避孕针剂Mesigyna、Cyclofem对育龄妇女凝血及纤溶系统影响的比较研究

A Comparative Study on Effects of Two Injectable Contraceptives (Mesigyna, Cyclofem) on Blood Coag-ulation and Fibrinolysis.

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。

The effects of consecutively injecting a once- a -month contraceptive (mesigyna or cyclofem) for 9 months on both blood coagulation and fibrinolysis were evaluated in 94 Chinese women. The changes in relevant parameters were observed after the 3rd and 9th injections and after 3 month postdose for the purpose of providing safety basis for long - term use. The results were as follows; in those women injected with mesigyna, the levels of factor VII and factor X declined significantly during treatment. The functional activity of AT -III and plasminogen and concentration of protein C also decreased. Moreover, the corresponding parameters did not recovered to the normal level after stopping treatment. PT and APTT were longer during the early period of treatment but were in the normal range 47 weeks later after stopping injection. No or slight change was observed in other parameters. In the women given with cyclofem, the concentrations of factor VII and plasminogen were at the lower level over time and t - PAI levels increased after the 9th injection with a normal value 47 weeks later after discontinuation of treatment. The results suggested that changes in some parameters of coagulation and of fibrinolysis were observed, but their impact on the fibrinolysis system was in question. The phenomenon observed did not mean that the two test contraceptives showed a tendency to facilitate thromboembolism and therefore did harm to the women given with either of the two drugs. Thus, the observed changes should be regarded as the reactions to keep the equilibrium between coagulation and fibrinolysis and had no marked clinical significance pathologically.