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Background: Benign prostatic hyperplasia (BPH) is common amongst the elderly. Even after transurethral resection of prostate (TURP), retention of urine may persist in some leading to significant morbidity adversely affecting the quality of life. The role of alpha blockers in this situation as a combination is unclear. The present study was conducted to evaluate and compare the efficacy of tamsulosin versus tamsulosin and deflazacort in relieving the postoperative retention of urine following TURP. Methods: After obtaining ethics approval and written informed consent, 72 patients satisfying the eligibility criteria were included. After TURP, patients with urinary retention following catheter removal were randomized into group A (tamsulosin hydrochloride) and group B (tamsulosin hydrochloride and deflazocort). baseline international prostate symptom score (IPSS) score was done to assess quality of life and findings of radiological investigations were noted. Thereafter, medical therapy was done as per assigned group and postoperative findings were documented and analyzed. Results: Both the groups were similar in terms of demographic characteristics and baseline characteristics. The relief of symptoms was significantly more in group B along with lower IPSS score and residual volume. Conclusions: We recommend addition of deflazacort to tamsulosin hydrochloride as medical therapy for the management of postoperative retention of urine (POUR), especially following TURP.
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Tamsulosin hydrochloride (TSH) is a selective α
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OBJECTIVE:To observe the clinical efficacy of qianliexin combined with tamsulosin hydrochloride and finasteride in the treatment of elderly benign prostatic hyperplasia.METHODS:Ninety-four patients diagnosed as benign prostatic hyperplasia in our hospital during May.2012-Oct.2014 were selected and divided into observation group (48 cases) and control group (46 cases) according to even and odd admission number.Both groups received Finasteride tablet 5 mg,po,qd.Basedon this,control group was additionally given Tamsulosin hydrochloride sustained-release capsules 0.2 mg,po,qd;observation group was additionally given Qianliexin capsules 2.5 g,po,tid,on the basis of control group.Clinical efficacies of 2 groups were observed as well as IPSS,BS,IIEF-5 score,ultrasonic measurement indexes and TCM syndrome score before and after treatment.RESULTS:Clinical total response rate of observation group was 93.75％,which was significantly higher than 76.09％ of control group,with statistical significance (P＜0.05).Before treatment,there was no statistical significance in IPSS,BS,IIEF-5 score,ultrasonic measurement indexes and TCM syndrome score between 2 groups (P＞0.05).After treatment,IPSS and BS score,prostate volume (PV),residual urine(RU),each item score and total score of TCM syndrome were significantly decreased in 2 groups,while IIEF-5 score and Qmax were increased significantly;the observation group was significantly better than the control group,with statistical significance (P＜0.05).CONCLUSIONS:Qianliexin combined with tamsulosin hydrochloride and finasteride shows significant therapeutic effi cacy for elderly benign prostatic hyperplasia,and is helpful to improve prostate symptoms and TCM syndromes,reduce PV and RU,and improve sexual function.
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Objective To study the effect of urine stone pills combined with tamsulosin hydrochloride sustained-release capsules in the treatment of chronic prostatitis with prostatic calculi. Methods 76 patients with chronic prostatitis with prostate stones who had been hospitalized were treated as 76 patients in this study. A total of 38 patients in a single group were treated with tylosine hydrochloride sustained-release capsules. 38 patients in the combined group were treated with Urethomide Pill on the basis of a single group of patients. The chronic prostatitis symptom index (NIH-CPSI) Clinical efficacy, white blood cell levels in prostatic fluid and the incidence of adverse reactions. Results The total effective rate was 94.74 % in the combined group, which was significantly lower than that in the single group (76.32 %)(P<0.05); the NIH-CPSI and prostatic fluid in the combined group were significantly lower than those in the single group(P<0.05), the incidence of adverse reactions in a single group was 7.89 %, and there was no significant difference between the combined group(5.26 %). Conclusion The treatment of chronic prostatitis with prostatic calculi is significant and feasible.
