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中华妇幼临床医学杂志(电子版) ›› 2020, Vol. 16 ›› Issue (02) : 181 -187. doi: 10.3877/cma.j.issn.1673-5250.2020.02.009

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论著

输卵管妊娠患者发生持续性异位妊娠危险因素及早期诊断的倾向性评分匹配分析
何浈1, 何翔1, 郄明蓉1,†()   
  1. 1. 四川大学华西第二医院妇产科、出生缺陷与相关妇儿疾病教育部重点实验室，成都　610041
  • 收稿日期:2019-09-18 修回日期:2020-03-18 出版日期:2020-04-01
  • 通信作者: 郄明蓉

Risk factors and early diagnosis of persistent ectopic pregnancy in fallopian tubal pregnancy patients: propensity score matching analysis

Zhen He1, Xiang He1, Mingrong Qie1,†()   

  1. 1. Department of Obstetrics and Gynecology, Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education, West China Second University Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China
  • Received:2019-09-18 Revised:2020-03-18 Published:2020-04-01
  • Corresponding author: Mingrong Qie
  • About author:
    Corresponding author: Qie Mingrong, Email:
  • Supported by:
    Science and Technology Plan Project of Science and Technology Department of Sichuan Province(2018JY0609)
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引用本文：

何浈, 何翔, 郄明蓉. 输卵管妊娠患者发生持续性异位妊娠危险因素及早期诊断的倾向性评分匹配分析[J]. 中华妇幼临床医学杂志(电子版), 2020, 16(02): 181-187.

Zhen He, Xiang He, Mingrong Qie. Risk factors and early diagnosis of persistent ectopic pregnancy in fallopian tubal pregnancy patients: propensity score matching analysis[J]. Chinese Journal of Obstetrics & Gynecology and Pediatrics(Electronic Edition), 2020, 16(02): 181-187.

目的

探讨输卵管妊娠(FTP)患者发生持续性异位妊娠(PEP)的高危因素，以及对早期诊断PEP的倾向性评分匹配(PSM)分析。

方法

选择2011年1月至2018年12月，于四川大学华西第二医院接受腹腔镜保守性手术治疗(COT)后，发生PEP的17例FTP患者为研究对象，纳入PEP组。同时，随机选取同期于本院接受相同术式，并且术后恢复良好的148例FTP患者作为对照，纳入对照组。采用回顾性分析方法，采集2组患者临床病例资料。采用Mann-Whitney U检验，PSM后，2组患者术后血清β-人绒毛膜促性腺激素(hCG)水平下降至<20 mIU/mL与<10 mIU/mL的时间，以及术后24～48 h血清β-hCG水平较术前下降率进行比较。采用χ2检验，比较2组患者的盆腔黏连、输卵管间质部及壶腹部妊娠发生率。绘制2组患者术后24～48 h血清β-hCG水平较术前下降率对于诊断FTP患者接受COT后发生PEP的受试者工作特征(ROC)曲线，并计算ROC曲线下面积(ROC-AUC)。根据约登指数最大原则，确定2组患者术后24～48 h血清β-hCG水平较术前下降率，对诊断FTP患者接受COT后，发生PEP的最佳临界值。本研究遵循的程序符合2013年新修订的《世界医学协会赫尔辛基宣言》要求。

结果

①PSM后，与研究组成功匹配的对照组患者为65例。PSM后，2组患者年龄、孕次、人体质量指数(BMI)、停经时间等一般临床资料比较，差异亦均无统计学意义(P>0.05)。②PSM后，PEP组患者盆腔黏连、输卵管间质部妊娠发生率分别为88.2%(15/17)、29.4%(5/17)，均显著高于对照组的61.5%(40/65)、3.1%(2/65)，2组分别比较，差异均有统计学意义(χ2＝4.349、P＝0.037，χ2＝8.834、P＝0.003)。③PSM后，PEP组患者术后血清β-hCG水平下降至<20 mIU/mL与<10 mIU/mL的时间分别为45.0 d(32.7～61.2 d)与59.5 d(41.0～68.7 d)，显著长于对照组的15.0 d(10.0～19.0 d)与17.5 d(10.7～27.2 d)，并且差异均有统计学意义(Z＝4.703、4.418，P<0.001)。④PSM后，PEP组患者术后24～48 h血清β-hCG水平较术前下降率为47.0%(－8.0%～70.1%)，显著低于对照组的69.0%(61.2%～79.2%)，2组比较，差异有统计学意义(Z＝3.506、P<0.001)。2组患者术后24～48 h血清β-hCG水平较术前下降率，诊断FTP患者接受COT后，发生PEP的ROC-AUC为0.777(95%CI：0.626～0.929，P<0.001)。根据约登指数最大原则，2组患者术后24～48 h血清β-hCG水平较术前下降率，诊断FTP患者接受COT后，发生PEP的最佳临界值为52.9%，此时其诊断PEP的敏感度为64.7%，特异度为95.4%，阳性预测值为78.6%，阴性预测值为91.2%，准确度为89.0%，漏诊率为35.3%，误诊率为4.6%。

