屈螺酮炔雌醇片(Ⅱ)的临床应用观察  

Clinical contraceptive effect of drospirenone and ethinyl estradiol tablets (Ⅱ)

作　　者：陈煜岊[1] 弋文娟[1] 魏彩平 杨岚[1] 兰丽芳 袁代东 陈静[1] 黄丽菊 CHEN Yu-jie;YI Wen-juan;WEI Cai-ping;YANG Lan;LAN Li-fang;YUAN Dai-dong;CHEN Jing;HUANG LI-ju(Department of Gynecology&Obstetrics,Liuzhou People’s Hospital Affiliated to Guangxi Medical University,Liuzhou 545006)

机构地区：[1]广西柳州市人民医院妇科,柳州545006

出　　处：《生殖医学杂志》2020年第10期1333-1337,共5页Journal of Reproductive Medicine

摘　　要：目的评估屈螺酮炔雌醇片(YAZ)服药后出血模式、月经周期控制、药物不良反应和避孕效果。方法本研究为开放标签、单组Ⅳ期临床药物试验,2017年2月至2018年2月共50例22~41岁要求避孕的健康妇女服用YAZ 6个周期,在服药第1、4、6周期后进行随访。观察意外妊娠数、周期控制、出血模式、药物不良反应,以及痛经、痤疮的变化情况;以Pearl指数(PI)评价避孕的有效性。结果 47例受试者完成了6个周期的观察,无1例妊娠。出血/点滴出血平均天数随服药时间的延长逐渐下降,从第1服药周期的(7.66±5.27)d下降至第6服药周期的(4.85±1.83)d(P=0.035);从服药第2周期至第6周期,撤退性出血的发生率从95.74%(45/47)下降至91.48%(43/47),95.0%以上撤退性出血为正常出血、少量出血和点滴出血,发生撤退性出血的平均周期天数与服用药物前平均月经周期天数无显著改变[(27.02±6.89)d vs.(28.65±3.94)d,P>0.05];痛经和中度痤疮缓解程度均在50%以上。治疗中出现不良事件者24例,主要为头痛、皮疹、鼻咽炎和眼炎、阴道出血、潮热。结论 YAZ有良好的避孕效果,出血模式接近于正常周期,周期控制良好,对于缓解痛经和面部痤疮也有效果。Objective:To evaluate the bleeding pattern,menstrual cycle control,adverse drug events and contraceptive effect of drospirenone and ethinyl estradiol tablets(YAZ)with 24+4 administration mode.Methods:This was a single-arm,open-label,post-authorization safety surveillance study of YAZ for 6 treatment cycles recruiting 50 healthy females aged 22-41 years who requested contraceptive.Follow-up was performed after the first,fourth,and sixth cycles of medication.The number of pregnancies,cycle control,bleeding patterns,adverse drug events,as well as changes in dysmenorrhea and acne were observed,and the effectiveness of contraception was evaluated with the Pearl Index(PI).Results:Forty seven women had completed 6 treatment cycles without pregnancy.The average number of bleeding/spotting bleeding days gradually decreased with the extension of the medication time.The mean number of bleeding/spotting days[(7.66±5.27)days]in the first medication cycle was declined to[(4.85±1.83)days]in the sixth medication cycle(P=0.035).From the second cycle to the sixth cycle of the medication,the incidence of withdrawal bleeding dropped from 95.74%(45/47)to 91.48%(43/47).More than 95.0%withdrawal bleeding was normal,light or spotting.There was no significant change between the average cycle days of withdrawal bleeding and the average menstrual cycle days before treatment[(27.02±6.89)vs.(28.65±3.94)days,P>0.05].The remission rates of dysmenorrhea and moderate acne were above 50%.The common adverse events relating treatment included headache,rash,nasopharyngitis,ophthalmitis,vaginal bleeding and hot flashes.Conclusions:YAZ has good contraceptive effect,bleeding pattern is close to the normal cycle,the cycle is well controlled,and it is also effective for relieving dysmenorrhea and facial acne.

关 键 词：复方口服避孕药 有效性 安全性 屈螺酮炔雌醇片 

分 类 号：R979.21[医药卫生—药品]