Gilbert Donders, Helena Kopp Kallner, Brian Hauck, Anja Bauerfeind, Ann-Kathrin Frenz, Michal Zvolanek, Dale W Stovall
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引用次数: 0
Abstract
Purpose: To investigate bleeding profile satisfaction and pain and ease of placement with levonorgestrel 19.5 mg IUD in routine clinical practice.
Methods: Women who independently chose levonorgestrel 19.5 mg IUD during routine counselling were invited to participate in this prospective, multinational, observational study. Patient-reported pain and clinician-reported ease of placement were assessed. Bleeding profile satisfaction was evaluated at 12 months/premature end of observation.
Results: Most participants (77.8%, n = 878/1129) rated levonorgestrel 19.5 mg IUD placement pain as 'none' or 'mild' and most clinicians (91.1%, n = 1029/1129) rated placement as 'easy'. Pain was more often rated higher in nulliparous compared with parous (p < .0001) and younger (<26 years) compared with older participants (p < .0001), although 67.7% and 69.0% of nulliparous and younger participants respectively reported 'none' or 'mild' pain. Bleeding profile satisfaction at 12 months/end of observation was similar in parous (72.9%, n = 318/436) and nulliparous (69.6%, n = 314/451) participants. Most participants irrespective of age reported bleeding profile satisfaction, ranging from 67.8% (n = 206/304) for 18-25 years to 76.5% (n = 218/285) for >35 years.
Conclusion: We observed high bleeding profile satisfaction regardless of age or parity with levonorgestrel 19.5 mg IUD and confirmed that device placement is easy and associated with no more than mild pain in most cases in routine clinical practice. Real-world evidence from the Kyleena® Satisfaction Study in routine clinical practice shows high bleeding profile satisfaction with levonorgestrel 19.5 mg IUD regardless of age or parity. IUD placement was easy and associated with little to no pain for most women.
目的:探讨左炔诺孕酮19.5 mg宫内节育器在临床常规应用中的出血情况、满意度、疼痛程度及放置难易程度。方法:邀请在常规咨询中独立选择左炔诺孕酮19.5 mg宫内节育器的妇女参加这项前瞻性、多国观察性研究。评估患者报告的疼痛和临床报告的放置难易程度。在12个月/提前结束观察时评估出血情况满意度。结果:大多数参与者(77.8%，n = 878/1129)认为左炔诺孕酮19.5 mg宫内节育器放置疼痛为“无”或“轻微”，大多数临床医生(91.1%，n = 1029/1129)认为放置疼痛“容易”。与已产(p p n = 318/436)和未产(p p n = 314/451)的参与者相比，未产的参与者对疼痛的评分更高(p p n = 318/436)。无论年龄大小，大多数参与者报告的出血情况满意度从18-25岁的67.8% (n = 206/304)到>35岁的76.5% (n = 218/285)。结论:我们观察到无论年龄或胎次使用左炔诺孕酮19.5 mg宫内节育器都有很高的出血满意度，并证实在常规临床实践中，大多数情况下装置放置容易且仅伴有轻微疼痛。Kyleena®满意度研究在常规临床实践中的真实证据表明，无论年龄或胎次，左炔诺孕酮19.5 mg宫内节育器的出血满意度很高。对大多数妇女来说，放置宫内节育器很容易，几乎没有疼痛。
期刊介绍：
Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance.
Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.
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