国产皮下埋植剂多中心研究

Multicenter Clinical Study of Sino - Subdermal Implant

目的:评价两种国产皮下埋植剂的避孕效果、副反应和继续使用率。方法:分两期进行。第一期为国产Ⅰ型、Ⅱ型皮下埋植剂与Norplant进行前瞻性临床对比研究,各100例,共300例。第二期为国产皮下埋植剂扩大临床应用,接受合格对象Ⅰ型999例,Ⅱ型998例,共1997例。随访5年。结果:5年随访率为99.5％。第一期国产Ⅰ型、Ⅱ型皮下埋植剂和Norplant的5年累计妊娠率分别为0/百妇女、1.0/百妇女、0/百妇女,5年继续使用率分别为77％、80％、80％,差异均无统计学意义(P>0.05)。主要副反应为月经紊乱,月经卡分析显示3种埋植剂的出血模型相似。第二期国产Ⅰ型、Ⅱ型皮下埋植剂5年累计妊娠率分别为0.20/百妇女,2.10/百妇女,5年继续使用分别为84.47％、82.28％。使用埋植剂6个月Ⅰ型和Ⅱ型月经问题主诉发生率分别为50.88％、57.16％,差异有显著意义(P<0.01),但随着使用时间延长,月经紊乱主诉发生率逐渐下降,两组间无差异。结论:5年研究表明两种国产皮下埋植剂的避孕效果、副反应发生率和继续使用率与Norplant相似,也是一种高效,长效的避孕制剂。国产皮下埋植剂Ⅱ型使用至第5年避孕失败率明显增加,建议国产Ⅱ型皮下埋植剂使用期限在3～4年为好。

Objective;To evaluate the effectiveness, side effects and continuation rates of thd Sinosubderraal implant typeⅠ and Ⅱ. Methods: This study is a forword multicentre one with clinical trial. The first phase study was a prospective comparative clinical one about Sino - subdermal implant type Ⅰ and Ⅱ and Norplant in 100 women, respectively. The second phase study was a expanded clinical one of typel in 999 women , and type Ⅱin 998 women. Three groups were followed up for five years. Results; Following up rate was 99. 5%. In the first phase. Cumulative pregnancy rate of Sino - subdermal implant Type land type Ⅱand Norplant during five years was 0,1. 0,0 per 100 women,respectively. Continoation rate of three type implants in 5 years was 77% ,80% and 80% , respectively. There is no significant difference amang three groups(P >0. 05). The main side effect of the 3 groups was menstrual disorder. Menstural events records showed bleeding model of three groups was similar. In the second phase,five - year cumulative pregnancy rates of Sino - subdermal implant typel and Ⅱwas 0. 20 and 2. 10 per 100 women ,five - year continuation rates of three groups was 84.47% and 82. 28% , respectively. Menstrual disorder was the main complaint of the users of Sino - subdermal implant type Ⅰ and Ⅱ six months after used implants. Incidence rate of menstrual disorder was 50. 88% and 57. 16% Respectively, and there was a significant difference between the two groups (P <0. 01). But the rate of menstrual disoder decreased with time,then difference was no statistically significance. Conclusions ;Five - year studies showed the effectiveness , side effects and continuation rates of Sino - subdermal implant type Ⅰand Ⅱare similar to Norplant and were high effective, long - term effective contraceptive implants; The failure rate of birth control of Sino -subdermal implant type Ⅱincreased obviously after used for 5 years. It was suggested that it is better that Sino - subdermal implant type Ⅱ is used for 3-4 years.