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甲氨蝶呤药物治疗未破裂输卵管异位妊娠成功的预测因素

Predictors of Successful Medical Management With Methotrexate in Unruptured Tubal Ectopic Pregnancy.

作者信息

Ray Alokananda, Gaur Ankita, Kumari Sarita

机构信息

Obstetrics and Gynaecology, Tata Main Hospital, Jamshedpur, IND.

出版信息

Cureus. 2022 Nov 26;14(11):e31923. doi: 10.7759/cureus.31923. eCollection 2022 Nov.

Abstract

Introduction Medical treatment with methotrexate (MTX) is a safe and effective alternative to surgery in carefully selected cases of ectopic pregnancies diagnosed early prior to rupture. Aim To determine the optimal pre-treatment levels of beta human chorionic gonadotropin (𝛽-hCG) and its changing trends most likely to have a successful outcome with medical management. Material and methods A prospective observational study was conducted in a tertiary teaching hospital from December 2018 to May 2021. "Single-dose" MTX regime was used for medical management of ectopic pregnancy in patients fulfilling the selection criteria. The 𝛽-hCG levels were recorded at baseline and on day 4 and day 7 of MTX injection. Thereafter, at weekly intervals till complete resolution or surgical intervention due to failure of medical management. In addition, receiver operating characteristic (ROC) curve analysis for a pre-treatment 𝛽-hCG cut-off value and changing trends in post-treatment 𝛽- hCG levels most likely to have a successful outcome with MTX treatment were determined. Results Fifty patients fulfilling the inclusion criteria were included in the study, with successful medical management in 33 (66%). The mean pre-treatment 𝛽-hCGlevels in women with successful medical management were 3270.97 (+/- 901) compared to 5249.17 (+/-808.02) for those with treatment failure (p=0.00001). The mean 𝛽-hCG level in the failed treatment group was significantly higher on day 4 than the pre-treatment levels (6742.56 +/- 572 vs. 5249.17+/- 808.02; p<0.05). Inadequate reduction of 𝛽-hCG level on day 7 (<15% of day 4 levels) requiring repeat dosage of MTX was more likely to have an unsuccessful outcome (p=0.00001). The area under curve (AUC) value of 0.905 (95% CI: 0.814-0.996) depicted that pre-treatment 𝛽-hCG level of 4000 mIU/ml taken as the cut-off value was able to predict levels ≤4000 mIU/ml had a greater likelihood of successful outcome with MTX, having a sensitivity of 84.5%, specificity of 83.3%, positive predictive value (PPV) of 90.3%, and negative predictive value (NPV) of 75% (p< 0.05). Demographic variables or previous clinical history, considered risk factors for ectopic pregnancy, did not affect the outcome of medical management in this study. Conclusion Medical management of ectopic pregnancy is a viable first-line treatment option in carefully selected patients. In this study, the most important predictors for the successful outcome of medical management were the pre-treatment β-hCG levels and their fall on day 4 and day 7 after MTX therapy.

摘要

引言 在精心挑选的早期诊断且未破裂的异位妊娠病例中,甲氨蝶呤(MTX)药物治疗是一种安全有效的手术替代方案。

目的 确定最有可能通过药物治疗获得成功结局的β-人绒毛膜促性腺激素(β-hCG)的最佳治疗前水平及其变化趋势。

材料与方法 2018年12月至2021年5月在一家三级教学医院进行了一项前瞻性观察研究。符合选择标准的患者采用“单剂量”MTX方案进行异位妊娠的药物治疗。在基线时以及MTX注射后第4天和第7天记录β-hCG水平。此后,每周记录一次,直至完全消退或因药物治疗失败而进行手术干预。此外,确定了治疗前β-hCG临界值的受试者工作特征(ROC)曲线分析以及MTX治疗最有可能获得成功结局的治疗后β-hCG水平变化趋势。

结果 50例符合纳入标准的患者纳入研究,33例(66%)药物治疗成功。药物治疗成功的女性患者治疗前β-hCG平均水平为3270.97(±901),而治疗失败的患者为5249.17(±808.02)(p = 0.00001)。治疗失败组第4天的β-hCG平均水平显著高于治疗前水平(6742.56±572 vs. 5249.17±808.02;p<0.05)。第7天β-hCG水平下降不足(<第4天水平的15%)需要重复使用MTX剂量的患者更有可能治疗失败(p = 0.00001)。曲线下面积(AUC)值为0.905(95%CI:0.814 - 0.996)表明,以4000 mIU/ml作为临界值的治疗前β-hCG水平能够预测≤4000 mIU/ml的水平使用MTX治疗成功结局的可能性更大,敏感性为84.5%,特异性为83.3%,阳性预测值(PPV)为90.3%,阴性预测值(NPV)为75%(p<0.05)。人口统计学变量或既往临床病史(被认为是异位妊娠的危险因素)在本研究中并未影响药物治疗的结局。

结论 在精心挑选的患者中,异位妊娠的药物治疗是一种可行的一线治疗选择。在本研究中,药物治疗成功结局的最重要预测因素是治疗前β-hCG水平及其在MTX治疗后第4天和第7天的下降情况。

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