枸橼酸爱地那非治疗勃起功能障碍的安全性和有效性研究  

Aildenafil Citrate: a New Potent and Highly Selective Phosphodiesterase Type 5 Inhibitor for the Treatment of Erectile Dysfunction

作　　者：贺占举[1] 张凯[1] 金杰[1] 李宁忱[1] 那彦群[1] 白文俊[2] 王晓峰[2] 朱积川[2] 姜辉[3] 袁仁培[3] 洪宝发[4] 宋涛[4] 杨勇[5] 戴东曦[5] 

机构地区：[1]北京大学第一医院泌尿外科,北京100034 [2]北京大学人民医院泌尿外科,北京100044 [3]北京大学第三医院泌尿外科,北京100083 [4]中国人民解放军总医院泌尿外科,北京100853 [5]首都医科大学附属朝阳医院泌尿外科,北京100020

出　　处：《中华男科学杂志》2006年第12期1080-1083,共4页National Journal of Andrology

基　　金：国家863计划(2005AA2Z3G50)

摘　　要：目的:探索枸橼酸爱地那非治疗男性勃起功能障碍(ED)的临床有效剂量,并评价其安全性和有效性。方法:采用多中心、随机、双盲、安慰剂对照研究方法,在国内5家医院对口服枸橼酸爱地那非30mg、60mg和安慰剂的250例ED患者进行临床观察。结果:3个主要疗效指标的统计学分析显示,试验药物组疗效均优于安慰剂组,60mg组更为明显。次要疗效指标分析结果与主要疗效指标一致。与药物相关的主要不良事件有头晕、头痛、面部潮红和恶心,严重程度为轻至中度,呈一过性,无需处理。结论:口服枸橼酸爱地那非30mg和60mg治疗ED安全、有效,60mg为最佳剂量。Objective ： To evaluate the efficacy and safety of aildenafil citrate, an oral phosphodiesterase type 5 inhibitor, in the treat- ment of erectile dysfunction. Methods： Integrated analyses were made of 8-week, randomized, double-blind, placebo-controlled phase 2 clinical trials involving 250 men with mild-to-severe erectile dysfunction of various etiologies who received aildenafil citrate 30 or 60 mg （ n = 167） or placebo （ n = 83 ）. Results ： The statistic results of International Index of Erectile Function, Patient Sexual Encounter Profile （SEP） diaries and Global Assessment Question （GAQ） were significantly higher in the aildenafil citrate patients thanin the placebo controls. The main drug-related adverse events were flushing, headache, dizziness and naupathia, which were mild and could be self-relieved. Conclusion： The aildenafil citrate therapy significantly ameliorated erectile function and was well tolerated by a wide range of patients with erectile dysfunction.

关 键 词：勃起功能障碍 5型磷酸二酯酶抑制剂 枸橼酸爱地那非 

分 类 号：R698[医药卫生—泌尿科学]