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两种左炔诺孕酮方案用于尼日利亚人紧急避孕的有效性和安全性的比较评估。

Comparative evaluation of the effectiveness and safety of two regimens of levonorgestrel for emergency contraception in Nigerians.

作者信息

Arowojolu A O, Okewole I A, Adekunle A O

机构信息

Fertility Research Unit, Obstetrics and Gynaecology Department, University College Hospital, Ibadan, Nigeria.

出版信息

Contraception. 2002 Oct;66(4):269-73. doi: 10.1016/s0010-7824(02)00337-2.

Abstract

Emergency contraception was introduced in Nigeria over two decades ago, but few women have used this method even in emergency situations because of the side effects. To find an acceptable levonorgestrel regimen for emergency contraception in our community, the two-dose regimen 0.75-mg levonorgestrel 12 h apart (group A) and the single dose 1.5-mg levonorgestrel (group B) were studied in 1118 volunteers. Mild side effects such as nausea, vomiting, lower abdominal pains, menorrhagia, dizziness, headache, and breast tenderness were reported. Significantly more women in the high-dose group reported headache, breast tenderness, and heavy menstrual flow. Eleven pregnancies (1.0%) were reported (7 in group A and 4 in group B). The crude relative risk of pregnancies was similar in the two groups (RR = 0.71, 95% CI = 0.32-1.55; p > 0.05) [corrected]. On the other hand, the estimated effectiveness rate of 86.80% in group A was significantly lower than the 92.99% for group B (p < 0.05). The pregnancy rates increased with delay in starting treatment and if further acts of unprotected sexual intercourse took place after treatment. It was concluded that both regimens were effective and safe.

摘要

二十多年前,紧急避孕措施被引入尼日利亚,但由于副作用,即使在紧急情况下,也很少有女性使用这种方法。为了在我们的社区找到一种可接受的左炔诺孕酮紧急避孕方案,对1118名志愿者进行了研究,一组采用两剂方案,间隔12小时服用0.75毫克左炔诺孕酮(A组),另一组采用单剂1.5毫克左炔诺孕酮(B组)。报告了恶心、呕吐、下腹部疼痛、月经过多、头晕、头痛和乳房压痛等轻微副作用。高剂量组报告头痛、乳房压痛和月经量过多的女性明显更多。报告了11例妊娠(1.0%)(A组7例,B组4例)。两组的妊娠粗相对风险相似(RR = 0.71,95% CI = 0.32 - 1.55;p > 0.05)[校正后]。另一方面,A组的估计有效率为86.80%,显著低于B组的92.99%(p < 0.05)。妊娠率随着开始治疗的延迟以及治疗后再次发生无保护性行为而增加。得出的结论是,两种方案都是有效且安全的。

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