结论

输卵管间质部妊娠与盆腔黏连，可能是FTP患者接受COT后发生PEP的高危因素。术后24～48 h血清β-hCG水平较术前下降率，可能可以作为FTP患者接受COT后发生PEP的早期诊断指标之一。

关键词: 妊娠，输卵管, 持续性异位妊娠, 倾向性评分匹配, 绒毛膜促性腺激素，β亚单位，人, 早期诊断, 女(雌)性
Objective

To explore risk factors and early diagnosis method of persistent ectopic pregnancy (PEP) in fallopian tubal pregnancy (FTP) patients based on propensity score matching (PSM) analysis.

Methods

From January 2011 to December 2018, a total of 17 patients with FTP who underwent laparoscopic conservative operations therapy (COT) in the West China Second University Hospital of Sichuan University and developed to PEP after operation were selected as research subjects and included into PEP group. At the same time, 148 patients who received laparoscopic COT in our hospital during the same period and recovered well after operation were randomly selected as control group. Clinical data of patients in two groups were collected by retrospective analysis. Mann-Whitney U test was used to compare the duration of serum β-human chorionic gonadotropin (hCG) decreased to <20 mIU/mL and <10 mIU/mL after operation, and the decrease ratio of serum β-hCG within 24-48 h after operation compared with that before operation in two matched groups. The incidence rates of pelvic adhesion, tubal interstitial and ampulla pregnancy were compared by chi-square test. The receiver operator characteristic (ROC) curve of decrease ratio of serum β-hCG within 24-48 h after operation compared with that before operation for diagnosis of PEP in FTP patients after COT was drawn and the area under ROC curve (ROC-AUC) was calculated. According to the maximum principle of Youden index, the optimal cut-off value of decrease ratio of serum β-hCG within 24-48 h after operation compared with that before operation for diagnosis of PEP in FTP patients after COT was determined. This study met the requirements of World Medical Association Declaration of Helsinki revised in 2013.

Results

①After PSM, 65 patients in control group were matched successfully. There were no significant differences between two groups matched by PSM in terms of age, gravidity, body mass index (BMI) and menopause duration (P>0.05). ②After PSM, the incidence rates of pelvic adhesion and tubal interstitial pregnancy in PEP group were 88.2% (15/17) and 29.4% (5/17), respectively, which were significantly higher than those 61.5% (40/65) and 3.1% (2/65) in control group, and both the differences were statistically significant (χ2=4.349, P=0.037; χ2=8.834, P=0.003). ③After PSM, the duration of serum β-hCG decreased to <20 mIU/mL and <10 mIU/mL after operation in PEP group was 45.0 d (32.7-61.2 d) and 59.5 d (41.0-68.7 d), respectively, which were significantly longer than those 15.0 d (10.0-19.0 d) and 17.5 d (10.7-27.2 d) in control group, and both the differences were statistically significant (Z=4.703, 4.418; P<0.001). ④After PSM, the decrease ratio of serum β-hCG within 24-48 h after operation compared with that before operation in PEP group was 47.0% (-8.0%-70.1%), which was significantly lower than that 69.0% (61.2%-79.2%) in control group, and the difference was statistically significant (Z=3.506, P<0.001). The ROC-AUC of decrease ratio of serum β-hCG within 24-48 h after operation compared with that before operation for diagnosis of PEP in FTP patients after COT was 0.777 (95%CI: 0.626-0.929, P<0.001). According to the maximum principle of Youden index, the optimal cut-off value of decrease ratio of serum β-hCG within 24-48 h after operation compared with that before operation for diagnosis of PEP in FTP patients after COT was 52.9%, and the sensitivity, specificity, positive predictive value, negative predictive value, accuracy, missed diagnosis rate and misdiagnosis rate were 64.7%, 95.4%, 78.6%, 91.2%, 89.0%, 35.3% and 4.6%, respectively.

