The structures of solid dosage forms determine their release behaviors and are critical attributes for the design and evaluation of the solid dosage forms.Here,the 3D structures of doxazosin mesylate sustained-release...The structures of solid dosage forms determine their release behaviors and are critical attributes for the design and evaluation of the solid dosage forms.Here,the 3D structures of doxazosin mesylate sustained-release tablets were parallelly assessed by micro-computed tomography(micro-CT).There were no significant differences observed in the release profiles between the RLD and the generic formulation in the conventional dissolution,but the generic preparation released slightly faster in media with ethanol during an alcohol-induced dose-dumping test.With their 3D structures obtained via micro-CT determination,the unique release behaviors of both RLD and the generic were investigated to reveal the effects of internal fine structure on the release kinetics.The structural parameters for both preparations were similar in conventional dissolution test,while the dissolutions in ethanol media showed some distinctions between RLD and generic preparations due to their static and dynamic structures.Furthermore,the findings revealed that the presence of ethanol accelerated dissolution and induced changes in internal structure of both RLD and generic preparations.Moreover,structure parameters like volume and area of outer contour,remaining solid volume and cavity volumewere not equivalent between the two formulations in 40%ethanol.In conclusion,the structure data obtained from this study provided valuable insights into the diverse release behaviors observed in various modified-release formulations in drug development and quality control.展开更多
This study sought to investigate the clinical efficacy and safety of combined oral therapy with sildenafil and doxazosin GITS compared to sildenafil monotherapy in treating Chinese patients with erectile dysfunction ...This study sought to investigate the clinical efficacy and safety of combined oral therapy with sildenafil and doxazosin GITS compared to sildenafil monotherapy in treating Chinese patients with erectile dysfunction （ED） and lower urinary tract symptoms secondary to benign prostatic hyperplasia （BPH/LUTS）. The trial was conducted in hospitals in Beijing, Shanghai, Changsha, Wuhan and Guangzhou, five major cities in China. A total of 250 patients diagnosed with ED and BPH/LUTS aged 50-75 years, and who had International Index of Erection Function-5 （IIEF-5） scores ≤ 21 and International Prostate Symptom Score （IPSS） ≥ 10 points, were enrolled and randomly divided into Group A （168 cases; doxazosin GITS 4 mg once daily plus sildenafi125-100 mg on demand） and Group B （82 cases; sildenafi125-100 mg on demand）. Efficacies were evaluated by IIEF-5 and IPSS scores and a quality of life （QoL） questionnaire, and adverse effects were evaluated during the treatment period. There were no statistically significant differences in mean age, and IIEF-5, IPSS and QoL scores pre-treatment between the two groups. After treatment, IIEF-5, IPSS and QoL scores were significantly improved in Group A, while only IIEF-5 scores were significantly improved in Group B compared with pre-treatment. There were no significant differences in side effects between the two groups. The results indicated that combined therapy with sildenafil and doxazosin GITS for the treatment of ED and BPH/LUTS is safe and effective compared to sildenafil monotherapy.展开更多
Objective To explore the effect of doxazosin on rabbit bladder compliance after partial bladder outlet ob- struction. Methods A total of 40 male New Zealand white rabbits were randomized into 4 groups,with 10 rabbits ...Objective To explore the effect of doxazosin on rabbit bladder compliance after partial bladder outlet ob- struction. Methods A total of 40 male New Zealand white rabbits were randomized into 4 groups,with 10 rabbits in each group. Partial bladder outlet展开更多
