A Randomized, Open-Label, Comparative Study of Efficacy and Safety of Tolterodine Combined with Tamsulosin or Doxazosin in Patients with Benign Prostatic Hyperplasia.
A Randomized, Open-Label, Comparative Study of Efficacy and Safety of Tolterodine Combined with Tamsulosin or Doxazosin in Patients with Benign Prostatic Hyperplasia.
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一项随机的，开放标签的，对良性前列腺增生症患者的甲状腺素和toLterosin和doxazosin结合的疗效和安全性的比较研究。
DOI：
10.12659/msm.896283
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发表时间：
2016-06-04
期刊：
影响因子：
--
通讯作者：
Niu H
中科院分区：
文献类型：
--
作者：
Cao Y;Wang Y;Guo L;Yang X;Chen T;Niu H
良性前列腺增生（BPH）是50岁以上男性的常见疾病，常引起膀胱出口梗阻和下尿路症状（LUTS）。α受体阻滞剂联合毒蕈碱受体拮抗剂可能有改善症状的潜力。本研究旨在评估多沙唑嗪或坦索罗辛联合托特罗定缓释剂（ER）治疗BPH和LUTS患者的疗效和安全性。在一项前瞻性、随机化、开放标签研究（ChiCTR-IPR-15005763）中，220例BPH和LUTS男性患者被分配接受多沙唑嗪4 mg和托特罗定ER 4 mg/天（多沙唑嗪组）或坦索罗辛0. 2 mg和托特罗定ER 4 mg/天（坦索罗辛组）。治疗持续12周。主要终点是国际前列腺症状评分（IPSS）。次要终点是生活质量（QoL）和最大流速（Qmax），在0、6和12周时进行评价，并在0和12周时评估尿动力学参数。共有192名患者完成了试验。基线测量显示两组之间无差异。6周后，两组的IPSS均有所改善，多沙唑嗪组的生活质量明显优于多沙唑嗪组（P=0.01）。12周后，多沙唑嗪组Qmax、IPSS、QoL、膀胱内压（Pves）和膀胱顺应性（BC）均显著优于坦索罗辛组（分别为P=0.03、P<0.001、P<0.001、P=0.027和P=0.044）。α受体阻滞剂联合毒蕈碱受体阻滞剂治疗12周可改善BPH患者的LUTS。
Benign prostatic hyperplasia (BPH), a common disease in men over age 50 years, often causes bladder outlet obstruction and lower urinary tract symptoms (LUTS). Alpha blockers in combination with muscarinic receptor antagonists may have the potential to improve symptoms. This study aimed to assess the efficacy and safety of doxazosin or tamsulosin combined with tolterodine extend release (ER) in patients with BPH and LUTS. In a prospective, randomized, open-label study (ChiCTR-IPR-15005763), 220 consecutive men with BPH and LUTS were allocated to receive doxazosin 4 mg and tolterodine ER 4 mg per day (doxazosin group) or tamsulosin 0.2 mg and tolterodine ER 4 mg per day (tamsulosin group). Treatment lasted 12 weeks. The primary endpoint was the international prostatic symptom score (IPSS). Secondary endpoints were quality of life (QoL) and maximum flow rate (Qmax), which were evaluated at 0, 6, and 12 weeks, and urodynamic parameters assessed at 0 and 12 weeks. A total of 192 patients completed the trial. Baseline measurements showed no differences between the groups. After 6 weeks, IPSS improved in both groups and QoL was significantly better in the doxazosin group (P=0.01). After 12 weeks, Qmax, IPSS, QoL, intravesical pressure (Pves), and bladder compliance (BC) in the doxazosin group were significantly better than in the tamsulosin group (P=0.03, P<0.001, P<0.001, P=0.027, and P=0.044, respectively). Administration of alpha blockers combined with muscarinic receptor blocker for 12 weeks improved LUTS in men with BPH.