Effect of Combined Norethisterone Enantate 50mg Monthly InjectableContraceptive on Carbohydrate Metabolism

Ｅｆｆｅｃｔ　ｏｆ　Ｃｏｍｂｉｎｅｄ　Ｎｏｒｅｔｈｉｓｔｅｒｏｎｅ　Ｅｎａｎｔａｔｅ　５０ｍｇ　Ｍｏｎｔｈｌｙ　Ｉｎｊｅｃｔａｂｌｅ　ＣｏｎｔｒａｃｅｐｔｉｖｅｏｎＣａｒｂｏｈｙｄｒａｔｅＭｅｔａｂｏｌｉｓｍＳｕｎＤａｎ－ｌｉ（孙丹利）；ＳｈｅｎｇＫ...     

哺乳妇女单次注射迪波盖司通~长效避孕针后血清和乳液中MPA浓度变化

目的:探讨中国妇女哺乳期使用迪波盖司通后血清和乳液醋酸甲羟孕酮(MPA)浓度变化。方法:10名产后哺乳妇女单次注射迪波盖司通(含MPA150mg),在注射后的第1、2、4、6、8、10和12周采集血样和乳液样本,用放射免疫方法测定MPA。结果:血清MPA浓度于注射后第1周最高,到第2、4周时下降明显,第4周后浓度下降趋势逐渐缓慢。乳液MPA浓度在第1周为最高,第2周比第1周降低了约1/2,之后10周平均浓度变化波动在5.09-8.15ng/ml之间。观察期间乳液/血清MPA浓度比值和曲线下浓度面积比值均为0.55。对象之间和同一对象不同时间点乳液/血清MPA浓度存在明显个体差异。结论:哺乳期使用迪波盖司通,将导致血液和乳液中含有一定量的MPA。     

两种长效避孕针对抗凝血酶Ⅲ活性和含量影响的研究

９６名健康育龄妇女，随机分为Ｃｙｃｌｏｆｅｍ组（复方醋酸甲孕酮）和Ｍｅｓｉｇｙｎａ组（复方庚炔诺酮），连续用针９个月，观察两针剂对抗凝血酶Ⅲ及Ｘ因子的影响，并以口服片Ｏｒｔｈｏ－Ｎｏｖｕｍ１／３５作对照。结果表明，Ｃｙｃｌｏｆｅｍ组，ＡＴ血活性变化不明显，其含量则呈现升高趋势．对Ｘ因子无明显影响。Ｍｅｓｉｇｙｎａ组，ＡＴⅢ活性略有下降．而其含量则无明显变化，同时，Ｘ因子明显下降（降低４．２％到１０．７％）．在ＯＣ组，ＡＴⅢ活性稍有下降，但不显著，其含量的基础值高于用什组（Ｐ＜０．０５），服药期间呈下降趋势，Ｘ因子则显著增加（１６．８％到２３．５％）。认为商种避孕针剂对ＡＴⅢ的影响均无重要的临床意义。     

杭州市长期使用口服避孕药妇女的健康状况调查

四十年来口服避孕药(OC)因其安全、有效,使用方便的特点,被我国广大育龄妇女选择使用,对人口的控制起到了巨大的作用。我市目前仍有相当数量的妇女长期服用OC     

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

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。     

黄体酮胶丸的生物等效性研究

目的研究两种黄体酮胶丸的生物等效性.方法20例绝经2年以上、健康状况良好的成年女性志愿者,随机分为两组,双周期、交叉、单剂量口服200mg黄体酮胶丸,给药前及给药后不同时间定时采取血样;用放射免疫(RIA)方法测定血清样品中黄体酮的浓度,并对两种黄体酮胶丸进行生物等效性评价.结果口服两种黄体酮胶丸后,试验药物和对照药物的血中黄体酮的最大血药浓度Cmax分别为(53.28±8.58)和(45.90±11.90)ng/ml,达到最大血药浓度时间Tmax分别为(1.50±0.67)和(1.78±0.80)小时,0～72小时药-时曲线下面积AUC0-72分别为(378.55±85.84)和(359.12±108.51)hr×ng/ml,平均滞留时间MBT分别为(13.33±2.17)和(13.75±2.17)小时.结论两种黄体酮胶丸生物等效.     

注射复方庚炔诺酮一年对 SGPT 及 Y-GT 的影响

21名健康育龄妇女注射复方庚炔诺酮一年,在注射前及注射后的第1、3、6、12周期和停药后1或2个周期测定 SGPT、γ-GT 的水平,并有20名妇女作为平行对照,比较研究该针剂对肝脏有无影响。结果表明使用复方庚炔诺酮针剂一年对血清 SGPT、γ-GT 的水平,无明显影响。     

A Comparison Study of the Effects Injectable Contraceptive Cyclofem on Blood Coagulation and Fibrinolysis

Forty-six healthy women received Cyclofem (25mg medroxyprogesterone acetate with 5mg estradiol cypionate) and other forty-five women, as control, received oral contraceptive pill (Orttm-Novum 1/35, containing norethisterone enantate 1mg and estradiol valerate 35μg) for nine months. Blood samples were taken during the follicular and luteal phases of pre- treatment, and for Cyclofem group, immediately prior to the 3rd and 9th injections and 1 and 3 weeks after the 3rd and 9th injections; for Ortho-Novum group, blood samples were taken on the irst day of the 3rd and 9th pill cycles and 1 and 3 weeks later in both cycles. For both groups after at least 3 months nonhormonal method of contraception, blood sampling was repeated at follicular and luteal phases of a normal mentrual cycle. Coagulation and fibrinolysis parameter were detected including hemoglobin, platelet count, prothrombin time, APTT, fibrinogen, factor Ⅶ, factor Ⅹ, plasminogen, t-PAL AT Ⅲ(functional and immunological assays) and protein C. In the Cyclofem group, hemoglobin, platelet count, fibrinogen and factor Ⅹ were not changed. Factor Ⅶ significantly reduced. Prothrombin time and APTT showed minor changes. Plasminogen and protein C decreased while t-PAI aad AT Ⅲ increased. These changes showed a dynamic balance between coagulation and fibrinolysis. In Ortho-Novum 1/35 group, platelet count, factor Ⅹ and fibrinogen increased and prothrombin time and APTT accelerated. In fibrinolysis and anticoagutation system, plasminogen increased as well as protein C, but AT Ⅲ declined. Those changes showed a tendency of hyper-eoagutability state, fibrinolysis and anticoagulation were enhanced to a certain extent.The result of our study is that there are slight changes on coagulation and fibrinolysis in Cyclofem injectable contraceptive users.