A Single Center, Randomized, Double-blind, Controlled Study On Two Kinds Of Uterine Artery Perfusion Chemotherapy And Embolization In The Treatment Of Ectopic Pregnancy

Background：Ectopic pregnancy (EP) is one of the common diseases of Obstetrics and Gynecology, theincidence rate of about2%of all the total number of pregnancies, and showing a risingtrend year by year, secondary infertility about30%of patients will occur EP can occur inthe fallopian tubes, ovaries, uterine incision scar, abdominal, cervical and uterine horn andother patrs，of which95%occur in the fallopian tube. Because of life-threatening bleedingoften occurs, and therefore is one of the acute abdomen requiring emergency treatment. Inrecent years, uterine artery chemoembolization (UACE) with many advantages such as itssafe, effective, low side effect, maximize the retention of the fallopian tubes intactanatomy，thereby saving fetrility，increasingly widely used in the treatment of ERMethotrexate (MIX) and5-Fluorouracil (5-FU) are the most commonly used drugs in thetreatment EP using the UACE. Efficacy of the two drugs treatment of ectopic pregnancyare reliable, but also have some side effects. Methods and indications are lack of uniformstandards in the treatment EP with UACE. Whether it is necessary MIX and5-FU for usein combination, is a clinical problem to be solved. There are also some foreign literaturesin this discussion, but all non-randomized, double-blind controlled study. For this reason, we designed this clinical tiral, the purpose is to evaluate the efficacy and safety of twokinds of UACE in the treatment of ERObjective:To evaluate the efficacy and safety of two kinds of UACE in the treatment of ERMethods:A single center, randomized, double-blind, controlled clinical trial was carried out. Atotal of50cases of EP patients were randomly divided into the treatment group (perfusionchemotherapy with MIX and5-FU and embolization) or the control group(perfusionchemotherapy with MIX and embolization) and were treated with two kinds uterine arteryperfusion chemotherapy and embolization. The primary eiffcacy endpoints were the serump-HCG value，the clinical healing time, the tubal patency rate after UACE. The adverseevents were recorded. Analysis of covariance，analysis of variance for repeated2measurement data, t test, and/test were used for statistical analysis.Results:The differences between the two groups of serum p-HCG values on the main effect oftreatment method and time interaction were not statistically significant. The difference oftime effect of the two group was statistically significant.There was no significantdifference between control group (26.74土5.57d) and treatment group (28.57土5.08d) onthe clinical healing time. There was no significant difference between control group(78.9%) and treatment group (76.2%) on the tubal patency rate. Two groups ofpostoperative adverse events were mild，there was significant difference between controlgroup (26.1%) and treatment group (58.3%) on the incidence of adverse events.Conclusion:Two kinds of intervention methods have the same clinical curative effect, however,the incidence of adverse events of control group is lower than treatment group. Werecommend using a signal MIX perfusion chemotherapy and embolization in thetreatment of ectopic pregnancy.