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Objective To study the effect of urine stone pills combined with tamsulosin hydrochloride sustained-release capsules in the treatment of chronic prostatitis with prostatic calculi. Methods 76 patients with chronic prostatitis with prostate stones who had been hospitalized were treated as 76 patients in this study. A total of 38 patients in a single group were treated with tylosine hydrochloride sustained-release capsules. 38 patients in the combined group were treated with Urethomide Pill on the basis of a single group of patients. The chronic prostatitis symptom index (NIH-CPSI) Clinical efficacy, white blood cell levels in prostatic fluid and the incidence of adverse reactions. Results The total effective rate was 94.74 % in the combined group, which was significantly lower than that in the single group (76.32 %)(P<0.05); the NIH-CPSI and prostatic fluid in the combined group were significantly lower than those in the single group(P<0.05), the incidence of adverse reactions in a single group was 7.89 %, and there was no significant difference between the combined group(5.26 %). Conclusion The treatment of chronic prostatitis with prostatic calculi is significant and feasible.
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Objective To investigate the efficacy of tamsulosin hydrochloride combined with clear stasis and kidney decoction on chronic prostatitis and its influence on immune function and urine flow rate. Methods In this study, 115 patients with chronic prostatitis were selected and divided into treatment group (58 patients) and control group (57 patients) according to the random number table method.The control group used tamsulosin hydrochloride treatment, and the treatment group was treated with clear stasis and kidney decoction on the basis of the control group.The patients in two groups were treated continuously for 4 weeks. The clinical efficacy was evaluated and compared, the changes of immune function, free flow rate and maximum urinary flow rate were measured and compared between two groups.Results The total effective rate of the treatment group was significantly higher than that of the control group:94.83%(55/58)vs.78.95%(45/57)P<0.05.The levels of IgA and IgG before treatment in two groups had no significant differences(P>0.05).After treatment, the levels of IgA and IgG in two groups significantly decreased compared with those before treatment(P<0.05), and the levels of IgA and IgG in treatment group were significantly lower than those in control group(P<0.05).The levels of NIH-CPSI scores and WBC before treatment in two groups had no significant differences (P > 0.05). After treatment, The levels of NIH-CPSI scores and WBC significantly decreased compared with those before treatment(P<0.01), and the levels of NIH-CPSI scores and WBC in treatment group were significantly lower than those in control group (P < 0.01). After treatment lecithin (+- ++) and (+++- +++++) in treatment group was 3,55 cases, in control group was 12,45 cases, and there was significant difference (χ2= 6.392, P = 0.011). Before treatment, the levels of free urine flow rate, maximum urine flow rate, maximum urine flow rate time and residual urine volume in two groups had no significant differences(P>0.05). After treatment, the levels of free urine flow rate and maximum urine flow rate in two groups significantly increased, the levels of maximum urine flow rate time and residual urine volume in two groups significantly decreased, and there were significantly differences compared those before treatment (P < 0.05).The levels of free urine flow rate, maximum urine flow rate, maximum urine flow rate time and residual urine volume between two groups had significant differences after treatment(P<0.01).The adverse reaction rate in control group and treatment group was 3.51%(2/57),6.90%(4/58), and there was no significant difference(χ2=0.414,P=0.667).Conclusions Tamsulosin hydrochloride combined with clear stasis and kidney decoction in patients with chronic prostatitis can significantly relieve the clinical symptoms and improve the immune function of the local prostate, and the effect is exact.
