Volume 27, Issue 5 (7-2020)                   RJMS 2020, 27(5): 12-21 | Back to browse issues page

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Farzaneh F, Mohammadzadeh M, Bandehei T. Evaluation of Methotrexate efficacy in ectopic pregnancy. RJMS 2020; 27 (5) :12-21
URL: http://rjms.iums.ac.ir/article-1-5882-en.html
, farahnaz1826@yahoo.com
Abstract:   (4507 Views)
Background: Ectopic pregnancy (EP) is the most common cause of death in pregnant women in the first trimester of pregnancy and causes 10% of maternal mortality.  It is a common complication in the world and its prevalence varies in different countries. Only one-third of women, who have had an ectopic pregnancy with tubal rupture, can have live birth in the future. Ectopic pregnancy treatment depends on the patient's clinical condition and desire to maintain fertility in the future. Early diagnosis and treatment of Ectopic pregnancy has been associated with a reduction in female mortality and has shifted treatment to conservative methods. In vitro evaluation, low levels of BHCG are the cornerstone of the diagnosis of EP. Immunological examination of HCG with a sensitivity of 25 mIU/ml is an accurate test for ectopic pregnancy. The standard treatment for EP is laparoscopic surgery and in cases of hemodynamic instability or in cases where the laparoscopic method is difficult, laparotomy is performed. The most widely used drug for medical treatment is methotrexate, which is used in a single-dose or multi-dose method with specific criteria. For the first time, Tanka et al. Introduced EP treatment using methotrexate (a folic acid analog). Methotrexate is a folic acid analog that inhibits the function of dihydrofolate reductase and inhibits DNA production. Methotrexate actively affects growing cells such as trophoblastic tissue, malignant cells, bone marrow, intestinal mucosa, and respiratory epithelium. This drug is widely used in the treatment of trophoblastic diseases. Initially, methotrexate was applied topically to residual trophoblastic tissue following ectopic pregnancy. About 35% of patients with ectopic pregnancies are candidates for initial treatment with methotrexate. In cases of stable ectopic pregnancy after surgery, the use of this drug is also indicated.  Medical treatment is considered due to less damage to the tube, lower cost, increasing in fertility, elimination of surgical complications and anesthesia. Medical treatment for ectopic pregnancy with methotrexate is both harmless and effective; But it cannot be used in all patients. According to the recommendations of the American School of Midwifery and Gynecology, methotrexate can be prescribed in patients with proven ectopic pregnancy or, most likely, in patients with stable hemodynamic conditions and in the absence of evidence of rupture. Patients who cannot complete the follow-up period after drug administration should not be a candidate for medical treatment. Due to the relatively high prevalence of ectopic pregnancy and its potential side effects, in this study we aimed to evaluate the efficacy of methotrexate in ectopic pregnancy patients.
Methods: In this descriptive-analytical-cross-sectional study, all pregnant women with ectopic pregnancies admitted to the gynecology ward of Ali Ibn-e Abitaleb Hospital of Zahedan in 2017 according to IR.ZAUMS.REC.1397.2120 ethics code were examined.
Inclusion criteria included, diagnosis of ectopic pregnancy based on transvaginal ultrasound and B HCG titration and treatment with methotrexate for   ectopic pregnancy and exclusion criteria included receiving surgical as the first step in treatment of ectopic pregnancy. 169 cases that were performed during a one-year period with easy and accessible sampling to review patients' medical records.
In this study, the aim of this study was to evaluate the efficacy of single-dose methotrexate in patients with ectopic pregnancies, response to treatment with methotrexate and the need for surgery. 169 patients who were initially treated with single-dose methotrexate ampoules at a dose of 50-100 mg based on the patient's weight with a diagnosis of ectopic pregnancy in the gynecology ward and were followed on days 4, 7, 11of methotrexate injection    by BHCG test (the decision for the next doses of methotrexate was made based on the test results) was extracted from the archive of Ali Ibn-e Abitaleb hospital and the necessary data were recorded in the information form. Finally, the obtained data were entered into SPSS software for statistical analysis. To describe the data, descriptive statistics including statistical tables and graphs, frequency in percentages and central index such as middle and view were used.
Results: The total number of reviewed cases was 169, of which 114 (67.5%) responded to methotrexate treatment and 55 (32.5%) did not respond to treatment. According to the test results, there is a significant difference between these two groups (p<0.001).     
The mean gestational age in patients who responded to methotrexate at the time of diagnosis of ectopic pregnancy was (5.91±2.55 weeks) also the mean gestational age in patients who did not respond to treatment (8.89±2.63 weeks). According to the test results, a significant difference (p<0.001) was observed between the two groups, which indicates that the younger gestational age response to the treatment.
 The mean mass volume   in patients who responded to methotrexate treatment was (1.76±0.60), also the mean mass volume in patients who did not respond to treatment (2.73±1.12), there is a significant difference between the two groups p<0.001. Also, according to the result of Spearman test (R=-0.40), this relationship is inversely and significantly with moderate correlation.
 The initial BHCG value in the group that responded to treatment was 10341.49±25848.08 while in the non-response group, was 19895.73±40235.31. The result of the statistical test din not showed a significant difference.
In these two groups (p=0.11).
The final BHCG in the responsed group was equal to (850.68±957), and in the non-responder group was equal (31959.12±49380.37). The test results show a statistically significant difference (p<0.001) between the two groups. Due to the higher BHCG in the non-responder group and the low BHCG in the treated group, the numbers will be predictable. This study also showed that there is a direct and potential relationship between the final BHCG value and the therapeutic response to methotrexate.
Conclusion:  In general, in the present study, methotrexate therapy shows a significant and logical response. Also, the factors of gestational age at the time of diagnosis, the initial and final HCG β values, as well as the volume of the observed mass   able to affect the   treatment in the study.
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Type of Study: Research | Subject: Gynecology

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