Carolina Women's Research and Wellness Center, Durham, NC 27713, USA.
Curr Med Res Opin. 2010 Nov;26(11):2673-8. doi: 10.1185/03007995.2010.526098. Epub 2010 Oct 13.
A dichotomy exists within the treatment of heavy menstrual bleeding (HMB); guidelines and expert opinion recommend that clinical management be guided by subjective, patient-centered measures, yet clinical trials often describe treatment efficacy in terms of objective reductions in menstrual blood loss (MBL). The purpose of this investigation was to correlate subjective and objective aspects of HMB treatment by identifying the minimum change in MBL that would be considered meaningful to women.
Receiver operating characteristic (ROC) curve analyses were performed using data from a multicenter, randomized, double-blind, placebo-controlled, parallel-group study of a novel, oral formulation of tranexamic acid (Lysteda). The study enrolled women ages 18-49 years with a history of cyclic HMB. Menstrual blood loss was measured objectively using the alkaline hematin method and subjectively using the Menorrhagia Impact Questionnaire (MIQ), a patient-reported outcome instrument previously validated in an HMB population. Additional subgroup analyses were performed after stratification by low (80-160 mL/cycle) or high (> 160 mL/cycle) baseline MBL.
NCT00401193 (NIH Clinical Trials Registry)
A total of 278 women were included in the ROC analyses. The best balance of sensitivity and specificity was achieved for predicting a patient-perceived meaningful improvement in MBL, at a cut point of 36 mL/cycle. Absolute reductions in MBL that were considered meaningful were more modest in women with lower baseline MBL (22 mL/cycle) and greater in women with higher baseline MBL (47 mL/cycle). However, an approximately 22% MBL reduction was meaningful to the majority of women in either the low or high baseline MBL subgroups.
Reducing measurable MBL by 36 mL/cycle, or approximately 22%, was considered to be a meaningful improvement for the majority of women with HMB in this study population.
在治疗月经过多（HMB）方面存在二分法；指南和专家意见建议临床管理应以主观的、以患者为中心的措施为指导，但临床试验通常以客观减少月经失血量（MBL）来描述治疗效果。本研究的目的是通过确定对女性有意义的 MBL 最小变化来关联 HMB 治疗的主观和客观方面。
使用一种新型口服氨甲环酸（Lysteda）的多中心、随机、双盲、安慰剂对照、平行组研究的数据进行接收者操作特征（ROC）曲线分析。该研究纳入了年龄在 18-49 岁之间、有周期性 HMB 病史的女性。月经失血量通过碱性正铁血红素法进行客观测量，通过 Menorrhagia Impact Questionnaire（MIQ）进行主观测量，MIQ 是一种以前在 HMB 人群中验证过的患者报告结局工具。还对低（80-160 mL/周期）或高（> 160 mL/周期）基线 MBL 分层后的亚组进行了额外的分析。
NCT00401193（美国国立卫生研究院临床试验注册处）
共有 278 名女性纳入 ROC 分析。在预测患者感知到的 MBL 有意义改善方面，达到最佳灵敏度和特异性平衡的截点为 36 mL/周期。在基线 MBL 较低的女性（22 mL/周期）和基线 MBL 较高的女性（47 mL/周期）中，认为有意义的 MBL 绝对减少幅度较小。然而，在低或高基线 MBL 亚组中，约 22%的 MBL 减少对大多数女性来说都是有意义的。
在本研究人群中，对于大多数 HMB 女性来说，将可测量的 MBL 减少 36 mL/周期，或约 22%，被认为是有意义的改善。
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