左炔诺孕酮硅胶棒的多中心临床研究

Two years multicentre clinical study of sino-implant type I for using contraceptive (levonorgestrel silastic rod)

目的 :通过多中心临床研究 ,对左炔诺孕酮硅胶棒 (国产Ⅰ型皮下埋植剂 )的长期应用效果及不良反应进行评价。方法 :采用统一的对象筛选标准、观察方法和记录表格 ,对 4个省 10 2 9例使用皮埋剂 2a的妇女进行临床随访。用t检验法对埋植剂妇女的体重和BP变化进行了统计分析 ,用生命表法对各种原因的累积终止率和累积续用率进行了统计分析。结果 :埋植 1a时 ,主要不良反应是月经失调 ,占总埋植人数的 47 71% ,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。累积续用率为 94 85 % ,月经问题是终止的主要原因。埋植 2a时 ,月经失调占埋植人数的 2 1 5 2 % ,累积续用率为 86 98% ,月经问题仍是终止的主要原因 ,因月经问题取出的终止率为 8 75 %。避孕有效率达 10 0 %。结论 :皮埋左炔诺孕酮硅胶棒是一种高效、长效。

AIM:To evaluate the applied efficacy and adverse drug reaction of sino-implant type I through a multicentre clinical study after 2 a of use. METHODS: One thousand and twenty-nine women who were implanted sino-implant type I had been followed up during two-year with unified standard, method and form. The body weight and blood pressure were analysed by t-test method. The cumulative termination rate and continuation rate of every causes was analysed by life table method. RESULTS: The major adverse drug reaction was the menstrual disturbance after 1 a of use, which accounted for 47.71% of the total number of women with implant, and the incidence of frequent menstruation, irregular bleeding and spotting was higher than that of infrequent/scanty menstruation, and amenorrhea. One-year cumulative continuation rate was 94.88%. Menstrual disturbance was the main reason of discontinuation. During a follow-up of 2 a, menstrual disturbance accounted for 21.52% of the total number of women with implant. The cumulative continuation rate was 87.35%. The cumulative terminative rate due to menstrual problems was 8.5%. The effective rate of contraception was 100%. CONCLUSION: Sino-implant type I is a high effective, long-term and safe contraceptive method.