From the Nuffield Department of Women's Health and Reproductive Research (A.S.C., P.S., M.V.), University of Oxford, United Kingdom.
Merton College (J.O.), University of Oxford, United Kingdom.
Hypertension. 2019 Oct;74(4):983-990. doi: 10.1161/HYPERTENSIONAHA.119.12739. Epub 2019 Aug 12.
The ratio of maternal serum sFlt-1 (soluble fms-like tyrosine kinase 1) to PlGF (placental growth factor) has been used retrospectively to rule out the occurrence of preeclampsia, a pregnancy hypertensive disorder, within 7 days in women presenting with clinical suspicion of preeclampsia. A prospective, interventional, parallel-group, randomized clinical trial evaluated the use of sFlt-1/PlGF ratio in women presenting with suspected preeclampsia. Women were assigned to reveal (sFlt-1/PlGF result known to clinicians) or nonreveal (result unknown) arms. A ratio cutoff of 38 was used to define low (≤38) and elevated risk (>38) of developing the condition in the subsequent week. The primary end point was hospitalization within 24 hours of the test. Secondary end points were development of preeclampsia and other adverse maternal-fetal outcomes. We recruited 370 women (186 reveal versus 184 nonreveal). Preeclampsia occurred in 85 women (23%). The number of admissions was not significantly different between groups (n=48 nonreveal versus n=60 reveal; =0.192). The reveal trial arm admitted 100% of the cases that developed preeclampsia within 7 days, whereas the nonreveal admitted 83% (=0.038). Use of the test yielded a sensitivity of 100% (95% CI, 85.8-100) and a negative predictive value of 100% (95% CI, 97.1-100) compared with a sensitivity of 83.3 (95% CI, 58.6-96.4) and negative predictive value of 97.8 (95% CI, 93.7-99.5) with clinical practice alone. Use of the sFlt-1/PlGF ratio significantly improved clinical precision without changing the admission rate. Clinical Trial Registration- URL: http://www.isrctn.com. Unique identifier: ISRCTN87470468.
母体血清 sFlt-1（可溶性 fms 样酪氨酸激酶 1）与 PlGF（胎盘生长因子）的比值已被用于回顾性排除有临床疑似子痫前期的女性在 7 天内发生子痫前期（妊娠高血压疾病）。一项前瞻性、干预性、平行组、随机临床试验评估了 sFlt-1/PlGF 比值在疑似子痫前期女性中的应用。将女性分配到揭示（临床医生已知 sFlt-1/PlGF 结果）或非揭示（结果未知）组。使用比值截断值 38 来定义低（≤38）和高（>38）风险，以在随后的一周内发生该疾病。主要终点是在测试后 24 小时内住院。次要终点是子痫前期和其他不良母婴结局的发生。我们招募了 370 名女性（186 名揭示组与 184 名非揭示组）。85 名女性发生子痫前期（23%）。两组的住院人数无显著差异（非揭示组 n=48 例与揭示组 n=60 例；=0.192）。在揭示试验组中，7 天内发生子痫前期的病例全部住院，而非揭示组仅 83%的病例住院（=0.038）。与仅使用临床实践相比，该检测的敏感性为 100%（95%CI，85.8-100），阴性预测值为 100%（95%CI，97.1-100），特异性为 83.3%（95%CI，58.6-96.4），阴性预测值为 97.8%（95%CI，93.7-99.5）。使用 sFlt-1/PlGF 比值可显著提高临床精度，而不改变入院率。临床试验注册- URL：http://www.isrctn.com。唯一标识符：ISRCTN87470468。