Conclusions

Tubal interstitial pregnancy and pelvic adhesion may be high risk factors of PEP in FTP patients after COT. The decrease ratio of serum β-hCG within 24-48 h after operation compared with that before operation may be one of the indicators for early diagnosis of PEP in FTP patients after COT.

Key words: Pregnancy, tubal, Persistent ectopic pregnancy, Propensity score matching, Chorionic gonadotropin, beta subunit, human, Early diagnose, Female
表1 PSM前、后，2组患者一般临床资料比较
组别 PSM前 PSM后
例数 年龄(岁，±s) 孕次[次，M(P25～P75)] BMI(kg/m2，±s) 停经时间(d，±s) 例数 年龄(岁，±s) 孕次[次，M(P25～P75)] BMI(kg/m2，±s) 停经时间(d，±s)
PEP组 17 29.2±5.6 3.0(2.0～4.0) 20.4±2.3 46.5±7.3 17 29.2±5.6 3.0(2.0～4.0) 20.4±2.3 46.5±7.3
对照组 148 30.2±5.3 2.0(1.0～3.0) 21.1±2.6 50.2±10.6 65 29.2±4.7 3.0(2.0～4.0) 20.7±2.7 46.3±7.9
检验值 ? t＝0.688 Z＝1.571 t＝0.928 t＝1.392 ? t＝0.003 Z＝0.404 t＝－0.374 t＝0.099
P值 ? 0.493 0.116 0.355 0.166 ? 0.997 0.687 0.709 0.921
表2 PSM后，2组患者术前相关临床资料比较
组别 例数 超声检查EP包块直径[cm，M(P25～P75)] 术前血清β-hCG水平[mIU/mL，M(P25～P75)] 既往EP史[例数(%)] 输卵管手术史[例数(%)] 其他盆腔手术史[例数(%)] 孕囊[例数(%)] 卵黄囊[例数(%)] 胎心搏动[例数(%)]
PEP组 17 3.0(2.1～3.9) 3 426.7(1 971.3～19 941.6) 3(17.6) 3(17.6) 6(35.3) 3(17.6) 3(17.6) 2(11.8)
对照组 65 3.1(2.2～3.8) 3 032.0(1 362.0～6 396.3) 25(38.5) 19(29.2) 17(26.2) 9(13.8) 8(12.3) 1(1.5)
检验值 ? Z＝0.452 Z＝1.355 χ2＝2.596 χ2＝0.426 χ2＝0.197 χ2<0.001 χ2＝0.031 —
P值 ? 0.651 0.175 0.107 0.514 0.657 0.993 0.861 0.107
表3 PSM后，2组患者术中情况比较
组别 例数 盆腔黏连[例数(%)] 左、右侧FTP[例数(%)] FTP部位[例数(%)] 手术持续时间[min， M(P25～P75)] 术中失血量[mL，M(P25～P75)]
左侧 右侧 间质部 壶腹部 伞部
PEP组 17 15(88.2) 3(17.6) 14(82.4) 5(29.4) 11(64.7) 1(5.9) 60.0(37.5～65.0) 150.0(32.5～400.0)
对照组 65 40(61.5) 27(41.5) 38(58.5) 2(3.1) 61(93.8) 2(3.1) 50.0(40.0～72.5) 150.0(60.0～245.0)
检验值 ? χ2＝4.349 χ2＝3.315 χ2＝8.834 χ2＝8.138 — Z＝0.304 Z＝0.366
P值 ? 0.037 0.069 0.003 0.004 0.507 0.761 0.714
表4 PSM后，2组患者术后血清β-hCG水平下降至<20 mIU/mL与<10 mIU/mL的时间，以及术后24～48 h血清β-hCG水平较术前下降率比较[M(P25～P75)]
组别 术后血清β-hCG水平下降至<20 mIU/mL的时间(d) 术后血清β-hCG水平下降至<10 mIU/mL的时间(d) 术后24～48 h血清β-hCG水平较术前下降率(%)
例数a 时间 例数a 时间 例数 下降率
PEP组 14 45.0(32.7～61.2) 12 59.5(41.0～68.7) 17 47.0(－8.0～70.1)
对照组 34 15.0(10.0～19.0) 32 17.5(10.7～27.2) 65 69.0(61.2～79.2)
Z值 ? 4.703 ? 4.418 ? 3.506
P值 ? <0.001 ? <0.001 ? <0.001
图1 术后24～48 h血清β-hCG水平较术前下降率诊断FTP患者接受COT后发生PEP的ROC曲线
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