不同时间窗复方甘菊利多卡因凝胶治疗早泄的前瞻性、单中心、随机对照研究  

Compound Chamomile and Lidocaine Hydrochloride Gel applied at different time-windows for premature ejaculation: A prospective single-center randomized controlled study

作　　者：蔡彪 蔡鸿财 庄锦涛[1] 杨璧铖 万子[1] 杨其运 涂响安[1] 孙祥宙[1] 邓春华[1] 张亚东[1,2] CAI Biao;CAI Hong-cai;ZHUANG Jin-tao;YANG Bi-cheng;WAN Zi;YANG Qi-yun;TU Xiang-an;SUN Xiang-zhou;DENG Chun-hua;ZHANG Ya-dong(Department of Andrology,The First Affiliated Hospital of Sun Yat-sen University,Guangzhou,Guangdong 510080,China;Department of Geriatrics,The First Affiliated Hospital of Sun Yat-sen University,Guangzhou,Guangdong 510080,China)

机构地区：[1]中山大学附属第一医院男科,广东广州510080 [2]中山大学附属第一医院老年病科,广东广州510080

出　　处：《中华男科学杂志》2022年第2期144-148,共5页National Journal of Andrology

摘　　要：目的:探讨不同时间窗复方甘菊利多卡因凝胶(甘美达?)对早泄(PE)的疗效与安全性。方法:将中山大学附属第一医院2021年2月至10月就诊的PE患者,根据给药时间,随机分为性生活插入前5 min组、15 min组,比较两组使用复方甘菊利多卡因凝胶治疗前、治疗1周后及2周后的射精潜伏期(IELT)、PEDT评分及男性生活质量评分,同时评估其安全性。结果:在治疗期间,62例完成随访的患者中,5 min组和15 min组在治疗PE 1周后、2周后,IELT较基线水平均有显著提升(P<0.001),PEDT评分较基线均改善(P<0.05);而两组间在各时间点IELT、PEDT的差异均无统计学意义。所有患者均未发生涂药部位红肿等过敏反应;61例勃起硬度未受显著不良影响,6例勃起硬度反而增加;57例无明显阴茎麻木感或不影响性体验,全部患者均能成功完成性生活。结论:不同时间窗复方甘菊利多卡因凝胶均能有效治疗PE,且性生活前5 min使用即可起效,安全性较高。Objective:To investigate the efficacy and safety of Compound Chamomile and Lidocaine Hydrochloride Gel(CCLH)(Kamistad?)applied at different time-windows on premature ejaculation(PE).Methods:This prospective study included 72 PE patients treated by application of CCLH to the glans and penile body in our hospital from February to October 2021.According to the time of drug administration before insertion into the vagina,we randomly divided the patients into a 5-minute group(n=39)and a 15-minute group(n=33).Before and after 1 and 2 weeks of treatment,we compared the intravaginal ejaculation latency time(IELT),PE diagnostic tool(PEDT)score,quality of life,and adverse reactions between the two groups of patients.Results:Totally 62 of the patients completed the follow-up,35 in the 5-minute group and 27 in the 15-minute group,and all showed significant improvement in IELT(P<0.01)and PEDT score(P<0.05)after treatment compared with the baseline.No allergic reactions,such as redness and swelling,developed at the application site in any of the patients,and no adverse significant effect was observed on the erectile hardness in 61 of the cases.Six cases showed increased erectile hardness instead.Fifty-seven of the patients experienced no obvious penile numbness or reduced sexual satisfaction,and all could complete their sexual activities.Conclusion:Compound Chamomile and Lidocaine Hydrochloride Gel applied at different time-windows is effective on PE,with a 5-minute rapid onset of action before intercourse,and no obvious adverse effects.

关 键 词：早泄 复方甘菊利多卡因 时间窗 疗效评估 安全性 

分 类 号：R698.3[医药卫生—泌尿科学]