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<p><b>OBJECTIVE</b>To observe the clinical effects differences and partial mechanism for chronic nonbacterial prostatitis (CNP) among drug oil moxibustion, simple moxibustion, and conventional western medicine.</p><p><b>METHODS</b>A total of 120 patients who met the criteria of inclusion were randomly assigned into a drug oil moxibustion group, a moxibustion group and a western medication group, 40 cases in each one. Moxibustion was used at Guanyuan (CV 4), Zhongji (CV 3), Qihai (CV 6) and bilateral Yinlingquan (SP 9), Sanyinjiao (SP 6), Shenshu (BL 23), Mingmen (GV 4), Pangguangshu (BL 28), Ciliao (BL 32), and Zhibian (BL 54), etc. The same moxibustion was used at the same acupoints in the drug oil moxibustion group after external application of medicated oil. Thirty min treatment was used once a day in alternated abdomen and back. In the western medication group, oral tamsulosin hydrochloride capsules were applied once a day, one capsule at a time. All the treatment was given for 30 days. Chronic prostatitis symptom index from National Institutes for Health (NIH-CPSI), the contents of Zinc (Zn) and C-reactive protein (CRP), as well as the number of white blood cells (WBC) and density of lecithin bodies were observed before and after treatment and 1 month after treatment. The effects were evaluated after treatment.</p><p><b>RESULTS</b>After treatment, the total effective rate of the drug oil moxibustion group was 90.0% (36/40), which was significantly higher than 72.5% (29/40) of the moxibustion group and 62.5% (25/40) of the western medication group (both<0.05). After treatment and at follow-up in the three groups, the NIH-CPSI scores were lower than those before treatment (all<0.05), and those in the drug oil moxibustion group were lower than the results in the moxibustion group and the western medication group (all<0.05). The contents of Zn in the three groups were higher than those before treatment (all<0.05), with better results in the drug oil moxibustion group (all<0.05), and higher Zn contents in the moxibustion group compared with those in the western medication group (both<0.05). The CRP levels were lower than those before treatment (all<0.05), and those in the drug oil moxibustion group were better than those in the moxibustion group and western medication group (all<0.05). The CRP contents in the moxibustion group were lower than those in the western medication group (both<0.05). The number of WBC were lower than those before treatment (all<0.05), with better results in the drug oil moxibustion group (all<0.05). The concentrations of lecithin were higher than those before treatment (all<0.05), with better results in the drug oil moxibustion group (all<0.05).</p><p><b>CONCLUSIONS</b>The clinical effect of drug oil moxibustion is better than those of simple moxibustion and western medicine, which has advantages in improving clinical symptoms, Zn, the density of lecithin body and decreasing CRP content and the number of WBC.</p>
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Objective:To explore the clinical effect ofpaishitang combined with tamsulosin hydrochloride on the patient with up per urinary calculi after extracorporeal shock wave lithotripsy (ESWL).Methods:120 cases with upper urinary calculi in our hospital from January 2015 to September 2016 were selected and divided into two groups according to the random number table,60 cases in each group.ESWL was given to both groups of patients and provided with tamsulosin hydrochloride postoperation,then paishitang were additionally given to the patients in the observation group.The clinical effect and changes of serum creatinine (Scr),neutrophil gelatinase as sociated lipocalin (NGAL),cystatin C (Cys-C) and glomerular filtration rate (GFR) levels before and after treatment were compared between two groups.Results:The total effective rate of observation group was 96.67％,which was 86.67％ in the control group,no signifi cant difference was found in the total effective rate between the two groups(P＜0.05).The stone discharge rate was 95.00％ in the observation group,which was significantly higher than that of the control group (P＜0.05);the incidence rate of renal colic was 6.67％,which was significantly lower than that of the control group(P＜0.05),the stone discharge time and the duration of hematuria were significantly shorter than those in the control group (P＜0.01).There was no significant difference in the recurrence rate between the two groups within one year (P＞0.05).The serum NGAL and Cys-C levels of both groups were gradually increased while the GFR levels were gradually decreased on the 1st,2nd day postoperation,but all the index mentioned above gradually recovered on the 3rd day postoperation.The levels of NGAL and Cys-C in the observation group were significantly lower than those in the control group on the 1st,3rd day postoperation while the GFR was significantly higher in the observation group than those of control group on the 1st,3rd day postoperation(P＜0.01).No significant difference was found in the Scr at different time points postoperation between two groups(P＞0.05).Conclusion:Paishitang combined with tamsulosin hydrochloride had significant clinical effect on thpatient with upper urinary calculus after ESWL and could effectively improve the renal injury induced by ESWL.
