不同子宫动脉灌注化疗方案加栓塞术治疗异位妊娠临床疗效的随机双盲对照研究  

Two kinds of uterine artery perfusion chemotherapy plus embolization for the treatment of ectopic pregnancy: a single center, randomized, double-blind and controlled study

作　　者：李中华[1] 李晓冰[1] 岳琨[1] 宫卫东[1] 刘振堂[1] 吴智群[1] 

机构地区：[1]第四军医大学唐都医院介入放射科,西安710038

出　　处：《介入放射学杂志》2014年第5期397-401,共5页Journal of Interventional Radiology

摘　　要：目的评估两种不同子宫动脉灌注化疗方案结合栓塞术的临床疗效及安全性。方法采用随机双盲对照研究,将50例确诊异位妊娠患者随机分为对照组[单纯子宫动脉甲氨蝶呤(MTX)灌注化疗栓塞]和治疗组(子宫动脉MTX联合5-FU灌注化疗栓塞)。术后在不同时间观察患者血β-HCG值,临床治愈时间,输卵管通畅率,并对不良事件进行统计,比较分析两组间相关数值的差异。结果两组各有1例患者剔除出组,剩余48例患者中对照组1例治疗失败,总治愈率为97.9%。治疗组和对照组血β-HCG值在治疗方法主效应、与时间交互作用方面的差异无统计学意义(P>0.05),两组时间效应差异有统计学意义(P<0.05)。对照组患者临床治愈时间为(26.74±5.57)d,治疗组为(28.57±5.08)d,组间差异无统计学意义(P>0.05)。对照组术后输卵管通畅率为78.9%,治疗组为76.2%,组间差异无统计学意义(P>0.05)。两组不良事件强度均为轻度,对照组不良事件发生率为26.1%,治疗组为58.3%,差异有统计学意义(P<0.05)。结论两种介入方法具有相同的临床疗效,但对照组不良事件发生率较治疗组低,因此,宜采用单纯MTX灌注化疗栓塞方案治疗异位妊娠。Objective To evaluate the clinical efficacy and safety of two kinds of uterine artery perfusion chemotherapy plus embolization （UACE） in treating ectopic pregnancy （EP）. Methods A single center, randomized, double-blind, controlled clinical trial was carried out at authors hospital. A total of 50 cases of EP patients were randomly and equally divided into the study group （perfusion chemotherapy of MTX and 5-FU plus embolization therapy） and the control group （perfusion chemotherapy of pure MTX plus embolization therapy）. After UACE, the serum β-HCG value, the clinical healing time and the tubal patency rate were determined at different time, and the adverse events were recorded. The results were statistically analyzed by using t test, and X2 test, and the data were compared between the two groups. Results One patient in both groups was excluded from the study. In the remaining 48 patients, one patient of the control group failed to respond the treatment, so the overall cure rate was 97.9%. The differences in the main effect of treatment method and the time interaction of the serum 13- HCG values between the two groups were not statistically significant （P 〉 0.05）, while the difference in the time effect between the two groups was statistically significant （P 〈 0.05）. The clinical healing time of the study group and the control group was （28.57 ± 5.08） days and （26.74 ±5.57） days respectively, and no statistically significant difference existed between the two groups（P 〉 0.05）. The tubal patency rate of the study group and the control group was 76.2% and 78.9% respectively, and no statistically significant difference existed between the two groups （P 〉 0.05）.The adverse events in both groups were mild, and the occurrence of the adverse events in the study group and the control group was58.3% and 26.1% respectively, and the difference between the two groups was statistically significant （P 〈 0.05）. Conclusion Two kinds of interventional methods have the same

关 键 词：异位妊娠 子宫动脉灌注化疗栓塞术 甲氨蝶呤 氟尿嘧啶 

分 类 号：R714.22[医药卫生—妇产科学]