目的 探讨他达拉非按时或按需治疗中老年男性勃起功能障碍(ED)的临床疗效和安全性. 方法 入选患有ED的中老年男性病人83例,随机分为按时组40例与按需组43例,按时组病人隔日口服他达拉非10 mg,按需组病人于性生活前口服他达拉非20 mg,治疗4周后分别采用国际勃起功能指数评分-15(IIEF-15)和性生活日记(SEP-2/SEP-3)、全球评估问卷(GAQ1/GAQ2)以及阴茎彩色多普勒超声,评估2种方案的安全性及有效性. 结果 2组病人治疗后性交满意度(IIEF-IS)及勃起功能评分(IIEF-EF)较治疗前明显增加(P<0.05),阴茎插入成功率及性交成功率均较治疗前明显改善(P<0.05),收缩期最大流速(PSV)较治疗前明显提高(P<0.05),且按时组各项指标明显优于按需组;按时或按需治疗后,中年组GAQ1及GAQ2的肯定回答率明显高于老年组(P<0.05);在老年组中,按时治疗后GAQ1及GAQ2的肯定回答率明显高于按需治疗组(P<0.05).2组安全性未见明显差异. 结论 他达拉非按时及按需治疗ED均为安全有效,针对老年ED男性的治疗中,按时治疗疗效优于按需治疗.%Objective To evaluate the safety and efficacy of tadalafil on demand or on time treatment in medium-elderly men with erectile dysfunction. Methods Totally 83 patients were divided into two groups:on-demand group with 43 patients,treated by tadalafil at 20 mg on demand before sexual activity,and on-time group with 40 patients, treated with tadalafil at 10 mg on time on alternate days. Before and 4 weeks after treatment,the safety and therapeutic efficacy of the two groups were compared by the scores on International Index of Erectile Function(IIEF-15), Sexual Encounter Profile(SEP-2/SEP-3),the Global Assessment Questionnaire(GAQ1/GAQ2)and colour Doppler ultrasound of the penis. Results Four weeks after treatment,the IIEF-IS and IIEF-EF scores were improved in both the on-time and on-demand groups(P<0.05);The YES answers to SEP-2/SEP-3 were improved in both the on-time and on-demand groups(P<0.05);The average value of peak systolic velocity(PSV)of penis was improved in both the on-time and on-demand groups(P<0.05), esecially in on-time group. The YES answers to GAQ1/GAQ2 were significantly higher in the medium age men compared with the elderly men after tadalafil treatment on-time or on-demand(P<0.05).In elderly men with ED,the YES answers to GAQ1/GAQ2 were significantly higher in the on-time group than those in on-demand groups after treatment(P<0.05). There was no significant differences in adverse reaction between the two groups. Conclusions Both on-time and on-demand dosing of tadalafil are efficacious and well tolerated in the treatment of ED,and on-time dosing of tadalafil has an even better effect than on-demand dosing for the elderly men with ED.
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