左炔诺孕酮宫内节育系统放置后初始出血或点滴出血的管理：一项随机对照试验。

Management of initial bleeding or spotting after levonorgestrel-releasing intrauterine system placement: a randomized controlled trial.

机构信息

Medicus AS, Trondheim, Norway; Global Medical Affairs Women's HealthCare and Global Clinical Statistics, Bayer Healthcare, Berlin, Germany; Gynecology, Skt Anne Plads, Odense, Denmark; and Town Centre Medical Practice, Cork, Ireland.

出版信息

Obstet Gynecol. 2013 May;121(5):934-941. doi: 10.1097/AOG.0b013e31828c65d8.

DOI:10.1097/AOG.0b013e31828c65d8

PMID:23635728

Abstract

OBJECTIVE

To assess the efficacy of tranexamic acid or mefenamic acid in the management of the initial "nuisance" bleeding or spotting in the period immediately after placement of the levonorgestrel-releasing intrauterine system.

METHODS

Women were randomized after levonorgestrel-releasing intrauterine system placement to oral tranexamic acid (500 mg), mefenamic acid (500 mg), or placebo three times daily during bleeding or spotting episodes over a 90-day treatment period. Treatment was initiated from onset of a bleeding or spotting episode and continued until the first day after bleeding or spotting stopped and restarted with a new bleeding or spotting episode. The primary efficacy variable was reduction in the number of bleeding or spotting days. Tranexamic acid and mefenamic acid were compared with placebo using a one-sided Wilcoxon rank-sum test. Bonferroni-Holm adjustment was used to account for multiple testing.

RESULTS

A total of 204 women were screened; 187 were randomized to tranexamic acid (n=63), mefenamic acid (n=63), or placebo (n=61). The median number of bleeding or spotting days experienced during treatment was 25, 29, and 33 days in the three groups, respectively. The median number of bleeding or spotting days was reduced by 6 days (95% confidence interval [CI] -14.0 to 1.0, P=.049) with tranexamic acid and by 3 days (95% CI -11.0 to 5.0, P=.229) with mefenamic acid compared with placebo. The relative risk of bleeding or spotting compared with placebo with tranexamic acid and mefenamic acid was 0.82 (95% CI 0.65-1.03) and 0.89 (95% CI 0.71-1.11), respectively. Most women (85% or more) were satisfied with the levonorgestrel-releasing intrauterine system across the groups.

CONCLUSIONS

Tranexamic acid and mefenamic acid during the first 90 days after levonorgestrel-releasing intrauterine system placement do not alleviate "nuisance" bleeding or spotting.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov, www.clinicaltrials.gov, NCT01295294.

LEVEL OF EVIDENCE

摘要

目的

评估氨甲环酸或甲芬那酸在管理左炔诺孕酮宫内节育系统放置后立即出现的初始“恼人”出血或点滴出血中的疗效。

方法

在左炔诺孕酮宫内节育系统放置后，女性被随机分为三组，分别接受氨甲环酸（500mg）、甲芬那酸（500mg）或安慰剂，每日三次，在 90 天的治疗期间，在出血或点滴出血期间使用。治疗从出血或点滴出血发作开始，并持续到出血或点滴出血停止后的第一天，然后在新的出血或点滴出血发作时重新开始。主要疗效变量是减少出血或点滴出血天数。使用单侧 Wilcoxon 秩和检验比较氨甲环酸和甲芬那酸与安慰剂的差异。采用 Bonferroni-Holm 调整法来校正多重检验。

结果

共筛选了 204 名女性；187 名被随机分配至氨甲环酸组（n=63）、甲芬那酸组（n=63）或安慰剂组（n=61）。三组治疗期间的中位出血或点滴出血天数分别为 25、29 和 33 天。与安慰剂相比，氨甲环酸可减少 6 天（95%置信区间[CI]-14.0 至 1.0，P=0.049），甲芬那酸可减少 3 天（95%CI-11.0 至 5.0，P=0.229）。与安慰剂相比，氨甲环酸和甲芬那酸的出血或点滴出血相对风险分别为 0.82（95%CI 0.65-1.03）和 0.89（95%CI 0.71-1.11）。大多数女性（85%或以上）对各组的左炔诺孕酮宫内节育系统感到满意。