Khani Behnaz, Behnamfar Fariba, Taghiyar Leila
Department of Obstetrics and Gynecology, Isfahan University of Medical Sciences, Isfahan, Iran.
Adv Biomed Res. 2020 Oct 30;9:59. doi: 10.4103/abr.abr_5_20. eCollection 2020.
Ectopic pregnancy (EP) is the most common cause of death in the first trimester of pregnancy. Methotrexate (MTX) is an acceptable treatment in the cases with the lack of tube rupture or no important one, which has reduced surgical treatment. Despite numerous studies, there is still no consensus about medications. The present study is aimed to evaluate the single- and multiple-dose of MTX among these patients.
This clinical trial study was done on 108 EP patients who were selected for the systemic MTX treatment and divided into two groups. For the single-dose group, MTX was administered once and β human chorionic gonadotropin (βHCG) levels were measured first and then on days 4 and 7. In the multi-dose group, 1 mg/kg MTX was injected on days 1, 3, 5, and 7. In both groups, MTX was prescribed following these days if βHCG was not reduced. In the two groups, βHCG levels were assessed after 1 week. The success rate of treatment and complications were followed up and recorded up to 6 weeks after treatment.
The success rate in the single-dose and multiple-dose MTX group was 47% and 51%. The MTX level in the single dose group decreased from 2532 ± 1154 mIU/mL to 1341 ± 553 mIU/mL and in the multiple dose group from 2671 ± 2685 mIU/mL to 1313 ± 605 mIU/mL ( < 0.05). Although a significant decrease was observed in each of the two groups over time, no significant difference was found between the two groups ( > 0.05).
Single and multi-dose regimen did not show a significant difference in terms of the success of treatment. Therefore, given that the lower dose of the drug associated with lower the risk of complications, it is safe to choose the single-dose regimen.
异位妊娠(EP)是妊娠早期最常见的死亡原因。甲氨蝶呤(MTX)是输卵管未破裂或无严重情况时可接受的治疗方法,减少了手术治疗。尽管有大量研究,但关于药物治疗仍未达成共识。本研究旨在评估这些患者中甲氨蝶呤的单剂量和多剂量治疗效果。
本临床试验研究对108例选择全身MTX治疗的EP患者进行,分为两组。单剂量组MTX给药一次,首先测量β人绒毛膜促性腺激素(βHCG)水平,然后在第4天和第7天测量。多剂量组在第1、3、5和7天注射1mg/kg MTX。如果βHCG未降低,两组在这些日期后继续给予MTX。两组在1周后评估βHCG水平。随访并记录治疗成功率和并发症,直至治疗后6周。
单剂量和多剂量MTX组的成功率分别为47%和51%。单剂量组MTX水平从2532±1154mIU/mL降至1341±553mIU/mL,多剂量组从2671±2685mIU/mL降至1313±605mIU/mL(P<0.05)。虽然两组随时间均观察到显著下降,但两组之间未发现显著差异(P>0.05)。
单剂量和多剂量方案在治疗成功率方面未显示出显著差异。因此,鉴于较低剂量药物并发症风险较低,选择单剂量方案是安全的。