Objective To evaluate the efficacy and safety of Dielofenac Sodium Suppository association with Tamsu-losin on nocturia in patients with benign prostatic hyperplasia (BPH). Methods A total of 54 BPH patients with 2 or more episodes of nocturia were enrolled in the study. The control group (27 patients) received only a single dose of 0.2 mg of Tamsulosin at night prior to sleep, while the combined treatment group (27 patients) received Tamsulosin plus Di-clofenac Sodium Suppository (25 mg) at night prior to sleep. The course was 4 weeks. The nocturnal frequency, TPSS and QOL, and side effects were recorded and compared between the two groups, once every 2 weeks. Results After four weeks of treatment IPSS and QOL improved significantly in two groups (P ＜ 0.05), but nocturia frequency decreased markedly only in the combined treatment group (P ＜ 0.05). Compared with the control group, the improvement in IPSS, QOL and nocturia frequency were more significant in the combined treatment group (P ＜ 0.05). No significant side effects were developed in both groups. Conclusion The combination of Dielofenac Sodium Suppository and Tamsulosin is safe and more effective for the treatment of nocturia in patients with BPH, with has no obvious adverse reactions.%目的 评价双氯芬酸钠栓和坦索罗辛联合治疗前列腺增生患者夜尿增多的有效性和安全性.方法 选择有明显夜尿增多症状的前列腺增生患者54例,随机分为两组,每组27例.对照组单服坦索罗辛(0.2 mg,每天1次),联合治疗组使用双氯芬酸钠栓(25 mg,每天1次,睡前1 h塞入直肠内)和坦索罗辛(0.2 mg,每天1次),疗程均为4 周,评估内容包括国际前列腺症状评分(IPSS评分)、生活质量评估(QOL)及夜尿次数,并登记不良事件,每2周评估1次.结果 治疗4周后,两组IPSS评分和QOL均较治疗前有明显改善(P ＜ 0.05).但对于夜尿状况,只有联合治疗组有明显疗效(P ＜ 0.05).两组比较,联合治疗组IPSS 评分下降优于对照组(P ＜ 0.05),减少夜尿次数和改善生活质量优于对照组(P ＜ 0.05).两组无明显不良事件发生.结论 双氯芬酸钠栓和坦索罗辛联合治疗前列腺患者夜尿增多,较单用坦索罗辛更为有效,且安全,无明显不良反应.
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