不同剂量、频次枸橼酸西地那非治疗勃起功能障碍患者的疗效观察

A clinical study of different doses and frequencies of Sildenafil in the treatment of erectile dysfunction

目的观察不同剂量、频次口服枸橼酸西地那非(Sildenafil)治疗勃起功能障碍患者的疗效和安全性的差异,评价新服用方法的疗效。方法采用随机、开放的临床研究方法,选择符合纳入排除标准的确诊为勃起功能障碍的患者120例,随机分为口服Sildenafil按时组(25 mg/d)、按需组(50 mg,无规律性生活前半小时)、新规律服用组(25 mg/d,每次性生活前加用50 mg)、规律服用组(100 mg/次,规律2次/周)。所有患者进行为期8周的治疗。随访指标为国际勃起功能指数问卷-5(IIEF-5)、勃起硬度(EHS)分级、性接触问题-2/3(SEP-2/3)以及不良反应的发生情况。结果四组患者IIEF-5评分治疗后均显著增加(P<0.001),但四组之间差异均无统计学意义(P>0.05)。在治疗有效率方面,第16周时按需组患者(10.7%)与新规律服用组患者(62.1%)、按需组患者(10.7%)与规律服用组患者(50.0%)的差异具有统计学意义(P<0.001)。EHS分级4级者在第8、16周时规律服用组均高于按需组,差异均具有统计学意义(P<0.05)。在SEP-3的阳性率变化上,第16周按需组与规律服用组的差异有统计学意义(P=0.042)。在治疗过程中,四组患者均出现了头痛、视物模糊、鼻塞、背痛等一过性不良反应,但未影响治疗。结论4种西地那非治疗方案在治疗期间均发挥出较好的临床效果。规律服用、新规律服用2种用药方式在随访期仍能维持较好的临床疗效,并且治疗效果优于按需组。新规律服用可以作为一种新的安全有效的治疗方案。

Objective To evaluate the efficacy and safety of different doses and frequencies of oral Sildenafil in the treatment of erectile dysfunction(ED).Methods The randomized,open clinical trial included 120 ED patients who met the inclusion and exclusion criteria.The patients were randomly divided into the following groups:on-schedule(25 mg/day),on-demand(50 mg,taken irregularly half an hour before each sexual life),new regular group(25 mg/day,50 mg more before each sexual life),regular group(100 mg/time,twice/week).All treatments lasted for 8 weeks.The follow-up indexes included the five-item International Index of Erectile Function(IIEF-5),Erection Hardness Scale(EHS)and Sexual Encounter Profile(SEP2/3).The adverse reactions were recorded.Results The IIEF-5 scores of the four groups were significantly higher than those after baseline treatment(P<0.001),but there was no significant difference among the four groups(P>0.05).In terms of effective rate,at the 16th week,there were significant differences between the on-demand group(10.7%)and new regular group(62.1%),and between the on-demand group(10.7%)and regular group(50.0%)(P<0.001).In terms of EHS,the percentage of grade 4 patients in regular group was significant higher than that in the on-demand group at the 8th week and 16th week(all P<0.05).In terms of positive rate of SEP-3,there was a significant difference between the on-demand group and regular group(P=0.042)at the 16th week.In the course of treatment,there were transient adverse reactions such as headache,blurred vision,stuffy nose and back pain,which did not affect the treatment.Conclusion All of the four treatment methods of oral sildenafil showed good efficacy.Both regular group and new regular group maintained good clinical efficacy during the follow-up,which is better than that of the on-demand group.The new regular scheme can be used as a new,safe and effective treatment option.