甲氨蝶呤治疗异位妊娠的真实世界数据分析

Real world data analysis of methotrexate for ectopic pregnancy

目的:通过对临床上甲氨蝶呤(MTX)治疗异位妊娠病例的研究,了解真实世界里MTX肌肉注射治疗异位妊娠的临床现状,以更好地指导临床规范合理治疗。方法:以2016年1月至2020年12月间南京医科大学附属妇产医院妇科电子病历为数据来源,对MTX肌肉注射治疗异位妊娠患者的临床资料进行分析。结果:临床上总药物治疗成功率为81.3%,大多数使用单剂量MTX肌肉注射治疗方案,实际使用剂量大多数低于标准剂量(50 mg·m^(-2)),并且实际使用剂量的差别对成功率没有影响。治疗后的随诊并不完全符合规范。治疗前血清β绒毛促性腺激素(β-hCG)值越高,MTX单次注射治疗的成功率越低(OR=0.638);停经天数(末次月经到注射MTX时间)越长,MTX单次注射治疗的成功率越高(OR=1.570)。成功组在注射后4~7 d血β-hCG值下降均显著高于失败组,但在第2、3天与失败组差异无统计学意义。结论:临床工作中异位妊娠药物治疗的管理规范并未被严格执行,需要更多关注。注射前越低的血β-hCG值及越长的停经天数是单次MTX治疗成功的重要预测因素。注射后第2、3天复查血β-hCG值对是否需要后继治疗无良好的预测价值。

Objective:To understand the status quo of methotrexate(MTX) treatment of ectopic pregnancy in the real world through the study of clinical cases of MTX treatment of ectopic pregnancy,so as to better guide the clinical standard and reasonable treatment.Methods:The clinical data of patients with pic pregnancy treated with MTX intramaterial injection were analyzed using the electronic medical records of gynecology in Women's Hospital of Nanjing Medical University from January 2016 to December 2020 as the data source.Results:The total success rate of drug therapy was 81.3%.Most of the single-dose MTX intramuscular injection treatment schemes were used,the actual dose used was mostly lower than the standard dose(50 mg·m~(-2)),and the difference of the actual dose had no effect on the success rate.Follow-up after treatment was not entirely up to standard.The higher the value of serum β subunit of human chorionic gonadotropin(β-hCG) before treatment,the lower the success rate of MTX single injection treatment(OR=0.638),and the longer the number of days without menstruation(time from the last menstruation to MTX injection),the higher the success rate of MTX treatment with a single injection(OR=1.570).The decrease of serum β-hCG value in the successful group was significantly higher than that in the failed group on days 4-7 after injection,but there was no significant difference between the successful group and the failed group on days 2 and 3.Conclusion:At present,the management norms of ectopic pregnancy drug therapy have not been strictly implemented,and more attention is needed.The lower serum β-hCG value before injection and the longer period of menopause are important predictors of the success of single MTX treatment.Reexaminations of blood β-hCG values 2 and 3 days after injection do not have good predictive value for the need for subsequent treatment.