盐酸达泊西汀按时与按需服用治疗原发性早泄患者的效果比较  

Efficacy differences of dapoxetine hydrochloride medication on-time and on-demand in patients with primaryprematureejaculation

作　　者：赵志强[1,2] 翟晓强[1] 李和程[1] 种铁[1] 赵军[1] Zhao Zhiqiang;Zhai Xiaoqiang;Li Hecheng;Chong Tie;Zhao Jun(Department of Urology,The Second Affiliated Hospital of Xi'an Jiaotong University,Xi'an 710004,China;The Second Affiliated Hospital of Xi'an Medical College,Xi'an 710038,China)

机构地区：[1]西安交通大学第二附属医院泌尿外科,西安710004 [2]西安医学院第二附属医院工作,西安710038

出　　处：《中华泌尿外科杂志》2023年第11期847-852,共6页Chinese Journal of Urology

基　　金：西安市创新能力强基计划-医学研究项目(22YXYJO137)。

摘　　要：目的比较盐酸达泊西汀按时服用与按需服用治疗原发性早泄的效果。方法本研究为前瞻性随机对照研究。纳入2018年9月至2019年6月在西安交通大学第二附属医院男科门诊确诊的原发性早泄患者。纳入标准:①年龄≥18周岁,非同性恋患者;②有固定性伴侣且与性伴侣关系融洽1年以上;③治疗前3个月内未使用5-羟色胺再摄取抑制剂;④在阴茎进入阴道后2min内射精,且该现象持续>6个月;⑤最近6个月未参加过其他类似试验;⑥性生活次数≥2次/周。排除标准:①勃起硬度评分<3分;②生殖器官畸形或发育不良;③泌尿生殖系统感染者;④严重心脏病、高血压病、糖尿病患者;⑤性腺功能低下者;⑥对盐酸达泊西汀及辅料过敏;⑦中、重度肝损伤患者。采用随机数字表法将患者随机分为按时服药组和按需服药组。按时服药组患者给予盐酸达泊西汀30mg/次,1次/日,晚饭后即刻服用;按需服药组予盐酸达泊西汀30mg/次,同房前2~3h服用。观察两组患者治疗8周及停药8周后的阴道内射精潜伏期(IELT)、早泄诊断工具(PEDT)评分、早泄指数(IPE)评分、焦虑自评量表(SAS)评分。结果本研究共纳人136例患者,两组各68例。最终共88例完成8周治疗,其中按时服药组50例(73.53%),按需服药组38例(55.88%),两组患者治疗依从性差异有统计学意义(P=0.048)。按时服药组与按需服药组治疗前IELT[(2.23±1.81)min与(1.80±1.51)min]、PEDT评分[(16.52±1.54)分与(16.84±1.59)分]、IPE评分[满意度(32.67±7.36)分与(32.37±5.90)分,控制力(23.31±5.48)分与(22.97±4.82)分,痛苦程度(36.43±3.51)分与(35.82±3.27)分]、SAS评分[(51.80±6.93)分与(53.82±4.47)分]差异均无统计学意义(P>0.05)。按时服药组与按需服药组患者治疗8周后,IELT[(5.45±2.64)min与(5.01±2.31)min]、PEDT评分[(13.68±2.15)分与(14.92±9.39)分]、IPE评分[满意度(42.58±5.13)分与(43.39±4.76)分,控制力(31.86±4.49)分与(32.Objective To compare the efficacy of dapoxetine hydrochloride for the treatment of primary premature ejaculation when taken on time and on demand.Methods This study was a randomized controlled study.Patients with primary premature ejaculation diagnosed at the Andrology Outpatient Department of the Second Affiliated Hospital of Xi an Jiaotong University between September 2018 and June 2019 were included.Inclusion criteria included①non-homosexual patients aged≥18 years,②regular sexual partner and rapport relationship with their sexual partner for more than 1 year,③no serotonin reuptake inhibitors application within 3 months before treatment,④ejaculated within 2 minutes of penile entry into the vagina that lasts>6 months,⑤on participation in other similar trials in the past 6 months,⑥had sexual intercourse≥2 times/week.Exclusion criteria included①erection hardness score<3 points,②malformation or dysplasia of reproductive organs,③genitourinary infection,④patients with severe heart disease,hypertension,diabetes mellitus,⑤hypogonadism,⑥allergy to dapoxetine hydrochloride and excipients,⑦patients with moderate or severe liver damage.The enrolled patients were divided into an on-time medication group and an on-demand medication group according to the randomized number table method.Patients took dapoxetine hydrochloride 30 mg/time,once a day,immediately after dinner in the on-time medication group,and the patients took dapoxetine hydrochloride 30 mg/time 2-3 h before intercourse in the on-demand medication group.The latency of intravaginal ejaculation(IELT),the score of the diagnostic tool for premature ejaculation(PEDT),the score of premature ejaculation index(IPE),and the score of anxiety level(SAS)of the two groups were observed within 8 weeks of medication intaking and 8 weeks of medication withdraw.Results A total of 136 patients were enrolled,and finally 88 completed the 8 weeks treatment,including 50 patients(73.53%)in the on-time medication group and 38 patients(55.88%)in the ondemand

关 键 词：早泄 盐酸达泊西汀 疗效 射精潜伏期 依从性 

分 类 号：R698[医药卫生—泌尿科学]