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含左炔诺孕酮避孕阴道环治疗月经过多的随机对照研究

Contraceptive vaginal ring treatment of heavy menstrual bleeding: a randomized controlled trial with norethisterone.

机构信息

Department of Obstetrics and Gynecology, Faculty of Medicine, Mansoura University, Mansoura, Egypt.

出版信息

Contraception. 2012 Mar;85(3):246-52. doi: 10.1016/j.contraception.2011.07.012. Epub 2011 Sep 13.

Abstract

BACKGROUND

This study compared the efficacy of the contraceptive vaginal ring (CVR; NuvaRing; N.V. Organon, Oss, the Netherlands) and norethisterone for treatment of idiopathic heavy menstrual bleeding (HMB) during the fertile age.

STUDY DESIGN

Ninety-five women with idiopathic HMB were selected in this randomized controlled trial. They were treated with either the CVR (n=48) or norethisterone (n=47) for three cycles. Each cycle consisted of 3 weeks of CVR use and then a 1-week ring-free period or norethisterone tablets, 5 mg three times daily from Cycle Days 5 to 26. Outcome measures were as follows: menstrual blood loss assessed by pictorial blood loss assessment chart (PBAC), duration of menses, hemoglobin, serum ferritin, quality of life (QoL) questionnaire, side effects and overall satisfaction with treatment.

RESULT

Significant improvements in PBAC score, the duration of menses, hemoglobin, serum ferritin and QoL were observed at the end of the study in each group. No statistically significant differences were found regarding the mean PBAC score (90.2±24.4 vs. 92.3±26.7) and its percent reduction (68.6% vs. 69.5%), duration of menses (5.3±1.2 vs. 5.5±1.1 days), hemoglobin and serum ferritin at the end of the study between the CVR and the norethisterone groups, respectively. Significantly more ring users were satisfied and elected to continue with treatment.

CONCLUSION

Both the CVR and oral norethisterone are effective treatments for idiopathic HMB. The CVR may be an attractive option especially for those requesting contraception as well.

摘要

背景

本研究比较了避孕阴道环(CVR;NuvaRing;荷兰 Organon 公司)和炔诺酮治疗生育期特发性月经过多(HMB)的疗效。

研究设计

本随机对照试验纳入了 95 例特发性 HMB 患者。他们分别接受 CVR(n=48)或炔诺酮(n=47)治疗,共 3 个周期。每个周期包括 3 周的 CVR 使用和 1 周的无环期,或炔诺酮片,5mg,每日 3 次,从周期第 5 天至第 26 天。疗效评估指标如下:采用图像出血量评估图表(PBAC)评估月经失血量、经期持续时间、血红蛋白、血清铁蛋白、生活质量(QoL)问卷、副作用和对治疗的总体满意度。

结果

研究结束时,两组的 PBAC 评分、经期持续时间、血红蛋白、血清铁蛋白和 QoL 均有显著改善。两组间 PBAC 评分的平均值(90.2±24.4 与 92.3±26.7)及其降低百分比(68.6%与 69.5%)、经期持续时间(5.3±1.2 与 5.5±1.1 天)、血红蛋白和血清铁蛋白均无统计学差异。CVR 组患者的满意度明显更高,且更愿意继续接受治疗。

结论

CVR 和口服炔诺酮均为治疗特发性 HMB 的有效方法。CVR 可能是一种特别有吸引力的选择,尤其是对那些同时需要避孕的患者。

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