他达拉非对下尿路症状伴勃起功能障碍的疗效研究

Therapeutic effect of tadalafil on lower urinary tract symptoms with erectile dysfunction

目的:探讨小剂量他达拉非对BPH所致下尿路症状(LUTS)合并ED患者的治疗效果。方法:收集BPH所致LUTS合并ED的患者126例,随机分为治疗Ⅰ组、治疗Ⅱ组、对照组,每组42例。治疗Ⅰ组每日口服他达拉非5 mg+盐酸坦索罗辛缓释胶囊0.2 mg,共12周;治疗Ⅱ组每日口服他达拉非5 mg,共12周;对照组每日服用安慰剂,共12周。在基线时、治疗6周、治疗12周、治疗停药4周、治疗停药8周共5个时间点接受随访,并在每个时间点记录研究对象的排尿期症状亚项评分、储尿期症状亚项评分、IPSS总评分及IIEF-5评分,并嘱患者记录研究期间性生活次数。结果:针对排尿期症状亚项评分:治疗Ⅰ组5个时间点间两两比较差异均有统计学意义(P<0.05);治疗Ⅱ组中治疗6周与基线、治疗停药8周与基线、治疗停药8周与治疗6周比较差异无统计学意义(P均>0.05);对照组5个时间点差异无统计学意义(P>0.05)。治疗6周时、治疗停药8周时治疗Ⅱ组与对照组比较差异无统计学意义(P均>0.05);治疗12周、治疗停药4周时3组间两两比较均有统计学意义(P<0.05)。针对储尿期症状亚项评分:治疗Ⅰ组、治疗Ⅱ组5个时间点间两两比较差异均有统计学意义(P<0.05);对照组5个时间点差异无统计学意义(P>0.05)。治疗6周时、治疗12周时、治疗停药4周时、治疗停药8周时治疗Ⅰ组与治疗Ⅱ组比较差异均无统计学意义(P均>0.05)。针对IPSS总评分:治疗Ⅰ组、治疗Ⅱ组中治疗停药8周与治疗6周比较差异无统计学意义(P均>0.05);对照组5个时间点差异无统计学意义(P>0.05)。治疗6周时、治疗12周时、治疗停药4周时、治疗停药8周时3组间两两比较均有统计学意义(P<0.05)。针对IIEF-5评分:3组随访期间性生活次数比较差异无统计学意义(P>0.05);治疗Ⅰ组中治疗停药4周与治疗6周、治疗停药8周与治疗6周、治疗停药8周与治疗停药4周比较差异无统计学意义(P均>0.05);治疗Ⅱ组中治疗停药8周与治疗6周比较差异无统计学意义(P>0.05);对照组5个时间点差异无统计学意义(P>0.05)。治疗12周时、治疗停药4周时治疗Ⅰ组与治疗Ⅱ组比较差异无统计学意义(P均>0.05);治疗6周时、治疗停药8周时3组间两两比较均有统计学意义(P<0.05)。结论:每日单用他达拉非5 mg对改善患者储尿期症状亚项评分、IIEF-5评分具有良好效果,且此疗效与联合用药方案效果相似,在停药后仍具有延续性,可推荐用于ED伴以储尿期症状为主的BPH/LUTS患者。

Objective: To investigate the therapeutic effect of low-dose tadalafil on BPH-induced lower urinary tract symptoms(LUTS) complicated with ED. Methods: We randomly assigned 126 patients with BPH-induced LUTS and ED to receive daily administration of tadalafil(5 mg) plus tamsulosin hydrochloride sustained-release capsules(0.2 mg)(treatment group Ⅰ[T-Ⅰ], n = 42), tadalafil(5 mg) only(treatment group Ⅱ[T-Ⅱ], n = 42) or placebo(control group, n = 42), all for 12 weeks. Before and after 6 and 12 weeks of medication, and at 4 and 8 weeks after drug withdrawal, we recorded and compared the IPSS sub-item scores in the voiding stage and urinary storage symptoms, total IPSS, IIEF-5 scores, and the frequency of sexual activities among the three groups of patients. Results: As for the IPSS sub-item scores in the voiding stage symptoms, T-Ⅰ showed statistically significant differences between any two of the five time points(P < 0.05), but not T-Ⅱ between the baseline and 6-week medication or 8-week withdrawal(P > 0.05), or between 6-week medication and 8-week withdrawal(P > 0.05), nor did the control group among the five time points(P > 0.05). Statistically significant differences were observed between any two of the three groups at 12 weeks of medication and 4 weeks after drug withdrawal(P < 0.05), but not between the T-Ⅱ and control groups at 6 weeks of medication or 8 weeks after withdrawal(P > 0.05). As to the IPSS sub-item scores in the urinary storage symptoms, there were significant differences between any two time points in T-Ⅰ and T-Ⅱ(P < 0.05), but not in the control(P > 0.05), nor between T-Ⅰ and T-Ⅱ at 6 or 12 weeks of medication or at 4 or 8 weeks after drug withdrawal(P > 0.05). With regard to the total IPSS, statistically significant differences were found between any two of the three groups at 6 and 12 weeks of medication and 4 and 8 weeks after drug withdrawal(P < 0.05), but not between 6-week medication and 8-week withdrawal in T-Ⅰ or T-Ⅱ(P > 0.05), nor among the five time points in the control group(P > 0.05). Concerning the IIEF-5 scores, there was no significant difference in the frequency of sexual activities between the three groups(P>0.05).There were statistically significant differences between any two of the three groups at 6 weeks of medication and 8 weeks after drug withdrawal(P<0.05), but not between 6-week medication and 4-or 8-week withdrawal(P > 0.05) or between 4-and 8-week withdrawal(P > 0.05) in T-Ⅰ, nor between 6-week medication and 8-week withdrawal in T-Ⅱ(P > 0.05) or among the five time points in the control(P > 0.05), nor between T-Ⅰ and T-Ⅱ at 12 weeks of medication(P > 0.05) or 4 weeks after drug withdrawal(P > 0.05). Conclusion: Daily administration of tadalafil at 5 mg can effectively improve the IPSS sub-item scores in the urinary storage symptoms and IIEF-5 scores, with a persistent effect after withdrawal similar to that of its combination with other drugs, and therefore can be recommended for the treatment of BPH-induced LUTS complicated with ED.