Steiner M J, Brache V, Taylor D, Callahan R, Halpern V, Jorge A, Wevill S, Sergison J, Venkatasubramanian L, Dorflinger L
Contraceptive Technology Innovation Division, FHI 360, 359 Blackwell Street, Durham, NC 27701, USA.
Asociación Dominicana Pro Bienestar de la Familia, Inc. (PROFAMILIA), Santo Domingo, Dominican Republic.
Contracept X. 2019;1:100006. doi: 10.1016/j.conx.2019.100006.
Sino-implant (II) is a contraceptive implant that had a commodity price one-third of the competing products a decade ago. To make Sino-implant (II) more widely available, we conducted a trial to collect safety and efficacy data required for World Health Organization (WHO) prequalification, a quality standard allowing global donors to procure a pharmaceutical product.
This was a randomized controlled trial allocating 650 participants to either Sino-implant (II) or Jadelle®. Participants were seen at 1 and 6 months, and then semiannually. The primary efficacy measure was the pregnancy Pearl Index [number of pregnancies per 100 women-years (WY) of follow-up] in the Sino-implant (II) group during up to 4 years of implant use.
For the primary outcome, Sino-implant (II) had a 4-year Pearl Index of 0.74 (95% confidence interval, 0.36-1.37) compared to 0.00 (95% confidence interval, 0.00-1.04) for Jadelle®. The Sino-implant (II) pregnancy rate was significantly higher in the fourth year (3.54 per 100 WY) than in the first 3 years combined (0.18 per 100 WY; p <.001). Total levonorgestrel concentrations were equivalent between groups at month 12, but were 19%, 22% and 32% lower in the Sino-implant (II) group at months 24, 36 and 48, respectively (p <.001 at each time point). Safety and acceptability of the two products were similar, while providers documented significantly higher breakage rates during removal of Sino-implant (II) (16.3% vs. 3.1%; p <.001).
Based on these results, WHO prequalified Sino-Implant (II) with a 3-year use label in June 2017, 2 years shorter than the 5-year duration of Jadelle®.
WHO prequalification allows global donors to procure Sino-implant (II), which means women in many low resource countries will have greater access to highly effective and acceptable contraceptive implants. Our study noted important clinical differences, including shorter duration of high effectiveness with Sino-implant (II) when compared to the other available two-rod system, Jadelle®. Introduction strategies should include appropriate training on these differences.
“欣妈富隆”（Ⅱ型）是一种避孕植入剂，十年前其商品价格仅为同类产品的三分之一。为了使“欣妈富隆”（Ⅱ型）更广泛地应用，我们开展了一项试验，以收集世界卫生组织（WHO）预认证所需的安全性和有效性数据，预认证是一项质量标准，可使全球捐助者采购某种药品。
这是一项随机对照试验，将650名参与者随机分配至“欣妈富隆”（Ⅱ型）组或“杰德勒”组。在第1个月和第6个月对参与者进行观察，之后每半年观察一次。主要疗效指标是“欣妈富隆”（Ⅱ型）组在长达4年的植入使用期内的妊娠珍珠指数[每100名妇女年（WY）随访期内的妊娠数]。
对于主要结局，“欣妈富隆”（Ⅱ型）的4年妊娠珍珠指数为0.74（95%置信区间，0.36 - 1.37），而“杰德勒”为0.00（95%置信区间，0.00 - 1.04）。“欣妈富隆”（Ⅱ型）在第4年的妊娠率（每100 WY为3.54）显著高于前3年的总和（每100 WY为0.18；p <.001）。两组在第12个月时左炔诺孕酮总浓度相当，但在第24个月、36个月和48个月时，“欣妈富隆”（Ⅱ型）组分别低19%、22%和32%（各时间点p <.001）。两种产品的安全性和可接受性相似，但提供者记录显示，取出“欣妈富隆”（Ⅱ型）时的破损率显著更高（16.3%对3.1%；p <.001）。
基于这些结果，WHO于2017年6月对“欣妈富隆”（Ⅱ型）进行了预认证，并给出3年使用标签，比“杰德勒”的5年使用期限短2年。
WHO预认证使全球捐助者能够采购“欣妈富隆”（Ⅱ型），这意味着许多资源匮乏国家的女性将有更多机会获得高效且可接受的避孕植入剂。我们的研究指出了重要的临床差异，包括与另一种可用的双棒系统“杰德勒”相比，“欣妈富隆”（Ⅱ型）的高效期更短。引入策略应包括针对这些差异的适当培训。
