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本研究在全国11个省100个分中心对国产Ⅰ型和Ⅱ型皮下埋植剂进行临床多中心比较研究,共接收合格对象19673例,目前已完成二年随访。二年随访率94.29％,累计继续使用率分别为88.89,％(Ⅰ型)和89.93％(Ⅱ型),Ⅱ型显著高于Ⅰ型,二年累积妊娠率Ⅰ型和Ⅱ型分别为每百妇女0.0462和0.281,其间呈显著性差异。Ⅰ型埋植剂无异位妊娠发生,Ⅱ型埋植剂发生异位妊娠3例,发生率为0.163/1000妇女年。副反应的发生率有随时间增长而减少的趋势。主要副反应为月经失调,占副反应的90％以上。月经异常中月经频发、不规则出血和点滴出血的发生率高于月经稀发/量少和闭经。闭经和月经稀发/量少的发生率Ⅰ型高于Ⅱ型。二年观察中,因月经问题而终止使用者占总终止人数的78％,与月经问题有关的二年累积终止率Ⅰ型为每百妇女8.96,Ⅱ型为7.84,差别有显著性。二年观察研究表明,两种国产皮下埋植剂的副反应发生率和避孕效果以及二年的续用率与Norplant相似。
In this study, 100 sub-centers of 11 provinces in China were used for clinical multi-center comparative study of domestic type I and type II subcutaneous implants. A total of 19,663 eligible patients were received and two years follow-up was completed. The two-year follow-up rate was 94.29%, and the cumulative continuous use rates were 88.89% (type I) and 89.93% (type II) respectively. Type II was significantly higher than type I. The two-year cumulative pregnancy rates were type I and type II Women 0.0462 and 0.281, during which there was a significant difference. Type I implants no ectopic pregnancy occurred, type Ⅱ implants occurred in 3 cases of ectopic pregnancy, the incidence was 0.163 / 1000 women years. The incidence of side effects tended to decrease with time. The main side effects of menstrual disorders, accounting for more than 90% of side effects. Abnormal menstruation abnormal menstruation, irregular bleeding and bleeding is higher than the incidence of rare / oligomenorrhea and amenorrhea. Amenorrhea and oligomenorrhea / low incidence of type Ⅰ higher than type Ⅱ. In the two-year observation, 78% of the total termination due to menstrual problems were terminated. The two-year cumulative termination rate related to menstrual problems was 8.96 per 100 women and 7.84 for type II, with significant difference. Two years of observational studies have shown that the incidence of side effects and contraceptive effects of two domestic subcutaneous implants as well as the two-year renewal rate are similar to those of Norplant.