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泰国女性使用透皮避孕贴片的临床研究。

A clinical study of transdermal contraceptive patch in Thai women.

作者信息

Suwanmalee Othanee, Taneepanichskul Surasak

机构信息

Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, Rama IV Rd, Bangkok 10330, Thailand.

出版信息

J Med Assoc Thai. 2006 Oct;89 Suppl 4:S1-4.

Abstract

OBJECTIVE

To study cycle control, compliance and safety of a transdermal contraceptive patch in Thai women.

MATERIAL AND METHOD

Sixty-nine healthy women were assigned to receive 3 cycles of contraceptive patch (ethinyl estradiol 20 microg and norelgestromin 150 miccrog/day). All participants aged 18-45 years were invited to participate at the family planning clinic at King Chulalongkorn Memorial Hospital. Adverse effects, perceived advantages, and disadvantages were collected.

RESULTS

The participants averaged 22.4 years old, height 158.9 cm, weight 52.5 kg, BMI 20.7. The most common location of patch application was abdomen and the most adverse event was application site reaction (29%) followed by breast tenderness, nausea vomiting, and headache. The breast symptom was mild in severity. The participants reported decrease in dysmenorrhea and shorter duration of bleeding. Only 1.1% had breakthrough bleeding. There were no significant changes in body weight and blood pressure. Improvement of their facial acne was reported. There were no pregnancies during the use and the adhesion of contraceptive patch was excellent, partial patch detachment was reported at only 14.4%. No complete patch detachment was found.

CONCLUSION

The study found an overall positive impression of new transdermal contraceptive patch. Good compliance and few side effects were demonstrated. The adhesive of the contraceptive patch was excellent.

摘要

目的

研究一种经皮避孕贴片在泰国女性中的周期控制、依从性及安全性。

材料与方法

69名健康女性被分配接受3个周期的避孕贴片(炔雌醇20微克和诺孕酯150微克/天)。所有年龄在18 - 45岁的参与者均在朱拉隆功国王纪念医院的计划生育诊所被邀请参与研究。收集不良反应、感知到的优点和缺点。

结果

参与者平均年龄22.4岁,身高158.9厘米,体重52.5千克,体重指数20.7。贴片最常应用的部位是腹部,最常见的不良事件是贴片应用部位反应(29%),其次是乳房压痛、恶心呕吐和头痛。乳房症状严重程度较轻。参与者报告痛经减轻且出血持续时间缩短。仅有1.1%出现突破性出血。体重和血压无显著变化。有参与者报告面部痤疮有所改善。使用期间无妊娠情况,避孕贴片的粘贴效果极佳,仅14.4%的人报告有部分贴片脱落。未发现完全脱落情况。

结论

该研究对新型经皮避孕贴片总体印象良好。显示出良好的依从性且副作用较少。避孕贴片的粘性极佳。

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