中国临床药理学杂志2017，Vol.33Issue(24)：2562-2565,4.DOI:10.13699/j.cnki.1001-6821.2017.24.002
坦索罗辛胶囊与多沙唑嗪片治疗良性前列腺增生伴下尿路症状的临床研究
Clinical trial of tamsulosin capsule and doxazosin tablet in the treatment of patients with benign prostatic hyperplasia and lower urinary tract symptoms
摘要
Abstract
Objective To observe the clinical efficacy and safety profile of tamsulosin in combination with tolterodine tartrate versus doxazosin plus tolterodine tartrate for the treatment of patients with benign prostatic hyperplasia and lower urinary tract symptoms.Methods A total of 120 patients were randomly divided into control group(n =60) and treatment group(n =60).The control group was given oral doxazosin 4 mg qn and tolterodine tartrate 4 mg qn.The treatment group was given oral administration of tansulosin 0.2 mg qn and tolterodine tartrate 4 mg qn.Both groups were treated for 3 cycles (1 cycle =3 weeks).The clinical efficacy,the international prostate symptom score (IPSS),the irritation score,maximum urinary flow rate (Qmax),quality of life index (QOL),overactive bladder score (OABSS),overactive bladder symptoms and the incidence of adverse drug reactions were compared between the 2 groups.Results After treatment,the total effective rates of the treatment group and the control group were 96.67％ (58 cases/60 cases) and 83.33％ (50 cases/60 cases),respectively,and the difference was statistically significant (P ＜ 0.05).After treatment,the IPSS scores of the treatment group and the control group were (14.08 ± 4.52) and (17.15 ± 4.34)point,the scores of irritation symptoms were (4.47 ± 1.11) and (5.77 ± 1.10) point,the values of Qmax were (14.15 ± 1.72),(13.21 ± 2.16) mL· s-1,QOL scores were (1.38 ±0.99) and (3.27 ± 1.39)point,the OABSS were (8.08 ±2.12) and (13.83 ± 4.37) point,the urination frequencies during the day were (7.52 ± 2.21),(8.68 ± 2.00) times,the nocturnal urination frequencies were (1.40 ± 0.76) and (2.48 ± 1.48) times,and the frequencies of urinary incontinence were (1.00 ± 0.55),(1.90 ± 0.35) times,and the frequencies of urinary urgency were (2.58 ± 1.08),(4.53 ± 0.98) times.There were statistical differences in all the above parameters between the two groups (P ＜0.05).The incidences of adverse reactions in the treatment group and the control group were 5％ (3 cases/60 cases) and 5％ (3 cases/60 cases),respectively,and no significant difference was found between the two groups (P ＞ 0.05).Conclusion Tamsulosin combined with tolterodine tartrate exerted higher efficacy and safety profile compared with doxazosin combined with tolterodine tartrate in treatment of benign prostatic hyperplasia with lower urinary tract symptoms.关键词
坦索罗辛胶囊/多沙唑嗪片/良性前列腺增生/酒石酸托特罗定Key words
tamsulosin capsule/doxazosin tablet/benign prostatic hyperplasia/tolterodine tartrate分类
医药卫生引用本文复制引用
胡文豪,陈光耀,沈立亮,金晓东..坦索罗辛胶囊与多沙唑嗪片治疗良性前列腺增生伴下尿路症状的临床研究[J].中国临床药理学杂志,2017,33(24):2562-2565,4.基金项目
国家自然科学基金资助项目(81370799) （81370799）
