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

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(32.75±5.43)分,痛苦程度(62.94±4.07)分与(61.22±4.25)分]及SAS评分[(49.70±4.16)分与(51.66±4.65)分]差异均无统计学意义(P>0.05)。两组治疗8周后上述指标与治疗前比较,差异均有统计学意义(P<0.05)。停药8周后,两组患者IELT、PEDT评分、IPE评分与治疗前差异均无统计学意义(P>0.05)。结论按时服用与按需服用盐酸达泊西汀均能有效缓解原发性早泄患者的症状,均能缓解患者焦虑情绪;按时服药组依从性更好。长期停药后早泄症状会复现。

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 medication group.There was a statistically significant difference between the two groups in terms of patient adherence(P=0.048).There were no significant differences in pre-treatment IELT[(2.23±1.81)min vs.(1.80±1.51)min],PEDT scores[(16.52±1.54)vs.(16.84±1.59)],IPE scores[satisfaction(32.67±7.36)vs.(32.37±5.90),control(23.31±5.48)vs.(22.97±4.82),pain severity(36.43±3.51)vs.(35.82±3.27)],and SAS scores[(51.80±6.93)vs.(53.82±4.47)]between the on-time medication group and on-demand medication group(P>0.05).After 8 weeks of treatment for patients in the on-time versus on-demand medication groups,the IELT[(5.45±2.64)min vs.(5.01±2.31)min],PEDT scores[(13.68±2.15)vs.(14.92±9.39)],IPE scores[satisfaction(42.58±5.13)vs.(43.39±4.76),control(31.86±4.49)vs.(32.75±5.43),pain severity(62.94±4.07)vs.s(61.22±4.25)],and SAS score[(49.70±4.16)vs.(51.66±4.65)]were not statistically different(P>0.05).However,the differences were statistically significant when compared with those at the initial consultation(P<O.05).After 8 weeks of drug withdrawal,the scores of IELT,PEDT and IPE in the two groups were not significantly different from those before treatment(P>0.05).Conclusions Taking dapoxetine hydrochloride on time and on demand can effectively alleviate the symptoms and anxiety of patients with primary premature ejaculation,and the compliance of the on-time medication group was better.Premature ejaculation symptoms recur after long-term discontinuation of the drug.