两种国产皮下埋植剂多中心临床研究(扩大应用)(第一年随访总结)

A Multicentre Study of 2 Types of Sino-implant(Expanded Application)(one year follow up)

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。

A multicentre comparative clinical study of two types of sino-implant was carried out in 100 subcentres in 11 provinces,and a total of 19673 subjects were recruited. To date one year follow up has been finished. The follow - up rate at the end of one year was 95. 9 %,one - year cumula-tive continuation rates per 100 women were 95. 49(type I ) and 95. 80 (type Ⅱ ) respectively. The incidence of side - effects after 6 and 12 months of use were 58. 45% and 47. 32% respectively.The incidence to side -effects tends of decrease with the time. In 6th month the incidence of side -effects for type I was about the same as that for type Ⅱ. In 12th was month the type Ⅰsino -implant (48. 90% ) had a significantly higher incidence of side -effects than type Ⅱ sino -implant (45. 78 % ) (P<0.001). The major side-effects were the menstrual disturbances,which account-ed for 92 %-94% of the total side-effects,and the incidence of frequent menstruation,irregular bleeding and spotting was higber than that of infrequent/scanty menstruation and amenorrhea.Type Ⅰ had a higher incidence of amenorrhea,infrequent/scanty menstruation and spotting than type,. During one - year follow - up,the number of discontinuation due to menstrual problems reached 76 % of the total number of discontinuation,one-year menstrual-related cumulative dis-continuation rates were 3. 44 per 100 women for type Ⅰ and 3. 21 per 100 women for type Ⅱ. One - year cumulative pregnancy rates per 100 women were 0.029 and 0. 073 respectively,there was no statistical significant difference between them. One-year study shows that the two types of sino-implant are similar to Norplant with regard to the incidence of side-effects and efficacy as well as one-year continuation rates.