Objective：To investigate the effect of Longbishu Capsule（癃闭舒胶囊,LBS）,doxazosin,and combination therapy on benign prostatic hyperplasia（BPH）.Methods：A randomized,double-blind,multi-center parallel trial was c...Objective：To investigate the effect of Longbishu Capsule（癃闭舒胶囊,LBS）,doxazosin,and combination therapy on benign prostatic hyperplasia（BPH）.Methods：A randomized,double-blind,multi-center parallel trial was conducted involving 360 patients in hospitals in Beijing（108 cases）,Heilongjiang（90 cases）,Sichuan（90 cases）,Shanghai（72 cases）,China.They were randomly assigned with central randomization method to group A（LBS placebo plus doxazosin）,group B（LBS plus doxazosin）or group C（LBS plus doxazosin placebo）,120 cases for each group.The international prostate symptom score,maximum urinary flow rate,postvoid residual urine volume and prostate volume were measured for evaluating the efficacy of the three treatments.Results：At baseline,there was no significant difference in the measured variables among the three groups.After 12-month treatment,the three groups showed significant improvements in IPSS and maximum urinary flow rate from baseline（P〈0.01）.Although postvoid residual urine volume was not significantly different from the baseline in group A（P〉0.05）,it significantly decreased in group B and C（P〈0.05）.The incidence of adverse events were similar among the three groups.Conclusions：The treatment of LBS alone or LBS plus doxazosin was able to significantly improve IPSS in patients with BPH.The treatments may reduce the increase in prostate volume and postvoid residual urine volume as well.展开更多
目的:探讨甲磺酸多沙唑嗪片联合厄贝沙坦氢氯噻嗪片治疗高血压患者的临床效果。方法:回顾性选取2021年1月—2023年9月泉州市光前医院收治的216例高血压患者作为研究对象,根据治疗方案不同将患者分为对照组与研究组,各108例。单一厄贝沙...目的:探讨甲磺酸多沙唑嗪片联合厄贝沙坦氢氯噻嗪片治疗高血压患者的临床效果。方法:回顾性选取2021年1月—2023年9月泉州市光前医院收治的216例高血压患者作为研究对象,根据治疗方案不同将患者分为对照组与研究组,各108例。单一厄贝沙坦氢氯噻嗪片治疗的设为对照组,甲磺酸多沙唑嗪片联合厄贝沙坦氢氯噻嗪片治疗的设为研究组。比较两组临床疗效、治疗前后血压变异性、血脂、血清细胞因子及不良反应。结果:研究组临床总有效率为98.15%,高于对照组的91.67%,差异有统计学意义(P<0.05);治疗后,两组24 h动脉收缩压变异性(24 h SBPV)、24 h动脉舒张压变异性(24 h DBPV)及血清C反应蛋白(CRP)、肿瘤坏死因子-α(TNF-α)、同型半胱氨酸(Hcy)水平降低,且研究组低于对照组,差异有统计学意义(P<0.05);治疗后,两组血清甘油三酯(TG)、总胆固醇(TC)、低密度脂蛋白胆固醇(LDL-C)水平降低,且研究组低于对照组,两组高密度脂蛋白胆固醇(HDL-C)水平升高,且研究组高于对照组,差异有统计学意义(P<0.05);研究组不良反应率为8.33%,与对照组的6.48%比较,差异无统计学意义(P>0.05)。结论:甲磺酸多沙唑嗪片联合厄贝沙坦氢氯噻嗪片治疗高血压,可调节血压变异性,降低血脂、血清细胞因子水平,疗效显著,且安全性高。展开更多
基金This work was supported by the Key Programfor International Science and Technology Cooperation Projects of China(2020YFE0201700)State Drug Administration key laboratory project(2024HYZX04).
文摘The structures of solid dosage forms determine their release behaviors and are critical attributes for the design and evaluation of the solid dosage forms.Here,the 3D structures of doxazosin mesylate sustained-release tablets were parallelly assessed by micro-computed tomography(micro-CT).There were no significant differences observed in the release profiles between the RLD and the generic formulation in the conventional dissolution,but the generic preparation released slightly faster in media with ethanol during an alcohol-induced dose-dumping test.With their 3D structures obtained via micro-CT determination,the unique release behaviors of both RLD and the generic were investigated to reveal the effects of internal fine structure on the release kinetics.The structural parameters for both preparations were similar in conventional dissolution test,while the dissolutions in ethanol media showed some distinctions between RLD and generic preparations due to their static and dynamic structures.Furthermore,the findings revealed that the presence of ethanol accelerated dissolution and induced changes in internal structure of both RLD and generic preparations.Moreover,structure parameters like volume and area of outer contour,remaining solid volume and cavity volumewere not equivalent between the two formulations in 40%ethanol.In conclusion,the structure data obtained from this study provided valuable insights into the diverse release behaviors observed in various modified-release formulations in drug development and quality control.
