国产长效皮下埋植避孕剂与Norplant多中心临床对比研究

目的 :观察两种国产皮下埋植避孕剂 I型、II型和 Norplant埋植剂的避孕效果、副反应和可接受性。方法 :采用前瞻性、随机分配原则的研究方法 ,在全国 1 0个临床中心开展本专题临床研究。统一研究方法 ,统一科研表格。每年随访一次 ,共随访 5年。结果 :共接收对象 2 999例。国产 型组 1 0 0 1例 , 型组 1 0 0 0例 ,Norplant组 998例。 5年随访率为 99.8%。 5年末 ,国产 型组 ,妊娠 3例 ,粗累积妊娠率 0 .4/1 0 0妇女。国产 型组 ,妊娠 5例 ,粗累积妊娠率 0 .7/1 0 0妇女。Norplant组无妊娠 ,三组间无统计学差异 ( P>0 .0 5 )。三组均无宫外孕发生。 5年末 ,三组共终止 82 2例。继续累积使用率 ,分别为 73.9,68.4和 75 .5 /1 0 0妇女。经 Log- Rankχ2 检验 ,三组无统计学意义 ( P>0 .0 5 )。月经问题是终止的主要原因。随埋植时间延长 ,月经出血模式正常比率明显增加。血红蛋白有上升趋势。 5年内未发生重大健康问题。结论 :国产皮埋剂 I型、II型和 Norplant是高效、长效、安全的节育方法

A Multicenter Clinical Comparative Study of Domestically Produced Implant Releasing Levonorgestrel No.Ⅰ(CLA) and No.Ⅱ(SINO) with Norplant

Objective:This report was the compare the efficacy, side effects and acceptability of two domestic implants No.I (cla) and No.II (sino) with Norplant. Methods:A multi center prospective, randomized comparative clinical trial was conducted in ten clinical centers in China. Results:Totally 1001, 1000 and 998 cases were recruited for domestic No. I, No. II implant and Norplant respectively since 1993. The follow up rate was 99.8% in five years. 3 pregnancies occurred in domestic No.I and 5 pregnancies in No. II group with the cumulative pregnancy rate of 0.4 and 0.7 per 100 women respectively in five years. No pregnancy occurred in the Norplant group. There was no statistical difference among 3 groups. There was no ectopic pregnancy in the three groups. The cumulative discontinuation rates were 26.1, 31.6 and 24.6 per 100 women respectively, with no significant difference. Menstrual problem is a mean reason for termination. Menstrual pattern happen change and the rate of menstrual normal was increasing as time of used implant. No serious health problems occurred due to implants. Conclusion:That the two domestic implants provided as high efficacy and safety as Norplant and can be used by women of reproductive age in difference areas, races, educational background and occupation.