Che Y, Taylor D, Luo D, Maldonado L Y, Wang M, Wevill S, Vahdat H, Han X, Halpern V, Dorflinger L, Steiner M J
Key Laboratory of Reproduction Regulation of NPFPC (SIPPR, IRD, Fudan University), Shanghai 200032, China.
Contraceptive Technology Innovation Division, FHI 360, 359 Blackwell Street, Durham, NC 27701, USA.
Contracept X. 2019;1:100008. doi: 10.1016/j.conx.2019.100008.
Sino-implant (II) is a contraceptive implant approved for 4 years of use in China. We evaluated the contraceptive efficacy during the third, fourth and fifth year, and assessed additional pharmacokinetics (PK), safety, and acceptability endpoints.
We enrolled a cohort of 255 current Sino-Implant (II) users entering their third year and a second cohort of 243 users entering their fourth year. We followed these two cohorts for 12 and 24 months, respectively. To characterize PK endpoints (i.e. levonorgestrel (LNG), sex hormone binding globulin and free LNG index) over 5 years, we collected blood samples in a subset of 50 participants we followed during the third, fourth and fifth year. We also enrolled small cohorts (n = 20) of Sino-implant (II) users entering their sixth month and second year and followed them each for up to 6 months. Our primary efficacy measures were the pregnancy Pearl Indices during Year 3 and 4. Secondary objectives included assessments of PK, safety, acceptability and efficacy in the fifth year.
We recorded four pregnancies, with a higher pregnancy rate during Year 3 [1.34 (95% CI: 0.28-3.93)] than Year 4 [0.44 (95% CI: 0.01-2.47)] or Year 5 [0.00 (95% CI: 0.00-2.02)]. The overall pregnancy rate for the third, fourth and fifth years of product use was 0.63 per 100 WY; 95% CI: (0.17-1.62). Mean LNG concentrations remained well above 200 pg/mL (Year 3 = 280.9; Year 4 = 233.6; Year 5 = 270.6). Most participants (93.7%) described their bleeding pattern as acceptable.
Sino-implant (II) is a highly effective contraceptive method in this population of Chinese women over 5 years.
Sino-implant (II) is a highly effective contraceptive method with an estimated Pearl Index of less than 1% over the third, fourth and fifth years of use in a population of Chinese women of reproductive age.
欣妈富隆（II）是一种在中国获批可使用4年的避孕植入剂。我们评估了其在第三、第四和第五年的避孕效果，并评估了其他药代动力学（PK）、安全性和可接受性终点。
我们招募了一组255名进入使用第三年的欣妈富隆（II）使用者和另一组243名进入使用第四年的使用者。我们分别对这两组人群进行了12个月和24个月的随访。为了描述5年内的PK终点（即左炔诺孕酮（LNG）、性激素结合球蛋白和游离LNG指数），我们在第三、第四和第五年随访的50名参与者子集中采集了血样。我们还招募了小队列（n = 20）进入使用第六个月和第二年的欣妈富隆（II）使用者，并分别对他们进行了长达6个月的随访。我们的主要疗效指标是第3年和第4年的妊娠珍珠指数。次要目标包括评估第5年的PK、安全性、可接受性和疗效。
我们记录到4例妊娠，第3年的妊娠率[1.34（95%CI：0.28 - 3.93）]高于第4年[0.44（95%CI：0.01 - 2.47）]或第5年[0.00（95%CI：0.00 - 2.02）]。产品使用第三、第四和第五年的总体妊娠率为每100妇女年0.63；95%CI：（0.17 - 1.62）。平均LNG浓度仍远高于200 pg/mL（第3年 = 280.9；第4年 = 233.6；第5年 = 270.6）。大多数参与者（93.7%）表示其出血模式可接受。
欣妈富隆（II）在这群中国女性中5年内是一种高效的避孕方法。
欣妈富隆（II）是一种高效的避孕方法，在育龄中国女性人群中使用的第三、第四和第五年，估计珍珠指数小于1%。
