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 OBJECTIVE: To observe the contraceptive effects, side effects and acceptability of two domestic subcutaneously implanted contraceptives, type I, type II and Norplant implants. Methods: A prospective, random allocation of research methods, in the country 10 clinical centers to carry out the special clinical studies. Unified research methods, unified scientific research forms. Follow-up every year for a total of 5 years. Results: A total of 2 999 recipients were received. There were 101 cases in the domestic group, 100 cases in the model group and 998 cases in the Norplant group. Five-year follow-up was 99.8%. At the end of the 5th year, the domestic-made group, 3 cases of pregnancy, the crude cumulative pregnancy rate of 0. 4/100 women. Domestic-made group, 5 cases of pregnancy, crude cumulative pregnancy rate 0. 7/1 0 0 women. Norplant group no pregnancy, no significant difference between the three groups (P> 0.05). No ectopic pregnancy occurred in all three groups. At the end of 5 years, 82 2 cases were terminated in all three groups. The cumulative utilization rate continued, at 73.9, 68.4 and 75.5 per 100 women respectively. Log-Rank 2 test showed that the three groups had no statistical significance (P> 0.05). Menstrual problems are the main reason for termination. With the planting time extended, the normal rate of menstrual bleeding increased significantly. Hemoglobin is on the rise. No major health problems occurred within 5 years. CONCLUSIONS: Domestic skin burilants Type I, Type II and Norplant are effective, long-lasting and safe birth control methods