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Tamsulosin hydrochloride is widely used for the treatment of lower urinary tract symptoms of benign prostatic hyperplasia ,requiring long-term medication .It reduces adverse reactions of hypotension and dizziness by rapid absorption from oral intake .The sustained-release (SR) formulation is recommended for clinical application .Currently in domestic and foreign market,SRproductsmainlyincludeSRcapsulesandSRtablets,likeFlomaxR○ andHarnalR○ .Thedomesticmarketmainlyuses the originally developed Harnal R○ SR capsules .In accordance with the drug′s potential market ,more and more SR studies have been done .This article reviews the research progress of tamsulosin hydrochloride sustained-release preparation .
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OBJECTIVE: To study the preparation technology of tamsulosion hydrochloride sustained-release capsules and investigate the release degree in vitro. METHODS: The pellets containing tamsulosin hydrochloride were prepeared in the fluid-bed using bottom gush medicine. Then, it was coated with ethylcellulose aqueous dispersion (surelease), and in the following procedures, water-based acrylic resin enteric system (Acryl-EZE®) was used as coating material, hydroxypropylmethylcellulose E6 (HPMCE6) was considered as porous agent by fluid-bed. Based on the release degree in vitro, prescription influence factors were evaluated, as well as drug releases curve was compared, according to the single factor experiment. RESULTS: The preparation technology referred in our research was available to make tamsulosin hydrochloride sustained-release capsules, and drug release curve of self-made sustained-release capsules was similar to the commercial one. Additionally, the products reproducibility of intra-batch and inter-batch was excellent. CONCLUSION: The tamsulosin hydrochloride sustained-release capsules prepared in this study exhibited ideal sustained-release characteristics in vitro. The formulation is reasonable and feasible. It is suitable for industrial production.
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Objective To prepare tamsulosin hydrochloride sustained-release pellet by coating with acrylic copolymers. Methods EUDRAGIT® NE 30 D was used as the main sustained-release material, EUDRAGIT® L 30 D-55 and Methocel® E3 were used as release adjust agent; a one layer sustained-release coating was done for tamsulosin hydrochloride-loaded pellet in bottom spray fluid bed. A three factor, three-level Box-Behnken design was used to optimize the percentages of EUDRAGIT® L 30 D-55 and Methocel® E3 in the total dry polymers and the weight gain of total dry polymers as the three nonlinear factors, which mainly influenced drug release of the pellets in the formula of sustained-release coating layer. In-vitro cumulative drug release after 2 h, 3 h and 5 h was tested and the following target range:2 h 12%-39%, 3 h 44%-70% and 5 h>70% were set for optimization. Results The formulation and process of one layer sustained-release coating, which was synergistically controlled by the three materials based on acrylic copolymers, was determined after optimization:the total dry polymers were applied with a weight gain of 12% on drug pellets, with EUDRAGIT® L 30 D-55 dry polymers and Methocel® E3 being 7% and 2% of the total dry polymers, respectively. The sustained-release pellets coated with the optimized formulation provided a release profile that was close to the predicted value and similar to that of the commercial product Harnal® capsule pellets by f2 similarity factor comparison (f2 values of three batches were 71,73 and 80). Conclusion The established formulation and process is a simple and reproducible method to prepare tamsulosin hydrochloride sustained-release pellets with good stability.
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Objective:To establish the conformity test model for tamsulosin hydrochloride sustained-release capsules by near infrared absorption spectroscopy. Methods:Tamsulosin hydrochloride sustained release capsules were scanned within the range of 4 200-12000 cm-1 to establish the conformity test model. Results:The spectral coverage of 9 000-7 500 cm-1 , 6 900-5 600 cm-1 and 5 000-4 250 cm-1 were chosen, and the second derivative vector normalization was used to detect the samples. The CI value was 7. The conformity test model could distinguish authentic and false tamsulosin hydrochloride sustained-release capsules. Conclusion:The method is simple, sensitive, accurate and fast, and can be used in the identification of tamsulosin hydrochloride sustained-release capsules.
