Myers Evan R, Bastian Lori A, Havrilesky Laura J, Kulasingam Shalini L, Terplan Mishka S, Cline Kathryn E, Gray Rebecca N, McCrory Douglas C
Evid Rep Technol Assess (Full Rep). 2006 Feb(130):1-145.
To assess diagnostic strategies for distinguishing benign from malignant adnexal masses.
MEDLINE(R) and reference lists of recent reviews; discharge data from the Nationwide Inpatient Sample.
The major diagnostic methods evaluated were bimanual pelvic examination, ultrasound (morphology and Doppler velocimetry), MRI, CT, FDG-PET, CA-125, and scoring systems that incorporated multiple clinical, laboratory, and radiologic findings. Meta-analysis using a random-effects model was used to estimate pooled sensitivity and specificity for discriminating benign from malignant. We reviewed evidence for followup strategies for masses considered benign, and for adverse outcomes of diagnostic surgery. We also reviewed published models of the natural history of ovarian cancer and compared the impact of assumptions about natural history on outcomes.
The majority of studies did not describe whether patients presented with asymptomatic masses detected through screening or with symptoms. Prevalence of malignant masses in a U.S. postmenopausal screening population was approximately 0.1 percent, while benign masses were found in 0.8 to 1.8 percent of women. Pooled (a) sensitivity and (b) specificity were: bimanual exam (a) 0.45, (b) 0.90; ultrasound morphology scores (a) 0.86 to 0.91, (b) 0.68 to 0.83; Doppler resistive index (a) 0.72, (b) 0.90; pulsatility index (a) 0.80, (b) 0.73; maximum systolic velocity (a) 0.74, (b) 0.81; presence of vessels (a) 0.88, (b) 0.78; combined morphology and Doppler (a) 0.86, (b) 0.91; MRI (a) 0.91, (b) 0.88; CT (a) 0.90, (b) 0.75; FDG-PET (a) 0.67, (b) 0.79; and CA-125 (a) 0.78, (b) 0.78. Both sensitivity and specificity of CA-125 were better in postmenopausal than in premenopausal women. In modeled outcomes, combinations of imaging and CA-125 were both more sensitive and more specific than either alone. Performance of scoring systems in validation studies was consistently worse than in development studies; the highest demonstrated specificity observed was 0.91, with a concurrent sensitivity of 0.74. Evidence on followup strategies was sparse, although one large study provided good evidence for safely following unilocular cysts less than 10 cm in diameter. Overall complication rates in studies of surgically managed adnexal masses were low, but important clinical information was not reported.
All diagnostic modalities showed trade-offs between sensitivity and specificity, but the available literature does not provide sufficient detail on relevant characteristics of study populations to allow confident estimation of the results of alternative diagnostic strategies. Although modeling studies may prove useful in evaluating diagnostic algorithms, further work is needed to explore the implications of uncertainty about the natural history of ovarian cancer.
评估鉴别附件包块良恶性的诊断策略。
医学期刊数据库（MEDLINE®）及近期综述的参考文献列表；全国住院患者样本的出院数据。
评估的主要诊断方法包括双合诊盆腔检查、超声（形态学及多普勒测速）、磁共振成像（MRI）、计算机断层扫描（CT）、氟代脱氧葡萄糖正电子发射断层显像（FDG-PET）、癌抗原125（CA-125）以及纳入多项临床、实验室和影像学检查结果的评分系统。采用随机效应模型进行荟萃分析，以估计鉴别良恶性的合并敏感度和特异度。我们回顾了关于考虑为良性的包块的随访策略以及诊断性手术不良后果的证据。我们还回顾了已发表的卵巢癌自然史模型，并比较了自然史假设对结果的影响。
大多数研究未描述患者是通过筛查发现无症状包块还是有症状。美国绝经后筛查人群中恶性包块的患病率约为0.1%，而良性包块在0.8%至1.8%的女性中被发现。合并（a）敏感度和（b）特异度分别为：双合诊检查（a）0.45，（b）0.90；超声形态学评分（a）0.86至0.91，（b）0.68至0.83；多普勒阻力指数（a）0.72，（b）0.90；搏动指数（a）0.80，（b）0.73；最大收缩期速度（a）0.74，（b）0.81；血管存在情况（a）0.88，（b）0.78；形态学和多普勒联合（a）0.86，（b）0.91；MRI（a）0.91，（b）0.88；CT（a）0.90，（b）0.75；FDG-PET（a）0.67，（b）0.79；以及CA-125（a）0.78，（b）0.78。绝经后女性CA-125的敏感度和特异度均高于绝经前女性。在模型化结果中，影像学检查和CA-125的联合应用比单独使用更敏感且更特异。验证研究中评分系统的表现始终比开发研究中更差；观察到的最高特异度为0.91，同时敏感度为0.74。关于随访策略的证据很少，尽管一项大型研究为安全随访直径小于10 cm的单房囊肿提供了有力证据。手术治疗附件包块的研究中总体并发症发生率较低，但未报告重要的临床信息。
所有诊断方法在敏感度和特异度之间均存在权衡，但现有文献未提供关于研究人群相关特征的足够详细信息，无法可靠估计替代诊断策略的结果。尽管模型化研究可能有助于评估诊断算法，但仍需进一步研究以探讨卵巢癌自然史不确定性的影响。
