Ray Alokananda, Gaur Ankita, Kumari Sarita
Obstetrics and Gynaecology, Tata Main Hospital, Jamshedpur, IND.
Cureus. 2022 Nov 26;14(11):e31923. doi: 10.7759/cureus.31923. eCollection 2022 Nov.
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.
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。