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目的评估他达拉非联合标准化药物方案[坦索罗辛和(或)非那雄胺]在治疗良性前列腺增生症(BPH)所致下尿路症状(LUTS)中的临床疗效以及安全性。方法研究纳入成都大学附属医院2015年6月—2016年1月因BPH所致LUTS且接受标准化药物治疗后处于稳定期的患者共62例。患者随机分为两组,每组31例。安慰剂组接受安慰剂及标准化药物治疗方案,即坦索罗辛和(或)非那雄胺;试验组接受他达拉非联合标准化药物治疗方案。治疗后3个月分别记录IPSS评分、最大尿流率(Qmax)以及生活质量评分(QOL)。结果治疗3个月后,试验组较安慰剂组IPSS总分值下降、QOL值下降,P均<0.05;Qmax增加,膀胱残余尿量减少,但两组差异无统计学意义(P>0.05)。患者对药物联用耐受良好,不良反应轻微。结论他达拉非联合BPH标准化药物治疗能安全、有效地改善BHP所致LUTS症状,尤其适合伴有勃起功能障碍(ED)的BPH患者。
Objective To evaluate the clinical efficacy and safety of tadalafil in combination with standardized drug regimens [tamsulosin and / or finasteride] in the treatment of lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH). Methods A total of 62 patients were enrolled in the Affiliated Hospital of Chengdu University from June 2015 to January 2016, with stable LUTS caused by BPH and receiving standardized drugs. Patients were randomly divided into two groups, 31 cases in each group. The placebo group received placebo and standardized drug regimens, tamsulosin and / or finasteride; the study group received tadalafil in combination with a standardized drug regimen. Three months after treatment, IPSS score, maximal flow rate (Qmax) and quality of life score (QOL) were recorded. Results After 3 months of treatment, the total score of IPSS and the QOL in test group decreased compared with placebo group (P <0.05); Qmax increased and bladder residual urine volume decreased, but there was no significant difference between the two groups (P> 0.05) . Patients with well-tolerated drugs, minor adverse reactions. Conclusion Tadalafil combined with BPH can improve the symptoms of LUTS caused by BHP safely and effectively, especially for BPH patients with erectile dysfunction (ED).