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单相左炔诺孕酮-炔雌醇 150/30 与三相左炔诺孕酮-炔雌醇 50-75-125/30-40-30 避孕药的副作用和患者满意度比较:伊朗的一项研究。

A comparison between monophasic levonorgestrel-ethinyl estradiol 150/30 and triphasic levonorgestrel-ethinyl estradiol 50-75-125/30-40-30 contraceptive pills for side effects and patient satisfaction: a study in Iran.

机构信息

Department of Obstetrics & Gynecology, Iran University of Medical Sciences, 16117 Tehran, Iran.

出版信息

Eur J Obstet Gynecol Reprod Biol. 2010 May;150(1):47-51. doi: 10.1016/j.ejogrb.2010.01.010. Epub 2010 Feb 24.

Abstract

OBJECTIVE

Oral contraceptive pills (OCPs) are one of the most effective reversible and accessible contraceptives, and patient acceptance for their use depends partly on the unfavorable adverse effects. The present study compared the two kinds of OCPs (monophasic; levonorgestrel (LNG)-ethinyl estradiol (EE) 150/30 versus triphasic; LNG-EE 50-75-125/30-40-30) for adverse effects and patient satisfaction.

STUDY DESIGN

A randomized clinical trial was performed on 314 women who used OCPs for the first time, as their contraception, for 6 months. Overall, 1884 cycles were studied. In the monophasic group (n=159 who finally finished the study), monophasic pills LNG-EE 150/30mcg, and in the triphasic group (n=155 who finally finished the study), triphasic pills LNG-EE 50-75-125/30-40-30 mcg were used. Statistical analysis was performed using SPSS 10: Chi square test, Fisher exact test and Student's t-test were used.

RESULTS

There were no significant differences between the two groups for common side effects, including nausea, headache, nervousness, facial hyperpigmentation (chloasma), and body weight (increase or decrease) but breakthrough bleeding and spotting (BTB/S) were less in the triphasic group, occurring in 30 cycles (18.86%) versus 10 cycles (6.45%), P=0.009*. Patient satisfaction for the two OCPs was similar and high. The rates of side effects were low.

CONCLUSION

It seems that the monophasic and triphasic pills are similar according to patient satisfaction and side effects; therefore there is no benefit of one over the other except for BTB/S, for which triphasic is superior.

摘要

目的

口服避孕药(OCPs)是最有效的可逆且易于获得的避孕方法之一,患者对其的接受程度部分取决于其不利的不良反应。本研究比较了两种 OCPs(单相;左炔诺孕酮(LNG)-炔雌醇(EE)150/30 与三相;LNG-EE 50-75-125/30-40-30)的不良反应和患者满意度。

研究设计

对 314 名首次使用 OCP 作为避孕方法的女性进行了一项随机临床试验,共研究了 1884 个周期。在单相组(n=159 人最终完成研究)中,使用单相 LNG-EE 150/30 mcg 避孕药,在三相组(n=155 人最终完成研究)中,使用三相 LNG-EE 50-75-125/30-40-30 mcg 避孕药。使用 SPSS 10 进行统计学分析:卡方检验、Fisher 确切检验和学生 t 检验。

结果

两组常见副作用(包括恶心、头痛、紧张、面部色素沉着(黄褐斑)和体重(增加或减少))无显著差异,但三相组突破性出血和点滴出血(BTB/S)较少,分别为 30 个周期(18.86%)和 10 个周期(6.45%),P=0.009*。两种 OCP 的患者满意度相似且较高。副作用发生率较低。

结论

根据患者满意度和副作用,单相和三相避孕药似乎相似;因此,除了 BTB/S 之外,三相没有优于单相的优势。

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