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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,目前已完成一年随访。一年随访率95.9%,继续使用率分别为95.49%(Ⅰ型)和95.80%(Ⅱ型)。埋植后6个月和12个月时副反应发生率分别为5845%和4732%。副反应的发生率有随着时间的增长而减少的趋势。6个月时Ⅰ型皮下埋植剂和Ⅱ型皮下埋植剂副反应发生率较接近。12个月时到反应发生率1型皮下埋植剂(48.90%)显著地高于巨型皮下埋植剂(45.78%)(P<0.001)。主要副反应为月经失调,约为副反应发生率的92%~94%。其中月经频发、不规则出血和点滴出血等问题发生率高于月经稀发和闭经。闭经、月经稀发/口量少和点滴出血的发生率Ⅰ型高于Ⅱ型。一年观察中,因月经问题而终止使用者占总终止人数的76%,与月经问题有关的一年累积终止率Ⅰ型为每百妇女3.44,Ⅱ型为3.21。一年的累积妊娠率Ⅰ型和Ⅱ型分别为每百妇女0.029和0.073,其间未见显著性差异。一年观察研究表明,两种国产皮下埋植剂的副反应发生率和避孕效果以及一年的续用率与进口的Norplant相似。
In this study, 100 sub-centers of 11 provinces in China were used to conduct clinical multi-center comparative study of domestic type I and type II subcutaneous implants. A total of 19,663 eligible patients were received and one year follow-up was completed. One-year follow-up rate was 95.9%, with 95.49% (type I) and 95.80% (type II) respectively. The incidence of side effects at 6 months and 12 months after implantation was 5845% and 4732%, respectively. The incidence of side effects tends to decrease over time. The incidence of side effects of type Ⅰ subcutaneous implants and type Ⅱ subcutaneous implants was similar at 6 months. The response rate to type 1 subcutaneous implants at 12 months (48.90%) was significantly higher than that of giant subcutaneous implants (45.78%) (P <0.001). The main side effects of menstrual disorders, the incidence of side effects of about 92% to 94%. Including frequent menstruation, irregular bleeding and drip bleeding problems higher than the incidence of menstrual thin hair and amenorrhea. Amenorrhea, oligomenorrhea menstruation / mouth less bleeding and the incidence of type Ⅰ was higher than type Ⅱ. One year observation, due to menstrual problems termination of the total number of terminators 76%, and menstrual problems related to one-year cumulative termination rate of type I was 3.44 per 100 women, type II was 3.21. One-year cumulative pregnancy rates of type I and type II were 0.029 and 0.073 per 100 women, respectively, with no significant difference between them. A year of observational studies have shown that the incidence of side effects and contraceptive efficacy of two domestic subterranean implants, as well as the one-year continuation rate, are similar to those of Norplant.