哈乐治疗103例良性前列腺增生的临床对照研究

目的观察哈乐治疗良性前列腺增生的有效性和安全性。方珐172例良性前列腺增生患者随机分成研究组（哈乐＋非那雄胺）（n=103）和对照组（非那雄胺）（n=69），比较两组治疗前后前列腺症状评分（IPSS）、最大尿流率（Qmax）、残余尿、前列腺体积及血清前列腺特异性抗原（PSA）变化。结果治疗后IPSS研究组下降了（9．8±0．6）分，对照组下降了（6．7±0．7）分，两组间比较差异有显著性（P〈0．05）；用药后两组Qmax[（7．2±0．4）mL／s％（4．1±0．3）mL／s]、残余尿量[（22．7±2．0）mL vs.（18． ±2．2）mL]差异存在显著性（P〈0．05），研究组前列腺体积和血清PSA下降幅度大于对照组，但无显著统计学意义（P〉0．05）。结论哈乐治疗良性前列腺增生可以显著改善患者主观症状及客观指标，且安全、有效。

Controlled clinical study of Harnal on 103 patients with benign prostatic hyperplasia

Objective To observe the treatment effects and safety of Harnal on benign prostatic hyperplasia （BPH）. Methods 172 patients with BPH were randomly assigned into Harnal ＋ Finasteride group （n = 103） and Finasteride group （n = 69）. International Prostate Symptom Score （IPSS）, and the correlated objective symptoms were recorded before and after treatment. The treatment effects and safety of Harnal on BPH patients were further evaluated. Results After treatment, the IPSS decreased by 9.8±0.6 in the Harnal ＋ Finasteride group, while decreased by 6.7 ±0.7 in the Finasteride group, which showed significant difference between the two groups （P 〈 0.05）. There was also significant difference in residual volume of urine, the volume of prostate and Qmax. PSA decreased more in the Harnal ＋ Finasteride group than in the Finasteride group, but without statistical significance （P〉0.05）. Conclusion Harnal could effectively decrease the objective parameters and subjective symptoms. It is safe in the treatment of BPH.