屈螺酮炔雌醇片(Ⅱ)治疗痛经的疗效与安全性

Clinical observation of combined oral contraceptives drospirenone and ethinylestradiol tablets(Ⅱ)in the treatment of dysmenorrhea in Chinese women

目的评估屈螺酮炔雌醇片(Ⅱ)用于治疗中国痛经妇女的疗效及安全性。方法本研究为屈螺酮炔雌醇片(Ⅱ)在中国妇女中进行的单臂、开放、干预性、多中心上市后安全性和有效性研究中的痛经亚组再分析,共526例受试者纳入痛经亚组。予屈螺酮炔雌醇片(Ⅱ)治疗6个周期,在不同随访时点使用视觉模拟评分(VAS)对经期疼痛严重程度进行评估;同时观察使用期间的避孕效果、周期控制、出血模式及安全性。结果研究期间,屈螺酮炔雌醇片(Ⅱ)对痛经症状具有缓解作用,随服药周期的延长痛经严重程度逐渐降低,基线VAS为(49.5±23.7)mm,第2次访视时VAS为(32.3±24.9)mm,第3次访视为(20.7±19.4)mm,第4次访视为(18.4±18.7)mm,各访视时点所有的VAS相对于基线的变化,差异均有统计学意义(P<0.01)。周期控制良好,从服药第2周期至第5周期,撤退性出血的发生率从93.9%(450/479)上升至96.4%(431/447),撤退性出血的时长由(5.7±2.7)降低至(5.4±1.8)d;经间期出血的发生率由9.0%(43/479)降至5.6%(25/447)。发生与研究药物有关的不良事件92例,发生率为17.5%(92/526),主要为乳房疼痛、恶心、乳房肿胀、头痛、异常子宫出血等,研究过程中未发生死亡、血栓栓塞等严重不良事件。结论屈螺酮炔雌醇片(Ⅱ)对于痛经症状的缓解具有显著作用且具有良好的安全性。

Objective To evaluate the efficacy and safety of drospirenone and ethinylestradiol tablets(Ⅱ)in Chinese women with dysmenorrhea.Methods This was a single-arm,open-label,interventional,multicenter,post-authorization safety/effectiveness study of drospirenone and ethinylestradiol tablets(Ⅱ)across 6 treatment cycles,a total of 526 patients were included in the dysmenorrhea subgroup.Visual analog scale(VAS)was used to assess the severity of menstrual pain.Secondary outcomes included unintended pregnancies,bleeding pattern,cycle control and safety.Results After treated with drospirenone and ethinylestradiol tablets(Ⅱ),VAS of pain had decreased significantly compared with baselines[(49.5±23.7)vs(32.3±24.9)vs(20.7±19.4)vs(18.4±18.7)mm,P<0.01].From the second cycle to the fifth cycle,the incidence of scheduled bleeding increased from 93.9%(450/479)to 96.4%(431/447).The duration of scheduled bleeding decreased from(5.7±2.7)to(5.4±1.8)days.The incidence of intermenstrual bleeding decreased from 9.0%(43/479)to 5.6%(25/447).17.5%(92/526)patients reported adverse drug reactions,most frequently reported adverse events were breast pain,nausea,breast swelling,headache,and uterine bleeding.No death occurred during the study.Conclusion Drospirenone and ethinylestradiol tablets(Ⅱ)is effective for the treatment of dysmenorrhea and has good safety.