高强度聚焦超声与子宫动脉栓塞术辅助治疗剖宫产瘢痕妊娠的临床效果比较

Comparative study of clinical efficacy of high-intensity focused ultrasound and uterine artery embolization for adjunctive treatment of cesarean scar pregnancy

目的探讨高强度聚焦超声(HIFU)与子宫动脉栓塞术(UAE)辅助治疗剖宫产瘢痕妊娠(CSP)的临床疗效及安全性。方法选择2014年1月至2016年6月,于西北妇女儿童医院确诊,并且收治入院进行终止妊娠手术的192例CSP患者为研究对象。根据患者自愿选择的辅助治疗方式,将其分为HIFU组(n=102,采取HIFU治疗)及UAE组(n=90,采取UAE治疗)。对2组患者HIFU或UAE治疗后的不良反应发生情况,清宫术术中及术后情况,以及随访期观察项目等计量资料或计数资料,分别采用成组t检验或χ~2检验进行统计学比较。本研究遵循的程序符合2013年修订的《世界医学协会赫尔辛基宣言》要求,所有患者均签署临床研究知情同意书。结果 (1)一般临床资料:2组CSP患者年龄、人体质量指数(BMI)、剖宫产次数、妊娠时间及妊娠囊直径等比较,差异均无统计学意义(P>0.05)。(2)2组CSP患者接受辅助治疗后的发热率,以及清宫手术时间、术中出血量、术后阴道出血持续时间及术后住院时间比较,差异均无统计学意义(P>0.05)。HIFU组患者HIFU治疗后视觉模拟评分(VAS)值及恶心、呕吐发生率[(3.2±0.9)分,7.8%],均低于UAE组患者UAE治疗后[(3.6±0.9)分,22.2%];HIFU组患者住院费用[(16 021±150)元],亦低于UAE组[(20 057±164)元],上述指标比较,差异均有统计学意义(t=3.455,P=0.001;χ~2=7.936,P=0.005;t=177.262,P<0.001)。(3)2组患者清宫术后2周、1个月及3个月的血清hCG阴转率比较,以及术后12个月闭经发生率比较,差异均无统计学差异(P>0.05)。术后3个月及6个月时,HIFU组患者月经量减少发生率(4.9%、5.9%),均显著低于UAE组(17.8%、20.0%),术后12个月内再次妊娠率(29.4%),则显著高于UAE组(15.6%),并且上述指标比较,差异均有统计学意义(χ~2=8.137,P=0.004;χ~2=8.713,P=0.003;χ~2=5.197,P=0.023)。结论采取HIFU辅助治疗CSP,与采取UAE具有相同的疗效,但是HIFU导致的不良反应及清宫术后并发症更少,更适宜作为CSP的辅助治疗方法。

Objective To investigate the clinical efficacy and safety of high intensity focused ultrasound （HIFU） and uterine artery embolization （UAE） for adjunctive treatment of cesarean scar pregnancy （CSP）. Methods From January 2014 to June 2016, a total of 192 CSP patients who made the definite diagnosis in the Northwestern Women and Children′s Hospital and were hospitalized for of surgery pregnancy termination, were chosen as research objects. They were divided into HIFU group and UAE group according to the methods of adjunctive treatments of their choice, HIFU group took HIFU （ n =102） adjunctive treatment and UAE group took UAE adjunctive treatment （ n =90）. We used independent-samples t test or chi-square test to compare and analyze the following measurement data or numeration data between two groups： the incidence of adverse reactions after HIFU or UAE treatment, the situations during and after uterine curettage, and the follow-up period observation items.This study was in line with World Medical Association Declaration of Helsinki revised in 2013 and informed contents were obtained from all patients. Results ①There were no significant differences between two groups of patients in general clinical data including patients′ age, body mass index （BMI）, times of cesarean section, pregnancy time and diameter of pregnancy sac （ P 〉0.05）. ②There were no significant differences between two groups of patients in incidence rate of fever after adjunctive treatment, also time of uterine curettage, volume of bleeding during operation, duration of vaginal bleeding after operation and hospital stay after operation （ P 〉0.05）. The visual analogue score （VAS） value and the incidence rate of nausea/vomiting in HIFU group patients after HIFU treatment[（3.2±0.9） scores, 7.8%], were all lower than those in UAE group patients after UAE treatment [（3.6±0.9） scores, 22.2%], the costs of hospitalization in HIFU group [（16 021±150） yuan] was also lower than that in UAE group [（20 057±164） yuan], and all the differences above were statistically significant （ t =3.455, P =0.001; χ 2=7.936, P =0.005; t =177.262, P 〈0.001）. ③There were no significant differences between two groups of patients in serum hCG negative conversion rates at 2 weeks, 1 month, 3 months after operation, respectively, and amenorrhoea rate at 12 months after operation （ P 〉0.05）. After 3 and 6 months of operation, the incidence rates of decreased menstrual of HIFU group patients （4.9%, 5.9%） were lower than those of UAE group （17.8%, 20.0%）, and pregnancy again rate of HIFU group patient within 12 months after operation （29.4%） was higher than that of UAE group （15.6%）, and all the differences above were statistically significant （ χ 2= 8.137, P =0.004; χ 2=8.713, P =0.003; χ 2=5.197, P =0.023）. Conclusions HIFU as an adjunctive treatment of CSP has the same clinical efficacy as UAE, caused less adverse reactions and postoperative complications, and it is more suitable as an adjunctive treatment for CSP.