多沙唑嗪缓释片改善老年良性前列腺增生患者下尿路症状的观察

Efficacy and security of sustained-release doxazosin in the treatment of lower urinary tract symptoms inelderly patients with benign prostatic hyperplasia

目的评价老年科良性前列腺增生患者使用多沙唑嗪缓释片治疗下尿路症状的有效性及安全性。方法全国16个地区、86家医院、4063名年龄≥60岁的老年科良性前列腺增生患者根据用药情况分为4组，各组患者加用或换用多沙唑嗪缓释片治疗4周，分析治疗前后国际前列腺症状评分、生活质量评分、最大尿流率的变化和药物不良反应的发生率。结果应用多沙唑嗪缓释片治疗后，各组患者下尿路症状均得到明显改善，国际前列腺症状评分依次下降至（12．3±4．6）分、（12．2±4．6）分、（10．9±4．5）分和（9．9±4．4）分；生活质量评分依次下降至（2．8±0．9）分、（2．8±1．0）分、（2．5±0．9）分及（2．4±0．9）分；最大尿流率依次提高至（16．4±4．5）ml／s、（15．0±4．7）ml／S、（15．3±4．8）ml／s及（16．7±5．7）ml／s；以上差异均有统计学意义（P〈0．001）。药物不良反应发生率为1．97％，常见的不良反应依次为头晕43例（1．06％）、体位性低血压10例（0．25％）、低血压8例（0．20％）等。结论多沙唑嗪缓释片可以改善良性前列腺增生患者下尿路症状，提高其生活质量，并具有良好的耐受性及依从性。

Objective To evaluate the efficacy and safety of doxazosin gastrointestinal therapeutic system （DOX GITS） in the treatment of lower urinary tract symptoms （LUTS） in patients with benign prostatic hyperplasia （BPH）. Methods A total of 4063 BPH patients aged ≥60 years from 16 regions and 86 hospitals were enrolled in this study. Patients were divided into 4 groups according to the previous medication： group 1 （treated with al receptor blocker but non-doxazosin）, group 2 （treated with drugs without al receptor blocker）, group 3 （without treatment）, group 4 （treated with cd receptor blocker but non-doxazosin and other drugs for BPH）. Patients received DOX GITS with a flexible-dosage for 4 weeks. International prostate symptom score （IPSS）, quality of life （QOL）, maximum urine flow rate （Qmax） and adverse effects were assessed. Results After 4 weeks of the treatment, lower urinary tract symptoms were significantly improved in the 4 group. IPSS in the 4 groups were decreased to （12.3±4.6） scores, （12.2±4.6） scores, （10.9±4.5） scores and （9.9±4.4） scores successively. QOL in the 4 groups were improved to （2.84±0.9） scores, （2.8 ±1.0） scores, （2.5±0.9） scores and （2.4±0.9） scores successively. Q in the 4 groups were increased to （16.4!4.5） ml/s, （15.0±4.7） ml/s, （15.3±4.8） ml/s and （16.7± 5.7） mi/s successively. There were significant differences in IPSS, QOL and Qmax of the 4 groups between before and after the treatment （P〈0.001）. Adverse events were reported in 64%0 of patients. The most common adverse events were dizziness of 43 cases （1.06%）, postural hypotension of 10 cases （0. 25%） and hypotension of 8 cases （0. 200%）. Conclusions DOX GITS can significantly improve LUTS and quality of life in BPH patients with a good tolerance and compliance.