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ObjectiveTo study the efficacy of different doses of tamsulosin hydrochloride sustained release tablets for treatment of premature ejaculation (PE). MethodsEighty PE patients from September 2010 to January 2011 were divided into two groups randomly,the 0.2 mg dose group and the 0.4 mg dose group.The therapeutic effect was assessed by the changes of the patients' CIPE-5 scores.ResultsThe intra-vaginal ejaculation latency time (IELT) of the two groups were (0.98 ± 0.47 ) and ( 0.89 ± 0.47 ) min respectively before treatment,and (4.40 ± 1.86 ) and (6.40 ± 5.10) min respectively after treatment.There were significant differences ( P ＜ 0.01 ).As for satisfaction degree of sexual life,lessening the patients' sexual anxiety and nervousness,and decreasing the difficulty in retarding ejaculation,the group of 0.4 mg had better effect than the other group.ConclusionLarge dose of tamsulosin hydrochloride sustained release tablets could prolong IELT and increase the sexual satisfaction.
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OBJECTIVE: To optimize the formulation of tamsulosin hydrochloride orally disintegrating tablets by orthogonal experiment and to determine its dissolution and stability.METHODS: The formulation of tablets was optimized by orthogonal experiment based on 3 factors: the proportions of microcrystalline cellulose(A),lactose(B),and the cross-link sodium starch glycolate(C) and 3 indexes: disintegrating time(td),the wet time(t) and the suspend stability(?A).The dissolution of the tablets was determined and its stability in different condition was followed for 24 months.RESULTS: To optimum preparation technical conditions for the tablets were as follows: the proportions of A,B,and C were 30%,15% and 10%,respectively.The tablets disintegrated completely within 30 s,with mean td at(20.1?4.2) s,t(24.2?2.1) s,and ?A 0.002 4.No obvious change was noted in appearance and content for the samples within 24 mouths.CONCLUSION: The tamsulosin hydrochloride orally disintegrating tablets were up to the standards of Chinese Pharmacopeia.
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OBJECTIVE:To prepare tamsulosin hydrochloride sustained-released tablets and to investigate the in vitro drug release feature and mechanism of the tablets.METHODS:Tamsulosin hydrochloride sustained-released tablets were prepared with HPMC as matrix.The effects of multiple factors on the in vitro drug release rate were evaluated with accumulative release rate as index,and the slow release feature was compared between the sustained tablets and the common tablets.RESULTS:The drug release rate was predominantly influenced by the amount of HPMC and the tablet compressing pressure,and the optimum values of the two were 25% and 8kg～11kg,respectively.The accumulative release rates of the sustained tablets and the common tablets at 0.5h were 10% and 50%,respectively.CONCLUSIONS:The sustained-release tablets had a better sustained release efficacy as compared with common tablets,and the drug release feature of the sustained tablets was the synergistic action of the tamsulosin hydrochloride diffusion and matrix degradation and the release pattern obeyed non-Fick diffusion mechanism.
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OBJECTIVE:To analyze the structure of tamsulosin hydrochloride by spectral data.METHODS:The spectra of 1H NMR,DEPT,13C NMR,1H-1HCOSY,HMQC、HMBC,MS,FT-IR and UV of tamsulosin hydrochloride were determined and interpreted.RESULTS:All the 1H NMR and 13C NMR chemical shifts were assigned rationally.The peaks of functional group vibrations(FT-IR),the main fragment peaks(MS)and UV characteristic absorption were all explained reasonably.CONCLUSION:The above analytical data of all kinds of spectra coincided with the structure of tamsulosin hydrochloride.