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Validation of Six Predictive Models for Adverse Outcomes of Hypertensive Disorders of Pregnancy in Eastern and Western China
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摘要:
目的 探究国内外文献报道的6种妊娠期高血压疾病(hypertensive disorders of pregnancy, HDP)不良结局预测模型在中国东西部地区人群中的应用价值。 方法 回顾性分析2011年5月1日至2019年4月30日于苏州大学附属第一医院、四川省妇幼保健院分娩且入院诊断为HDP的所有患者临床资料。采用fullPIERS、miniPIERS、Zwertbroek、PREP、Ngwenya、马国珺等模型对不良结局风险进行预测，并从区分度和校准度两个方面评估模型的预测性能。 结果 共入选符合纳入和排除标准的HDP患者2978例，其中苏州大学附属第一医院1492例，四川省妇幼保健院1486例。住院期间共655例(22.0%)患者发生不良结局事件，其中405例(13.6%)发生于入院48 h内；孕＜34周分娩(49.4%, 200/405)、需输血治疗(43.5%, 176/405)、胎盘早剥(23.5%, 95/405)是入院48 h内最常见的不良结局事件。6种模型预测HDP患者入院48 h内/住院期间发生不良结局的曲线下面积分布于0.600~0.897，灵敏度分布于57.1%~69.5%，特异度分布于60.1%~76.6%。Hosmer-Lemeshow拟合优度检验显示，除PREP模型(该模型的验证人群较少，未进行校准度评估)外，其他5种模型的P值均小于0.05。 结论 6种预测模型在中国东西部地区HDP患者不良结局预测中均有一定应用价值，但拟合性欠佳，且部分模型涉及的预测因子并非常规检查指标，模型大范围开展的可行性有待商榷。需基于中国人群的临床特征，建立更适合本土使用的HDP不良结局预测模型。 Abstract:Objective To explore the application value of six prediction models reported at home and abroad for adverse outcomes of hypertensive disorders of pregnancy(HDP) in eastern and western China. Methods For all patients who delivered in the First Affiliated Hospital of Soochow University and Sichuan Provincial Maternal and Child Health Care Hospital from May 1, 2011 to April 30, 2019 and were diagnosed with HDP, their clinical data were retrospectively analyzed. Six models, fullPIERS, miniPIERS, Zwertbroek, PREP, Ngwenya, and Ma Guojun, were used to predict the risk of adverse outcomes for the patients. The predictive performance of the models was evaluated in terms of discrimination and calibration. Results A total of 2978 patients were eligible. Combined adverse outcomes occurred in 13.6% (405/2978) of women within 48 h of admission, and 22.0% (655/2978) at any time during admission. The delivery < 34 weeks (49.4%, 200/405), need for blood product transfusion (43.5%, 176/405), and placental abruption (23.5%, 95/405) were the most common adverse outcomes within 48 hours of admission. The area under of the curve of the six models for predicting adverse outcomes in the patients with HDP within 48 hours of admission/during hospitalization ranged from 0.600 to 0.897, the sensitivity ranged from 57.1% to 69.5%, and the specificity ranged from 60.1% to 76.6%. The Hosmer-Lemeshow test showed that except for the PREP model (which had a small validation population and was not evaluated for calibration), the P-values of all the other 5 models were less than 0.05. Conclusions The six prediction models have certain application value in the prediction of adverse outcomes of HDP patients in the eastern and western regions of China, but the fitting is poor. The predictors involved in some models are not routine inspection indicators, and the feasibility of large-scale model application is still open to question. It is still necessary to establish a better prognostic model suitable for local areas based on Chinese characteristics. -
Key words:
- hypertensive disorders of pregnancy /
- preeclampsia /
- adverse outcome /
