Rabe T, Thuro H C, Goebel K, Borchardt C, Grunwald K, Runnebaum B
Div. of Gynaecological Endocrinology, Women's Hospital, University of Heidelberg, West Germany.
Contraception. 1992 Jan;45(1):21-37. doi: 10.1016/0010-7824(92)90138-j.
Changes in lipid metabolism in 25 healthy female volunteers during a 24-month application of Norplant-2 were evaluated in an open clinical trial. Total serum cholesterol decreased significantly (p less than 0.05/p less than 0.05) by 10%/9% after 12 months and by 3%/7% (n.s./n.s.) after 24 months of Norplant-2 use (all subjects/subjects completing 24 cycles). Serum triglycerides decreased by 34%/28% (n.s./p less than 0.05) after 12 months and by 29%/25% (p less than 0.05/p less than 0.05) after 24 months of Norplant-2 use (all subjects/subjects completing 24 cycles). HDL-cholesterol decreased significantly by 18%/12% (p less than 0.01/p less than 0.05) after 12 months and by 12%/12% (p less than 0.05/p less than 0.05) after 24 months of Norplant-2 use (all subjects/subjects completing 24 cycles). No statistically significant difference between serum levels of LDL-cholesterol prior to and after 12 and 24 months of Norplant-2 use could be found. VLDL-cholesterol levels decreased significantly by 38%/38% (p less than 0.05) after 12 and by 25%/25% after 24 months of Norplant-2 application (p less than 0.01) (all subjects/subjects completing 24 cycles). Apolipoprotein Al decreased significantly by 23%/23% (p less than 0.001/p less than 0.01) after 12 and by 21%/22% after 24 months of Norplant-2 application (p less than 0.01/p less than 0.01) (all subjects/subjects completing 24 cycles). No statistically significant difference between apolipoprotein All levels prior to and after 12 and 24 months of Norplant-2 implantation could be found. Apolipoprotein B decreased significantly by 27%/17% (p less than 0.05/p less than 0.05) after 12 months of Norplant-2 application (all subjects/subjects completing 24 cycles). The decline after 24 months of Norplant-2 use was not significant. Changes in lipid metabolism caused by oral hormonal contraceptives differ in the various clinical trials; however, most investigators found that serum levels of total cholesterol and triglycerides increase under the application of OCs. Contrary to this, a decrease of total cholesterol and triglycerides under Norplant-2 use was noted. Furthermore, we found a significant decrease of lipoproteins and apolipoproteins--with the exception of LDL-cholesterol and apolipoprotein All, which did not show any significant modifications. Thus, Norplant-2 seems to be non-contributory to cardiovascular risk and might even provide protection against such risks.
在一项开放临床试验中，对25名健康女性志愿者在使用Norplant-2的24个月期间的脂质代谢变化进行了评估。使用Norplant-2 12个月后，总血清胆固醇显著降低（p<0.05/p<0.05），降幅为10%/9%；使用24个月后，降幅为3%/7%（无统计学意义/无统计学意义）（所有受试者/完成24个周期的受试者）。使用Norplant-2 12个月后，血清甘油三酯降低34%/28%（无统计学意义/p<0.05）；使用24个月后，降低29%/25%（p<0.05/p<0.05）（所有受试者/完成24个周期的受试者）。使用Norplant-2 12个月后，高密度脂蛋白胆固醇显著降低18%/12%（p<0.01/p<0.05）；使用24个月后，降低12%/12%（p<0.05/p<0.05）（所有受试者/完成24个周期的受试者）。在使用Norplant-2 12个月和24个月前后，低密度脂蛋白胆固醇的血清水平未发现有统计学意义的差异。使用Norplant-2 12个月后，极低密度脂蛋白胆固醇水平显著降低38%/38%（p<0.05）；使用24个月后，降低25%/25%（p<0.01）（所有受试者/完成24个周期的受试者）。使用Norplant-2 12个月后，载脂蛋白A1显著降低23%/23%（p<0.001/p<0.01）；使用24个月后，降低21%/22%（p<0.01/p<0.01）（所有受试者/完成24个周期的受试者）。在植入Norplant-2 12个月和24个月前后，载脂蛋白AⅡ水平未发现有统计学意义的差异。使用Norplant-2 12个月后，载脂蛋白B显著降低27%/17%（p<0.05/p<0.05）（所有受试者/完成24个周期的受试者）。使用Norplant-2 24个月后的下降不显著。在各种临床试验中，口服激素避孕药引起的脂质代谢变化有所不同；然而，大多数研究者发现，在使用口服避孕药期间，总胆固醇和甘油三酯的血清水平会升高。与此相反，在使用Norplant-2期间，总胆固醇和甘油三酯出现了降低。此外，我们发现脂蛋白和载脂蛋白显著降低——低密度脂蛋白胆固醇和载脂蛋白AⅡ除外，它们未显示出任何显著变化。因此，Norplant-2似乎不会增加心血管风险，甚至可能提供针对此类风险的保护作用。
