他达拉非按需与按时治疗勃起功能障碍前瞻性、多中心研究

On-demand versus on-time dosing of tadalafil for erectile dysfunction:A prospective multi-center study

目的:探讨他达拉非按需与按时治疗ED的安全性和有效性。方法:采用多中心随机对照研究,按需组于性生活前口服他达拉非10 mg/20 mg,按时组每周两次口服他达拉非10 mg/20 mg,治疗期为8周,于治疗前(V0)、治疗4周(V1)、治疗8周(V2)和治疗8周停药1个月(V3)时分别行IIEF-5、EDITS和SF-PAIRS评分,评估两种方案的安全性和有效性。结果:共有110例患者完成本研究,其中按时组56例,按需组54例。按时组与按需组V1、V2和V3的IIEF-5评分相比V0均明显改善,且V2[(21.6±2.9)分vs(18.5±1.7)分]和V3[(20.9±2.1)分vs(17.9±2.3)分]时按时组的得分明显高于按需组(P<0.05)。按时组V2[(31.7±6.9)分]和V3[(30.6±4.7)分]的EDITS评分与按需组V2[(28.6±5.8)分]和V3[(27.9±6.5)分]相比明显提高(P<0.05)。两组患者SF-PAIRS性自信指数、性自然指数和性时间顾虑指数评分与基线期相比均有明显改善(P<0.05),且在治疗8周停药1个月(V3)时按时组三者的评分明显优于按需组。两组安全性无明显差异。结论:他达拉非按时用药方案治疗ED安全有效,在治疗8周及停药1个月时按时组疗效优于按需组。按时治疗作为他达拉非一种新的用药方案,有望成为ED治疗的新策略。

Objective： To evaluate the safety and efficacy of tadalafil on demand and on time in men with erectile dysfunction. Methods ： We conducted a multi-centered randomized controlled study on 120 ED males, who were assigned to take tadalafil at 10 mg/ 20 mg on demand before sexual activity and at the same dose on time twice a week for 8 weeks. Before and at 4 and 8 weeks after treatment, and 1 month after withdrawal, we obtained the scores on IIEF-5, ED Inventory of Treatment Satisfaction （EDITS） and the short form of Psychological and Interpersonal Relationship Scales （ SF-PAIRS）, and compared the safety and efficacy of medication between the two groups of patients. Results ： Totally, 110 patients accomplished the trial, 56 in the on-time and 54 in the on-demand group. At 4 and 8 weeks of medication and 1 month after withdrawal, the IIEF-5 scores were improved in both the on-time and on-demand groups, even more significantly in the former than in the latter at 8 weeks of treatment （21.6 ± 2.9 vs 18.5 ± 1.7） and 1 month after withdrawal （20.9± 2.1 vs 17.9± 2.3 ） （P 〈 0.05 ）. The EDITS scores were significantly higher in the on-time than in the on-demand group at 8 weeks of treatment （31.7 ± 6.9 vs 28.6 ± 5.8） and 1 month after withdrawal （ 30.6 ± 4.7 vs 27.9 ± 6.5 ） （ P 〈 0.05 ）. The scores on the sexual self-confidence, spontaneity and time-concern domains of SF-PAIRS were remarkably improved after medication as compared with the baseline （P 〈 0.05）, even more significantly in the on-time than in the on-demand group at l month after withdrawal. Both dosing schedules were well tolerated and no significant differences were observed in safety between the two groups. Conclusion ： On-time dosing of tadalafil is efficacious and well tolerated in the treatment of ED, and has an even better effect than ondemand dosing at 8 weeks of medication and 1 month after withdrawal.