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对94名健康育龄中国妇女连续注射每月1次避孕针剂Mesigyna或Cyclofem,9个月后观察注射第3、9针及停药3个月后妇女血浆中主要凝血及纤溶参数的变化,为长期应用的安全性研究提供依据。结果显示:注射Mesigyna的妇女在整个用药期间凝血因子Ⅶ、Ⅹ浓度显著减少,纤溶酶原、AT-Ⅲ活性及蛋白C含量下降,停药后未恢复;凝血酶原时间、部分凝血活酶时间在用药初期出现延长,停药第47周恢复至用药前基础水平;其他参数没有或轻微改变。注射Cyclofem的妇女在整个研究中凝血因子Ⅶ、纤溶酶原浓度下降;组织纤溶酶原激活抑制剂在注射第9针后含量增加,停药后第47周恢复。本研究结果提示:妇女长期应用Mesigyna或Cyclofem后血浆中凝血和纤溶参数发生了改变,这种改变虽然在统计学上有显著性差异,但观察到的相关变化在凝血系统的意义并不表示增加用针妇女血栓形成的危险性,对纤溶系统没有明确作用。故这些变化被视为机体为保持凝血和纤溶系统的动态平衡而作出的反应,对用药妇女不具有显著临床病理意义。
Ninety-four healthy women of childbearing age were continuously injected with Mesigyna or Cyclofem once a month. After 9 months, the changes of major coagulation and fibrinolytic parameters in plasma were observed at the 3rd, 9th and the 3rd month after drug withdrawal Long-term application of safety research to provide the basis. The results showed that the concentration of coagulation factors Ⅶ and Ⅹ decreased significantly in women injected with Mesigyna, the activity of plasminogen, AT-Ⅲ and the content of protein C decreased in the whole period of medication, and did not recover after stopping the treatment. The prothrombin time, partial thromboplastin Time in the beginning of the drug appears to extend the withdrawal of 47 weeks to the baseline level before treatment; other parameters did not or slightly changed. For women injected with Cyclofem, coagulation factor Ⅶ and plasminogen concentrations decreased throughout the study. Tissue plasminogen activator levels increased after the 9th injection and restored at week 47 after discontinuation. The results of this study suggest that changes in plasma coagulation and fibrinolytic parameters in women after long-term use of Mesigyna or Cyclofem have been shown to be statistically significant, although the observed changes in coagulation system do not indicate Increase the risk of needle thrombosis in women, fibrinolysis system does not have a clear role. Therefore, these changes are considered as the body to maintain the dynamic balance of coagulation and fibrinolysis reaction, the medication does not have a significant clinical and pathological significance.