Family Health International, Research Triangle Park, NC 27709, USA.
Contraception. 2010 Mar;81(3):197-201. doi: 10.1016/j.contraception.2009.10.013. Epub 2009 Dec 5.
Sino-implant (II) is a subdermal contraceptive implant manufactured in China. This two-rod levonorgestrel-releasing implant has the same amount of active ingredient (150 mg levonorgestrel) and mechanism of action as the widely available contraceptive implant Jadelle. We examined randomized controlled trials of Sino-implant (II) for effectiveness and side effects.
We searched electronic databases for studies of Sino-implant (II) and then restricted our review to randomized controlled trials. The primary outcome of this review was pregnancy.
Four randomized trials with a total of 15,943 women assigned to Sino-implant (II) had first-year probabilities of pregnancy ranging from 0.0% to 0.1%. Cumulative probabilities of pregnancy during the 4 years of the product's approved duration of use were 0.9% and 1.06% in the two trials that presented date for 4-year use. Five-year cumulative probabilities of pregnancy ranged from 0.7% to 2.1%. In one trial, the cumulative probability of pregnancy more than doubled during the fifth year (from 0.9% to 2.1%), which may be why the implant is approved for 4 years of use in China. Five-year cumulative probabilities of discontinuation due to menstrual problems ranged from 12.5% to 15.5% for Sino-implant (II).
Sino-implant (II) is one of the most effective contraceptives available today. These available clinical data, combined with independent laboratory testing, and the knowledge that 7 million women have used this method since 1994, support the safety and effectiveness of Sino-implant (II). The lower cost of Sino-implant (II) compared with other subdermal implants could improve access to implants in resource-constrained settings.
Sino-implant(II) 是一种中国制造的皮下避孕植入物。这种双棒左炔诺孕酮释放植入物与广泛使用的避孕植入物 Jadelle 具有相同的活性成分（150 毫克左炔诺孕酮）和作用机制。我们检查了 Sino-implant(II) 的有效性和副作用的随机对照试验。
我们搜索了电子数据库中关于 Sino-implant(II) 的研究，然后将我们的综述仅限于随机对照试验。本综述的主要结果是妊娠。
四项随机试验共纳入 15943 名妇女，其中 Sino-implant(II) 组第一年的妊娠率为 0.0%至 0.1%。在批准的 4 年使用期限内的 4 年中，两项报告了 4 年使用数据的试验中，累积妊娠率分别为 0.9%和 1.06%。在五年内，妊娠累积率从 0.7%到 2.1%不等。在一项试验中，第五年妊娠累积概率增加了一倍以上（从 0.9%到 2.1%），这可能是该植入物在中国仅批准使用 4 年的原因。因月经问题而停止使用 Sino-implant(II) 的五年累积率为 12.5%至 15.5%。
Sino-implant(II) 是目前最有效的避孕方法之一。这些现有的临床数据，结合独立的实验室测试，以及自 1994 年以来有 700 万妇女使用这种方法的知识，支持了 Sino-implant(II) 的安全性和有效性。与其他皮下植入物相比，Sino-implant(II) 的成本较低，可能会改善资源有限环境中对植入物的获取。
