalin, the addition of celecoxib has a significant effect, which can effectively improve the patient's pain, improve their quality of life to a certain extent, and reduce the consumption of OxyContin. Lowering the dose of OxyContin reduces the occurrence of adverse reactions related to the drug, especially the incidence of constipation and urinary retention. Tamsulosin hydrochloride sustained-release capsules can effectively relieve urinary disorders caused by OxyContin. Chinese Clinical Trial Registry ChiCTR2100046045.

Efficacy of Phloroglucinol Tamsulosin Combination Therapy for Medical Expulsion of Lower Ureteral Calculi and Influence on Patients’ Cys-C Level

Objective: Phloroglucinol is a myotropic, non-atropine and non-papaverine smooth muscle antispasmodic which directly acts on the smooth muscles of the gastrointestinal tract and the urogenital tract with no anticholinergic effect, no symptoms like xerostomia, visual impairment, dysuria, hypotension, increased heart rate, and arrhythmia etc. To investigate the efficacy of phloroglucinol tamsulosin combination therapy for medical expulsion of lower ureteral calculi and influence on patients’ Cys-C level. Methods: Equally randomized 136 patients with lower ureteral calculi in our hospital into mono therapy group (phloroglucinol alone) and combination therapy group (additional tamsulosin was advised). The expulsion rate, expulsion time, stone diameter and levels of IL-10, CRP, NGAL, Cys-C, KIM-1 were compared between two groups, also with the effectiveness and the rate of adverse reactions. Results: The combination therapy group showed higher expulsion rate (P 0.05). Conclusions: Phloroglucinol tamsulosin combination therapy had clear advantages on medical expulsion of lower ureteral calculi in respect of higher expulsion rate and elevated IL-10, CRP, NGAL, Cys-C and KIM-1 levels with larger stone diameter in a shorter time.

Application of reusable flat-membrane in electro-membrane extraction for tamsulosin hydrochloride determination in cleaning validation samples of sterile production line equipment by RP-HPLC

In order to ensure compliance with the current Good Manufacturing Practice (cGMP), cleaning process of pharmaceutical manufacturers should be validated. This study was aimed to utilize a reusable flat-membrane in the electromembrane extraction (EME) for isolation of tamsulosin hydrochloride (TMS) from rinse samples of sterile production of pharmaceutical line. Moreover, validation of mentioned method was done. The residual concentration of TMS was determined by RP-HPLC. Effective parameters such as pH, applying voltage and extraction time were optimized individually. Optimum conditions were found 12, 100 V and 10 min for pH, applying voltage and extraction time, respectively. Figures of merit were calculated under optimum conditions, therefore, linear range and limit of detection (LOD) were obtained 0.5-1000 ng mL−1 with a good coefficient of determination (R2=0.9901) and 0.05 ng mL−1, respectively. Last but not least, RSD of determination was found 0.67% which shows a satisfactory repeatability. According to the obtained results, proposed method is a precise, accurate, relatively fast and applicable route to determine TMS concentrations in rinse samples.

Crystal structure of tamsulosin hydrochloride, C20H29N2O5SCl

The crystal structure of tamsulosin hydrochloride has been solved and refined using synchrotron X-ray powder diffraction data and optimized using density functional techniques. Tamsulosin hydrochloride crystallizes in space groupP21(#4) witha= 7.62988(2),b= 9.27652(2),c= 31.84996(12) Å,β= 93.2221(2)°,V= 2250.734(7) Å3, andZ= 4. In the crystal structure, two arene rings are connected by a carbon chain oriented roughly parallel to thec-axis. The crystal structure is characterized by two slabs of tamsulosin hydrochloride molecules perpendicular to thec-axis. As expected, each of the hydrogens on the protonated nitrogen atoms makes a strong hydrogen bond to one of the chloride anions. The result is to link the cations and anions into columns along theb-axis. One hydrogen atom of each sulfonamide group also makes a hydrogen bond to a chloride anion. The other hydrogen atom of each sulfonamide group forms bifurcated hydrogen bonds to two ether oxygen atoms. The powder pattern is included in the Powder Diffraction File™ as entry 00-065-1415.