- predictive model /
- China
作者贡献：孙芳璨负责研究设计、数据收集与整理、统计分析、论文撰写；韩冰负责研究设计、研究指导、数据分析、论文修订；高岩负责研究设计、研究指导、论文修订；沈敏红负责数据收集与整理；陈友国负责研究指导、数据分析；钟文负责数据收集。利益冲突：所有作者均声明不存在利益冲突 -
表 1 本研究选取待验证的6种HDP不良结局预测模型
模型 发表时间 预测公式 AUC(95%CI) fullPIERS[8] 2011年 logit(P)=2.68-0.0541×(孕龄)+1.23×(胸痛或呼吸困难)-0.0271×(Cr)+0.207× (PLT) +4.00×10-5×(PLT)2+0.0101×(AST)-3.05×10-6× (AST)2+2.50×10-4×(Cr)× (PLT)-6.99×10-5×(PLT)×(AST)-2.56× 10-3×(PLT)×(SpO2) 0.88(0.84~0.92) miniPIERS[9] 2014年 logit(P)=-5.77-0.298 ×(经产妇)-1.07× log(孕龄) + 1.34× log(收缩压) -0.218× (随机尿蛋白++) + 0.424 × (随机尿蛋白+++) +0.512× (随机尿蛋白++++) +1.18×(阴道出血伴腹痛)+ 0.422 ×(头痛或视觉障碍)+0.847 × (胸痛或呼吸困难) 0.768(0.735~0.801) Zwertbroek[11] 2017年 logit(P)=-2.036-0.086×(年龄)+0.418×(合并症)+0.863 ×(慢性高血压)-0.135×(孕周)+0.045 ×(收缩压)-0.004×(PLT)+0.015×(Cr)+0.003×(LDH)+0.570×ln(存在蛋白尿，即PCR≥30 mg/mmol或24 h尿蛋白定量≥300 mg) 0.760(0.731~0.807) PREP[12] 2017年 PREP-L(从诊断早发型PE至产后出院期间整体不良结局风险评估)：
Probability (P) =exp(X)/[1 + exp(X)]
X=-1.507-0.020×(年龄) + 12.052×{[log(孕周)]3-39.902 41}-7.930×{[log(孕周)]3×log[log(孕周)]-49.081 88}-0.330× (存在一项既往史)-0.579×(存在两项及以上既往史)+ 0.146×log(PCR)-0.951×[log(Ure)-1]-0.004×(PLT)+ 0.024×(收缩压)+0.409×(使用降压药)+1.252×(使用硫酸镁)
PREP-S(从诊断早发型PE至孕34周期间不同时间点生存率评估)：
S(t)=S0 (t)§ ^exp [(β1×X1 + …+βn×Xn)]
S(t)=S0(t)^exp(K)
K=-0.031×(年龄)+1.514×{[log(孕周/10)]-2-0.834 513 6}+ 5.707×{[log(孕周/10)]-2×ln[log(孕周/10)]-0.065 215 5}+ 0.122(腱反射亢进)-0.169×(存在一项既往史)-0.384×(存在两项及以上既往史)+ 0.016×(收缩压)+0.797×(SpO2＜94%)-0.002×(PLT)+ 0.126×log(ALT)+ 0.605×log(Ure)2-0.144×log(Ure)3+0.265×log(Cr)+ 0.080×log(PCR)+ 0.176×(使用降压药)+ 1.066×(使用硫酸镁)
§S0 (t)-基线生存调整为适合的时间t
S0(48 h)=0.991 42, S0(72 h)=0.985 42, S0(1周)=0.964 92,
S0(1个月)=0.873 77PREP-L：
0.82 (0.80~0.84)
PREP-S：
0.84 (0.81~0.87)Ngwenya[15] 2020年 logit(P)=1.549 -0.041×(年龄)-0.044 ×(孕周)+ 0.133×(上腹部疼痛) +0.39 ×(阴道出血伴腹痛)-0.135 ×(Hb)-0.160×(PLT) 0.796(0.758~0.833) 马国珺[17] 2020年 logit(P)=-2.846+2.344×(蛋白尿)+1.054×(肝功能损伤)+1.116×(血小板减少症)+1.254×(早发型PE) 0.754(0.720~0.789) HDP: 妊娠期高血压疾病；AUC：曲线下面积(原文献中)；Cr：肌酐；PLT：血小板计数；AST：谷草转氨酶；ALT：谷丙转氨酶；SpO2：脉搏血氧饱和度；LDH：乳酸脱氢酶；PCR：尿蛋白肌酐比；Hb：血红蛋白；Ure：尿素；PE：子痫前期 
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表 2 6种模型预测HDP患者不良结局的预测价值
模型 验证人群 验证人数
(n)入院48 h内发生不良结局患者
[n(%)]预测入院48 h内发生不良结局的AUC(95% CI) 最佳临界值
(%)灵敏度
[%(95% CI)]特异度
[%(95% CI)]阳性似然比
(95% CI)阴性似然比
(95% CI)fullPIERS HDP患者 2978 405(13.6) 0.711
(0.682~0.739)1.9 65.9
(61.1~70.5)65.9
(64.0~67.7)1.93
(1.8~2.1)0.52
(0.5~0.6)miniPIERS HDP患者 2978 405(13.6) 0.723
(0.692~0.754)1.1 64.4
(59.6~69.1)76.6
(74.9~78.2)2.75
(2.5~3.0)0.46
(0.4~0.5)Zwertbroek 孕34+0~36+6周HDP患者 580 95(16.4) 0.739
(0.680~0.797)29.1 69.5
(59.2~78.5)71.1
(66.9~75.1)2.41
(2.0~2.9)0.43
(0.3~0.6)PREP* PREP-L 孕＜34周PE患者 21 17(81.0)† 0.897
(0.754~1)§- - - - - PREP-S 孕＜34周PE患者 21 11(52.4) 0.745
(0.528~0.963)- - - - - Ngwenya 重度PE患者 1248 326(26.1) 0.600
(0.562~0.638)22.6 57.1
(51.5~62.5)60.1
(56.8~63.3)1.43
(1.3~1.6)0.71
(0.6~0.8)马国珺 重度PE患者 1248 326(26.1) 0.729
(0.696~0.761)63.5 66.3
(60.8~71.4)70.0
(66.9~72.9)2.21
(1.9~2.5)0.48
(0.4~0.6)HDP、PE、AUC：同表 1；†住院期间发生不良结局的患者数及其所占比例；§住院期间发生不良结局的AUC(95%CI)；*鉴于PREP模型的验证人数较少，未检验其灵敏度、特异度、阳性似然比、阴性似然比
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