Abbott Laboratories, Abbott Park, IL, USA.
Reprod Sci. 2013 Jun;20(6):680-7. doi: 10.1177/1933719112463252. Epub 2012 Nov 27.
The menstrual pictogram (MP), a semiquantitative, easy-to-use tool to assess blood loss, was validated against the reference standard of alkaline hematin (AH) quantitation using data pooled from 3 clinical trials.
Premenopausal women aged ≥18 years with heavy menstrual bleeding (HMB) associated with uterine leiomyomata were randomized to asoprisnil (10 or 25 mg) or placebo. Patients completed the MP and collected feminine hygiene products for assessment of blood loss by the AH method. Agreement between the MP and the AH method was calculated.
The positive predictive value of the MP total to distinguish women with HMB against the AH total was 91%. The agreement (κ-statistic) between AH and MP totals for classifying patients with ≥50% or <50% decreases in HMB was 0.88 (95% confidence interval [CI], 0.78-0.98), and the MP was 96% sensitive and 92% specific. The methods showed good association for percentage change in blood (intraclass correlation coefficient [ICC] of 0.86, 95% CI, 0.80-0.91) but not for actual blood loss per cycle (ICC of 0.64, [95% CI, 0.55-0.71]); the greatest underestimation occurred for severely stained napkins.
In this study, the MP distinguished women with HMB and adequately assessed improvements with therapy.
月经图像（MP）是一种半定量的、易于使用的工具，用于评估出血量，本研究使用来自 3 项临床试验的数据对其进行了验证，验证标准为碱性血红素（AH）定量。
年龄≥18 岁的伴有子宫肌瘤的月经过多（HMB）的绝经前妇女被随机分配至阿索普里斯nil（10 或 25mg）或安慰剂组。患者完成 MP 并收集卫生棉条以通过 AH 法评估出血量。计算 MP 与 AH 法之间的一致性。
MP 总量区分 HMB 女性的阳性预测值为 91%。AH 和 MP 总量区分 HMB 减少≥50%或<50%的患者的一致性（κ 统计量）为 0.88（95%置信区间[CI]，0.78-0.98），MP 的敏感性为 96%，特异性为 92%。这两种方法在血液变化百分比方面具有良好的相关性（组内相关系数[ICC]为 0.86，95%CI，0.80-0.91），但与每个周期的实际失血量相关性不佳（ICC 为 0.64，95%CI，0.55-0.71）；严重染色的卫生巾会导致最大的低估。
在这项研究中，MP 区分了 HMB 女性，并充分评估了治疗的改善情况。