文摘This study sought to investigate the clinical efficacy and safety of combined oral therapy with sildenafil and doxazosin GITS compared to sildenafil monotherapy in treating Chinese patients with erectile dysfunction （ED） and lower urinary tract symptoms secondary to benign prostatic hyperplasia （BPH/LUTS）. The trial was conducted in hospitals in Beijing, Shanghai, Changsha, Wuhan and Guangzhou, five major cities in China. A total of 250 patients diagnosed with ED and BPH/LUTS aged 50-75 years, and who had International Index of Erection Function-5 （IIEF-5） scores ≤ 21 and International Prostate Symptom Score （IPSS） ≥ 10 points, were enrolled and randomly divided into Group A （168 cases; doxazosin GITS 4 mg once daily plus sildenafi125-100 mg on demand） and Group B （82 cases; sildenafi125-100 mg on demand）. Efficacies were evaluated by IIEF-5 and IPSS scores and a quality of life （QoL） questionnaire, and adverse effects were evaluated during the treatment period. There were no statistically significant differences in mean age, and IIEF-5, IPSS and QoL scores pre-treatment between the two groups. After treatment, IIEF-5, IPSS and QoL scores were significantly improved in Group A, while only IIEF-5 scores were significantly improved in Group B compared with pre-treatment. There were no significant differences in side effects between the two groups. The results indicated that combined therapy with sildenafil and doxazosin GITS for the treatment of ED and BPH/LUTS is safe and effective compared to sildenafil monotherapy.
文摘Objective To explore the effect of doxazosin on rabbit bladder compliance after partial bladder outlet ob- struction. Methods A total of 40 male New Zealand white rabbits were randomized into 4 groups,with 10 rabbits in each group. Partial bladder outlet
基金Supported by the Project of Science Research for the 11th FiveYear Plan(No.2007BAI20B044)
文摘Objective：To investigate the effect of Longbishu Capsule（癃闭舒胶囊,LBS）,doxazosin,and combination therapy on benign prostatic hyperplasia（BPH）.Methods：A randomized,double-blind,multi-center parallel trial was conducted involving 360 patients in hospitals in Beijing（108 cases）,Heilongjiang（90 cases）,Sichuan（90 cases）,Shanghai（72 cases）,China.They were randomly assigned with central randomization method to group A（LBS placebo plus doxazosin）,group B（LBS plus doxazosin）or group C（LBS plus doxazosin placebo）,120 cases for each group.The international prostate symptom score,maximum urinary flow rate,postvoid residual urine volume and prostate volume were measured for evaluating the efficacy of the three treatments.Results：At baseline,there was no significant difference in the measured variables among the three groups.After 12-month treatment,the three groups showed significant improvements in IPSS and maximum urinary flow rate from baseline（P〈0.01）.Although postvoid residual urine volume was not significantly different from the baseline in group A（P〉0.05）,it significantly decreased in group B and C（P〈0.05）.The incidence of adverse events were similar among the three groups.Conclusions：The treatment of LBS alone or LBS plus doxazosin was able to significantly improve IPSS in patients with BPH.The treatments may reduce the increase in prostate volume and postvoid residual urine volume as well.
文摘目的:探讨甲磺酸多沙唑嗪片联合厄贝沙坦氢氯噻嗪片治疗高血压患者的临床效果。方法:回顾性选取2021年1月—2023年9月泉州市光前医院收治的216例高血压患者作为研究对象,根据治疗方案不同将患者分为对照组与研究组,各108例。单一厄贝沙坦氢氯噻嗪片治疗的设为对照组,甲磺酸多沙唑嗪片联合厄贝沙坦氢氯噻嗪片治疗的设为研究组。比较两组临床疗效、治疗前后血压变异性、血脂、血清细胞因子及不良反应。结果:研究组临床总有效率为98.15%,高于对照组的91.67%,差异有统计学意义(P<0.05);治疗后,两组24 h动脉收缩压变异性(24 h SBPV)、24 h动脉舒张压变异性(24 h DBPV)及血清C反应蛋白(CRP)、肿瘤坏死因子-α(TNF-α)、同型半胱氨酸(Hcy)水平降低,且研究组低于对照组,差异有统计学意义(P<0.05);治疗后,两组血清甘油三酯(TG)、总胆固醇(TC)、低密度脂蛋白胆固醇(LDL-C)水平降低,且研究组低于对照组,两组高密度脂蛋白胆固醇(HDL-C)水平升高,且研究组高于对照组,差异有统计学意义(P<0.05);研究组不良反应率为8.33%,与对照组的6.48%比较,差异无统计学意义(P>0.05)。结论:甲磺酸多沙唑嗪片联合厄贝沙坦氢氯噻嗪片治疗高血压,可调节血压变异性,降低血脂、血清细胞因子水平,疗效显著,且安全性高。
