输卵管再通术联合碘油灌注的随机对照研究

Fallopian tube recanalization plus lipiodol perfusion versus simple fallopian tube recanalization for tubal infertility:a randomized controlled study

目的对比输卵管再通术(FTR)联合碘油灌注与常规FTR的疗效差异。方法选取2019年1月至2019年3月因输卵管不孕在南京医科大学附属妇产医院行FTR治疗的60例育龄患者,将其随机分为碘油灌注组(30例)和常规再通组(30例)。常规再通组在输卵管疏通完成后向输卵管腔内注入地塞米松、糜蛋白酶和胎盘组织液防止粘连,并于次月行输卵管通液1次,通液1个月后备孕;碘油灌注组将防粘连药物加入碘油制成乳剂后注入输卵管,次月不通液直接备孕,其余操作同常规再通组。随访期为12个月,比较两组患者妊娠率、治疗后妊娠所需时间、输卵管妊娠率、自然流产率以及输卵管通畅度维持情况(未妊娠者)。结果两组患者基线指标及术前输卵管通畅程度差异无统计学意义(P>0.05)。碘油灌注组患者妊娠率高于常规再通组、输卵管妊娠率低于常规再通组,在未能妊娠的患者中维持输卵管通畅的比例高于常规再通组,妊娠所需时间短于常规再通组,差异均有统计学意义(P<0.05)。而两组患者自然流产率差异无统计学意义(P>0.05)。结论FTR联合碘油灌注可提高妊娠率,缩短术后妊娠所需时间,降低输卵管妊娠发生率,并延长输卵管维持通畅时间。该方案操作简便,不良反应发生率低,且不增加技术难度和硬件要求,在具备FTR开展条件的各级医疗机构中均可推广。

Objective To compare the therapeutic effect of fallopian tube recanalization(FTR)plus lipiodol perfusion with that of simple FTR in treating tubal infertility.Methods A total of 60 childbearingaged women with tubal infertility,who were admitted to the Affiliated Hospital of Gynecology and Obstetrics of Nanjing Medical University of China to receive FTR during the period from January 2019 to March 2019,were enrolled in this study.The patients were randomly divided into lipiodol perfusion group(n=30)and routine FTR group(n=30).For the patients of routine FTR group,FTR was carried out first,which was followed by injection of dexamethasone,chymotrypsin and placental tissue fluid in tubal lumen to prevent adhesion and in the next month tubal patent test by liquid instillation was performed once,and after one month the patient became ready for pregnancy.For the patients of lipiodol perfusion group,FTR was performed first,which was followed by injection of lipiodol mixed with anti-adhesion drugs(i.e.dexamethasone,chymotrypsin and placental tissue fluid),in the next month the patient didn’t receive tubal patent test by liquid instillation and was directly ready for pregnancy.All patients were followed up for 12 months.The pregnancy rate,the time interval between treatment and obtaining a successful pregnancy,tubal pregnancy rate,spontaneous abortion rate and the maintenance of tubal patency(in patients having no pregnancy)were compared between the two groups.Results There were no statistically significant differences in the values of preoperative baseline indexes and the degree of tubal patency between the two groups(P>0.05).The pregnancy rate in lipiodol perfusion group was higher than that in routine FTR group,and the incidence of tubal pregnancy in lipiodol perfusion group was lower than that in routine FTR group.In the patients who were unable to get pregnancy,the proportion of unobstructed fallopian tube in lipiodol perfusion group was higher than that in routine FTR group,and the time interval between treatment and obtaining a successful pregnancy in lipiodol perfusion group was shorter than that in routine FTR group,these differences were statistically significant(P<0.05).No statistically significant difference in spontaneous abortion rate existed between the two groups(P>0.05).Conclusion FTR combined with lipiodol perfusion can improve the pregnancy rate,shorten the time interval between treatment and obtaining a successful pregnancy,reduce the incidence of tubal pregnancy,and prolong the time of tubal patency.This method is easy to operate with low incidence of adverse reactions,in addition,it doesn’t increase the technical difficulties and hardware requirements.Therefore,this technique can be popularized in all levels of medical institutions where FTR procedure is able to be conducted.(J Intervent Radiol,2021,30:719-723)